424B3 1 d424b3.htm FORM 424B3 FORM 424B3
 
Filed Pursuant to Rule 424(b)(3)
Registration No. 333-63568
    
PROSPECTUS
 
BIOJECT MEDICAL TECHNOLOGIES INC.
 
5,313,946 Shares of Common Stock
 
        The security holders of Bioject Medical Technologies Inc. named in this prospectus may sell shares of our common stock. The shares will be sold from time to time by the Selling Shareholders named in this Prospectus. We will not receive any of the proceeds from the sale of the shares.
 
        Our common stock is traded on the Nasdaq SmallCap Market under the symbol “BJCT.” On July 6, 2001, the last sale price of our common stock as reported on the Nasdaq SmallCap Market was $10.80 per share.
 
 
Investment in the common stock involves a high degree of risk.
See section titled “Risk Factors” beginning on page 6 to read about certain factors you should consider before buying shares of common stock.
 
 
        Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined if this Prospectus is truthful or complete. Any representation to the contrary is a criminal offense.
 
 
The date of this Prospectus is July 6, 2001.
 
TABLE OF CONTENTS
 
       Page
About This Prospectus      2
Where You Can Find More Information      2
Summary      4
Forward-Looking Statements      5
Risk Factors      6
Use of Proceeds      13
Selling Shareholders      13
Plan of Distribution      22
Legal Matters      23
Experts      23
 
ABOUT THIS PROSPECTUS
 
        This Prospectus is part of a registration statement that we filed with the Securities and Exchange Commission (the “SEC”). This Prospectus relates to 5,313,946 shares (the “Shares”) of our common stock being offered for sale by the selling shareholders of the Company (the “Selling Shareholders”). Some Shares were acquired in connection with our acquisition of Vitajet Corporation in March 1998. Some Shares were acquired in two private placements by the Company in May and June, 2001 or will be acquired upon exercise of the common stock purchase warrants issued in connection with those private placements. Some shares will be acquired upon exercise of the common stock purchase warrants issued in November 2000 and May 2001 in connection with consulting services performed for the Company. In addition, some Shares will be acquired upon conversion of preferred stock and the exercise of warrants issued by the Company in 1997, 1998 and 1999 in connection with a joint venture. We will not receive any of the proceeds from these sales. We have agreed to pay the expenses incurred in registering the Shares, including legal and accounting fees.
 
        The Shares have not been registered under the securities laws of any state or other jurisdiction as of the date of this Prospectus. Brokers or dealers should confirm the existence of an exemption from registration or effectuate such registration in connection with any offer and sale of the Shares.
 
        This Prospectus describes certain risk factors that you should consider before purchasing the Shares. See “Risk Factors” beginning on page 6. You should read this Prospectus together with the additional information described under the heading “Where You Can Find More Information.”
 
WHERE YOU CAN FIND MORE INFORMATION
 
        Federal securities law requires us to file information with the SEC concerning our business and operations. We file annual, quarterly and special reports, proxy statements and other information with the SEC. You can read and copy these documents at the public reference facility maintained by the SEC at Judiciary Plaza, 450 Fifth Street, NW, Room 1024, Washington, DC 20549. You can also copy and inspect such reports, proxy statements and other information at the following regional offices of the SEC:
 
New York Regional Office
Seven World Trade Center
Suite 1300
New York, NY 10048
Chicago Regional Office
Citicorp Center
500 West Madison Street, Suite 1400
Chicago, Illinois 60661
 
        Please call the SEC at 1-800-SEC-0330 for further information on the public reference rooms. Our SEC filings are also available to the public on the SEC’s web site at http://www.sec.gov. You can also inspect our reports, proxy statements and other information at the offices of the Nasdaq Stock Market.
 
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        The SEC allows us to “incorporate by reference” the information we file with it, which means that we can disclose important information to you by referring you to those documents. The information that we incorporate by reference is considered to be part of this Prospectus, and later information that we file with the SEC will automatically update and supersede this information. We incorporate by reference the documents listed below and any future filings made with the SEC under Sections 13(a), 13(c), 14 or 15(d) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”):
 
        1.    Our Annual Report on Form 10-K for the year ended March 31, 2001.
 
        2.    The description of our Common Stock contained in our 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, our Current Reports on Form 8-K dated December 17, 1992, November 29, 1995 and December 14, 1995.
 
        This Prospectus is part of a registration statement we filed with the SEC (Registration No. 333-63568). You may request a free copy of any of the above filings by writing or calling:
 
Christine M. Farrell
Secretary
7620 SW Bridgeport Road
Portland, Oregon 97224
(503) 639-7221
 
        You should rely only on the information incorporated by reference or provided in this Prospectus or any supplement to this Prospectus. We have not authorized anyone else to provide you with different information. The Selling Shareholders should not make an offer of these Shares in any state where the offer is not permitted. You should not assume that the information in this Prospectus or any supplement to this Prospectus is accurate as of any date other than the date on the cover page of this Prospectus or any supplement.
 
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SUMMARY
 
        This summary highlights information contained elsewhere in this Prospectus and in the materials incorporated by reference. It contains a summary of the most significant aspects of the offering that you should consider before investing in our securities. This summary may not contain all of the information that is important to you. You should read carefully the entire prospectus and the materials incorporated by reference.
 
        We develop, manufacture and market jet injection systems for needle-free drug delivery. We license our technology to leading pharmaceutical and biotechnology companies for whose products our technology provides potentially increased medical efficacy or enhanced market acceptance. We also sell our products directly to healthcare providers.
 
        We manufacture and market a professional needle-free injection system, the Biojector® 2000, which allows healthcare professionals to inject medications through the skin, both intramuscularly and subcutaneously, without a needle. Using this technology to administer injections virtually eliminates the risk of contaminated needlestick injuries and the resulting blood-borne pathogen transmission, which is a major concern throughout the healthcare industry. The Biojector 2000 system consists of two components: a handheld, reusable jet-injector (the “Biojector 2000” or “B-2000”) and a sterile, single-use disposable syringe (the “Biojector syringe”). We also manufacture and market a device that allows the Biojector syringe to be filled without a needle (the “Vial Adapter”). The Vial Adapter may be purchased either separately or as a pre-packaged component of the B-2000 system. The B-2000 system is capable of delivering needle-free injections in varying doses up to 1 ml.
 
