As filed with the Securities and Exchange Commission on August 4, 1997.
Registration No. 333-30955
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
____________________________
AMENDMENT NO. 1 TO
FORM S-3
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
____________________________________
BIOJECT MEDICAL TECHNOLOGIES INC.
(Exact Name of Registrant as Specified in Its Charter)
7620 SW Bridgeport Road
Portland, Oregon 97224
(503) 639-7221
(Address, including zip code, and telephone number, including area code, of
registrant's principal executive offices)
Oregon 3845 93-1099680
(State of other jurisdiction (Primary Standard Industrial (I.R.S. Employer
incorporation or organization Classification Code Number) Identification
Number)
James C. O'Shea
Chief Executive Officer
Bioject Medical Technologies Inc.
7620 SW Bridgeport Road
Portland, Oregon 97224
(503) 639-7221
(Name, address, including zip code, and telephone number, including area code,
of agent for service)
____________________
Copies to:
Christopher J. Barry, Esq.
BOGLE & GATES P.L.L.C.
Two Union Square, 601 Union Street
Seattle, Washington 98101
206-682-5151
___________________
Approximate date of commencement of proposed sale to the public: At such time
or from time to time after the effective date of this Registration Statement as
the respective Selling Shareholders shall determine.
If the only securities being registered on this Form are being offered
pursuant to dividend or interest reinvestment plans, please check the
following box. [ ]
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, other than securities offered only in connection with dividend or
interest reinvestment plans, please check the following box. [X]
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 the delivery of the prospectus is expected to be made pursuant to Rule 434,
please check the following box. [ ] ______________________
CALCULATION OF REGISTRATION FEE
Title of Shares Amount to be Proposed Maximum Proposed Maximum Amount of
to be Registered Registered (1) Offering Aggregate Registration
Price Per Share Offering Fee (3)
(2) Price (2)
Common Stock 4,385,467 $0.7528 $3,301,510.40 $1000.46
<PAGE>
(1)Includes an indeterminate number of shares of Common Stock that may be
issued in connection with a stock split, stock dividend, recapitalization or
similar event.
(2)Estimated solely for purposes of calculating the registration fee pursuant
to Rule 457(c). The registrant initially filed this Registration Statement on
July 9, 1997, and at that time paid a fee in the amount of $612.30, reflecting
2,641,279 shares and a maximum aggregate price of $2,020,578.40, such fee
based on $0.76, the average of the bid and asked price of the Common Stock
of the Registrant reported on the NASDAQ National Market on July 1, 1997.
The current total of 4,385,467 shares includes an additional 1,744,188 shares
for registration. The proposed maximum aggregate offering price for the
additional shares to be registered is $1,280,932.00 based on $.7344, the
average of the bid and asked price of the Common Stock of the Registrant
reported on the NASDAQ National Market on July 29, 1997.
(3)Of the total registration fee of $1000.46, $612.30 was paid at the time of
the initial filing of the Registration Statement on July 9, 1997.
____________________
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 this Registration Statement
shall thereafter become effective in accordance with Section 8(a) of the
Securities Act of 1933, as amended, or until this Registration Statement shall
become effective on such date as the Commission, acting pursuant to said
Section 8(a), may determine.
______________________________________________________________________________
PROSPECTUS
4,385,467 SHARES
BIOJECT MEDICAL TECHNOLOGIES INC.
COMMON STOCK
_____________________
This Prospectus pertains to the offer and sale from time to time of up to
4,385,466 shares (the "Shares") of common stock, without par value
(the "Common Stock"), of Bioject Medical Technologies Inc. ("Bioject" or
the "Company") by or for the account of certain of the Company's shareholders
(collectively, the "Selling Shareholders"). See "Selling Shareholders."
The Shares offered hereby may be sold by the Selling Shareholders directly or
through agents, underwriters or dealers as designated from time to time or
through a combination of such methods. The Company will receive none of the
proceeds from any sale of Shares by or for the account of the Selling
Shareholders. The Selling Shareholders and any broker-dealers that participate
with one or more of the Selling Shareholders in the distribution of the Shares
may be deemed to be underwriters and any commissions received or profit
realized by them in connection with the resale of the Shares might be deemed
to be underwriting discounts and commissions under the Securities Act of
1933, as amended (the "Securities Act"). See "Selling Shareholders" and
"Plan of Distribution."
The Company has agreed to bear all expenses relating to this registration,
other than underwriting discounts and commissions. In addition, the Company
has agreed to indemnify the Selling Shareholders against certain liabilities,
including liabilities under the Securities Act. See "Selling Shareholders"
and "Plan of Distribution."
The Common Stock is quoted on the NASDAQ National Market under the symbol
"BJCT". On July 31, 1997, the closing bid price of the Common Stock as
reported by NASDAQ was $0.75.
_____________________
See "Risk Factors" beginning on page four of this Prospectus for a discussion
of certain factors that should be considered by prospective purchasers of
the Common Stock.
______________________________
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.
<PAGE> I-1
The Shares may be offered from time to time in negotiated transactions or
otherwise at market prices prevailing at the time of each sale, subject to the
right of the Selling Shareholders to reject any order in whole or in part.
The date of this Prospectus is August 4, 1997.
