<PAGE>
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q/A-1
X QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
----- EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED MARCH 31, 1997 OR
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
----- EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD
FROM __________________ TO _____________________.
COMMISSION FILE NUMBER 0-19975
BIOCIRCUITS CORPORATION
(Exact name of registrant as specified in its charter)
DELAWARE 94-3088884
(State or other jurisdiction of (I.R.S. Employer
incorporation or organization) Identification No.)
1324 CHESAPEAKE TERRACE
SUNNYVALE, CALIFORNIA 94089
(Address of principal executive offices) (Zip Code)
(408) 745-1961
(Registrant's telephone number, including area code)
Indicate by check mark whether the registrant (1) has filed all reports required
to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during
the preceding 12 months (or for such shorter period that the Registrant was
required to file such reports), and (2) has been subject to such filing
requirements for the past 90 days.
Yes X No
----- ------
At July 16, 1997, Registrant had 17,335,605 shares of Common Stock issued
and outstanding.
<PAGE>
BIOCIRCUITS CORPORATION
INDEX
PART I: FINANCIAL INFORMATION
ITEM 1. Financial Statements and Notes
Condensed balance sheets (unaudited) - March 31, 1997 and
December 31, 1996.............................................. 3
Condensed statements of operations (unaudited) - three months
ended March 31, 1997 and 1996 and the period from
March 7, 1989 (inception) through March 31, 1997 ........ 4
Condensed statements of cash flows (unaudited) - three months
ended March 31, 1997 and 1996 and the period from
March 7, 1989 (inception) through March 31, 1997 ......... 5
Notes to Condensed Financial Statements (unaudited)............ 6
ITEM 2. Management's Discussion and Analysis of
Financial Condition and Results of Operations............. 8
PART II: OTHER INFORMATION
ITEM 5. Other Information.............................................. 13
ITEM 6. Exhibits and Reports on Form 8-K............................... 13
Signatures .............................................................. 14
2
<PAGE>
PART I: FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
BIOCIRCUITS CORPORATION
(A DEVELOPMENT STAGE COMPANY)
CONDENSED BALANCE SHEETS
(IN THOUSANDS, EXCEPT FOR SHARE AND PER SHARE DATA)
(UNAUDITED)
<TABLE>
<CAPTION>
MARCH 31, 1997 DECEMBER 31, 1996
-------------- -----------------
(NOTE)
<S> <C> <C>
ASSETS
Current assets:
Cash and cash equivalents. . . . . . . . . . . . . . . . . . . . . . . . . . . $ 593 $ 4,944
Accounts receivable, net of allowance for doubtful accounts of $54, ($43
on December 31, 1996). . . . . . . . . . . . . . . . . . . . . . . . . . . . 281 201
Inventory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1,225 928
Prepaid inventory. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 263 375
Prepaid expenses and other current assets. . . . . . . . . . . . . . . . . . . 199 381
Restricted cash. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 813 102
--------- ---------
Total current assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3,374 6,931
Property and equipment, net of accumulated depreciation and
amortization of $1,763 ($1,671 in 1996). . . . . . . . . . . . . . . . . . . . 1,441 1,375
Restricted cash. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 263 376
Other assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44 44
--------- ---------
$ 5,122 $ 8,726
--------- ---------
--------- ---------
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 957 $ 1,108
Accrued liabilities. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 220 208
Accrued compensation and related expenses. . . . . . . . . . . . . . . . . . . 155 142
Current portion of capital lease obligations . . . . . . . . . . . . . . . . . 121 118
--------- ---------
Total current liabilities. . . . . . . . . . . . . . . . . . . . . . . . . . . . 1,453 1,576
Long-term portion of capital lease obligations . . . . . . . . . . . . . . . . . 13 72
Stockholders' equity:
Preferred stock, $0.001 par value, 40,000,000 shares authorized, issuable
in series: Series A convertible, 30,000,000 shares designated,
12,446,103 shares issued and outstanding (12,455,137 shares
outstanding at December 31, 1996), aggregate liquidation preference
of $.55 per share . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9,903 9,903
Common stock, $0001 par value, 70,000,000 shares authorized,
8,592,584 shares issued and outstanding (8,589,930 shares issued
and outstanding at December 31, 1996). . . . . . . . . . . . . . . . . . . . 48,905 48,784
Deficit accumulated during the development stage . . . . . . . . . . . . . . . (55,096) (51,548)
Notes receivable secured by common stock . . . . . . . . . . . . . . . . . . . (15) (15)
Deferred compensation and other. . . . . . . . . . . . . . . . . . . . . . . . (41) (46)
--------- ---------
Total stockholders' equity . . . . . . . . . . . . . . . . . . . . . . . . . . . 3,656 7,078
--------- ---------
$ 5,122 $ 8,726
--------- ---------
--------- ---------
</TABLE>
Note: Derived from the audited balance sheet at December 31, 1996
See accompanying notes