        We also market the Vitajet 3® (“Vitajet”), a spring-powered, needle-free, self-injection device, the rights to which were acquired in a transaction with Vitajet Corporation in March 1998. The Vitajet currently has regulatory clearance for administering injections of insulin and a modified Vitajet, called the cool.click™, has regulatory clearance for administering the Serono human growth hormone Saizen®. In addition, a modified Vitajet called the SeroJet™, has regulatory clearance for administering the Serono human growth hormone Serostim® for the treatment of Aids wasting.
 
        Although we are focused on developing a single expertise, namely needle free injections, we have developed numerous products and marketing strategies to address three large, distinct markets: drug delivery, immunization and immunotherapeutics, and safety. We intend to grow sales of our needle-free injection systems by focusing our direct sales force on the world-wide public health market while seeking strategic partners to enter the much larger physician office market. Our primary corporate objective is to develop partnerships with pharmaceutical and biotechnology companies to enhance the delivery of their injected medications and vaccines. Because of needle-phobia, many injected products are under-utilized by patients. By licensing its needle-free injection technology, Bioject can provide a more appealing format for the drug company’s injected products. In return, the drug manufacturer can create substantial demand for Bioject’s injection systems. By enhancing injected products with proprietary, customized needle-free injection systems, we expect to help our partners expand the market for their injected products.
 
        We are actively pursuing strategic partnering relationships with a number of pharmaceutical and biotechnology companies under which we plan to grant specified rights or licenses to some or all of our products. The strategy anticipates that the rights or licenses will allow strategic partners to i) use the licensed products for specific applications or purposes or ii) market the licensed products in conjunction with certain of their products.
 
        Currently, Bioject has three strategic partners: Amgen, Microheart (the successor to AngioSense), and Ares-Serono.
 
        Amgen, Inc. and the Company entered into a clinical development and supply agreement for the disposable Iject system for delivery of injected medications for two undisclosed medical indications. In addition, Amgen has options to license the Iject for additional indications.
 
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        AngioSense, Inc. licensed three of Bioject’s systems to jointly develop novel delivery systems to deliver angiogenic and other compounds directly to the cardiovascular system. These systems will include a pre-filled disposable injection system, the Aject, which will be designed for epicardial injections during surgical procedures and catheter-based endocardial injections. In June 2001, Microheart, Inc. purchased AngioSense and the license was transferred to Microheart.
 
        Ares-Serono Group, plc. (“Serono”) licensed Bioject’s Vitajet 3 injection system for delivery of Saizen human growth hormone. The Vitajet has been customized for use in the pediatric growth market, and is marketed as the cool.click™. During the third quarter of fiscal 2001, the Company amended its agreement with Serono to provide Serono with exclusive worldwide distribution rights for its Saizen recombinant human growth hormone. In addition, Serono was given exclusive worldwide rights to the Vitajet 3 device for AIDS wasting applications. In March 2001, the SeroJet™, a customized version of the Vitajet 3, was cleared by the FDA for use with Serostim for the treatment of AIDS wasting.
 
        A primary focus of our research efforts is on clinical research in the area of DNA-based vaccines and medications. Currently, to the best of the Company’s knowledge, its devices are being used in more than 35 clinical research projects both within and outside of the United States, approximately 25 of which are DNA-based. These research projects are being conducted by companies leading the development of DNA-based medications as well as by the leading universities and governmental institutions conducting research in this area. There can be no assurance that further clinical studies will prove conclusively that Bioject’s technology is more effective in delivering DNA-based medications than alternative delivery systems that are currently available or that may be developed in the future.
 
        “Biojector,” “Bioject” and “Vitajet” are trademarks of Bioject.
 
FORWARD-LOOKING STATEMENTS
 
        Certain statements in this Registration Statement and the documents incorporated by reference to this Registration Statement constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, assumptions or future events or performance (often, but not always, using words or phrases such as “expects” or “does not expect,” “is expected,” “anticipates” or “does not anticipate,” “plans,” “estimates” or “intends,” or stating that certain actions, events or results “may,” “could,” “would,” “might” or “will” be taken, occur or be achieved) are not statements of historical fact and may be “forward-looking statements.” Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Bioject, or industry results, to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements. Such risks, uncertainties and factors include, among others, those described under “Risk Factors” and identified as risks or uncertainties in the documents incorporated by reference.
 
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RISK FACTORS
 
        An investment in the Shares involves a high degree of risk. You should consider carefully the following risk factors, together with the other information in this Prospectus, before buying any Shares. You should also be aware that certain statements contained in this Prospectus that are not related to historical results are forward-looking statements. These forward-looking statements, such as statements of our strategies, plans, objectives, expectations and intentions, involve risks and uncertainties. Our actual results could differ materially from those anticipated in these forward-looking statements.
 
        If our products are not accepted by the market, our business could fail.    Our success will depend on market acceptance of our needle-free injection drug delivery systems, the Biojector 2000 system and the Vitajet system, and on market acceptance of other products under development. If our products do not achieve market acceptance, our business could fail. 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 eliminates the associated risk of these injuries; however, the cost per injection is significantly higher. The Biojector 2000, the Vitajet system or any of our products under development may be unable to compete successfully with needle-syringes. A previous needle-free injection system manufactured by us did not achieve market acceptance and is no longer being marketed. Failure of the Biojector 2000 system or the Vitajet system to gain market acceptance would have a material adverse effect on our financial condition and results of operations.
 
        We have reduced our sales force and may be unable to penetrate targeted market segments.     In late fiscal 1998 and early fiscal 1999, we dramatically reduced our direct product sales force from one national and five district sales managers and we currently have one national sales manager and one east coast sales representative who are focused on specifically targeted market segments. This reduced sales force may not have sufficient resources to adequately penetrate one or more of the targeted market segments. Further, if the sales force is successful in penetrating one or more of the targeted market segments, we are unable to assure you that our products will be accepted in those segments or that product acceptance will result in product revenues which, together with revenues from corporate licensing and supply agreements, will be sufficient for us to operate profitably.
 
