<PAGE>
AS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION ON OCTOBER 3, 1996
SEC REGISTRATION NO. 333-09011
- --------------------------------------------------------------------------------
- --------------------------------------------------------------------------------
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
--------------------------
PRE-EFFECTIVE AMENDMENT NO. 3
TO
FORM S-2
REGISTRATION STATEMENT
UNDER THE SECURITIES ACT OF 1933
------------------------
ACCUMED INTERNATIONAL, INC.
(Exact name of registrant as specified in its charter)
------------------------------
<TABLE>
<S> <C> <C>
DELAWARE 2835 36-4054899
(State or other jurisdiction (Primary Standard Industrial (I.R.S. Employer
of Classification Code Number) Identification
incorporation or organization) No.)
</TABLE>
--------------------------
900 NORTH FRANKLIN STREET, SUITE 401
CHICAGO, ILLINOIS 60610
(312) 642-9200
(Address and Telephone Number of Registrant's Principal Executive Offices)
------------------------------
PETER P. GOMBRICH
CHIEF EXECUTIVE OFFICER
ACCUMED INTERNATIONAL, INC.
900 NORTH FRANKLIN STREET, SUITE 401
CHICAGO, ILLINOIS 60610
(312) 642-9200
(Name, Address, and Telephone Number, of Agent for Service)
------------------------------
COPIES TO:
<TABLE>
<S> <C>
GILLES S. ATTIA, ESQ.
KEVIN A. COYLE, ESQ. CHARLES W. MULANEY, JR., ESQ.
GRAHAM & JAMES LLP SKADDEN, ARPS, SLATE, MEAGHER & FLOM
400 CAPITOL MALL, SUITE 2400 333 WEST WACKER DRIVE, SUITE 2100
SACRAMENTO, CALIFORNIA 95814 CHICAGO, ILLINOIS 60606
FACSIMILE: (916) 441-6700 FACSIMILE: (312) 407-0411
TELEPHONE: (916) 558-6700 TELEPHONE: (312) 407-0700
</TABLE>
Approximate date of commencement of proposed sale to the public: as soon as
practicable on or after the effective date of this Registration Statement.
If any of the securities being registered on this form are to be offered on
a delayed or continuous basis pursuant to Rule 415 under the Securities Act of
1933, check the following box. [ ]
If the registrant elects to deliver its latest annual report to
security-holders, or a complete and legible facsimile thereof, pursuant to Item
11(a)(1) of this form, check the following box. [ ]
If this Form is filed to register additional securities for an offering
pursuant to Rule 462(b) under the Securities Act, please check the following box
and list the Securities Act registration statement number of the earlier
effective registration statement for the same offering. [ ]
If this Form is a post-effective amendment filed pursuant to Rule 462(c)
under the Securities Act, check the following box and list the Securities Act
registration statement number of the earlier effective registration statement
for the same offering. [ ] ________
If delivery of the prospectus is expected to be made pursuant to Rule 434,
please check the following box. [ ]
THE REGISTRANT HEREBY AMENDS THIS REGISTRATION STATEMENT ON SUCH DATE OR
DATES AS MAY BE NECESSARY TO DELAY ITS EFFECTIVE DATE UNTIL THE REGISTRANT SHALL
FILE A FURTHER AMENDMENT WHICH SPECIFICALLY STATES THAT THE REGISTRATION
STATEMENT SHALL THEREAFTER BECOME EFFECTIVE IN ACCORDANCE WITH SECTION 8(a) OF
THE SECURITIES ACT OF 1933 OR UNTIL THE REGISTRATION STATEMENT SHALL BECOME
EFFECTIVE ON SUCH DATE AS THE COMMISSION, ACTING PURSUANT TO SAID SECTION 8(a),
MAY DETERMINE.
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<PAGE>
PROSPECTUS
3,000,000 SHARES
[LOGO]
COMMON STOCK
All of the 3,000,000 shares of Common Stock offered hereby (the "Offering")
are being sold by AccuMed International, Inc. ("AccuMed" or the "Company"). The
Company's Common Stock is quoted on the Nasdaq Market under the symbol "ACMI."
The Common Stock has been approved for quotation on the Nasdaq National Market
under the symbol "ACMI," subject to commencement of the Offering. On October 2,
1996, the last reported sale price for the Common Stock on the Nasdaq Market was
$4.63 per share. See "Price Range of Common Stock."
THE COMMON STOCK OFFERED HEREBY INVOLVES A HIGH DEGREE OF RISK. SEE "RISK
FACTORS," BEGINNING ON PAGE 6.
THESE SECURITIES HAVE NOT BEEN APPROVED OR DISAPPROVED BY THE SECURITIES
AND EXCHANGE COMMISSION OR ANY STATE SECURITIES COMMISSION NOR
HAS THE SECURITIES AND EXCHANGE COMMISSION OR ANY STATE
SECURITIES COMMISSION PASSED UPON THE ACCURACY OR
ADEQUACY OF THIS PROSPECTUS. ANY REPRESENTATION
TO THE CONTRARY IS A CRIMINAL OFFENSE.
<TABLE>
<CAPTION>
UNDERWRITING
DISCOUNTS AND PROCEEDS TO
PRICE TO PUBLIC COMMISSIONS (1) COMPANY (2)
Per Share..................................... $4.50 $0.315 $4.185
<S> <C> <C> <C>
Total(3)...................................... $13,500,000 $945,000 $12,555,000
</TABLE>
(1) The Company has agreed to indemnify the Underwriters against certain
liabilities, including liabilities under the Securities Act of 1933, as
amended. See "Underwriting."
(2) Before deducting expenses of the Offering payable by the Company, estimated
at $835,850.
(3) The Company has granted the Underwriters a 30-day option to purchase up to
an aggregate of 450,000 additional shares of Common Stock on the same terms
and conditions set forth above, solely to cover over-allotments, if any. If
such option is exercised in full, the total Price to Public, Underwriting
Discounts and Commissions and Proceeds to Company will be $15,525,000,
$1,086,750 and $14,438,250, respectively. See "Underwriting."
--------------------------
The shares of Common Stock offered by the Underwriters are subject to prior
sale, receipt and acceptance by them and subject to the right of the
Underwriters to reject any order in whole or in part and certain other
conditions. It is expected that delivery of such shares will be made in New
York, New York on or about October 8, 1996.
------------------------
Vector Securities International, Inc. Tucker Anthony
Incorporated
OCTOBER 3, 1996
<PAGE>
[GRAPHIC]
The graphic consists of two photographs. The first photograph is of the
TracCell-TM- 2000 automated specimen maping workstation along with the caption
"TracCell-TM- automated specimen maping workstation (pictured right), currently
in development."
The second photograph is of the AcCell-TM- 2001 automated slide-handling and
microscopy workstation along with the caption "AcCell-TM- 2001 automated
slide-handling and microscopy workstation (pictured left)."
The TracCell 2000 has not been approved by the United States Food and Drug
Administration (the "FDA") or any other regulatory authority for sale in the
United States or elsewhere in the world. There can be no assurance that the
TracCell 2000 will be approved by the FDA or any foreign regulatory authority on
a timely basis, if ever. See "Risk Factors -- Government Regulation."
The following are trade names and trademarks of the Company used in this
Prospectus: the "Alamar" logo and name, alamarBlue-TM-, AccuMed, Inc., AccuMed
International, Inc., the "AccuMed" logo and name, AcCell-TM-, TracCell-TM-,
MacroVision-TM-, Sensititre-Registered Trademark-, SensiTouch-TM-, ARIS-TM-,
AutoReader-TM-, AutoInnoculator-TM- Relational Cytopathology Reference Guide-TM-
and FluoreTone-TM- 48. This Prospectus also contains trademarks of other
companies.
--------------------------
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
Certain statements under the captions "Prospectus Summary," "Risk Factors,"
"Use of Proceeds," "Management's Discussion and Analysis of Financial Condition
and Results of Operations" and "Business" and elsewhere in this Prospectus
constitute "forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995 (the "Reform Act"). Such
forward-looking statements involve known and unknown risks, uncertainties and
other factors which may cause the actual results, performance or achievements of
the Company, or industry results, to be materially different from any future
results, performance or achievements expressed or implied by such
forward-looking statements. Such factors include, among other things, the
following: the Company's history of losses and uncertainty of profitability; the
uncertainty of market acceptance of the Company's products; the Company's
limited sales, marketing and distribution experience and dependence on
distributors; the Company's highly competitive industry and rapid technological
change within such industry; the Company's ability to obtain rights to
technology and obtain and enforce patents and other proprietary rights; the
Company's ability to commercialize and manufacture products; the results of
clinical studies; the results of the Company's research and development
activities; the business
2
<PAGE>
abilities and judgment of the Company's personnel; the availability of qualified
personnel; changes in, or failure to comply with, governmental regulations; the
ability to obtain adequate financing in the future; general and business
conditions; and other factors referenced in this Prospectus. See "Risk Factors."
IN CONNECTION WITH THE OFFERING, THE UNDERWRITERS MAY OVER-ALLOT OR EFFECT
TRANSACTIONS WHICH STABILIZE OR MAINTAIN THE MARKET PRICE OF THE COMMON STOCK OF
THE COMPANY AT A LEVEL ABOVE THAT WHICH MIGHT OTHERWISE PREVAIL IN THE OPEN
MARKET. SUCH STABILIZING, IF COMMENCED, MAY BE DISCONTINUED AT ANY TIME.
3
<PAGE>
PROSPECTUS SUMMARY
THE FOLLOWING SUMMARY IS QUALIFIED IN ITS ENTIRETY BY THE MORE DETAILED
INFORMATION AND FINANCIAL STATEMENTS APPEARING ELSEWHERE IN THIS PROSPECTUS,
INCLUDING INFORMATION UNDER "RISK FACTORS." EXCEPT AS OTHERWISE NOTED, ALL
INFORMATION IN THIS PROSPECTUS, INCLUDING FINANCIAL INFORMATION AND SHARE AND
PER SHARE DATA, ASSUMES NO EXERCISE OF THE UNDERWRITERS' OVER-ALLOTMENT OPTION.
SEE "UNDERWRITING." SPECIAL NOTE: CERTAIN STATEMENTS SET FORTH BELOW CONSTITUTE
"FORWARD-LOOKING STATEMENTS" WITHIN THE MEANING OF THE REFORM ACT. SEE "SPECIAL
NOTE REGARDING FORWARD-LOOKING STATEMENTS" ON PAGE 2 FOR ADDITIONAL FACTORS
RELATING TO SUCH STATEMENTS.
THE COMPANY
AccuMed designs, manufactures and markets diagnostic screening products for
clinical diagnostic laboratories serving the cytopathology and microbiology
markets. The Company's primary focus is on the development of cytopathology
products that support the review and analysis of Pap smears in order to improve
the quality of cell analysis and increase accuracy and productivity in the
laboratory. The Company commenced sales of its initial cytopathology product,
the AcCell-TM- Series 2000 automated slide handling and microscopy workstation,
at the end of the first quarter of 1996. The Company is currently testing a
prototype specimen mapping workstation, the TracCell-TM- 2000, which
automatically pre-screens Pap smear slides to identify and create a computerized
map of empty space and certain non-clinically relevant portions of the specimen
to permit a more efficient analysis of the test slide. The Company expects to
file a 510(k) pre-market notification with the FDA for the TracCell 2000 by the
end of 1996. The Company has recently entered into an agreement with Olympus
America Inc. ("Olympus America"), a leading supplier of microscopes to the
cytopathology market, pursuant to which Olympus America has exclusive third
party distribution rights to the AcCell Series 2000 and, if successfully
developed and cleared for marketing by the FDA and other applicable regulatory
authorities, the TracCell 2000 in North, Central and South America.
An estimated 440,000 new cases of cervical cancer are reported annually
worldwide. The American Cancer Society estimates that, in the United States in
1996, 15,700 women will be diagnosed with invasive cervical cancer and 4,900
women will die of cervical cancer. Furthermore, in 1996, an estimated 65,000
American women will be diagnosed with cervical carcinoma IN SITU, a precancerous
condition. However, virtually all cervical cancer cases can be effectively
treated with timely intervention if detected early. The Pap smear is currently
the most widely-used screening test for early detection of cervical cancer and
related precancerous conditions. It is estimated that in 1996 over 150 million
Pap smear specimens will be screened worldwide, including over 50 million in the
United States. According to the American Cancer Society, widespread and regular
use of the Pap smear as a screening test is believed to have contributed to a
greater than 70% decrease in mortality from cervical cancer in the United States
in the past 45 years.
Initial Pap smear testing is performed by specially trained professionals
known as cytotechnologists, who use a microscope to screen and interpret up to
100 Pap smear slides per day. In general, this process is complex and tedious,
and is prone to error. Over 90% of specimens reviewed are negative. Even non-
negative specimens may contain only 20 to 30 abnormal cells out of a total of as
many as 50,000 to 300,000 cells on the slide. As a result, slide interpretation
errors can be caused by fatigue of the cytotechnologist and the habituation
effect of constantly viewing predominantly negative specimens. According to the
JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, clinical laboratories generally
experience false negative Pap smear diagnosis rates of 5% to 30%. In addition,
conventional Pap smear testing is subject to administrative errors and exposes
clinical laboratories to the risk of litigation and consequent liability.
The Company's cytopathology products are intended to provide cost-effective
solutions to many of the problems of conventional Pap smear testing without
significantly modifying existing laboratory practices. The Company's AcCell
Series 2000 workstation is an interactive computer-controlled slide handling and
precision microscopy workstation that is supported with a comprehensive data
management system. The TracCell 2000, currently under development, is designed
to automatically pre-screen Pap smear slides to identify and create a
computerized map of empty space and certain non-clinically relevant material.
Tests conducted by the Company suggest that the TracCell 2000, by locating and
mapping such empty space and non-clinically relevant material, can eliminate 15%
to 50% of the slide area required to be reviewed by a cytotechnologist. The
Company believes that the AcCell Series 2000 and the TracCell 2000 have the
potential to reduce cytotechnologist fatigue and habituation, reduce the time
needed to evaluate specimens, and allow the cytotechnologist to focus on more
thoroughly evaluating potential abnormalities. The Company is also developing
software and hardware for a second generation, fully automated, high volume
mapping product, the TracCell 3000, and is developing a series of related
educational and testing products. There can be no assurance that any such
products will be successfully developed or marketed.
The Company also develops, manufactures and markets IN VITRO diagnostic
microbiology products for the clinical laboratory, veterinary and pharmaceutical
markets. The Company offers the microbiology laboratory a variety of FDA-cleared
products, under the trade name Sensititre-Registered Trademark-, for the minimum
inhibitory concentration and identification ("MIC/ID") testing of bacteria
suspected of causing infections
3
<PAGE>
and for measuring the susceptibility of such bacteria to different types and
concentrations of antibiotics. In September 1996, the Company entered into an
agreement with Fisher Scientific Company, a leading distributor of clinical
laboratory products, operating through its Curtin Matheson Scientific Division
("CMS"), pursuant to which CMS has been granted exclusive rights to distribute
the Company's microbiology products marketed under the Sensititre trade name in
the United States. AccuMed's microbiology products include disposable test kits
and a range of automated instruments. The Company also markets alamarBlue-TM-, a
proprietary, non-toxic indicator reagent that measures cell growth for IN VITRO
testing. The Company is developing an automated instrument designed to read the
results of a Kirby-Bauer method susceptibility test (the "KB Reader") and,
pursuant to an agreement with RADCO Ventures, Inc. ("RADCO"), a joint-venture
formed by the Company and certain investors, is developing the FluoreTone-TM-
48, a diagnostic microbiology test panel and an automated reading instrument.
There can be no assurance that any such products will be successfully developed
or marketed.
AccuMed's objective is to establish the AcCell Series 2000 and the TracCell
2000 as the leading microscopy workstations for the primary screening and
analysis of cytology specimens while developing other new cytopathology and
microbiology products. The key elements of the Company's strategy include: (i)
establishing the AcCell Series 2000 and, if cleared for marketing by the FDA and
other applicable regulatory authorities, the TracCell 2000 in the worldwide Pap
smear screening market through distribution agreements and strategic alliances
with major market participants, (ii) exploiting other applications for the
Company's cytopathology technology such as histology and pathology laboratory
work, (iii) continuing to acquire, develop and enhance technologies that
complement the Company's existing technology base and (iv) integrating the
Company's proprietary microbiology technologies into new products.
In August 1996, the Company entered into definitive agreements to acquire a
two-thirds equity interest in Oncometrics Imaging Corp. ("Oncometrics") for
aggregate consideration of $4.0 million in cash (the "Oncometrics Acquisition").
Of such consideration, $2.0 million is to be paid to Oncometrics' parent
company, Xillix Technologies Corp. ("Xillix"), for currently outstanding
Oncometrics stock and $2.0 million is to be paid to Oncometrics for newly issued
Oncometrics stock. Oncometrics is developing an automated instrument designed to
capture and analyze images from microscope slides that have been stained using
Oncometrics' proprietary staining method. Prototypes of the Oncometrics
instrument have been developed which are capable of isolating small variations
in cell nucleus DNA, which can assist the cytotechnologist in detecting lung
cancer in an early stage of development. The Company believes that the
Oncometrics technology may potentially have applications in the early detection
of cervical cancer as well. In August 1996, the Company also entered into a
definitive agreement to acquire the outstanding shares of common stock of RADCO
and retire approximately $1.2 million in aggregate principal amount of certain
promissory notes sold by RADCO to its initial investors (the "RADCO Notes") at
an aggregate cost to the Company of approximately $1.4 million in cash (the
"RADCO Acquisition"). Such acquisitions are contingent upon, among other things,
consummation of the Offering and, with respect to the Oncometrics Acquisition,
negotiation and execution of related shareholder and operating agreements. As
such, there can be no assurance that such acquisitions will be completed. See
"Use of Proceeds," "Business -- Cytopathology -- Potential Acquisition of
Interest in Oncometrics" and "-- Microbiology -- Potential Acquisition of
RADCO."
BACKGROUND
The Company was incorporated in California in June 1988 under the name
Alamar Biosciences, Inc. Prior to December 29, 1995, the Company was engaged in
developing, manufacturing and marketing microbiology products, including
alamarBlue and certain diagnostic test kits under the name Alamar. AccuMed,
Inc., an Illinois corporation, was formed in February 1994 and was engaged in
researching and developing cytopathology products. Effective January 1995,
AccuMed, Inc. acquired the Sensititre microbiology business by purchasing
certain assets of a division of Radiometer America, Inc. and purchasing from
Radiometer (UK) Limited all of the shares of Sensititre Limited, an English
registry company (renamed AccuMed International Limited, "Sensititre," and
collectively, such businesses are referred to as "AccuMed, Inc."). On December
29, 1995, AccuMed, Inc. merged with and into the Company (the "Merger"). The
Company then changed its name to AccuMed International, Inc., reincorporated
under Delaware law and changed its fiscal year end from September 30 to December
31. The Company is currently seeking to enter into an agreement pursuant to
which a third party would manufacture the Company's Alamar microbiology
products, other than alamarBlue. However, there can be no assurance that such an
agreement can be reached. If such an agreement is not reached, the Company
intends to cease manufacturing such products.
The Company's principal executive offices are located at 900 North Franklin
Street, Suite 401, Chicago, Illinois 60610, and its telephone number is (312)
642-9200.
4
<PAGE>
THE OFFERING
<TABLE>
<CAPTION>
Common Stock offered............................. 3,000,000 shares
<S> <C>
Common Stock to be outstanding after the 21,934,710 shares (1)
Offering........................................
Use of proceeds.................................. To fund product research and
development; scale-up of manufacturing;
the Oncometrics Acquisition; the RADCO
Acquisition; and working capital and
general corporate purposes, including
reduction in accounts payable. See "Use
of Proceeds."
Nasdaq National Market symbol.................... ACMI
</TABLE>
SUMMARY CONSOLIDATED FINANCIAL DATA
(IN THOUSANDS, EXCEPT PER SHARE DATA)
<TABLE>
<CAPTION>
THREE MONTH
FISCAL TRANSITION SIX MONTHS ENDED
YEAR ENDED PERIOD ENDED JUNE 30, 1996
SEPTEMBER 30, 1995 DECEMBER 31, 1995 -----------------------------------
PRO FORMA (2) PRO FORMA (2) ACTUAL PRO FORMA (2)
------------------- ------------------ ---------------- ----------------
<S> <C> <C> <C> <C>
STATEMENT OF OPERATIONS DATA:
Sales............................................ $ 4,144 $ 1,184 $ 2,312 $ 2,318
Operating loss.................................. (7,056) (7,060)(3) (6,576)(3) (7,147)(3)
Net loss........................................ (6,740) (7,077) (4,459) (4,858)
Net loss per common share....................... (0.69) (0.60) (0.27) (0.30)
Weighted average common shares outstanding...... 9,832 11,743 16,319 16,319
</TABLE>
<TABLE>
<CAPTION>
JUNE 30, 1996
----------------------------
DECEMBER 31, PRO FORMA
1995 ACTUAL AS ADJUSTED (4)
------------- ----------- ---------------
<S> <C> <C> <C>
BALANCE SHEET DATA:
Working capital (deficit)............................................ $ (2,459) $ 572 $ 9,717
Total assets........................................................ 5,974 8,720 21,478
Long-term debt, net of current portion (5).......................... 90 45 272
Total stockholders' equity.......................................... 729 5,487 17,207
</TABLE>
- ------------------------------
(1) Based upon shares outstanding at October 1, 1996, of which (i) 940,955
shares are subject to forfeiture if certain specified earnings per share or
stock price performance thresholds are not met during 1997; (ii) 69,308
shares are subject to forfeiture if the Company is unable through August
1997 to perfect and maintain rights free of liens in certain recently
acquired patents; and (iii) 116,000 shares are subject to forfeiture if
certain milestones under a microbiology product development agreement are
not achieved. Excludes: (i) an aggregate of 5,912,605 shares reserved for
issuance upon exercise of warrants outstanding at October 1, 1996 with a
weighted average exercise price of $3.21 per share; (ii) an aggregate of
1,830,138 shares reserved for issuance upon the exercise of stock options
outstanding at October 1, 1996, including options to purchase 283,666 shares
the granting of which is subject to stockholder approval of an amendment
increasing the shares available under the 1995 Stock Option Plan, with a
weighted average exercise price of $3.15 per share; and (iii) an aggregate
of 401,575 shares reserved for issuance upon exercise of options available
for future grant under the Company's stock option plans, including 216,334
shares the reservation of which is subject to stockholder approval of such
amendment. See "Management's Discussion and Analysis of Financial Condition
and Results of Operations," "Management -- Stock Option Plans" and Note 11
and Note 18 of Notes to Consolidated Financial Statements.
(2) Includes the operating results of AccuMed, Inc. and Oncometrics on a pro
forma basis assuming that the Merger and the Oncometrics Acquisition
occurred on October 1, 1994. See "The Company" and Pro Forma Condensed
Combining Financial Statements.
(3) Includes $4.0 million and $3.5 million for the three month transition period
ended December 31, 1995 and six months ended June 30, 1996, respectively,
recorded as a non-cash charge against operations relating to the write-off
of in-process research and development acquired in connection with the
Merger. See "Management's Discussion and Analysis of Financial Condition and
Results of Operations."
(4) Includes the net assets of Oncometrics and RADCO assuming the Oncometrics
Acquisition and the RADCO Acquisition occurred on June 30, 1996. Adjusted to
reflect the receipt and application of the net proceeds from the sale of
3,000,000 shares of Common Stock offered hereby. See "Use of Proceeds" and
"Description of Capital Stock."
(5) Long-term debt consists of capital lease obligations. See Note 13 of Notes
to Consolidated Financial Statements.
5
<PAGE>
RISK FACTORS
AN INVESTMENT IN THE SHARES OF COMMON STOCK OFFERED HEREBY INVOLVES A HIGH
DEGREE OF RISK. PROSPECTIVE INVESTORS SHOULD CAREFULLY CONSIDER THE FOLLOWING
RISK FACTORS, IN ADDITION TO THE OTHER INFORMATION IN THIS PROSPECTUS. SPECIAL
NOTE: CERTAIN STATEMENTS SET FORTH BELOW CONSTITUTE "FORWARD-LOOKING STATEMENTS"
WITHIN THE MEANING OF THE REFORM ACT. SEE "SPECIAL NOTE REGARDING
FORWARD-LOOKING STATEMENTS" ON PAGE 2 FOR ADDITIONAL FACTORS RELATING TO SUCH
STATEMENTS.
LIMITED RELEVANT OPERATING HISTORY; SIGNIFICANT OPERATING LOSSES;
ACCUMULATED DEFICIT; SUBSTANTIAL COSTS OF INTEGRATION AND CONSOLIDATION;
UNCERTAINTY OF PROFITABILITY. The Company was formed in 1988 under the name
Alamar Biosciences, Inc. and was engaged primarily in research and development
of microbiology products based on the alamarBlue technology. Prior to the
Merger, the Company never realized any significant revenues from product sales.
AccuMed, Inc. was incorporated in February 1994 and, effective January 1995,
acquired the Sensititre microbiology business. Until such acquisition, AccuMed,
Inc. had no revenues and operations consisted of a limited amount of
cytopathology research and development. Accordingly, although the Sensititre
business had a significant operating history and revenues from sales, AccuMed,
Inc., as a separate entity, had very limited operating history prior to the
Merger. Upon consummation of the Merger, the operations of the Company and
AccuMed, Inc. were combined, and the Company began to develop, manufacture and
sell both the alamarBlue and the Sensititre microbiology products and recently
began to commercialize certain AccuMed cytopathology products. Thus, the Company
has a limited relevant operating history upon which an evaluation of its
prospects can be made. Such prospects must be considered in light of the risks,
expenses and difficulties frequently encountered in establishing a new business
in a continually evolving industry with an increasing number of market entrants
and intense competition as well as the risks, expenses and difficulties
encountered in the shift from development to commercialization of new products
based on innovative technology.
The Company has incurred significant net operating losses in each fiscal
quarter since its inception. For the fiscal years ended September 30, 1994 and
1995, and for the transition period ended December 31, 1995 and the six months
ended June 30, 1996, the Company's net losses were approximately $3.1 million,
$3.8 million, $5.7 million and $4.5 million, respectively. Losses for the fiscal
years ended September 30, 1994 and 1995 and for the transition period ended
December 31, 1995 relate solely to the Company's operations prior to the Merger.
As of June 30, 1996, the Company had an accumulated deficit of approximately
$27.2 million. Losses are expected to continue for the foreseeable future until
such time, if ever, as the Company is able to attain sales levels sufficient to
support its operations. There can be no assurance that the Company will be able
to implement successfully its operating strategy, generate increased revenues or
ever achieve profitable operations. See "-- Uncertainty of Market Acceptance and
Initial Investment in Cytopathology Products."
UNCERTAINTY OF MARKET ACCEPTANCE AND INITIAL INVESTMENT IN CYTOPATHOLOGY
PRODUCTS. The Company has generated limited revenues from the sale of its
cytopathology products to date. The Company's success, growth and profitability
will depend primarily on market acceptance of the AcCell Series 2000 and the
TracCell 2000, if cleared for marketing by the FDA and other applicable
regulatory authorities, for use in connection with cervical cancer screening by
cytopathology laboratories. Market acceptance will depend on the Company's
ability to demonstrate to such laboratories that the limitations associated with
conventional Pap smear screening and analysis can be cost effectively addressed
by its products. There can be no assurance that the Company can demonstrate that
the high initial cost of equipping existing laboratories with the AcCell Series
2000 and the TracCell 2000, if cleared for marketing, will be offset by a
reduction in costs associated with increased efficiency and decreased
malpractice liability risks resulting from more accurate diagnoses, better data
management capability and better documentation of slide review procedures. The
Company believes that many clinical laboratories offer Pap smear tests at lower
gross margins than other tests in order to receive orders for other, higher
margin, laboratory tests. As a result, clinical laboratories may be reluctant or
unwilling to accept the additional costs related to installing and utilizing the
AcCell Series 2000 and the TracCell 2000. Furthermore, clinical laboratories
have recently been presented with a variety of new products claimed to improve
the cervical cancer
6
<PAGE>
screening process either through changing the slide preparation method,
automating the re-examination or rescreening of conventional specimens
previously diagnosed as negative or rescreening such specimens using reagents to
detect certain RNA/DNA hybrid cells claimed to indicate the presence of cervical
cancer. This proliferation of competing claims, products and approaches to
cervical cancer screening may cause market confusion which could result in a
laboratory maintaining its current equipment and practices or delaying a
decision of whether to purchase the Company's products or a competing product.
See "-- Technological Change and Competition."
LIMITED NUMBER OF CUSTOMERS. Due in part to a recent trend toward
consolidation of clinical laboratories, the Company expects that the number of
potential domestic customers for its cytopathology products will decrease. Due
to the relative size of the largest U.S. laboratories, it is likely that a
significant portion of the sales of the AcCell Series 2000 and the TracCell
2000, if cleared for marketing, will be concentrated among a relatively small
number of customers. In order to promote acceptance in the market, the Company
will need to foster an awareness of and acceptance by these potential customers
of the AcCell Series 2000 and the TracCell 2000 and of the benefits of such
systems over current methods. The Company's dependence on sales to large
laboratories may strengthen the purchasing leverage of these potential
customers. There can be no assurance that the Company will be successful in
selling its products, or that any such sales will result in sufficient revenue
to allow the Company to become profitable.
DELAYED OR UNSUCCESSFUL PRODUCT DEVELOPMENT. The Company's growth and
profitability will depend, in part, upon its ability to complete development of
and successfully introduce new products, including the TracCell 2000. The
Company will likely be required to undertake time-consuming and costly
development activities and seek regulatory approval for new products. There can
be no assurance that the Company will not experience difficulties that could
delay or prevent the successful development, introduction and marketing of new
products, that regulatory clearance or approval of these or any new products
will be granted on a timely basis, if ever, or that the new products will
adequately meet the requirements of the applicable market or achieve market
acceptance. The completion of the development of any of the Company's products
under development remains subject to all the risks associated with the
commercialization of new products based on innovative technologies, including
unanticipated technical or other problems, manufacturing difficulties and the
possible insufficiency of the funds allocated for the completion of such
development, which could result in a change in the design, delay in the
development or the abandonment of such products. Consequently, there can be no
assurance that any of the Company's products under development will be
successfully developed or manufactured or, if developed and manufactured, that
such products will meet price or performance objectives, be developed on a
timely basis or prove to be as effective as competing products. The inability to
successfully complete development of a product or application, or a
determination by the Company, for financial, technical or other reasons, not to
complete development of any product or application, particularly in instances in
which the Company has made significant capital expenditures, could have a
material adverse effect on the Company's business, financial condition and
results of operations and could cause the Company to reassess its business
strategy. Such reassessment could lead to changes in the Company's overall
business plan, including the relative emphasis on current, as well as future,
products. See "-- Government Regulation," "Business -- Cytopathology --
Cytopathology Products" and "-- Microbiology -- Microbiology Products."
LIMITED SALES, MARKETING AND DISTRIBUTION EXPERIENCE; DEPENDENCE ON THIRD
PARTY DISTRIBUTORS. In order for the Company to increase revenues and achieve
profitability, the Company's products, particularly its current and proposed
cytopathology products, must achieve a significant degree of market acceptance.
The Company has only limited experience marketing and selling its cytopathology
products. The Company intends to distribute its cytopathology and microbiology
products primarily through a limited number of distributors. The Company has
only recently entered into its current distribution arrangements. With respect
to cytopathlogy products, the Company has entered into an exclusive, three year
distribution agreement for North, Central and South America (the "Olympus
Territory") with Olympus America. With respect to microbiology products marketed
under the Sensititre trade name, the
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Company has entered into an exclusive, four year distribution agreement for the
United States with CMS. The Company will be required to enter into additional
distribution arrangements in order to achieve broad distribution of its
products. There can be no assurance that the Company will be able to maintain
the distribution arrangements with Olympus America or CMS or that the Company
will be able to enter into and maintain arrangements with additional
distributors on acceptable terms, or on a timely basis, if ever. The Company
will be dependent upon these distributors to assist it in promoting market
acceptance of and demand for its products. In addition, because the Company
intends to rely on a limited number of distributors, sales to these distributors
could account for a significant portion of the Company's revenues. There can be
no assurance that these distributors will devote the resources necessary to
provide effective sales and marketing support to the Company. In addition, the
Company's distributors may give higher priority to the products of other medical
suppliers or their own products, thus reducing their efforts to sell the
Company's products. If any of the Company's distributors becomes unwilling or
unable to promote, market and sell its products, the Company's business,
financial condition and results of operations would be materially adversely
affected. Further, Olympus America is the exclusive distributor of the AcCell
Series 2000 and, if successfully developed and cleared for marketing, the
TracCell 2000 in the Olympus Territory and CMS is the exclusive distributor of
the Sensititre microbiology products in the United States, and other
distributors also may be granted exclusive distribution rights. To the extent
any exclusive distributor fails to adequately promote, market and sell the
Company's products, the Company may not be able to secure a replacement
distributor until after the term of the distribution contract is complete or
until such contract can otherwise be terminated.
TECHNOLOGICAL CHANGE AND COMPETITION. The Company's AcCell Series 2000
currently faces and the TracCell 2000, if successfully developed and cleared for
marketing, will face competition from companies that have developed or may be
developing competing systems. The Company believes that many of the Company's
existing and potential competitors possess substantially greater financial,
marketing, sales, distribution and technical resources than the Company, and
more experience in research and development, clinical trials, regulatory
matters, manufacturing and marketing. The Company is aware of two companies that
currently market imaging systems to re-examine or rescreen conventional Pap
smear specimens previously diagnosed as negative as well as two companies that
are developing devices for the preparation and analysis of Pap smear slides. The
Company is aware that at least one such company has submitted an imaging system
for use as a primary means of screening Pap smear slides under a pre-market
approval application (a "PMA") to the FDA under the United States Food, Drug and
Cosmetic Act (the "FD&C Act"). Another company markets a manual rescreening test
claimed to detect the presence of cervical cancer using reagents to detect
certain RNA/DNA hybrid cells. If any company currently marketing rescreening
products receives FDA clearance or approval for use of its product as a primary
screening system to replace or work in conjunction with conventional Pap smear
screening or if automated analysis systems are developed and receive FDA
clearance or approval, the use of conventional Pap smear screening could be
substantially affected and the Company's business, financial condition and
results of operations could be materially adversely affected.
The market for the Company's current and, if developed, proposed
microbiology products is highly competitive, and the Company competes with
numerous well-established foreign and domestic companies, most of which possess
substantially greater financial, technical, marketing, personnel and other
resources than the Company and have established reputations for success in the
development, sale and service of manual and/or automated IN VITRO diagnostic
testing products. A significant portion of the MIC/ ID testing market in the
United States is controlled by two companies, MicroScan, Inc., a wholly-owned
subsidiary of Dade International, Inc. ("MicroScan"), and bioMerieux Vitek, a
division of bioMerieux, a French company ("bioMerieux Vitek"). Difco
Laboratories, Inc. ("Difco") has been issued a U.S. patent covering technology
related to the alamarBlue technology covered in one of the Company's patents.
There can be no assurance that Difco, which has substantially greater resources
and experience in research, development, manufacturing and marketing than the
Company, will not use its patented technology to develop products that will
compete directly with the Company's microbiology products.
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The medical diagnostics industry is characterized by rapid product
development and technological advances. There can be no assurance that other
technologies or products that are functionally similar to those of the Company
are not currently available or under development, or that other companies with
expertise and resources that would encourage them to attempt to develop and
market competitive products will not develop new products that compete directly
with the Company's products. The Company's products could be rendered obsolete
or uneconomical by the introduction and market acceptance of competing products,
technological advances of the Company's current or potential competitors, or by
other approaches. There can be no assurance that the Company will be able to
compete successfully against current or future competitors or that competition,
including the development and commercialization of new products and technology,
will not have a material adverse effect on the Company's business, financial
condition and results of operations. See "Business -- Competition."
GOVERNMENT REGULATION. The Company's products and manufacturing processes
are regulated by state and federal authorities, including the FDA and comparable
authorities in certain states and other countries. Failure to comply with the
FD&C Act and applicable regulatory requirements can result in, among other
things, civil and criminal fines, product recalls, detentions, seizures,
injunctions and criminal prosecutions.
United States regulatory requirements promulgated under the FD&C Act provide
that many of the Company's products may not be shipped in interstate commerce
without prior authorization from the FDA. Such authorization is based on a
review by the FDA of a product's safety and effectiveness for its intended uses.
Medical devices may be authorized by the FDA for marketing either pursuant to a
pre-market notification under Section 510(k) of the FD&C Act (a "510(k)
Notification") or a PMA under the FD&C Act. The process of obtaining clearances
or approvals from the FDA and other applicable regulatory authorities can be
expensive, uncertain and time consuming, frequently requiring several years from
the commencement of clinical trials or submission of data to the receipt of
regulatory approval.
A 510(k) Notification, among other things, requires an applicant to show
that its products are "substantially equivalent" in terms of safety and
effectiveness to existing products that are currently permitted to be marketed.
An applicant is permitted to begin marketing a product as to which it has
submitted a 510(k) Notification at such time as the FDA issues a written finding
of substantial equivalence. Requests for additional information may delay the
market introduction of certain of an applicant's products and, in practice,
initial clearance of products often takes substantially longer than the FDA pre-
market notification review period of 90 days.
A PMA consists of the submission to the FDA of information sufficient to
establish independently that a device is safe and effective for its intended
use. A PMA must be supported by extensive data, including preclinical and
clinical trial data, as well as extensive literature to prove the safety and
effectiveness of the device. By statute, the FDA is required to respond to a PMA
within 180 days from the date of its submission; however, the approval process
usually takes substantially longer, often as long as several years. During the
review period, the FDA may conduct extensive reviews of the Company's
facilities, deliver multiple requests for additional information and
clarifications and convene advisory panels to assist in its determination.
FDA clearances and approvals, if granted, may include significant
limitations on the intended uses for which a product may be marketed. FDA
enforcement policy strictly prohibits the promotion of cleared or approved
medical devices for non-approved or "off-label" uses. In addition, product
clearances or approvals may be withdrawn for failure to comply with regulatory
standards or the occurrence of unforeseen problems following initial marketing.
Under current interpretation of FDA regulations, marketing of the AcCell
Series 2000 in the United States does not require FDA clearance or approval.
Marketing of the TracCell 2000 in the United States, however, will require
pre-marketing clearance or approval by the FDA. The Company anticipates that
such clearance will be sought through submission to the FDA of a 510(k)
Notification rather than a PMA. The Company is currently conducting the required
testing of the TracCell 2000 and expects to submit a 510(k) Notification with
respect to the TracCell 2000 by the end of 1996. There can be no assurance that
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the Company will successfully complete the necessary testing on a timely basis,
if ever, that a 510(k) Notification with respect to the TracCell 2000 will be
submitted to the FDA by the end of 1996, if ever, or that the FDA will clear the
TracCell 2000 for marketing in the United States on a timely basis, if ever. It
is also possible that the FDA could require a PMA for the TracCell 2000, which
would result in significant delays in bringing the TracCell 2000 to the U.S.
market and could have a material adverse effect on the Company's business,
financial condition and results of operations.
Under current interpretation of FDA regulations, marketing of the Company's
MIC/ID microbiology products in the United States requires FDA clearance through
the 510(k) Notification process. With respect to the Company's MIC/ID testing
products, 510(k) Notifications must be filed and cleared with respect to each
antibiotic used. The Company may submit applications to add individual
antibiotics to those previously cleared as the market warrants. However, there
can be no assurance that clearances will continue to be obtained or that
obtained clearances will not be withdrawn.
At the current time, alamarBlue is marketed for use in the industrial and
research markets and therefore does not require FDA clearance or approval. The
FDA could change its interpretation of the regulations and require a 510(k)
Notification or PMA submission which, if pursued, may not be cleared or approved
or, if approved, may contain significant limitations on the intended uses for
which the product is marketed.
Marketing in the United States of the Company's products under development
may require additional FDA clearances or approvals. For example, the Company's
proposed automated pre-screening specimen mapping workstation, the TracCell
3000, if developed, may not be sold in the United States unless and until the
Company has obtained FDA clearance or approval, either through a 510(k)
Notification or a PMA. In addition, marketing of the Company's proposed KB
Reader and other proposed microbiology products, if developed, is likely to
require FDA clearance through 510(k) Notifications. The Company is currently
conducting research and development with respect to such products and has not
yet begun clinical trials. There can be no assurance that any such products will
be developed or, if developed, that such products will be cleared or approved
for marketing by the FDA or other applicable regulatory authorities or, if such
clearance or approval is received, that it will not be withdrawn. See "Business
- -- Cytopathology -- Cytopathology Products" and "-- Microbiology -- Microbiology
Products."
Sales of medical devices outside the United States are subject to foreign
regulatory requirements that vary from country to country. The time required to
obtain approval by a foreign country may be longer or shorter than that required
for FDA clearance or approval, and the requirements may differ. Export sales of
certain devices that have not received FDA marketing clearance or approval
generally are subject to both FDA export permit requirements and, in some cases,
general U.S. export regulations. In order to obtain a FDA export permit, the
Company may be required to provide the FDA with documentation from the medical
device regulatory authority of the country in which the purchaser is located. No
assurance can be given that foreign regulatory approvals will be granted on a
timely basis, if ever, or that the Company will not be required to incur
significant costs in obtaining or maintaining its foreign regulatory approvals.
The Company intends to seek qualification for its international
manufacturing operations under the International Standards Organization ("ISO")
9001 Series of Standards, and to seek the "CE" mark for the AcCell Series 2000
and proposed products. The CE mark is recognized by countries that are members
of the European Union and the European Free Trade Association and, effective in
1998, will be required to be affixed to all medical devices sold in the European
Union. The AcCell Series 2000 is expected to be certified as complying with CE
mark requirements upon completion of the CE mark qualification process which is
underway; however, no assurance can be given that the Company will obtain the CE
mark for the AcCell Series 2000 or any proposed products or satisfy ISO 9001
standards, or that any product that the Company may develop or commercialize
will obtain the CE mark or will obtain any other required regulatory clearance
or approval on a timely basis, if ever.
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The Company is subject to certain FDA registration, record-keeping and
reporting requirements, and most of the Company's manufacturing facilities are
obligated to follow FDA Good Manufacturing Practice ("GMP") regulations and are
subject to periodic FDA inspection. Any failure to comply with GMP regulations
or any other FDA or other government regulations could have a material adverse
effect on the Company's business, financial condition and results of operations.
In July 1996, the Company received from the FDA a warning letter regarding
certain procedures used in connection with the manufacture of its microbiology
products at the Sensititre facility in the United Kingdom. In such letter, the
FDA stated that the Company manufactured sterile products at such facility and
was not in compliance with GMP regulations relating to the manufacture of
sterile products. On August 7, 1996, the Company submitted a written response to
the FDA asserting that the products manufactured at the Sensititre facility are
not sterile. The FDA has acknowledged in writing that the products are not
represented as sterile and accepted the Company's GMP responses as adequate. The
FDA has indicated that it will verify the Company's implementation during its
next inspection and that import of the Company's devices will be permitted to
continue.
Federal, state and foreign regulations regarding the manufacture and sale of
healthcare products and diagnostic devices are subject to future change. The
Company cannot predict what material impact, if any, such changes might have on
its business. Future changes in regulations or enforcement policies could impose
more stringent requirements on the Company, compliance with which could
adversely affect the Company's business. Such changes may relax certain
requirements, which could prove beneficial to the Company's competitors and thus
adversely affect the Company's business. In addition, regulations of the FDA,
including GMP regulations, and state and foreign laws and regulations, depend
heavily on administrative interpretations, and there can be no assurance that
future interpretations made by the FDA, or other regulatory authorities, with
possible retroactive effect, will not adversely affect the Company. See "--
Technological Change and Competition."
In addition to the regulations directly pertaining to the Company and its
products, many of the Company's existing and potential customers are subject to
extensive regulation and governmental oversight. Regulatory changes in the
healthcare industry that adversely affect the business of the Company's
customers could have a material adverse effect on the Company's business,
financial condition and results of operations. See "Business -- Government
Regulation."
There can be no assurance that the Company will be able to obtain necessary
regulatory approvals or clearances in the United States or internationally on a
timely basis, if ever. Delays in the receipt of, or failure to receive, such
approvals or clearances, the loss of previously received approvals or
clearances, or failure to comply with existing or future regulatory requirements
would have a material adverse effect on the Company's business, financial
condition and results of operations.
DEPENDENCE ON KEY EMPLOYEES. The Company believes that its success will
depend to a significant extent upon the efforts and abilities of a small group
of executive, scientific and marketing personnel, and in particular on Peter P.
Gombrich, the Company's Chairman of the Board, Chief Executive Officer and
President. The loss of the services of one or more of these key personnel could
have a material adverse effect on the Company's business, financial condition
and results of operations. In addition, the Company's future success will depend
upon its ability to continue to attract and retain qualified scientific and
management personnel who are in great demand. There can be no assurance that the
Company will be successful in attracting and retaining such personnel.
PROTECTION OF INTELLECTUAL PROPERTY. The Company relies on a combination of
patents, licensing arrangements, trade names, trademarks, trade secrets,
know-how and proprietary technology and policies and procedures for maintaining
the secrecy of trade secrets, know-how and proprietary technology in order to
secure and protect its intellectual property rights. The Company has filed or
been assigned eight U.S. patent applications (one of which has been abandoned)
and nine foreign patent applications covering certain aspects of its
cytopathology products, and four U.S. patent applications, one Japanese patent
application and one Canadian patent application related to its microbiology
products. Additional U.S. and foreign patent applications covering the Company's
cytopathology products
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are being prepared. The Company holds certain licenses on several U.S. and
foreign patents and other intellectual property rights regarding aspects of the
technology embodied in the Sensititre product line and is the licensee of
certain automated cell analysis technology. The Company holds a U.S. patent and
has received a notice of intent to grant a related European patent with respect
to a portion of the alamarBlue microbiology technology.
None of the Company's patent applications has been granted as of the date of
this Prospectus, and there can be no assurance that any such patent application
will result in an issued patent. The Company may, in the future, file additional
patent applications; however, there can be no assurance that the Company will be
successful in obtaining approval of any future patent applications it files with
respect to its technologies. In addition, since patent applications in the
United States are maintained in secrecy until patents issue, and since
publications of discoveries in the scientific or patent literature tend to lag
behind actual discoveries by several months, the Company cannot be certain that
the Company or other relevant patent application filer was the first creator of
inventions covered by pending patent applications or that such persons were the
first to file patent applications for such inventions.