AVAILABLE INFORMATION
The Company has filed with the Securities and Exchange Commission (the
"Commission"), 450 Fifth Street N.W., Washington, D.C. 20549, a Registration
Statement on Form S-3 (the "Registration Statement") under the Securities Act,
and the rules and regulations promulgated thereunder, with respect to the
Shares offered pursuant to this Prospectus. This Prospectus, which is part
of the Registration Statement, does not contain all of the information set
forth in the Registration Statement and the exhibits thereto. Certain
financial and other information relating to the Company is contained in the
documents indicated below under "Incorporation of Certain Documents By
Reference" which are not presented herein or delivered herewith. For further
information with respect to the Company and the Shares, reference is made to
the Registration Statement and such exhibits, copies of which may be examined
without charge at, or obtained upon payment of prescribed fees from, the
Public Reference Section of the Commission at Room 1024, Judiciary Plaza, 450
Fifth Street, N.W., Washington, D.C. 20549 and will also be available for
inspection and copying at the regional offices of the Commission located at 7
World Trade Center, Suite 1300, New York, New York 10048 and at Citicorp
Center, 500 W. Madison Street, Suite 1400, Chicago, Illinois 60661-2511.
Statements contained in this Prospectus as to the contents of any contract or
other document which is filed as an exhibit to the Registration Statement are
not necessarily complete, and each such statement is qualified in its entirety
by reference to the full text of such contract or document.
The Company is subject to the informational requirements of the Securities
Exchange Act of 1934, as amended (the "Exchange Act"), and, in accordance
therewith, files reports, proxy statements and other information with the
Commission. Such reports, proxy statements and other information can be
inspected and copied at the locations described above. Copies of such
materials can be obtained by mail from the Public Reference Section of the
Commission at 450 Fifth Street, N.W., Washington, DC 20549, at prescribed
rates. In addition, the Common Stock is listed on the NASDAQ National Market.
Material filed by the Company can be inspected at the offices of the National
Association of Securities Dealers, Inc., 1735 K Street, N.W., Washington, D.C.
20006.
INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE
The following documents, which have been filed by the Company with the
Commission, are incorporated herein by reference:
1. The Company's Annual Report on Form 10-K for the year ended March 31, 1997.
2. The description of the Company's Common Stock contained in the Company's
registration statement under Section 12 of the Exchange Act, dated January
29, 1987, and any amendment or report updating such description, including
without limitation, Amendment No. 1 thereto dated October 5, 1987,
Amendment No. 2 thereto dated October 26, 1987, Amendment No. 3 thereto
dated December 23, 1987, Amendment No. 4 thereto dated January 27, 1988 and
Amendment No. 5 thereto dated February 9, 1988, the Company's Current
Reports on Form 8-K dated December 17, 1992, November 29, 1995 and December
14, 1995.
All reports and other documents subsequently filed by the Company pursuant to
Sections 13(a), 13(c), 14 and 15(d) of the Exchange Act, prior to the filing
of a post-effective amendment which indicates that all securities offered
thereby have been sold or which deregisters all securities then remaining
unsold, shall be deemed to be incorporated by reference in and to be a part
of this Prospectus from the date of filing of such reports and documents.
Any statement contained in a document incorporated or deemed to be 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 the
Registration Statement containing this Prospectus 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 the request of such
person, a copy of any or all of the foregoing documents referred to above
which have been or may be incorporated herein by reference, other than exhibits
to such documents (unless such exhibits are specifically incorporated by
reference into the information that this Prospectus incorporates). Requests
for such documents should be directed to the Secretary of the Company at 7620
SW Bridgeport Road, Portland, Oregon 97224 (telephone number: (503) 639-7221).
<PAGE> I-2
THE COMPANY
Bioject develops, manufactures and markets a jet injection system for
needle-free drug delivery. Using this technology for injections virtually
eliminates the associated risk of contaminated needlestick injuries and
resulting blood-borne pathogen transmission, a major concern throughout the
healthcare industry. The Company manufactures and markets a professional jet
injection system, the Biojector 2000, which allows healthcare professionals
to inject medications through the skin, both intramuscularly and
subcutaneously, without a needle. The Biojector 2000 system consists of two
components: a hand-held, reusable jet-injector; and a sterile, single-use
disposable syringe. The system is capable of delivering variable dose
needle-free injections up to 1 ml. Additionally, the Company has
developed a self-injection system for delivery of various medications up to
1 ml for use by non-professionals, and the Company is also developing systems
for Hoffmann-La Roche to use with certain of their products pursuant to an
agreement signed January 10, 1995.
The Company was formed in December 1992 for the sole purpose of acquiring all
the capital stock of Bioject Medical Systems Ltd. in a stock-for-stock exchange
in order to establish a U.S. domestic corporation as the publicly traded parent
company of Bioject Inc. and Bioject Medical Systems Ltd. Bioject Medical
Systems Ltd. was terminated in July 1996. All references to the Company herein
are to Bioject Medical Technologies Inc. and its subsidiary, Bioject, Inc.,
unless the context requires otherwise. The Company's executive offices and
operations are located at 7620 S.W. Bridgeport Road, Portland, Oregon 97224,
and its telephone number is (503) 639-7221.
The Company's operations are conducted by Bioject Inc., an Oregon corporation,
which is a wholly-owned subsidiary of the Company.
"Biojector(r)" and "Bioject(r)" are trademarks of the Company.
RECENT DEVELOPMENTS
In June and July 1997, the Company completed a private placement (the
"Placement") of 2,906,977 units, each unit consisting of one share of Common
Stock and one warrant (a "Warrant") to purchase one-half share of Common Stock
at an exercise price of $0.71 per share. The Warrants, which are exercisable
in whole or from time to time in part, expire five years from the date of
issuance, and are transferable subject to compliance with all applicable
federal and state securities laws. Proceeds to the Company (excluding
estimated expenses) totalled $1,250,000. In May 1997, in return for services
provided, the Company granted to Amy Factor a warrant to purchase 25,000
shares of common stock at an exercise price of $0.50 per share.