        We may be unable to enter into strategic corporate licensing and supply agreements, which could cause our business to suffer.    A key component of our sales and marketing strategy is to enter into licensing and supply arrangements with leading pharmaceutical and biotechnology companies for whose products our technology provides either increased medical effectiveness or a higher degree of market acceptance. If we cannot enter into these agreements on terms favorable to us or at all, our business may suffer. In January 1995, we entered into an agreement with Hoffman La Roche Pharmaceuticals, whereby the parties anticipated that the product development phase of the agreement would develop into a supply and distribution agreement between us and Roche. In June 1999, Roche advised us that due to a longer and more costly than expected regulatory process to gain clearance to use the B-2020 in conjunction with Roche’s products, Roche had changed its marketing strategy. In making that change in marketing strategy, Roche abandoned its exclusive distribution rights to the B-2020 and did not seek a supply of the B-2020 from us. In July 1998, we entered into an agreement with Merck & Co., whereby the parties anticipated that the initial July 1998 agreement would lead to a long-term licensing and supply agreement between the two companies. In February 1999, Merck & Co. advised us that it would not continue, at that time, to pursue exclusive license to or supply of our products. Both of these agreements resulted in significant short-term revenue. Neither agreement developed into the long-term revenue stream anticipated by our strategic partnering strategy. We may be unable to enter into future licensing or supply agreements with major pharmaceutical or biotechnology companies. Even if we enter into these agreements, they may not result in sustainable long-term revenues which, when combined with revenues from product sales, could be sufficient for us to operate profitably.
 
        An important component of our corporate licensing and supply agreement strategy is specifically targeted at entering into agreements of this nature with pharmaceutical and biotechnology companies developing DNA-
 
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based vaccines and medications. The component of the strategy which focuses on companies developing DNA-based therapies arises in great part from preliminary data from clinical studies with animals which indicates that use of the Biojector technology may result in better performance of some DNA-based medications than can be achieved through the use of traditional needle-syringes. We cannot assure you that further clinical studies will prove conclusively that our technology is more effective in delivering DNA-based medications than alternative delivery systems that are either currently available or that may be developed in the future. Further, should our technology prove to be more effective in delivering DNA-based medications, we may be unable to gain regulatory clearance to deliver any DNA-based medications using our products. Further, even if intradermal delivery of DNA-based medications is critical to effective delivery of those compounds, we may be unable to gain regulatory clearance for intradermal delivery of DNA-based medications with our products. In addition, there can be no assurance that any company will be successful in developing one or more DNA-based therapies or successful in bringing those therapies to market. Further, should any companies be successful in developing and marketing DNA-based therapies, we may be unable to enter into long-term license or supply agreements with any such company, which could cause our financial condition and results of operations to suffer.
 
        We may never receive future royalties from the blood glucose monitoring technology, which could cause our financial condition to suffer.    In May 1999, rather than continue to fund the cost of its development, we entered into negotiations to sell Marathon Medical Technologies Inc.’s blood glucose monitoring technology, and certain fixed assets related to developing the technology, to a third party. The sale was completed on June 30, 1999. The terms of the sale of the blood glucose monitoring technology provide for us to receive a royalty on net sales of future products, if any, which may be developed from the licensed technology. The agreement calls for a royalty of three percent of net sales until we have received total royalty payments of $10 million. The agreement then calls for royalty payments of one percent of net sales thereafter. Future products may never be successfully developed from the blood glucose monitoring technology, and if products are developed, they may not be commercially successful, which would mean that we would receive no future royalties and this could cause our financial condition to suffer.
 
        We have a history of losses and may never be profitable.    Since our formation in 1985, we have incurred significant annual operating losses and negative cash flow. At March 31, 2001, we had an accumulated deficit of $67.1 million. We may never be profitable, which could have a negative effect on our stock price. Historically, our revenues have been derived primarily from licensing and technology fees and from limited product sales. The product sales were principally sales to dealers in order to stock their inventories and to Homecare Management Inc., a company that we no longer sell to. More recently, we have sold our products to end-users, primarily to public health clinics for vaccinations and to nursing organizations for flu immunizations. We have not attained profitability at these sales levels. We may never be able to generate significant revenues or achieve profitability.
 
        We will need additional financing in the future, and if we cannot obtain the necessary financing our business could fail.    To date, our revenues from operations have not been sufficient to meet our cash requirements. As a result, since our inception in 1985, we have financed our operations, working capital needs and capital expenditures primarily from private placements of securities, exercises of stock options and warrants, proceeds received from our initial public offering in 1986, proceeds received from a public offering of Common Stock in November 1993, licensing and technology revenues, equity investments from Elan and Amgen, proceeds from the sale of the glucose monitoring technology, proceeds received from a private placement of Common Stock in July and August 2000, proceeds received from two private placements of Common Stock in May and June 2001, and through sales of products. We do not have a credit facility. We plan to fund our future cash requirements through revenues, debt, and sales of equity securities. However, we may be unable to obtain the financing sufficient to fund our business activities on favorable terms or at all. Failure to obtain adequate financing would have a material adverse impact on our business. In addition, sale of our equity securities on unfavorable terms to meet our obligations could result in material dilution to the existing shareholders.
 
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        We have outstanding convertible preferred stock, which is convertible into Common Stock at prices which may be lower than market price at the time of conversion which could result in dilution to existing Common Stock holders.    Our Common Stock is subject to the rights and preferences of the Series A and C Convertible Preferred Stock, which may be converted into Common Stock at prices which may be lower than market price at the time of conversion, causing substantial dilution to existing holders of Common Stock. Each share of Series A and Series C Convertible Preferred Stock is convertible into two shares of Common Stock. In October, 2004, unless it is converted earlier by the holders or redeemed by us, the shares of Series A and C Convertible Preferred Stock and accrued but unpaid dividends on the Series A Convertible Preferred Stock convert automatically into Common Stock.
 
        We have limited manufacturing experience, and may be unable to produce our products at the unit costs necessary for the products to be competitive in the market, which could cause our financial condition to suffer.    We have limited experience manufacturing our products in commercially viable quantities. We have increased our production capacity for the Biojector 2000 system and the Vitajet product line through automation of, and changes in, production methods, in order to achieve savings through higher volumes of production. If we are unable to do so, then our results of operations and financial condition could suffer. The current cost per injection of the Biojector 2000 system and Vitajet product line is substantially higher than that of traditional needle-syringes, our principal competition. A key element of our business strategy has been to reduce the overall manufacturing cost through automating production and packaging. This automation is substantially complete. There can be no assurance that we will achieve sales and manufacturing volumes necessary to realize cost savings from volume production at levels necessary to result in significant unit manufacturing cost reductions. Failure to do so will continue to make competing with needle-syringes on the basis of cost very difficult and will adversely affect our financial condition and results of operations. We may be unable to successfully manufacture devices at a unit cost that will allow the product to be sold profitably. Failure to do so would adversely affect our financial condition and results of operations.
 