There also can be no assurance that any patents, patent applications and
patent licenses will adequately cover the Company's technologies. Protection
relating to portions of such technologies may be challenged or circumvented by
competitors, and other portions may be in the public domain or protectable only
under state trade secret laws.
The Company owns two U.S. trademark registrations for the trademark
"Sensititre," has filed U.S. trademark applications for the trademarks "AcCell,"
"MacCell," "FluoreTone," "SpeciFind," "Relational Cytopathology Review Guide,"
"MacroVision" and "TracCell" and is currently preparing one more trademark
application for filing. The Company may file additional U.S. and foreign
trademark applications in the future. However, no trademark registrations have
yet been granted to the Company, and there can be no assurance that any such
registrations will be granted. In addition, there can be no assurance that third
parties have not or will not adopt or register marks that are the same or
substantially similar to those of the Company, or that such third parties will
not be entitled to use such marks to the exclusion of the Company. Selecting new
trademarks to resolve such situations could involve significant costs, including
the loss of goodwill already gained by the marks previously used.
The Company relies for protection of its trade secrets, know-how and
proprietary technology on nondisclosure and confidentiality agreements with its
employees, consultants, distributors, suppliers, researchers and advisors. There
can be no assurance that such agreements will provide meaningful protection for
the Company's trade secrets, know-how or proprietary technology in the event of
any unauthorized use or disclosure of such information. In addition, others may
obtain access to, or independently develop, technologies or know-how similar to
that of the Company.
There can be no assurance that the Company's patents, patent applications,
patent licenses, trademarks and trade secret protections will adequately protect
the Company from potential infringement or misappropriation by third parties.
Historically, the Company has been required to undertake costly litigation to
enforce its intellectual property rights. Although the Company is not currently
aware of any potential infringement, future litigation by the Company may be
necessary to enforce its patent rights, as well as to protect its trade secrets,
know-how and proprietary technology, or to determine the scope and validity of
the proprietary rights of others. Any such litigation could result in
substantial cost to and diversion of effort by the Company.
The Company's success will also depend on its ability to avoid infringement
of patent or other proprietary rights of others. The Company is not aware that
it is infringing any such rights of a third party, nor is it aware of
proprietary rights of others for which it will be required to obtain a license
in order to develop its products. However, there can be no assurance that the
Company is not infringing the proprietary rights of others, or that the Company
will not be required to defend itself against claimed infringement of the rights
of others. Adverse determinations in any such litigation could subject the
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Company to significant liability to third parties, could require the Company to
seek licenses from third parties and could prevent the Company from
manufacturing, selling or using certain of its products or technologies, any of
which could have a material adverse effect on the Company.
POTENTIAL FLUCTUATIONS IN FUTURE QUARTERLY RESULTS. The Company expects
that its operating results will fluctuate significantly from quarter to quarter
in the future and will depend on various factors, many of which are outside the
Company's control. These factors include the success of the marketing efforts of
the Company and its distribution partners, the likelihood, timing and costs
associated with obtaining necessary regulatory clearances or approvals, the
timing and level of expenditures associated with expansion of sales and
marketing activities and overall operations, the Company's ability to cost
effectively expand manufacturing capacity and maintain consistently acceptable
yields, the timing of establishment of strategic distribution arrangements and
the success of the activities conducted under such arrangements, changes in
demand for the Company's products, order cancellations, competition, changes in
government regulation and other factors, the timing of significant orders from
and shipments to customers, and general economic conditions. These factors are
difficult to forecast, and these or other factors could have a material adverse
effect on the Company's business, financial condition and results of operations.
Fluctuations in quarterly demand for products may adversely affect the
continuity of the Company's manufacturing operations, increase uncertainty in
operational planning, disrupt cash flow from operations and increase the
volatility of the Company's stock price. The Company's expenditures are based in
part on the Company's expectations as to future revenue levels and to a large
extent are fixed in the short term. If revenues do not meet expectations, the
Company's business, financial condition and results of operations could be
materially adversely affected. The Company believes that period to period
comparisons of its operating results are not necessarily meaningful and should
not be relied upon as indications of future performance. As a result of the
foregoing factors, it is likely that in some future quarter the Company's
revenue or operating results will be below the expectations of public market
analysts and investors. In such event, the price of the Company's Common Stock
could be materially adversely affected.
Additionally, if specified earnings per share or stock price performance
thresholds are met during 1997, contingencies will be satisfied with respect to
940,955 shares of Common Stock and warrants to purchase 63,472 shares of Common
Stock issued in connection with the Merger and an amount equal to the fair
market value of such securities at the date on which such contingencies are
satisfied is expected to be recorded as goodwill and amortized over ten years.
Under the terms of the Agreement and Plan of Reorganization relating to the
Merger (the "Merger Agreement"), such contingencies will be satisfied if, during
1997, (i) earnings, on a fully diluted basis, exceed $0.03 per share of Common
Stock or (ii) the fair market value of the Common Stock equals or exceeds $2.50
per share for a period of 45 consecutive trading days. Furthermore, the Company
has entered into definitive agreements to acquire a two-thirds equity interest
in Oncometrics for approximately $4.0 million in cash. It is expected that the
allocation of the purchase price payable in connection with the Oncometrics
Acquisition will include approximately $1.6 million of acquired in-process
research and development and approximately $1.1 million of purchased technology.
The purchased technology is expected to be amortized over the expected useful
life of such technology, currently anticipated to be ten years, with the
acquired in-process research and development expensed in the Company's
consolidated statement of operations as a non-cash charge against operations in
the period of acquisition. The Company has also entered into a definitive
agreement to acquire the remaining outstanding shares of Common Stock of RADCO
and retire approximately $1.2 million in aggregate principal amount of RADCO
Notes at an aggregate cost to the Company of approximately $1.4 million in cash.
Approximately $630,000 of the purchase price payable in connection with the
RADCO Acquisition is expected to be allocated to acquired in-process research
and development and charged against operations in the Company's consolidated
statement of operations in the period of acquisition. To the extent that the
accounting treatments described above change, the Company's reported results of
operations may be adversely affected. In addition, if the Company determines in
accordance with its existing accounting policy that the undiscounted future
operating
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cash flows from its operations are insufficient to support the aggregate amount
of its unamortized goodwill, the Company will be required to reflect an
impairment charge in the amount of unrecoverable goodwill against then current
earnings. See "Management's Discussion and Analysis of Financial Condition and
Results of Operations" and Pro Forma Condensed Combining Financial Statements.
SIGNIFICANT CAPITAL REQUIREMENTS; DEPENDENCE ON PROCEEDS OF THE OFFERING;
POSSIBLE NEED FOR ADDITIONAL CAPITAL. The Company intends to expend substantial
funds for research and product development, scale-up of cytopathology
manufacturing capacity, reduction of accounts payable, possible acquisitions,
and other working capital and general corporate purposes. Although the Company
believes that the net proceeds of the Offering, together with interest thereon,
existing cash balances and internally generated funds will be sufficient to
finance the Company's projected operations through at least the next twelve
months, there can be no assurance to that effect. The Company's future liquidity
and capital requirements will depend upon numerous factors, including the costs
and timing of expansion of manufacturing capacity, the costs, timing and success
of the Company's product development efforts, the costs and timing of potential
acquisitions, the extent to which the Company's existing and new products gain
market acceptance, competing technological and market developments, the progress
of commercialization efforts by the Company and its distributors, the costs
involved in preparing, filing, prosecuting, maintaining, enforcing and defending
patent claims and other intellectual property rights, developments related to
regulatory and third party reimbursement matters, including the Clinical
Laboratory Improvement Amendments of 1988 ("CLIA"), and other factors. If
additional financing is needed, the Company may seek to raise additional funds
through public or private financings, collaborative relationships or other
arrangements. The Company currently has no commitments with respect to sources
of additional financing, and there can be no assurance that any such financing
sources, if needed, would be available to the Company or that adequate funds for
the Company's operations, whether from the Company's revenues, financial
markets, collaborative or other arrangements with corporate partners or from
other sources, will be available when needed or on terms satisfactory to the
Company. The failure of the Company to obtain adequate additional financing may
require the Company to delay, curtail or scale back some or all of its research
and development programs, sales and marketing efforts, manufacturing operations,
clinical studies and regulatory activities and, potentially, to cease its
operations. Any additional equity financing may involve substantial dilution to
the Company's then-existing stockholders. See "Use of Proceeds."
NEED TO MANAGE EXPANDING OPERATIONS. The Company will be required to expand
its operations, particularly in the areas of sales and marketing and
manufacturing. Such expansion will likely result in new and increased
responsibilities for management personnel and place significant strain upon the
Company's management, operating and financial systems and resources. To
accommodate any such growth and compete effectively, the Company may be required
to implement and/or improve its information systems, procedures and controls,
and to expand, train, motivate and manage its work force. The Company's future
success will depend to a significant extent on the ability of its current and
future management personnel to operate effectively, both independently and as a
group. There can be no assurance that the Company's personnel, systems,
procedures and controls will be adequate to support the Company's future
operations. Any failure to implement and improve the Company's operational,
financial and management systems or to expand, train, motivate or manage
employees as required by future growth, if any, could have a material adverse
effect on the Company's business, financial condition and results of operations.
RISK OF LITIGATION; RISK OF PRODUCT RECALLS; POTENTIAL UNAVAILABILITY OF
INSURANCE. Commercial screening of Pap smear tests has been characterized by
significant malpractice litigation. The Company faces a risk of exposure to
product liability, errors and omissions or other claims if the use of its AcCell
Series 2000 or any future potential products, including the TracCell 2000, is
alleged to have contributed to or resulted in a false negative diagnosis. While
neither the AcCell Series 2000 nor the TracCell 2000 is purported to offer any
clinical diagnosis, there can be no assurance that the Company will avoid
significant litigation. The Company also faces the possibility that defects in
designs or manufacture of its products could result in product recall.
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The Company currently maintains a product liability insurance policy
providing maximum coverage of $10.0 million and per occurrence coverage of $10.0
million. The medical device industry in general has experienced increasing
difficulty in obtaining and maintaining reasonable product liability coverage,
and substantial increases in insurance premium costs in many cases have rendered
coverage economically impractical. There can be no assurance that the Company's
existing product liability insurance will be adequate or continue to be
available, or that additional product liability insurance will be available to
the Company when needed or at a reasonable cost. An inability to maintain
insurance at acceptable costs or otherwise protect against potential product
liability could prevent or inhibit the continued commercialization of the
Company's products. In addition, a product liability claim in excess of relevant
insurance coverage or a product recall could have a material adverse effect on
the Company's business, financial condition and results of operations.
ENVIRONMENTAL REGULATION. The Company is subject to a variety of local,
state, federal and foreign government regulations relating to the storage,
discharge, handling, emission, generation, manufacture and disposal of toxic,
infectious and other hazardous substances used to manufacture the Company's
products. The failure to comply with current or future regulations could result
in the imposition of substantial fines against the Company, suspension of
production, alteration of its manufacturing processes or cessation of
operations. There can be no assurance that the Company will not be required to
incur significant costs to comply with any such laws and regulations in the
future, or that such laws or regulations will not have a material adverse effect
on the Company's business, financial condition and results of operations. Any
failure by the Company to control the use, disposal, removal or storage of, or
to adequately restrict the discharge of, or assist in the cleanup of, hazardous
chemicals or hazardous, infectious or toxic substances could subject the Company
to significant liabilities, including joint and several liability under certain
statutes. The imposition of such liabilities could have a material adverse
effect on the Company's business, financial condition and results of operations.
UNCERTAINTY OF PROFITABLE CYTOPATHOLOGY MANUFACTURING. The Company has only
recently developed the AcCell Series 2000 and marketing and sales of the AcCell
Series 2000 have only recently begun. The Company is also currently developing
the manufacturing processes for the TracCell 2000. There can be no assurance
that the Company will be able to sell sufficient numbers of systems or develop
volume manufacturing processes that will lead to the cost-effective manufacture
of the AcCell Series 2000 or the TracCell 2000. The Company also faces the
possibility that defects in designs or manufacture of its products could result
in product recall. See "Business -- Manufacturing."
DEPENDENCE ON SUPPLIERS. Certain key components and raw materials used in
the manufacturing of the Company's products are currently obtained from single
vendors. Although the Company believes that alternative sources for such
components and raw materials are available, any supply interruption in a
single-sourced component or raw material would have a material adverse effect on
the Company's ability to manufacture products until a new source of supply were
qualified. There can be no assurance that the Company would be successful in
qualifying additional sources on a timely basis, if ever. Failure to do so would
have a material adverse effect on the Company's business, financial condition
and results of operations. In addition, an uncorrected impurity or a supplier's
variation in a raw material, either unknown to the Company or incompatible with
the Company's manufacturing process, could have a material adverse effect on the
Company's ability to manufacture certain of its products. See "Business --
Manufacturing."
IMPACT OF MEDICARE, MEDICAID AND OTHER THIRD PARTY REIMBURSEMENT. In the
United States, some Pap smear screenings and MIC/ID tests are currently paid for
by the patient directly, and the level of reimbursement by third party payors
that do provide reimbursement varies considerably. Third party payors
(Medicare/Medicaid, private health insurance, health administration authorities
in foreign countries and other organizations) may affect the demand, pricing or
relative attractiveness of the Company's products and services by regulating the
frequency and maximum amount of reimbursement for Pap smear screening and MIC/ID
testing provided by such payors or by not providing any reimbursement at all.
Restrictions on reimbursement for Pap smear screening and MIC/ID testing may
limit the price that the Company can charge for its products or reduce the
demand for them. In addition, if the level of
15
<PAGE>
reimbursement provided by Medicare and Medicaid is significantly below the
amount laboratories and hospitals charge patients to perform Pap smear screening
and MIC/ID testing, respectively, the size of the potential market available to
the Company may be reduced. There can be no assurance that the level of
reimbursement for Pap smear screening and MIC/ID testing will achieve, or be
maintained at, levels necessary to permit the Company to generate substantial
revenues or be profitable.
In the international market, reimbursement by private third party medical
insurance providers, including governmental insurers and providers, varies from
country to country. In certain countries, the Company's ability to achieve
significant market penetration may depend upon the availability of third party
or governmental reimbursement.
UNCERTAINTY AND POSSIBLE NEGATIVE EFFECTS OF HEALTH CARE REFORM. The health
care industry is undergoing fundamental changes that are the result of
political, economic and regulatory influences. In the United States,
comprehensive programs have been proposed that seek to control the escalation of
health care expenditures within the economy. Reforms that have been, and may be,
considered include controls on health care spending through limitations on the
increase in private health insurance premiums and Medicare and Medicaid
spending, the creation of large insurance purchasing groups and other
fundamental changes to the health care delivery system. Health care reform
could, for example, result in a reduction in the recommended frequency of Pap
smear screening or limitations on reimbursement which would likely reduce the
demand for the Company's cytopathology products. Demand for the Company's MIC/ID
products could be similarly affected. The Company anticipates that Congress and
state legislatures will continue to review and assess cost containment measures,
alternative health care delivery systems and methods of payment, and that public
debate of these issues will likely continue. Due to uncertainties regarding the
outcome of health care reform initiatives and their enactment and
implementation, the Company cannot predict what reforms will be proposed or
adopted or the effect that such proposals or their adoption may have on the
Company. There can be no assurance that future health care legislation or other
changes in the administration or interpretation of government health care or
third party reimbursement programs will not have a material adverse effect on
the Company's business, financial condition and results of operations.
INTERNATIONAL SALES AND OPERATIONS RISKS. The Company sells microbiology
products and intends to sell its cytopathology and any future products to
customers both domestically and internationally. International sales and
operations may be limited or disrupted by the imposition of government controls,
export license requirements, political instability, trade restrictions, changes
in tariffs or difficulties in staffing and managing international operations.
Foreign regulatory authorities often establish product standards different from
those in the United States and any inability to obtain foreign regulatory
approvals on a timely basis could have a material adverse effect on the
Company's international business operations. Additionally, the Company's
business, financial condition and results of operations may be adversely
affected by increases in duty rates and difficulties in obtaining required
licenses and permits. There can be no assurance that the Company will be able to
successfully commercialize its products, or any future products, in any foreign
market.
POSSIBLE VOLATILITY OF STOCK PRICE. The market price of the shares of the
Company's Common Stock, like that of the common stock of many other medical
products and high technology companies, has in the past been, and is likely in
the future to continue to be, highly volatile. Factors such as fluctuations in
the Company's operating results, announcements of technological innovations or
new commercial products by the Company or competitors, government regulation,
changes in the current structure of the health care financing and payment
systems, developments in or disputes regarding patent or other proprietary
rights, economic and other external factors and general market conditions may
have a significant effect on the market price of the Common Stock. Moreover, the
stock market has from time to time experienced extreme price and volume
fluctuations which have particularly affected the market prices for medical
products and high technology companies and which have often been unrelated to
the operating performance of such companies. These broad market fluctuations, as
well as general economic, political and market conditions, may adversely affect
the market price of the Company's Common Stock. In the past, following periods
of volatility in the market price of a company's common stock,
16
<PAGE>
securities class action litigations have occurred against the issuing company.
There can be no assurance that such litigation will not occur in the future with
respect to the Company. Such litigation could result in substantial costs and
diversion of management's attention and resources, which could have a material
adverse effect on the Company's business, financial condition and results of
operations. Any adverse determination in such litigation could also subject the
Company to significant liabilities.
LACK OF DIVIDENDS. The Company has never paid cash or other dividends on
its Common Stock and does not anticipate paying any cash dividends on its Common
Stock in the foreseeable future. See "Dividend Policy."
AUTHORIZATION AND POTENTIAL ISSUANCE OF PREFERRED STOCK; DELAWARE
ANTI-TAKEOVER LAW. The Company's Certificate of Incorporation authorizes the
issuance of Preferred Stock with such designations, rights and preferences as
may be determined from time to time by the Board of Directors. Accordingly, the
Board of Directors is empowered, without stockholder approval, to issue
Preferred Stock with dividend, liquidation, conversion, voting or other rights
which could adversely affect the voting power or other rights of the holders of
the Company's Common Stock. Although the Company does not currently intend to
issue any shares of its Preferred Stock, in the event of issuance, such shares
could be utilized, under certain circumstances, as a method of discouraging,
delaying or preventing a change in control of the Company. There can be no
assurance that the Company will not, under certain circumstances, issue shares
of its Preferred Stock. Furthermore, the Company may in the future adopt other
measures that may have the effect of delaying, deferring or preventing a change
in control of the Company. Certain of such measures may be adopted without any
further vote or action by the stockholders, although the Company has no present
plans to adopt any such measures. The Company is also afforded the protections
of Section 203 of the Delaware General Corporation Law, which could delay or
prevent a change in control of the Company, impede a merger, consolidation or
other business combination involving the Company or discourage a potential
acquiror from making a tender offer or otherwise attempting to obtain control of
the Company. See "Description of Capital Stock -- Preferred Stock" and "--
Delaware Anti-Takeover Law; Certain Charter Provisions."
IMMEDIATE AND SUBSTANTIAL DILUTION; OUTSTANDING WARRANTS AND
OPTIONS. Because the offering price will be substantially higher than the book
value per share of the Common Stock, purchasers of shares of Common Stock in the
Offering will incur immediate and substantial dilution. In addition, investors
purchasing shares in the Offering will incur additional dilution to the extent
outstanding stock options and warrants are exercised. See "Dilution."
SHARES ELIGIBLE FOR FUTURE SALE. Sales of substantial amounts of Common
Stock in the public market after the Offering, or the possibility of such sales
occurring, could adversely affect prevailing market prices for the Common Stock
or the future ability of the Company to raise capital through an offering of
equity securities. Upon completion of the Offering, the Company will have
outstanding 21,934,710 shares of Common Stock, warrants to purchase 5,912,605
shares of Common Stock and options to purchase 1,830,138 shares of Common Stock
(based on shares, warrants and options outstanding as of October 1, 1996). Of
the outstanding shares, (i) 940,955 shares are subject to forfeiture if certain
specified earnings per share or stock price thresholds are not met during 1997;
(ii) 69,308 shares are subject to forfeiture if the Company is unable through
Agust 1997 to perfect and maintain rights free of liens in certain recently
acquired patents; and (iii) 116,000 shares are subject to forfeiture if certain
milestones under a microbiology product development agreement are not achieved.
In addition to the 3,000,000 shares of Common Stock to be sold in the Offering,
8,889,251 shares have been sold or are available for immediate sale in the
public market pursuant to effective registration statements or exemptions from
registration under the Securities Act of 1933, as amended (the "Securities
Act"), subject in the case of certain holders to the limitations applicable to
affiliates pursuant to Rule 144 under the Securities Act. An additional
1,733,875 shares of Common Stock that were issued in connection with the Merger
will become available for immediate sale in the public market on June 30, 1997
upon the expiration of certain restrictions placed on such shares in connection
with the Merger (including 380,649 of such shares currently subject to
forfeiture). The directors, executive officers and certain securityholders of
the Company, who hold in the aggregate 8,242,276 of the remaining outstanding
shares have entered into
17
<PAGE>
"lock-up" agreements with Vector Securities International, Inc. and Tucker
Anthony Incorporated, as representatives of the Underwriters (the
"Representatives"). In accordance with such lock-up agreements, an aggregate of
1,584,004 shares of Common Stock will become available for immediate sale in the
public market commencing 91 days after the date of this Prospectus, 1,583,997
shares will become available for immediate sale in the public market commencing
181 days after the date of this Prospectus and 5,074,275 shares (including
560,306 of such shares currently subject to forfeiture) will become available
for immediate sale in the public market commencing 271 days after the date of
this Prospectus, subject in the case of certain holders to the limitations
applicable to affiliates pursuant to Rule 144, and, with respect to 116,000
shares, release from escrow. The remaining 69,308 shares were issued in August
1996 and are restricted securities under Rule 144 and may not be sold unless
registered or pursuant to an applicable exemption from registration. Holders of
approximately 1,387,500 of the outstanding warrants have entered into lock-up
agreements with the Representatives restricting the sale of shares underlying
such warrants in the public market for a period of 60 days from the date of this
Prospectus. Holders of an additional 2,595,808 of the outstanding warrants have
entered into lock-up agreements restricting the sale of such warrants and the
shares underlying such warrants for a period of 90 days with respect to 865,270
warrants, 180 days with respect to 865,269 warrants and 270 days with respect to
865,269 warrants. The Company has registered the issuance of 2,190,492 shares of
Common Stock issuable upon the exercise of options currently outstanding or
available to be granted pursuant to the Company's stock option plans. Such
shares are available for immediate sale in the public market upon exercise of
the options, subject in the case of certain holders to the limitations
applicable to affiliates pursuant to Rule 144 and, in the case of 500,000
shares, stockholder approval of an amendment increasing the authorized shares
available under the 1995 Stock Option Plan. Holders of approximately 756,700 of
such options have executed lock-up agreements with the Representatives
restricting the sale of such shares in the public market for a period of 90 days
with respect to 185,567 option shares, 180 days with respect to 185,567 option
shares and 270 days with respect to 385,566 option shares. The Company has also
agreed that it will not, without the prior written consent of the
Representatives, offer, sell or otherwise dispose of any shares of Common Stock,
options or warrants to acquire shares of Common Stock or securities exchangeable
for or convertible into shares of Common Stock for a period of one year
following the date of this Prospectus other than pursuant to existing stock
option plans or upon the exercise of outstanding warrants. The Representatives
may, in their sole discretion and at any time without notice, release all or any
portion of the securities subject to such lock-up agreements. The Company has
agreed to file a registration statement under the Securities Act covering the
resale of approximately 8,265,000 shares of Common Stock (including shares of
Common Stock underlying certain options and warrants) promptly following
consummation of the Offering. Approximately 7,013,000 of such shares (including
shares underlying certain options and warrants) are subject to the lock-up
agreements described above. Following the effectiveness of such registration
statement and the expiration of the applicable lock-up periods, such shares will
be available for immediate sale in the public market without limitation. See
"Description of Capital Stock" and "Underwriting."
18
<PAGE>
THE COMPANY
The Company was incorporated in California in June 1988 under the name
Alamar Biosciences, Inc. From its inception, the Company was engaged in
developing, manufacturing and marketing microbiology products, including
alamarBlue and diagnostic test kits under the name Alamar. AccuMed, Inc. was
incorporated in Illinois in February 1994 to acquire products and technologies
in the fields of cytology and microbiology. Effective January 1995, AccuMed,
Inc. acquired Sensititre as a wholly-owned subsidiary and acquired certain
assets relating to Sensititre products in the United States from the
microbiology division of Radiometer America, Inc. Sensititre has been renamed
AccuMed International Limited and is currently a wholly-owned subsidiary of the
Company. In April 1995, the Company and AccuMed, Inc. entered into the Merger
Agreement providing for the merger of AccuMed, Inc. into the Company. Pending
consummation of the Merger, the Company's facilities in California were closed,
its manufacturing, sales, marketing and research and development functions were
conducted under contract by AccuMed, Inc. and its executive offices were moved
to Chicago, Illinois. The Merger was consummated on December 29, 1995, at which
time the surviving company was renamed AccuMed International, Inc. and was
reincorporated under Delaware law. The Company commenced sales of its initial
cytopathology product, the AcCell Series 2000, at the end of the first quarter
of 1996. The Company is currently seeking to enter into an agreement pursuant to
which a third party would manufacture the Company's Alamar microbiology
products, other than alamarBlue. However, there can be no assurance that such an
agreement can be reached. If such an agreement is not reached, the Company
intends to cease manufacturing such products. The Company is headquartered in
Chicago, Illinois with additional facilities in Westlake, Ohio and East
Grinstead, Sussex, England.
19
<PAGE>
USE OF PROCEEDS
The net proceeds to the Company from the sale of the 3,000,000 shares of
Common Stock offered hereby are estimated to be $11.7 million ($13.6 million if
the Underwriters' over-allotment option is exercised in full), after deducting
underwriting discounts and commissions and estimated offering expenses.
Management anticipates that up to $3.3 million of the net proceeds from the
Offering will be used for the research, development, testing and pursuit of
regulatory approvals for new cytopathology product offerings, and up to
approximately $1.0 million will be used to scale-up manufacturing for the AcCell
Series 2000 and, if cleared for marketing, the TracCell 2000. The Company
intends to use $4.0 million of the net proceeds from the Offering to fund the
proposed Oncometrics Acquisition and approximately $1.4 million of the net
proceeds to fund the proposed RADCO Acquisition. The consummation of the
Oncometrics Acquisition and the RADCO Acquisition are subject to various
conditions. As such, there can be no assurance that either the Oncometrics
Acquisition or the RADCO Acquisition will be completed. Any net proceeds not
used as described above will be used for working capital and other general
corporate purposes, including up to $1.0 million to reduce accounts payable. A
portion of the proceeds allocated for working capital and general corporate
purposes may be used to acquire complementary businesses, products or
technologies, although there are no current agreements, arrangements or
understandings with respect to any material acquisitions, other than as
described in this Prospectus. Pending such uses, the Company intends to invest
such funds in short-term, interest-bearing, investment grade obligations.
The amounts actually expended for each purpose may vary significantly,
depending on numerous factors, including the cost and timing of expansion of
manufacturing capacity, the costs, timing and success of the Company's product
development efforts, the costs and timing of potential acquisitions, the extent
to which the Company's existing and new products gain market acceptance,
competing technological and market developments, the progress of
commercialization efforts of the Company and its distributors, the costs
involved in preparing, filing, prosecuting, maintaining, enforcing and defending
patent claims and other intellectual property rights, developments relating to
regulatory and third party reimbursement matters, including CLIA, and other
matters. See "Management's Discussion and Analysis of Financial Condition and
Results of Operations," "Business -- Cytopathology -- Potential Acquisition of
Interest in Oncometrics" and "-- Microbiology -- Potential Acquisition of
RADCO."
20
<PAGE>
PRICE RANGE OF COMMON STOCK
The Company's Common Stock is quoted on the Nasdaq Market under the symbol
"ACMI." The Common Stock has been approved, subject to effectiveness of the
Offering, for inclusion on the Nasdaq National Market under the symbol "ACMI."
On October 2, 1996, the last reported sale price of the Common Stock on the
Nasdaq Market was $4.63 per share. The table below sets forth, for the periods
indicated, the range of high and low sales prices for the Common Stock on the
Nasdaq Market. At October 1, 1996, the Company had approximately 286
stockholders of record.
<TABLE>
<CAPTION>
HIGH LOW
--------- ---------
<S> <C> <C>
1994 FISCAL YEAR
First Quarter.......................................................... $ 4.13 $ 2.13
Second Quarter......................................................... 3.00 1.75
Third Quarter.......................................................... 2.75 1.00
Fourth Quarter......................................................... 2.63 1.25
1995 FISCAL YEAR
First Quarter.......................................................... $ 1.75 $ 0.31
Second Quarter......................................................... 1.75 0.50
Third Quarter.......................................................... 1.50 0.81
Fourth Quarter......................................................... 1.50 0.75
TRANSITION PERIOD (1)
October 1, 1995 through December 31, 1995.............................. $ 1.69 $ 1.00
1996 FISCAL YEAR (1)
First Quarter.......................................................... $ 6.25 $ 1.06
Second Quarter......................................................... 9.38 4.88
Third Quarter (through October 2, 1996)................................ 7.00 4.25
</TABLE>
- --------------------------
(1) On December 31, 1995, the Company changed its fiscal year end from September
30 to December 31.
DIVIDEND POLICY
The Company has not paid any cash or other dividends on its Common Stock to
date. The Company currently intends to retain future earnings, if any, to
finance the growth and development of its business and does not anticipate
paying any cash dividends on its Common Stock in the foreseeable future.
21
<PAGE>
CAPITALIZATION
The following table sets forth the short-term debt and capitalization of the
Company (i) at June 30, 1996, and (ii) giving pro forma effect to (a) the
Oncometrics Acquisition for $4.0 million in cash, (b) the RADCO Acquisition for
$1.4 million in cash and (c) the sale of the 3,000,000 shares of Common Stock
offered hereby, after deducting underwriting discounts and commissions and the
estimated expenses of the Offering. This table should be read in conjunction
with the Consolidated Financial Statements of the Company, including the related
Notes thereto and the Pro Forma Condensed Combining Financial Statements,
appearing elsewhere in this Prospectus. See also "Use of Proceeds" and "Business
- -- Cytopathology -- Potential Acquisition of Interest in Oncometrics" and "--
Microbiology -- Potential Acquisition of RADCO."
<TABLE>
<CAPTION>
JUNE 30, 1996
-----------------------
PRO FORMA AS
ACTUAL ADJUSTED
--------- ------------
(IN THOUSANDS)
<S> <C> <C>
Short-term debt, including current portion of long-term liabilities (1)................. $ 124 $ 131
Long-term debt, net of current portion (2).............................................. 45 272
--------- ------------
Total debt.......................................................................... 169 403
--------- ------------
Minority interest....................................................................... -- 677
--------- ------------
Stockholders' equity:
Preferred Stock, $0.01 par value: 5,000,000 shares authorized; no shares issued and
outstanding (actual and pro forma as adjusted)....................................... -- --
Common Stock, $0.01 par value: 30,000,000 shares authorized; 17,525,748 shares issued
and outstanding, actual; 20,525,748 shares issued and outstanding, pro forma as
adjusted (3)......................................................................... 175 205
Additional paid-in capital............................................................ 32,694 44,384
Cumulative translation adjustment..................................................... (2) (2)
Accumulated deficit................................................................... (27,220) (27,220)
Less treasury stock................................................................... (160) (160)
--------- ------------
Total stockholders' equity.......................................................... 5,487 17,207
--------- ------------
Total capitalization.............................................................. $ 5,656 $ 18,287
--------- ------------
--------- ------------
</TABLE>
- ------------------------------
(1) Includes notes payable and capital lease obligations due within one year.
(2) Includes long-term portion of capital lease obligations.
(3) Based on the number of shares outstanding as of June 30, 1996, excluding (i)
940,955 outstanding shares which are subject to forefeiture if certain
specified earnings per share or stock price performance thresholds are not
met during 1997 and (ii) 116,000 shares which are subject to forefeiture if
certain milestones under a microbiology product development agreement are
not achieved. Excludes: (i) an aggregate of 5,912,605 shares reserved for
issuance upon exercise of warrants outstanding at October 1, 1996 at
exercise prices ranging from $0.25 to $5.00 per share, with a weighted
average exercise price of $3.21 per share; (ii) an aggregate of 1,830,138
shares reserved for issuance upon the exercise of stock options outstanding
at October 1, 1996, including options to purchase 283,666 shares the
granting of which is subject to stockholder approval of an amendment
increasing the shares authorized under the 1995 Stock Option Plan, at
exercise prices ranging from $0.63 to $8.38 per share, with a weighted
average exercise price of $3.15 per share; and (iii) an aggregate of 401,575
shares reserved for issuance upon exercise of options available at October
1, 1996 for future grant under the Company's stock option plans, including
216,334 shares the reservation of which is subject to stockholder approval
of such amendment. See "Management -- Stock Option Plans" and Note 11, Note
16 and Note 18 of Notes to Consolidated Financial Statements.
22
<PAGE>
DILUTION
The pro forma net tangible book value of the Company at June 30, 1996 was
approximately negative $2.2 million or negative $0.13 per share of Common Stock.
Pro forma net tangible book value per share represents the amount of the
Company's total pro forma tangible net worth (pro forma tangible assets less
total pro forma liabilities), after giving effect to the Oncometrics Acquisition
and the RADCO Acquisition, divided by 17,525,748 shares which represents the
number of shares of Common Stock outstanding at June 30, 1996 (excluding (i)
940,955 shares of Common Stock subject to forfeiture if certain specified
earnings per share or stock price performance thresholds are not met during 1997
and (ii) 116,000 shares subject to forfeiture if certain milestones under a
microbiology product development agreement are not achieved). Without taking
into account any other changes in pro forma net tangible book value after June
30, 1996, other than to give effect to the receipt and application of the
estimated net proceeds from the sale of the 3,000,000 shares of Common Stock
offered hereby, the pro forma net tangible book value of the Company as of June
30, 1996 would have been approximately $9.5 million or $0.46 per share of Common
Stock. This represents an immediate increase in pro forma net tangible book
value of $0.59 per share to existing stockholders and an immediate dilution in
pro forma net tangible book value of $4.04 per share to new investors purchasing
shares in the Offering. The following table illustrates this per share dilution
to new investors in the Offering:
<TABLE>
<CAPTION>
Assumed offering price per share.................................... $ 4.50
<S> <C> <C>
Pro forma net tangible book value per share at June 30, 1996...... $ (0.13)
Increase per share attributable to new investors.................. 0.59
---------
Pro forma net tangible book value per share after the Offering...... 0.46
---------
Dilution per share to new investors................................. $ 4.04
---------
---------
</TABLE>
The foregoing calculations assume no exercise of options or warrants
subsequent to June 30, 1996, except as described above. As of October 1, 1996,
there were : (i) an aggregate of 5,912,605 shares reserved for issuance upon
exercise of outstanding warrants at exercise prices ranging from $0.25 to $5.00
per share, with a weighted average exercise price of $3.21 per share; and (ii)
an aggregate of 1,830,138 shares reserved for issuance upon the exercise of
outstanding stock options, including options to purchase 283,666 shares the
granting of which is subject to stockholder approval of an amendment increasing
the shares authorized under the 1995 Stock Option Plan, at exercise prices
ranging from $0.63 to $8.38 per share, with a weighted average exercise price of
$3.15 per share. To the extent such options or warrants are exercised, there
will be further dilution to new investors. See "Management -- Stock Option
Plans" and Note 11 of Notes to Consolidated Financial Statements.
23
<PAGE>
SELECTED CONSOLIDATED FINANCIAL DATA
The following Selected Consolidated Financial Data for the fiscal year ended
September 30, 1995 and for the three month transition period ended December 31,
1995 have been derived from the audited consolidated financial statements of the
Company as adjusted, where indicated, to reflect the Merger. The Consolidated
Financial Statements for the fiscal year ended September 30, 1995 have been
audited by Coopers & Lybrand, L.L.P., independent certified public accountants.
The Consolidated Financial Statements for the three month transition period
ended December 31, 1995 have been audited by KPMG Peat Marwick LLP, independent
certified public accountants. The information presented for the six months ended
June 30, 1996 is unaudited, but, in the opinion of the Company's management, all
adjustments (consisting of normal recurring adjustments) necessary for a fair
presentation of the information for such period have been made. Results for
interim periods are not necessarily indicative of the results that may be
expected for the full year. The following should be read in conjunction with
"Management's Discussion and Analysis of Financial Condition and Results of
Operations," and the Consolidated Financial Statements and related Notes thereto
and the Pro Forma Condensed Combining Financial Statements included elsewhere in
this Prospectus.
<TABLE>
<CAPTION>
THREE MONTH
TRANSITION SIX MONTHS ENDED
FISCAL YEAR ENDED PERIOD ENDED JUNE 30, 1996
SEPTEMBER 30, 1995 DECEMBER 31, 1995 ----------------------------
PRO FORMA (1) PRO FORMA (1) ACTUAL PRO FORMA (1)
------------------ ------------------ ------------- -------------
(IN THOUSANDS, EXCEPT PER SHARE DATA)
<S> <C> <C> <C> <C>
STATEMENT OF OPERATIONS DATA:
Sales................................................. $ 4,144 $ 1,184 $ 2,312 $ 2,318
Cost of sales......................................... (3,674) (1,186) (1,466) (1,469)
------- ------- ------------- -------------
Gross profit (loss)................................... 470 (2) 846 849
Operating expenses.................................... 7,526 7,058(2) 7,422(2) 7,996
------- ------- ------------- -------------
Operating loss........................................ (7,056) (7,060) (6,576) (7,147)
Other income (expense)................................ (113) (81) 2,118 2,115
Provision for income taxes............................ (1) (1) (1) (1)
Minority interest..................................... 430 65 -- 175
------- ------- ------------- -------------
Net loss.............................................. $ (6,740) $ (7,077) $ (4,459) $ (4,858)
------- ------- ------------- -------------
------- ------- ------------- -------------
Net loss per common share............................. $ (0.69) $ (0.60) $ (0.27) $ (0.30)
------- ------- ------------- -------------
------- ------- ------------- -------------
Weighted average common shares outstanding............ 9,832 11,743 16,319 16,319
------- ------- ------------- -------------
------- ------- ------------- -------------
</TABLE>
<TABLE>
<CAPTION>
JUNE 30, 1996
----------------------------
PRO FORMA
DECEMBER 31, 1995 ACTUAL AS ADJUSTED (3)
------------------ ----------- ---------------
(IN THOUSANDS)
<S> <C> <C> <C>
BALANCE SHEET DATA:
Working capital (deficit)................................................. $ (2,459) $ 572 $ 9,717
Total assets.............................................................. 5,974 8,720 21,478
Long-term debt, net of current portion (4)................................ 90 45 272
Total stockholders' equity................................................ 729 5,487 17,207
</TABLE>
- --------------------------
(1) Includes the operating results of AccuMed, Inc. and Oncometrics on a pro
forma basis assuming the Merger and the Oncometrics Acquisition occurred on
October 1, 1994. See "The Company" and Pro Forma Condensed Combining
Financial Statements.
(2) Includes $4.0 million and $3.5 million for the three month transition period
ended December 31, 1995 and the six months ended June 30, 1996,
respectively, recorded as a non-cash charge against operations relating to
the write-off of in-process research and development acquired in connection
with the Merger.
(3) Includes the net assets of Oncometrics and RADCO assuming that the
Oncometrics Acquisition and the RADCO Acquisition occurred on June 30, 1996,
adjusted to reflect receipt and application of the net proceeds from the
sale of the 3,000,000 shares of Common Stock offered hereby. See "Use of
Proceeds" and "Description of Capital Stock."
(4) Long-term debt consists of capital lease obligations. See Note 13 to Notes
to Consolidated Financial Statements.
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MANAGEMENT'S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
THIS PROSPECTUS CONTAINS, IN ADDITION TO HISTORICAL INFORMATION,
FORWARD-LOOKING STATEMENTS THAT INVOLVE RISKS AND UNCERTAINTIES. THE COMPANY'S
ACTUAL RESULTS COULD DIFFER SIGNIFICANTLY FROM THE RESULTS DISCUSSED IN THE
FORWARD-LOOKING STATEMENTS. FACTORS THAT COULD CAUSE OR CONTRIBUTE TO SUCH
DIFFERENCES INCLUDE THE FACTORS DISCUSSED BELOW AS WELL AS THE FACTORS DISCUSSED
IN "RISK FACTORS" AND ELSEWHERE IN THIS PROSPECTUS. SPECIAL NOTE: CERTAIN
STATEMENTS SET FORTH BELOW CONSTITUTE "FORWARD-LOOKING STATEMENTS" WITHIN THE
MEANING OF THE REFORM ACT. SEE "SPECIAL NOTE REGARDING FORWARD-LOOKING
STATEMENTS" ON PAGE 2 FOR ADDITIONAL FACTORS RELATING TO SUCH STATEMENTS.
OVERVIEW
Effective December 29, 1995, AccuMed, Inc. was merged with and into the
Company. The results of operations reflected in the Company's consolidated
statement of operations for the quarter ended March 31, 1996 and subsequent
periods include the operations of the two merged businesses, whereas results of
operations from prior periods and years reflect the operations and sales of the
Alamar microbiology product line only. The historical results of operations of
the Company presented herein are not necessarily indicative of future results of
operations of the Company. See "The Company."
The Merger has been accounted for as a purchase, which resulted in certain
charges. The value of the securities not subject to contingencies issued by the
Company upon consummation of the Merger exceeded the value of the assets
acquired by $6.6 million. At December 31, 1995, $4.0 million of such amount was
allocated to acquired in-process research and development and written off
immediately as a non-cash charge against operations. The remaining $2.6 million
was recorded as purchased technology and is being amortized over ten years
beginning December 31, 1995. Certain of the securities issued by the Company
upon consummation of the Merger were subject to forfeiture if specified earnings
per share or stock price performance goals were not met following the Merger.
During the quarter ended March 31, 1996, the contingencies were satisfied with
respect to a portion of such securities having a then current fair market value
of $5.4 million. Of such amount, $3.5 million was allocated to acquired in-
process research and development and written off immediately as a non-cash
charge against operations. The remaining $1.9 million was recorded as purchased
technology and is being amortized over ten years beginning March 31, 1996. If
specified contingencies applicable to the remaining 940,955 shares of Common
Stock and warrants to purchase up to 63,472 shares of Common Stock issued in the
Merger are met during 1997, an amount equal to the fair market value of such
securities at the time such contingencies are satisfied will be recorded as
goodwill. It is anticipated that such goodwill will be amortized over ten years
and that the Company will continue to assess the recoverability of such asset as
prescribed by the Company's current accounting policies. See "Risk Factors --
Potential Fluctuations in Future Quarterly Results" and Note 16 of Notes to
Consolidated Financial Statements.
Pending consummation of the Merger, the Company took various actions to
streamline and relocate its operations. The Company's manufacturing facility in
Sacramento, California was closed in August 1995, and all obligations under its
lease were satisfied during the second quarter of 1996. During the summer and
fall of 1995, the Company terminated the employment of all its employees, other
than two officers. From July 1, 1995 until consummation of the Merger, the
Company's manufacturing, marketing, sales, distribution and research and
development functions were performed by AccuMed, Inc. under contracts. After
consummation of the Merger, the Company resumed research and development,
manufacturing and marketing and sales activities, and hired a significant number
of employees.
At June 30, 1996, the Company had an accumulated deficit of $27.2 million.
On December 31, 1995, the Company changed its fiscal year end from September 30
to December 31.
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RESULTS OF OPERATIONS
SIX MONTHS ENDED JUNE 30, 1995 AND 1996
Revenues from sales increased from $321,000 for the six months ended June
30, 1995 to $2.3 million for the comparable 1996 period, primarily due to the
inclusion of sales of the Sensititre product line as a result of the acquisition
of the Sensititre business at the end of 1995 and initial sales of the Company's
cytopathology products.
Cost of sales increased from $471,000 for the six months ended June 30, 1995
to $1.5 million for the comparable 1996 period, primarily due to the additional
cost of sales of the microbiology product line and initial cytopathology
instrument sales.
General and administrative expenses increased from $860,000 for the six
months ended June 30, 1995 to $1.8 million for the comparable 1996 period,
primarily due to (i) recognition of a non-cash charge attributable to the
issuance of warrants to purchase an aggregate of 100,000 shares of Common Stock
at an exercise price of $2.125 per share as compensation for consulting
services, (ii) costs of consolidating staff and relocating operations, and (iii)
increased investor relations efforts.
Research and development expenses increased from $140,000 for the six months
ended June 30, 1995 to $4.8 million for the comparable 1996 period, primarily
due to a non-cash charge against operations of $3.5 million representing the
write-off of in-process research and development acquired in connection with the
Merger, and resumption of research and development activities following the
Merger.
Sales and marketing expenses increased from $75,000 for the six months ended
June 30, 1995 to $842,000 for the comparable 1996 period, due to reinstatement
of domestic sales and marketing efforts which had been suspended during the 1995
period.
Other income increased from $96,000 for the six months ended June 30, 1995
to $2.5 million for the six months ended June 30, 1996, primarily due to
payments of $3.5 million from Becton, Dickinson and Company ("Becton") pursuant
to a license agreement entered into in October 1995 (the "Becton Agreement"). At
December 31, 1995, $1.4 million of such payments had been recorded as deferred
revenues pending resolution of subsequently resolved litigation. Offsetting such
income was $954,000 of expense for the first six months of 1996 recorded as a
non-cash charge representing the fair market value of warrants issued. Of such
amount, (i) $852,000 is attributable to warrants to purchase an aggregate of
687,500 shares of Common Stock, with a weighted average exercise price of $3.73
per share, issued to investors in connection with the initial capitalization of
RADCO and (ii) $102,000 is attributable to warrants to purchase an aggregate of
100,000 shares of Common Stock, at an exercise price of $1.25 per share, issued
in consideration of a loan to the Company of $250,000 from the warrantholder.