RISK FACTORS
The Shares offered hereby involve a high degree of risk. In addition to the
other information in this Prospectus, the following factors should be
considered carefully in evaluating the Company and its business before making
an investment in the Shares offered hereby. This Registration Statement and
documents incorporated herein contain forward-looking statement within the
meaning of Section 27A of the Securities Act. Discussion containing such
forward-looking statements may be found in the material within this
Registration Statement generally as well as within the documents listed under
"Incorporation of Certain Documents by Reference" and documents subsequently
filed pursuant to Section 13(a), 13(c) 14 and 15(d) of the Exchange Act.
Actual results could differ materially from those projected in the
forward-looking statements as a result of the risk factors set forth below and
the matters set forth in the Registration Statement generally. The Company
cautions the reader that this list of factors may not be exhaustive.
Need For Additional Financing. The Company believes that its current cash
position and cash received from a private placement of common stock and
warrants in June and July 1997, combined with revenues and other cash receipts
will not be adequate to fund the Company's operations through the end of fiscal
1998. The Company has identified a number of potential financing sources and is
pursuing them aggressively. See "Forward Looking Statements". Even if the
Company is successful in raising additional financing, unforeseen costs and
expenses or lower than anticipated cash receipts from product sales or research
and development activities could accelerate or increase the financing
requirements. The Company has been successful in raising additional financing
in the past and believes that sufficient funds will be available to fund future
operations. See "Forward Looking Statements." However, there can be no
assurance that the Company's efforts will be successful, and there can be no
assurance that such financing will be available on terms which are not
significantly dilutive to existing shareholders. Failure to obtain needed
additional capital on terms acceptable to the Company, or at all, would
significantly restrict the Company's operations and ability to continue product
development and growth and materially adversely affect the Company's business.
The Company has no banking line of credit or other established source of
borrowing. The Company's independent accountants have qualified their opinion
with respect to their audit of the Company's consolidated balance sheets as of
March 31, 1997 and 1996, and the related consolidated statements of operations
and shareholders equity and cash flows for the each of the three years ended
March 31, 1997, as the result of doubts concerning the Company's ability to
continue as a going concern in the absence of additional financing.
<PAGE> I-3
Uncertainty of Market Acceptance. The Company's success will depend upon
market acceptance of its jet injection drug delivery system, the Biojector
2000 system, and, to other products under development. Currently, the
dominant technology used for intramuscular and subcutaneous injections is the
hollow-needle syringe. Needle-syringes, while low in cost, have limitations,
particularly relating to contaminated needlestick injuries. Use of the
Biojector 2000 system for intramuscular and subcutaneous injections virtually
eliminates the associated risk of these injuries; however, the cost per
injection is significantly higher. As with any new technology, there can be
no assurance that the Biojector 2000 system will compete successfully. A
previous jet injection system manufactured by the Company did not achieve
market acceptance and is no longer being marketed. The Biojector 2000 was
introduced in January 1993. To date, the major portion of sales have
been to HMI which have not been placed in service and which the Company has
committed to repurchase at a substantial discount to the original selling
price. Failure of the Biojector 2000 system to gain market acceptance would
have a material adverse effect on the Company's financial condition and results
of operations.
History of Losses; Uncertain Profitability. Since its formation in 1985, the
Company has incurred significant annual operating losses and negative cash
flow. At March 31, 1997, the Company had an accumulated deficit of $34.3
million. The Company's revenues to date have been derived primarily from
licensing and technology fees, and from limited product sales, which were
principally sales to dealers for the stocking of inventories and to HMI.
There can be no assurance that the Company will be able to generate significant
revenues or achieve profitability.
Limited Manufacturing Experience; Need to Reduce Unit Cost. The Company has
limited experience manufacturing its products in commercial quantities. The
Company has increased its production capacity for the Biojector 2000 system
through automation of, and changes in, production methods. The current cost
per injection of the Biojector 2000 system is substantially higher than that
of traditional needle-syringes, its principal competition. A key element of
the Company's business strategy is to reduce the overall system cost through
automating production and packaging. The Company has experienced and may
experience setbacks and delays in its cost reduction efforts including failure
to deliver reduced cost parts to specifications. There can be no assurance
that the Company will be able to develop and implement effective high volume
production or achieve necessary unit cost reductions. Failure to do either
would adversely affect the Company's financial condition and results of
operations.
Governmental Regulation. The Company's products and manufacturing operations
are subject to extensive government regulation, both in the U.S. and abroad.
In the U.S., the development, manufacture, marketing and promotion of medical
devices are regulated by the Food and Drug Administration ("FDA") under the
Federal Food, Drug, and Cosmetic Act ("FFDCA"). In 1987, the Company received
clearance from the FDA under Section 510(k) of the FFDCA to market a hand-held
CO2-powered jet injection system. The FFDCA provides that new premarket
notifications under Section 510(k) of the FFDCA are required to be filed when,
among other things, there is a major change or modification in the intended use
of a device or a change or modification to a legally marketed device that
could significantly affect its safety or effectiveness. A device manufacturer
is expected to make the initial determination as to whether the change to its
device or its intended use is of a kind that would necessitate the filing of
a new 510(k) notification. Although the Biojector 2000 system incorporates
changes from the system with respect to which the Company's 1987 510(k)
marketing clearance was received and expands its intended use, the Company
made the determination that these were not major changes or modifications in
intended use or changes in the device that could significantly affect the
safety or effectiveness of the device and that, accordingly, the 1987 510(k)
clearance permitted the Company to market the Biojector 2000 system in the
U.S. In June 1994, the Company received clearance from the FDA under 510(k)
to market a version of its Biojector 2000 system in a configuration targeted
at high volume injection applications. In October 1996, the Company received
510(k) clearance for a non-needle disposable vial access device. In March
1997, the Company received FDA 510(k) clearance to market the Biojector 2000
incorporating certain enhancements to the product.