3
<PAGE>
BIOCIRCUITS CORPORATION
(A DEVELOPMENT STAGE COMPANY)
CONDENSED STATEMENTS OF OPERATIONS
(IN THOUSANDS EXCEPT PER SHARE DATA)
(UNAUDITED)
<TABLE>
<CAPTION>
THREE MONTHS ENDED PERIOD FROM
MARCH 31, MARCH 7, 1989
------------------------- (INCEPTION) THROUGH
1997 1996 MARCH 31, 1997
------------ ---------- ------------------
<S> <C> <C> <C>
REVENUES:
Product Sales. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 234 $ 45 $ 655
OPERATING COSTS AND EXPENSES:
Cost of sales. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1,034 307 3,344
Research and development . . . . . . . . . . . . . . . . . . . . . . . . . . . 1,480 2,353 35,837
Sales, general and administrative. . . . . . . . . . . . . . . . . . . . . . . 1,316 1,250 17,594
--------- --------- --------
3,830 3,910 56,775
Loss from operations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (3,596) (3,865) (56,120)
Interest income. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64 92 2,412
Interest and other expense . . . . . . . . . . . . . . . . . . . . . . . . . . . (16) (89) (1,388)
--------- --------- --------
Net loss . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ (3,548) $ (3,862) $(55,096)
--------- --------- --------
--------- --------- --------
Net loss per share . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ (0.41) $ (0.99)
--------- ---------
--------- ---------
Shares used in computing net loss per share. . . . . . . . . . . . . . . . . . . 8,592 3,902
--------- ---------
--------- ---------
</TABLE>
See accompanying notes
4
<PAGE>
BIOCIRCUITS CORPORATION
(A DEVELOPMENT STAGE COMPANY)
CONDENSED STATEMENTS OF CASH FLOWS
(IN THOUSANDS)
(UNAUDITED)
<TABLE>
<CAPTION>
THREE MONTHS ENDED PERIOD FROM
MARCH 31, MARCH 7, 1989
------------------------- (INCEPTION) THROUGH
1997 1996 MARCH 31, 1997
------------ ---------- ------------------
<S> <C> <C> <C>
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ (3,548) $ (3,862) $ (55,096)
Adjustments to reconcile net loss to net cash
used in operating activities:
Depreciation and amortization. . . . . . . . . . . . . . . . . . . . . . . . 95 114 3,626
Other. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122 --- 488
Changes in:
Accounts receivable. . . . . . . . . . . . . . . . . . . . . . . . . . . . (56) (45) (257)
Prepaid Inventory. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112 (179) (263)
Inventory. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (297) (69) (1,225)
Other current assets . . . . . . . . . . . . . . . . . . . . . . . . . . . 158 178 (293)
Other assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . --- -- 12
Other current liabilities. . . . . . . . . . . . . . . . . . . . . . . . . (150) 544 1,306
--------- --------- ----------
Net cash used in operating activities . . . . . . . . . . . . . . . . (3,564) (3,319) (51,702)
--------- --------- ----------
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchase of property and equipment . . . . . . . . . . . . . . . . . . . . . . (133) (92) (2,061)
Short-term investments purchased . . . . . . . . . . . . . . . . . . . . . . . --- --- (30,337)
Short-term investments sold/redeemed . . . . . . . . . . . . . . . . . . . . . --- 602 30,337
Restricted cash. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (598) 93 (1,109)
--------- --------- ----------
Net cash provided by (used in) investing activities. . . . . . . . . . . . . (731) 603 (3,170)
--------- --------- ----------
CASH FLOWS FROM FINANCING ACTIVITIES:
Issuance of preferred stock, net of issuance costs . . . . . . . . . . . . . . --- 5,938 26,933
Issuance of common stock, net of issuance costs. . . . . . . . . . . . . . . . --- 4 27,301
Issuance of long-term debt . . . . . . . . . . . . . . . . . . . . . . . . . . --- 6 4,949
Payments on long-term obligations. . . . . . . . . . . . . . . . . . . . . . . (56) (164) (3,718)
--------- --------- ----------
Net cash provided by (used in) financing activities. . . . . . . . . . . . . (56) 5,840 55,465
--------- --------- ----------
Net increase (decrease) in cash and cash equivalents . . . . . . . . . . . . . . (4,351) 3,124 593
Cash and cash equivalents, beginning of period . . . . . . . . . . . . . . . . . 4,944 6,028 ---
--------- --------- ----------
Cash and cash equivalents, end of period . . . . . . . . . . . . . . . . . . . . $ 593 $ 9,152 $ 593
--------- --------- ----------
--------- --------- ----------
</TABLE>
See accompanying notes
5
<PAGE>
BIOCIRCUITS CORPORATION
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONDENSED FINANCIAL STATEMENTS
MARCH 31, 1997
(UNAUDITED)
1. NATURE OF BUSINESS AND FINANCING
Biocircuits Corporation (a development stage company) (the "Company")
was incorporated in Delaware on March 7, 1989. The Company is engaged
in developing and commercializing new immunodiagnostic testing systems.
The accompanying financial statements have been prepared assuming that
the Company will continue as a going concern. The Company's first sale
and shipment of its IOS system occurred in March 1996. The Company
has incurred a loss in each period since its inception. At March 31,
1997, the Company's accumulated deficit was $55.1 million.
Biocircuits expects to incur additional losses over the next several
years.