Net loss increased from $1.2 million for the six months ended June 30, 1995
to $4.5 million for the six months ended June 30, 1996, primarily attributable
to the non-cash charge against operations relating to the write-off of
in-process research and development and the fair value of warrants issued, as
described above. The net loss per share for the first six months of 1995 was
$0.20 compared to $0.27 for the comparable 1996 period. The increased net loss
was diluted by an increase in the weighted average shares outstanding.
The Company's accounts receivable increased by $530,000 from December 31,
1995 to June 30, 1996, primarily due to sales of the Company's initial
cytopathology products and varying payment terms for the Company's international
microbiology distributors.
The Company's production inventory increased by $371,000 from December 31,
1995 to June 30, 1996 as a result of increased levels of raw materials and
finished goods inventories acquired to support sales of the Company's initial
cytopathology products.
The Company's accounts payable were $2.2 million as of June 30, 1996, an
increase of $236,000 from December 31, 1995, primarily attributable to the
increase in inventories described above.
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THREE MONTHS ENDED DECEMBER 31, 1994 AND 1995
The three months ended December 31, 1995 represent the transition period
resulting from the change in the Company's fiscal year end from September 30 to
December 31. While revenues remained virtually unchanged, cost of sales
increased from $227,000 in the 1994 quarter to $339,000 in the 1995 period.
General and administrative costs increased substantially from $384,000 in the
1994 quarter to $1.4 million in the 1995 period, primarily due to (i) legal
expenses related to subsequently resolved litigation, (ii) expenses of
relocating the Company's operations, and (iii) payments to AccuMed, Inc. for its
services pursuant to manufacturing, distribution and research and development
agreements pending consummation of the Merger. Research and development expenses
increased from $151,000 in the 1994 quarter to $4.0 million in the 1995 period,
due to a non-cash charge against operations relating almost entirely to the
write-off of in-process research and development acquired in connection with the
Merger. Sales and marketing expenses decreased from $171,000 in the 1994 period
to $7,000 in the 1995 period, as the sales and marketing activities were
performed by AccuMed, Inc. prior to the Merger pursuant to a distribution
agreement.
The net loss increased from $846,000 for the 1994 period to $5.7 million for
the 1995 period. The increase resulted primarily from a non-cash charge against
operations relating to the write-off of in-process research and development
acquired in connection with the Merger, and increased administrative expense.
The net loss per share for the 1994 period was $0.17 compared to $0.49 for the
1995 period.
FISCAL YEARS ENDED SEPTEMBER 30, 1993, 1994 AND 1995
Revenues for the fiscal years ended September 30, 1993, 1994 and 1995 were
$419,000, $1.2 million and $515,000, respectively. Revenues in fiscal 1994
included approximately $473,000 of international instrument shipments and
$92,000 of contract research, both of which were absent from the fiscal 1995
year and account for the decrease in revenues from fiscal 1994 to fiscal 1995.
During fiscal 1994, the Company had additional products available for sale that
were in development during fiscal 1993. Cost of sales increased from $911,000 in
fiscal 1993 to $1.5 million in fiscal 1994 and decreased slightly to $1.4
million in fiscal 1995. The cost of sales relative to revenues was higher in
1993 and 1995 as compared to 1994 due to increased sales of instruments in 1994
which carry a higher margin as compared to the test panels to which the 1993 and
1995 revenues related. General and administrative expenses increased slightly
from $1.1 million in fiscal 1993 to $1.2 million in fiscal 1994, and increased
substantially to $2.1 million in fiscal 1995. The increase from fiscal 1994 to
fiscal 1995 was primarily due to legal and accounting expenses related to the
Merger and subsequently resolved litigation. Research and development expenses
decreased from $683,000 in fiscal 1993 to $580,000 in fiscal 1994 and to
$387,000 in fiscal 1995, primarily due to the suspension of virtually all
research and development activities during the 1995 fiscal year. Sales and
marketing expenses decreased from $960,000 in fiscal 1994 to $309,000 in fiscal
1995, due to suspension of virtually all of the Company's domestic sales and
marketing efforts beginning in November 1994.
The net loss for fiscal 1993 was virtually unchanged compared to fiscal
1994. The net loss increased from $3.1 million for fiscal 1994 to $3.8 million
for fiscal 1995, primarily due to increased legal and administrative expenses
associated with subsequently resolved litigation. The net loss per share
decreased from $1.00 for fiscal 1993 to $0.65 in 1994 and $0.59 in 1995,
primarily due to increases in the weighted average shares outstanding offset in
part by a lower net loss in fiscal 1994 compared to fiscal 1995.
LIQUIDITY AND CAPITAL RESOURCES
The Company has been substantially dependent on the private placements of
its debt and equity securities and the proceeds of its initial public offering
of securities consummated in October 1992 to fund its cash requirements. From
the initial public offering through June 30, 1996, the Company has raised
approximately $22.3 million in aggregate net proceeds from the initial public
offering and certain equity private placements. The Company's most recent
private placements were closed in May and June 1996, resulting in the issuance
of an aggregate of 255,000 shares of Common Stock for net proceeds of
approximately $1.4 million. During the second quarter of 1996, the Company
expected to receive $2.0
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million in cash consideration for a debenture that was to have been issued
effective April 30, 1996; however, such consideration was not received and such
debenture was not issued. During the second quarter of 1996, the Company
received an aggregate of $471,000 upon the exercise of certain stock options and
an aggregate of $441,000 upon the exercise of certain warrants.
In connection with the Company's initial public offering and certain private
placements, the Company issued warrants to purchase an aggregate of 2,702,905
shares of Common Stock (the "Redeemable Warrants"). As of October 1, 1996, 200
shares of Common Stock had been issued as a result of the exercise of Redeemable
Warrants. If the closing price per share of Common Stock exceeds $7.50 per share
(subject to adjustment) for a minimum of 20 consecutive trading days, the
Company would have the right to redeem the Redeemable Warrants, upon notice of
not less than 60 days given to holders within three days following any such 20
day period, at a redemption price of $0.25 per underlying share. The exercise
price of the Redeemable Warrants, which expire October 1, 1997, is $5.00 per
share. If all Redeemable Warrants were exercised, of which there can be no
assurance, the Company would receive approximately $13.5 million in gross
proceeds. If the Offering is completed, the Company has agreed with the
Underwriters not to redeem the Redeemable Warrants, without the Representatives'
consent, prior to one year following the date of this Prospectus.
Pursuant to the Becton Agreement, Becton has a semi-exclusive, worldwide
license to the Company's alamarBlue technology for a specific field of use.
Becton was obligated to pay $3.5 million in cash for use of the technology, of
which $1.5 million was received during 1995 and $2.0 million was received during
the first quarter of 1996. Of such amount, $500,000 will be creditable against
future royalty payments, if any. Becton is obligated to pay the Company
royalties on net sales of products incorporating the technology licensed under
the Becton Agreeement during its five-year term. To the Company's knowledge, as
of the date of this Prospectus, Becton has not produced or sold any products
incorporating such technology.
At June 30, 1996, the Company had $2.2 million of accounts payable, of which
$1.7 million was past the respective original due dates. In late 1995 and early
1996, the Company reached agreements with certain vendors providing for the
extended repayment of amounts owed by the Company to such vendors. At June 30,
1996, pursuant to such agreements, approximately $522,000 remained payable by
the Company to such vendors in scheduled monthly installments through the
remainder of 1996. Other amounts owed to various vendors and suppliers may be
subject to late charges of up to 1.5% per month. The Company intends to apply up
to $1.0 million of the net proceeds of the Offering to the repayment of a
portion of the accounts payable not subject to extended repayment agreements.
The Company intends to expend substantial funds for research and product
development, possible acquisitions, scale-up of manufacturing capacity,
reduction of accounts payable and other working capital and general corporate
purposes. Although the Company believes that the net proceeds of the Offering,
together with interest thereon, existing cash balances and internally generated
funds will be sufficient to finance the Company's projected operations through
at least the next twelve months, there can be no assurance to that effect. The
Company's future liquidity and capital requirements will depend upon numerous
factors, including the costs and timing of expansion of manufacturing capacity,
the costs, timing and success of the Company's product development efforts, the
costs and timing of potential acquisitions, the extent to which the Company's
existing and new products gain market acceptance, competing technological and
market developments, the progress of commercialization efforts of the Company
and its distributors, the costs involved in preparing, filing, prosecuting,
maintaining, enforcing and defending patent claims and other intellectual
property rights, developments related to regulatory and third party
reimbursement matters, including CLIA, and other factors. If additional
financing is needed, the Company may seek to raise additional funds through
public or private financings, collaborative relationships or other arrangements.
The Company currently has no commitments with respect to sources of
additional financing, and there can be no assurance that any such financing
sources, if needed, would be available to the Company or that adequate funds for
the Company's operations, whether from the Company's revenues, financial
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markets, collaborative or other arrangements with corporate partners or from
other sources, will be available when needed or on terms satisfactory to the
Company. The failure of the Company to obtain adequate additional financing may
require the Company to delay, curtail or scale back some or all of its research
and development programs, sales and marketing efforts, manufacturing operations,
clinical studies and regulatory activities and, potentially, to cease its
operations. Any additional equity financing may involve substantial dilution to
the Company's then-existing stockholders. See "Use of Proceeds" and the
Consolidated Financial Statements and the Pro Forma Condensed Combining
Financial Statements and Notes thereto.
POTENTIAL IMPACT OF ACQUISITION OF INTEREST IN ONCOMETRICS
In August 1996, the Company entered into definitive agreements to acquire a
two-thirds equity interest, on a fully-diluted basis, in Oncometrics for
aggregate cash consideration of $4.0 million. Of such consideration, $2.0
million is to be paid to Xillix for currently outstanding Oncometrics stock, and
$2.0 million is to be paid to Oncometrics for newly issued Oncometrics stock. It
is anticipated that such transaction, if completed, would be accounted for under
the purchase method of accounting, resulting in approximately $1.6 million of
acquired in-process research and development and approximately $1.1 million of
purchased technology. Amounts recorded as acquired in-process research and
development would be written off as a charge to earnings in the period of the
Oncometrics Acquisition. Amounts recorded as purchased technology would be
amortized over the expected useful life of such technology, currently
anticipated to be ten years. Furthermore, at June 30, 1996, Oncometrics had
approximately $234,000 in long-term, third party debt, including the current
portion of long-term debt, which the Company will assume if the Oncometrtics
Acquisition is completed. See "Risk Factors -- Potential Fluctuations in Future
Quarterly Results," "Use of Proceeds" and "Business -- Cytopathology --
Potential Acquisition of Interest in Oncometrics" and Pro Forma Condensed
Combining Financial Statements.
POTENTIAL IMPACT OF ACQUISITION OF RADCO
In August 1996, the Company also entered into a definitive agreement to
acquire the common stock of RADCO not currently owned by the Company and to
retire approximately $1.2 million in aggregate principal amount of RADCO Notes
issued by RADCO in connection with the initial capitalization of RADCO at an
aggregate cost to the Company of approximately $1.4 million in cash. It is
anticipated that such transaction, if completed, would be accounted for under
the purchase method of accounting, resulting in approximately $630,000 of
acquired in-process research and development. Such amount is expected to be
written-off as a charge to earnings in the period of the RADCO Acquisition. See
"Risk Factors -- Potential Fluctuations in Future Quarterly Results," "Use of
Proceeds" and "Business -- Microbiology -- Potential Acquisition of RADCO" and
Pro Forma Condensed Combining Financial Statements.
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BUSINESS
AccuMed designs, manufactures and markets diagnostic screening products for
clinical diagnostic laboratories serving the cytopathology and microbiology
markets. The Company's primary focus is on the development of cytopathology
products that support the review and analysis of Pap smears in order to improve
the quality of cell analysis and increase accuracy and productivity in the
laboratory. The Company commenced sales of its initial cytopathology product,
the AcCell Series 2000 automated slide handling and microscopy workstation, at
the end of the first quarter of 1996. The Company is currently testing a
prototype specimen mapping workstation, the TracCell 2000, which automatically
pre-screens Pap smear slides to identify and create a computerized map of empty
space and certain non-clinically relevant portions of the specimen to permit a
more efficient analysis of the test slide. The Company expects to file a 510(k)
Notification with the FDA for the TracCell 2000 by the end of 1996. The Company
has recently entered into an agreement with Olympus America, a leading supplier
of microscopes to the cytopathology market, pursuant to which Olympus America
has exclusive third party distribution rights to the AcCell Series 2000 and, if
successfully developed and cleared for marketing by the FDA and other applicable
regulatory authorities, the TracCell 2000 in the Olympus Territory.
The Company also develops, manufactures and markets IN VITRO diagnostic
microbiology products for the clinical laboratory, veterinary and pharmaceutical
markets. The Company offers the microbiology laboratory a variety of FDA-cleared
products, under the trade name Sensititre, for the MIC/ID testing of bacteria
suspected of causing infections and for measuring the susceptibility of such
bacteria to different types and concentrations of antibiotics. AccuMed's
microbiology products include disposable test kits and a range of automated
instruments. In September 1996, the Company entered into an agreement with CMS,
a division of Fisher Scientific Company, a leading distributor of clinical
laboratory products, pursuant to which CMS has been granted exclusive rights to
distribute the Company's Sensititre microbiology products in the United States.
The Company also markets alamarBlue, a proprietary, non-toxic indicator reagent
that measures cell growth for IN VITRO testing. The Company is developing the KB
Reader, an automated instrument designed to read the results of a Kirby-Bauer
method susceptibility test, and, pursuant to an agreement with RADCO, is
developing a diagnostic microbiology test panel and an automated reading
instrument. There can be no assurance that any such products will be
successfully developed or marketed.
AccuMed's objective is to establish the AcCell Series 2000 and the TracCell
2000 as the leading microscopy workstations for the primary screening and
analysis of cytology specimens while developing other new cytopathology and
microbiology products. The key elements of the Company's strategy include: (i)
establishing the AcCell Series 2000 and, if cleared for marketing by the FDA and
other applicable regulatory authorities, the TracCell 2000 in the worldwide Pap
smear screening market through distribution agreements and strategic alliances
with major market participants, (ii) exploiting other applications for the
Company's cytopathology technology such as histology and pathology laboratory
work, (iii) continuing to acquire, develop and enhance technologies that
complement the Company's existing technology base and (iv) integrating the
Company's proprietary microbiology technologies into new products.
CYTOPATHOLOGY
CERVICAL CANCER SCREENING
An estimated 440,000 new cases of cervical cancer are reported annually
worldwide. The American Cancer Society estimates that, in 1996 in the United
States, 15,700 women will be diagnosed with invasive cervical cancer and 4,900
women will die of cervical cancer. However, virtually all cervical cancer cases
can be effectively treated with timely intervention if detected early. The
treatment of cervical cancer after it reaches the invasive stage, however, may
require surgery and chemotherapy or radiation treatments, which are difficult,
expensive and may be unsuccessful. Cervical cancer is preceded by curable
precancerous lesions that progress without symptoms over a period of years until
they become invasive, penetrating the cervical epithelium (cellular covering)
and entering the bloodstream or lymph system. In
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1996, an estimated 65,000 American women will be diagnosed with cervical
carcinoma IN SITU, a precancerous condition. In order to detect precancerous
lesions, gynecologists in the United States typically recommend annual screening
examinations for all women over the age of 18.
The Pap smear is currently the most widely-used screening test for early
detection of cervical cancer and related precancerous conditions. Pap smear
tests are generally performed by an estimated 4,500 clinical laboratories in the
United States, including hospital laboratories, commercial laboratories,
reference laboratories and gynecologists' office laboratories. It is estimated
that in 1996 over 150 million Pap smear specimens will be screened worldwide,
including over 50 million in the United States. According to the American Cancer
Society, widespread and regular use of the Pap smear as a screening test is
believed to have contributed to a greater than 70% decrease in mortality from
cervical cancer in the United States in the past 45 years.
PAP SMEAR TESTS
The conventional Pap smear testing process begins with the collection of a
cervical specimen during a gynecological examination. The physician then
manually smears the specimen onto a microscope slide, which is then submitted to
the clinical laboratory for cytopathological microscopic examination, along with
patient data such as medical history, day in menstrual cycle, family history and
known risk factors. Gathering and collating these patient data, which are
critical to the proper evaluation of a specimen, is a time-consuming and
labor-intensive process at both the physician's office and the laboratory. The
laboratory administrative personnel who gather such data are also responsible
for manually recording the results of the Pap smear tests and ensuring that both
the slide and paperwork provided to the cytotechnologist relate to the same
patient.
At the laboratory, a cytotechnologist, a medical professional with special
training in the examination and interpretation of human cells, conducts an
initial microscopic review of a prepared slide. The cytotechnologist screens
each slide with a microscope to differentiate diseased or abnormal cells from
healthy cells based on numerous physical characteristics, including size, shape
and structural details of the cells and nuclei. Other factors considered are the
texture of the specimen, the structure of cell grouping, background of the smear
and the patient medical data supplied by the referring physician. Typically,
each Pap smear specimen is then classified in accordance with The Bethesda
System for Reporting Cervical/Vaginal Cytologic Diagnoses into one of several
categories ranging from normal (negative) to cancerous. Any specimen classified
as other than negative is generally referred to a senior cytotechnologist and
then a pathologist for further review and final diagnosis. A woman with an
abnormal Pap smear test may have a repeat Pap smear test or undergo costly
colposcopy and biopsy procedures.
Cytotechnologists are regulated under CLIA, which requires cytology
laboratories to perform proficiency testing and quality control by testing
cytotechnologists to assure a minimum competence level. Pap smear screening is
exceedingly complex and tedious work. Cytotechnologists are required by CLIA to
screen 100% of each Pap smear slide, which when done correctly requires six to
eight minutes of microscope viewing per slide. Over 90% of specimens reviewed
are negative. Even non-negative specimens may contain only 20 to 30 abnormal
cells out of a total of as many as 50,000 to 300,000 cells on the slide. As a
result, slide interpretation errors can be caused by fatigue of the
cytotechnologist and the habituation effect of constantly viewing predominantly
negative specimens. To potentially reduce the effects of fatigue and
habituation, CLIA limits to 100 the number of slides that a cytotechnologist is
permitted to screen in a day, and many states and foreign countries have
established even lower slide-per-day limits. Although CLIA permits a
cytotechnologist to review up to 100 Pap smear slides per day, management
estimates that, as a practical matter, the manual review process requiring 100%
slide review limits the ability of the cytotechnologist to reviewing an average
of 60 slides per day.
In conducting the conventional Pap smear screening, cytotechnologists are
required to locate and review information from the patient's file, load and
position the slide on the microscope stage, manually move the slide and
continually focus the microscope on as many as 400 fields of view per slide.
They then place a mark on selected abnormal cells on the slide and manually
record the diagnosis. CLIA requires
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that at least 10% of specimens classified as negative be rescreened for quality
control. Rescreening is accomplished either by the methods described above or by
rescreening instruments. See "-- Competition."
CONVENTIONAL PAP SMEAR TEST LIMITATIONS
The conventional Pap smear screening process has significant limitations,
primarily relating to how individual cytotechnologists and administrative
personnel analyze slides, diagnose, record the results of such analysis,
document the screening process and gather and collate relevant patient data. Any
breakdown in this process could result in slide interpretation errors,
administrative errors and increased potential for litigation/liability risks.
SLIDE INTERPRETATION ERRORS. The process of screening and interpreting a
Pap smear test is complex and tedious, and is prone to error due to the
difficulty of properly locating, evaluating and categorizing subtle changes in a
very small number of cells among a vastly larger cell population as well as the
fact that most of the specimens reviewed are classified as negative. In
addition, cytotechnologists are usually encouraged by laboratory economics to
review as many slides as possible within the current CLIA constraint of 100 per
day. As a result, slide interpretation errors can be caused by cytotechnologist
fatigue and the habituation effect of constantly viewing predominantly negative
specimens. A false negative diagnosis may allow the disease to progress to a
later stage of development before being detected, thereby requiring a more
expensive and invasive course of treatment and diminishing the likelihood of
successful treatment. According to the JOURNAL OF THE AMERICAN MEDICAL
ASSOCIATION, clinical laboratories generally experience false negative diagnosis
rates of 5% to 30%.
ADMINISTRATIVE ERRORS. Gathering accurate patient data and ensuring that
the data are correctly matched with the patient's slides provide significant
administrative challenges. Laboratories employ full-time administrative
personnel to assemble patient data, enter patient data on a physical report and
collate that data with the corresponding slide. However, the volume of
information that must be processed and organized manually can lead to
mismatching errors which, in turn, may lead to diagnostic errors.
LITIGATION/LIABILITY RISKS. Failure by a laboratory to properly diagnose a
Pap smear specimen can result in significant legal liability. Because there are
no current means to objectively demonstrate what procedures were conducted by
the cytotechnologist or that 100% of the slide was reviewed, suits claiming
negligent misdiagnosis are difficult to defend and may result in unwarranted
liability.
CYTOPATHOLOGY PRODUCTS
AccuMed's primary focus is on the development and marketing of cytopathology
products that support the review and analysis of cervical Pap smears, including
slide management and mapping and critical data management functions. The
Company's products are designed to automate multiple aspects of the Pap smear
screening process without significantly modifying existing laboratory practices.
The Company's current cytopathology products are the AcCell Series 2000
workstations. The Company has developed and is currently testing a prototype of
the TracCell 2000 slide mapping workstation. The Company is developing software
and hardware for a second generation, fully automated, high volume, mapping
product, the TracCell 3000, to augment its workstation product offering. The
Company is also developing a series of educational and testing products.
THE ACCELL SERIES 2000. The AcCell Series 2000 workstations consist of the
AcCell 2000 and the AcCell 2001. The AcCell 2000 is an interactive
computer-controlled slide handling and precision microscopy workstation that is
supported with comprehensive data management capabilities. The workstation
consists of a high quality precision microscope (supplied by the Company or the
customer), a computer-controlled moveable stage, a bar code reader, a
proprietary slide marking mechanism (the "dotter"), an optional personal
computer for the data management system and a stage-control mouse developed by
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the Company. The system operates in a Microsoft Windows-Registered Trademark-
environment using the Company's proprietary software. The AcCell 2001 contains
all the features of the AcCell 2000 in addition to an automated cassette slide
loading and unloading system which handles up to 30 slides per cassette. The
AcCell 2001 is designed to be used in conjunction with a TracCell 2000.
The AcCell Series 2000 can be linked to the gynecologist's office and to the
laboratory's internal information system in order to provide computerized
support, from the time of entering patient information when the specimen is
taken through the time of generating reports at the laboratory and doctor's
office and finally to billing of the patient or payor. After specimen collection
by the gynecologist, the gynecologist's staff, using software provided by the
Company through the laboratory either on a network or on a disk, enters the
patient's relevant medical history into the system and generates a bar code that
is placed on the slide and the hard copy of the work order sent with the slide
to the laboratory. The bar code contains basic patient information such as the
patient's name and date of specimen collection. The slides and patient data,
either in electronic format or hard copy, are then transferred from the
gynecologist to the clinical laboratory for review.
At the laboratory, the slide is assigned by the laboratory administrator to
the cytotechnologist for review. The slide is placed, either manually or
automatically, on the AcCell stage and is read by the bar code reader to ensure
that proper patient data is displayed on the computer monitor for
cytotechnologist review. The slide is then automatically moved under the
microscope, and the microscope is power-focused by the cytotechnologist. The
AcCell Series 2000 automatically moves the stage under the microscope in a
pattern and at a speed selected by the cytotechnologist that the
cytotechnologist can override at any time. As the slide is moved under the
microscope, the cytotechnologist records into the system's memory the exact
coordinates of abnormal cells by clicking a button on the stage-control mouse.
At the conclusion of the review, selected abnormal cells are automatically
marked by the dotter with a small physical dot on the slide so that they may be
relocated easily for further manual review. The AcCell Series 2000 will record a
complete analysis only after 100% of the slide has been scanned or a sufficient
number of abnormal cells have been located to designate the slide as potentially
positive. Typically, review of a single slide takes five to seven minutes using
the AcCell Series 2000.
After completing review of the slide, the cytotechnologist selects the
appropriate diagnosis from a table in the data management system. The data
management system records all aspects of the Pap smear screening and saves the
information for future review. The AcCell Series 2000 generates management
reports, records the exact location of marked cells for a given specimen,
digitally stores relevant information and provides full documentation for
laboratory quality control and regulatory compliance. The Company believes that
by providing a variety of automated features and a comprehensive data management
system, the AcCell Series 2000 has the potential to reduce the risk of human
slide reading and administrative error.
To extend the functionality of the AcCell Series 2000, several system
configuration options are available, and multiple workstations can be networked
together within a laboratory. The MacroVision-TM-, a proprietary image
enhancement system, can be attached to the AcCell platform in order to allow a
cytotechnologist to view on a monitor the specimen being reviewed under the
microscope. The Company is currently developing proprietary telepathology
software which, if developed, would enable the AcCell workstation to be operated
remotely using the Company's MacroVision product.
Although the Pap smear test is the largest volume cytology test, the
cytopathology laboratory routinely conducts other tests based on samples from
numerous organs and areas of the body, all of which require precision microscopy
and careful management of data to be effectively implemented. Although the
Company is not currently developing any products for these applications, the
Company believes that its AcCell technology may be adapted for use in connection
with the analysis of these tests in a manner similar to that of Pap smear tests.
THE TRACCELL 2000. The Company has developed a prototype of the TracCell
2000 pre-screening, mapping and slide handling product designed to identify and
create a computerized map of empty space and certain non-clinically relevant
areas on the slide and thereby reduce the amount of matter on
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the specimen that must be reviewed by the cytotechnologist using the AcCell
Series 2000. Much of the material contained in a Pap smear specimen is not
clinically relevant to cervical cancer screening. In addition to human cells, a
typical Pap smear slide contains a certain amount of vacant space, blood, mucus
and other non-clinically relevant material. Currently, the cytotechnologist is
required to review all portions of the slide, including those portions that are
not relevant to diagnosis, because there is no basis upon which to distinguish
such material until it is reviewed manually under the microscope.
The TracCell 2000 is designed to first evaluate whether a sample is properly
stained and has sufficient material to be statistically significant. The
TracCell 2000 then automatically pre-screens the slide to locate and create a
computerized map of empty space and certain non-clinically relevant material. In
tests conducted by the Company, it has been demonstrated that the TracCell 2000
can eliminate from 15% to 50% of the slide area to be reviewed. As a result, the
Company believes that the TracCell 2000 has the potential to reduce the time
needed to evaluate specimens and allow the cytotechnologist to focus on more
thoroughly evaluating potential abnormalities.
The TracCell 2000 is designed to be used before the slide is reviewed using
the AcCell 2001. A single TracCell 2000 is designed to support up to five AcCell
2001 instruments based on normal laboratory usage. The TracCell 2000 creates a
pre-screening pattern for the slide based on the computerized map, which is used
by the AcCell 2001 to automatically move the slide to the relevant area and
automatically focus the microscope during the cytotechnologist's review. If the
cytotechnologist wants to alter the pre-screened sequence, he or she can
override the system for a particular slide. Regardless of whether the
cytotechnologist chooses to override the prescribed sequence, the system is
designed to facilitate and document 100% review of the slide. The TracCell 2000,
if successfully developed and cleared by the FDA or other applicable regulatory
authorities for marketing, will be marketed with software for which the
laboratory will pay a software license fee each time a slide is reviewed.
The Company is currently testing the TracCell 2000 with the goal of
supporting the filing of a 510(k) Notification by the end of 1996. There can be
no assurance that the testing will be successfully completed, that the 510(k)
Notification will be submitted to the FDA on a timely basis, if ever, that the
FDA or other applicable regulatory authorities will clear the TracCell 2000 or
that the TracCell 2000 will be successfully marketed. See "Risk Factors --
Uncertainty of Market Acceptance and Initial Investment in Cytopathology
Products," "-- Delayed or Unsuccessful Product Development" and "-- Government
Regulation."
THE TRACCELL 3000. The Company is developing a second generation specimen
pre-screening and slide mapping product, the TracCell 3000, to further automate
the mapping process. The TracCell 3000, if successfully developed, will
eliminate not only empty space, debris and other material eliminated by the
TracCell 2000, but will also eliminate certain normal cellular material. The
Company believes, based on preliminary studies it has conducted, that the
technology embodied in the TracCell 3000 may be capable of further reducing the
portion of the specimen required to be reviewed by the cytotechnologist. The
TracCell 3000 is being designed to accommodate automated mapping of 500 slides
per eight hour period. Further testing and development and additional resources
are necessary to determine whether a commercially viable TracCell 3000
instrument can be developed. Development of the TracCell 3000 is subject to all
of the risks associated with the development of new products based on innovative
technologies and new software, including unanticipated technical or other
problems and the possible insufficiency of the funds allocated for the
completion of such development, which could result in a change in the design,
delay in the development, or abandonment of such products. There can be no
assurance that the Company will successfully develop the TracCell 3000, that the
TracCell 3000 will be cleared or approved for marketing by the FDA or other
applicable regulatory authorities, or that the TracCell 3000 will be
successfully marketed. See "Risk Factors -- Uncertainty of Market Acceptance and
Initial Investment in Cytopathology Products," "-- Delayed or Unsuccessful
Product Development," "-- Significant Capital Requirements; Dependence on
Proceeds of the Offering; Possible Need for Additional Capital" and "--
Government Regulation."
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CYTOPATHOLOGY EDUCATIONAL AND TRAINING PRODUCTS. The Company has recently
developed the MacroVision feature, a specially modified AcCell product for
on-screen specimen review. This system can also be used by teaching institutions
and laboratories to provide hands-on cytotechnology training through a single
microscope. Cytotechnologists are required by CLIA to attain and maintain
minimum standards of competence, and cytology laboratories are charged with
ensuring that their cytology professionals meet such competency standards
through continuing training and testing. Current training and testing involve
the use of multiple microscopes or specialized microscopes equipped with
multiple eyepieces which are difficult to use. Using the MacroVision feature,
the teacher or trainer can display the specimen being reviewed on one or more
computer monitors. The monitor can be viewed directly by the students or can be
linked with other computers and monitors to provide remote or even off-site
viewing. For testing purposes, AccuMed is also developing a glass slide
Proficiency Testing Station that provides automated scoring of the screener's
locator and identification skills on user defined test slide sets.
In addition, the Company is developing the Relational Cytopathology
Reference Guide (the "Reference Guide"), a library of electronically stored,
digitized cell images. The Reference Guide may be used in training to allow
students to analyze typical and atypical specimens as slides are being reviewed.
In the clinical laboratory, the Reference Guide is being designed to provide a
reference database to assist the cytotechnologist and cytopathologist in Pap
smear analysis. Each of the Company's educational products is being designed to
record and document continuing education activity to assist in compliance with
CLIA requirements.
POTENTIAL ACQUISITION OF INTEREST IN ONCOMETRICS
In August 1996, the Company entered into definitive agreements to acquire a
two-thirds equity interest in Oncometrics for aggregate consideration of $4.0
million in cash.
Oncometrics was formed in 1995 as a wholly-owned subsidiary of Xillix to
complete the development of an automated instrument designed to be used in the
detection, diagnosis and prognosis of early-stage cancer by measuring the DNA in
cells on microscope slides. Oncometrics is developing a proprietary high
resolution image cytometer that uses a solid state microscope, a high resolution
digital camera, proprietary image analysis software and high speed computer
processors to capture and analyze cell images from a microscope slide that has
been stained using Oncometrics' proprietary staining method. Prototypes of the
Oncometrics instrument have been developed that are capable of isolating small
variations in cell nucleus DNA, which assists the cytotechnologist in detecting
lung cancer in an early stage of development. Because the presence of cancer
cells can cause changes in the nuclear DNA of normal cells, in some cases the
Oncometrics instrument can detect cancer even in the absence of cells with
visibly detectable disease.
Oncometrics has demonstrated the feasibility of its technology as it applies
to the detection of early cancer in lung mucus. Oncometrics believes that its
technology may be potentially applied to other types of cancer, such as cervical
cancer.
Oncometrics is currently testing several prototypes of its instrument with
scientists and cancer research institutions. There can be no assurance that
Oncometrics or the Company will, if the Oncometrics Acquisition is completed,
successfully develop this instrument for lung or cervical or other cancer
applications or, if developed, that this instrument will be approved for
marketing by the FDA or other applicable regulatory authorities or that it will
be successfully marketed. See "Risk Factors -- Delayed or Unsuccessful Product
Development" and "-- Government Regulation."
Of the consideration, $2.0 million is to be paid to Xillix for currently
outstanding Oncometrics stock and $2.0 million is to be paid to Oncometrics in
consideration for newly issued Oncometrics stock. The Company expects to use a
portion of the net proceeds of the Offering to fund the Oncometrics Acquisition.
Consummation of the transactions with Xillix and Oncometrics is subject to
various conditions, including consummation of the Offering, the satisfactory
completion by the Company of a due diligence review with respect to intellectual
property matters and the execution of a definitive shareholders agreement
pursuant to which Xillix and the Company will provide operating funding to
Oncometrics on a pro rata basis as well as a related operating agreement. The
Company's portion of such operating
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funding is estimated to be $1.0 million, although it could be higher, and is
expected to be provided during the second year following the date of this
Prospectus. There can be no assurance that the Oncometrics Acquisition will be
consummated. See "Use of Proceeds" and "Risk Factors -- Significant Capital
Requirements; Dependence on Proceeds of the Offering; Possible Need for
Additional Capital."
CYTOPATHOLOGY SALES AND MARKETING
Pap smear screening is performed in approximately 4,500 laboratories in the
United States. The Company is currently marketing the AcCell Series 2000
workstations to the clinical laboratory market, primarily in the United States.
In order to expand its markets, the Company is implementing a dual-track
marketing strategy pursuant to which it intends to enter into distribution
arrangements with major market participants, as well as establish a direct
marketing group to support the marketing activities of its distribution
partners. The Company intends to tailor its marketing strategy by region and
country as appropriate to address significant differences among such markets.
The AcCell Series 2000 is distributed in the Olympus Territory by Olympus
America pursuant to an exclusive agreement entered into in May 1996. The Company
currently has a two-person direct cytopathology sales force and is planning to
add additional sales personnel to support distributors of its products.
Olympus America is a leading supplier of precision microscopes to the
cytology market in the United States and throughout the Olympus Territory. The
Olympus Agreement grants to Olympus America exclusive third party distribution
rights to the AcCell Series 2000 and the TracCell 2000 in the Olympus Territory
through May 1999. These products are expected to be incorporated with the
Olympus microscope and marketed under and labeled with the Olympus America and
AcCell names. The Olympus Agreement permits the Company to conduct direct sales
efforts in the Olympus Territory and direct or indirect sales efforts throughout
the world. Olympus America is required to purchase specified minimum units of
the AcCell Series 2000 in each year of the term, although direct sales by the
Company in the Olympus Territory can be used to satisfy the minimum purchase
obligation. Olympus America has a right of first refusal to distribute in the
Olympus Territory certain additional cytopathology products that may be
developed by AccuMed. The Company's direct sales staff will work in concert to
train the Olympus America sales team and support their efforts at industry trade
shows and conventions, and will be compensated directly by Olympus America for
providing training and installation support for the distributed products.
MICROBIOLOGY
The Company develops, manufactures and markets IN VITRO diagnostic tests for
the clinical laboratory, veterinary and pharmaceutical markets. The Company
offers the microbiology laboratory a variety of FDA-cleared products, under the
trade name Sensititre, for identifying bacteria suspected of causing infections
and measuring the susceptibility of such bacteria to different types and
concentrations of antibiotics. The Company has recently entered into an
agreement (the "CMS Agreement") with CMS whereby CMS has been granted exclusive
rights to distribute the Company's Sensititre product line in the United States.
AccuMed's microbiology products include a series of disposable test kits and
a range of automated instruments. The Company also markets alamarBlue, a
proprietary, non-toxic indicator reagent that measures cell growth for IN VITRO
testing. The Company is developing the KB Reader, an automated instrument
designed to read the results of a Kirby-Bauer method susceptibility test. In
conjunction with RADCO, the Company is also developing the FluoreTone 48, a
diagnostic microbiology test panel and an automated reading instrument. There
can be no assurance that any such products will be successfully developed, that
such products will be cleared or approved for marketing by the FDA or other
applicable regulatory authorities, or that such products will be successfully
marketed. See "Risk Factors -- Delayed or Unsuccessful Product Development" and
"-- Government Regulation."
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BACKGROUND
MIC/ID testing by hospitals and laboratories assists physicians, other
health care professionals and veterinarians in determining the most effective
course of treatment for bacterial infections. MIC/ID testing technology measures
the ability of organisms or cells to grow in different combinations and
concentrations of an antibiotic or other introduced substance. By measuring
growth, MIC/ID testing products can, for example, provide physicians and
veterinarians guidance in determining which antibiotics are most effective in
treating a given case of bacterial infection.
Current MIC/ID testing technology consists of (i) a variety of methodologies
employing a plastic panel with a matrix of testing microwells and (ii) the
Kirby-Bauer disk diffusion method. Panel testing technology involves the
placement of a solution known as a "reagent" containing selected antibiotics in
a matrix of microwells and adding to each microwell a broth which contains a
sample of the patient's blood or other fluid in which bacteria may be present.
After an incubation period, the effectiveness of the antibiotic can be
determined by observing chemical changes to the solution. By constructing a
matrix of testing wells with specific antibiotics in increasing concentrations,
it is possible to determine not only the effectiveness of a given antibiotic but
also the minimum required dosage. Kirby-Bauer testing involves placing paper
disks impregnated with a selected antibiotic in a culture containing bacterium
and observing, after the incubation period, whether the bacterium continues to
grow in proximity to the disk. The results of a Kirby-Bauer test determine
whether a given antibiotic is effective against the bacterium, but, unlike panel
testing, offer no information as to the minimum dosage required.
MICROBIOLOGY PRODUCTS
SENSITITRE. Sensititre, which was acquired by the Company in 1995, first
began offering MIC/ID testing products over 15 years ago. Sensititre was one of
the first companies to introduce a range of systems for MIC/ID testing utilizing
microwell panel technology. The Sensititre products incorporate a range of
accessories including substrate strips, dosing heads, broths, and test panels
for both susceptibility and identification applications. The Sensititre panels
have significant advantages over competitors, including a two-year shelf life
and the ability to be stored at room temperature. The Sensititre product line
also includes four automated instruments, each of which uses compatible
technologies, and allows customers to upgrade without replacing the entire
system. The AutoReader-TM- is a microprocessor-based fluorimeter designed to
automatically and rapidly measure intensity levels of fluorescence from MIC/ID
testing panels. ARIS-TM- is a fully automated panel handling, incubating and
reading instrument that offers robotic processing of testing plates.
SensiTouch-TM- is a device that guides the user through the manual reading of
Sensititre susceptibility test panels and transmits the data to a host computer.
The AutoInoculator-TM- is a rapid microprocessor-controlled dispensing
instrument designed to automatically deliver the proper amount of the patient's
specimen to a Sensititre test panel. The Company also offers the Sensititre
Automated Microbiology System, which is a sophisticated data management system
that provides a wide range of data tracking and reporting capabilities.
ALAMARBLUE. The Company manufactures and markets alamarBlue, a proprietary,
non-toxic, water-soluble indicator reagent that measures cell growth for IN
VITRO testing. alamarBlue has applications in biological research, bacteria
testing, toxicity testing for consumer products, and pharmaceutical and
therapeutic research. For example, companies that produce consumer products such
as soaps, shampoos, lotions or cosmetics can conduct IN VITRO cell culture
toxicity tests in lieu of live animal testing. The Company has marketed a series
of MIC/ID panel tests using alamarBlue under the trade name Alamar. The Company
is currently negotiating to enter into an agreement pursuant to which a third
party would manufacture the Alamar microbiology products, other than alamarBlue,
although there can be no assurance that such an agreement can be reached.
In October 1995, the Company entered into the Becton Agreement pursuant to
which Becton has rights in and to the Company's alamarBlue technology and
related trade secrets, know-how and patent rights (the "Licensed Technology")
for the production and sale of disposable anti-microbial testing panels. The
worldwide license is exclusive to Becton for certain applications in the
microbiology market; however, the license permits the Company to continue to
exploit the Licensed Technology, subject to
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certain restrictions on the Company's ability to sublicense the Licensed
Technology or to engage in significant transactions with substantial competitors
of Becton. Becton is obligated to pay royalties on net sales of any product
which encompasses or incorporates the Licensed Technology for five years
following the first commercial use of the Licensed Technology, subject to
certain conditions and restrictions, and Becton has paid the Company a total of
$3.5 million, which includes $500,000 creditable against future royalties. To
the Company's knowledge, as of the date of this Prospectus, Becton has not
produced or sold any products incorporating the Licensed Technology. See
"Management's Discussion and Analysis of Financial Condition and Results of
Operations."
KB READER. In February 1996, the Company entered into a license and
distribution agreement with Biokit, S.A., Barcelona, Spain, to develop a low
cost KB Reader designed to read automatically the results of a Kirby-Bauer
method susceptibility test. Currently, most laboratories interpret the results
of a disk diffusion test visually and manually enter the test result. The
Company has licensed from Biokit, S.A. certain software algorithms that are
intended to be integrated into the hardware being developed by the Company. The
Company has developed a prototype KB Reader and expects to begin clinical trials
by the end of 1996. The Company has an exclusive worldwide license to
manufacture and market the KB Reader, except that Biokit, S.A. has exclusive
rights to market the KB Reader in Italy and may also market the KB Reader in any
country in which the Company does not at such time directly or indirectly market
the KB Reader. Development of the KB Reader is subject to all of the risks
associated with the development of new products based on innovative technologies
and new software, including unanticipated technical or other problems and the
possible insufficiency of the funds allocated for the completion of such
development, which could result in a change in the design, delay in the
development, or abandonment of such products. Consequently, there can be no
assurance that the KB Reader will be successfully developed, that the KB Reader
will be cleared for marketing by the FDA or other applicable regulatory
authorities or that the KB Reader will be successfully marketed. See "Risk
Factors -- Delayed or Unsuccessful Product Development," "-- Significant Capital
Requirements; Dependence on Proceeds of the Offering; Possible Need for
Additional Capital" and "-- Government Regulation."
POTENTIAL ACQUISITION OF RADCO
In March 1996, the Company and certain investors formed RADCO for the
purpose of developing a diagnostic microbiology test panel and an automated
reading instrument. The RADCO automated product would allow AccuMed to provide a
single product to both low-end and high-end volume users. RADCO was initially
capitalized through the private placements of units consisting of an aggregate
of 400,000 shares of RADCO common stock (the "RADCO Stock"), the RADCO Notes in
the aggregate principal amount of approximately $1.2 million (bearing interest
at a rate of 10% per annum) and warrants to purchase an aggregate of 687,500
shares of AccuMed Common Stock with a weighted average exercise price of $3.73
per share. In consideration for the issuance of such warrants, the Company
received 10% of the outstanding RADCO Stock. In August 1996, the Company entered
into a definitive agreement to acquire the outstanding RADCO Stock not owned by
it and to retire the outstanding RADCO Notes at an aggregate cost to the Company
of approximately $1.4 million in cash. The Company expects to use a portion of
the net proceeds of the Offering to fund the RADCO Acquisition. Consummation of
the transaction is subject to various conditions, including consummation of the
Offering. There can be no assurance that the transaction will be consummated.
Development of the FluoreTone 48 diagnostic test panel and automated reading
instrument is subject to all of the risks associated with the development of new
products based on innovative technologies and new software, including
unanticipated technical or other problems and the possible insufficiency of the
funds allocated for the completion of such development, which could result in a
change in the design, delay in the development, or abandonment of such products.
Consequently, there can be no assurance that the FluoreTone 48 will be
successfully developed, that the FluoreTone 48 will be cleared or approved for
marketing by the FDA or other applicable regulatory authorities or that the
FluoreTone 48 will be successfully marketed. See "Risk Factors -- Delayed or
Unsuccessful Product Development," "-- Significant Capital Requirements;
Dependence on Proceeds of the Offering; Possible Need for Additional Capital"
and "-- Government Regulation."
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MICROBIOLOGY SALES AND MARKETING
The Company's Sensititre products are marketed in the pharmaceutical,
veterinary laboratory and clinical/hospital reference laboratory markets. The
Company's Sensititre microbiology products will be distributed in the United
States pursuant to the CMS Agreement entered into with CMS in September 1996.
The CMS Agreement grants to CMS exclusive rights to distribute the Company's
Sensititre microbiology products in the United States. The CMS Agreement
contains no minimum purchase obiligation. The Company is required to provide
training and technical support to the sales personnel and customers of CMS. The
CMS Agreement expires on December 31, 2000; however, it may be terminated
without cause by either party upon six months' prior written notice. The Company
markets alamarBlue directly to industrial and research customers, including the
biotechnology industry. Prior to execution of the CMS Agreement, the Company
marketed its microbiology products in the United States through a seven-person
direct sales staff and in certain foreign countries through exclusive diagnostic
manufacturers and distributors. Most sales to the veterinary market are through
direct sales. alamarBlue is being marketed by the Company, primarily to
industrial and research customers, directly through advertising and trade shows.
COMPETITION
The Company believes that the principal competitive factors in the market
for both cytopathology and microbiology products include functionality and
product features, effectiveness of the product in standard medical practice, the
cost of the product to the laboratory and the demonstrated cost/benefit
justification for purchasing new products. The Company believes that it is also
important to provide products that enhance and assist standard practice rather
than products that require completely new practices.
The Company's AcCell Series 2000 currently faces and the TracCell 2000, if
successfully developed and cleared for marketing, will face competition from
companies that have developed or may be developing competing systems. The
Company believes that many of the Company's existing and potential competitors
possess substantially greater financial, marketing, sales, distribution and
technical resources than the Company, and more experience in research and
development, clinical trials, regulatory matters, manufacturing and marketing.
The Company is aware of two companies that currently market imaging systems to
re-examine or rescreen conventional Pap smear specimens previously diagnosed as
negative as well as two companies that are developing devices for the
preparation and analysis of Pap smear slides. The Company is aware that at least
one such company has submitted an imaging system for use as a primary means of
screening Pap smear slides under a PMA application. Another company markets a
manual rescreening test claimed to detect the presence of cervical cancer using
reagents to detect certain RNA/DNA hybrid cells. If any company currently
marketing rescreening products receives FDA clearance or approval for use of its
product as a primary screening system to replace or work in conjunction with
conventional Pap smear screening or if automated analysis systems are developed
and receive FDA clearance or approval, the use of conventional Pap smear
screening could be substantially affected and the Company's business, financial
condition and results of operations would be materially adversely affected.