<PAGE> I-4
Future changes to manufacturing procedures could necessitate the filing
of a new 510(k) notification. Also, future products, product enhancements or
changes, or changes in product use may require clearance under Section 510(k),
or they may require FDA premarket approval ("PMA") or other regulatory
approvals. PMAs and these other regulatory approvals generally involve more
extensive prefiling testing than a 510(k) clearance and a longer FDA review
process. Under current FDA policy, applications involving prefilled syringes
would be evaluated by the FDA as drugs rather than devices, requiring NDAs or
ANDAs. Depending on the circumstances, drug regulation can be more
bureaucratic and time consuming than devise regulation.
FDA regulatory processes are time consuming and expensive, and there can be
no assurance that product applications submitted by the Company will be cleared
or approved by the FDA. In addition, the Company's products must be
manufactured in compliance with Good Manufacturing Practices ("GMP") specified
in regulations under the FDA Act. The FDA has broad discretion in enforcing
the FDA Act, and noncompliance with the Act could result in a variety of
regulatory actions ranging from product detentions, device alerts or field
corrections, to mandatory recalls, seizures, injunctive actions, and civil or
criminal penalties.
Distribution of the Company's products in countries other than the U.S. may be
subject to regulation in those countries. An application was made to the
Japan Ministry of Health and Welfare to obtain necessary approvals to market
the Biojector 2000 system in Japan which was not carried to completion by the
Company's then Japanese distributor.
Uncertainty in Healthcare Industry; Government Healthcare Reform Proposal. The
healthcare industry is subject to changing political, economic and regulatory
influences that may affect the procurement practices and operations of
healthcare facilities. During the past several years, the healthcare industry
has been subject to increased government regulation of reimbursement rates and
capital expenditures. Among other things, third party payors are increasingly
attempting to contain healthcare costs by limiting both coverage and
reimbursement levels for healthcare products and procedures. Because the price
of the Biojector 2000 system exceeds the price of needle injection systems,
cost control policies of third party payors, including government agencies,
may adversely affect use of the Biojector 2000 system.
Dependence on Third-Party Relationships. The Company is dependent on third
parties for distribution of the Biojector 2000 system to certain market
segments, for the manufacture of component parts, and for assistance with the
development and distribution of its future Betaseron self-injection and
application specific systems.
The Company intends to seek relationships to distribute to the physician office
market in the future. Past dealer relationships have not been successful.
There can be no assurance that the Company's future dealers will provide
sufficient sales support to establish the Company's current product.
The Company's current manufacturing processes for the Biojector 2000 jet
injector and disposable syringes consist primarily of assembly of component
parts supplied by outside suppliers. Certain of these components are currently
obtained from single sources, with some components requiring significant
production lead times. In the past, the Company has experienced delays in the
delivery of certain components, although to date no such delays have had a
material adverse effect on the Company's operations. There can be no assurance
that the Company will not experience delays in the future, or that such delays
would not have a material adverse effect on the Company's financial condition
and result of operations.
The Company has entered into agreements with certain major pharmaceutical
companies for development and distribution of jet injection systems. These
companies have the right to terminate these agreements at certain phases as
defined in the agreements. There can be no assurance these companies' interest
and participation in the projects will continue. Failure to receive additional
funding from these companies could adversely affect the development and
production of the products involved and, correspondingly, the Company's
financial condition and results of operations.
Ability to Manage Growth. If the Company's products achieve market acceptance,
the Company expects to achieve rapid growth. This growth strategy will require
expanded customer services and support, increased personnel throughout the
Company, expanded operational and financial systems, and the implementation of
new control procedures. There can be no assurance that the Company will be
able to attract qualified personnel or successfully manage expanded operations.
As the Company expands, it may from time to time experience constraints that
would adversely affect its ability to satisfy customer demand in a timely
fashion. Failure to manage growth effectively could adversely affect the
Company's financial condition and results of operations.
<PAGE> I-5
Competition. The medical equipment market is highly competitive and
competition is likely to intensify. The Company's products compete
primarily with traditional needle-syringes, "safety syringes" and also with
other alternative drug delivery systems. In recent years, some needle-free
self injectors have also gained some market prominence including signing of
certain corporate partnerships. While the Company believes its
products provide a superior drug delivery method, there can be no assurance
that the Company will be able to compete successfully with existing drug
delivery products. Many of the Company's competitors have longer operating
histories as well as substantially greater financial, technical, marketing
and customer support resources than the Company. There can be no assurance
that one or more of these competitors will not develop an alternative drug
delivery system that competes more directly with the Company's products, or
that the Company's products would be able to compete successfully with such a
product.
Dependence on Single Technology. The Company's strategy has been to focus its
development and marketing efforts on its jet injection technology. This focus
renders the Company particularly sensitive to competing products and
alternative drug delivery systems. The Company believes that healthcare
providers' desire to minimize the use of the traditional needle-syringe has
stimulated development of a variety of alternative drug delivery systems such
as "safety syringes," jet injection systems and transdermal diffusion
"patches." In addition, pharmaceutical companies frequently attempt to
develop drugs for oral delivery instead of injection.
While the Company believes that for the foreseeable future there will continue
to be a significant need for injections, there can be no assurance that
alternative drug delivery methods will not be developed which are preferable to
injection.
Patents and Proprietary Rights. The Company relies on a combination of trade
secrets, confidentiality agreements and procedures, and patent prosecution to
protect its proprietary technologies. The Company has been granted seven
patents in the United States and two patents in certain other countries
covering certain technology embodied in its current jet injection system and
certain manufacturing processes. Additional patent applications are pending
in the U.S. and certain foreign countries. There can be no assurance that the
claims contained in any patent application will be allowed, or that any patent
will provide adequate protection for the Company's products and technology.