The Company's bank informed it in late March 1997 that the Company
was no longer in compliance with the bank's terms for the Kollsman
standby letter of credit. As a result, the bank collateralized the
full amount of the standby letter of credit, resulting in a
$949,000 reduction in available cash to the Company. Subsequently,
also in late March 1997, the Company and Kollsman reached an
agreement to reduce the current amount of the standby letter of
credit to $700,000, resulting in an increase of available cash of
$249,000. The collateralization of the standby letter of credit
meant that the Company's remaining available cash would satisfy its
requirements until only mid-April 1997. In early May 1997, the
Company subsequently agreed with Kollsman to extend the instrument
production line shutdown until August 1997. The Company has further
agreed to and has paid Kollsman $436,000 to cover the cost of raw
material and work in process currently at, or to be delivered to
Kollsman. Such prepaid inventory funds will be credited back
against future deliveries of IOS instruments to Biocircuits. In
return, Kollsman has canceled the $700,000 standby letter of credit
and the associated funds collateralized by the Company's bank have
been released back to the Company, resulting in an additional
increase of available cash of $264,000.
On April 15, 1997, the Company closed the first tranches in two
private placements in which the Company sold its common stock and
issued warrants to purchase common stock (defined hereinafter as the
"April 1997 Financings"). The first private placement, the April
Common Stock Financing, was to consist of the sale of 2,500,000 shares
of common stock at $1.00 per share to be issued in three tranches. The
second private placement, the April Warrant Financing, was to consist
of the sale of 5,447,000 units at $1.00 per unit, each unit consisting
of one share of common stock and one warrant to purchase one share of
common stock at $0.75 per share, to be issued in two tranches.
The closing of the second tranches of the April 1997 Financings were
conditional upon the Company installing a minimum of eighty-eight (88)
Good Manufacturing Practices ("GMP") units of the IOS system during
the three month period ended June 30, 1997 that were sold directly or
indirectly by the Company. Although the Company implemented various
sales and marketing programs, including evaluation programs targeted
to physicians and incentive programs for its sales representatives and
distributor sales representatives in order to reach this milestone,
the milestone was not met by the Company and the second tranches of
the April 1997 Financings did not close. The closing of the third
tranche of the April Common Stock Financing was conditional upon the
Company installing a minimum of two hundred thirty-five (235) GMP
units of the IOS system that are sold directly or indirectly by the
Company. Investors in the April Common Stock Financing have elected
not to fund the Company in the third tranche.
The Company issued 531,250 shares of its common stock in the first
tranche of the April Common Stock Financing and 1,157,488 units in the
first tranche of the April Units Financing. The April Financing
Warrants expire eighteen months after April 15, 1997, subject to certain
adjustments. At the Company's option, the Company may shorten the
exercise period of the April Financing Warrants in which case they may
become redeemable by the Company at $0.01 per share if the closing
price for the Company's common stock is greater than or equal to $2.00
per share for ten days. The first tranches of the April 1997
Financings resulted in gross proceeds to the Company of approximately
$1.7 million. With these funds, the Company believes its cash
resources will be adequate to satisfy its requirements until the end
of the second quarter of 1997.
On July 3, 1997, the Company closed the July Financing in which the
Company sold 6,853,567 units at $0.75 per unit, each unit consisting
of one share of common stock and one warrant to purchase one share of
common stock at $0.75 per share. The warrants issued in the July
Financing expire eighteen months after July 3, 1997, subject to
certain adjustments. The July Financing resulted in gross proceeds to
the Company of approximately $5.1 million. With these funds, the
Company believes its cash resources will be adequate to satisfy its
requirements until the end of the second quarter of 1998.
Obtaining additional funds will be critical to the Company's ability
to maintain operations during 1997. The Company will therefore
continue to seek funding from various equity financing sources.
Raising additional funds from public or private sources will result in
significant dilution to then existing shareholders. If adequate
funding is not available on a timely basis, the Company will be
required to curtail its operations significantly or to cease
operations. There can be no assurance that the Company will be
successful in obtaining additional financing during 1997.
6
<PAGE>
2. BASIS OF PRESENTATION
The accompanying unaudited condensed financial statements have been
prepared in accordance with generally accepted accounting principles
for interim financial information and with the instructions to Form
10-Q and Article 10 of Regulation S-X. Accordingly, they do not
include all of the information and footnotes required by generally
accepted accounting principles for complete financial statements. In
the opinion of management, all adjustments (consisting of normal
recurring accruals) considered necessary for a fair presentation have
been included. Operating results for the three month period ended
March 31, 1997 are not necessarily indicative of the results that may
be expected for the year ended December 31, 1997. For further
information, refer to the consolidated financial statements and
footnotes thereto included in the Company's annual report on Form
10-K/A-2 for the year ended December 31, 1996.
Net loss per share is computed on the basis of the weighted average
number of common shares outstanding. Common equivalent shares are
excluded from the computation as their effect is anti-dilutive.