The market for the Company's current and, if developed, proposed
microbiology products is highly competitive, and the Company competes with
numerous well-established foreign and domestic companies, many of which possess
substantially greater financial, technical, marketing, personnel and other
resources than the Company and have established reputations for success in the
development, sale and service of manual and/or automated IN VITRO diagnostic
testing products. A significant portion of the MIC/ID testing market in the
United States is controlled by MicroScan and bioMerieux Vitek. These companies
market a range of medically related products and have resources far greater than
those of the Company. Difco has been issued a U.S. patent covering technology
related to the alamarBlue technology covered in one of the Company's patents.
There can be no assurance that Difco, which has substantially greater resources
and experience in research, development, manufacturing and marketing than the
Company, will not use its patented technology to develop products that will
compete directly with the Company's microbiology products.
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The medical diagnostics industry is characterized by rapid product
development and technological advances. The Company expects its competitors to
continue to attempt to improve the design and performance of their current
products and to introduce new systems and processes with improved price/
performance characteristics. There can be no assurance that other technologies
or products that are functionally similar to those of the Company are not
currently available or under development, or that other companies with expertise
and resources that would encourage them to attempt to develop and market
competitive products will not develop new products that compete directly with
the Company's products. The Company's products could be rendered obsolete or
uneconomical by the introduction and market acceptance of competing products,
technological advances of the Company's current or potential competitors, or by
other approaches. There can be no assurance that the Company will be able to
compete successfully against current or future competitors or that competition,
including the development and commercialization of new products and technology,
will not have a material adverse effect on the Company's business, financial
condition and results of operations.
MANUFACTURING
The Company assembles and tests its cytopathology products at its Chicago
manufacturing facility. The Company's microbiology products are manufactured at
the Company's GMP-approved manufacturing facility in England. The Company is
currently seeking to enter into an agreement pursuant to which a third party
would manufacture the Company's Alamar microbiology products, other than
alamarBlue. However, there can be no assurance that such an agreement can be
reached. If such an agreement is not reached, the Company intends to cease
manufacturing such products. The Company believes that it has sufficient
manufacturing capacity to meet production requirements for the foreseeable
future. Product components are purchased or are custom fabricated by third party
vendors. The Company has purchased and modified the stage-control mouse for use
with the AcCell Series 2000 but is currently developing a proprietary
stage-control mouse which it expects to manufacture along with the AcCell Series
2000. The Company has only recently begun to scale up its manufacturing capacity
for the AcCell Series 2000. The Company is also currently developing the
manufacturing processes for the TracCell 2000. There can be no assurance that
the Company will be able to sell sufficient numbers of systems or develop volume
manufacturing processes that will lead to the cost-effective manufacture of the
AcCell Series 2000 or the TracCell 2000. See "Risk Factors -- Uncertainty of
Profitable Cytopathology Manufacturing."
Certain key components and raw materials used in the manufacturing of the
Company's products are currently provided by single-source vendors. Although the
Company believes that alternative sources for such components and raw materials
are available, any supply interruption in a single-sourced component or raw
material would have a material adverse effect on the Company's ability to
manufacture products until a new source of supply were qualified. There can be
no assurance that the Company would be successful in qualifying additional
sources on a timely basis, if ever, which would have a material adverse effect
on the Company's business, financial condition and results of operations. In
addition, an uncorrected impurity or a supplier's variation in a raw material,
either unknown to the Company or incompatible with the Company's manufacturing
process, could have a material adverse effect on the Company's ability to
manufacture products. See "Risk Factors -- Dependence on Suppliers."
RESEARCH AND DEVELOPMENT
The Company's research and development efforts are focused on introducing
new products as well as enhancement of its existing products. The Company
believes that a commitment to research and development is critical to its
ability to achieve its strategic plan. During the fiscal years ended September
30, 1994 and 1995, the three month transition period ended December 31, 1995
(during which the Company had suspended research and development activities
prior to consummation of the Merger) and the six months ended June 30, 1996, the
amounts recorded for research and development were $580,000, $387,000, $4.0
million and $4.8 million, respectively. Of the amounts recorded for the three
month transition period ended December 31, 1995 and the six months ended June
30, 1996, $4.0 million
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and $3.5 million, respectively, reflected certain significant non-cash charges
against operations representing the write-off of in-process research and
development acquired in connection with the Merger. See "Management's Discussion
and Analysis of Financial Condition and Results of Operations."
INTELLECTUAL PROPERTY
The Company relies on a combination of patents, licensing arrangements,
trade names, trademarks, trade secrets, know-how and proprietary technology and
policies and procedures for maintaining the secrecy of trade secrets, know-how
and proprietary technology in order to secure and protect its intellectual
property rights. The Company has filed or been assigned eight U.S. patent
applications (one of which has been abandoned) and nine foreign patent
applications covering certain aspects of its cytopathology products, and four
U.S. patent applications, one Japanese patent application and one Canadian
patent application related to its microbiology products. Additional U.S. and
foreign patent applications covering the Company's cytopathology products are
being prepared. The Company holds certain licenses on several U.S. and foreign
patents and other intellectual property rights regarding aspects of the
technology embodied in the Sensititre product line and is the licensee of
certain automated cell analysis technology. The Company holds a U.S. patent and
has received a notice of intent to grant a related European patent with respect
to a portion of the alamarBlue microbiology technology.
None of the Company's patent applications has been granted as of the date of
this Prospectus, and there can be no assurance that any such patent application
will result in an issued patent. The Company may, in the future, file additional
patent applications; however, there can be no assurance that the Company will be
successful in obtaining approval of any future patent applications it files with
respect to its technologies. In addition, since patent applications in the
United States are maintained in secrecy until patents issue, and since
publications of discoveries in the scientific or patent literature tend to lag
behind actual discoveries by several months, the Company cannot be certain that
the Company or other relevant patent application filer was the first creator of
inventions covered by pending patent applications or that such persons were the
first to file patent applications for such inventions.
There also can be no assurance that any patents, patent applications and
patent licenses will adequately cover the Company's technologies. Protections
relating to portions of such technologies may be challenged or circumvented by
competitors, and other portions may be in the public domain or protectable only
under state trade secret laws.
The Company owns two U.S. trademark registrations for the trademark
"Sensititre," has filed U.S. trademark applications for the trademarks "AcCell,"
"MacCell," "FluoreTone," "SpeciFind," "Relational Cytopathology Review Guide,"
"MacroVision" and "TracCell" and is currently preparing one more trademark
application for filing. The Company may file additional U.S. and foreign
trademark applications in the future. However, no trademark registrations have
yet been granted to the Company, and there can be no assurance that any such
registrations will be granted. In addition, there can be no assurance that third
parties have not or will not adopt or register marks that are the same or
substantially similar to those of the Company, or that such third parties will
not be entitled to use such marks to the exclusion of the Company. Selecting new
trademarks to resolve such situations could involve significant costs, including
the loss of goodwill already gained by the marks previously used.
The Company relies for protection of its trade secrets, know-how and
proprietary technology on nondisclosure and confidentiality agreements with its
employees, consultants, distributors, suppliers, researchers and advisors. There
can be no assurance that such agreements will provide meaningful protection for
the Company's trade secrets, know-how or proprietary technology in the event of
any unauthorized use or disclosure of such information. In addition, others may
obtain access to, or independently develop, technologies or know-how similar to
that of the Company.
There can be no assurance that the Company's patents, patent applications,
patent licenses, trademarks and trade secret protections will adequately protect
the Company from potential infringement or misappropriation by third parties.
Historically, the Company has been required to undertake costly litigation to
enforce its intellectual property rights. Although the Company is not currently
aware of any potential infringement, future litigation by the Company may be
necessary to enforce its patent rights, as
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well as to protect its trade secrets, know-how and proprietary technology, or to
determine the scope and validity of the proprietary rights of others. Any such
litigation could result in substantial cost to and diversion of effort by the
Company.
The Company's success will also depend on its ability to avoid infringement
of patent or other proprietary rights of others. The Company is not aware that
it is infringing any such rights of a third party, nor is it aware of
proprietary rights of others for which it will be required to obtain a license
in order to develop its products. However, there can be no assurance that the
Company is not infringing the proprietary rights of others, or that the Company
will not be required to defend itself against claimed infringement of the rights
of others. Adverse determinations in any such litigation could subject the
Company to significant liability to third parties, could require the Company to
seek licenses from third parties and could prevent the Company from
manufacturing, selling or using certain of its products or technologies, any of
which could have a material adverse effect on the Company.
GOVERNMENT REGULATION
The Company's products and manufacturing processes are regulated by state
and federal authorities, including the FDA and comparable authorities in certain
states and other countries. Failure to comply with the FD&C Act and any
applicable regulatory requirements can result in, among other things, civil and
criminal fines, product recalls, detentions, seizures, injunctions and criminal
prosecutions.
United States regulatory requirements promulgated under the FD&C Act provide
that many of the Company's products may not be shipped in interstate commerce
without prior authorization from the FDA. Such authorization is based on a
review by the FDA of the product's safety and effectiveness for its intended
uses. Medical devices may be authorized by the FDA for marketing in the United
States either pursuant to a 510(k) Notification or a PMA. The process of
obtaining clearances or approvals from the FDA and other applicable regulatory
authorities can be expensive, uncertain and time consuming, frequently requiring
several years from the commencement of clinical trials or submission of data to
the receipt of regulatory approval.
A 510(k) Notification, among other things, requires an applicant to show
that its products are "substantially equivalent" in terms of safety and
effectiveness to existing products that are currently permitted to be marketed.
An applicant is permitted to begin marketing a product as to which it has
submitted a 510(k) Notification at such time as the FDA issues a written finding
of substantial equivalence. Requests for additional information may delay the
market introduction of certain of an applicant's products and, in practice,
initial clearance of products often takes substantially longer than the FDA pre-
market notification review period of 90 days.
A PMA consists of the submission to the FDA of information sufficient to
establish independently that a device is safe and effective for its intended
use. A PMA must be supported by extensive data, including preclinical and
clinical trial data, as well as extensive literature to prove the safety and
effectiveness of the device. By statute, the FDA is required to respond to a PMA
within 180 days from the date of its submission; however, the approval process
usually takes substantially longer, often as long as several years. During the
review period, the FDA may conduct extensive reviews of the Company's
facilities, deliver multiple requests for additional information and
clarifications and convene advisory panels to assist in its determination.
FDA clearances and approvals, if granted, may include significant
limitations on the intended uses for which a product may be marketed. FDA
enforcement policy strictly prohibits the promotion of cleared or approved
medical devices for non-approved or "off-label" uses. In addition, product
clearances or approvals may be withdrawn for failure to comply with regulatory
standards or the occurrence of unforeseen problems following initial marketing.
Under current interpretation of FDA regulations, marketing of the AcCell
Series 2000 in the United States does not require FDA clearance or approval.
Marketing of the TracCell 2000 in the United States, however, will require
pre-marketing clearance or approval by the FDA. The Company anticipates that
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<PAGE>
such clearance will be sought through submission to the FDA of a 510(k)
Notification rather than a PMA. The Company is currently conducting the required
testing of the TracCell 2000 and expects to submit a 510(k) Notification with
respect to the TracCell 2000 by the end of 1996. There can be no assurance that
the Company will successfully complete the necessary testing on a timely basis,
if ever, that a 510(k) Notification with respect to the TracCell 2000 will be
submitted to the FDA by the end of 1996, if ever, or that the FDA will clear the
TracCell 2000 for marketing in the United States on a timely basis, if ever. It
is also possible that the FDA could require a PMA for the TracCell 2000, which
would result in significant delays in bringing the TracCell 2000 to the U.S.
market and could have a material adverse effect on the Company's business,
financial condition and results of operations.
Under current interpretation of FDA regulations, marketing of the Company's
MIC/ID microbiology products in the United States requires FDA clearance through
the 510(k) Notification process. With respect to the Company's MIC/ID testing
products, 510(k) Notifications must be filed and cleared with respect to each
antibiotic used. The Company may submit applications to add individual
antibiotics to those previously cleared as the market warrants. However, there
can be no assurance that clearances will continue to be obtained or that
obtained clearances will not be withdrawn.
At the current time, alamarBlue is marketed for use in the industrial and
research markets and therefore does not require FDA clearance or approval. The
FDA could change its interpretation of the regulations and require a 510(k)
Notification or PMA submission which, if pursued, may not be cleared or approved
or, if approved, may contain certain significant limitations on the intended
uses for which the product is marketed.
Marketing in the United States of the Company's products under development
may require additional FDA clearances or approvals. For example, the Company's
proposed automated pre-screening, specimen mapping workstation, the TracCell
3000, if developed, may not be sold in the United States unless and until the
Company has obtained FDA clearance or approval, either through a 510(k)
Notification or a PMA. In addition, marketing of the Company's proposed KB
Reader and other proposed microbiology products, if developed, is likely to
require FDA clearance through 510(k) Notifications. The Company is currently
conducting research and development with respect to such products and has not
yet begun clinical trials. There can be no assurance that any such products will
be developed or, if developed, that such products will be cleared or approved
for marketing by the FDA or other applicable regulatory authorities or, if such
clearance or approval is received, that such clearance or approval will not be
withdrawn. See "-- Cytopathology -- Cytopathology Products" and "-- Microbiology
- -- Microbiology Products."
Sales of medical devices outside of the United States are subject to foreign
regulatory requirements that vary from country to country. The time required to
obtain approval by a foreign country may be longer or shorter than that required
for FDA clearance or approval, and the requirements may differ. Export sales of
certain devices that have not received FDA marketing clearance or approval
generally are subject to both FDA export permit requirements and, in some cases,
general U.S. export regulations. In order to obtain a FDA export permit, the
Company may be required to provide the FDA with documentation from the medical
device regulatory authority of the country in which the purchaser is located. No
assurance can be given that foreign regulatory approvals will be granted on a
timely basis, if ever, or that the Company will not be required to incur
significant costs in obtaining or maintaining its foreign regulatory approvals.
The Company intends to seek ISO 9001 qualification, an international
manufacturing quality standard, and to seek the "CE" mark for the AcCell Series
2000 and proposed products. The CE mark is recognized by countries that are
members of the European Union and the European Free Trade Association and,
effective in 1998, will be required to be affixed to all medical devices sold in
the European Union. The AcCell Series 2000 is expected to be certified as
complying with CE mark requirements upon completion of the CE mark qualification
process which is underway; however, no assurance can be given
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<PAGE>
that the Company will obtain the CE mark for the AcCell Series 2000 or any
proposed products or satisfy ISO 9001 standards, or that any product that the
Company may develop or commercialize will obtain the CE mark or will obtain any
other required regulatory clearance or approval on a timely basis, if ever.
The Company is subject to certain FDA registration, record-keeping and
reporting requirements, and certain of the Company's manufacturing facilities
are obligated to follow FDA GMP regulations and are subject to periodic FDA
inspection. Any failure to comply with GMP regulations or any other FDA or other
govermment regulations could have a material adverse effect on the Company's
business, financial condition and results of operations.
In July 1996, the Company received from the FDA a warning letter regarding
certain procedures used in connection with the manufacture of its microbiology
products at the Sensititre facility in the United Kingdom. In such letter, the
FDA stated that the Company manufactured sterile products at such facility and
was not in compliance with GMP regulations relating to the manufacture of
sterile products. On August 7, 1996, the Company submitted a written response to
the FDA asserting that the products manufactured at the Sensititre facility are
not sterile. The FDA has acknowledged in writing that the products are not
represented as sterile and accepted the Company's GMP responses as adequate. The
FDA has indicated that it will verify the Company's implementation during its
next inspection and that import of the Company's devices will be permitted to
continue.
Federal, state and foreign regulations regarding the manufacture and sale of
healthcare products and diagnostic devices are subject to future change. The
Company cannot predict what material impact, if any, such changes might have on
its business. Future changes in regulations or enforcement policies could impose
more stringent requirements on the Company, compliance with which could
adversely affect the Company's business. Such changes may relax certain
requirements, which could prove beneficial to the Company's competitors and thus
adversely affect the Company's business. In addition, regulations of the FDA,
including GMP regulations, and state and foreign laws and regulations, depend
heavily on administrative interpretations, and there can be no assurance that
future interpretations made by the FDA, or other regulatory authorities, with
possible retroactive effect, will not adversely affect the Company. See "Risk
Factors -- Technological Change and Competition."
In addition to the regulations directly pertaining to the Company and its
products, many of the Company's existing and potential customers are subject to
extensive regulation and governmental oversight. Regulatory changes in the
healthcare industry that adversely affect the business of the Company's
customers could have a material adverse effect on the Company's business,
financial condition and results of operations.
There can be no assurance that the Company will be able to obtain necessary
regulatory approvals or clearances in the United States or internationally on a
timely basis, if ever. Delays in the receipt of, or failure to receive, such
approvals or clearances, the loss of previously received approvals or
clearances, or failure to comply with existing or future regulatory requirements
would have a material adverse effect on the Company's business, financial
condition and results of operations.
EMPLOYEES
As of October 1, 1996, the Company had a total of 90 employees, of whom two
are part-time employees, in the following departments: 21 in general and
administrative, 15 in sales and marketing, 34 in manufacturing and 20 in
research and development. The Company considers its relations with its employees
to be good.
FACILITIES
The Company currently leases (i) a 5,088 square foot facility at 900 North
Franklin Street, Chicago, Illinois, pursuant to a lease expiring September 30,
2004, and (ii) an additional 3,110 square foot facility located at 920 North
Franklin Street, Chicago, Illinois, pursuant to a lease expiring September 30,
2004, each subject to renewal by the Company. The Company's executive offices
were relocated to the 900
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North Franklin Street facility in July 1996. Collectively, the Company's
Chicago, Illinois facilities also house its research and development facilities,
an engineering laboratory and cytopathology product assembly facilities.
The Company also leases a 10,980 square foot facility in Westlake, Ohio,
pursuant to a five year lease expiring April 1, 2000 which is renewable by the
Company. Sensititre leases an 18,000 square foot microbiology manufacturing
facility in East Grinstead, West Sussex, England, pursuant to a lease expiring
in 2009.
The Company believes that its facilities are adequate for its proposed needs
through 1996 and that additional suitable space is likely to be available, if
required.
LEGAL PROCEEDINGS
The Company is not currently a party to any material litigation and is not
aware of any pending or threatened litigation against the Company that could
have a material adverse effect upon the Company's business, operating results or
financial condition.
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MANAGEMENT
EXECUTIVE OFFICERS, KEY EMPLOYEES AND DIRECTORS
The executive officers, key employees and directors of the Company and their
ages are as follows:
<TABLE>
<CAPTION>
NAME AGE POSITION
- --------------------------------------------- --------- ------------------------------------------------------------
<S> <C> <C>
Peter P. Gombrich............................ 58 Chairman of the Board, Chief Executive Officer and President
Norman J. Pressman, Ph.D..................... 47 Senior Vice President of AccuMed and President,
Cytopathology Division
Michael D. Burke............................. 46 Senior Vice President of AccuMed and President, Microbiology
Division
Leonard R. Prange............................ 51 Chief Financial Officer, Corporate Vice President
Richard A. Domanik, Ph.D..................... 49 Senior Vice President
Dawn H. Grohs................................ 54 Senior Vice President, Cytopathology Division
John H. Abeles, M.D.......................... 51 Director
Harold S. Blue............................... 35 Director
Jack H. Halperin, Esq. (1)................... 50 Director
Paul F. Lavallee (1)......................... 56 Director
Joseph W. Plandowski......................... 55 Director
Leonard M. Schiller, Esq. (1)................ 54 Director
</TABLE>
- ------------------------
(1) Member of the Audit Committee and Compensation Committee.
EXECUTIVE OFFICERS
PETER P. GOMBRICH. Mr. Gombrich served as Acting Chief Executive Officer
and a director of the Company from the date of execution of the Merger
Agreement, April 21, 1995, until consummation of the Merger on December 29, 1995
(the "Merger Date"), at which time he became Chairman of the Board of Directors,
Chief Executive Officer and President. Mr. Gombrich founded AccuMed, Inc. in
February 1994, and, from then until the Merger Date, Mr. Gombrich served as
Chairman, President and Chief Executive Officer of AccuMed, Inc. Mr. Gombrich
was a consultant in the cytology and microbiology industries from August 1990
until forming AccuMed, Inc., serving companies including Accuron Corporation, a
designer of automated Pap smear screening systems. From July 1985 until November
1990, Mr. Gombrich was the President and Chief Executive Officer of CliniCom
Incorporated, a bedside clinical information systems company which he founded.
From 1982 until 1985, Mr. Gombrich was Executive Vice President of the ventures
group of ADC Telecommunications. From January 1980 until February 1982, Mr.
Gombrich was President of the pacemaker division of St. Jude Medical, Inc., a
company that he co-founded in 1976 and of which he served as Executive Vice
President from July 1976 to January 1980. Mr. Gombrich has more than 27 years of
experience in the healthcare industry. Mr. Gombrich has a B.S. degree in
electrical engineering and a M.B.A. degree from the University of Denver.
NORMAN J. PRESSMAN, PH.D. Dr. Pressman has been a Senior Vice President of
AccuMed and President of the Company's Cytopathology Division since July 1996.
From July 1993 until joining the Company, Dr. Pressman was Manager for
Biotechnology Development, Strategic Business Development Group of Olympus
America, the exclusive distributor of the Company's AcCell Series 2000 and the
TracCell 2000 in the Olympus Territory. Between July and September 1989, Dr.
Pressman was engaged in the formation of Cell Systems International, Inc., a
consulting firm in biomedical specimen collection, processing and analysis, of
which he served as President from September 1989 until July 1993. Dr. Pressman
was the lead research scientist in the Cytometry and Histometry program of the
Central Research and Development Department at E.I. du Pont de Nemours & Company
from December 1986 until July 1989. From September 1976 until December 1986, he
was an Assistant Professor (Pathology and Engineering) at The Johns Hopkins
University School of Medicine and Head of the Quantitative
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<PAGE>
Cytopathology Laboratories at The Johns Hopkins Medical Institutions. Dr.
Pressman has a B.S. degree in electrical engineering from Columbia University, a
M.S. degree in systems engineering and a Ph.D. in biomedical engineering from
the University of Pennsylvania.
MICHAEL D. BURKE. Mr. Burke has been a Senior Vice President of AccuMed and
President of the Company's Microbiology Division since the Merger Date. From May
1995 until the Merger Date, Mr. Burke was a Senior Vice President and President
of the Microbiology Division of AccuMed, Inc. From April 1992 until joining
AccuMed, Inc., Mr. Burke was Vice President -- Sales and Distribution, and from
November 1982 until April 1992 was Vice President -- Operations, for Picker
International, Inc., a diagnostic imaging manufacturer and supplier. Mr. Burke
has a B.A. degree in political science from Knox College.
LEONARD R. PRANGE. Mr. Prange has been Chief Financial Officer and
Corporate Vice President of the Company since September 9, 1996. Mr. Prange also
serves as a consultant to Richardson Electronics, Ltd., a global distributor and
manufacturer of electronic components. From July 1995 until September 1996, Mr.
Prange served as a managing director of Lovett International, Inc., an
international trading and consulting firm. Mr. Prange served Richardson
Electronics, Ltd. as Group Vice President from June 1994 until July 1995, as
Chief Financial Officer and Vice President from December 1984 until July 1995
and as Treasurer from December 1981 to December 1984. From March 1976 until
December 1981, Mr. Prange served as Treasurer of Cetron Electronic Corporation,
a manufacturer of electronic components, and as Controller from March 1972 until
March 1976. Mr. Prange has a B.S. degree in accounting from DePaul University
and is a Certified Public Accountant.
KEY EMPLOYEES
RICHARD A. DOMANIK, PH.D. Dr. Domanik has been Senior Vice President of
Technology of the Company since May 1996 and was Vice President of Technology
from the Merger Date until May 1996. From August 1994 until the Merger Date, Dr.
Domanik was Vice President of Engineering of AccuMed, Inc. From June 1979 until
joining AccuMed, Inc., Dr. Domanik served Abbott Laboratories in several
positions relating to research and development of healthcare products, including
Laboratory Manager and Research and Development Manager. Dr. Domanik has a B.S.
degree in chemistry from Ripon College and a Ph.D. in biochemistry from
Northwestern University.
DAWN H. GROHS. Ms. Grohs has been Senior Vice President of the Company's
Cytopathology Division since May 1996 and served as Vice President -- Corporate
Development of the Company's Cytopathology Division from the Merger Date until
May 1996. From March 1994 until the Merger Date, Ms. Grohs was a consultant to
AccuMed, Inc. From 1983 until August 1995, Ms. Grohs was President of The Med
Companies, a healthcare business development management company. Ms. Grohs has a
M.S. degree in mathematics from Memphis State University.
DIRECTORS
JOHN H. ABELES, M.D. Dr. Abeles has been a director of the Company since
October 1988. Since March 1996, Dr. Abeles has been the President and a director
of Health Care Acquisition Corp., a special purpose acquisition company. Since
1992, Dr. Abeles has also been a general partner of Northlea Partners, Ltd., an
investment and venture capital partnership. Since 1980, Dr. Abeles has also been
the President of MedVest, Inc., a medical consulting company. Dr. Abeles has a
M.D. from the University of Birmingham, England. Dr. Abeles is a member of the
boards of directors of I-Flow Corporation, Oryx Technology Corp. and DUSA
Pharmaceuticals, Inc.
HAROLD S. BLUE. Mr. Blue has been a director of the Company since July
1996. Since February 1993, Mr. Blue has been Chief Executive Officer and
Chairman of the Board of ProxyMed, Inc., a healthcare information technology
company. From July 1992 until February 1995, Mr. Blue served as Chairman of the
Board and Chief Executive Officer of Health Services of Miami Lakes, Inc.,
Health Services of Pembroke Lakes, Inc. and Health Services of North Miami,
Inc., each a physician practice management group. From June 1979 to February
1992, Mr. Blue was President and Chief Executive Officer of Budget
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<PAGE>
Drugs, Inc., a retail discount pharmacy chain. From September 1984 to August
1988, Mr. Blue was Executive Vice President of Best Generics Incorporated, a
national generic distribution company, which he co-founded.
JACK H. HALPERIN, ESQ. Mr. Halperin has been a director of the Company
since June 1991 and served as Chairman of the Board of Directors from April 1995
until the Merger Date. Mr. Halperin is a corporate attorney with expertise in
venture capital financing and has been practicing law independently since 1987.
Mr. Halperin has a B.A. degree in english from Columbia University and a law
degree from New York University School of Law. Mr. Halperin is also a member of
the boards of directors of Xytronyx, Inc., I-Flow Corporation and Memry
Corporation.
PAUL F. LAVALLEE. Mr. Lavallee has been a director of the Company since
December 1995. Since January 1996, Mr. Lavallee has served as a consultant to
Sigmedics, Inc., a biomedical company. From 1989 until December 1995, Mr.
Lavallee served as Chairman, President and Chief Executive Officer of Sigmedics,
Inc. Mr. Lavallee has a B.S. degree in biology from Bates College and a M.B.A.
degree from the University of Chicago.
JOSEPH W. PLANDOWSKI. Mr. Plandowski has been a director of the Company
since December 1995. He has been President of The Lakewood Group, a healthcare
consulting firm, since February 1995. From May 1993 until February 1995, Mr.
Plandowski was Vice President -- Acquisitions of National Health Laboratories
Inc., which owns clinical and anatomic laboratories nationwide. From October
1992 through May 1993, he was Chief Operating Officer of Nichols Institute, a
clinical reference laboratory. From February 1991 through October 1992, Mr.
Plandowski was President, Chief Executive Officer and a director of Genetrix,
Inc. Mr. Plandowski has a B.S. degree in mechanical engineering and a M.B.A.
degree from the State University of New York.
LEONARD M. SCHILLER, ESQ. Mr. Schiller has been a director of the Company
since April 1995. Since 1970, Mr. Schiller has been practicing real estate law,
specializing in contesting real estate taxes in the State of Illinois. Since
1980, he has also been President of The Dearborn Group, a residential property
management and real estate acquisition company. Mr. Schiller has a B.A. degree
in liberal arts from the University of Iowa and a law degree from the ITT Kent
College Law School.
48
<PAGE>
MEDICAL ADVISORY BOARD
AccuMed's Cytopathology Medical Advisory Board is composed of physicians,
scientists and professors who provide advisory consultation to the Company
regarding technology application, design, development, marketing and customer
support issues relative to the Company's cytopathology products.
<TABLE>
<CAPTION>
BOARD MEMBER POSITION
- -------------------------------------------------------- --------------------------------------------------------
<S> <C>
William J. Frable, M.D.................................. Director of the Division of Surgical & Cytopathology at
the Medical College of Virginia
Shirley E. Greening, M.S., J.D., CFIAC.................. Chairman and Professor of the Department of Laboratory
Sciences, Thomas Jefferson University
Heinz K. Grohs, M.D. ................................... Chairman, Associate Director of Pathology and Chief of
Cytopathology, North Shore Medical Center, Salem,
Massachusetts
L. Patrick James, M.D................................... Director of Laboratories, Health Midwest, Kansas City,
Missouri
Perry A. Lambird, M.D. ................................. President and Chief Executive Officer, PATHCOR, Oklahoma
City, Oklahoma
Bjorn Stenkvist, M.D., Ph.D. ........................... Director of Clinical Cytology, Karolinska Institute and
Hospital, Stockholm, Sweden
David S. Weinberg, M.D., Ph.D........................... Staff Pathologist, Department of Pathology, Brigham and
Women's Hospital, Boston, Massachusetts
</TABLE>
BOARD OF DIRECTORS
Directors are elected at each annual meeting to serve one-year terms.
Pursuant to the Merger Agreement, from the Merger Date until the next annual
meeting of stockholders of the Company, the Board of Directors is to be
comprised as follows: (i) Mr. Gombrich, as Chairman of the Board of Directors,
(ii) two directors designated by AccuMed, Inc., (iii) three directors designated
by Commonwealth Associates and American Equities Overseas, Inc. ("AEO"),
jointly, and (iv) one director selected mutually by the other six directors. In
accordance therewith, (i) Commonwealth Associates and AEO have designated
Messrs. Schiller, Blue and Halperin (who is legal counsel to AEO), (ii) AccuMed,
Inc. has designated Messrs. Lavallee and Plandowski, and (iii) the other six
directors selected Dr. Abeles to serve on the Board of Directors.
COMMITTEES OF THE BOARD OF DIRECTORS.
The Company has established Audit and Compensation Committees. Each of these
committees is responsible to the full Board of Directors, and its activities are
therefore subject to approval of the Board of Directors. The functions performed
by these committees are summarized below.
The Audit Committee is responsible for reviewing the Company's internal
accounting controls, meeting and conferring with the Company's certified public
accountants, and reviewing the results of the accountants' auditing engagement.
The Compensation Committee of the Board of Directors is comprised entirely
of "disinterested" directors (within the meaning of Rule 16b-3 under the
Securities Exchange Act of 1934, as amended (the "Exchange Act")). The
Compensation Committee determines base compensation and discretionary cash
bonuses for the Company's senior executives. These determinations are subject to
the approval or ratification of the full Board of Directors. The Compensation
Committee also determines the number and terms of stock options to be granted to
employees, directors and consultants of the Company under the Company' stock
option plans. See "-- Stock Option Plans."
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DIRECTOR COMPENSATION
Pursuant to the Board of Directors Compensation Plan adopted by the Board of
Directors on January 18, 1996, each non-employee director is entitled to the
following compensation for services as a director: (i) an immediately
exercisable, nonqualified stock option to purchase 20,000 shares of Common Stock
to be granted upon appointment to the Board of Directors, and (ii) an
immediately exercisable, nonqualified stock option to purchase 20,000 shares of
Common Stock to be granted on the first trading day of each January thereafter
during which a non-employee director continues to serve on the Board of
Directors. Such options are to be granted under the Company's 1995 Stock Option
Plan or subsequent option plans. The exercise price per share shall be the fair
market value of a share of Common Stock on the date of grant. Directors are
reimbursed for reasonable expenses incurred in attending meetings of the Board
of Directors and committees thereof.
EXECUTIVE COMPENSATION
SUMMARY COMPENSATION INFORMATION. The following tables set forth
information concerning compensation paid or accrued for the fiscal years ended
September 30, 1993, 1994 and 1995 and the twelve months ended December 31, 1995
by the Company to or on behalf of the Chief Executive Officer and the only other
executive officer of the Company whose total salary and bonus for the fiscal
year ended September 30, 1995 exceeded $100,000 (collectively, the "Named
Executive Officers").
SUMMARY COMPENSATION TABLES
<TABLE>
<CAPTION>
FISCAL ANNUAL
YEAR ENDED COMPENSATION/
NAME AND PRINCIPAL POSITION SEPTEMBER 30, SALARY
- ---------------------------------------------------------------------------------- --------------- --------------
<S> <C> <C>
Peter P. Gombrich ................................................................ 1995 $ 65,625
Acting Chief Executive Officer (1)
Kenneth D. Miller ................................................................ 1995 110,556
former Chief Executive Officer (2) 1994 114,000
1993 117,500
</TABLE>
- ------------------------------
(1) Mr. Gombrich became Acting Chief Executive Officer of the Company on April
21, 1995 and became Chairman of the Board of Directors, Chief Executive
Officer and President on December 29, 1995.
(2) Mr. Miller served as Chief Executive Officer until April 21, 1995. He
served as Senior Vice President from April 21, 1995 until June 30, 1996.
<TABLE>
<CAPTION>
TWELVE MONTHS ENDED
DECEMBER 31, 1995
-----------------------------------------------------
LONG-TERM
COMPENSATION AWARDS
ANNUAL ---------------------
COMPENSATION/ ALL OTHER SHARES UNDERLYING
NAME AND PRINCIPAL POSITION SALARY COMPENSATION STOCK OPTIONS(#)(1)
- ---------------------------------------------------------- -------------- -------------- ---------------------
<S> <C> <C> <C>
Peter P. Gombrich ........................................ $ 103,125 $ -- 200,000
Chief Executive Officer (2)
Kenneth D. Miller ........................................ 116,463 21,952 75,000
former Chief Executive Officer (3)
</TABLE>
- ------------------------------
(1) All such options were granted under the 1995 Stock Option Plan at an
exercise price of $1.13 per share, the last reported sale price of the
Common Stock on the Nasdaq Market on the date of grant.
(2) Mr. Gombrich became Acting Chief Executive Officer of the Company on April
21, 1995 and became Chairman of the Board of Directors, Chief Executive
Officer and President on December 29, 1995.
(3) Mr. Miller served as Chief Executive Officer until April 21, 1995. He
served as Senior Vice President from April 21, 1995 until June 30, 1996.
The amount listed under the column "All Other Compensation" represents a
relocation allowance.
50
<PAGE>
STOCK OPTION GRANTS. The following table contains information concerning
grants of stock options to the Named Executive Officers during the twelve months
ended December 31, 1995. All such options were granted under the Company's 1995
Stock Option Plan.
OPTION GRANTS DURING THE TWELVE MONTHS ENDED DECEMBER 31, 1995
<TABLE>
<CAPTION>
INDIVIDUAL GRANTS
-----------------------------------------------------------------
NUMBER OF % OF TOTAL SHARES
SHARES UNDERLYING
UNDERLYING OPTIONS GRANTED EXERCISE
OPTIONS TO EMPLOYEES PRICE
NAME GRANTED (#) IN YEAR (1) ($/SHARE) (2) EXPIRATION DATE
- -------------------------------------------------- ------------ ------------------- ------------- ---------------
<S> <C> <C> <C> <C>
Peter P. Gombrich................................. 200,000 18.7% $ 1.13 12/29/05
Kenneth D. Miller (3)............................. 75,000 7.0 1.13 12/29/05
</TABLE>
- ------------------------------
(1) The Company granted to employees options to purchase an aggregate of
1,072,000 shares of Common Stock during the twelve months ended December
31, 1995.
(2) All such options were granted under the 1995 Stock Option Plan at an
exercise price of $1.13 per share, the last reported sale price of the
Common Stock on the Nasdaq Market on the date of grant.
(3) Mr. Miller was granted an option to purchase 75,000 shares of Common Stock
on December 29, 1995. The option was immediately exercisable with respect
to 25,000 shares and was to become exercisable with respect to an
additional 25,000 shares on December 29, 1996 and with respect to the
remaining 25,000 shares on December 29, 1997. Pursuant to the terms of the
1995 Stock Option Plan, the remaining options to purchase 50,000 shares
terminated on June 30, 1996, the effective date of Mr. Miller's
resignation. See "-- Stock Option Plans."
YEAR-END OPTION HOLDINGS. The following table provides certain information
regarding the unexercised options held by the Named Executive Officers as of
December 31, 1995. No options were exercised by the Named Executive Officers
during the twelve months ended December 31, 1995.
UNEXERCISED OPTIONS AT DECEMBER 31, 1995
<TABLE>
<CAPTION>
NUMBER OF SHARES
UNDERLYING
UNEXERCISED OPTIONS
AT DECEMBER 31, 1995
(#)(1)
--------------------------
NAME EXERCISABLE UNEXERCISABLE
- -------------------------------------------------------------------------------- ----------- -------------
<S> <C> <C>
Peter P. Gombrich............................................................... 66,666 133,334
Kenneth D. Miller............................................................... 167,000 50,000
</TABLE>
- ------------------------------
(1) None of such options was in the money at December 31, 1995, based on the
last reported sale price of the Common Stock on December 29, 1995, which
was the last trading day prior to December 31, 1995.
EMPLOYMENT, SEVERANCE AND SEPARATION AGREEMENTS
GOMBRICH EMPLOYMENT AND SEVERANCE AGREEMENT. Pursuant to an Employment
Agreement dated August 1, 1994 between Peter P. Gombrich and AccuMed, Inc. which
was assumed by the Company as a result of the Merger (the "Gombrich Employment
Agreement"), Mr. Gombrich serves as Chairman of the Board of Directors, Chief
Executive Officer and President of the Company. Pursuant to the Gombrich
Employment Agreement, Mr. Gombrich is entitled to receive (i) annual
compensation of $175,000 and (ii) a minimum annual cash bonus equal to 30% of
base salary for the relevant year, and additional bonuses as determined by the
Board of Directors, at its discretion. If the Company terminates Mr. Gombrich's
employment without cause or Mr. Gombrich terminates his employment for good
reason or at any time after 180 days following the date on which a Change of
Control (as defined below) occurs, Mr. Gombrich would be entitled to a lump-sum
severance payment equal to three times his annual salary. In addition, upon the
occurrence of a Change of Control, any stock options held by Mr. Gombrich would
immediately vest and be fully exercisable. For purposes of the Gombrich
Employment Agreement, a Change of Control shall be deemed to occur if: (i) any
third party directly or indirectly acquires 20% or more of the outstanding
Common Stock, (ii) the Company engages in a merger, consolidation or
reorganization that results in holders of Common Stock immediately prior to
51
<PAGE>
such transaction holding less than a majority of the voting power of the
resulting entity, (iii) the Company sells all or substantially all of its assets
or (iv) Mr. Gombrich's employment is terminated by the Company on a date within
90 days prior to the date on which a Change of Control occurs.
The employment term continues until August 1, 1999. Thereafter, the term
will be automatically extended for additional one-year periods unless either
party delivers notice of election not to extend the employment at least 60 days
prior to the end of the then current term.
PRESSMAN EMPLOYMENT AGREEMENT. Pursuant to the Employment Agreement dated
June 13, 1996 as amended July 16, 1996, between the Company and Dr. Pressman
(the "Pressman Employment Agreement"), Dr. Pressman will serve as President,
Cytopathology Division and Corporate Senior Vice President of the Company for
five years beginning July 5, 1996. Dr. Pressman's annual salary is $157,500 and
he is eligible to receive annually (i) cash bonuses of up to 30% of such annual
salary, and (ii) incentive stock options to purchase up to 50,000 shares of
Common Stock based on the achievement of mutually agreed upon goals and
objectives. On July 8, 1996, Dr. Pressman was granted an option to purchase an
aggregate of 250,000 shares of Common Stock at an exercise price of $6.25 per
share (the last reported sale price of the Common Stock on the Nasdaq Market on
the date on which Dr. Pressman's employment commenced) which is immediately
exercisable with respect to 50,000 shares and will become exercisable with
respect to 50,000 additional shares on each of the first through fourth
anniversaries of the grant date. Dr. Pressman was granted 25,000 shares of
Common Stock on the date on which Dr. Pressman's employment commenced. Such
shares may not be transferred during the 18-month period following the date of
issuance and would be forfeited to the Company if Dr. Pressman terminates the
Pressman Employment Agreement during such period, other than due to a breach by
the Company. Dr. Pressman is entitled to borrow up to $85,200 from the Company
for the purpose of paying taxes due in connection with the grant of such shares.
Such loan shall be repaid without interest in installments to be mutually agreed
upon by Dr. Pressman and the Company. The Company may terminate Dr. Pressman's
employment for cause at any time upon written notice. The Company may terminate
his employment without cause upon six months' written notice, in which case Mr.
Pressman would be entitled to an amount equal to twelve months' salary as
severance, paid over twelve months. Mr. Pressman may terminate the Pressman
Employment Agreement for any reason upon six months' written notice.
MILLER SEPARATION AGREEMENT. Pursuant to the Merger Agreement, Mr. Miller
and the Company entered into a letter agreement dated as of November 21, 1995
(the "Miller Employment Letter") pursuant to which Mr. Miller served as Senior
Vice President of the Company. Pursuant to the Miller Employment Letter, Mr.
Miller was entitled to receive (i) an annual salary of $105,000 and (ii) a
quarterly bonus of $6,250. He also received 25,000 shares of Common Stock in
January 1996 and an option to purchase 75,000 shares of Common Stock at an
exercise price of $1.13 per share (the last reported sale price of the Common
Stock on the Nasdaq Market on the Merger Date). The employment term commenced
October 1, 1995. Pursuant to the Employment Separation Agreement and Release
(the "Miller Separation Agreement") dated June 24, 1996 between Mr. Miller and
the Company, Mr. Miller voluntarily resigned from the Company effective June 30,
1996. During July through October 1996, Mr. Miller is to spend 70% of the normal
work week discharging responsibilities as acting President of RADCO and as a
consultant to the Company. For rendering such services, Mr. Miller is to receive
$1,875 per month from the Company and $4,250 per month from RADCO. Pursuant to
the Miller Separation Agreement, Mr. Miller received approximately $8,600 in
respect of accrued vacation time and $7,437 with respect to relocation expenses
and is entitled to receive as a severance payment up to an additional $35,000 to
be paid in monthly installments prior to February 1997. Mr. Miller has also
agreed to a one-year covenant-not-to-compete with the Company.
PRANGE EMPLOYMENT AGREEMENT. Pursuant to the Employment Agreement dated as
of September 9, 1996 between the Company and Mr. Prange (the "Prange Employment
Agreement"), Mr. Prange serves as Chief Financial Officer and Corporate Vice
President of the Company. Mr. Prange's annual salary is $125,000 and he is
eligible to receive annual cash bonuses of up to 25% of such annual salary. Upon
joining the Company, Mr. Prange was granted options to purchase an aggregate of
150,000 shares of Common Stock at an exercise price of $5.38 per share (the fair
market value of the Common Stock on the
52
<PAGE>
grant date) which will become immediately exercisable with respect to 25,000
shares upon stockholder approval of an amendment increasing the authorized
shares under the 1995 Stock Option Plan and will become exercisable with respect
to 25,000 additional shares on each of the first through fifth anniversaries of
the grant date. In the event of a change of control of the Company or if Peter
P. Gombrich ceases to be Chairman of the Board and Chief Executive Officer, the
options shall become fully vested and immediately exercisable. The Company may
terminate Mr. Prange's employment for Cause (as defined in the Prange Employment
Agreement) at any time upon written notice. The Company may terminate his
employment without Cause upon written notice, in which case Mr. Prange would be
entitled to an amount of cash equal to 12 months' salary as severance, paid
semi-monthly over 12 months, and his options shall become fully vested and
immediately exercisable. Mr. Prange's employment shall be extended for
additional one year terms unless either party delivers written notice of
termination at least 60 days prior to the end of the then current period.
STOCK OPTION PLANS
The Company has in effect three stock option plans, the 1995 Stock Option
Plan, as amended (the "1995 Plan"), the Amended and Restated 1992 Stock Option
Plan (the "1992 Plan"), and the Amended and Restated 1990 Stock Option Plan (the
"1990 Plan," and together with the 1995 Plan and the 1992 Plan, the "Plans").
Administration of the Plans has been delegated to the Compensation Committee of
the Board of Directors, consisting entirely of "disinterested" directors within
the meaning of Rule 16b-3 promulgated under the Exchange Act. Each Plan
authorizes the Compensation Committee to grant to employees, directors and
consultants of the Company incentive stock options intended to meet the
requirements of Section 422 of the Internal Revenue Code of 1986, as amended, as
well as nonqualified stock options. The terms of the Plans are summarized below.
As of October 1, 1996, (i) options to purchase an aggregate of 1,715,167
shares of Common Stock were outstanding under the 1995 Plan (including options
to purchase 283,666 shares of Common stock which have been granted subject to
stockholder approval of an amendment increasing the shares available under the
1995 Plan to be acted upon at the Company's next annual meeting of stockholders)
and 216,334 shares remained available for future grant thereunder, subject to
stockholder approval of such amendment, (ii) options to purchase an aggregate of
54,711 shares of Common Stock were outstanding under the 1992 Plan and 104,447
shares remained available for future grant thereunder, and (iii) options to
purchase an aggregate of 7,815 shares of Common Stock were outstanding under the
1990 Plan and 80,794 shares remained available for future grant thereunder.
1995 PLAN
The 1995 Plan was adopted by the Company's Board of Directors and
stockholders in October 1995 and December 1995, respectively, authorizing the
granting of a combination of incentive stock options and nonqualified stock
options to purchase an aggregate of up to 1,500,000 shares of Common Stock. In
July 1996, the Board of Directors amended the 1995 Plan, subject to stockholder
approval, to increase from 1,500,000 to 2,000,000 the number of shares available
for issuance upon exercise of options authorized to be granted under the 1995
Plan. No option may be granted after October 6, 2005.