In the absence of patent protection, the Company may be vulnerable to
competitors who attempt to copy the Company's products or gain access to its
trade secrets and know-how. In addition, the laws of foreign countries may
not protect the Company's proprietary rights to this technology to the same
extent as the laws of the U.S. The Company believes that it has independently
developed its technology and attempts to ensure that its products do not
infringe the proprietary rights of others, and the Company knows of no
infringement claims. However, any such claims could have a material adverse
affect on the Company's financial condition and results of operations.
Product Liability. Producers of medical devices may face substantial liability
for damages in the event of product failure or if it is alleged the product
caused harm. The Company currently maintains product liability insurance and
has not experienced any product liability claims to date. There can be no
assurance, however, that the Company will not be subject to such claims, that
the Company's current insurance would cover such claims, or that adequate
insurance will continue to be available on acceptable terms to the Company in
the future. The Company's business could be adversely affected by product
liability claims.
Dependence upon Key Employees. The Company's success is dependent upon the
retention of its executive officers and other key employees. Competition
exists for qualified personnel and the Company's success will depend in part
upon attracting and retaining such personnel. Failure in these efforts could
have a material adverse effect on the Company's business, financial condition
or results of operations.
Shares Eligible For Future Sale. In November and December 1995, the
Company completed a private placement of 2,303,009 units (each unit
representing one share of common stock and a warrant to purchase three-quarters
of one share of common stock). The Company also granted a warrant to its
placement agent in the private placement to purchase 137,086 shares of common
stock. The shares issued in the 1995 private placement were registered
for resale on a Registration Statement on Form S-3. In December 1996, the
Company completed a private placement of 3,434,493 units (each unit
representing one share of common stock and a warrant to purchase one share of
common stock). The Company also granted a warrant to its placement agent in
the private placement to purchase 156,000 shares of common stock. The shares
issued in the private placement and the underlying shares issuable upon
exercise of the warrants were registered for resale on a Form S-3 registration
statement. In June and July 1997, the Company completed the Placement of
2,906,977 units (each unit representing one share of common stock and a warrant
to purchase one-half share of common stock). See "Recent Developments." In
each of the private placements, the Company also granted registration rights
with respect to the shares issuable upon exercise of the warrants. Sales of
substantial numbers of common stock in the public market, or the availability
of such shares for sale, could adversely affect the market price for the
common stock and make it more difficult for the Company to raise funds through
equity offerings in the future.
<PAGE) I-6
Possible Adverse Effects on Trading Market. The Common Stock is quoted on the
NASDAQ National Market. There are a number of continuing requirements that
must be met in order for the Common Stock offered hereby to remain eligible
for quotation on the NASDAQ National Market or the NASDAQ SmallCap Market. In
November 1996, NASDAQ approved changes to its quantitative and qualitative
standards for issuers listing on NASDAQ, subject to public comment and approval
by the Commission. Among the proposed changes are the elimination of the
alternative test for issuers failing to meet the minimum bid price of $1.00 and
an increase in the quantitative standards for both the NASDAQ National Market
and the NASDAQ SmallCap Market.
The failure to meet the maintenance criteria in the future could result in the
delisting of the Company's Common Stock from NASDAQ. In such event, trading,
if any, in the Common Stock may then continue to be conducted in the non-NASDAQ
over-the-counter market. As a result, an investor may find it more difficult
to dispose of, or to obtain accurate quotations as to the market value of, the
Company's Common Stock. In addition, if the Common Stock was delisted from
trading on NASDAQ and the trading price of the Common Stock was less than $5.00
per share, trading in the Common Stock would also be subject to the
requirements of certain rules promulgated under the Exchange Act, which require
additional disclosure by broker-dealers in connection with any trades involving
a stock defined as a penny stock. The additional burdens imposed upon broker-
dealers may discourage broker-dealers from effecting transactions in penny
stocks, which could reduce the liquidity of the shares of Common Stock and
thereby have a material adverse effect on the trading market for the
securities.
Possible Volatility of Stock Price. The market for the Company's Common Stock
and for the securities of other early stage, small market-capitalization
companies has been highly volatile in recent years. The Company believes that
factors such as quarter-to-quarter fluctuations in financial results, new
product introductions by the Company or its competition, public announcements,
changing regulatory environments, sales of Common Stock by certain existing
shareholders and substantial product orders could contribute to the volatility
of the price of the Company's Common Stock, causing it to fluctuate
dramatically. General economic trends such as recessionary cycles and changing
interest rates may also adversely affect the market price of the Company's
Common Stock.
USE OF PROCEEDS
The Shares offered hereby are being registered for the account of the Selling
Shareholders and, accordingly, the Company will not receive any of the proceeds
from the sale of the Shares.
SELLING SHAREHOLDERS
The Shares being offered for resale by the Selling Shareholders were acquired
in connection with the Placement and include (i) the Common Stock sold
thereunder and (ii) the Common Stock issuable upon exercise of the Warrants.
The term "Selling Shareholder" includes all persons acquiring securities in the
Placement and persons acquiring such securities in permitted transfers from
original holders thereof pursuant to the Registration Rights Agreement
(described below) in transactions not requiring registration under the
Securities Act.