Following is supplemental proforma earnings per share, calculated
giving effect to the conversion of the outstanding convertible
preferred stock on an if converted basis (in thousands, except per
share data):
THREE MONTHS ENDED
MARCH 31,
--------------------
1997 1996
--------- ---------
Net loss as reported............................ $ (3,548) $ (3,862)
--------- ---------
--------- ---------
Shares used in computing net
loss per share as reported................. 8,592 3,902
Adjustment to include outstanding convertible
preferred stock previously excluded
as it is anti-dilutive..................... 3,113 3,366
--------- ---------
Shares used in computing proforma net
loss per share............................. 11,705 7,268
--------- ---------
--------- ---------
Proforma net loss per share..................... $ (0.30) $ (0.53)
--------- ---------
--------- ---------
3. EARNINGS PER SHARE
In February 1997, the Financial Accounting Standards Board issued
Statement No. 128, Earnings Per Share, which is required to be adopted
on December 31, 1997. At that time, the Company will be required to
change the method currently used to compute earnings per share and to
restate all prior periods. Under the new requirements for calculating
primary earnings per share, the dilutive effect of stock options will
be excluded. The Company expects no impact from the implementation of
FASB 128 as common equivalent shares are excluded from the computation
as their effect is anti-dilutive.
7
<PAGE>
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS
IN ADDITION TO THE HISTORICAL INFORMATION CONTAINED HEREIN, THE
FOLLOWING DISCUSSION CONTAINS FORWARD-LOOKING STATEMENTS THAT INVOLVE RISKS
AND UNCERTAINTIES. THE COMPANY'S ACTUAL RESULTS MAY DIFFER MATERIALLY FROM
THOSE DISCUSSED HEREIN. FACTORS THAT COULD CAUSE OR CONTRIBUTE TO SUCH
DIFFERENCES INCLUDE, BUT ARE NOT LIMITED TO, THOSE DISCUSSED IN THIS SECTION,
IN THE COMPANY'S ANNUAL REPORT ON FORM 10-K/A FOR THE YEAR ENDED DECEMBER 31,
1996.
THE COMPANY HAS RECENTLY ENTERED INTO A LETTER OF INTENT (THE "LETTER OF
INTENT") WITH THE BECTON-DICKINSON MICROBIOLOGY SYSTEMS DIVISION OF BECTON,
DICKINSON AND COMPANY ("BECTON") TO ENTER INTO AN AGREEMENT (THE "AGREEMENT")
THAT WOULD GIVE BECTON EXCLUSIVE WORLDWIDE MARKETING RIGHTS TO THE IOS SYSTEM
AND ALL CARTRIDGES CURRENTLY AVAILABLE AS WELL AS THOSE THAT WILL BE
DEVELOPED IN THE FUTURE. IT IS ALSO POSSIBLE THAT BECTON WILL ASSUME
RESPONSIBILITY FOR MANUFACTURING THE IOS INSTRUMENT IN 1998. THE COMPANY
CURRENTLY PLANS TO CONTINUE TO MANUFACTURE CARTRIDGES FOR TRANSFER TO BECTON
AS WELL AS TO DEVELOP NEW TEST CARTRIDGES. THE LETTER OF INTENT IS NOT
LEGALLY BINDING AND THE AGREEMENT, WHICH IS CURRENTLY BEING NEGOTIATED BY THE
PARTIES, MAY NEVER BE FINALIZED AND EXECUTED. IF THE AGREEMENT IS EXECUTED,
THE COMPANY'S OPERATIONS WILL BE MATERIALLY AFFECTED AND THE COMPANY'S
RESULTS COULD DIFFER MATERIALLY FROM THOSE ANTICIPATED IN THESE
FORWARD-LOOKING STATEMENTS.
RESULTS OF OPERATIONS
Since its inception in 1989, the Company has been engaged in
research and development and marketing of medical diagnostic applications of
its technologies.
The Company has incurred a loss in each period since its inception.
At March 31, 1997, the Company's accumulated deficit was $55.1 million.
Biocircuits expects to incur additional losses over the next several years.
The Company expects that currently available funds will be used primarily for
sales and marketing programs for its IOS point-of-care system and development
of additional assays for the IOS point-of-care system. The losses may vary
from period to period, including from quarter to quarter, and may increase,
due to the uncertainty of whether the sales and marketing programs of the
Company will achieve the desired results. Accordingly, the Company believes
that quarter-to-quarter results are not a useful indicator of the Company's
performance.
The Company's first sale and shipment of its IOS system occurred in
March 1996, with cartridges capable of performing the T4 and T Uptake tests.
The selling process typically requires the Company's sales force to work
closely with distributors, generate qualified physician leads and perform
demonstrations of the IOS system in physicians' offices. The selling process
can be time-consuming. To date, the number of instrument sales to
distributors and placements in physicians' offices have been, and continues
to be, significantly less than the Company's expectations. As a result, the
Company has incurred significant losses. There can be no assurance that the
Company will be successful in marketing the IOS system, that the rate of
sales growth will ever meet expectations or that the marketing programs of
the Company will achieve the desired results.