Under the 1995 Plan, full-time employees of the Company, including officers
and directors who are employees of the Company, are eligible to receive grants
of either incentive stock options or nonqualified stock options. Consultants and
non-employee directors are eligible to be granted only nonqualified stock
options under the 1995 Plan. The Compensation Committee, within the parameters
of the 1995 Plan, has authority to determine to whom options are granted, the
number of shares underlying options granted, and the terms of such options. Each
option grant is evidenced by a stock option agreement.
EXERCISE PRICE. The option exercise price per share with respect to
nonqualified stock options granted under the 1995 Plan must be at least 75% of
the fair market value per share of the Company's Common Stock on the date of
grant of the option. The exercise price per share of Common Stock underlying
incentive stock options granted under the 1995 Plan must be at least the fair
market value of the Common Stock on the grant date, except that incentive stock
options granted to an employee who on the grant date owns more than 10% of the
combined voting power of all classes of stock of the Company
53
<PAGE>
(a "Ten Percent Holder") must have an exercise price of at least 110% of fair
market value. Fair market value for purposes of the 1995 Plan is the last
reported sale price of the Common Stock on the Nasdaq Market on the date of
grant.
EXERCISE. The options may be immediately exercisable on the date of grant
or the right to acquire shares underlying the options may become vested as
determined by the Compensation Committee and specified in the stock option
agreement. In no event may any option be exercised more than ten years, or in
the case of incentive stock options held by a Ten Percent Holder, more than five
years, after the date of grant. Payment of the exercise price is to be made in
cash, by the delivery to the Company of shares of Common Stock or, in the case
of nonqualified options, by a so-called "cashless exercise." Common Stock
surrendered in payment of the exercise price will be valued at its fair market
value as of the exercise date.
TERMINATION. The 1995 Plan provides that an optionee whose engagement by or
employment with the Company has terminated, other than by reason of retirement,
death or permanent disability, may exercise his or her outstanding incentive
stock options for a period of 30 days from the date of such termination. If an
incentive stock option holder retires after the age of 55, dies or is
permanently disabled, such optionee, or his or her personal representative, may
exercise such outstanding incentive stock options within one year after the date
of such retirement, death or disability. A nonqualified stock option granted to
directors may be exercised by the optionee after he or she ceases to be a
director of the Company until such option expires in accordance with the option
agreement governing such option. The Compensation Committee shall specify in
each nonqualified stock option agreement the circumstances under and time
periods during which an optionee who is no longer an employee or consultant of
the Company may exercise his or her outstanding nonqualified stock options. To
the extent that an optionee was not entitled to exercise options at the date of
termination of his or her employment, or if the optionee does not exercise such
options within the time specified in the applicable stock option agreement, the
options terminate. Under no circumstances will an option be exercisable after
the termination date specified in the option agreement governing the option.
1990 PLAN AND 1992 PLAN
The 1990 Plan was adopted by the Board of Directors and stockholders in
October 1990 and February 1991, respectively. The 1990 Plan authorizes the
granting of incentive stock options and nonqualified stock options to purchase
an aggregate of 177,324 shares of Common Stock. The 1992 Plan was adopted by the
Board of Directors and stockholders in February 1992 and May 1992, respectively.
The 1992 Plan authorizes the granting of incentive stock options and
nonqualified stock options to purchase an aggregate of 505,000 shares of Common
Stock.
The 1990 Plan and the 1992 Plan permit the granting of incentive stock
options to employees and nonqualified stock options to employees, directors and
consultants. The Compensation Committee, within the parameters of the respective
Plans, has the authority to determine to whom options are granted and the terms
of such options. Each option grant is evidenced by a stock option agreement.
EXERCISE PRICE. The exercise price of options granted under the 1990 Plan
or the 1992 Plan is determined by the Compensation Committee and must be at
least the fair market value of the Common Stock on the date of grant of the
option, except that an incentive stock option granted to a Ten Percent Holder
must have an exercise price of at least 110% of such fair market value.
EXERCISE. The options may be immediately exercisable on the date of grant
or the right to acquire shares underlying the options may become vested as
determined by the Compensation Committee and specified in the option agreement,
except that all options shall become exercisable with respect to at least 20% of
the underlying shares per year on each of the first through fifth anniversaries
of the grant date. In no event may any option be exercised more than five years
after the date of grant. Payment of the exercise price is to be made in cash, by
the delivery to the Company of shares of Common Stock or by such other method as
the Compensation Committee may approve.
54
<PAGE>
IMMEDIATELY EXERCISABLE OPTIONS. The 1990 Plan and the 1992 Plan permit the
Compensation Committee to grant immediately exercisable nonqualified options for
which the Company will retain a repurchase option. The Company's repurchase
option lapses over a period of time in accordance with the terms of a restricted
stock purchase agreement governing the terms of the grant.
TERMINATION. The 1990 Plan and the 1992 Plan provide that an optionee whose
engagement by or employment with the Company has terminated, other than by
reason of his or her death or permanent disability, may exercise his or her
stock options upon the terms provided in the applicable stock option agreement,
provided that all incentive stock options shall terminate three months after the
optionee ceases to be an employee of the Company. If an optionee's employment
with or position as a director of the Company is terminated because of the death
or disability of the optionee, the option, to the extent exercisable by the
optionee on the date of such termination, may be exercised by the optionee (or
the optionee's legal representative) until the earlier of the twelve months
following the termination date or the date upon which such option expires. To
the extent that an optionee was not entitled to exercise the options at the date
of termination of his or her employment, or if the optionee does not exercise
such options within the time specified in the applicable stock option agreement,
the options terminate. Under no circumstances will an option be exercisable
after the termination date specified in the option agreement governing the
option.
55
<PAGE>
CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS
Commonwealth Associates is a principal stockholder. Pursuant to a letter
agreement dated as of February 14, 1995 among the Company, AccuMed, Inc. and
Commonwealth Associates, Commonwealth Associates was paid a fee for acting as a
"finder" in connection with the Merger. The fee was paid in the form of $50,000
in cash, 444,444 shares of Common Stock, and a five-year warrant to purchase up
to 750,000 shares of Common Stock at an exercise price of $1.25 per share.
During 1995, Commonwealth Associates acted as placement agent for the Company in
certain private placements of Common Stock for which Commonwealth Associates
received an aggregate of (i) $353,000 in cash commissions, (ii) a non-
accountable expense allowance of $106,000, (iii) approximately $10,600 in
reimbursement for the fees and expenses of counsel, and (iv) a warrant to
purchase an aggregate of 564,840 shares of the Common Stock at an exercise price
of $0.625 per share. During 1995, the Company paid Commonwealth Associates an
aggregate of $59,000 in cash pursuant to a Consulting Agreement in effect from
January 1, 1995 through December 31, 1995. As reimbursement for certain expenses
incurred by Commonwealth Associates in connection with a terminated private
placement of securities for which Commonwealth Associates was to act as
placement agent, the Company (i) issued to Commonwealth Associates on December
31, 1994 a five-year warrant to purchase an aggregate of 420,000 shares of
Common Stock at an exercise price of $0.25 per share and (ii) issued to
designees of Commonwealth Associates on December 29, 1995 five-year warrants to
purchase an aggregate of 104,000 shares of Common Stock at an exercise price of
$2.125 per share, which warrants expire on October 31, 1997.
The Company has agreed, with respect to the exercise of the Redeemable
Warrants issued in connection with the Company's initial public offering, to pay
to Commonwealth Associates a fee of 5% of the exercise price of each Redeemable
Warrant exercised; provided, however, that Commonwealth Associates will not be
entitled to receive such compensation for Redeemable Warrant exercise
transactions in which: (i) the market price of the Common Stock at the time of
the exercise is lower than the exercise price of the Redeemable Warrants; (ii)
the Redeemable Warrants are held in any discretionary account; (iii) disclosure
of compensation arrangements is not made in documents provided to holders of
Redeemable Warrants at the time of exercise; (iv) the exercise of the Redeemable
Warrants is unsolicited; and (v) the transaction was in violation of Rule 10b-6
promulgated under the Exchange Act. As of October 1, 1996, Redeemable Warrants
had been exercised to purchase 200 shares of Common Stock.
The Company issued to AEO an immediately exercisable, five-year warrant to
purchase up to 100,000 shares of Common Stock at an exercise price of $0.25 per
share. Such warrant was issued to AEO by the Company in September 1995 as
reimbursement for expenses incurred by AEO in connection with a terminated
private placement in 1994 and advisory services in connection with certain of
the Company's European stockholders. In March 1996, the Company issued to AEO
immediately exercisable five-year warrants to purchase an aggregate of 42,500
shares of Common Stock at an exercise price of $3.87 per share and 20,000 shares
at an exercise price of $3.42 per share, as partial compensation for its
services in placing warrants to purchase Common Stock and securities of RADCO in
connection with the capitalization of RADCO. AEO acted as placement agent in
connection with the sale of Common Stock to certain European investors in May
1996, for which it received aggregate cash commissions of $56,250. Pursuant to
an agreement dated July 18, 1996 among the Company, RADCO and AEO, the Company
will be obligated to pay to AEO a fee of $15,000 in cash upon consummation of
the RADCO Acquisition. As a part of the RADCO Acquisition, the Company will
purchase from AEO 50,000 shares of RADCO Stock in consideration of payment of
approximately $14,000 in cash.
Pursuant to the Merger Agreement, from the Merger Date until the next annual
meeting of stockholders of the Company, the Board of Directors is to be
comprised as follows: (i) Mr. Gombrich, as Chairman of the Board of Directors,
(ii) two directors designated by AccuMed, Inc., (iii) three directors designated
mutually by Commonwealth Associates and AEO, and (iv) one director selected
mutually by the other six directors. In accordance therewith, (i) Commonwealth
Associates and AEO have designated Messrs. Schiller, Blue and Halperin (legal
counsel to AEO), (ii) AccuMed, Inc. designated Messrs. Lavallee and Plandowski,
and (iii) the other six directors selected Dr. Abeles to serve on the Board of
Directors.
56
<PAGE>
The Company loaned to Peter P. Gombrich, Chairman of the Board of Directors,
Chief Executive Officer and President of the Company, $61,000 evidenced by a
promissory note made May 22, 1996, initially bearing interest at a rate of 10%
per annum, payable monthly in arrears, with principal and accrued interest due
within ten days following the date of such promissory note. In August 1996, Mr.
Gombrich paid the loan balance in full.
On December 29, 1995, the Company issued a warrant to purchase 75,000 shares
of Common Stock to Leonard M. Schiller, a director of the Company, in
consideration for services provided by Mr. Schiller to AccuMed, Inc. in
connection with the Merger. Such warrant is currently exercisable at $1.13 per
share (the closing sale price of the Common Stock on the Nasdaq Market on the
date of issuance of such warrant) and expires on December 29, 2000.
Gwenda Jay Gombrich, the wife of Peter P. Gombrich, the Company's Chairman
of the Board of Directors, Chief Executive Officer and President, loaned to
AccuMed, Inc. an aggregate of $65,000 pursuant to a letter agreement between
AccuMed, Inc. and Ms. Gombrich dated October 28, 1994, which was assumed by the
Company in connection with the Merger. Interest was payable at the rate of 1%
per month on the outstanding balance, with a minimum interest payment of $750.
In June 1996, the loan balance was paid in full.
Ms. Gombrich contributed an aggregate of $75,000 to AccuMed, Inc. prior to
the Merger, evidenced by Promissory Notes dated May 18, 1994 and August 31, 1994
(the "Gombrich Promissory Notes") and the Interim Financing Agreements dated May
18, 1994 and December 1994 (the "Interim Financing Agreements"), each among
AccuMed, Inc. and Ms. Gombrich as custodian for her minor children. Pursuant to
the Interim Financing Agreements, the principal amount and the accrued and
unpaid interest on the Gombrich Promissory Notes were required to be converted
into shares of common stock of AccuMed, Inc. prior to the Merger. Such
conversion did not take place. Upon consummation of the Merger, the obligations
of AccuMed, Inc. to Ms. Gombrich pursuant to the Interim Financing Agreements
and the Gombrich Promissory Notes were assumed by the Company. In June 1996, the
Company issued to Ms. Gombrich as custodian for certain minor children an
aggregate of 166,586 shares of the Company's Common Stock in full satisfaction
of the Company's obligations pursuant to the Interim Financing Agreements and
the Gombrich Promissory Notes.
57
<PAGE>
PRINCIPAL STOCKHOLDERS
The table below sets forth certain information as of October 1, 1996 (the
"Reference Date") with respect to the beneficial ownership of Common Stock by
(i) each person known by the Company to be the beneficial owner of more than 5%
of the outstanding shares of Common Stock; (ii) each director; (iii) the Named
Executive Officers and (iv) officers and directors as a group. On the Reference
Date, there were 18,934,710 shares of Common Stock outstanding of which (i)
940,955 are subject to forfeiture if certain specified earnings per share or
stock price thresholds are not met during 1997; (ii) 69,308 shares are subject
to forfeiture if the Company is unable through August 1997 to perfect and
maintain rights free of liens in certain recently acquired patents; and (iii)
116,000 shares are subject to forfeiture if certain milestones pursuant to a
microbiology product development agreement are not achieved.
<TABLE>
<CAPTION>
PERCENT OF SHARES
BENEFICIALLY
OWNED (2)
-----------------
NUMBER OF SHARES PRIOR
NAME AND ADDRESS BENEFICIALLY TO AFTER
OF BENEFICIAL OWNER (1) OWNED (2) OFFERING OFFERING
- ------------------------------------------------------------------ ----------------- ------- -------
<S> <C> <C> <C>
Peter P. Gombrich................................................. 3,556,950(3) 18.7% 16.2%
Michael Falk ..................................................... 2,796,931(4) 13.1 11.5
c/o Commonwealth Associates
733 Third Avenue
New York, NY 10017
Commonwealth Associates .......................................... 1,889,300(5) 9.2 8.0
733 Third Avenue
New York, NY 10017
John H. Abeles.................................................... 326,657(6) 1.7 1.5
Leonard M. Schiller............................................... 172,159(7) * *
Michael D. Burke.................................................. 85,797(8) * *
Jack H. Halperin.................................................. 80,388(9) * *
Norman J. Pressman................................................ 43,834(10) * *
Paul F. Lavallee.................................................. 25,000(11) * *
Joseph W. Plandowski.............................................. 25,000(12) * *
Harold S. Blue.................................................... -- * *
Leonard R. Prange (13)............................................ -- * *
All directors and executive officers as a group 4,315,785(14) 22.4% 19.3%
(10 persons).....................................................
</TABLE>
- ------------------------------
* Represents less than 1%.
(1) Except as otherwise noted, the address for each person is c/o AccuMed
International, Inc., 900 North Franklin Street, Suite 401, Chicago, Illinois
60610.
(2) Unless otherwise noted, the Company believes that all persons named in the
table have sole voting and investment power with respect to all shares of
Common Stock listed as beneficially owned by them. A person is deemed to be
the beneficial holder of securities that can be acquired by such person
within 60 days from the Reference Date upon the exercise of warrants or
options. Each beneficial owner's percentage ownership is determined by
including shares, underlying options or warrants which are exercisable by
such person currently, or within 60 days following the Reference Date, and
excluding shares underlying options and warrants held by any other
person.The percentage of shares owned after the Offering is calculated based
on 21,934,710 shares to be outstanding after the Offering.
(3) Includes 66,666 shares underlying stock options held by Mr. Gombrich that
are exercisable currently or within 60 days following the Reference Date.
Includes 513,818 shares held of record by Gwenda Gombrich, Mr. Gombrich's
wife, directly or as custodian for minor children, as to which Mr. Gombrich
disclaims beneficial ownership. Includes 537,381 shares subject to
forfeiture if the Company fails to meet certain earnings per share or stock
price performance thresholds during 1997 (the "Performance Shares"). See
"Management's Discussion and Analysis of Financial Condition and Results of
Operations."
(4) Mr. Falk directly owns 222,222 shares of Common Stock and warrants to
purchase up to 585,409 shares of Common Stock. The number shown includes an
additional 222,222 shares, and 1,667,078 shares underlying warrants that are
exercisable currently or within 60 days following the Reference Date, held
by Commonwealth Associates (excluding securities held in Commonwealth
Associates' trading account). Mr. Falk is a control person of the corporate
general partner of Commonwealth Associates and may be deemed to be
beneficial owner of securities held by Commonwealth Associates. The number
of shares also includes an additional 100,000 shares underlying warrants
that are exercisable currently or within 60 days following the Reference
Date held by Anne Falk, Mr. Falk's spouse. Mr. Falk disclaims beneficial
ownership of the securities held by Commonwealth Associates except to the
extent of his percentage ownership interests in Commonwealth Associates.
Shares and warrants held directly by Mr. Falk were transferred to him by
Commonwealth Associates.
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(5) Includes 1,667,078 shares underlying warrants held by Commonwealth
Associates that are exercisable currently or within 60 days following the
Reference Date. Excludes securities held in Commonwealth Associates' trading
account.
(6) Includes 34,895 shares underlying stock options held by Dr. Abeles that are
exercisable currently or within 60 days following the Reference Date.
Includes 253,713 shares of Common Stock held of record, and 38,049 shares
underlying warrants exercisable currently or within 60 days following the
Reference Date, by Northlea Partners Limited, as to which Dr. Abeles
disclaims beneficial ownership except with respect to his 1% general partner
ownership.
(7) Includes 100,000 shares underlying stock options and warrants held by Mr.
Schiller that are exercisable currently or within 60 days following the
Reference Date.
(8) Includes 25,000 shares underlying stock options held by Mr. Burke that are
exercisable currently or within 60 days following the Reference Date.
Includes 9,841 Performance Shares. See "Management's Discussion and Analysis
of Financial Condition and Results of Operations."
(9) Includes 35,800 shares underlying stock options held by Mr. Halperin that
are exercisable currently or within 60 days following the Reference Date.
Includes 1,968 Performance Shares. See "Management's Discussion and Analysis
of Financial Condition and Results of Operations."
(10) Includes 18,834 shares underlying stock options held by Mr. Pressman that
are exercisable currently or within 60 days of the Reference Date.
(11) Consists of shares underlying stock options held by Mr. Lavallee that are
exercisable currently or within 60 days following the Reference Date.
(12) Consists of shares underlying stock options or warrants held by Mr.
Plandowski that are exercisable currently or within 60 days following the
Reference Date.
(13) Mr. Prange became the Chief Financial Officer and Corporate Vice President
of the Company on September 9, 1996.
(14) Includes 369,244 shares underlying warrants or options held by officers and
directors that are exercisable currently or within 60 days of the Reference
Date.
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DESCRIPTION OF CAPITAL STOCK
The following summary is a description of certain provisions of the
Company's Certificate of Incorporation and Bylaws. Such summary does not purport
to be complete and is subject to, and is qualified in its entirety by, all of
the provisions of the Certificate of Incorporation and Bylaws, including the
definitions therein of certain terms. Copies of the Certificate of Incorporation
and Bylaws are filed as exhibits to the Registration Statement of which this
Prospectus forms a part.
COMMON STOCK
Pursuant to the Company's Certificate of Incorporation, the Board of
Directors has the authority to issue up to 30,000,000 shares of Common Stock. As
of October 1, 1996, there were 18,934,710 shares of Common Stock outstanding, of
which (i) 940,955 shares are subject to forfeiture if certain specified earnings
per share or stock price thresholds are not met during 1997; (ii) 69,308 shares
are subject to forfeiture if the Company is unable through August 1997 to
perfect and maintain rights free of liens in certain recently acquired patents;
and (iii) 116,000 shares are subject to forfeiture if certain milestones under a
microbiology product development agreement are not achieved. There were 286
holders of record of Common Stock at October 1, 1996. Each holder of Common
Stock is entitled to one vote per share held of record on all matters submitted
to a vote of the stockholders. There are no cumulative voting or preemptive
rights applicable to any shares of Common Stock. All shares of Common Stock are
entitled to participate pro rata in distributions and in such dividends as may
be declared by the Board of Directors out of funds legally available therefor,
subject to any preferential dividend rights of any outstanding shares of
Preferred Stock. Subject to the prior rights of creditors, all shares of Common
Stock are entitled, in the event of liquidation, dissolution or winding up of
the Company, to participate ratably in the distribution of all the remaining
assets of the Company after distribution in full of preferential amounts, if
any, to be distributed to holders of Preferred Stock. The rights, preferences
and privileges of holders of Common Stock are subject to, and may be adversely
affected by, the rights of any series of Preferred Stock that the Company may
designate and issue in the future.
PREFERRED STOCK
Pursuant to the Company's Certificate of Incorporation, the Board of
Directors has the authority, without further action by the stockholders, to
issue up to 5,000,000 shares of Preferred Stock in one or more series and to fix
the designations, powers, preferences, privileges, and relative participating,
optional or special rights and the qualifications, limitations or restrictions
thereof, including dividend rights, conversion rights, voting rights, terms of
redemption and liquidation preferences, any or all of which may be greater than
the rights of the Common Stock. The Board of Directors, without stockholder
approval, can issue Preferred Stock with voting, conversion or other rights that
could adversely affect the voting power and other rights of the holders of
Common Stock. Preferred Stock could thus be issued quickly with terms calculated
to delay or prevent a change in control of the Company or make removal of
management more difficult. Additionally, the issuance of Preferred Stock may
have the effect of decreasing the market price of the Common Stock, and may
adversely affect the voting and other rights of the holders of Common Stock. At
present, there are no shares of Preferred Stock outstanding and the Company has
no plans to issue any Preferred Stock.
WARRANTS
As of October 1, 1996, the Company had outstanding warrants to purchase up
to 5,912,605 shares of Common Stock, of which warrants to purchase 63,472 shares
are subject to forfeiture if certain specified earnings per share or stock price
performance thresholds are not met in 1997.
REDEEMABLE WARRANTS
Redeemable Warrants to purchase a total of 2,702,705 shares of Common Stock
are tradeable on the Nasdaq Market under the symbol "ACMIW." The Redeemable
Warrants have been approved for quotation on the Nasdaq National Market under
the symbol "ACMIW," subject to commencement of the Offering. The Redeemable
Warrants are exercisable at any time prior to October 15, 1997, at an exercise
price of $5.00 per share. The Redeemable Warrants are redeemable by the Company
at any time prior to their expiration at a price of $.25 per underlying share,
provided that: (i) notice of not less than 60 days is
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given to the warrantholders; (ii) the closing bid quotation of the Common Stock
on each of the 20 trading days ending on the third day prior to the date on
which the Company gives notice has been at least 150% (currently $7.50, subject
to adjustment) of the then effective exercise price of the Redeemable Warrants;
and (iii) the warrantholders shall have exercise rights until the close of
business on the date fixed for redemption. The Company has agreed with the
Underwriters not to redeem the Redeemable Warrants for a period of one year from
the date of this Prospectus without the consent of the Representatives. See
"Underwriting."
PRIVATELY-ISSUED WARRANTS
The Company has from time to time issued warrants to purchase shares of
Common Stock to various vendors and financial advisors. Currently outstanding
warrants are as follows:
On March 14, 1996, the Company issued warrants (the "RADCO Warrants") to
purchase up to an aggregate of 687,500 shares of Common Stock to certain
investors as part of a private placement of Units consisting of RADCO Notes,
RADCO Stock and RADCO Warrants. Of the RADCO Warrants, 220,000 are exercisable
at a price of $3.42 per share and 467,500 are exercisable at a price of $3.87
per share (in each case subject to adjustment) for a period of three years. As
of October 1, 1996, RADCO Warrants to purchase an aggregate of 200,000 shares of
Common Stock had been exercised with aggregate proceeds to the Company of
$729,000.
On January 25, 1996, the Company issued to Robert Priddy a warrant to
purchase up to 100,000 shares of Common Stock exercisable at a price of $1.25
per share (subject to adjustment).
On January 18, 1996, the Company issued to The Research Works, Inc. a
warrant to purchase up to 100,000 shares of Common Stock exercisable at a price
of $2.125 per share (subject to adjustment) for a period of five years, in
consideration of certain research services to be performed by The Research
Works, Inc. A portion of the warrant was first exercisable on January 18, 1996.
The remaining portion of the warrant is exercisable in increments upon
completion of the second and third research reports by The Research Works, Inc.
On December 29, 1995, the Company (i) issued to Commonwealth Associates and
certain of its designees warrants to purchase an aggregate of 750,000 shares of
Common Stock at an exercise price of $1.25 per share (subject to adjustment) for
a period of five years, (ii) issued to Commonwealth Associates and certain of
its designees warrants to purchase up to 104,000 shares of Common Stock, from
the date of issuance to October 31, 1997, at an exercise price of $2.125 per
share (subject to adjustment), and (iii) issued to Leonard Schiller a warrant to
purchase up to 75,000 shares of Common Stock at an exercise price of $1.13 per
share for a period of five years. See "Certain Relationships and Related
Transactions."
On December 29, 1995, the Company also issued to The P.L. Thomas Group
warrants to purchase up to an aggregate of 364,785 shares of Common Stock. One
third of such warrants are exercisable at a price of $0.82 per share, one third
are exercisable at a price of $1.64 per share and one third are exercisable at a
price of $2.47 per share. Such warrants are exercisable at any time with respect
to 301,313 of the underlying shares and with respect to the remaining 63,472
shares will become exercisable only if specified earnings per share and stock
price performance goals are met during 1997.
On September 1, 1995, the Company issued to AEO warrants to purchase up to
100,000 shares of Common Stock at an exercise price of $0.25 per share (subject
to adjustment) for a period of five years. As of October 1, 1996, warrants to
purchase an aggregate of 36,500 shares had been exercised.
On May 9, 1995, August 14, 1995 and August 22, 1995 the Company issued to
Commonwealth Associates and certain of its designees warrants to purchase up to
an aggregate of 564,840 shares of Common Stock at an exercise price of $0.625
per share (subject to adjustment) for a period of five years. See "Certain
Relationships and Related Transactions."
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On December 31, 1994, the Company issued to Commonwealth Associates and
certain of its designees warrants to purchase up to 420,000 shares of Common
Stock at an exercise price of $0.25 per share (subject to adjustment) for a
period of five years. As of October 1, 1996, warrants to purchase an aggregate
of 20,000 shares had been exercised. See "Certain Relationships and Related
Transactions."
On March 29, 1994, the Company issued to G&G Dispensing, Inc. warrants to
purchase up to 175,000 shares of Common Stock at an exercise price of $5.00 per
share (subject to adjustment).
On April 30, 1990, the Company issued to AEO a warrant to purchase up to
25,275 shares of Common Stock at an exercise price of $5.00 per share (subject
to adjustment).
REGISTRATION RIGHTS
The Company has granted certain demand and so-called "piggy-back"
registration rights to certain holders of Common Stock and warrants to purchase
Common Stock. In addition, the Company has offered to register under the
Securities Act the offer and resale of certain shares of Common Stock by holders
not contractually entitled to such registration. Certain holders of such rights
have agreed with the Representatives to limit the sale of shares of Common Stock
owned by them during specified periods. In satisfaction of the Company's
obligations to such holders, the Company has agreed with such holders to file
with the Securities and Exchange Commission (the "Commission") promptly
following consummation of the Offering a registration statement covering the
offer and resale of an aggregate of approximately 8,265,000 (including shares
underlying options and warrants) shares of Common Stock. Approximately 7,013,000
of such shares (including shares underlying options and warrants) are subject to
certain lock-up agreements with the Representatives. No other holders of the
Company's securities are entitled to registration rights. See "Risk Factors --
Shares Eligible for Future Sale" and "Underwriting."
RIGHT OF FIRST REFUSAL IN CERTAIN EQUITY OFFERINGS
Pursuant to a Securities Purchase Agreement dated May 31, 1996 between the
Company and affiliated purchasers of an aggregate of 130,000 shares of Common
Stock, such purchasers are entitled to a right of first refusal in connection
with certain equity offerings by the Company from the date of such agreement
until May 31, 1997. Such right of first refusal does not apply to (i) the
issuance of securities pursuant to an underwritten public offering, (ii) the
issuance of securities upon exercise or conversion of options, warrants or other
convertible securities outstanding as of May 31, 1996, (iii) the grant of
additional options or warrants or other securities under a stock option plan or
restricted stock plan for employees, directors or consultants of the Company, or
any exercise of options by employees, directors or consultants, (iv) issuances
of securities in certain specified proposed private placements, and (v)
issuances of securities in connection with commercial banking arrangements, a
merger, consolidation or sale of assets or strategic partnership or joint
venture (the primary purpose of which is not to raise equity capital) or in
connection with the disposition or acquisition of a business, product or license
by the Company. If the Company proposes to offer equity securities under
circumstances other than as described in the preceding sentence, the Company
must give such purchasers written notice of the proposed offering at least ten
business days prior to the proposed closing date of such offering. During such
ten day period, such purchasers would be entitled to elect to purchase their
respective pro rata percentages (determined with reference to the percentage of
such 130,000 shares purchased by a specified purchaser) of the securities
offered on the same terms as the proposed offering.
TRANSFER AGENT AND REGISTRAR
American Stock Transfer & Trust Company is the transfer agent and registrar
for the Company's Common Stock.
DELAWARE ANTI-TAKEOVER LAW; CERTAIN CHARTER PROVISIONS
The Company is subject to the provisions of Section 203 of the Delaware
General Corporation Law (the "DGCL"), an anti-takeover law. In general, the
statute prohibits a publicly-held Delaware corporation from engaging in a
"business combination" with an "interested stockholder" for a period of three
years after the date of the transaction in which the person became an interested
stockholder, unless the
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business combination is, or the transaction in which the person became an
interested stockholder was, approved in a prescribed manner or another
prescribed exemption applies. For purposes of Section 203, a "business
combination" is defined broadly to include a merger, asset sale or other
transaction resulting in a financial benefit to the interested stockholder. In
general, an "interested stockholder" is a person who, together with affiliates
and associates, owns (or within the three years prior to such transaction did
own) 15% or more of the corporation's voting stock.
In addition, certain provisions of the Company's Certificate of
Incorporation may have the effect of preventing, discouraging or delaying any
change in control of the Company. The authorization of undesignated Preferred
Stock makes it possible for the Board of Directors to issue Preferred Stock with
voting or other rights or preferences that could impede the success of any
attempt to change control of the Company. See "-- Preferred Stock."
LIMITATION OF LIABILITY AND INDEMNIFICATION
Pursuant to the provisions of the DGCL, the Company has adopted provisions
in the Certificate of Incorporation that eliminate the personal liability of its
directors to the Company or its stockholders for monetary damages for breach of
their fiduciary duty as a director to the fullest extent permitted by the DGCL
except for liability (i) for any breach of their duty of loyalty to the Company
or its stockholders, (ii) for acts or omissions not in good faith or which
involve intentional misconduct or a knowing violation of law, (iii) under
Section 174 of the DGCL (unlawful payments of dividends or unlawful stock
repurchases or redemptions), or (iv) for any transaction from which the director
derived an improper personal benefit. This provision also does not affect a
director's responsibilities under any other laws, such as the federal securities
laws or state or federal environmental laws.
The Company's Certificate of Incorporation contains provisions indemnifying
directors, officers, employees and agents of the Company against certain
liabilities that may arise by reason of their status or service as such
directors, officers, employees or agents. Insofar as indemnification for
liabilities arising under the Securities Act may be permitted to directors,
officers and controlling persons of the Company pursuant to the foregoing
provisions, or otherwise, the Company has been advised that in the opinion of
the Commission such indemnification is against public policy as expressed in the
Securities Act and is, therefore, unenforceable.
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UNDERWRITING
Subject to the terms and conditions of the Underwriting Agreement, the
underwriters named below (the "Underwriters"), for whom Vector Securities
International, Inc. and Tucker Anthony Incorporated are acting as
Representatives, have severally agreed to purchase from the Company, and the
Company has agreed to sell to the Underwriters, the following respective number
of shares of Common Stock:
<TABLE>
<CAPTION>
NUMBER OF
UNDERWRITERS SHARES
- --------------------------------------------------------------------------------- -----------
<S> <C>
Vector Securities International, Inc. ........................................... 940,000
Tucker Anthony Incorporated...................................................... 940,000
Cowen & Company.................................................................. 65,000
Donaldson, Lufkin & Jenrette Securities Corporation.............................. 65,000
A.G. Edwards & Sons, Inc......................................................... 65,000
Lehman Brothers Inc.............................................................. 65,000
Montgomery Securities............................................................ 65,000
Prudential Securities Incorporated............................................... 65,000
Robertson, Stephens & Company LLC................................................ 65,000
Sutro & Co. Incorporated......................................................... 65,000
Adams, Harkness & Hill, Inc...................................................... 30,000
Advest, Inc...................................................................... 30,000
Robert W. Baird & Co. Incorporated............................................... 30,000
The Boston Group................................................................. 30,000
Cleary Gull Reiland & McDevitt Inc............................................... 30,000
Cruttenden Roth Incorporated..................................................... 30,000
Dain Bosworth Incorporated....................................................... 30,000
Equitable Securities Corporation................................................. 30,000
Interstate/Johnson Lane Corporation.............................................. 30,000
Janney Montgomery Scott Inc...................................................... 30,000
Jeffries & Company, Inc.......................................................... 30,000
McDonald & Company Securities, Inc............................................... 30,000
Morgan Keegan & Company, Inc..................................................... 30,000
Needham & Company, Inc........................................................... 30,000
The Ohio Company................................................................. 30,000
Piper Jaffray Inc................................................................ 30,000
The Robinson-Humphrey Company, Inc............................................... 30,000
Rodman & Renshaw, Inc............................................................ 30,000
Van Kasper & Company............................................................. 30,000
H.C. Wainwright & Co., Inc....................................................... 30,000
-----------
Total........................................................................ 3,000,000
-----------
-----------
</TABLE>
The Underwriting Agreement provides that the obligations of the Underwriters
are subject to certain conditions precedent, including the absence of any
material adverse change in the Company's business and the receipt of certain
certificates, opinions and letters from the Company and its counsel. The nature
of the Underwriters' obligation is such that they are committed to purchase all
shares of Common Stock offered hereby if any of such shares are purchased.
The Underwriters propose to offer the shares of Common Stock to the public
at the public offering price set forth on the cover page of this Prospectus, and
to certain dealers at such price less a concession not in excess of $.15 per
share. The Underwriters may allow, and such dealers may reallow, a concession
not in excess of $.05 per share to certain other dealers. After the public
offering of the shares of Common Stock, the offering price and other selling
terms may be changed by the Representatives.
The Company has granted to the Underwriters an option, exercisable at any
time during the 30-day period after the date of this Prospectus, to purchase up
to an additional 450,000 shares of Common Stock
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at the public offering price set forth on the cover page of this Prospectus,
less underwriting discounts and commissions. The Underwriters may exercise such
option solely for the purpose of covering over-allotments, if any, in connection
with the Offering. To the extent such option is exercised, each Underwriter will
be obligated, subject to certain conditions, to purchase approximately the same
percentage of such additional shares as the number of shares of Common Stock set
forth next to such Underwriter's name in the preceding table bears to the total
number of shares listed in the table.
The offering of shares is made for delivery when, as and if accepted by the
Underwriters and subject to prior sale and to withdrawal, cancellation or
modification of the Offering without notice. The Underwriters reserve the right
to reject an order for the purchase of shares in whole or in part.
The Company has agreed to indemnify the Underwriters against certain
liabilities, including liabilities under the Securities Act, and to contribute
to payments the Underwriters may be required to make in respect thereof.
The Representatives have advised the Company that the Underwriters do not
intend to confirm sales to any account over which they exercise discretionary
authority.
Except as set forth below, the directors, executive officers and certain
securityholders of the Company have agreed that they will not, without the prior
written consent of the Representatives, offer, sell or otherwise dispose of any
shares of Common Stock, options or warrants to acquire shares of Common Stock or
securities exchangeable for or convertible into shares of Common Stock owned by
them for a period of 270 days after the date of this Prospectus, except that the
holders may (i) after 90 days following the date of this Prospectus, dispose of
one third of their shares of Common Stock, options, warrants and exchangeable
securities and (ii) after 180 days following the date of this Prospectus,
dispose of an additional one third of their shares of Common Stock, options,
warrants and exchangeable securities. Mr. Gombrich has agreed that he will not,
without the prior written consent of the Representatives, offer, sell or
otherwise dispose of any shares of Common Stock, options, warrants or securities
exchangeable for or convertible into shares of Common Stock beneficially owned
by him for a period of 270 days after the date of this Prospectus. In addition,
Commonwealth Associates has agreed to the transfer restrictions referred to
above, except as such restrictions relate to certain warrants held by it.
Commonwealth Associates has agreed that, during the 60 day period following the
date of this Prospectus, it will not offer, sell or otherwise dispose of shares
of Common Stock underlying Redeemable Warrants to purchase 900,000 shares of
Common Stock. There are no restrictions on transfer of the remaining 77,807
warrants, including the underlying shares, owned by Commonwealth Associates. AEO
and the other holders of the RADCO Warrants have also agreed not to offer, sell
or otherwise dispose of any shares of Common Stock underlying the RADCO Warrants
during the 60 day period following the date of this Prospectus. The Company has
agreed that it will not, without the prior written consent of the
Representatives, offer, sell, or otherwise dispose of any shares of Common
Stock, options or warrants to acquire shares of Common Stock or securities
exchangeable for or convertible into shares of Common Stock for a period of 180
days after the date of this Prospectus, except that the Company may (i) grant
additional options under its stock options plans and (ii) issue shares upon the
exercise of outstanding stock options or warrants. Furthermore, the Company has
agreed that it will not, without the prior written consent of the
Representatives, redeem the Redeemable Warrants prior to one year following the
date of this Prospectus. See "Risk Factors -- Shares Eligible for Future Sale."
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CHANGE IN INDEPENDENT ACCOUNTANTS
Coopers & Lybrand LLP ("C&L") were previously the principal accountants for
the Company. On January 15, 1996, C&L's appointment as principal accountants was
terminated and the Company engaged KPMG Peat Marwick LLP as the Company's
principal accountants. The Company's Board of Directors approved the decision to
change accountants. The opinions of C&L on the balance sheet of AccuMed, Inc. as
of December 31, 1994, and the statement of operations, stockholders' deficit,
and cash flows for the period from February 7, 1994 (inception) through December
31, 1994, the balance sheets of Alamar Biosciences, Inc. as of September 30,
1995 and 1994, and the statements of operations, stockholders' equity, and cash
flows for each of the three years in the period ended September 30, 1995, and
the balance sheet of Sensititre/Alamar, the Microbiology Division of AccuMed,
Inc., as of December 31, 1994 and the statements of net sales, cost of sales,
and selling expenses for the eight months ended December 31, 1994 and for each
of the two years in the period ended April 30, 1994 did not contain any adverse
opinions or disclaimers or opinions, or modifications as to uncertainty, audit
scope or accounting principles, except that for the opinions related to AccuMed,
Inc. and Alamar Biosciences, Inc., C&L modified its reports to include an
uncertainty explanatory paragraph which expressed substantial doubt as to
AccuMed, Inc.'s and Alamar Biosciences, Inc.'s ability to continue as a going
concern. There were no disagreements between the Company and C&L on any matter
of accounting principles or practices, financial statement disclosure, or
auditing scope or procedures, which disagreements, if not resolved to the
satisfaction of C&L, would have caused it to make reference to the subject
matter of the disagreements in connection with its report.
AVAILABLE INFORMATION
The Company is subject to the informational requirements of the Exchange Act
and, in accordance therewith, files reports, proxy statements and other
information with the Commission. Such reports, proxy statements and other
information filed by the Company may be inspected and copied at the public
reference facilities maintained by the Commission at 450 Fifth Street, N.W.,
Room 1024, Washington, D.C. 20549, and at the following regional offices: New
York Regional Office, 7 World Trade Center, Room 1400, New York, New York 10048
and Chicago Regional Office, 500 West Madison Street, Suite 1400, Chicago,
Illinois 60661. Copies of such material may also be obtained from the Public
Reference Section of the Commission at 450 Fifth Street, N.W., Washington, D.C.
20549, at prescribed rates. The Commission also maintains a site on the World
Wide Web that contains reports, proxy statements, information statements and
other information regarding companies that file such documents with the
Commission electronically. The website address is http://www.sec.gov. The Common
Stock is quoted on the Nasdaq Market and reports and other information regarding
the Company may be inspected at the National Association of Securities Dealers,
Inc. at 1735 K Street, N.W., Washington, D.C. 20006.
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INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE
The following documents which have heretofore been filed by the Company with
the Commission pursuant to the Exchange Act are incorporated by reference herein
and shall be deemed to be a part hereof:
(1) The Company's Annual Report on Form 10-KSB for the year ended September
30, 1995.
(2) The Company's Current Report on Form 8-K filed with the Commission on
January 16, 1996.
(3) The Company's Current Report on Form 8-K filed with the Commission on
January 17, 1996.
(4) The Company's Current Report on Form 8-K filed with the Commission on
January 19, 1996.
(5) The Company's Amendment No. 1 to the Current Report on Form 8-K/A filed
with the Commission on January 24, 1996.
(6) The Company's Transition Report on Form 10-KSB for the transition period
ended December 31, 1995.
(7) The Company's Quarterly Report on Form 10-QSB for the quarter ended
March 31, 1996.
(8) The Company's Quarterly Report on Form 10-QSB for the quarter ended June
30, 1996.
(9) The Company's Amendment No. 1 to its Quarterly Report on Form 10-QSB for
the quarter ended June 30, 1996.
(10) The description of Common Stock contained in the Company's Registration
Statement on Form 8-A filed with the Commission on September 18, 1992 by
which the Common Stock of the Company was registered under Section 12 of
the Exchange Act, and the description of the Common Stock incorporated
therein by reference to the Registration Statement on Form S-1 (Reg. No.
33-48302) filed with the Commission on June 3, 1992 and amended on June
25, 1992, July 23, 1992 and September 10, 1992, under the caption
"Description of Securities" therein.
(11) The description of the Common Stock contained in the Company's
Amendment No. 1 to Registration Statement on Form 8-A/A filed with the
Commission on January 2, 1996.
All documents filed by the Company pursuant to Sections 13(a), 13(c), 14 or
15(d) of the Exchange Act, after the date of this Prospectus and prior to the
termination of the Offering, shall be deemed to be incorporated by reference in
this Prospectus and to be a part hereof from the date of filing of such
documents. Any statement incorporated by reference herein shall be deemed to be
modified or superseded for purposes of this Prospectus to the extent that a
statement contained herein, or in any other subsequently filed document which
also is or is deemed to be incorporated by reference herein, modifies or
supersedes such statement. Any statement so modified or superseded shall not be
deemed, except as so modified or superseded, to constitute a part of this
Prospectus.
The Company will provide, without charge to each person to whom this
Prospectus is delivered, upon written or oral request, a copy of any or all of
the documents incorporated by reference in this Prospectus (not including
exhibits and other information that is incorporated by reference unless the
exhibits are themselves specifically incorporated by reference). Requests for
such documents should be directed to AccuMed International, Inc., located at 900
North Franklin Street, Suite 401, Chicago, Illinois 60610, Attention: Chief
Financial Officer, telephone (312) 642-9200.
67
<PAGE>
ADDITIONAL INFORMATION
Additional information regarding the Company and the securities offered
hereby is contained in the Registration Statement on Form S-2 (Reg. No.
333-09011) of which this Prospectus forms a part, and the exhibits thereto filed
with the Commission under the Securities Act. For further information pertaining
to the Company and the securities offered hereby, reference is made to the
Registration Statement and the exhibits thereto, which may be inspected without
charge at, and copies may be obtained at prescribed fees from, the office of the
Commission at 450 Fifth Street, N.W., Washington, D.C. 20549.
The Company furnishes stockholders with annual reports containing audited
financial statements and other periodic reports as the Company may deem to be
appropriate, or as required by law or the rules of the National Association of
Securities Dealers, Inc.
LEGAL MATTERS
The legality of the securities offered by this Prospectus will be passed
upon for the Company by Graham & James LLP, Sacramento, California. Certain
partners in Graham & James LLP own an aggregate of 1,458 shares of Common Stock
and 1,000 Redeemable Warrants. Certain legal matters relating to the Offering
will be passed upon for the Underwriters by Skadden, Arps, Slate, Meagher &
Flom, Chicago, Illinois.
EXPERTS
The balance sheet of AccuMed, Inc as of December 31, 1994, and the
statements of operations, stockholders' deficit, and cash flows for the period
from February 7, 1994 (inception) through December 31, 1994, the balance sheets
of Alamar Biosciences, Inc. as of September 30, 1995 and 1994, incorporated by
reference in this Prospectus, and the statements of operations, stockholders'
equity, and cash flows for each of the three years in the period ended September
30, 1995, included or incorporated by reference in this Prospectus, and the
balance sheet of Sensititre/Alamar, the Microbiology Division of AccuMed, Inc.,
as of December 31, 1994 and the statements of net sales, cost of sales, and
selling expenses for the eight months ended December 31, 1994 and for each of
the two years in the period ended April 30, 1994, incorporated by reference in
this Prospectus, have been so included or incorporated by reference in reliance
on the reports, which included explanatory paragraphs related to AccuMed, Inc.'s
and Alamar Biosciences, Inc.'s ability to continue as going concerns, of C&L,
given on the authority of said firm as experts in accounting and auditing.
The balance sheets of AccuMed International Limited as of December 31, 1994,
April 30, 1994 and 1993, and the statements of operations and cash flows for the
eight months ended December 31, 1994, and for each of the two years in the
period ended April 30, 1994, as incorporated by reference in this Prospectus,
have been included herein in reliance on the report of C&L, given on the
authority of said firm as experts in accounting and auditing.
The consolidated financial statements of AccuMed International, Inc. and
subsidiaries as of December 31, 1995, and for the three months ended December
31, 1995, included in this Prospectus and incorporated herein by reference from
the Company's Transition Report on Form 10-KSB for the three month period ended
December 31, 1995 have been so included or incorporated by reference in reliance
upon the report of KPMG Peat Marwick LLP, independent certified public
accountants ("KPMG"), and upon the authority of said firm as experts in
accounting and auditing.
The financial statements of Oncometrics Imaging Corp. as of August 31, 1995,
December 31, 1995 and May 31, 1996, and for the year ended August 31, 1995, for
the four months ended December 31, 1995 and for the five months ended May 31,
1996, included in this Prospectus, have been so included in reliance upon the
report of KPMG, chartered accountants, and upon the authority of said firm as
experts in accounting and auditing.