        We are subject to extensive government regulation and must continue to comply with these regulations or our business could suffer.    Our products and manufacturing operations are subject to extensive government regulation in both the U.S. and abroad. If we cannot comply with these regulations, we may be unable to distribute our products, which could cause our business to suffer or fail. 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 (“FD&C”). In 1987, we received clearance from the FDA under Section 510(k) of the FD&C to market a hand-held CO2-powered needle-free injection system. The FD&C provides that new premarket notifications under Section 510(k) of the FD&C 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 our 1987 510(k) marketing clearance was received and expands its intended use, we 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. Accordingly, we further concluded that the 1987 510(k) clearance permitted us to market the Biojector 2000 system in the U.S. In June 1994, we received clearance from the FDA under 510(k) to market a version of our Biojector 2000 system in a configuration targeted at high volume injection applications. In October 1996, we received 510(k) clearance for a needle-free disposable vial access device. In March 1997, we received additional 510(k) clearance for certain enhancements to our Biojector 2000 system. In June 2000, we received 510(k) clearance for the cool.click, a modified Vitajet. In March 2001, we received 510(k) clearance for the SeroJet, a modified Vitajet. In April 2001, we received 501(k) clearance to market a reconstitution kit and vial injector. The FDA may not concur with our determination that our current and future products can be qualified by means of a 510(k) submission.
 
        Future changes to manufacturing procedures could require that we file a new 510(k) notification. Also, future products, product enhancements or changes, or changes in product use may require clearance under
 
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Section 510(k), or they may require FDA premarket approval (“PMA”) or other regulatory clearances. PMAs and regulatory clearances other than 510(k) clearance generally involve more extensive prefiling testing than a 510(k) clearance and a longer FDA review process. Under current FDA policy, applications involving pre-filled syringes would be evaluated by the FDA as drugs rather than devices, requiring FDA new drug applications (“NDAS”) or abbreviated new drug applications (“ANDAs”). Depending on the circumstances, drug regulation can be much more extensive and time consuming than device regulation.
 
        FDA regulatory processes are time consuming and expensive. Product applications submitted by the Company may not be cleared or approved by the FDA. In addition, our products must be manufactured in compliance with Good Manufacturing Practices as specified in regulations under the FD&C. The FDA has broad discretion in enforcing the FD&C, and noncompliance with the FD&C 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.
 
        If we cannot meet international product standards, we will be unable to distribute our products outside of the United States, which could cause our business to suffer.    Distribution of our products in countries other than the U.S. may be subject to regulation in those countries. Failure to satisfy these regulations would impact our ability to sell our products in these countries and could cause our business to suffer. In January 1999, we received certification from TUV Product Services for our quality system, which meets the requirements of ISO 9001 and EN 46001. In November 1999, we received certification from TUV Product Services for the applicable requirements of EC-Directive 93/42/EEC Annex. II.3 Medical Device Directive. This certification allows us to label our products with the CE Mark and sell them in the European Community. We may be unable to continue to meet the standards of ISO 9001 or CE Mark certification.
 
        If the healthcare industry limits coverage or reimbursement levels, the acceptance of our products could suffer.    The price of our products exceeds the price of needle-syringes and if coverage or reimbursement levels are reduced, market acceptance of our products could be harmed. 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 payers are increasingly attempting to contain or reduce healthcare costs by limiting both coverage and levels of reimbursement for healthcare products and procedures. Because the price of the Biojector 2000 system and Vitajet product line exceeds the price of a needle-syringe, cost control policies of third party payers, including government agencies, may adversely affect acceptance and use of the Biojector 2000 system and Vitajet product line.
 
        We are highly dependent on third-party relationships, and our business could suffer if we cannot maintain these relationships.    We are 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 future application-specific systems. If we cannot maintain these relationships, or if the third parties are unable to provide the services we require, our business could suffer.
 
        Our current manufacturing processes for the Biojector 2000 jet injector and disposable syringes as well as manufacturing processes to produce the Vitajet consist primarily of assembling component parts supplied by outside suppliers. Some of these components are currently obtained from single sources, with some components requiring significant production lead times. In the past, we have experienced delays in the delivery of certain components. To date, such delays have not had a material adverse effect on our operations. We may experience delays in the future, and these delays could have a material adverse effect on our financial condition and results of operations.
 
        In the past, we have entered into agreements with certain major pharmaceutical or biotechnology companies for development and distribution of needle-free injection systems and for use of our needle-free injection systems in conjunction with the pharmaceutical companies’ products. In all cases to date, these companies have had the
 
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right to terminate those agreements at certain phases as defined in the agreements. In several instances, those agreements have been terminated before yielding sustained long-term licensing or product sales revenues. Entering into agreements of this nature is an important part of our overall business strategy. We may be unable to interest any major pharmaceutical or biotechnology companies in entering into such agreements. If interested parties are found, we may be unsuccessful at negotiating and entering into long-term licensing and supply agreements with the interested parties. Further, if such agreements are entered into, there can be no assurance that the companies’ interest and participation in the agreements and projects will continue and result in long-term, sustainable revenues as contemplated by this aspect of our overall business strategy. Failure to enter into future licensing and product supply agreements with major pharmaceutical or biotechnology companies and failure of those future agreements to result in significant, sustainable long-term revenues could adversely affect our financial condition.
 
        If we are unable to manage our growth, our results of operations could suffer.    If our products achieve market acceptance or if we are successful in entering into product supply agreements with major pharmaceutical or biotechnology companies, we expect to experience rapid growth. Such growth would require expanded customer service and support, increased personnel, expanded operational and financial systems, and implementing new and expanded control procedures. We may be unable to attract sufficient qualified personnel or successfully manage expanded operations. As we expand, we may periodically experience constraints that would adversely affect our ability to satisfy customer demand in a timely fashion. Failure to manage growth effectively could adversely affect our financial condition and results of operations.
 
        We may be unable to compete in the medical equipment field, which could cause our business to fail.     The medical equipment market is highly competitive and competition is likely to intensify. If we cannot compete, our business will fail. Our products compete primarily with traditional needle-syringes, “safety syringes” and also with other alternative drug delivery systems. While we believe our products provide a superior drug delivery method, there can be no assurance that we will be able to compete successfully with existing or newly developed drug delivery products. Many of our competitors have longer operating histories as well as substantially greater financial, technical, marketing and customer support resources. One or more of these competitors may develop an alternative drug delivery system that competes more directly with our products, and our products may be unable to compete successfully with such a product.
 
        We are dependent on a single technology, and if it cannot compete or find market acceptance, our business will suffer.    Our strategy has been to focus our development and marketing efforts on our needle-free injection technology. Focus on this single technology leaves us vulnerable to competing products and alternative drug delivery systems. If our technology cannot find market acceptance or cannot compete against other technologies, business will suffer. We perceive 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, nasal delivery systems and transdermal diffusion “patches”. In addition, pharmaceutical companies frequently attempt to develop drugs for oral delivery instead of injection. While we believe that for the foreseeable future there will continue to be a significant need for injections, alternative drug delivery methods may be developed which are preferable to injection.
 