In connection with the Placement, the Company and the purchasers entered into a
Registration Rights Agreement pursuant to which the Company agreed to use its
best efforts to keep the registration, of which this Prospectus is a part,
effective for at least two years from the date hereof. In addition, the
Company granted the Selling Shareholders certain "piggyback" registration
rights in connection with the registration under the Securities Act of
securities in connection with a public offering (other than a registration
relating to the sale of securities solely to participants in employee benefit
plans or in connection with certain transactions requiring shareholder
approval). All rights granted pursuant to the Registration Rights Agreement
terminate on the earlier of June 15, 2002 or such time as the aggregate
number of Shares held by the Selling Shareholders represents less than 1% of
the outstanding shares of the Company's Common Stock.
<PAGE> I-7
The following table sets forth certain information regarding the beneficial
ownership of shares of Common Stock by the Selling Shareholders as of August 4,
1997, and as adjusted to reflect the sale of the Shares.
Number of Shares Maximum Number of Shares Owned After
Owned Shares to be Sold Offering (1)
Name Prior to Offering under this Prospectus ___________________
Number Percent
_______________________________________________________________________________
Awbry Company (2) 872,093 872,093 0 *
Eric P. Grant (2) 872,093 872,093 0 *
Summit Fund LP (3) 872,094 872,094 0 *
Tiburon Fund LP (3) 872,094 872,094 0 *
Richard S. Huson (4) 523,256 523,256 0 *
Tower Rock Partners (5) 348,837 348,837 0 *
Amy Factor (6) 25,000 25,000 0 *
Total 4,385,467 4,385,467 0
____________
* Less than 1%
(1) Assumes that all of the Selling Shareholders will sell all Shares during
the effective period.
(2) Includes (i) 581,395 shares of Common Stock and (ii) 290,698 shares of
Common Stock issuable upon exercise of Warrants.
(3) Includes (i) 581,396 shares of Common Stock and (ii) 290,698 shares of
Common Stock issuable upon exercise of Warrants.
(4) Includes (i) 348,837 shares of Common Stock and (ii) 174,419 shares of
Common Stock issuable upon exercise of Warrants.
(5) Includes (i) 232,558 shares of Common Stock and (ii) 116,279 shares of
Common Stock issuable upon exercise of a warrant.
(6) Includes 25,000 shares of Common Stock issuable upon exercise of a warrant.
No Selling Shareholder has held any position or office, or other material
relationship with the Company or any of its predecessors or affiliates within
the past three years, with the exception of Amy Factor, who acted as a
financial advisor for the Company.
PLAN OF DISTRIBUTION
The distribution of the Shares by the Selling Shareholders may be effected
from time to time in one or more transactions (which may involve block
transactions), in special offerings, exchange distributions and/or secondary
distributions, in negotiated transactions, or a combination or such methods
of sale, at market prices prevailing at the time of sale, at prices related
to such prevailing market prices or at negotiated prices. Such transactions
may be effected on a stock exchange or the over-the-counter market. The
Selling Shareholders may effect such transactions by selling the Shares to or
through broker-dealers, and such broker-dealers may receive compensation in
the form of underwriting discounts, concessions or commissions from one or
more of the Selling Shareholders for whom they may act as agent (which
compensation may be in excess of customary commissions). Without limiting
the foregoing, such brokers may act as dealers by purchasing any and all of
the Shares covered by this Prospectus either as agents for others or as
principals for their own accounts and reselling such securities pursuant to
this Prospectus. The Selling Shareholders and any broker-dealers or other
persons acting on the behalf that participate with such Selling Shareholders
in the distribution of the Shares may be deemed to be underwriters and any
commissions received or profit realized by them on the resale of the Shares
may be deemed to be underwriting discounts and commissions under the
Securities Act. As of the date of this Prospectus, the Company is not aware
of any agreement, arrangement or understanding between any broker or dealer
and any of the Selling Shareholders with respect to the offer or sale of the
Shares pursuant to this Prospectus.
At the time that any particular offering of Shares is made, to the extent
required by the Securities Act, a prospectus supplement will be distributed,
setting forth the terms of the offering, including the aggregate number of
Shares being offered, the names of any underwriters, dealers or agents, any
discounts, commissions and other items constituting compensation from the
Selling Shareholders and any discounts, commissions or concessions allowed or
reallowed or paid to dealers.
<PAGE> I-8
The Selling Shareholders may from time to time pledge the Shares owned by them
to secure margin or other loans made to one or more of the Selling
Shareholders. Thus, the person or entity receiving the pledge of any of the
Shares may sell them, in a foreclosure sale or otherwise, in the same manner
as described above for a Selling Shareholder.
The Company will not receive any of the proceeds from any sale of the Shares
by the Selling Shareholders offered hereby.
Pursuant to the Registration Rights Agreement, the Company has agreed to
indemnify the Selling Shareholders against certain liabilities, including
liabilities under the Securities Act. The Company shall bear customary
expenses incident to the registration of the Shares for the benefit of the
Selling Shareholders in accordance with the Registration Rights Agreement,
other than underwriting discounts and commissions directly attributable to the
sale of such securities by or on behalf of the Selling Shareholders.
The Company has agreed to use its best efforts to keep the Registration
Statement of which this Prospectus is a part effective for at least two years
from June 16, 1997.
LEGAL MATTERS
The validity of the issuance of the shares of Common Stock offered hereby will
be passed upon for the Company by Bogle & Gates P.L.L.C., Seattle, Washington.
EXPERTS
The consolidated financial statements and schedule incorporated by reference in
this Prospectus and elsewhere in the Registration Statement have been audited
by Arthur Andersen LLP, independent public accountants, as indicated in their
reports with respect thereto, and are incorporated by reference herein in
reliance upon the authority of said firm as experts in accounting and auditing
in giving said reports.
Future financial statements of the Company and the reports thereon of Arthur
Andersen LLP also will be incorporated by reference in this Prospectus in
reliance upon the authority of that firm as experts in accounting and auditing
in giving those reports to the extent said firm has audited those financial
statements and consented to the use of their reports thereon.