Statements in this Prospectus under the captions "Risk Factors -- Protection
of Intellectual Property" and "Business -- Intellectual Property," insofar as
they relate to patent matters, other than with
68
<PAGE>
respect to certain matters in connection with the Company's microbiology
technology, have been reviewed and approved by Banner & Witcoff, Ltd., special
patent counsel to the Company, and have been included herein in reliance upon
the review and approval by such firm as experts in patent law.
Statements in this Prospectus under the captions "Risk Factors -- Protection
of Intellectual Property" and "Business -- Intellectual Property," insofar as
they relate to patent matters in connection with the Alamar microbiology
technology and the trade secret litigation which occurred from late 1994 until
early 1996, have been reviewed and approved by Townsend and Townsend and Crew
LLP, special patent counsel to the Company, and have been included herein in
reliance upon the review and approval by such firm as experts in patent law.
69
<PAGE>
INDEX TO FINANCIAL STATEMENTS
<TABLE>
<CAPTION>
PAGE
---------
<S> <C>
ACCUMED INTERNATIONAL, INC. AND SUBSIDIARIES
Independent Auditors' Report............................................................................. F-2
Independent Accountants' Report.......................................................................... F-3
Consolidated Balance Sheets as of September 30, 1995, December 31, 1995 and June 30, 1996 (unaudited).... F-4
Consolidated Statements of Operations for the years ended September 30, 1994 and 1995, for the three
months ended December 31, 1995 and for the six months ended June 30, 1996 (unaudited)................... F-5
Consolidated Statements of Stockholders' Equity for the years ended September 30, 1994 and 1995, for the
three months ended December 31, 1995 and for the six months ended June 30, 1996 (unaudited)............. F-6
Consolidated Statements of Cash Flows for the years ended September 30, 1994 and 1995, for the three
months ended December 31, 1995 and for the six months ended June 30, 1996 (unaudited)................... F-7
Notes to Consolidated Financial Statements............................................................... F-8
ONCOMETRICS IMAGING CORP.
Auditors' Report......................................................................................... F-23
Balance Sheets as of August 31, 1995, December 31, 1995 and May 31, 1996................................. F-24
Statements of Operations and Deficit for the year ended August 31, 1995, for the four months ended
December 31, 1995 and for the five months ended May 31, 1996............................................ F-25
Statements of Changes in Financial Position for the year ended August 31, 1995, for the four months ended
December 31, 1995 and for the five months ended May 31, 1996............................................ F-26
Notes to Financial Statements............................................................................ F-27
PRO FORMA CONDENSED COMBINING FINANCIAL STATEMENTS (UNAUDITED)
Pro Forma Condensed Combining Balance Sheet as of June 30, 1996.......................................... F-31
Pro Forma Condensed Combining Statement of Operations for the six months ended
June 30, 1996........................................................................................... F-32
Pro Forma Condensed Combining Statement of Operations for the three months ended December 31, 1995....... F-33
Pro Forma Condensed Combining Statement of Operations for the year ended September 30, 1995.............. F-34
Notes to Pro Forma Condensed Combining Financial Statements.............................................. F-35
</TABLE>
F-1
<PAGE>
INDEPENDENT AUDITORS' REPORT
The Board of Directors and Stockholders
AccuMed International, Inc.:
We have audited the accompanying consolidated balance sheet of AccuMed
International, Inc. and subsidiaries as of December 31, 1995, and the related
consolidated statements of operations, stockholders' equity, and cash flows for
the three months ended December 31, 1995. These consolidated financial
statements are the responsibility of the Company's management. Our
responsibility is to express an opinion on these consolidated financial
statements based on our audit.
We conducted our audit in accordance with generally accepted auditing
standards. Those standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are free of material
misstatement. An audit includes examining, on a test basis, evidence supporting
the amounts and disclosures in the financial statements. An audit also includes
assessing the accounting principles used and significant estimates made by
management, as well as evaluating the overall financial statement presentation.
We believe that our audit provides a reasonable basis for our opinion.
In our opinion, the consolidated financial statements referred to above
present fairly, in all material respects, the financial position of AccuMed
International, Inc. and subsidiaries as of December 31, 1995, and the results of
their operations and their cash flows for the three months ended December 31,
1995, in conformity with generally accepted accounting principles.
/s/ KPMG PEAT MARWICK LLP
Chicago, Illinois
April 5, 1996
F-2
<PAGE>
INDEPENDENT ACCOUNTANTS' REPORT
The Stockholders
Alamar Biosciences, Inc.
We have audited the accompanying balance sheet of Alamar Biosciences, Inc.,
as of September 30, 1995 and related statements of operations, stockholders'
equity, and cash flows for the years ended September 30, 1994 and 1995. These
financial statements are the responsibility of the Company's management. Our
responsibility is to express an opinion on these financial statements based on
our audits.
We conducted our audits in accordance with generally accepted auditing
standards. Those standards require that we plan and perform the audits to obtain
reasonable assurance about whether the financial statements are free of material
misstatement. An audit includes examining, on a test basis, evidence supporting
the amounts and disclosures in the financial statements. An audit also includes
assessing the accounting principles used and significant estimates made by
management, as well as evaluating the overall financial statement presentation.
We believe that our audits provided a reasonable basis for our opinion.
In our opinion, the financial statements referred to above present fairly,
in all material respects, the financial position of Alamar Biosciences, Inc., at
September 30, 1995, and the results of its operations and its cash flows for the
years ended September 30, 1994 and 1995, in conformity with generally accepted
accounting principles.
The accompanying financial statements have been prepared assuming that the
Company will continue as a going concern. As discussed in Note 3, the Company is
involved in litigation and is proposing to merge with another company. The
Company has taken certain actions to meet cash flow requirements, including a
reduction in work force, overhead and product development, until the disputes
can be resolved. There can be no assurance that the Company's efforts related to
the lawsuits will be successful. In addition, there can be no assurance that
combined operations of the proposed merger will produce the necessary cash flow
required. These factors raise substantial doubt about the Company's ability to
continue as a going concern. The financial statements do not include any
adjustments that might be necessary if the Company is unable to continue as a
going concern.
/s/ COOPERS & LYBRAND L.L.P.
Sacramento, California
November 19, 1995
F-3
<PAGE>
ACCUMED INTERNATIONAL, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
<TABLE>
<CAPTION>
SEPTEMBER 30, DECEMBER 31,
1995 1995
-------------- -------------- JUNE 30, 1996
--------------
(UNAUDITED)
<S> <C> <C> <C>
ASSETS
Current assets:
Cash and cash equivalents....................................... $ 716,211 $ 180,508 $ 595,265
Restricted cash................................................. 185,000 363,000 --
Accounts receivable............................................. 245,092 874,712 1,405,486
Prepaid expenses and deposits................................... 73,260 124,836 231,194
Production inventory............................................ 314,006 1,143,120 1,513,760
-------------- -------------- --------------
Total current assets........................................ 1,533,569 2,686,176 3,745,705
-------------- -------------- --------------
Fixed assets, net................................................. 411,126 528,402 401,970
Notes receivable.................................................. 700,000 -- --
Deferred merger costs............................................. 299,650 -- --
Intangible assets................................................. -- 2,644,556 4,403,677
Other assets...................................................... 44,621 115,069 168,402
-------------- -------------- --------------
$ 2,988,966 $ 5,974,203 $ 8,719,754
-------------- -------------- --------------
-------------- -------------- --------------
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable................................................ $ 1,017,103 $ 2,005,861 $ 2,242,433
Other current liabilities....................................... 203,497 870,313 772,465
Deferred revenue................................................ 470,238 1,454,450 35,358
Notes payable................................................... -- 726,514 37,497
Capital lease obligations due within one year................... 89,406 88,270 86,067
-------------- -------------- --------------
Total current liabilities................................... 1,780,244 5,145,408 3,173,820
-------------- -------------- --------------
Long-term portion of capital lease obligations.................... 110,806 89,810 45,243
Deferred rent..................................................... -- 10,278 13,393
Stockholders' equity:
Common stock, $.01 par value, 30,000,000 shares authorized,
10,929,339 shares issued and outstanding at September 30, 1995,
15,571,184 at December 31, 1995 and 17,525,748 at June 30,
1996........................................................... 109,293 155,712 175,257
Additional paid in capital...................................... 18,008,086 23,334,495 32,694,471
Cumulative translation adjustment............................... -- -- (2,236)
Accumulated deficit............................................. (17,019,463) (22,761,500) (27,220,237)
-------------- -------------- --------------
1,097,916 728,707 5,647,255
Less treasury stock, 0 shares at September 30, 1995 and December
31, 1995 and 26,270 shares at June 30, 1996.................... -- -- (159,957)
-------------- -------------- --------------
Total stockholders' equity.................................. 1,097,916 728,707 5,487,298
-------------- -------------- --------------
$ 2,988,966 $ 5,974,203 $ 8,719,754
-------------- -------------- --------------
-------------- -------------- --------------
</TABLE>
See accompanying notes to consolidated financial statements.
F-4
<PAGE>
ACCUMED INTERNATIONAL, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
<TABLE>
<CAPTION>
YEARS ENDED SEPTEMBER 30, THREE MONTHS
-------------------------- ENDED DECEMBER
1994 1995 31, 1995
------------ ------------ -------------- SIX MONTHS ENDED JUNE 30,
--------------------------
1995 1996
------------ ------------
(UNAUDITED) (UNAUDITED)
<S> <C> <C> <C> <C> <C>
Sales.................................. $ 1,161,822 $ 514,776 $ 100,130 $ 320,505 $ 2,312,094
Cost of sales.......................... (1,549,350) (1,431,187) (338,730) (471,065) (1,465,457)
------------ ------------ -------------- ------------ ------------
Gross profit (loss).................... (387,528) (916,411) (238,600) (150,560) 846,637
------------ ------------ -------------- ------------ ------------
Operating expenses:
General and administrative........... 1,219,249 2,094,890 1,418,797 860,253 1,791,534
Research and development............. 580,180 386,882 3,997,600 139,842 4,789,412
Sales and marketing.................. 959,519 309,208 7,197 74,959 841,565
------------ ------------ -------------- ------------ ------------
Total operating expenses......... 2,758,948 2,790,980 5,423,594 1,075,054 7,422,511
------------ ------------ -------------- ------------ ------------
Operating loss......................... (3,146,476) (3,707,391) (5,662,194) (1,225,614) (6,575,874)
------------ ------------ -------------- ------------ ------------
Other income (expense):
Interest income...................... 46,624 7,949 4,748 2,693 11,460
Interest expense..................... (12,836) (46,657) (10,862) (25,973) (437,986)
Other................................ 298 (13,211) (72,929) 95,734 2,544,513
------------ ------------ -------------- ------------ ------------
Total other income (expense)..... 34,086 (51,919) (79,043) (72,454) 2,117,987
------------ ------------ -------------- ------------ ------------
Loss before income taxes............... (3,112,390) (3,759,310) (5,741,237) (1,153,160) (4,457,887)
Income tax expense..................... 800 800 800 400 850
------------ ------------ -------------- ------------ ------------
Net loss......................... $ (3,113,190) $ (3,760,110) $ (5,742,037) $ (1,153,560) $ (4,458,737)
------------ ------------ -------------- ------------ ------------
------------ ------------ -------------- ------------ ------------
Net loss per share..................... $ (0.65) $ (0.59) $ (0.49) $ (0.20) $ (0.27)
------------ ------------ -------------- ------------ ------------
------------ ------------ -------------- ------------ ------------
Weighted average common shares
outstanding........................... 4,776,139 6,375,627 11,742,980 5,653,437 16,319,105
------------ ------------ -------------- ------------ ------------
------------ ------------ -------------- ------------ ------------
</TABLE>
See accompanying notes to consolidated financial statements.
F-5
<PAGE>
ACCUMED INTERNATIONAL, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY
<TABLE>
<CAPTION>
COMMON STOCK ADDITIONAL CUMULATIVE
--------------------- PAID-IN ACCUMULATED TRANSLATION TREASURY
SHARES AMOUNT CAPITAL DEFICIT ADJUSTMENT STOCK
--------- ---------- ---------- ------------ ----------- ---------
<S> <C> <C> <C> <C> <C> <C>
Balances at September 30, 1993............... 4,710,553 $ 47,106 $14,243,494 ($10,146,163) -- --
Issuances of common stock:
November 1993 at $0.80..................... 3,491 35 2,758 -- -- --
December 1993 at $0.80..................... 1,250 12 988 -- -- --
December 1993 at $2.50..................... 50,000 500 124,500 -- -- --
March 1994 at $2.07........................ 29,000 290 59,710 -- -- --
August 1994 at $2.50....................... 50,000 500 124,500 -- -- --
Net loss..................................... -- -- -- (3,113,190) -- --
--------- ---------- ---------- ------------ ----------- ---------
Balances at September 30, 1994............... 4,844,294 48,443 14,555,950 (13,259,353) -- --
--------- ---------- ---------- ------------ ----------- ---------
Issuances of common stock:
November 1994 at $2.50..................... 100,000 1,000 249,000 -- -- --
March 1995 at $0.62........................ 80,645 807 41,693 -- -- --
May 1995 at $.625.......................... 2,648,400 26,484 1,369,115 -- -- --
August 1995 at $.625....................... 3,000,000 30,000 1,505,887 -- -- --
August 1995 at $.625....................... 240,000 2,400 128,100 -- -- --
August 1995 at $1.00....................... 16,000 160 15,840 -- -- --
Issuances of warrants........................ -- -- 142,500 -- -- --
Net loss..................................... -- -- -- (3,760,110) -- --
--------- ---------- ---------- ------------ ----------- ---------
Balances at September 30, 1995............... 10,929,339 109,294 18,008,085 (17,019,463) -- --
--------- ---------- ---------- ------------ ----------- ---------
Issuances of common stock:
October 1995 at $0.625..................... 50,000 500 30,750 -- -- --
November 1995 at $0.625.................... 20,000 200 12,300 -- -- --
December 1995 at $1.125.................... 4,431,845 44,318 4,941,508 -- -- --
Issuance of warrants......................... -- -- 308,252 -- -- --
Warrants exercised December 1995 @ $0.25..... 140,000 1,400 33,600 -- -- --
Net loss..................................... -- -- -- (5,742,037) -- --
--------- ---------- ---------- ------------ ----------- ---------
Balances at December 31, 1995................ 15,571,184 155,712 23,334,495 (22,761,500) -- --
--------- ---------- ---------- ------------ ----------- ---------
Issuances of common stock (unaudited):
January 1996 at $1.125..................... 60,000 600 66,900 -- -- --
March 1996 at $5.50........................ 940,955 9,410 5,165,842 -- -- --
May 1996 at $8.125......................... 3,750 37 30,432 -- -- --
June 1996 at $6.00......................... 255,000 2,550 1,407,115 -- -- --
Issuances of warrants (unaudited)............ -- -- 1,689,464 -- -- --
Stock options exercised (unaudited):
March 1996 at $0.63........................ 7,895 78 4,896 -- -- --
March 1996 at $1.39........................ 5,000 50 6,900 -- -- --
May 1996 at $0.63.......................... 17,765 178 11,014 -- -- --
May 1996 at $0.75.......................... 6,690 67 4,950 -- -- --
May 1996 at $1.13.......................... 9,333 93 10,453 -- -- --
May 1996 at $1.39.......................... 98,153 981 135,452 -- -- --
June 1996 at $0.63......................... 7,895 79 4,895 -- -- --
June 1996 at $1.13......................... 19,167 192 21,467 -- -- --
June 1996 at $1.39......................... 202,375 2,024 279,277 -- -- --
Warrants exercised (unaudited):
January 1996 at $0.25...................... 17,500 175 4,200 -- -- --
March 1996 at $0.25........................ 2,500 25 600 -- -- --
April 1996 at $0.25........................ 9,000 90 2,160 -- -- --
May 1996 at $3.42.......................... 100,000 1,000 341,000 -- -- --
June 1996 at $3.87......................... 25,000 250 96,500 -- -- --
Conversion of debt (unaudited)............... 166,586 1,666 76,459 -- -- --
Cumulative translation adjustment
(unaudited)................................. -- -- -- -- (2,236)
Shares received for litigation settlement
(unaudited)................................. -- -- -- -- -- (159,957)
Net loss (unaudited)......................... -- -- -- (4,458,737) -- --
--------- ---------- ---------- ------------ ----------- ---------
Balances at June 30, 1996 (unaudited)...... 17,525,748 $ 175,257 $32,694,471 ($27,220,237) $ (2,236) $(159,957)
--------- ---------- ---------- ------------ ----------- ---------
--------- ---------- ---------- ------------ ----------- ---------
<CAPTION>
TOTAL
STOCKHOLDERS'
EQUITY
-------------
<S> <C>
Balances at September 30, 1993............... $ 4,144,437
Issuances of common stock:
November 1993 at $0.80..................... 2,793
December 1993 at $0.80..................... 1,000
December 1993 at $2.50..................... 125,000
March 1994 at $2.07........................ 60,000
August 1994 at $2.50....................... 125,000
Net loss..................................... (3,113,190)
-------------
Balances at September 30, 1994............... 1,345,040
-------------
Issuances of common stock:
November 1994 at $2.50..................... 250,000
March 1995 at $0.62........................ 42,500
May 1995 at $.625.......................... 1,395,599
August 1995 at $.625....................... 1,535,887
August 1995 at $.625....................... 130,500
August 1995 at $1.00....................... 16,000
Issuances of warrants........................ 142,500
Net loss..................................... (3,760,110)
-------------
Balances at September 30, 1995............... 1,097,916
-------------
Issuances of common stock:
October 1995 at $0.625..................... 31,250
November 1995 at $0.625.................... 12,500
December 1995 at $1.125.................... 4,985,826
Issuance of warrants......................... 308,252
Warrants exercised December 1995 @ $0.25..... 35,000
Net loss..................................... (5,742,037)
-------------
Balances at December 31, 1995................ 728,707
-------------
Issuances of common stock (unaudited):
January 1996 at $1.125..................... 67,500
March 1996 at $5.50........................ 5,175,252
May 1996 at $8.125......................... 30,469
June 1996 at $6.00......................... 1,409,665
Issuances of warrants (unaudited)............ 1,689,464
Stock options exercised (unaudited):
March 1996 at $0.63........................ 4,974
March 1996 at $1.39........................ 6,950
May 1996 at $0.63.......................... 11,192
May 1996 at $0.75.......................... 5,017
May 1996 at $1.13.......................... 10,546
May 1996 at $1.39.......................... 136,433
June 1996 at $0.63......................... 4,974
June 1996 at $1.13......................... 21,659
June 1996 at $1.39......................... 281,301
Warrants exercised (unaudited):
January 1996 at $0.25...................... 4,375
March 1996 at $0.25........................ 625
April 1996 at $0.25........................ 2,250
May 1996 at $3.42.......................... 342,000
June 1996 at $3.87......................... 96,750
Conversion of debt (unaudited)............... 78,125
Cumulative translation adjustment
(unaudited)................................. (2,236)
Shares received for litigation settlement
(unaudited)................................. (159,957)
Net loss (unaudited)......................... (4,458,737)
-------------
Balances at June 30, 1996 (unaudited)...... $ 5,487,298
-------------
-------------
</TABLE>
See accompanying notes to consolidated financial statements.
F-6
<PAGE>
ACCUMED INTERNATIONAL, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
<TABLE>
<CAPTION>
YEARS ENDED
SEPTEMBER 30, THREE MONTHS
------------------------ ENDED DECEMBER
1994 1995 31, 1995
----------- ----------- -------------- SIX MONTHS ENDED
JUNE 30,
------------------------
1995 1996
----------- -----------
(UNAUDITED) (UNAUDITED)
<S> <C> <C> <C> <C> <C>
Cash flows from operating activities:
Net loss................................. $(3,113,190) $(3,760,110) $ (5,742,037) ($1,151,402) ($4,458,737)
Adjustments to reconcile net loss to net
cash used in operating activities:
Depreciation and amortization.......... 216,603 235,529 38,400 123,066 704,465
Write-off of acquired in-process
research and development.............. -- -- 3,965,000 -- 3,499,727
Expenses paid with issuance of common
stock................................. 60,000 166,000 606,750 -- 101,094
Expenses paid with issuance of
warrants.............................. -- 142,500 -- -- 1,184,390
Shares received for litigation
settlement............................ -- -- -- -- (159,957)
Loss on disposal of assets............. -- 63,609 -- (19,810) 74,706
Changes in assets and liabilities:
Restricted cash...................... -- (185,000) (178,000) -- 363,000
Accounts receivable.................. (389,087) 271,145 107,906 121,650 (531,403)
Prepaid expenses and deposits........ 44,417 20,035 1,833 14,606 (106,358)
Production inventory................. (338,395) 193,796 64,999 86,740 (371,877)
Other assets......................... -- (1,525) 80,059 (63,728) (57,584)
Accounts payable..................... 52,762 766,900 168,460 93,535 237,548
Other current liabilities............ 53,150 8,571 155,941 4,970 (94,588)
Deferred merger costs................ -- (299,650) (750,352) -- --
Deferred revenue..................... -- 470,238 946,429 -- (1,419,092)
----------- ----------- -------------- ----------- -----------
Net cash used in operating
activities.......................... (3,413,740) (1,907,962) (534,612) (790,373) (1,034,666)
----------- ----------- -------------- ----------- -----------
Cash flows from investing activities:
Purchase of fixed assets................. (42,657) (49,834) (62,196) (1,354) (202,010)
Acquisition of business, net............. -- -- 48,237 -- --
Proceeds from refundable deposits........ -- -- -- 400,000 --
----------- ----------- -------------- ----------- -----------
Net cash provided by (used in)
investment activities................. (42,657) (49,834) (13,959) 398,646 (202,010)
----------- ----------- -------------- ----------- -----------
Cash flows from financing activities:
Proceeds from issuance of common stock,
net..................................... 253,793 3,204,486 35,000 1,438,099 2,338,711
Proceeds from issuance of notes
payable................................. -- -- -- -- 250,000
Notes receivable issued.................. -- (700,000) -- (350,000) --
Payment of notes payable................. -- -- -- -- (889,017)
Payment of capital lease obligation...... (32,312) (50,115) (22,132) (34,340) (46,770)
----------- ----------- -------------- ----------- -----------
Net cash provided by financing
activities............................ 221,481 2,454,371 12,868 1,053,759 1,652,924
----------- ----------- -------------- ----------- -----------
Effect of exchange rate changes to cash.... -- -- -- -- (1,491)
----------- ----------- -------------- ----------- -----------
Net increase (decrease) in cash and cash
equivalents............................... (3,234,916) 496,575 (535,703) (662,032) 414,757
Cash and cash equivalents at beginning of
period.................................... 3,454,552 219,636 716,211 42,173 180,508
----------- ----------- -------------- ----------- -----------
Cash and cash equivalents at end of
period.................................... $ 219,636 $ 716,211 $ 180,508 $ 704,205 $ 595,265
----------- ----------- -------------- ----------- -----------
----------- ----------- -------------- ----------- -----------
</TABLE>
See accompanying notes to consolidated financial statements.
F-7
<PAGE>
ACCUMED INTERNATIONAL, INC. AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
1. DESCRIPTION OF BUSINESS
AccuMed International, Inc. and subsidiaries develop, manufacture and market
state-of-the-art medical devices and instruments for laboratories, hospitals and
others. The Company was founded in January 1988, incorporated in June 1988 and
reincorporated in Delaware in 1995.
2. SIGNIFICANT ACCOUNTING POLICIES
PRINCIPLES OF CONSOLIDATION
The consolidated financial statements include the accounts of AccuMed
International, Inc. and its subsidiary ("the Company")(formerly Alamar
Biosciences, Inc.). All significant intercompany accounts and transactions have
been eliminated in consolidation.
REVENUE RECOGNITION
The Company recognizes revenue from sale of products when the products are
shipped to its customers. Contract revenue from research agreements is recorded
when earned and as the related costs are incurred. Payments received which are
related to future performance are deferred and recognized as revenue when earned
over future performance periods.
CASH AND CASH EQUIVALENTS
Cash and cash equivalents include cash in banks and short-term investments
with original maturities of three months or less.
RESTRICTED CASH
The restricted cash as of December 31, 1995 consists of $310,000 of
certificates of deposit with maturities less than one year which were placed as
collateral against a loan made by a financial institution and $53,000 held in an
escrow account.
Restricted cash as of September 30, 1995 includes an escrow deposit of
$150,000 pursuant to an agreement entered into in 1995 between the Company and
an outside legal counsel to the Company. Pursuant to the agreement the Company
issued to their counsel 240,000 shares of common stock, net of issuance costs of
$19,500, in exchange for a reduction of $150,000 in accounts payable. The escrow
deposits were released in proportion to the amounts realized by the counsel from
the sale of such shares in the public market. As of December 31, 1995 $97,000
had been released from the escrow account with the remaining $53,000 released in
February 1996.
INVENTORIES
Inventories consist primarily of raw materials and finished goods and are
stated at the lower of cost (average cost) or market. Cost is determined by the
first-in first-out method (FIFO).
FIXED ASSETS
Fixed assets are stated at cost. Depreciation of plant and equipment is
provided using the straight line method over the estimated useful lives of the
assets. Amortization of leasehold improvements is provided on the straight-line
method over the shorter of the estimated useful life of the improvement or the
term of the lease. Expenditures for repairs and maintenance are charged to
operations when incurred.
INTANGIBLE ASSETS
Intangible assets consists principally of values assigned to acquired
proprietary technology and the excess of cost over the fair value of net assets
acquired. Such amounts are being amortized on a straight-line basis over the
expected periods to be benefited, generally 10 years. The Company assesses the
F-8
<PAGE>
ACCUMED INTERNATIONAL, INC. AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS -- (CONTINUED)
2. SIGNIFICANT ACCOUNTING POLICIES (CONTINUED)
recoverability of the excess of cost over the fair value of net assets acquired
by determining whether the amortization of the balance over its remaining life
can be recovered through undiscounted future operating cash flows of the
acquired operation.
RESEARCH AND DEVELOPMENT COSTS
Research and development costs are charged to operations as incurred.
INCOME TAXES
Deferred tax assets and liabilities are recognized for the future tax
consequences attributable to the difference between the financial statement
carrying amount of existing assets and liabilities and their respective tax
bases and operating loss and tax credit carryforwards. Deferred tax assets and
liabilities are measured using enacted tax rates expected to apply to taxable
income in the years in which those temporary differences are expected to be
recovered or settled. The effect on deferred tax assets and liabilities of a
change in tax rates is recognized in income in the period that includes the
enactment date.
NET LOSS PER SHARE
Net loss per share is computed using the weighted average number of common
shares outstanding during each period. Common equivalent shares from stock
options and warrants are excluded from the computation as their effect is
antidilutive.
USE OF ESTIMATES
Management of the Company has made a number of estimates and assumptions
relating to the reporting of assets and liabilities and the disclosure of
contingent assets and liabilities to prepare these financial statements in
conformity with generally accepted accounting principles. Actual results could
differ from those estimates.
INTERIM FINANCIAL STATEMENTS
The consolidated financial statements as of June 30, 1995 and 1996 are
unaudited. In the opinion of management, the unaudited consolidated financial
statements contain all adjustments (consisting of only normal recurring
adjustments) necessary to present fairly the financial position and results of
operations for such periods. Results of operations for interim periods are not
necessarily indicative of results that will be achieved for the entire year.
3. BASIS OF PRESENTATION FOR THE FISCAL YEARS ENDED SEPTEMBER 30, 1994 AND 1995
In November 1994, the Company filed a lawsuit in United States District
Court against Difco, a competitor, alleging misappropriation of its trade
secrets, and is seeking a constructive trust over a patent covering important
aspects of the Company's technology issued to Difco. The patent, which was
issued to Difco as a result of its alleged misappropriation, covers the basic
technology used in the Company's manual testing kits. Difco has agreed to a
Stipulated Order that it will not market or sell products based on the patent in
controversy unless it gives the Company 60 days advance notice. Upon receipt of
such notice, the Company would have an opportunity to renew its Preliminary
Injunction Motion originally scheduled for February 1995, but suspended in light
of the Stipulated Order. The judge has allowed Difco to file a complaint
alleging infringement of the disputed patent by the Company. A hearing on
Difco's summary judgment against the Company was held on September 8, 1995. Due
to the discovery of the alleged misappropriation, the Company declined to accept
the proceeds of a $2,500,000 financing scheduled to close on November 10, 1994
and implemented significant cutbacks in operations pending the outcome of the
lawsuit, including the elimination of its domestic sales force and suspension of
research and development efforts and contract research. The judge in the case
has set a trial date of January 28, 1996, to hear the merits of the case. (The
above referenced litigation has been subsequently settled, see note 15).
F-9
<PAGE>
ACCUMED INTERNATIONAL, INC. AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS -- (CONTINUED)
3. BASIS OF PRESENTATION FOR THE FISCAL YEARS ENDED SEPTEMBER 30, 1994 AND
1995 (CONTINUED)
On May 2, 1995, the Company received notice that MicroScan, Inc.,
(MicroScan), a wholly-owned subsidiary of Dade International, Inc., filed an
intervention complaint with the court against both the Company and Difco, which
alleges that one of the Company's founders misappropriated confidential
information of MicroScan while an employee of MicroScan prior to co-founding the
Company in 1988, and used such information to develop the Company's technology.
The Company filed a motion for summary judgment and, on October 17, 1995, the
Court granted the Company's summary judgment motion and dismissed the
intervention complaint with prejudice.
As discussed in note 7 and note 16, the Company merged with AccuMed and
loaned AccuMed $700,000 to support their operations. In addition, the Company
completed two financings in 1995 and received advances for a licensing agreement
which substantially improved its cash position. The Company closed it's
Sacramento manufacturing facility in August 1995 and has significantly reduced
overhead costs. Manufacturing and distribution agreements have been established
with AccuMed.
There can be no assurance that combined operations of the proposed merger
will produce the necessary cash flow required. The financial statements do not
include any adjustments that might be necessary if the Company is unable to
continue as a going concern.
4. CHANGE IN FISCAL YEAR
In 1995, the Company changed to a fiscal year ending December 31. The
consolidated statement of operations for the three months ended December 31,
1994 (unaudited) is presented for comparative purposes only.
<TABLE>
<CAPTION>
THREE MONTHS ENDED
CONSOLIDATED STATEMENT OF OPERATIONS (UNAUDITED) DECEMBER 31, 1994
- -------------------------------------------------------------------------------------------- --------------------
<S> <C>
Sales....................................................................................... $ 100,614
Less cost of sales.......................................................................... (227,300)
----------
Gross profit (loss)......................................................................... (126,686)
----------
Operating expenses:
General and administrative................................................................ 384,181
Research and development.................................................................. 150,983
Sales and marketing....................................................................... 171,420
----------
Total operating expenses................................................................ 706,584
----------
Operating loss.............................................................................. (833,270)
----------
Other income (expense):
Interest income........................................................................... 664
Interest expense.......................................................................... (13,267)
----------
Total other income (expense)............................................................ (12,603)
----------
Loss before income taxes.................................................................... (845,873)
Income tax expense.......................................................................... 200
----------
Net loss.................................................................................... $ (846,073)
----------
----------
Net loss per share.......................................................................... $ (0.17)
----------
----------
Weighted average common shares outstanding.................................................. 4,894,294
----------
----------
</TABLE>
F-10
<PAGE>
ACCUMED INTERNATIONAL, INC. AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS -- (CONTINUED)
5. ACCOUNTS RECEIVABLE
Accounts receivable includes the following at:
<TABLE>
<CAPTION>
SEPTEMBER 30, DECEMBER 31,
1995 1995
------------- -------------
<S> <C> <C>
Trade receivables.................................................................. $ 221,767 $ 842,994
Contract refunds due............................................................... 43,050 43,050
Other receivables.................................................................. -- 6,600
Allowance for doubtful accounts.................................................... (19,725) (17,932)
------------- -------------
Total............................................................................ $ 245,092 $ 874,712
------------- -------------
------------- -------------
</TABLE>
Accounts receivable are carried at their net realizable value.
6. FIXED ASSETS
Fixed assets includes the following at:
<TABLE>
<CAPTION>
ESTIMATED SEPTEMBER 30, DECEMBER 31,
USEFUL LIFE 1995 1995
------------- ------------- -------------
<S> <C> <C> <C>
Equipment.......................................................... 3 - 5 years $ 776,867 $ 871,595
Leasehold improvements............................................. 5 - 13 years -- 60,947
Equipment under capital lease...................................... 5 years 299,090 299,090
------------- -------------
1,075,957 1,231,632
Less accumulated depreciation and amortization..................... 664,831 703,230
------------- -------------
$ 411,126 $ 528,402
------------- -------------
------------- -------------
</TABLE>
7. NOTES RECEIVABLE
Pursuant to the merger agreement (note 16), the Company extended the
following loans, which bear interest at 10% per annum, to AccuMed Inc. to
provide working capital.
<TABLE>
<CAPTION>
DATE AMOUNT
- ---------------------------------------------------------------------------------- ----------
<S> <C>
May 9, 1995....................................................................... $ 150,000
May 31, 1995...................................................................... 125,000
June 28, 1995..................................................................... 125,000
August 7, 1995.................................................................... 125,000
August 29, 1995................................................................... 175,000
----------
$ 700,000
----------
----------
</TABLE>
On November 20, 1995, the Company's Board of Directors agreed to consolidate
the various notes above into a single $700,000 note. Upon consummation of the
merger on December 29, 1995, such amounts have been eliminated in consolidation.
F-11
<PAGE>
ACCUMED INTERNATIONAL, INC. AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS -- (CONTINUED)
8. OTHER CURRENT LIABILITIES
Other current liabilities consist of the following at:
<TABLE>
<CAPTION>
SEPTEMBER 30, DECEMBER 31,
1995 1995
------------- -------------
<S> <C> <C>
Deferred rent............................................................ $ -- $ --
Payroll and related costs................................................ 84,970 286,998
Sales & use taxes........................................................ 908 --
Customer deposits........................................................ 2,169 47,169
Accrued rent............................................................. 89,750 64,255
Other accrued expenses................................................... 18,913 471,891
------------- -------------
Total................................................................ $ 203,497 $ 870,313
------------- -------------
------------- -------------
</TABLE>
9. DEFERRED REVENUE
On May 3, 1995, the Company entered into a letter of intent with Becton
Dickinson, Inc., (Becton) pursuant to which the Company agreed to grant Becton a
semi-exclusive, worldwide license of the Company's alamarBlue-TM- technology for
a specific field of use. On October 10, 1995, the license agreement (License)
between the Company and Becton was executed.
On signing the letter of intent, Becton paid the Company $100,000. On June
28, 1995, Becton paid an additional $400,000 to the Company. In October 1995,
the Company received $250,000 for executing the license agreement, and $750,000
upon the initial favorable resolution of the MicroScan lawsuit. In February
1996, Becton paid an additional $1,000,000 upon final favorable resolution of
the MicroScan lawsuit and $1,000,000 in March 1996 upon final favorable
resolution of the Difco lawsuit. Of this last amount, $500,000 is creditable
against future royalties.
The $1,500,000 received by the Company through December 31, 1995 has been
deferred pending resolution of the above mentioned lawsuits. Due to the
settlement of the lawsuits in February and March 1996, all of the remaining
deferred revenues will become income during the quarter ending March 31, 1996.
10. NOTES PAYABLE
Notes payable consist of the following at:
<TABLE>
<CAPTION>
DECEMBER 31,
1995
-------------
<S> <C>
Note payable to bank, guaranteed by stockholders, interest at 11.75% payable
monthly with principal payment due on April 30, 1996.......................... $ 100,000
Note payable to bank, guaranteed by stockholders, interest at 10.75% payable
monthly with principal payment due on April 30, 1996.......................... 455,000
Notes payable to stockholders, interest at 10%, due on demand.................. 90,610
Bank line of credit, collateralized by substantially all assets of AccuMed
International Limited, a wholly-owned subsidiary of the Company, due on
demand........................................................................ 80,904
-------------
$ 726,514
-------------
-------------
</TABLE>
11. STOCKHOLDERS' EQUITY
The Board of Directors is authorized to issue 5,000,000 shares of preferred
stock, the terms and rights to be established upon issuance. Of these shares,
382,500 have been designated as Series A 8% Cumulative Preferred Stock. None of
these shares have been issued.
F-12
<PAGE>
ACCUMED INTERNATIONAL, INC. AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS -- (CONTINUED)
11. STOCKHOLDERS' EQUITY (CONTINUED)
WARRANTS
In February 1995, the Company granted warrants to a consulting firm for the
right to purchase 140,000 shares of the Company's common stock at a price of
$.25 per share in lieu of the Company's liability of $105,000 to the consulting
firm. These warrants were exercised in December 1995. In May 1995, the Company
granted warrants to a placement agent for the right to purchase 100,000 shares
of the Company's common stock at a price of $.25 per share as compensation for
services performed relating to the canceled $2.5 million financing in November
1994. The warrants expire in August 2000. The difference between the fair market
value of the stock and the common stock purchase price has been recorded as
issuance of common stock warrants.
Additionally, contingent upon consummation of the merger, a consulting firm
was granted a five year warrant to purchase up to 750,000 shares of common at a
price of $1.25 per share, subject to certain limitations. The fair value of
these warrants has been recorded as issuance of common stock warrants.
At December 31, 1995, outstanding warrants to purchase shares of common
stock at any time through the expiration date were as follows:
<TABLE>
<CAPTION>
SHARES PRICE EXPIRATION DATE
- ---------- ----------- -----------------
<S> <C> <C>
2,702,905 5.00 10/97
104,000 2.125 10/97
420,000 0.25 12/99
175,000 5.00 12/99
25,275 5.00 4/00
264,840 0.625 5/00
300,000 0.625 8/00
100,000 0.25 8/00
79,280 0.82 8/00
79,280 1.64 8/00
79,280 2.47 8/00
750,000 1.25 12/00
75,000 1.125 12/00
- ----------
5,154,860
- ----------
- ----------
</TABLE>
STOCK OPTION PLAN
The Company has in effect three stock option plans for certain employees. On
October 15, 1990, the Company adopted the 1990 Stock Option Plan (1990 Plan).
The Company's employees, directors, and consultants are eligible to participate
in the Plan. The Company has reserved 177,324 shares of authorized but unissued
common stock for issuance under the 1990 Plan.
On February 4, 1992, the Company adopted the 1992 Stock Option Plan (1992
Plan), for which the Company has reserved an additional 405,000 shares of
authorized but unissued common stock. Options issued under the 1992 Plan are
issued, exercisable, and governed by substantially the same terms as options
issued under the 1990 Plan, with the exception of provisions in the 1990 Plan
accelerating the vesting of options in instances of acquisition or liquidation,
which have been deleted from the 1992 Plan.
On November 17, 1992, the Board of Directors also approved an increase,
approved by the stockholders on March 2, 1993, of the number of shares of common
stock reserved for issuance under the 1992 Plan from 405,000 to 505,000 shares.
F-13
<PAGE>
ACCUMED INTERNATIONAL, INC. AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS -- (CONTINUED)
11. STOCKHOLDERS' EQUITY (CONTINUED)
On December 29, 1995, the Company adopted the 1995 Stock Option Plan (1995
Plan), for which the Company has reserved an additional 1,500,000 shares of
authorized but unissued common stock. Options issued under the 1995 Plan are
issued, exercisable, and governed by substantially the same terms as options
issued under the 1992 Plan.
Terms of the Plans include:
EXERCISE PRICE -- For the 1990 Plan, fair market value determined by the
Board of Directors and not less than 110% of the determined fair market value in
certain instances. For the 1992 Plan and the 1995 Plan fair market value as
determined by the closing price of the Common Stock on the date of issuance as
reported by NASDAQ.
VESTING PERIOD -- A portion of the options granted to participants vests
immediately with the remaining options vesting on varying schedules not
exceeding three years from date of grant.
EXERCISE PERIOD -- The options are exercisable as to be determined by the
Board of Directors provided that not less than 20% of the options are
exercisable per year and no option shall be exercisable after ten years from the
date the option is granted.
SHARES AVAILABLE -- The maximum number of shares that may be issued under
the 1995 Plan is 1,500,000 at December 31, 1995.
In the year ended September 30, 1994, options for 4,741 shares were
exercised at a price of $0.80 per share and options to purchase 81,834 shares
were canceled. In the year ended September 30, 1995, no options were exercised
and options to purchase 123,023 shares were canceled. In the three months ended
December 31, 1995, no options were exercised and options to purchase 32,917
shares were canceled.
F-14
<PAGE>
ACCUMED INTERNATIONAL, INC. AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS -- (CONTINUED)
11. STOCKHOLDERS' EQUITY (CONTINUED)
At December 31, 1995, there were 1,586,845 shares under options outstanding
of which 913,499 were exercisable as follows:
<TABLE>
<CAPTION>
GRANT EXERCISE EXPIRATION
DATE GRANTED EXERCISABLE PRICE DATE
- --------- ------------ ----------- ----------- -----------
<S> <C> <C> <C> <C>
11/88 627 627 $ .80 12/96
5/91 4,028 4,028 1.39 5/96
6/91 85,000 85,000 1.39 6/96
3/92 1,153 1,153 1.39 3/97
5/92 303,890 303,890 1.39 5/97
7/92 5,625 5,625 1.39 7/97
11/92 7,455 7,455 1.39 11/97
3/93 5,000 5,000 1.39 3/98
6/93 1,500 1,500 1.39 6/98
7/93 1,500 1,500 1.39 7/98
8/93 4,457 4,457 1.39 8/98
11/93 3,450 3,450 1.39 11/98
5/94 42,000 42,000 1.39 5/99
11/94 10,160 10,160 0.75 11/99
3/95 50,000 50,000 0.63 3/00
4/95 10,000 10,000 1.44 4/00
8/95 5,000 5,000 1.00 11/98
12/95 36,000 36,000 1.00 12/00
12/95 1,010,000 336,654 1.13 12/05
------------ -----------
1,586,845 913,499
------------ -----------
------------ -----------
</TABLE>
COMMON STOCK
In March 1994, the Company finalized an agreement with one of the Company's
distributors, to purchase the Company's securities in exchange for certain
distribution, licensing and product development rights. Under the terms of the
agreement, the Company was obligated to issue 200,000 shares of common stock for
a total consideration of $500,000. At September 30, 1994, the distributor had
purchased $250,000 in common stock. In November 1994, the distributor purchased
the remaining $250,000 in common stock and was issued warrants to purchase
166,667 additional shares of stock at an exercise price of $3.00 per share,
which warrants expired in December 1995.
In March 1995, the Company granted 80,645 shares of the Company's common
stock at a price $0.62 per share for a total of $42,500 (net of financing costs
of $7,500) to a private investor.
During May and August 1995, the Company completed two separate private
offerings for an aggregate of 5,648,400 shares of the Company's common stock
providing net proceeds of $2,931,486 (net of $598,764 of financing expenses).
Also, the Company's placement agent received warrants for the future purchase of
564,840 shares of the Company's common stock at an exercise price of $0.625.
Such warrants expire from May through August 2000.
In August 1995, the Company granted 16,000 shares of the Company's common
stock at a price of $1 per share to a vendor as compensation for services
performed in lieu of the Company's liability of $16,000 to the vendor.
F-15
<PAGE>
ACCUMED INTERNATIONAL, INC. AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS -- (CONTINUED)
11. STOCKHOLDERS' EQUITY (CONTINUED)
In October 1995, the Company granted to each nonemployee director of the
Company 10,000 shares of the Company's common stock at a price of $.625 per
share as compensation for services performed. Compensation expense in the amount
of $31,250 has been reflected in the Consolidated Statements of Operations.
In November 1995, the Company granted 20,000 shares of the Company's common
stock at a price of $.625 per share to a director for consulting services
performed related to the merger. Consulting expense in the amount of $12,500 has
been reflected in the Consolidated Statements of Operations.
12. INCOME TAXES
Effective October 1, 1993, the Company adopted the provisions of Statement
of Financial Accounting Standards No. 109 (SFAS No. 109), ACCOUNTING FOR INCOME
TAXES. SFAS No. 109 requires the recognition of deferred tax liabilities and
assets resulting from differences between the tax basis of assets and
liabilities and their reported amounts in the financial statements that will
result in taxable or deductible amounts in future years. Prior to October 1,
1993, the Company accounted for income taxes in accordance with Accounting
Principles Board Opinion No. 11. The effect of this change on operating results
for the year ended September 30, 1994, the year of implementation, was not
material.
The net deferred tax assets and liabilities consist of the following at:
<TABLE>
<CAPTION>
SEPTEMBER 30,
-------------------------- DECEMBER 31,
1994 1995 1995
------------ ------------ -------------
<S> <C> <C> <C>
Deferred tax assets:
Net operating loss carryforwards............... $ 4,400,000 $ 5,460,000 $ 6,520,000
Research and development credits............... 285,000 295,000 300,000
Capitalized research and development costs..... 274,000 280,000 --
Depreciation................................... 158,000 175,000 162,000
Other.......................................... 58,000 65,000 114,000
------------ ------------ -------------
Total...................................... 5,175,000 6,275,000 7,096,000
Valuation allowance.............................. (5,175,000) (6,275,000) (7,096,000)
------------ ------------ -------------
Net deferred tax assets and liabilities........ $ -- $ -- $ --
------------ ------------ -------------
------------ ------------ -------------
</TABLE>
At December 31, 1995, the Company had approximately $18,641,000 and
$3,101,000 in net operating losses for federal and state tax purposes,
respectively, available to be carried forward to future periods. The
carryforwards expire from 2003 to 2011 for federal purposes and from 2010 to
2011 for state purposes. The Company also has credits for research and
development of $300,000 available to offset future federal income taxes, which
expire from 2003 to 2011.
As a result of providing a valuation allowance equal to the deferred tax
assets, there is no federal tax provision. The provision for tax is the state
minimum tax.
During the last three years, the Company has had more than a 50% change in
ownership. Section 382 of the Internal Revenue Code and comparable state
statutes impose certain annual limitations on the utilization of net operating
loss carryforwards and research and development credits that can be used to
offset income in future periods.
F-16
<PAGE>
ACCUMED INTERNATIONAL, INC. AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS -- (CONTINUED)
13. LEASES
OPERATING LEASES
The Company leased its facilities and one automobile under operating leases.