        We rely on patents and proprietary rights to protect our proprietary technology.    We rely on a combination of trade secrets, confidentiality agreements and procedures, and patents to protect our proprietary technologies. We have been granted a number of patents in the United States and several patents in other countries covering certain technology embodied in our current jet injection system and certain manufacturing processes. Additional patent applications are pending in the U.S. and certain foreign countries. The claims contained in any patent application may not be allowed, or any patent or our patents collectively may not provide adequate protection for our products and technology. In the absence of patent protection, we may be vulnerable to competitors who attempt to copy our products or gain access to our trade secrets and know-how. In addition, the laws of foreign countries may not protect our proprietary rights to this technology to the same extent as the laws of the U.S. We believe we have independently developed our technology and attempt to ensure that our
 
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products do not infringe the proprietary rights of others. We know of no such infringement claims. However, any claims could have a material adverse affect on our financial condition and results of operations.
 
        If our products fail or cause harm, we could be subject to substantial product liability, which could cause our business to suffer.    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. We currently maintain product liability insurance and, to date, have experienced only one product liability claim. There can be no assurance, however, that we will not be subject to a number of such claims, that our product liability insurance would cover such claims, or that adequate insurance will continue to be available to us on acceptable terms in the future. Our business could be adversely affected by product liability claims or by the cost of insuring against such claims.
 
        We are highly dependent on our key employees, and our business could suffer if they were to leave.     Our success depends on the retention of our executive officers, Mr. James O’Shea, Dr. Richard Stout, and Mr. Michael Redmond, and other key employees. Competition exists for qualified personnel and our success will depend, in part, on attracting and retaining qualified personnel. Failure in these efforts could have a material adverse effect on our business, financial condition or results of operations.
 
        There are a large number of shares eligible for sale into the public market in the near future, which may reduce the price of our Common Stock.    The market price of our Common Stock could decline as a result of sales of a large number of shares of our Common Stock in the market, or the perception that such sales could occur. We have a large number of shares of Common Stock outstanding and available for resale beginning at various points in time in the future. These sales also might make it more difficult for us to sell equity securities in the future at a time and at a price that we deem appropriate. The shares of our Common Stock currently outstanding will become eligible for sale without registration pursuant to Rule 144 under the Securities Act, subject to certain conditions of Rule 144. Certain holders of our Common Stock also have certain demand and piggyback registration rights enabling them to register their shares under the Securities Act for sale. Including shares being offered by this Prospectus, we have registered approximately 11 million shares for resale on Form S-3 registration statements, including approximately 3.3 million shares issuable upon exercise of warrants and 2.2 million shares issuable upon conversion of preferred stock held by Elan Pharmaceutical Investments, Ltd. In addition, we have approximately 400,000 shares of Common Stock reserved for issuance under our stock option plan. As of May 31, 2001, options to purchase approximately 1 million shares of Common Stock were outstanding and will be eligible for sale in the public market from time to time subject to vesting. These stock options generally have exercise prices significantly below the current price of our Common Stock. The possible sale of a significant number of these shares may cause the price of our Common Stock to fall.
 
        We may be unable to maintain our listing on Nasdaq, which could cause our stock price to fall and decrease the liquidity of our Common Stock.    Our Common Stock is quoted on the Nasdaq SmallCap Market. If we cannot comply with the continuing requirements, we may be delisted which could cause the stock price to fall and decrease the liquidity of our Common Stock for existing shareholders. There are a number of continuing requirements that must be met in order for the Common Stock to remain eligible for quotation on the Nasdaq SmallCap Market. The failure to meet the maintenance criteria in the future could result in the delisting of our 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 our Common Stock. In addition, if the Common Stock were delisted from trading on Nasdaq and the trading price of the Common Stock were 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 on 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.
 
        Our stock price may be highly volatile, which increases the risk of securities litigation.     The market for our Common Stock and for the securities of other early-stage, small market-capitalization companies has been
 
11
highly volatile in recent years. This increases the risk of securities litigation relating to such volatility. We believe that factors such as quarter-to-quarter fluctuations in financial results, reduction in the number of outstanding shares due to the recent reverse stock split, new product introductions by us or our competition, public announcements, changing regulatory environments, sales of Common Stock by certain existing shareholders, substantial product orders and announcement of licensing or product supply agreements with major pharmaceutical or biotechnology companies could contribute to the volatility of the price of our 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 our Common Stock.
 
12
 
USE OF PROCEEDS
 
        If all the Shares being offered by this Prospectus that are issuable upon exercise of warrants to purchase common stock are purchased from us, we will receive net proceeds of approximately $14.4 million. We expect to use the net proceeds from the exercise of the warrants for working capital and other general corporate purposes.
 
SELLING SHAREHOLDERS
 
        1,500,000 of the Shares being offered for resale by the Selling Shareholders were acquired pursuant to Subscription Agreements in a private placement that took place in May 2001. 344,898 of the Shares will be acquired upon exercise of our Series “V” Common Stock Purchase Warrants, which were issued as part of the May 2001 private placement. 130,000 of the Shares were acquired by the Selling Shareholders pursuant to Subscription Agreements in a private placement in June 2001. Another 29,900 of the Shares will be acquired upon exercise of our Series “W” Common Stock Purchase Warrants, which were issued as part of the June 2001 private placement. 20,000 of the Shares will be acquired upon exercise of our Series “U” Common Stock Purchase Warrants, which we issued to a consultant in November 2000 and May 2001. 12,000 of the Shares were acquired in connection with our acquisition of Vitajet Corporation in March of 1998. 1,108,000 of the Shares will be acquired upon exercise of warrants held by Elan Pharmaceutical Investments, Ltd. (“EPI”) issued in October 1997 and June 1999 and 2,169,048 of the Shares will be acquired upon conversion of preferred stock held by EPI issued in February 1998 and March 1999. The term “Selling Shareholder” includes persons acquiring such securities in permitted transfers from the original holders thereof in transactions not requiring registration under the Securities Act.
 
        The following table sets forth certain information regarding the beneficial ownership of shares of Common Stock by the Selling Shareholders as of June 6, 2001, and as adjusted to reflect the sale of the Shares.
 