No dealer, salesperson, or any other person
has been authorized to give any information or to
make any representations other than those
contained in this Prospectus in connection 4,385,467 Shares
contained herein, and, if given Common Stock
or made, such information or representations must (without par value)
not be relied upon as having been
authorized by the Company. This Prospectus does
not constitute an offer of any securities other than
those to which it relates or an offer to sell, or a
solicitation of an offer to buy, those to which it
relates in any jurisdiction where, or to any person
to whom, it is unlawful to make such an offer.
The delivery of this Prospectus at any time does
not imply that there has been no change in the
information set forth herein or in the affairs of
the Company since the date hereof.
________________________ BIOJECT MEDICAL
TECHNOLOGIES INC.
TABLE OF CONTENTS
________________________
Page
Available Information..................2
Incorporation of Certain Documents -----------------------
by Reference..........................2 PROSPECTUS
The Company............................3 -----------------------
Recent Developments....................3
Risk Factors...........................4
Use Of Proceeds........................7
Selling Shareholders...................7
Plan of Distribution...................8
Legal Matters..........................9
Experts................................9
<PAGE> I-9
August 4, 1997
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
ITEM 14. OTHER EXPENSES OF ISSUANCE AND DISTRIBUTION.
The following table itemizes the expenses incurred by the Company in connection
with the shares of Common Stock being registered. All of the amounts shown
are estimates except the Securities and Exchange registration fee.
Item Amount
_______________________________________________________________
Securities and Exchange Commission Registration $1,000.46
Fee
Blue Sky Fees and Expenses 0.00
Accounting Fees and Expenses 5,000.00
Legal Fees and Expenses 7,000.00
Miscellaneous
Total $13,000.46
The Selling Shareholders will pay no portion of the foregoing expenses.
ITEM 15. INDEMNIFICATION OF DIRECTORS AND OFFICERS.
Generally, Sections 60.387 through 60.414 of the Oregon Business Corporation
Act (the "Act") authorize a court to award, or a corporation's board of
directors to grant, indemnification to directors and officers in
circumstances where the officer or director acted in good faith, in a manner
that the director or officer reasonably believed to be in (or at least not
opposed to) the best interests of the corporation and, if in a criminal
proceeding, if the director or officer had no reasonable cause to believe his
conduct was unlawful. Article IX of the Company's Bylaws provides for
indemnification to the greatest extent permitted by the Oregon Act.
Section 60.047 of the Oregon Act authorizes a corporation to limit a director's
liability to the corporation or its shareholders for monetary damages resulting
from conduct as a director, except in certain circumstances involving breach
of the director's duty of loyalty to the corporation or its shareholders,
intentional misconduct or knowing violation of the law, self dealing or
approval of illegal corporate loans or distributions, or any transaction from
which the director personally receives a benefit in money, property or services
to which the director is not legally entitled. Article VII of the Company's
Articles of Incorporation contains provisions implementing, to the fullest
extent allowed, limitations on a director's liability to the Company or its
shareholders. The Company currently maintains officers' and directors'
liability insurance.
(a) EXHIBITS.
Exhibit
Number Description
4.1 Form of Registration Rights Agreement (Incorporated by reference
to Exhibit 10.38 of the Registrant's Annual Report on Form 10-K
for the year ended March 31, 1997 (the "Form 10-K"))
4.2 Form of Series F Common Stock Purchase Warrant (Incorporated by
reference to Exhibit 10.36 of the Form 10-K)
4.3 Form of Series G Common Stock Purchase Warrant (Incorporated by
reference to Exhibit 10.37 of the Form 10-K)
5.1 Opinion of Bogle & Gates P.L.L.C.
23.1 Consent of Bogle & Gates P.L.L.C. (included in Exhibit 5.1)
23.2 Consent of Arthur Andersen LLP
24.1 Power of Attorney (see page II-4)
<PAGE> II-1
ITEM 17 UNDERTAKINGS.
(a) Rule 415 Offering.
The undersigned Registrant hereby undertakes:
(1) To file, during any period in which offers or sales are being made, a
post-effective amendment to this Registration Statement;
(i) To include any prospectus required by Section 10(a)(3) of the Securities
Act of 1933;
(ii) To reflect in the prospectus any facts or events arising after the
effective date of this Registration Statement (or the most recent post-
effective amendment thereof), which, individually or in the aggregate,
represent a fundamental change in the information set forth in this
Registration Statement. Notwithstanding the foregoing, any increase or
decrease in volume of securities offered (if the total dollar value of
securities offered would not exceed that which was registered) and any
deviation from the low or high and of the estimated maximum offering range
may be reflected in the form of prospectus filed with the commission pursuant
to Rule 424(b) if, in the aggregate, the changes in volume and price
represent no more than 20 percent change in the maximum aggregate offering
price set forth in the "Calculation of Registration Fee" table in the
effective registration statement.
(iii) To include any material information with respect to the plan of
distribution not previously disclosed in this Registration Statement or any
material change to such information in this Registration Statement; provided,
however, that the undertakings set forth in paragraphs (a)(1)(i)and (a)(1)(ii)
above do not apply if this Registration Statement is on Form S-3, Form S-8 or
Form F-3, and the information required to be included in a post-effective
amendment by those paragraphs is contained in periodic reports filed by the
Registrant pursuant to Section 13 or Section 15(d) of the Securities Exchange
Act of 1934 that are incorporated by reference in this Registration Statement.
(2) That, for the purpose of determining any liability under the Securities Act
of 1933, 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 as that time shall be deemed to be the initial
bona fide offering thereof;
(3) To remove from registration by means of post-effective amendment any of
the securities being registered which remain unsold at the termination of
the offering.