Certain design changes to the IOS instrument were required since
the first sale and shipment of the IOS system. In April 1996, problems in
some of the IOS instrument's circuitry and software, which caused the
instrument to cease operating, required certain parts and software
modifications. Futher product shipments were suspended at that time while the
problems were diagnosed and corrected. In order to correct the problems, the
Company changed some electrical components within the instrument, revised an
electronic circuit board, revised the embedded software which operates the
instrument, and upgraded all systems, including instruments in inventory at
the Company's instrument supplier. All changes were validated and documented
and shipments to distributors were resumed in the middle of June. In
addition, all instruments previously shipped to customers were retrofitted.
The requirements to make the design changes to the instrument and the
suspension of product shipments had an adverse impact on 1996 revenue and
overall financial performance. There can be no assurance that additional
design changes may not be required in the future or that the system
performance will be reliable over time.
On April 3, 1997, in order to reduce its losses and conserve
approximately $250,000 per month, the Company reduced its work force from 92
employees to 54 employees. The Company is highly dependent upon the
principal members of its management and scientific staff and key individuals
in all areas of the Company. Although the Company believes it has retained
sufficient employees to achieve its near-term business objectives after its
reduction in force on April 3, 1997, there can be no assurance that the loss
of services of such employees might not impede the achievement of the
Company's business objectives. Furthermore, there can be no assurance that
the reduction in force will not adversely affect the Company's ability to
retain its remaining employees, however, the Company has implemented certain
programs which it believes may help in retaining the key employees. The
Company faces competition for qualified individuals from numerous
manufacturers of medical products and other high technology products, as well
as universities and academic institutions. There can be no assurance that the
Company will be able to attract qualified new personnel on acceptable terms.
In order for the Company to have success in penetrating the
point-of-care immunodiagnostic market and to achieve significant sales of IOS
systems and test cartridges, the Company believes it will need to continue to
expand its menu of tests. In September 1996, the Company received FDA
clearance to market a qualitative serum
8
<PAGE>
pregnancy assay. The Company also received clearances from the FDA for a TSH
assay in November 1996 and a quantitative hCG assay in December 1996. During
1996, the Company developed an improved second generation cartridge for its
new assays as well as existing assays. Development of the second generation
cartridge and optimization of the assays in the new cartridge took several
months longer than anticipated due to design iterations. Product optimization
followed cartridge design completion. Optimization is also an iterative
process of developing the specific chemistries and system fluidies to ensure
each assay performs at its claimed specifications. As a result, launch of the
new assays (TSH, Quantitative hCG and Serum hCG) have experienced delays. In
December 1996, the Company launched its TSH assay on the second generation
cartridge and in March 1997, the Company began shipping the T4 and T Uptake
tests on the second generation cartridge. The second generation cartridge
will be utilized for the market launch of all new assays, including the FDA
cleared assays as well as those in development. Biocircuits is currently
developing three additional assays: a PSA test for management of prostate
cancer patients, a Digoxin test for monitoring the therapeutic usage of this
drug in the treatment of heart disease and a Free T4 test for diagnosing true
clinical thyroid status. In the past, the Company has experienced delays in
completing the development of new tests. Furthermore, the April 1997
reduction in force reduced the number of product development employees, and
there can be no assurance that the reduction will not result in further
delays in completing the development of these new tests or that any expansion
of the test menu will not be delayed.
Biocircuits has developed its initial proprietary manufacturing
process for producing the test cartridges for its IOS point-of-care system.
Various plastic components and other materials for the cartridges are and
will be obtained from contract manufacturers. The Company has experienced
cartridge backlogs at various times since the March 1996 launch of the IOS
point-of-care system and there can be no assurance that the Company will be
able to meet customer demand for cartridges in the future, or that any order
backlog will not materially adversely affect the Company's sales and
marketing efforts. The Company's cartridge manufacturing milestones include
improving manufacturing efficiencies, expanding mold and cartridge
manufacturing capacity as both the test menu and test manufacturing volume
expand, initiating manufacturing automation efforts and manufacturing the
cartridge at the Company's targeted cost. Following the introduction of the
second generation cartridge and several manufacturing process improvements,
yields have improved to the targeted level of 90% and the Company has not
experienced any backlogs. The Company plans further manufacturing
improvements including the use of a multiple cavity mold and a 30% increase
in capacity with no increase in direct labor. The cartridge manufacturing
scale-up process will require the Company to develop advanced manufacturing
techniques and rigorous process controls. The automation effort will be
critical to meeting the Company's longer-term cartridge manufacturing demands
and cost targets. There can be no assurance that the Company will be
successful in these efforts or that such efforts will result in the Company
meeting expected cartridge demand or achieving the Company's longer-term
cartridge manufacturing cost targets.
In August and December 1995, the Company entered into agreements
with Nunc to manufacture the plastic components of its disposable test
cartridges. Under the terms of the agreement, Nunc has the exclusive right to
supply the plastic components for the test cartridges for all sales in North
America. The Company will be entirely dependent on Nunc as the sole source
for the plastic components and treatment thereof. There can be no assurance
that Nunc will be able to deliver the required quantities of test cartridge
components on schedule or at costs acceptable to the Company.