       Amount of
common stock
beneficially owned
by shareholder
before this offering
      Amount offered
for selling
shareholder’s
account by
this prospectus
      Shares Owned
After Offering(A)
Name
      Number
      Percent
Leonard J. Adams      2,875 1      2,875      0      *
ANO LLC      2,875 2      2,875      0      *
Robert Apple      3,450 3      3,450      0      *
Don A. Backlund      3,680 4      3,680      0      *
Baker Street Capital Partners, L.P.       43,125 5      43,125      0      *
Baker Street Technology Partners, L.P.       43,125 6      43,125      0      *
Kevin Barbary and Deborah J. Barbary, JTWROS      3,450 7      3,450      0      *
Louis Barlow Trust      5,750 8      5,750      0      *
Barnett & Co.       115,000 9      115,000      0      *
Blinn Family Trust DTD 10/11/94, John C. Blinn III and
    Adriana E. Blinn TTEES		      5,750 10      5,750      0      *
Steven L. Bock IRA      2,875 11      2,875      0      *
William C. Brown      4,312 12      4,312      0      *
Ira Daniel Sherman & Darlene Bryant, JTWROS      5,750 13      5,750      0      *
Chase Nominees Ltd. For the Fleming US Discovery Trust      299,900 14      46,000      253,900      2.6
Chase Nominees Ltd. For FF US Micro Cap Fund      457,400 15      103,500      353,900      3.6
Andrew Chesnick and Lydia Chesnick, JTWROS      2,875 16      2,875      0      *
Janet R. Childs      2,875 17      2,875      0      *
John F. Combs      2,875 18      2,875      0      *
John Connor      8,625 19      8,625      0      *
Mark W. Cooper      2,875 20      2,875      0      *
Bear Stearns Security Corp. Custodian for Richard Cote      4,375 21      2,875      1,500      *
Gordon B. Crary III Trust dated 1/3/69, Gordon B. Crary
    TTEE		      2,875 22      2,875      0      *
John Langdon Crary Trust dated 8/12/72, John L. Crary TTEE    4,600 23    4,600    0    *
Alan R. Curtis    2,875 24    2,875    0    *
Joseph Cuzzupoli    2,875 25    2,875    0    *
 
13
 
       Amount of
common stock
beneficially owned
by shareholder
before this offering
      Amount offered
for selling
shareholder’s
account by
this prospectus
      Shares Owned
After Offering(A)
Name
      Number
      Percent
Robyn C. Davis    2,875 26    2,875    0      *  
David J. Day    11,500 27    11,500    0      *  
Diamond Point Fund    11,500 28    11,500    0      *  
Joseph DiBenedetto, Jr.     5,750 29    5,750    0      *  
Chris Di Napoli    2, 875 30    2,875    0      *  
Lester and Karla Ducote, JTWROS    5,750 31    5,750    0      *  
E-Fay Limited Partnership    8,750 32    5,750    3,000      *  
Bruce Efron    9,200 33    9,200    0      *  
Bear Stearns Security Corp. Custodian for Bruce Efron    5,175 34    5,175    0      *  
Elan Pharmaceutical Investments, Ltd.     3,822,503 35    3,277,048    545,455      5.6  
William S. Ellsworth M/P Pension Plan    3,375 36    2,875    500      *  
Dirk Foreman and Valeria Foreman, JTWROS    2,875 37    2,875    0      *  
Paul Fraser IRA    2,875 38    2,875    0      *  
Paul J. Fraser and Laurie C. Fraser, JTWROS    2,875 39    2,875    0      *  
William A. Galvin    5,750 40    5,750    0      *  
William H. Gaudreau Trust, 4/1/93, William Gaudreau TTEE    2,875 41    2,875    0      *  
David Goldberg BSSC Master Defined Contribution Profit
    Sharing Plan		    5,750 42    5,750    0      *  
Peter Grabler    2,875 43    2,875    0      *  
Donald D. Graham    6,325 44    6,325    0      *  
Charles J. Hammerstrom, Jr.     2,875 45    2,875    0      *  
Hare & Co.     80,500 46    80,500    0      *  
Simon Helfgott SEP IRA    2,875 47    2,875    0      *  
Daniel J. Hochman    5,525 48    4,025    1,500      *  
Joseph & Evelyn Jenkins, JTWROS    2,875 49    2,875    0      *  
Frank Kasilowski and Margaret Kasilowski, JTWROS    2,875 50    2,875    0      *  
Yi H. Kao M.D. and Marianne Kao, JTWROS    5,807 51    5,807    0      *  
James David Kelsey and Shari Jo Kelsey, JTWROS    2,875 52    2,875    0      *  
Harvey Kimmel    2,875 53    2,875    0      *  
LAB Partners    23,000 54    23,000    0      *  
Sergio Landau    74,816 55    12,000    62,816      *  
Jeffrey M. Lavin    5,750 56    5,750    0      *  
Leerink Swann & Company    130,400 57    130,400    0 57    * 57
Lighthouse Management L.P.     11,500 58    11,500    0      *  
Little Wing L.P.     108,100 59    108,100    0      *  
Steven K. Luminais and Elizabeth K. Luminais    2,875 60    2,875    0      *  
Norman A. Marowitz    5,750 61    5,750    0      *  
John P. McDonald    2,875 62    2,875    0      *  
Timothy W. McGibney and Kelly C. McGibney, JTWROS    2,875 63    2,875    0      *  
Thomas L. McGrath & Susan B. McGrath, JTWROS    5,750 64    5,750    0      *  
MedaCorp, Inc.    20,000 65    20,000    0      *  
Merlin BioMed II, L.P.     58,650 66    58,650    0      *  
Merlin BioMed III, L.P.     27,600 67    27,600    0      *  
Merlin BioMed International, Ltd.     118,450 68    118,450    0      *  
Merlin BioMed, L.P.     74,750 69    74,750    0      *  
Steven and Mark Mscisz, JTWROS    2,875 70    2,875    0      *  
Robert F. Mustard Trust dated 4/22/88, Robert F. Mustard
    TTEE		    2,875 71    2,875    0      *  
Ronald E. Myrick IRA    2,875 72    2,875    0      *  
Narragansett I, L.P.     47,437 73    47,437    0      *  
Narragansett Offshore, Ltd.     96,312 74    96,312    0      *  
James C. Neary    2,875 75    2,875    0      *  
 