Rental expense is recognized on a straight-line basis over the life of the
lease. Rental expense for the years ended September 30, 1994 and 1995 and for
the three months ended December 31, 1995 was $172,000, $156,000 and $71,000,
respectively.
Minimum future annual rent payments are as follows for years ending December
31:
<TABLE>
<CAPTION>
YEAR AMOUNT
- ------------ ------------
<S> <C>
1996 $ 380,205
1997 315,950
1998 315,950
1999 309,642
2000 197,876
Thereafter 1,431,198
------------
Total $ 2,950,821
------------
------------
</TABLE>
CAPITAL LEASES
In July and September 1994, the Company entered into capital leases for
production equipment in the total amount of $231,693, with principal and
interest payable monthly, interest at approximately 21%, and total residuals of
$34,754 due in July and September 1997.
In October 1994, the Company entered into a capital lease for office
equipment in the total amount of $29,000, with principle and interest payable
monthly, interest at 8.71%, and a residual of $4,350, due in October 1997.
Future minimum lease payments under capital lease obligations for the years
ending December 31 are as follows:
<TABLE>
<CAPTION>
YEAR AMOUNT
- ------------------------------------------------ ----------
<S> <C>
1996............................................ $ 114,417
1997............................................ 97,598
----------
212,015
Less amount representing interest............... (33,935)
----------
178,080
Less current portion............................ (88,270)
----------
Long-term portion............................... $ 89,810
----------
----------
</TABLE>
14. SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION
Noncash investing and financing activities:
During the years ended September 30, 1994 and 1995 and the three month
period ending December 31, 1995, the Company acquired assets under capital
leases in the amounts of $231,693, $21,341 and $0, respectively.
During the three months ended December 31, 1995, the Company acquired all of
the outstanding shares of AccuMed, Inc. in exchange for common stock of the
Company. The fair value of net liabilities assumed was $828,476. Cash acquired
totaled $48,237.
F-17
<PAGE>
ACCUMED INTERNATIONAL, INC. AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS -- (CONTINUED)
14. SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION (CONTINUED)
Cash paid for interest and income taxes:
<TABLE>
<CAPTION>
YEARS ENDED
SEPTEMBER 30,
-------------------- THREE MONTHS ENDED
1994 1995 DECEMBER 31, 1995
--------- --------- --------------------
<S> <C> <C> <C>
Cash paid during the period for:
Interest...................................... $ 12,836 $ 46,657 $ 19,122
Income taxes.................................. 800 800 --
</TABLE>
15. COMMITMENTS
PFIZER AGREEMENT
In October 1992, the Company entered into an agreement to conduct a research
project for the purpose of developing a testing procedure for another entity.
The maximum payments the Company may receive for completion of the agreement are
$246,000. As of December 31, 1995, the Company had received payments of $184,500
based on procedures completed to date.
LEGAL PROCEEDINGS
In November 1994, the company initiated a civil action against a competitor
for misappropriation of the Company's trade secrets covering a key technology in
the Company's principle product line while under a confidentiality and non-use
agreement. The Company settled this lawsuit in February 1996 for technology
rights and other consideration.
16. MERGER AND RELATED TRANSACTIONS
On December 29, 1995, the Company acquired all of the common stock of
AccuMed, Inc. and its wholly owned subsidiary ("AccuMed"). AccuMed is primarily
engaged in the research and development of diagnostic screening products for the
cytopathology and microbiology clinical laboratory, pharmaceutical and
veterinary segments of the health care industry. Following the acquisition,
AccuMed ceased to exist as a legal entity and the merged entity was renamed
AccuMed International, Inc. Pursuant to the terms of the merger agreement the
Company issued 3,931,401 unconditional shares of common stock valued at
$4,422,826 and 237,840 warrants valued at $68,252 on December 29, 1995. An
additional 1,881,910 shares and 126,945 warrants were issued to AccuMed
stockholders on December 29, 1995, however, such shares and warrants are
contingent and subject to forfeiture if specified performance goals are not
achieved by the merged entity during the 24 months beginning January 1, 1996.
The contingent consideration will be recorded when the goals are achieved and
will be computed based upon the stock price on such date.
The acquisition has been accounted for using the purchase method of
accounting, and, accordingly, the purchase price has been allocated to the
assets purchased and liabilities assumed based upon the fair values at the date
of acquisition. The excess of the purchase price over the fair value of the
tangible assets has been allocated to identifiable intangibles of acquired
proprietary technology ($2,644,556) and in-process research and development
($3,965,000). The acquired proprietary technology will be amortized over the
expected period to be benefited, which is estimated to be 10 years with the
in-process research and development charged to operations at the date of
acquisition.
The contingency associated with 940,955 shares and 63,472 warrants was
resolved (performance goal achieved) in March 1996 resulting in contingent
consideration of approximately $5,273,000. Such amount will be allocated to
acquired proprietary technology ($1,775,000) and in-process research and
development ($3,498,000) and recorded in March 1996.
The results of operations of AccuMed have not been included in the
Consolidated Statements of Operations because the acquisition occurred at the
end of the three month period ended December 31,
F-18
<PAGE>
ACCUMED INTERNATIONAL, INC. AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS -- (CONTINUED)
16. MERGER AND RELATED TRANSACTIONS (CONTINUED)
1995. The following pro forma information has been prepared assuming that the
acquisition had taken place at the beginning of the respective periods. The pro
forma information includes adjustments for the amortization of intangibles and
write-off of in-process research and development arising from the transaction.
The pro forma financial information is not necessarily indicative of the results
of operations as they would have been had the transaction been effected on the
assumed dates.
<TABLE>
<CAPTION>
YEAR ENDED THREE MONTHS
SEPTEMBER 30, 1995 DECEMBER 31, 1995
------------------ ------------------
(UNAUDITED)
<S> <C> <C>
Sales........................................................... $ 3,979,930 $ 1,109,506
Net loss........................................................ (9,844,326) (7,016,824)
Net loss per share.............................................. $ (1.00) $ (.60)
</TABLE>
The Company, AccuMed and AccuMed International Limited, a wholly-owned
subsidiary of AccuMed, entered into a Manufacturing and Supply Agreement
effective as of July 1, 1995, (the Manufacturing Agreement) pursuant to which
the Company purchased ID/MIC panels from Sensititre Limited. The Manufacturing
Agreement was terminated on December 29, 1995. Amounts paid to AccuMed for the
year ended September 30, 1995 under the Manufacturing Agreement were $277,172.
Additionally, the Company gave a deposit to AccuMed of $50,000 in October 1995,
for the purchase of supplies and raw materials in relation to this agreement.
Pursuant to a Distributor Agreement effective as of July 1, 1995 between
AccuMed and the Company (the Distributor Agreement), the Company appointed
AccuMed as its distributor for microbiology products. AccuMed was the exclusive
distributor in the United States, Canada, Mexico, Puerto Rico, Japan, the Far
East, Australia and Europe (except Italy, Portugal, Germany, Austria, Belgium,
Cyprus, Greece, Luxembourg, The Netherlands, Switzerland and Turkey), and a
non-exclusive distributor in Central America, South America, Africa, South
Africa, Korea, East Europe, the Middle East, China and Taiwan. The Distributor
Agreement was terminated on December 29, 1995. Amounts paid to AccuMed for the
year ended September 30, 1995 under the Distributor Agreement were $35,677.
Pursuant to an oral agreement (the Oral Agreement), the Company paid AccuMed
an amount equal to 30% of AccuMed's lease payment (approximately $2,500 per
month) for its manufacturing facility in Cleveland, Ohio and 30% of AccuMed's
general overhead expenses in consideration for AccuMed providing sales,
marketing and distribution services on behalf of the Company. Such arrangement
terminated on December 29, 1995. Amounts paid to AccuMed for the year ended
September 30, 1995, under this Oral Agreement were $67,508.
Pursuant to a Research and Development Agreement, effective as of July 1,
1995, (the R&D Agreement) between the Company and AccuMed the Company granted to
Sensititre Limited, a wholly-owned subsidiary of AccuMed, a non-exclusive
license to use the Company's intellectual property, including know-how, trade
secrets and technology relating to alamarBlue-TM- for the sole purpose of
conducting research and development activities using such intellectual property.
Under the R&D Agreement, the Company paid the actual hourly wage per employee
hour spent on such research and development and reimburses AccuMed for its
expenses relating thereto. The R&D Agreement terminated on December 29, 1995.
Amounts paid to AccuMed for the year-ended September 30, 1995, under this R&D
Agreement were $20,000.
At September 30, 1995, the Company had recorded an accounts receivable of
$53,499 from AccuMed which resulted from the sale of inventory to AccuMed.
Additionally, the Company had recorded
F-19
<PAGE>
ACCUMED INTERNATIONAL, INC. AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS -- (CONTINUED)
16. MERGER AND RELATED TRANSACTIONS (CONTINUED)
approximately $123,000 of accounts payable to AccuMed for services received
pursuant to the Manufacturing, Distributor and Oral Agreements. Upon
consummation of the merger on December 29, 1995 such amounts were eliminated in
consolidation.
The Company recorded a deferred asset at September 30, 1995, of $299,650
relating to direct costs paid to unrelated entities for services performed
related to the merger. These deferred costs have been included in determining
the cost of AccuMed.
In February 1995, the Company and AccuMed entered into an agreement with a
consulting firm (Consulting Firm) to pay the Consulting Firm an aggregate
finders fee for assistance with the merger, of which $50,000 was paid with
proceeds from the Company's private offering in August 1995 and is non-
refundable. The remaining obligation was satisfied through the issuance of
444,444 shares of common stock on December 29, 1995 and the issuance of a
five-year warrant to purchase 750,000 shares of common stock at $1.25 per share.
The total finders fee of $790,000 has been included as direct costs of the
acquisition.
The Company entered into an agreement with Bridgemere Capital (Bridgemere),
which has been acting as special advisor to the Company, pursuant to which the
Company has paid to Bridgemere a fee of $50,000 and has agreed to pay an
additional $55,000 in cash and issued 56,000 shares of common stock on December
29, 1995. The total finders fee of $168,000 has been included as direct costs of
the acquisition.
17. RELATED-PARTY TRANSACTIONS
All nonemployee directors have received an option to purchase 750 common
shares and option to purchase 250 additional shares annually. In 1993 and 1994,
all nonemployee directors received an option to purchase 1,000 shares and 5,000
shares of the Company's common stock, respectively. In 1995, all nonemployee
directors received options to purchase 5,000 to 9,215 shares of the Company's
common stock, contingent upon their length of service. These directors will
receive options for 5,000 additional shares annually. All such awards are made
pursuant to the 1992 Plan.
On November 21, 1994, the Company issued to certain officers and employees
of the Company options to purchase an aggregate of 16,020 shares of the
Company's common stock at an exercise price of $0.75 per share. Also, on August
31, 1995, the Company issued to certain employees of the Company options to
purchase an aggregate of 30,000 shares of the Company's common stock at an
exercise price of $1 per share.
In December 1994, the Company entered into a Consulting Services Agreement,
effective January 1, 1995, with a Placement Agent, also a stockholder of the
Company, pursuant to which the Placement Agent agreed to provide certain
financial consulting services to the Company for a period of 12 months with an
option to renew the agreement for an additional 12 months at the consent of both
the Placement Agent and the Company. In exchange for the consulting services,
the Company will pay the Placement Agent an aggregate sum of $58,500. At
September 30, 1995, the Company had paid the Placement Agent $42,500.
In September 1995, the Company paid $12,500 to a director for consulting
services performed related to the private financings in May and August 1995 and
the proposed merger between the Company and AccuMed. Additionally, in November
1995, the Company issued 20,000 shares of the Company's common stock at a price
of $.625 per share to the same director for the consulting services described
above.
F-20
<PAGE>
ACCUMED INTERNATIONAL, INC. AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS -- (CONTINUED)
17. RELATED-PARTY TRANSACTIONS (CONTINUED)
During the year ended September 30, 1994, the Company entered into an
agreement with an Italian company, which is also a stockholder, for distribution
of the Company's products in Europe. Sales to this stockholder constituted 51%
and 18% of the Company's total sales for the years ended September 30, 1994 and
1995, respectively. At September 30, 1994 and 1995, accounts receivable from the
stockholder amounted to approximately $313,000 and $65,000, respectively. The
distributor is no longer a stockholder of the Company.
18. SUBSEQUENT EVENTS (UNAUDITED)
In January 1996, the Company received $250,000 cash in exchange for a note
payable bearing interest at 11% due in April 1996, and warrants to purchase
100,000 shares of common stock at $1.25 per share. The total proceeds received
of $250,000 were allocated to the warrants based on their estimated fair value
of $352,000. The difference of $102,000 has been reflected as other expense in
the Consolidated Statement of Operations for the three month period ended March
31, 1996. The original issue discount of $250,000 relating to the notes payable
will be amortized over the term of the note with $166,000 reflected as interest
expense in the Consolidated Statement of Operations for the three month period
ended March 31, 1996.
At December 31, 1995, the Company had deferred revenue of $1,454,550 pending
resolution of the Microscan lawsuit and the Difco lawsuit. Upon settlement of
these lawsuits in February 1996, the Company received an additional $2,000,000
from Becton, $1,000,000 each in February and March 1996, per the terms of the
worldwide license agreement executed on October 10, 1995. Total income
recognized for the three month period ended March 31, 1996 per the terms of this
agreement was $3,454,450 and has been reflected as other income in the
Consolidated Statement of Operations.
On December 29, 1995, the Company acquired all of the common stock of
AccuMed and its wholly-owned subsidiary. Pursuant to the terms of the merger
agreement, 1,881,910 shares of common stock and 126,945 warrants were issued to
AccuMed stockholders which were contingent and subject to forfeiture if
specified performance goals were not achieved by the merged entity. The
contingency associated with 940,955 shares of common stock and 63,472 warrants
was resolved (performance goal achieved) in March 1996 resulting in contingent
consideration of $5,430,326. Such amount has been allocated to identifiable
intangibles of acquired proprietary technology ($1,930,599) and in-process
research and development ($3,499,727). The acquired proprietary technology will
be amortized over the expected period to be benefited, which is estimated to be
ten years, with the in-process research and development charged to operations
during the three months ended March 31, 1996.
In January 1996, the Company granted to an individual in exchange for
consulting services rendered warrants to purchase 100,000 shares of common stock
at a price of $2.125 per share. These warrants expire in January 2001. The fair
market value of these warrants of $230,000 has been recorded as issuance of
common stock warrants with an offsetting charge reflected as administration
expense in the Consolidated Statement of Operations for the three month period
ended March 31, 1996.
In March 1996, the Company granted to certain investors in a related party
warrants to purchase 687,500 shares of common stock at a price of $3.42 to $3.87
per share. These warrants expire in March 1999. The fair market value of these
warrants of $852,390 has been recorded as issuance of common stock warrants with
an offsetting charge reflected as other expense in the Consolidated Statement of
Operations for the three month period ended March 31, 1996.
In April 1996, the Company entered into a settlement agreement with several
stockholders. Under the terms of this agreement, 26,270 shares of common stock
held by these stockholders with a fair value
F-21
<PAGE>
ACCUMED INTERNATIONAL, INC. AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS -- (CONTINUED)
18. SUBSEQUENT EVENTS (UNAUDITED) (CONTINUED)
of $159,957 were returned to the Company and are being held as treasury stock.
An additional 11,786 shares of common stock contingent and subject to forfeiture
if specified performance goals are not achieved in 1997 were also returned to
the Company.
In June 1996, 166,586 shares of common stock were issued to a related party
pursuant to an agreement requiring conversion of the outstanding principal and
the accrued and unpaid interest totalling $75,000 into 68,500 shares of common
stock of AccuMed prior to the merger with the Company.
For the six month period ended June 30, 1996, the Company granted options to
purchase 631,500 shares at prices of $1.75 to $8.38 per share, options for
374,273 shares were exercised at prices of $0.63 to $1.39 per share and options
to purchase 52,101 shares were canceled.
In July 1996, the Company signed a letter of intent with a distributor to
outsource the manufacturing of one of the Company's microbiology product lines.
In August 1996, the Company entered into definitive agreements to acquire a
two-thirds interest in Oncometrics Imaging Corp. ("Oncometrics") for a total
purchase price of approximately $4.0 million which includes approximately $2.0
million to be used solely as working capital for Oncometrics.
In August 1996, the Company entered into a definitive agreement to acquire
the remaining 90% interest in Radco Ventures, Inc. ("Radco"), for approximately
$1.4 million in cash.
In August 1996, the Company acquired assets from Technostics Corp. in
consideration for the issuance of 69,308 shares of common stock, which shares
are being held in escrow pending resolution of a contingency regarding any
challenge or claim filed in the succeeding twelve months calling into question
the ownership rights to such patents. The assets to be acquired consist largely
of U.S. and foreign patents in the areas of image analysis and automated
cytology. The Company did not assume any liabilities of Technostics. The
contingent consideration relating to the issuance of these shares will be
recorded when the contingency is resolved and will be computed based upon the
stock price on such date.
F-22
<PAGE>
AUDITORS' REPORT
To the Board of Directors
Oncometrics Imaging Corp.
We have audited the balance sheets of the AIC division of Xillix
Technologies Corp. as at August 31, 1995 and December 31, 1995 and Oncometrics
Imaging Corp. at May 31, 1996 and the statements of operations and deficit and
changes in financial position for the periods then ended. These financial
statements are the responsibility of the Company's management. Our
responsibility is to express an opinion on these financial statements based on
our audit.
We conducted our audit in accordance generally accepted auditing standards.
Those standards require that we plan and perform an audit to obtain reasonable
assurance whether the financial statements are free of material misstatement. An
audit includes examining, on a test basis, evidence supporting the amounts and
disclosures in the financial statements. An audit also includes assessing the
accounting principles used and significant estimates made by management, as well
as evaluating the overall financial statement presentation.
In our opinion, these financial statements present fairly, in all material
respects, the financial position of the Division and the Company as at August
31, 1995, December 31, 1995, and May 31, 1996 and the results of its operations
and the changes in its financial position for the periods then ended in
accordance with generally accepted accounting principles. As required by the
Company Act (British Columbia), we report that, in our opinion, these principles
have been applied on a basis consistent with that of the preceding year.
Generally accepted accounting principles in Canada vary in certain
significant respects from generally accepted accounting principles in the United
States. As indicated in note 12 there are no material differences which affect
the results of operations in each of the periods and shareholders' deficiency as
of August 31, 1995, December 31, 1995 and May 31, 1996.
/s/ KPMG
Chartered Accountants
Vancouver, Canada
July 18, 1996
F-23
<PAGE>
ONCOMETRICS IMAGING CORP.
BALANCE SHEETS
<TABLE>
<CAPTION>
AUGUST 31, DECEMBER 31, MAY 31,
1995 1995 1996
----------- ------------- ----------
<S> <C> <C> <C>
ASSETS
Current assets:
Cash.................................................................... $ -- $ -- $ 18,006
Accounts receivable..................................................... 37,818 222,576 35,960
Inventories (note 3) 147,592 80,249 138,050
Other................................................................... -- -- 5,438
----------- ------------- ----------
185,410 302,825 197,454
----------- ------------- ----------
Capital assets, net (note 4).............................................. 244,916 238,197 236,847
----------- ------------- ----------
$ 430,326 $ 541,022 $ 434,301
----------- ------------- ----------
----------- ------------- ----------
LIABILITIES AND EQUITY (DEFICIENCY)
Current liabilities:
Accounts payable and accrued liabilities (note 5)....................... $ 45,600 $ 22,700 $ 105,962
Current portion of long-term debt (note 6).............................. 10,000 10,000
----------- ------------- ----------
45,600 32,700 115,962
----------- ------------- ----------
Long-term debt (note 6)................................................... 318,338 308,338 308,338
----------- ------------- ----------
Equity (deficiency):
Share capital (note 7).................................................. -- -- 199,984
Xillix divisional equity, net of operating loss (note 8)................ 66,388 199,984 --
Xillix capital contributions (note 9)................................... -- -- 302,374
----------- ------------- ----------
66,388 199,984 502,358
Deficit................................................................. -- -- (492,357)
----------- ------------- ----------
66,388 199,984 10,001
----------- ------------- ----------
$ 430,326 $ 541,022 $ 434,301
----------- ------------- ----------
----------- ------------- ----------
</TABLE>
See accompanying notes to financial statements.
F-24
<PAGE>
ONCOMETRICS IMAGING CORP.
STATEMENTS OF OPERATIONS AND DEFICIT
<TABLE>
<CAPTION>
TWELVE MONTHS FIVE MONTHS
ENDED FOUR MONTHS ENDED ENDED
AUGUST 31, 1995 DECEMBER 31, 1995 MAY 31, 1996
--------------- ------------------ ------------
<S> <C> <C> <C>
Revenues
Product sales............................................... $ 220,862 $ 198,845 $ 7,012
Interest income............................................. -- -- 1,554
--------------- -------- ------------
220,862 198,845 8,566
--------------- -------- ------------
Cost and expenses:
Cost of sales............................................... 183,927 119,325 4,297
Marketing, sales and support................................ -- -- 82,062
Research and development.................................... 1,290,188 300,853 283,522
General and administrative.................................. -- -- 100,435
General and administrative allocation from parent company... 235,826 60,320 --
Depreciation and amortization............................... 71,840 23,680 30,607
--------------- -------- ------------
1,781,781 504,178 500,923
--------------- -------- ------------
Loss for the period........................................... $ 1,560,919 $ 305,333 492,357
--------------- --------
--------------- --------
Deficit, beginning of period.................................. --
------------
Deficit, end of period........................................ $ 492,357
------------
------------
</TABLE>
See accompanying notes to financial statements.
F-25
<PAGE>
ONCOMETRICS IMAGING CORP.
STATEMENTS OF CHANGES IN FINANCIAL POSITION
<TABLE>
<CAPTION>
TWELVE MONTHS FIVE MONTHS
ENDED FOUR MONTHS ENDED ENDED
AUGUST 31, 1995 DECEMBER 31, 1995 MAY 31, 1996
--------------- ------------------ ------------
<S> <C> <C> <C>
Cash provided by (used in):
Operations:
Loss for the period......................................... $ (1,560,919) $ (305,333) $ (492,357)
Depreciation and amortization an item not involving cash.... 71,840 23,680 30,607
--------------- ---------- ------------
(1,489,079) (281,653) (461,750)
--------------- ---------- ------------
Changes in non-cash operating working capital:
Accounts receivable....................................... (37,818) (184,758) 186,616
Inventories............................................... (147,592) 67,343 (57,801)
Other current assets...................................... -- -- (5,438)
Accounts payable and accrued liabilities.................. 45,600 (22,900) 83,262
--------------- ---------- ------------
(1,628,889) (421,968) (255,111)
--------------- ---------- ------------
Financing:
Increase in equity.......................................... 1,627,307 438,929 302,374
Increase in long-term debt.................................. 318,338 -- --
--------------- ---------- ------------
1,945,645 438,929 302,374
--------------- ---------- ------------
Investments:
Purchase of capital assets, net............................. (316,756) (16,961) (29,257)
--------------- ---------- ------------
Increase in cash.............................................. -- -- 18,006
Cash, beginning of period..................................... -- -- --
--------------- ---------- ------------
Cash, end of period........................................... $ -- $ -- $ 18,006
--------------- ---------- ------------
--------------- ---------- ------------
</TABLE>
See accompanying notes to financial statements.
F-26
<PAGE>
ONCOMETRICS IMAGING CORP.
NOTES TO FINANCIAL STATEMENTS
1. FORMATION AND OPERATIONS:
A Division of Xillix Technologies Inc. ("Xillix") has specialized in the
research and development of Automated Image Cytometry equipment ("AIC
Division").
In contemplation of raising additional capital for the AIC Division,
Oncometrics Imaging Corp. (the "Company") was formed as a wholly-owned
subsidiary of Xillix in October 1995. Effective January 1, 1996 the operations
of the AIC Division were transferred to the Company. The net assets of the AIC
Division were transferred on January 20, 1996 in consideration of shares of the
Company. The value assigned to the shares was equal to the historical value of
net assets transferred.
The accompanying financial statements include the accounts of the Company
for the period January 1, 1996 to May 31, 1996 and the accounts of the AIC
Division for the year ended August 31, 1995 and the four months ended December
31, 1995.
The financial statements for the year ended August 31, 1995 and four months
ended December 31, 1995 include an allocation of the overhead of Xillix
applicable to the AIC Division, based on proportionate wages.
2. SIGNIFICANT ACCOUNTING POLICIES:
These financial statements have been prepared by management in accordance
with generally accepted accounting principles in Canada (Canadian GAAP) and
presented in Canadian dollars. These financial statements also conform, in all
material respects, with those accounting principles that are generally accepted
in the United States (US GAAP), except for these matters referred to in note 12.
(a) Basis of presentation:
These financial statements are prepared for inclusion in a SEC filing
statement for purposes of funding the acquisition of a 66 2/3% equity interest
of Oncometrics Imaging Corp. pursuant to a letter of intent dated July 3, 1996.
The financial statements have been prepared on the basis which assumes the
realization of assets and settlement of liabilities in the normal course of
business. The ability of the Company to continue its planned course of action is
dependent upon continued financial support from its parent company and upon
additional financing and obtaining future profitable operations.
(b) Inventories:
Inventories are included at the lower of average cost and net realizable
value.
(c) Capital assets:
Capital assets are stated at cost. Depreciation is provided using the
following methods and annual rates:
<TABLE>
<CAPTION>
ASSET BASIC RATE
- ----------------------------------------------------- ------------------------------- ---------
<S> <C> <C>
Computer and laboratory equipment declining-balance 30%
Furniture and office equipment declining-balance 20%
Demonstration equipment straight-line over 3 years
Leasehold improvements straight-line over 5 years
Intellectual property and patents straight-line over 17 years
</TABLE>
(d) Research and development costs:
Research and development (R&D) costs are expensed as incurred. Research and
related government assistance is accounted for using the cost reduction method
and is credited against R&D expenditures.
F-27
<PAGE>
ONCOMETRICS IMAGING CORP.
NOTES TO FINANCIAL STATEMENTS (CONTINUED)
2. SIGNIFICANT ACCOUNTING POLICIES: (CONTINUED)
(e) Estimates:
Preparation of financial statements in conformity with GAAP requires
management to make estimates and assumptions that effect the reported amounts of
assets and liabilities and disclosure of contingent assets and liabilities at
the date of the financial statements and the reported amounts of revenue and
expenses during the period. Actual results could differ from these estimates.
3. INVENTORIES:
Inventories comprises finished goods of $ nil (August 31, 1995 -- $70,000;
December 31, 1995 -- $ nil) and materials of $138,050 (August 31, 1995 --
$77,592; December 31, 1995 -- $80,249).
4. CAPITAL ASSETS:
<TABLE>
<CAPTION>
AUGUST 31, DECEMBER 31, MAY 31,
1995 1995 1996
----------- ------------- ----------
<S> <C> <C> <C>
Computer and laboratory equipment......................................... $ 194,130 $ 207,891 $ 221,811
Furniture and office equipment............................................ 7,923 7,923 11,339
Demonstration equipment................................................... 107,562 108,623 108,623
Leasehold improvements.................................................... -- -- 3,883
Intellectual property and patents......................................... 121,901 124,040 132,078
----------- ------------- ----------
431,516 448,477 477,734
Less accumulated depreciation and amortization............................ 186,600 210,280 240,887
----------- ------------- ----------
$ 244,916 $ 238,197 $ 236,847
----------- ------------- ----------
----------- ------------- ----------
</TABLE>
5. ACCOUNTS PAYABLE AND ACCRUED LIABILITIES:
Accrued liabilities include a warranty reserve of $9,120 (August 31, 1995 --
$20,000; December 31, 1995 -- $10,000) and accrued salary and vacation pay of $
nil (August 31, 1995 -- $25,600; -- December 31, 1995 -- $ nil).
6. LONG-TERM DEBT:
Long-term debt consists of repayable contribution from the Western Economic
Diversification Program which was assumed from Xillix Technologies Corp.
("Xillix") and is still in the name of Xillix as follows:
<TABLE>
<CAPTION>
AUGUST 31, DECEMBER 31, MAY 31,
1995 1995 1996
----------- ------------- ----------
<S> <C> <C> <C>
Balance assumed........................................................... $ 318,338 $ 318,338 $ 318,338
Less current portion...................................................... -- 10,000 10,000
----------- ------------- ----------
$ 318,338 $ 308,338 $ 308,338
----------- ------------- ----------
----------- ------------- ----------
</TABLE>
The Western Diversification construction does not bear interest. This is
repayable in semi-annual contributions commencing January 31, 1994. Repayments
are based on future sales of the ACCESS device.
The estimated aggregate maximum repayments for each of the five years
subsequent to December 31, 1995 are as follows:
<TABLE>
<S> <C>
1996...................................................................... $ 10,000
1997...................................................................... 100,000
1998...................................................................... 100,000
1999...................................................................... 100,000
2000...................................................................... 8,338
</TABLE>
F-28
<PAGE>
ONCOMETRICS IMAGING CORP.
NOTES TO FINANCIAL STATEMENTS (CONTINUED)
7. SHARE CAPITAL:
(a) Authorized:
The authorized share capital of the Company consists of 50,000,000 common
shares without par value.
(b) Issued:
<TABLE>
<CAPTION>
AUGUST 31, DECEMBER 31, MAY 31,
1995 1995 1996
----------- --------------- ----------
<S> <C> <C> <C>
1,775,000 (1 -- December 31, 1995) common shares.......................... $ N/A $ -- $ 199,984
----------- --- ----------
----------- --- ----------
</TABLE>
8. DIVISIONAL EQUITY:
The divisional equity at December 31, 1995 and August 31, 1995 represents
the sum of cash contributions, plus the net assets of the division less the
divisional loss.
9. XILLIX CAPITAL CONTRIBUTION:
This represents loans by Xillix to the Company which will be converted to
shares.
10. INCOME TAXES:
As at May 31, 1996 the Company has non-capital losses for income tax
purposes of approximately $256,000 available to reduce taxes of future years,
which expire in 2000. The Company also has Scientific Research Experimental
Development Expenditures of approximately $214,000 at May 31, 1996.
No recognition has been given in these financial statements to the potential
future tax benefits which may arise from claiming these losses and Scientific
Research and Experimental Development Expenditures.
11. EXPORT SALES:
The Company's division had export sales in the following geographic regions:
<TABLE>
<CAPTION>
FOUR MONTHS
TWELVE MONTHS ENDED FIVE MONTHS
ENDED AUGUST DECEMBER 31, ENDED MAY 31,
31, 1995 1995 1996
-------------- ------------- -------------
<S> <C> <C> <C>
United States................................... $ 148,453 $ 8,190 $ 4,326
Europe.......................................... 2,428 129,675 2,186
-------------- ------------- ------
$ 150,881 $ 137,865 $ 6,512
-------------- ------------- ------
-------------- ------------- ------
</TABLE>
12. DIFFERENCES BETWEEN CANADIAN AND UNITED STATES GENERALLY ACCEPTED ACCOUNTING
PRINCIPLES:
In February 1992, the Financial Accounting Standards Board issued Statement
No. 109, "ACCOUNTING FOR INCOME TAXES". Statement 109 changed the method
companies used to account for income taxes from the deferral method to the asset
and liability method. This statement is effective for fiscal years beginning
after December 15, 1992. The Company has determined that the adoption of
Statement 109 does not result in a material effect on the net deferred income
tax position of the Company as any deferred tax assets initially recognized are
fully offset by a valuation allowance as at December 31, 1995.
F-29
<PAGE>
PRO FORMA CONDENSED COMBINING FINANCIAL STATEMENTS
The accompanying pro forma condensed combining financial statements reflects
the proposed acquisition of a 66% interest in Oncometrics Imaging Corp.
(Oncometrics) by AccuMed International, Inc. (AccuMed International) (formerly
Alamar Biosciences, Inc), the proposed acquisition of the remaining 90% interest
in Radco Ventures, Inc. (Radco), the merger of AccuMed International and AccuMed
Inc. (AccuMed), and the purchase of certain assets and the assumption of certain
liabilities from Sensititre US and Sensititre Ltd. by AccuMed.
The pro forma condensed combining balance sheet as of June 30, 1996 assumes
that the proposed acquisition of the 66% interest in Oncometrics and the
proposed acquisition of the remaining 90% interest in Radco occurred on June 30,
1996. The pro forma condensed combining statements of operations for the six
months ended June 30, 1996, for the six months ended December 31, 1995 and for
the year ended September 30, 1995 assume that the proposed acquisition of the
66% interest in Oncometrics occurred on October 1, 1994. In addition, the pro
forma condensed combining statements of operations for the three months ended
December 31, 1995 and for the year ended September 30, 1995 assume that the
merger of AccuMed International with Accumed and the purchase of Sensititre US
and Sensititre Ltd. occurred on October 1, 1994. The condensed combining
statements of operations do not reflect results of operations for Radco since
its' incorporation on March 6, 1996. Such results are not deemed significant.
The transactions have been accounted for using purchase accounting. The pro
forma adjustments are based on preliminary assumptions of the allocation of the
purchase price and are subject to substantial revision once evaluations of the
fair value of the assets and liabilities are completed. Actual purchase
accounting adjustments may differ from the pro forma adjustments presented
herein.
The respective Oncometrics financial results have been translated from
Canadian dollars to U.S. dollars using an exchange rate of .7451 for the year
ended September 30, 1995, .7391 for the three months ended December 31, 1995,
.7331 for the six months ended June 30, 1996, and .7333 as of June 30, 1996.
The pro forma condensed combining financial information is not necessarily
indicative of the results that actually would have occurred if the acquisitions
had been completed on the assumed dates nor are the statements indicative of
future combined financial position or earnings.
F-30
<PAGE>
ACCUMED INTERNATIONAL, INC. AND SUBSIDIARIES
PRO FORMA CONDENSED COMBINING BALANCE SHEET
JUNE 30, 1996
(UNAUDITED)
<TABLE>
<CAPTION>
ACCUMED ONCOMETRICS RADCO
INTERNATIONAL, IMAGING VENTURES,
INC. CORP. (A) INC. (B) ADJUSTMENTS PRO FORMA
-------------- ------------ ------------ ---------------- --------------
<S> <C> <C> <C> <C> <C>
ASSETS:
Cash and cash equivalents........... $ 595,265 $ 13,246 $ 800,000 $ 2,000,000(1) $ 3,408,511
Accounts receivable................. 1,405,486 26,455 -- -- 1,431,941
Prepaid expenses and deposits....... 231,194 -- -- -- 231,194
Production inventory................ 1,513,760 101,559 -- -- 1,615,319
-------------- ------------ ------------ ---------------- --------------
Total current assets.............. 3,745,705 141,260 800,000 2,000,000 6,686,965
-------------- ------------ ------------ ---------------- --------------
Fixed assets, net................... 401,970 174,241 -- 576,211
Intangible assets................... 4,403,677 -- -- 2,670,000(1) 7,703,677
630,000(2)
Other assets........................ 168,402 4,001 -- 172,403
-------------- ------------ ------------ ---------------- --------------
$ 8,719,754 $ 319,502 $ 800,000 $ 5,300,000 $ 15,139,256
-------------- ------------ ------------ ---------------- --------------
-------------- ------------ ------------ ---------------- --------------
LIABILITIES AND STOCKHOLDERS' EQUITY
Current portion of long-term debt... $ -- $ 7,357 $ -- $ -- $ 7,357
Capital lease obligations due within
one year........................... 86,067 -- -- -- 86,067
Accounts payable.................... 2,242,433 77,952 50,000 2,370,385
Due to Xillix Technologies Corp..... -- -- -- 4,000,000(1) 4,000,000
Due to Radco Ventures............... -- -- -- 1,380,000(2) 1,380,000
Other current liabilities........... 807,823 -- -- -- 807,823
Notes payable....................... 37,497 -- -- -- 37,497
-------------- ------------ ------------ ---------------- --------------
Total current liabilities......... 3,173,820 85,309 50,000 5,380,000 8,689,129
-------------- ------------ ------------ ---------------- --------------
Long-term portion of capital lease
obligations........................ 45,243 -- -- -- 45,243
Long-term debt...................... -- 226,835 -- -- 226,835
Deferred rent....................... 13,393 -- -- -- 13,393
Minority interest................... -- -- -- 677,358 677,358
Stockholders' equity:
Common stock...................... 175,257 -- -- -- 175,257
Additional paid-in capital........ 32,694,471 -- 750,000 (750,000)(2) 32,694,471
Cumulative translation
adjustment....................... (2,236) -- -- -- (2,236)
Accumulated deficit............... (27,220,237) 7,358 -- (7,358)(1) (27,220,237)
Less treasury stock............... (159,957) -- -- -- (159,957)
-------------- ------------ ------------ ---------------- --------------
Total stockholders' equity...... 5,487,298 7,358 750,000 (757,358) 5,487,298
-------------- ------------ ------------ ---------------- --------------
$ 8,719,754 $ 319,502 $ 800,000 $ 5,300,000 $ 15,139,256
-------------- ------------ ------------ ---------------- --------------
-------------- ------------ ------------ ---------------- --------------
</TABLE>
- ------------------------
(A) Represents net assets of Oncometrics as of May 31, 1996.
(B) Represents net assets of Radco as of June 30, 1996.
See accompanying notes to the pro forma condensed
combining financial statements.
F-31
<PAGE>
ACCUMED INTERNATIONAL, INC. AND SUBSIDIARIES
PRO FORMA CONDENSED COMBINING STATEMENT OF OPERATIONS
FOR THE SIX MONTHS ENDED JUNE 30, 1996
(UNAUDITED)
<TABLE>
<CAPTION>
ACCUMED ONCOMETRICS
INTERNATIONAL, IMAGING
INC. CORP. (A) ADJUSTMENTS PRO FORMA
------------- ------------ ------------- -------------
<S> <C> <C> <C> <C>
Sales................................................. $ 2,312,094 $ 6,044 $ -- $ 2,318,138
Cost of sales......................................... (1,465,457) (3,402) -- (1,468,859)
------------- ------------ ------------- -------------
Gross profit.......................................... 846,637 2,642 -- 849,279
------------- ------------ ------------- -------------
Operating expenses:
General and administrative.......................... 1,791,534 113,465 54,000(4) 1,958,999
Research and development............................ 4,789,412 335,869 -- 5,125,281
Sales and marketing................................. 841,565 70,931 -- 912,496
------------- ------------ ------------- -------------
Total operating expenses.......................... 7,422,511 520,265 54,000 7,996,776
------------- ------------ ------------- -------------
Operating loss........................................ (6,575,874) (517,623) (54,000) (7,147,497)
Other income (expense):
Interest income..................................... 11,460 -- 11,460
Interest expense.................................... (437,986) -- -- (437,986)
Other income........................................ 2,544,513 (2,738) -- 2,541,775
------------- ------------ ------------- -------------
Loss before income taxes and minority interest........ (4,457,887) (520,361) (54,000) (5,032,248)
Income tax expense.................................... 850 -- 850
------------- ------------ ------------- -------------
Net loss before minority interest..................... (4,458,737) (520,361) (54,000) (5,033,098)
Minority interest..................................... -- -- 175,000(5) 175,000
------------- ------------ ------------- -------------
Net earnings (loss)............................... $(4,458,737) $ (520,361) $ 121,000 $ (4,858,098)
------------- ------------ ------------- -------------
------------- ------------ ------------- -------------
Net loss per share.................................... $ (0.30)
-------------
-------------
Weighted average common shares outstanding............ 16,319,105
-------------
-------------
</TABLE>
- ------------------------
(A) Includes the six months ended June 30, 1996 for Oncometrics.
See accompanying notes to the pro forma condensed
combining financial statements.
F-32
<PAGE>
ACCUMED INTERNATIONAL, INC. AND SUBSIDIARIES
PRO FORMA CONDENSED COMBINING STATEMENT OF OPERATIONS
FOR THE THREE MONTHS ENDED DECEMBER 31, 1995
(UNAUDITED)
<TABLE>
<CAPTION>
ACCUMED ONCOMETRICS
INTERNATIONAL, IMAGING CORP.
INC. ACCUMED INC. (A) ADJUSTMENTS PRO FORMA
--------------- --------------- -------------- --------------- --------------
<S> <C> <C> <C> <C> <C>
Sales.......................................... $ 100,130 $ 1,009,376 $ 146,959 $ (73,005)(6) $ 1,183,460
Cost of sales.................................. (338,730 ) (830,497 ) (88,189 ) 71,892(7) (1,185,524)
--------------- --------------- -------------- --------------- --------------
Gross profit (loss)............................ (238,600 ) 178,879 58,770 (1,113 ) (2,064)
--------------- --------------- -------------- --------------- --------------
Operating expenses:
General and administration................... 1,418,797 758,066 49,759 27,000(4) 2,253,622
Research and development..................... 3,997,600 338,178 172,259 -- 4,508,037
Sales and marketing.......................... 7,197 289,360 -- -- 296,557
--------------- --------------- -------------- --------------- --------------
Total operating expenses....................... 5,423,594 1,385,604 222,018 27,000 7,058,216
--------------- --------------- -------------- --------------- --------------
Operating loss................................. (5,662,194 ) (1,206,725 ) (163,248 ) (28,113 ) (7,060,280)
Other income (expense):
Interest income.............................. 4,748 -- -- -- 4,748
Interest (expense)........................... (10,862 ) (1,948 ) -- -- (12,810)
Other........................................ (72,929 ) -- -- -- (72,929)
--------------- --------------- -------------- --------------- --------------
Loss before income taxes and minority
interest...................................... (5,741,237 ) (1,208,673 ) (163,248 ) (28,113 ) (7,141,271)
Provision for income taxes..................... 800 -- -- -- 800
--------------- --------------- -------------- --------------- --------------
Net loss before minority interest.............. (5,742,037 ) (1,208,673 ) (163,248 ) (28,113 ) (7,142,071)
Minority interest.............................. -- -- -- 65,000(5) 65,000
--------------- --------------- -------------- --------------- --------------
Net earnings (loss)............................ $ (5,742,037 ) $ (1,208,673 ) $ (163,248 ) $ 36,887 $ (7,077,071)
--------------- --------------- -------------- --------------- --------------
--------------- --------------- -------------- --------------- --------------
Net loss per share............................. $ (0.60)
--------------
--------------
Weighted average common shares outstanding..... 11,742,980
--------------
--------------
</TABLE>
- ------------------------
(A) Includes the three months ended December 31, 1995 for Oncometrics.
See accompanying notes to the pro forma condensed
combining financial statements.
F-33
<PAGE>
ACCUMED INTERNATIONAL, INC. AND SUBSIDIARIES
PRO FORMA CONDENSED COMBINING STATEMENT OF OPERATIONS
FOR THE YEAR ENDED SEPTEMBER 30, 1995
(UNAUDITED)
<TABLE>
<CAPTION>
PRO FORMA
-----------------------------
HISTORICAL ACCUMED,
------------- AS ADJUSTED,
ACCUMED HISTORICAL FOR THE YEAR
INTERNATIONAL ---------------------------------- ENDED
YEAR ENDED SENSITITRE SENSITITRE SEPTEMBER 30,
SEPTEMBER 30, ACCUMED US UK 1995
1995 (A) (B) (B) ADJUSTMENTS (C)
------------- ------------ --------- --------- -------------- -------------
<S> <C> <C> <C> <C> <C> <C>
Sales...................................... $ 514,776 $ 2,609,233 $ 409,360 $ 639,561 $ (193,000)(6) $ 3,465,154
Cost of sales.............................. (1,431,187) (1,510,143) (247,860) (457,056) 109,000(7) (2,106,059)
------------- ------------ --------- --------- -------------- -------------
Gross profit (loss)........................ (916,411) 1,099,090 161,500 182,505 (84,000) 1,359,095
------------- ------------ --------- --------- -------------- -------------
Operating expenses:
General and administration............... 2,094,890 1,040,083 208,420 74,589 100,000(8) 1,423,092
Research and development................. 386,882 453,277 -- 88,872 -- 542,149
Sales and marketing...................... 309,208 1,187,177 -- -- -- 1,187,177
------------- ------------ --------- --------- -------------- -------------
Total operating expenses................... 2,790,980 2,680,537 208,420 163,461 100,000 3,152,418
------------- ------------ --------- --------- -------------- -------------
Operating income (loss).................... (3,707,391) (1,581,447) (46,920) 19,044 (184,000) (1,793,323)
Other income (expense):
Interest income.......................... 7,949 12,930 -- -- -- 12,930
Interest expense......................... (46,657) (40,201) -- -- (35,475)(9) (75,676)
Other income............................. 32,566 1,308 -- -- -- 1,308
Other expense............................ (45,777) -- -- -- -- --
------------- ------------ --------- --------- -------------- -------------
Earnings (loss) before income taxes and
minority interest......................... (3,759,310) (1,607,410) (46,920) 19,044 (219,475) (1,854,761)
Provision for income taxes................. 800 -- -- -- -- --
------------- ------------ --------- --------- -------------- -------------
Net earnings (loss) before minority
interest.................................. (3,760,110) (1,607,410) (46,920) 19,044 (219,475) (1,854,761)
------------- ------------ --------- --------- -------------- -------------
Minority interest.......................... -- -- -- -- -- --
------------- ------------ --------- --------- -------------- -------------
Net earnings (loss)........................ $ 3,760,110) $ (1,607,410) $ (46,920) $ 19,044 $ (219,425) $(1,854,761)
------------- ------------ --------- --------- -------------- -------------
------------- ------------ --------- --------- -------------- -------------
Net loss per equivalent share.............. $ (0.59) $ (0.92) $ (1.06)
------------- ------------ -------------
------------- ------------ -------------
Weighted average shares outstanding (F).... 6,375,627 1,748,940 1,748,940
------------- ------------ -------------
------------- ------------ -------------
<CAPTION>
PRO FORMA
-----------------------------
ACCUMED
INTERNATIONAL
AS ADJUSTED HISTORICAL
FOR THE YEAR -----------
ENDED ONCOMETRICS
SEPTEMBER 30, IMAGING
1995 CORP.
ADJUSTMENTS (D) (E) ADJUSTMENTS PRO FORMA
-------------- ------------- ----------- -------------- -----------
<S> <C> <C> <C> <C> <C>
Sales...................................... $ -- $ 3,979,930 $ 164,552 $ -- $ 4,144,482
Cost of sales.............................. -- (3,537,246) (137,034) -- (3,674,280)
-------------- ------------- ----------- -------------- -----------
Gross profit (loss)........................ -- 442,684 27,518 -- 470,202
-------------- ------------- ----------- -------------- -----------
Operating expenses:
General and administration............... 284,570 (10 3,802,552 229,225 108,000(4) 4,139,777
Research and development................. -- 929,031 961,248 -- 1,890,279
Sales and marketing...................... -- 1,496,385 -- 1,496,385
-------------- ------------- ----------- -------------- -----------
Total operating expenses................... 284,570 6,227,968 1,190,473 108,000 7,526,441
-------------- ------------- ----------- -------------- -----------
Operating income (loss).................... (284,570) (5,785,284) (1,162,955) (108,000) (7,056,239)
Other income (expense):
Interest income.......................... -- 20,879 -- -- 20,879
Interest expense......................... -- (122,333) -- -- (122,333)
Other income............................. -- 33,874 -- -- 33,874
Other expense............................ -- (45,777) -- -- (45,777)
-------------- ------------- ----------- -------------- -----------
Earnings (loss) before income taxes and
minority interest......................... (284,570) (5,899,441) (1,162,955) (108,000) (7,169,596)
Provision for income taxes................. -- 800 -- 800
-------------- ------------- ----------- -------------- -----------
Net earnings (loss) before minority
interest.................................. (284,570) (5,899,441) (1,162,955) (108,000) (7,170,396)
-------------- ------------- ----------- -------------- -----------
Minority interest.......................... -- -- -- 430,000(5) 430,000
-------------- ------------- ----------- -------------- -----------
Net earnings (loss)........................ $ (284,570) $(5,899,441) ($1,162,955) $ 322,000 $(6,740,396)
-------------- ------------- ----------- -------------- -----------
-------------- ------------- ----------- -------------- -----------
Net loss per equivalent share.............. $ (0.60) $ (0.69)
------------- -----------
------------- -----------
Weighted average shares outstanding (F).... 9,831,682 9,831,682
------------- -----------
------------- -----------
</TABLE>
- ----------------------------------
(A) Includes the twelve months and nine months ended September 30, 1995 for
AccuMed, Inc. and Sensititre US/UK, respectively.