In December 1992, the Company entered into an agreement with
Kollsman pursuant to which Kollsman was appointed the exclusive North
American supplier of the IOS instrument. The agreement with Kollsman
contained certain minimum purchase requirements and expired three years from
the date of first commercial production, subject to certain rights of earlier
termination. In April 1996, the Company and Kollsman executed a letter
agreement to amend the 1992 agreement (the "Letter Agreement"), pursuant to
which Kollsman will be the exclusive supplier of the IOS instrument through
1997, the minimum purchase requirements were eliminated and the Company and
Kollsman agreed to an acceptable fixed transfer price to be paid through
1997, the revised term of the agreement. Also pursuant to the Letter
Agreement, the Company agreed to issue Kollsman a warrant to purchase 250,000
shares of Common Stock at an exercise price of $7.00 per share, subject to an
increase of 50,000 shares under certain circumstances. The warrant expires
at year end 1997, subject to certain extension rights. In November 1996, the
Company and Kollsman amended the Letter Agreement to extend the expiration
date of the warrant to June 1998, subject to certain extension rights. In
order to secure an adequate supply of IOS instruments, the Company
established a standby letter of credit for the benefit of Kollsman. In late
March 1997, the Company and Kollsman agreed to reduce the amount of the
standby letter of credit by $249,000 in exchange for reducing the exercise
price of the warrant from $7.00 to $2.00 per share. Also in late March 1997,
the Company and Kollsman agreed to issue Kollsman a warrant to purchase
50,000 shares of Common Stock in exchange for a one month shutdown of
instrument production. In the quarter ended March 31, 1997, the Company
recorded a $124,000 expense as manufacturing overhead, $60,000 for the
warrant price reduction from $7.00 to $2.00 per share and $64,000 for the
issuance of the 50,000 warrant to purchase Common Stock. Such expense
determination was calculated according to Financial Accounting Standard Board
Statement No. 123. In early May 1997, the Company subsequently agreed with
Kollsman to extend the instrument production line shutdown until August 1997.
The Company further agreed to and has paid Kollsman $436,000 to cover the
cost of raw material and work in process currently at, or to be delivered to,
Kollsman. Such prepaid inventory will be credited back against future
deliveries of IOS instruments to Biocircuits. In return, Kollsman canceled
the $700,000 standby letter of credit and the associated funds collateralized
by the Company's bank have been released back to the Company. The Company is
entirely dependent on Kollsman as the sole source
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of production of its IOS instruments. Kollsman, in turn, relies upon
sole-source suppliers for certain components. Failure of Kollsman's suppliers
to deliver the required quantities on a timely basis and at commercially
reasonable prices, or Kollsman's failure to deliver the IOS instruments to
the Company on a timely basis or at commercially reasonable costs could
materially adversely affect the Company.
The Company's inventory, including prepaid inventory, has increased
to approximately $1,488,000 as of March 31, 1997. Of this amount, a major
portion is associated with the instrument, approximately $660,000 of IOS
instrument finished goods, $263,000 of prepaid instrument inventory and
$200,000 of instrument raw materials. The instrument production shutdown which
is expected to last through August 1997, is designed to reduce the inventory
of instrument finished goods and, with expected builds for the balance of
1997, the Company expects that the instrument prepaid inventory and raw
materials will be significantly reduced. Therefore, based on the Company's
build rates for the balance of the year, the Company does not expect to
encounter any major obsolete or excess inventory issues which may require
writedowns other than issues that would normally be expected in the course of
normal operations for which the Company has $90,000 of reserves recorded.
On October 21, 1996, the Company closed a private placement which
consisted of the sale of 965,231 units at $6.00 per unit. Proceeds to the
Company were approximately $5.2 million, net of issuance costs. A unit
consisted of two shares of Common Stock and a Financing Warrant expiring
October 20, 1997, to purchase one share of Common Stock at $3.43 per share.
The Financing Warrants contain an automatic exercise provision which occurs,
upon notice from the Company, at any time beginning six months prior to the
expiration date when the average market value for the Company's Common Stock
equals or exceeds $5.25 per share for 10 consecutive trading days. If the
Financing Warrants are exercised, the Company will receive gross proceeds of
up to an additional $3.3 million.
In August 1995, Biocircuits entered into an agreement with Beckman
and received $3,500,000 in the form of a Note in exchange for granting
Beckman options for licensing and marketing rights to certain testing
applications using the Company's lipid/polymer technology. Pursuant to the
terms of the agreement, Biocircuits completed a feasibility study in August
1996. Because Beckman subsequently elected not to exercise its development
license option, Biocircuits regained full rights to the lipid/polymer
technology in December 1996, including all improvements made during the
feasibility study. In connection with their decision, Beckman also elected
to convert the Note into the Company's Common Stock and a warrant to purchase
the Company's Common Stock.
On April 15, 1997, the Company closed the first tranches in two private
placements, the April 1997 Financings, in which the Company sold its common
stock and issued warrants to purchase common stock. The first private
placement, the April Common Stock Financing, was to consist of the sale of
2,500,000 shares of common stock at $1.00 per share to be issued in three
tranches. The second private placement, the April Warrant Financing, was to
consist of the sale of 5,447,000 units at $1.00 per unit, each unit
consisting of one share of common stock and one warrant to purchase one share
of common stock at $0.75 per share, to be issued in two tranches.