14
 
       Amount of
common stock
beneficially owned
by shareholder
before this offering
      Amount offered
for selling
shareholder’s
account by
this prospectus
      Shares Owned
After Offering(A)
Name
      Number
      Percent
David E. Nelson and Rosie Nelson, JTWROS    3,875 76    2,875    1,000    *
John S. Newberry      2,875 77      2,875      0      *
NMJ Limited Partnership      3,450 78      3,450      0      *
Charles F. Norton Jr.       3,450 79      3,450      0      *
Mary H. Odoy      2,875 80      2,875      0      *
Pequot Navigator Offshore Fund, Inc.       78,500 81      57,500      21,000      *
Pequot Scout Fund, L.P.       178,500 82      57,500      121,000      1.2
Philosophe Nominee Trust, Ralph & Ruth Philosophe TTEES      4,025 83      4,025      0      *
Bear Stearns Security Corp. Custodian for Scott Pickett      2,875 84      2,875      0      *
Bear Stearns Security Corp. Custodian for Steven Pickett      5,750 85      5,750      0      *
Steven and Robin Pickett, JTWROS      11,500 86      11,500      0      *
Rainbow Trading Corporation      34,500 87      34,500      0      *
Steven M. Ratner 1999 Revocable Trust dtd 1/5/00, Steven M.
    Ratner TTEE		      2,875 88      2,875      0      *
Michael A. Russell Trust Dtd. 2/5/99, Michael A. Russell
    TTEE		      2,875 89      2,875      0      *
SAFCO Ultra Fund      43,125 90      43,125      0      *
Wayne Saker      11,500 91      11,500      0      *
Sands Point Partners      23,000 92      23,000      0      *
SBL Fund, Series J      129,375 93      129,375      0      *
Shuman & Ross PSP Trust F/B/O Howard S. Ross      2,875 94      2,875      0      *
Lois Silverman      2,875 95      2,875      0      *
Alan D. Solomont      2,875 96      2,875      0      *
Bear Stearns Security Corp. Custodian for Jack James Sorci      12,500 97      11,500      1,000      *
Samuel and Shirley Straface, JTWROS      3,450 98      3,450      0      *
Taib BioMed Fund, Ltd.       8,050 99      8,050      0      *
Todd Taplin      2,875 100      2,875      0      *
Jiri Tichy IRA      6,750 101      5,750      1,000      *
Toledano Capital LLC      13,800 102      13,800      0      *
Tradewinds Fund Ltd.       35,650 103      35,650      0      *
Tribophysics Corporation      17,250 104      17,250      0      *
Ursus Capital L.P.       36,800 105      36,800      0      *
Ursus Offshore LTD      9,200 106      9,200      0      *
West Coast Distributing Inc.       2,875 107      2,875      0      *
Brian D. White      2,875 108      2,875      0      *
Scott Wilfong      5,750 109      5,750      0      *
John Wilkinson      3,875 110      2,875      1,000      *
Worthington Growth, L.P.       57,500 111      57,500      0      *
Bear Stearns Security Corp. Custodian for George Yaffe      13,050 112      8,050      5,000      *
Bear Stearns Security Corp. Custodian for Richard B. Yaffe      2,875 113      2,875      0      *
Mark Zides      2,875 114      2,875      0      *
 *   
Less than 1 %
 
(A)  
Assumes that the Selling Shareholders will sell all Shares during the effective period.
 
   1   
Includes 2,500 shares of common stock and 375 shares of common stock subject to common stock purchase warrants.
 
   2   
Includes 2,500 shares of common stock and 375 shares of common stock subject to common stock purchase warrants.
 
   3   
Includes 3,000 shares of common stock and 450 shares of common stock subject to common stock purchase warrants.
 
15
 
   4   
Includes 3,200 shares of common stock and 480 shares of common stock subject to common stock purchase warrants.
 
   5   
Includes 37,500 shares of common stock and 5,625 shares of common stock subject to common stock purchase warrants.
 
   6   
Includes 37,500 shares of common stock and 5,625 shares of common stock subject to common stock purchase warrants.
 
   7   
Includes 3,000 shares of common stock and 450 shares of common stock subject to common stock purchase warrants.
 
   8   
Includes 5,000 shares of common stock and 750 shares of common stock subject to common stock purchase warrants.
 
   9   
Includes 100,000 shares of common stock and 15,000 shares of common stock subject to common stock purchase warrants.
 
  10   
Includes 5,000 shares of common stock and 750 shares of common stock subject to common stock purchase warrants.
 
  11   
Includes 2,500 shares of common stock and 375 shares of common stock subject to common stock purchase warrants.
 
  12   
Includes 3,750 shares of common stock and 562 shares of common stock subject to common stock purchase warrants.
 
  13   
Includes 5,000 shares of common stock and 750 shares of common stock subject to common stock purchase warrants.
 
  14   
Includes 293,900 shares of common stock and 6,000 shares of common stock subject to common stock purchase warrants.
 
  15   
Includes 443,900 shares of common stock and 13,500 shares of common stock subject to common stock purchase warrants.
 
  16   
Includes 2,500 shares of common stock and 375 shares of common stock subject to common stock purchase warrants.
 
  17   
Includes 2,500 shares of common stock and 375 shares of common stock subject to common stock purchase warrants.
 
  18   
Includes 2,500 shares of common stock and 375 shares of common stock subject to common stock purchase warrants.
 
  19   
Includes 7,500 shares of common stock and 1,125 shares of common stock subject to common stock purchase warrants.
 
  20   
Includes 2,500 shares of common stock and 375 shares of common stock subject to common stock purchase warrants.
 
  21   
Includes 4,000 shares of common stock and 375 shares of common stock subject to common stock purchase warrants.
 
  22   
Includes 2,500 shares of common stock and 375 shares of common stock subject to common stock purchase warrants.
 
  23   
Includes 4,000 shares of common stock and 600 shares of common stock subject to common stock purchase warrants.
 
  24   
Includes 2,500 shares of common stock and 375 shares of common stock subject to common stock purchase warrants.
 
  25   
Includes 2,500 shares of common stock and 375 shares of common stock subject to common stock purchase warrants.
 
16
 
  26   
Includes 2,500 shares of common stock and 375 shares of common stock subject to common stock purchase warrants.
 
  27   
Includes 10,000 shares of common stock and 1,500 shares of common stock subject to common stock purchase warrants.
 
  28   
Includes 10,000 shares of common stock and 1,500 shares of common stock subject to common stock purchase warrants.
 
  29   
Includes 5,000 shares of common stock and 750 shares of common stock subject to common stock purchase warrants.
 
  30   
Includes 2,500 shares of common stock and 375 shares of common stock subject to common stock purchase warrants.
 
  31   
Includes 5,000 shares of common stock and 750 shares of common stock subject to common stock purchase warrants.
 
  32   
Includes 8,000 shares of common stock and 750 shares of common stock subject to common stock purchase warrants.
 
  33   
Includes 8,000 shares of common stock and 1,200 shares of common stock subject to common stock purchase warrants.
 
  34   
Includes 4,500 shares of common stock and 675 shares of common stock subject to common stock purchase warrants.
 
  35   
Includes 545,455 shares of common stock, 1,108,000 shares of common stock subject to common stock purchase warrants and 2,169,048 shares of common stock issuable upon conversion of preferred stock.
 