(B) Includes the three months ended December 31, 1994, before the acquisitions
by AccuMed, Inc.
(C) AccuMed Consolidated includes AccuMed, Inc., Sensititre US, and Sensititre
UK, Ltd. after purchase accounting adjustments
(D) AccuMed International Consolidated includes AccuMed International (formerly
Alamar Biosciences, Inc.), and AccuMed Consolidated after purchase
accounting adjustments.
(E) Includes the twelve months ended August 31, 1995 for Oncometrics.
(F) Weighted average shares outstanding are 9,831,682 which represents 6,375,627
shares for AccuMed International before the merger plus the weighted average
(3,456,055) of the 4,178,104 shares (6,178,104 shares per the merger
agreement less 2,000,000 shares issued but subject to forfeiture) to be
issued in connection with the AccuMed merger. The weighted average shares
outstanding for AccuMed gives effect to the shares issued by AccuMed during
the year ended September 30,1995 using the exchange ratio of 1.98 to 1. The
total shares outstanding at September 30, 1995 are 15,107,443 (10,929,339
shares of AccuMed International and 4,178,104 shares issued to AccuMed)
which does not include the 2,000,000 shares issued but subject to
forfeiture.
See accompanying notes to the pro forma condensed
combining financial statements.
F-34
<PAGE>
ACCUMED INTERNATIONAL, INC., AND SUBSIDIARIES
NOTES TO PRO FORMA CONDENSED COMBINING
FINANCIAL STATEMENTS
(UNAUDITED)
NOTE A -- DESCRIPTION OF ACQUISITIONS
On December 29, 1995, AccuMed International (the "Company") (formerly Alamar
Biosciences, Inc.) acquired all of the common stock of AccuMed, which included
the recent acquisition of certain assets and assumption of certain liabilities
of Sensititre US and Sensititre Ltd. by AccuMed. Pursuant to the terms of the
merger agreement, the Company issued 3,931,401 unconditional shares of common
stock valued at $4,422,826 and 237,840 warrants valued at $68,252. An additional
1,881,910 shares and 126,945 warrants were issued to AccuMed shareholders on
December 29, 1995, however, such shares and warrants are contingent and subject
to forfeiture if specified performance goals are not achieved by the merged
entity during the 24 months beginning January 1, 1996. In March 1996 the
contingency associated with 940,955 shares and 63,472 warrants was resolved
(performance goal achieved) resulting in contingent consideration of $5,430,326.
The remaining contingent consideration will be recorded when the goals are
achieved and will be computed based upon the stock price on such date. The
acquisition has been accounted for using the purchase method of accounting.
In August, 1996, the Company entered into definitive agreements to acquire a
66% interest in Oncometrics Imaging Corp. (Oncometrics), for approximately $4.0
million in cash. The closing of this transaction is subject to the execution of
a definitive Transaction Agreement and the satisfaction of conditions customary
in such agreements. It is expected that the acquisition will be accounted for
using the purchase method of accounting and that a portion of the purchase price
will be charged to acquired in-process research and development in the period in
which the transaction is consummated.
In August, 1996, the Company entered into a definitive agreement to acquire
the remaining 90% interest in Radco Ventures, Inc. (Radco), for approximately
$1.4 million in cash. The closing of this transaction is subject to the approval
of the Radco Stockholders and the satisfaction of conditions customary in
acquisition agreements. It is expected that the acquisition will be accounted
for using the purchase method of accounting and that a portion of the purchase
price will be charged to acquired in-process research and development in the
period in which the transaction is consummated.
NOTE B -- PRO FORMA ADJUSTMENTS
The following adjustments are reflected in the Pro Forma Condensed Combining
Financial Statements under the columns headed "Adjustments".
(1) Purchase Price Allocation-Oncometrics
To reflect the estimated allocation of the $4 million purchase price
associated with the proposed acquisition of the 66% interest in Oncometrics.
The purchase price will be paid from the net proceeds of the Offering and
has been reflected in the Pro Forma Condensed Combining Balance Sheet as Due
to Xillix Technologies Corp. The allocation of the purchase price represents
an estimate of the fair value of the assets acquired and liabilities
assumed, includes approximately $1.6 million of acquired in-process research
and development and $1.1 million of purchased technology and reflects the
33% minority interest holdings. The Pro Forma Condensed Combining Balance
Sheet reflects the estimated $1.6 million of acquired in-process research
and development as Intangible Assets. Such amount will be written off as a
charge to earnings in the period subsequent to the acquisition. The
allocation is subject to change and is not necessarily indicative of the
ultimate purchase price allocation.
(2) Purchase Price Allocation -- Radco
To reflect the estimated allocation of the $1.4 million purchase price
associated with the proposed acquisition of the remaining 90% interest in
Radco. The purchase price will be paid from the net proceeds of The Offering
and has been reflected in The Pro Forma Condensed Combining Balance
F-35
<PAGE>
ACCUMED INTERNATIONAL, INC., AND SUBSIDIARIES
NOTES TO PRO FORMA CONDENSED COMBINING
FINANCIAL STATEMENTS (CONTINUED)
(UNAUDITED)
NOTE B -- PRO FORMA ADJUSTMENTS (CONTINUED)
Sheet as Due to Radco Ventures, Inc. The allocation of the purchase price
represents an estimate of the fair value of the assets acquired and
liabilities assumed and includes approximately $630,000 of acquired
in-process research and development. The Pro Forma Condensed Combining
Balance Sheet reflects the estimated $630,000 of acquired in-process
research and development as Intangible Assets. Such amount will be written
off as a charge to earnings in the period subsequent to the acquisition. The
allocation is subject to change and is not necessarily indicative of the
ultimate purchase price allocation.
(3) Acquired In-Process Research and Development
The estimated charges of approximately $1.6 million and $630,000 for
acquired in-process research and development relating to the Oncometric and
Radco acquisitions, respectively, are not reflected in the accompanying Pro
Forma Condensed Combining Statements of Operations. Such amounts will result
in a charge to earnings in the period subsequent to the acquisitions.
The charge for acquired in-process research and development relating to the
AccuMed acquisition is not reflected in the accompanying Pro Forma Condensed
Combined Statements of Operations for the year ended September 30, 1995.
This charge in the amount of approximately $4.0 million has been reflected
in the historical financial results of AccuMed International in the
accompanying Pro Forma Condensed Combining Statement of Operations for the
three months ended December 31, 1995. In addition, a charge of $3.5 million
relating to the allocation of purchase price to acquire in-process research
and development following the resolution of a portion of the contingency has
been reflected in the historical financial results of AccuMed International
in the accompanying Pro Forma Condensed Combining Statement of Operations
for the six months ended June 30, 1996.
(4) Amortization of Intangibles
To reflect the amortization of the excess of cost over net assets acquired
and purchased technology of Oncometrics using the straight-line method over
10 years.
(5) To reflect the minority interest share (33%) of net loss of Oncometrics
Imaging Corp.
(6) To eliminate intercompany sales from AccuMed International Limited
(formerly Sensititre UK Ltd.) to AccuMed (formerly Sensititre U.S.).
(7) To eliminate intercompany profit from the cost of product sold from AccuMed
International Limited (formerly Sensititre UK Ltd.) to Accumed (formerly
Sensititre U.S.).
(8) To reduce amortization expense ($20,000) for the amortization of the
purchase price of AccuMed in excess of the fair market value of acquired
assets, less assumed liabilities, and transaction costs incurred with the
acquisition of AccuMed, amortized over a 10 year life, and to adjust
amortization expense for Sensititre U.S., and Sensititre UK Ltd.
Adjustment to reflect a reasonable estimation ($120,000) of corporate
overhead costs for the three months ended December 31, 1994 carve out period
for Sensititre U.S. The estimate is based on a percentage of total sales of
Radiometer America Inc., (of which Sensititre U.S. was a division) to the
Sensititre U.S. product line.
(9) To adjust interest expense for $35,475, assuming that the $430,000 loan to
finance the Sensititre acquisition occurred on October 1, 1994.
F-36
<PAGE>
ACCUMED INTERNATIONAL, INC., AND SUBSIDIARIES
NOTES TO PRO FORMA CONDENSED COMBINING
FINANCIAL STATEMENTS (CONTINUED)
(UNAUDITED)
NOTE B -- PRO FORMA ADJUSTMENTS (CONTINUED)
(10)To adjust amortization expense for the amortization of the purchase price
of AccuMed in excess of the fair market value of acquired assets, less
assumed liabilities, and transaction costs incurred with the Merger of
AccuMed, amortized over a 10 year life, and to adjust amortization expense
for Sensititre U.S., and Sensititre UK Ltd.
F-37
<PAGE>
- --------------------------------------------------------------------------------
- --------------------------------------------------------------------------------
NO DEALER, SALES REPRESENTATIVE OR ANY OTHER PERSON IS AUTHORIZED IN
CONNECTION WITH ANY OFFERING MADE HEREBY TO GIVE ANY INFORMATION OR TO MAKE ANY
REPRESENTATION NOT CONTAINED HEREIN AND, IF GIVEN OR MADE, SUCH INFORMATION OR
REPRESENTATION MUST NOT BE RELIED UPON AS HAVING BEEN AUTHORIZED BY THE COMPANY
OR THE UNDERWRITERS. THIS PROSPECTUS DOES NOT CONSTITUTE AN OFFER TO SELL, OR A
SOLICITATION OF AN OFFER TO BUY, ANY SECURITY OTHER THAN THE SECURITIES OFFERED
HEREBY, NOR DOES IT CONSTITUTE AN OFFER TO SELL OR A SOLICITATION OF AN OFFER TO
BUY ANY SUCH SECURITIES TO ANY PERSON IN ANY JURISDICTION IN WHICH IT IS
UNLAWFUL TO MAKE SUCH AN OFFER OR SOLICITATION. NEITHER THE DELIVERY OF THIS
PROSPECTUS NOR ANY SALE MADE HEREUNDER SHALL UNDER ANY CIRCUMSTANCES CREATE ANY
IMPLICATION THAT THERE HAS BEEN NO CHANGE IN THE AFFAIRS OF THE COMPANY SINCE
THE DATE HEREOF OR THAT THE INFORMATION CONTAINED HEREIN IS CORRECT AS OF ANY
DATE SUBSEQUENT TO THE DATE HEREOF.
--------------------------
TABLE OF CONTENTS
<TABLE>
<CAPTION>
PAGE
-----
<S> <C>
Prospectus Summary............................. 3
Risk Factors................................... 6
The Company.................................... 19
Use of Proceeds................................ 20
Price Range Of Common Stock.................... 21
Dividend Policy................................ 21
Capitalization................................. 22
Dilution....................................... 23
Selected Consolidated Financial Data........... 24
Management's Discussion and Analysis of
Financial Condition and Results of
Operations.................................... 25
Business....................................... 30
Management..................................... 46
Certain Relationships and Related
Transactions.................................. 56
Principal Stockholders......................... 58
Description of Capital Stock................... 60
Underwriting................................... 64
Change in Independent Accountants.............. 66
Available Information.......................... 66
Incorporation of Certain Documents by
Reference..................................... 67
Additional Information......................... 68
Legal Matters.................................. 68
Experts........................................ 68
Index to Consolidated Financial Statements..... F-1
</TABLE>
3,000,000 SHARES
[LOGO]
COMMON STOCK
---------------------
PROSPECTUS
---------------------
Vector Securities International, Inc.
Tucker Anthony
Incorporated
October 3, 1996
- --------------------------------------------------------------------------------
- --------------------------------------------------------------------------------
<PAGE>
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
ITEM 14. OTHER EXPENSES OF ISSUANCE AND DISTRIBUTION
The following table sets forth the costs and expenses, other than
underwriting discounts and commissions, payable by the Company in connection
with the issuance and distribution of the securities being registered hereunder.
All of the amounts shown are estimates (except for the SEC and NASD registration
fees).
<TABLE>
<CAPTION>
SEC registration fee........................................... $ 10,003
<S> <C>
NASD registration fee.......................................... 3,401
Printing and engraving expenses................................ 175,000
Accounting fees and expenses................................... 100,000
Legal fees and expenses........................................ 505,000
Blue Sky fees and expenses..................................... 30,000
Miscellaneous.................................................. 12,446
---------
TOTAL...................................................... $ 835,850
---------
---------
</TABLE>
None of these expenses will be paid by the Selling Stockholders pursuant to
the terms of the agreements under which the shares of Common Stock to be sold
hereby are being registered.
ITEM 15. INDEMNIFICATION OF DIRECTORS AND OFFICERS
The Company has provisions in its Certificate of Incorporation which
eliminate the liability of the Company's directors to the Company and its
stockholders for monetary damages to the fullest extent permissible under
Delaware law and provisions which authorize the Company to indemnify its
directors and agents by Bylaws, agreements or otherwise, to the fullest extent
permitted by law. Such limitation of liability does not affect the availability
of equitable remedies such as injunctive relief or rescission. The Company's
Bylaws provide that the Company shall indemnify its directors and officers to
the fullest extent permitted by Delaware law, including circumstances in which
indemnification is otherwise discretionary under Delaware law.
The Company's officers and directors are covered by a directors' and
officers' liability insurance policy maintained by the Company. Under the
insurance policy, the Company is entitled to be reimbursed for indemnity
payments that it is required or permitted to make to its directors and officers.
ITEM 16. EXHIBITS AND INDEX OF EXHIBITS.
(a) Exhibits. The following exhibits are filed herewith.
<TABLE>
<CAPTION>
EXHIBIT
NUMBER DESCRIPTION
- ---------- -----------------------------------------------------------------------------------------------------
<C> <S>
1.1 Form of Underwriting Agreement.(1)
3.1 Certificate of Incorporation of the Registrant (incorporated by reference to the Registrant's
Transition Report on Form 10-KSB for the transition period ended December 31, 1995 (the "Transition
Report")).
3.2 Bylaws of the Registrant (incorporated by reference to the Transition Report).
4.1 Specimen stock certificate for Common Stock (incorporated by reference to the Transition Report).
4.2 Certificate of Appointment of American Stock Transfer & Trust Company as Transfer Agent and Registrar
(incorporated by reference to Pre-Effective Amendment No. 4 to the Registration Statement on Form
S-1 (Reg. No. 33-48302), filed with the Commission on October 9, 1993 ("Pre-Effective Amendment No.
4 to Form S-1")).
5.1 Opinion of Graham & James LLP, counsel to the Registrant, regarding the legality of the securities
offered hereby.
</TABLE>
II-1
<PAGE>
<TABLE>
<CAPTION>
EXHIBIT
NUMBER DESCRIPTION
- ---------- -----------------------------------------------------------------------------------------------------
10.1 Agreement and Plan of Reorganization dated as of April 21, 1995 between the Registrant and AccuMed,
Inc., as amended by Amendment No. 1 dated as of August 1, 1995 and Amendment No. 2 dated as of
October 6, 1995 (incorporated by reference to the Registrant's Registration Statement on Form S-4
(File No. 33-99680), filed with the Commission on November 22, 1995 (the "Form S-4")).
<C> <S>
10.2 The Registrant's Board of Directors Compensation Plan (the "Plan") (incorporated by reference to
Exhibit 10.11 to Form S-1) with Minutes of Board of Directors meeting dated January 18, 1996
amending the Plan by authorizing grants of stock options to non-employee directors (incorporated by
reference to the Transition Report). (2)
10.3 Sale and Leaseback Agreement between the Registrant and Leasetec, Inc. (incorporated by reference to
the Registration Statement on Form S-1 (Reg. No. 33-48302), filed with the Commission on June 3,
1992 ("Form S-1")).
10.4 Employment Agreement between the Registrant and Peter P. Gombrich dated August 1, 1994 (incorporated
by reference to the Transition Report).(2)
10.5 Employment Letter between the Registrant and Kenneth Miller dated March 2, 1995 (incorporated by
reference to the Transition Report).(2)
10.6 Employment Letter between the Registrant and Mark L. Santor dated February 28, 1995 (incorporated by
reference to the Transition Report).(2)
10.7 Employment Letter between the Registrant and Michael Burke dated April 21, 1995 (incorporated by
reference to the Transition Report).(2)
10.8 Employment Agreement between the Registrant and Norman J. Pressman dated June 13, 1996 and Addendum
to Employment Agreement between the Registrant and Norman J. Pressman dated July 16, 1996. (2)(3)
10.9 European Distributor Agreement, dated November 22, 1993, by and between the Registrant and Sclavo
(incorporated by reference to Exhibit 10.22 to the Registrant's Annual Report on Form 10-KSB for the
year ended September 30, 1994 (the "1994 10-K")).
10.10 United States Distributor Agreement, dated November 22, 1993, by and between the Registrant and
Sclavo (incorporated by reference to the 1994 10-K).
10.11 Joint Research and Development Agreement, dated November 22, 1993, by and between the Registrant and
Sclavo (incorporated by reference to Exhibit 10.24 to the 1994 10-K).
10.12 Securities Purchase Agreement, dated November 22, 1993, by and between the Registrant and Sclavo
(incorporated by reference to Exhibit 10.25 to the 1994 10-K).
10.13 Escrow Agreement dated as of March 22, 1994, between the Registrant and G&G Dispensing, Inc.
(incorporated by reference to Exhibit 10.13 to the Form S-4).
10.14 License Agreement between the Registrant and Becton, Dickinson and Company effective as of October
11, 1995 (incorporated by reference to Exhibit 10.17 to the Form S-4).
10.15 Research and Development Service Agreement between the Registrant and RADCO Ventures, Inc. dated
March 15, 1996.(3)+
10.16 License and Distribution Agreement dated February 20, 1996 between the Registrant and BioKit, S.A.
(incorporated by reference to the Transition Report).
10.17 1995 Stock Option Plan (incorporated by reference to the Transition Report). (2)
10.18 Amendment No. 1 to the Registrant's 1995 Stock Option Plan. (2)(4)
10.19 Form of Non-Qualified Stock Option Agreement governing options granted to former employees of
AccuMed, Inc. pursuant to the Agreement and Plan of Reorganization dated as of April 21, 1995, as
amended (incorporated by reference to the Transition Report). (2)
</TABLE>
II-2
<PAGE>
<TABLE>
<CAPTION>
EXHIBIT
NUMBER DESCRIPTION
- ---------- -----------------------------------------------------------------------------------------------------
10.20 Form of Non-Qualified Stock Option Agreement governing options granted to employees and consultants
under the 1995 Stock Option Plan (incorporated by reference to the Transition Report). (2)
<C> <S>
10.21 Form of Incentive Stock Option Agreement Governing options granted to employees under the 1995 Stock
Option Plan (incorporated by reference to the Transition
Report). (2)
10.22 Amended and Restated 1990 Stock Option Plan (incorporated by reference to the Form S-1). (2)
10.23 The Registrant's Amended and Restated 1992 Stock Option Plan (incorporated by reference to
Pre-Effective Amendment No. 1 to Form SB-2, filed with the Commission on November 8, 1993). (2)
10.24 Lease between the Registrant and NCP, LTD dated February 20, 1995 pertaining to the offices located
at 29299 Clemens, Suite I-K, Westlake, Ohio 44145 (incorporated by reference to the Transition
Report).
10.25 Franklin Square Commercial Lease dated July 13, 1994 between the Registrant and the Lumber Company as
Agent for the Beneficiary of LaSalle National Trust, N.A. pertaining to the premises located at
Suite 401, 4th Floor North, 900 North Franklin Street, Chicago, Illinois (incorporated by reference
to the Transition Report).
10.26 Rider 1 to Franklin Square Commercial Lease between the Registrant and the Lumber Company dated May
30, 1996.(3)
10.27 License Agreement dated July 6, 1994, between the Registrant, Vanellus AB, and Uppsala
Bildbehandlings AB (incorporated by reference to the Transition Report).
10.28 Collaboration Agreement and Worldwide Exclusive License between the Registrant and G&G Dispensing,
Inc. dated March 22, 1994.(3)
10.29 O.E.M. Supply Agreement between Olympus America, Inc., Precision Instrument division and the
Registrant dated May 31, 1996.(1)+
10.30 Securities Purchase Agreement dated May 31, 1996 among the Registrant, Kingdon Associates, L.P.,
Kingdon Partners, L.P., and Kingdon Offshore N.V. (incorporated by reference to the Registrant's
Registration Statement on Form S-3 (Reg. No. 333-07681), filed with the Commission on July 3, 1996).
10.31 Promissory Note in the original principal amount of $61,000 made May 22, 1996 by Peter P. Gombrich in
favor of the Registrant.(3)
10.32 Non-negotiable Promissory Note in the original principal amount of $775,000 made July 22, 1996 by the
Registrant in favor of RADCO Ventures, Inc.(3)
10.33 Employment Separation Agreement and Release between the Registrant and Kenneth D. Miller dated June
27, 1996.(2)(3)
10.34 Employment Separation Agreement and Release between the Registrant and Mark L. Santor dated June 10,
1996.(2)(3)
10.35 Amended and Restated Employment Separation Agreement and Release between the Registrant, Kenneth D.
Miller and RADCO Ventures, Inc., dated August 8, 1996.(2)(4)
10.36 Share Purchase Agreement between the Registrant and Xillix Technologies Corp. dated as of August 16,
1996.(4)
10.37 Subscription Agreement between the Registrant and Oncometrics Imaging Corp. dated as of August 16,
1996.(4)
10.38 Stock Purchase Agreement by and among the Registrant, RADCO Ventures, Inc. and the Selling
Stockholders named therein dated as of August 15, 1996.(2)
10.39 Distribution Agreement by and between the Registrant and Fisher Scientific Company, dated September
10, 1996.(1)+
</TABLE>
II-3
<PAGE>
<TABLE>
<CAPTION>
EXHIBIT
NUMBER DESCRIPTION
- ---------- -----------------------------------------------------------------------------------------------------
10.40 Employment Agreement between the Registrant and Leonard Prange dated September 9, 1996.(2)
<C> <S>
10.41 Commercial Guaranty, Assignment of Deposit Account, Disbursement Request and Authorization and
Promissory Note between the Registrant and The Northern Trust Company dated July 22, 1996.(1)
23.1 Consent of Graham & James, LLP (contained in Exhibit 5.1).
23.2 Consent of Coopers & Lybrand LLP.
23.3 Consent of Coopers & Lybrand (UK).
23.4 Consent of KPMG Peat Marwick LLP.
23.5 Consent of KPMG.
23.6 Consent of Banner & Witcoff, Ltd.
23.7 Consent of Townsend and Townsend and Crew.
24.1 Powers of Attorney included on signature page to the Pre-effective Amendment No. 1, with respect to
Mr. Lavallee, and the signature page of the Registration Statement previously filed with the
Commission, with respect to all other signatories.
</TABLE>
- ------------------------
(1) Previously filed with Pre-effective Amendment No. 2 to the Registration
Statement on September 23, 1996.
(2) Represents a management contract or compensatory plan or arrangement
required to be filed as an exhibit to this Registration Statement.
(3) Previously filed with the Registration Statement on July 26, 1996.
(4) Previously filed with Pre-effective Amendment No. 1 to the Registration
Statement on August 29, 1996.
+ Confidential treatment requested as to certain portions.
ITEM 17. UNDERTAKINGS.
The undersigned registrant hereby undertakes:
(1) That, for the purpose of determining any liability under the
Securties Act, the Registrant will treat the information ommitted from the
form of Prospectus filed as part of this Registration Statement as of the
time the Commission declares it effective.
(2) That, for the purpose of determining any liability under the
Securities Act, each such post-effective amendment shall be deemed to be a
new registration statement relating to the securities offered therein, and
the offering of such securities at that time shall be deemed to be the
initial bona fide offering thereof.
Insofar as indemnification for liabilities arising under the Securities Act
of 1933 (the "Securities Act") may be permitted to directors, officers and
controlling persons of the Company pursuant to the foregoing provisions, or
otherwise, the Company has been advised that in the opinion of the Securities
and Exchange Commission such indemnification is against public policy as
expressed in the Securities Act and is, therefore, unenforceable. In the event
that a claim for indemnification against such liabilities (other than the
payment by the Company of expenses incurred or paid by a director, officer or
controlling person of the Company in the successful defense of any action, suit
or proceeding) is asserted by such director, officer or controlling person in
connection with the securities being registered, the Company will, unless in the
opinion of its counsel the matter has been settled by controlling precedent,
submit to a court of appropriate jurisdiction the question whether such
indemnification by it is against public policy as expressed in the Act and will
be governed by the final adjudication of such issue.
II-4
<PAGE>
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, the Registrant
certifies that it has reasonable grounds to believe it meets all of the
requirements for filing on Form S-2 and duly caused this Pre-effective Amendment
No. 3 to the Registration Statement on Form S-2 (Reg. No. 333-09011) to be
signed on its behalf by the undersigned, hereunto duly authorized, in the City
of Chicago, State of Illinois on October 3, 1996.
ACCUMED INTERNATIONAL, INC.
By: /s/ PETER P. GOMBRICH
-----------------------------------
Peter P. Gombrich
CHIEF EXECUTIVE OFFICER
POWER OF ATTORNEY
In accordance with the requirements of the Securities Act of 1933, this
Pre-effective Amendment No. 3 to the Registration Statement on Form S-2 (Reg.
No. 333-09011) has been signed by the following persons in the capacities and on
the dates stated.
<TABLE>
<C> <S> <C>
SIGNATURE TITLE DATE
- ------------------------------------------------------ ------------------------------------- ------------------
/s/ PETER P. GOMBRICH Chairman of the Board, Chief October 3, 1996
------------------------------------------- Executive Officer and President
(Peter P. Gombrich) (Principal Executive Officer)
/s/ LEONARD R. PRANGE Chief Financial Officer and Corporate October 3, 1996
------------------------------------------- Vice President (Principal Financial
(Leonard R. Prange) and Accounting Officer)
/s/ JOHN H. ABELES* Director October 3, 1996
-------------------------------------------
(John H. Abeles)
/s/ HAROLD S. BLUE* Director October 3, 1996
-------------------------------------------
(Harold S. Blue)
/s/ JACK H. HALPERIN* Director October 3, 1996
-------------------------------------------
(Jack H. Halperin)
/s/ PAUL F. LAVALLEE* Director October 3, 1996
-------------------------------------------
(Paul F. Lavallee)
</TABLE>
II-5
<PAGE>
<TABLE>
<C> <S> <C>
/s/ JOSEPH W. PLANDOWSKI* Director October 3, 1996
-------------------------------------------
(Joseph W. Plandowski)
/s/ LEONARD M. SCHILLER* Director October 3, 1996
-------------------------------------------
(Leonard M. Schiller)
* /s/ PETER P. GOMBRICH
-------------------------------------------
Peter P. Gombrich,
as Attorney-in-fact
</TABLE>
II-6
<PAGE>
INDEX TO EXHIBITS
<TABLE>
<CAPTION>
EXHIBIT
NUMBER DESCRIPTION
- ---------- -----------------------------------------------------------------------------------------------------
<C> <S>
1.1 Form of Underwriting Agreement. (1)
3.1 Certificate of Incorporation of the Registrant (incorporated by reference to the Registrant's
Transition Report on Form 10-KSB for the transition period ended December 31, 1995 (the "Transition
Report")).
3.2 Bylaws of the Registrant (incorporated by reference to the Transition Report).
4.1 Specimen stock certificate for Common Stock (incorporated by reference to the Transition Report).
4.2 Certificate of Appointment of American Stock Transfer & Trust Company as Transfer Agent and Registrar
(incorporated by reference to Pre-Effective Amendment No. 4 to the Registration Statement on Form
S-1 (Reg. No. 33-48302), filed with the Commission on October 9, 1993 ("Pre-Effective Amendment No.
4 to Form S-1")).
5.1 Opinion of Graham & James LLP, counsel to the Registrant, regarding the legality of the securities
offered hereby.
10.1 Agreement and Plan of Reorganization dated as of April 21, 1995 between the Registrant and AccuMed,
Inc., as amended by Amendment No. 1 dated as of August 1, 1995 and Amendment No. 2 dated as of
October 6, 1995 (incorporated by reference to the Registrant's Registration Statement on Form S-4
(File No. 33-99680), filed with the Commission on November 22, 1995 (the "Form S-4")).
10.2 The Registrant's Board of Directors Compensation Plan (the "Plan") (incorporated by reference to
Exhibit 10.11 to Form S-1) with Minutes of Board of Directors meeting dated January 18, 1996
amending the Plan by authorizing grants of stock options to non-employee directors (incorporated by
reference to the Transition Report).(2)
10.3 Sale and Leaseback Agreement between the Registrant and Leasetec, Inc. (incorporated by reference to
the Registration Statement on Form S-1 (Reg. No. 33-48302), filed with the Commission on June 3,
1992 ("Form S-1")).
10.4 Employment Agreement between the Registrant and Peter P. Gombrich dated August 1, 1994 (incorporated
by reference to the Transition Report).(2)
10.5 Employment Letter between the Registrant and Kenneth Miller dated March 2, 1995 (incorporated by
reference to the Transition Report).(2)
10.6 Employment Letter between the Registrant and Mark L. Santor dated February 28, 1995 (incorporated by
reference to the Transition Report).(2)
10.7 Employment Letter between the Registrant and Michael Burke dated April 21, 1995 (incorporated by
reference to the Transition Report).(2)
10.8 Employment Agreement between the Registrant and Norman J. Pressman dated June 13, 1996 and Addendum
to Employment Agreement between the Registrant and Norman J. Pressman dated July 16, 1996. (2)(3)
10.9 European Distributor Agreement, dated November 22, 1993, by and between the Registrant and Sclavo
(incorporated by reference to Exhibit 10.22 to the Registrant's Annual Report on Form 10-KSB for the
year ended September 30, 1994 (the "1994 10-K")).
10.10 United States Distributor Agreement, dated November 22, 1993, by and between the Registrant and
Sclavo (incorporated by reference to the 1994 10-K).
10.11 Joint Research and Development Agreement, dated November 22, 1993, by and between the Registrant and
Sclavo (incorporated by reference to Exhibit 10.24 to the 1994 10-K).
10.12 Securities Purchase Agreement, dated November 22, 1993, by and between the Registrant and Sclavo
(incorporated by reference to Exhibit 10.25 to the 1994 10-K).
10.13 Escrow Agreement dated as of March 22, 1994, between the Registrant and G&G Dispensing, Inc.
(incorporated by reference to Exhibit 10.13 to the Form S-4).
</TABLE>
<PAGE>
<TABLE>
<CAPTION>
EXHIBIT
NUMBER DESCRIPTION
- ---------- -----------------------------------------------------------------------------------------------------
<C> <S>
10.14 License Agreement between the Registrant and Becton, Dickinson and Company effective as of October
11, 1995 (incorporated by reference to Exhibit 10.17 to the Form S-4).
10.15 Research and Development Service Agreement between the Registrant and RADCO Ventures, Inc. dated
March 15, 1996.(3)+
10.16 License and Distribution Agreement dated February 20, 1996 between the Registrant and BioKit, S.A.
(incorporated by reference to the Transition Report).
10.17 1995 Stock Option Plan (incorporated by reference to the Transition Report). (2)
10.18 Amendment No. 1 to the Registrant's 1995 Stock Option Plan. (2)(4)
10.19 Form of Non-Qualified Stock Option Agreement governing options granted to former employees of
AccuMed, Inc. pursuant to the Agreement and Plan of Reorganization dated as of April 21, 1995, as
amended (incorporated by reference to the Transition Report). (2)
10.20 Form of Non-Qualified Stock Option Agreement governing options granted to employees and consultants
under the 1995 Stock Option Plan (incorporated by reference to the Transition Report). (2)
10.21 Form of Incentive Stock Option Agreement Governing options granted to employees under the 1995 Stock
Option Plan (incorporated by reference to the Transition
Report). (2)
10.22 Amended and Restated 1990 Stock Option Plan (incorporated by reference to the Form S-1). (2)
10.23 The Registrant's Amended and Restated 1992 Stock Option Plan (incorporated by reference to
Pre-Effective Amendment No. 1 to Form SB-2, filed with the Commission on November 8, 1993). (2)
10.24 Lease between the Registrant and NCP, LTD dated February 20, 1995 pertaining to the offices located
at 29299 Clemens, Suite I-K, Westlake, Ohio 44145 (incorporated by reference to the Transition
Report).
10.25 Franklin Square Commercial Lease dated July 13, 1994 between the Registrant and the Lumber Company as
Agent for the Beneficiary of LaSalle National Trust, N.A. pertaining to the premises located at
Suite 401, 4th Floor North, 900 North Franklin Street, Chicago, Illinois (incorporated by reference
to the Transition Report).
10.26 Rider 1 to Franklin Square Commercial Lease between the Registrant and the Lumber Company dated May
30, 1996.(3)
10.27 License Agreement dated July 6, 1994, between the Registrant, Vanellus AB, and Uppsala
Bildbehandlings AB (incorporated by reference to the Transition Report).
10.28 Collaboration Agreement and Worldwide Exclusive License between the Registrant and G&G Dispensing,
Inc. dated March 22, 1994.(3)
10.29 O.E.M. Supply Agreement between Olympus America, Inc., Precision Instrument division and the
Registrant dated May 31, 1996.(1)+
10.30 Securities Purchase Agreement dated May 31, 1996 among the Registrant, Kingdon Associates, L.P.,
Kingdon Partners, L.P., and Kingdon Offshore N.V. (incorporated by reference to the Registrant's
Registration Statement on Form S-3 (Reg. No. 333-07681), filed with the Commission on July 3, 1996).
10.31 Promissory Note in the original principal amount of $61,000 made May 22, 1996 by Peter P. Gombrich in
favor of the Registrant.(3)
10.32 Non-negotiable Promissory Note in the original principal amount of $775,000 made July 22, 1996 by the
Registrant in favor of RADCO Ventures, Inc.(3)
10.33 Employment Separation Agreement and Release between the Registrant and Kenneth D. Miller dated June
27, 1996.(2)(3)
</TABLE>
<PAGE>
<TABLE>
<CAPTION>
EXHIBIT
NUMBER DESCRIPTION
- ---------- -----------------------------------------------------------------------------------------------------
<C> <S>
10.34 Employment Separation Agreement and Release between the Registrant and Mark L. Santor dated June 10,
1996.(2)(3)
10.35 Amended and Restated Employment Separation Agreement and Release between the Registrant, Kenneth D.
Miller and RADCO Ventures, Inc., dated August 8, 1996.(2)(4)
10.36 Share Purchase Agreement between the Registrant and Xillix Technologies Corp. dated as of August 16,
1996.(4)
10.37 Subscription Agreement between the Registrant and Oncometrics Imaging Corp. dated as of August 16,
1996.(4)
10.38 Stock Purchase Agreement by and among the Registrant, RADCO Ventures, Inc. and the Selling
Stockholders named therein dated as of August 15, 1996.(4)
10.39 Distribution Agreement by and between the Registrant and Fisher Scientific Company, dated September
10, 1996.(1)+
10.40 Employment Agreement between the Registrant and Leonard Prange dated September 9, 1996.(2)
10.41 Commercial Guaranty, Assignment of Deposit Account, Disbursement Request and Authorization and
Promissory Note between the Registrant and The Northern Trust Company dated July 22, 1996.
23.1 Consent of Graham & James, LLP (contained in Exhibit 5.1).
23.2 Consent of Coopers & Lybrand LLP.
23.3 Consent of Coopers & Lybrand (UK).
23.4 Consent of KPMG Peat Marwick LLP.
23.5 Consent of KPMG.
23.6 Consent of Banner & Witcoff, Ltd.
23.7 Consent of Townsend and Townsend and Crew.
24.1 Powers of Attorney included on signature page to the Pre-effective Amendment No. 1, with respect to
Mr. Lavallee, and the signature page of the Registration Statement previously filed with the
Commission, with respect to all other signatories.
</TABLE>
- ------------------------
(1) Previously filed with Pre-effective Amendment No. 2 to the Registration
Statement on September 23, 1996.
(2) Represents a management contract or compensatory plan or arrangement
required to be filed as an exhibit to this Registration Statement.
(3) Previously filed with the Registration Statement on July 26, 1996.
(4) Previously filed with Pre-effective Amendment No. 1 to the Registration
Statement on August 29, 1996.
+ Confidential treatment requested as to certain portions.
<PAGE>
[Letterhead]
October 3, 1996
AccuMed International, Inc.
900 N. Franklin Street, Suite 401
Chicago, Illinois 60610
Gentlemen:
You have requested our opinion as counsel for AccuMed International, Inc., a
Delaware corporation (the "Company"), in connection with the registration
under the Securities Act of 1933, as amended (the "Act"), and the Rules and
Regulations promulgated thereunder, and the public offering by the Company of
3,000,000 shares (the "Primary Shares") of the Common Stock, $0.01 par value
per share (the "Common Stock"), together with up to an additional 450,000
shares of the Common Stock to cover over-allotments, if any, (collectively,
the "Secondary Shares" and together with the Primary Shares, the "Shares"),
to Vector Securities International, Inc. and Tucker Anthony Incorporated, as
representatives of the underwriters.
This opinion is rendered pursuant to Item 601(b)(5)(i) of Regulation
S-B promulgated under the Act.
For purposes of this opinion, we have examined the Company's Registration
Statement on Form S-2 filed with the Securities and Exchange Commission (the
"Commission") on July 26, 1996 (the "Registration Statement"), as amended by
Pre-effective Amendment No.1 filed with the Commission on August 29, 1996,
Pre-effective Amendment No. 2 filed with the Commission on September 23, 1996
and Pre-effective Amendment No. 3 filed with the Commission on the date
hereof including the prospectus which is a part thereof (the "Prospectus"),
and the form of Underwriting Agreement between the Company and Vector
Securities International, Inc. and Tucker Anthony Incorporated, as
representatives of the underwriters (the "Underwriting Agreement"). We have
also been furnished with and have examined originals or copies, certified or
otherwise identified to our satisfaction, of all such records of the Company,
agreements and other instruments, certificates of officers and
representatives of the Company, certificates of public officials and other
documents as we have deemed it necessary to require as a basis for the
opinions hereafter expressed. As to questions of fact material to such
opinions, we have, where relevant facts were not independently established,
relied upon
<PAGE>
AccuMed International, Inc.
October 3, 1996
Page 2
certificates by principal officers of the Company. We have made such further
legal and factual examination and investigation as we deem necessary for
purposes of rendering the following opinions.
In our examination we have assumed the genuineness of all signatures, the legal
capacity of natural persons, the correctness of facts set forth in certificates,
the authenticity of all documents submitted to us as originals, the conformity
to original documents of all documents submitted to us as certificated or
photostatic copies, and the authenticity of the originals of such copies. We
have also assumed that such documents have each been duly authorized, properly
executed and delivered by each of the parties thereto other than the Company.
We are members of the bar of the State of California. Our opinions below are
limited to the laws of the State of California, the corporate laws of the State
of Delaware and the federal law of the United States.
Based on the foregoing, it is our opinion that all of the Shares, when sold,
issued and delivered in the manner described in the final Prospectus and in
accordance with the terms of the Underwriting Agreement, will be legally and
validly issued, fully paid nonassessable.
We consent to the filing of this opinion as an exhibit to the Registration
Statement and consent to the use of our name under the caption "Legal Matters"
in the Prospectus.
Very truly yours,
/s/ Graham & James LLP
- --------------------------
GRAHAM & JAMES LLP
<PAGE>
EXHIBIT 23.2
CONSENT OF INDEPENDENT ACCOUNTANTS
We consent to the inclusion or incorporation by reference in this
Pre-effective Amendment No. 3 to the Form S-2 (Regis. No. 333-09011) of our
report dated September 14, 1995, on our audit of the balance sheet of
Sensititre/Alamar, the Microbiology Division of AccuMed, Inc., as of December
31, 1994, and the net sales, cost of sales and selling expenses for the eight
months ended December 31, 1994, and the years ended April 30, 1994 and 1993; of
our report, which includes an explanatory paragraph related to substantial doubt
about the ability of AccuMed, Inc. to continue as a going concern, dated
September 29, 1995, on our audit of the balance sheet of AccuMed, Inc. as of
December 31, 1994, and for the period from February 7, 1994 (inception) through
December 31, 1994, both appearing in the registration statement on Form S-4 (SEC
File No. 33-99680) of Alamar Biosciences, Inc. filed with the Securities and
Exchange Commission pursuant to the Securities Act of 1933 as incorporated by
reference in the Current Report on Form 8-K dated December 29, 1995; and of our
report, which includes an explanatory paragraph related to substantial doubt
about the ability of Alamar Biosciences, Inc. to continue as a going concern,
dated November 19, 1995, on our audits of the financial statements of Alamar
Biosciences, Inc. as of September 30, 1995 and 1994, and for the years ended
September 30, 1995, 1994 and 1993, which report is included in the Annual Report
on Form 10-KSB for the year ended September 30, 1995. We also consent to the
reference to our firm under the caption "Experts."
/s/ COOPERS & LYBRAND L.L.P.
Sacramento, CA
September 30, 1996
<PAGE>
EXHIBIT 23.3
CONSENT OF INDEPENDENT ACCOUNTANTS
We consent to the incorporation by reference in this Pre-effective Amendment
No. 3 to the registration statement on Form S-2 (SEC File No. 333-09011) of our
report dated December 8, 1995, on our audit of the balance sheets of AccuMed
International Limited as of December 31, 1994, April 30, 1994 and 1993, and
related statements of operations and cashflows for the eight months ended
December 31, 1994, and the years ended April 30, 1994 and 1993, appearing in the
registration statement on Form S-4 (SEC File No. 33-99680) of Alamar
Biosciences, Inc. filed with the Securities and Exchange Commission pursuant to
the Securities Act of 1933 as incorporated by reference in the current Report on
Form 8-K dated December 29, 1995.
/s/ COOPERS & LYBRAND
Croydon
United Kingdom
September 30, 1996
<PAGE>
EXHIBIT 23.4
INDEPENDENT AUDITORS' CONSENT
The Board of Directors
AccuMed International, Inc.
We consent to the use of our report dated April 5, 1996 relating to the
consolidated balance sheet of AccuMed International, Inc. and subsidiary as of
December 31, 1995 and the related consolidated statements of operations,
stockholders' equity and cash flows for three months ended December 31, 1995,
included in this Prospectus and incorporated herein by reference from the
Company's transition report on Form 10-KSB for the three months ended December
31, 1995, and to the reference to our firm under the heading "Selected
Consolidated Financial Data" and "Experts" in the prospectus.
/s/ KPMG Peat Marwick LLP
Chicago, Illinois
September 30, 1996
<PAGE>
EXHIBIT 23.5
INDEPENDENT AUDITORS' CONSENT
The Board of Directors
Oncometrics Imaging Corp.
We consent to the use of our report included herein and to reference to our firm
under the heading "Experts" in the prospectus.
/s/ KPMG
Chartered Accountants
Vancouver, British Columbia
September 30, 1996
<PAGE>
CONSENT OF EXPERTS
We consent to the reference to our firm under the heading "Experts" in the
Prospectus constituting part of the Pre-Effective Amendment No. 3 to the
Registration Statement on Form S-2 (Regis. No. 333-09011) and amendments
thereto.
We further consent to the incorporation by reference of this consent
pursuant to Rule 439(b) under the Securities Act of 1933, as amended (the
"Securities Act"), pursuant to any subsequent registration statement for the
same offering that may be filed pursuant to Rule 462(b) under the Securities
Act.
/s/ Bradley J. Hulbert
---------------------------------
By: Bradley J. Hulbert
10 S. Wacker Drive
Chicago, Illinois 60606
September 30, 1996
<PAGE>
CONSENT OF EXPERTS
We consent to the reference to our firm under the heading "Experts" in the
Prospectus constituting part of the Pre-Effective Amendment No. 3 to the
Registration Statement on Form S-2 (Regis. No. 333-09011) and amendments
thereto.
We further consent to the incorporation by reference of this consent
pursuant to Rule 439(b) under the Securities Act of 1933, as amended (the
"Securities Act"), pursuant to any subsequent registration statement for the
same offering that may be filed pursuant to Rule 462(b) under the Securities
Act.
/s/ James Heslin
----------------------------------
Townsend and Townsend and Crew LLP
379 Lytton Avenue
Palo Alto, California 94301
September 30, 1996