The closing of the second tranches of the April 1997 Financings were
conditional upon the Company installing a minimum of eighty-eight (88) Good
Manufacturing Practices ("GMP") units of the IOS system during the three
month period ended June 30, 1997 that were sold directly or indirectly by the
Company. Although the Company implemented various sales and marketing
programs, including evaluation programs targeted to physicians and incentive
programs for its sales representatives and distributor sales representatives
in order to reach this milestone, the milestone was not met by the Company
and the second tranches of the April 1997 Financings did not close. The
closing of the third tranche of the April Common Stock Financing was
conditional upon the Company installing a minimum of two hundred thirty-five
(235) GMP units of the IOS system that are sold directly or indirectly by the
Company. Investors in the April Common Stock Financing have elected not to
fund the Company in the third tranche.
The Company issued 531,250 shares of its common stock in the first
tranche of the April Common Stock Financing and 1,157,488 units in the first
tranche of the April Units Financing. The April Financing Warrants expire
eighteen months after June 5, 1997, subject to certain adjustments. At the
Company's option, the Company may shorten the exercise period of the April
Financing Warrants in which case they may become redeemable by the Company at
$0.01 per share if the closing price for the Company's common stock is
greater than or equal to $2.00 per share for ten days. The first tranches of
the April 1997 Financings resulted in gross proceeds to the Company of
approximately $1.7 million. With these funds, the Company
believes its cash resources will be adequate to satisfy its requirements
until the end of the second quarter of 1997.
On July 3, 1997, the Company closed the July Financing in which the
Company sold 6,853,567 units at $0.75 per unit, each unit consisting of one
share of common stock and one warrant to purchase one share of common stock
at $0.75 per share. The warrants issued in the July Financing expire eighteen
months after July 3, 1997, subject to certain adjustments. The July Financing
resulted in gross proceeds to the Company of approximately $5.1 million. With
these funds, the Company believes its cash resources will be adequate to
satisfy its requirements until the end of the second quarter of 1998.
FIRST QUARTER FY 1997 COMPARED TO FIRST QUARTER FY 1996
Revenue in the first quarter totaled $234,000, an increase of $189,000
or 420% from the $45,000 reported in the first quarter of 1996 when the
Company initially launched its IOS system.
Total operating costs and expenses decreased from $3,910,000 in the
first quarter of 1996 to $3,830,000 in the first quarter of 1997, a decrease
of $80,000 or 2%.
Cost of sales expenses increased from $307,000 in the first quarter of
1996 to $1,034,000 in the first quarter of 1997, an increase $727,000 or
236%. The increase in cost of sales results primarily from a full quarter of
production activity and expenses in 1997 compared to expenses incurred during
a partial period in first quarter 1996 as the Company launched its IOS system
in March 1996. These costs consist primarily of manufacturing overhead,
startup costs and material costs associated with the production of a
revenue-generating product.
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Research and development expenses decreased from $2,353,000 in the first
quarter of 1996 to $1,480,000 in the first quarter of 1997, a decrease of
$873,000 or 37%. This decrease was due primarily to a reduction in outside
services, primarily non-recurring engineering charges from Kollsman.
Sales, general and administrative expenses increased from $1,250,000 in
the first quarter of 1996 to $1,316,000 in the first quarter of 1997, an
increase of $66,000 or 5%. This increase was due primarily to the increased
sales and marketing expenses resulting from the preparation for and marketing
of the IOS point-of-care system.
Interest income decreased from $92,000 in the first quarter of 1996 to
$64,000 in the first quarter of 1997, a decrease of $28,000 or 30%. The
decrease was due to decreased cash balances from ongoing operating losses,
purchases of property and equipment and payments on long-term obligations.
Interest and other expense decreased from $89,000 in the first quarter of
1996 to $16,000 in the first quarter of 1997, a decrease of $73,000.
Interest expense results from the Company's long-term debt and capital leases
related to its property and equipment.
Net loss decreased from $3,862,000 or $0.99 per share in the first
quarter of 1996 to $3,548,000 or $0.41 per share in the first quarter of
1997, a decrease of $314,000 or 8%.
LIQUIDITY AND CAPITAL RESOURCES
The Company historically has financed its operations primarily
through sales of common and preferred stock, interest income on the cash
balances available after such financings, long term debt and capital asset
lease financings. Since its inception through March 31, 1997, the Company
raised a total of approximately $54.2 million in the sale of common and
preferred stock.
The Company's cash and cash equivalents and short-term investments
were $0.6 million as of March 31, 1997, compared to $4.9 million at the end
of 1996. The decrease was due primarily to operating losses in the first
quarter 1997.
The Company's bank informed it in late March 1997 that the Company
was no longer in compliance with the bank's terms for the Kollsman standby
letter of credit. As a result, the bank collateralized the full amount of the
standby letter of credit, resulting in a $949,000 reduction in available cash
to the Company. Subsequently, also in late March 1997, the Company and
Kollsman reached an agreement to reduce the current amount of the standby
letter of credit to $700,000, resulting in an increase of available cash of
$249,000. The collateralization of the standby letter of credit meant that
the Company's remaining available cash would satisfy its requirements until
only mid-April 1997. In early May 1997, the Company subsequently agreed with
Kollsman to extend the instrument production line shutdown until August 1997.