(b) Filings Incorporating Subsequent Exchange Act Documents by Reference.
The undersigned Registrant hereby undertakes that, for the purposes of
determining any liability under the Securities Act of 1933, each filing of the
Registrant's annual report pursuant to Section 13(a) or Section 15(d) of the
Securities Exchange Act of 1934 (and, where applicable, each filing of an
employee benefit plan's annual report pursuant to Section 15(d) of the
Securities Exchange Act of 1934) that is incorporated by reference in the
Registration Statement 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.
(h) Indemnification for Liabilities.
Insofar as indemnification for liabilities arising under the Securities Act
of 1933 may be permitted to directors, officers and controlling persons of
the Registrant pursuant to the provisions described in Item 15 above, or
otherwise, the Registrant 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 of 1933 and is, therefore,
unenforceable. In the event that a claim for indemnification against such
liabilities (other than the payment by the Registrant of expense incurred or
paid by a director, officer or controlling person of the Registrant 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 Registrant 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 Securities Act of 1933 and will be
governed by the final adjudication of such issue.
<PAGE> II-2
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, the Registrant
certifies that it has reasonable grounds to believe that it meets all the
requirements for filing on Form S-3 and has duly caused this Registration
Statement to be signed on its behalf by the undersigned, thereunto duly
authorized, in the City of Portland, State of Oregon, on August 4, 1997.
BIOJECT MEDICAL TECHNOLOGIES INC.
BY: /s/ James C. O'Shea
James C. O'Shea
Chairman, Chief Executive Officer
and President
POWER OF ATTORNEY
Each person whose signature appears below constitutes and appoints James C.
O'Shea and Peggy J. Miller, or either of them, his/her attorneys-in-fact,
with the power of substitution, for him/her in any and all capacities, to
sign any amendments to this Registration Statement, and to file the same, with
exhibits thereto and other documents in connection therewith, with the
Securities and Exchange Commission, hereby ratifying and confirming all that
each of said attorneys-in-fact, or their substitute or substitutes, may do
or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Act of 1933, this Registration
Statement has been signed by the following persons in the capacities and on
the dates indicated.
Signature Title Date
/s/James C. O'Shea
James C. O'Shea Chairman of the Board, August 4, 1997
Chief Executive Officer
and President
(Principal Executive Officer)
/s/ Peggy J. Miller Vice President, Chief August 4, 1997
Peggy J. Miller Executive Officer and
Secretary/Treasurer
(Principal Accounting and
Financial Officer)
*
David H. de Weese Director August 4, 1997
*
Grace Keeney Fey Director August 4, 1997
*
William A. Gouveia Director August 4, 1997
*
Eric T. Herfindal Director August 4, 1997
*
John Ruedy, M.D. Director August 4, 1997
*
Richard J. Plestina Director August 4, 1997
* By:/s/James C. O'Shea
James C. O'Shea, Attorney-in-Fact
<PAGE> II-3
INDEX TO EXHIBITS
Exhibit
Number Description
23.2 Consent of Arthur Andersen LLP
5.1 Opinion of Bogle & Gates P.L.L.C.
<PAGE> II-4
Exhibit 23.2
CONSENT OF INDEPENDENT PUBLIC ACCOUNTANTS
As independent public accountants, we hereby consent to the incorporation by
reference in this Form S-3 Registration Statement and related Prospectus of
our report dated May 2, 1997 (except with respect to the matter discussed in
Note 7 included in the Bioject Medical Technologies, Inc. Annual Report on
Form 10-K for which the date is June 18, 1997) included in the Bioject Medical
Technologies, Inc. Annual Report on Form 10-K for the fiscal year ended March
31, 1997 and to all references to our firm included in this Registration
Statement and related Prospectus.
/S/ ARTHUR ANDERSEN LLP
Portland, Oregon
July 31, 1997
<PAGE> II-5
Exhibit 5.1
August 4, 1997
Bioject Medical Technologies Inc.
7620 S.W. Bridgeport Road
Portland OR 97224
Gentlemen and Ladies:
We are delivering this opinion in connection with the Registration
Statement on Form S-3 (the "Registration Statement") of Bioject Medical
Technologies Inc. (the "Company") to be filed with the Securities and Exchange
Commission under the Securities Act of 1933, as amended (the "Securities Act"),
with respect to an aggregate of 4,385,467 shares, without par value, of common
stock of the Company (the "Shares") to be resold by certain selling
shareholders named therein (the "Selling Shareholders").
We have examined and are familiar with originals or copies, certified or
otherwise identified to our satisfaction, of such documents, corporate records
and other instruments relating to the incorporation of the Company and to the
authorization and issuance of the Shares, and have made such investigations of
law, as we have deemed necessary and advisable.
Based upon the foregoing and having due regard for such legal questions
as we have deemed relevant, we are of the opinion that:
The 2,906,977 Shares, which were purchased by the Selling
Shareholders, have been duly authorized, and, when issued,
constituted or will constitute duly authorized, legally issued,
fully paid and nonassessable shares of common stock of the
Company.
The 1,478,490 Shares, which will be issued to the Selling
Shareholders upon the exercise of warrants, have been duly
authorized, and, upon issuance and receipt of payment therefore
in accordance with the terms of the warrants, will constitute duly
authorized, legally issued, fully paid and nonassessable shares of
common stock of the Company.
We hereby consent to the filing of this opinion as an exhibit to the
Registration Statement referred to above, and to the reference to our firm in
the Prospectus constituting a part of the Registration Statement.
Very truly yours,
/s/ Bogle & Gates P.L.L.C.