The Company further agreed to and has paid Kollsman $436,000 to cover the
cost of raw material and work in process currently at, or to be delivered to,
Kollsman. Such prepaid inventory funds will be credited back against future
deliveries of IOS instruments to Biocircuits. In return, Kollsman has
canceled the $700,000 standby letter of credit and the associated funds
collateralized by the Company's bank have been released back to the Company,
resulting in an additional increase of available cash of $264,000.
On April 15, 1997, the Company closed the April 1997 Financings
which consisted of the sale of common stock and warrants to purchase common
stock. With the receipt of funds from the April 1997 Financings, the Company
received adequate cash resources to satisfy its requirements through the end
of the second quarter of 1997. With the proceeds from the July Financing,
which closed on July 3, 1997, the Company believes its cash resources will be
adequate to satisfy its requirements through second quarter 1998.
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Obtaining additional funds will be critical to the Company's
ability to maintain operations during 1997. The Company will therefore
continue to seek funding from various equity financing sources. Raising
additional funds from public or private sources will result in significant
dilution to then existing shareholders. If adequate funding is not available
on a timely basis, the Company will be required to curtail its operations
significantly or to cease operations. There can be no assurance that the
Company will be successful in obtaining additional financing during 1997.
The Company believes that maintaining its listing on the Nasdaq
National Market System ("Nasdaq") is central to its ability to raise
additional funds as well as to provide liquidity to investors. The conversion
of the Beckman Note resulted in the Company meeting Nasdaq listing
requirements at year end 1996. The Company failed temporarily to meet the
Nasdaq net tangible assets listing requirement at the end of the first
quarter of 1997. However, the proceeds from the first tranche of the April
1997 Financings allowed the Company to meet the Nasdaq listing requirement,
on a proforma basis, for the first quarter of 1997. Proceeds from the July
Financing allowed the Company to meet the Nasdaq net tangible asset listing
requirement, on a proforma basis, for the second quarter of 1997. In
addition, the Company believes the proceeds from the July Financing will
result in it meeting Nasdaq listing requirements through third quarter 1997.
Thereafter, the Company may be required to generate sufficient revenue or
raise additional capital to maintain Nasdaq listing requirements through year
end 1997.
The Company believes its cash requirements may increase in future
periods due to higher expenses. The Company expects to incur substantial
additional costs, including costs related to ongoing research and development
activities, either alone or in collaboration with strategic partners,
clinical trials, expansion of manufacturing, research and development and
administrative facilities, development of manufacturing capabilities,
obtaining regulatory approvals and establishing sales, marketing and
distribution capabilities. The Company's long-term capital requirements will
depend on numerous factors, including the progress of the Company's research
and product development, the timing and cost of obtaining regulatory
approvals, the costs associated with patents and other intellectual property
rights, the levels of resources devoted to the development of manufacturing
and marketing capabilities and potential collaborative partnerships. The
Company intends to seek additional funding through collaborative
relationships and public or private financings. Other methods of financing
the acquisition of capital equipment, including lease financing, may be
utilized if available on attractive terms. Raising additional funds from
public or private financings may result in further dilution to then-existing
shareholders. The Company also may attempt to obtain funds through
arrangements with strategic partners or others that may require the Company
to relinquish rights to certain of its technologies, products or marketing
territories in exchange for funding. If adequate funds are not available
from these sources, the Company will be required to curtail its operations
significantly. No assurance can be given that any additional financing will
be available, or, if available, that it will be available on acceptable
terms.
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BIOCIRCUITS CORPORATION
PART II: OTHER INFORMATION
ITEM 5. Other Information
On April 16, 1997, the Company issued a press release announcing
that it had closed a private placement and had received net
proceeds of approximately $1.5 million in the first tranche of the
April 1997 Financings, which proceeds allowed the Company to meet
Nasdaq listing requirements for the first quarter of 1997 on a
proforma basis.
ITEM 6. Exhibits and Reports on Form 8-K.
a) Exhibits
27.1 Financial Data Schedule*
99.1 Press Release dated April 16, 1997*
99.2 Proforma March 31, 1997 Balance Sheets and
Statements of Operations assuming completion
of a private placement and receipt of net proceeds
of $1.5 million therefrom.*
b) Reports on Form 8-K
Form 8-K filed July 18, 1997.
* Incorporated by reference to exhibits filed with the
Registrant's Quarterly Report on Form 10-Q for the
fiscal period ended March 31, 1997, filed May 15, 1997.
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BIOCIRCUITS CORPORATION
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned thereunto duly authorized.
BIOCIRCUITS CORPORATION
Date: July 18, 1997
By: /s/ John Kaiser
------------------------------------
John Kaiser
Chairman of the Board, President and
Chief Executive Officer (Principal
Executive Officer)
By: /s/ James Welch
------------------------------------
James Welch
Secretary, Treasurer and Controller
(Principal Financial and Accounting
Officer)
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