  36   
Includes 3,000 shares of common stock and 375 shares of common stock subject to common stock purchase warrants.
 
  37   
Includes 2,500 shares of common stock and 375 shares of common stock subject to common stock purchase warrants.
 
  38   
Includes 2,500 shares of common stock and 375 shares of common stock subject to common stock purchase warrants.
 
  39   
Includes 2,500 shares of common stock and 375 shares of common stock subject to common stock purchase warrants.
 
  40   
Includes 5,000 shares of common stock and 750 shares of common stock subject to common stock purchase warrants.
 
  41   
Includes 2,500 shares of common stock and 375 shares of common stock subject to common stock purchase warrants.
 
  42   
Includes 5,000 shares of common stock and 750 shares of common stock subject to common stock purchase warrants.
 
  43   
Includes 2,500 shares of common stock and 375 shares of common stock subject to common stock purchase warrants.
 
  44   
Includes 5,500 shares of common stock and 825 shares of common stock subject to common stock purchase warrants.
 
  45   
Includes 2,500 shares of common stock and 375 shares of common stock subject to common stock purchase warrants.
 
  46   
Includes 70,000 shares of common stock and 10,500 shares of common stock subject to common stock purchase warrants.
 
  47   
Includes 2,500 shares of common stock and 375 shares of common stock subject to common stock purchase warrants.
 
17
 
  48   
Includes 5,000 shares of common stock and 525 shares of common stock subject to common stock purchase warrants.
 
  49   
Includes 2,500 shares of common stock and 375 shares of common stock subject to common stock purchase warrants.
 
  50   
Includes 2,500 shares of common stock and 375 shares of common stock subject to common stock purchase warrants.
 
  51   
Includes 5,050 shares of common stock and 757 shares of common stock subject to common stock purchase warrants.
 
  52   
Includes 2,500 shares of common stock and 375 shares of common stock subject to common stock purchase warrants.
 
  53   
Includes 2,500 shares of common stock and 375 shares of common stock subject to common stock purchase warrants.
 
  54   
Includes 20,000 shares of common stock and 3,000 shares of common stock subject to common stock purchase warrants.
 
  55   
Includes 3,000 shares of common stock held in the name of Mara Landau, Sergio Landau’s wife.
 
  56   
Includes 5,000 shares of common stock and 750 shares of common stock subject to common stock purchase warrants.
 
  57   
Includes 130,400 shares of common stock subject to common stock purchase warrants. Leerink Swann & Company is a market maker in the Company’s common stock and accordingly holds shares of common stock in varying amounts as inventory.
 
  58   
Includes 10,000 shares of common stock and 1,500 shares of common stock subject to common stock purchase warrants.
 
  59   
Includes 94,000 shares of common stock and 14,100 shares of common stock subject to common stock purchase warrants.
 
  60   
Includes 2,500 shares of common stock and 375 shares of common stock subject to common stock purchase warrants.
 
  61   
Includes 5,000 shares of common stock and 750 shares of common stock subject to common stock purchase warrants.
 
  62   
Includes 2,500 shares of common stock and 375 shares of common stock subject to common stock purchase warrants.
 
  63   
Includes 2,500 shares of common stock and 375 shares of common stock subject to common stock purchase warrants.
 
  64   
Includes 5,000 shares of common stock and 750 shares of common stock subject to common stock purchase warrants.
 
  65   
Includes 20,000 shares subject to common stock purchase warrants.
 
  66   
Includes 51,000 shares of common stock and 7,650 shares of common stock subject to common stock purchase warrants.
 
  67   
Includes 24,000 shares of common stock and 3,600 shares of common stock subject to common stock purchase warrants.
 
  68   
Includes 103,000 shares of common stock and 15,450 shares of common stock subject to common stock purchase warrants.
 
  69   
Includes 65,000 shares of common stock and 9,750 shares of common stock subject to common stock purchase warrants.
 
  70   
Includes 2,500 shares of common stock and 375 shares of common stock subject to common stock purchase warrants.
 
18
 
  71   
Includes 2,500 shares of common stock and 375 shares of common stock subject to common stock purchase warrants.
 
  72   
Includes 2,500 shares of common stock and 375 shares of common stock subject to common stock purchase warrants.
 
  73   
Includes 41,250 shares of common stock and 6,187 shares of common stock subject to common stock purchase warrants.
 
  74   
Includes 83,750 shares of common stock and 12,562 shares of common stock subject to common stock purchase warrants.
 
  75   
Includes 2,500 shares of common stock and 375 shares of common stock subject to common stock purchase warrants.
 
  76   
Includes 3,500 shares of common stock and 375 shares of common stock subject to common stock purchase warrants.
 
  77   
Includes 2,500 shares of common stock and 375 shares of common stock subject to common stock purchase warrants.
 
  78   
Includes 3,000 shares of common stock and 450 shares of common stock subject to common stock purchase warrants.
 
  79   
Includes 3,000 shares of common stock and 450 shares of common stock subject to common stock purchase warrants.
 
  80   
Includes 2,500 shares of common stock and 375 shares of common stock subject to common stock purchase warrants.
 
  81   
Includes 71,000 shares of common stock and 7,500 shares of common stock subject to common stock purchase warrants.
 
  82   
Includes 171,000 shares of common stock and 7,500 shares of common stock subject to common stock purchase warrants.
 
  83   
Includes 3,500 shares of common stock and 525 shares of common stock subject to common stock purchase warrants.
 
  84   
Includes 2,500 shares of common stock and 375 shares of common stock subject to common stock purchase warrants.
 
  85   
Includes 5,000 shares of common stock and 750 shares of common stock subject to common stock purchase warrants.
 
  86   
Includes 10,000 shares of common stock and 1,500 shares of common stock subject to common stock purchase warrants.
 
  87   
Includes 30,000 shares of common stock and 4,500 shares of common stock subject to common stock purchase warrants.
 
  88   
Includes 2,500 shares of common stock and 375 shares of common stock subject to common stock purchase warrants.
 
  89   
Includes 2,500 shares of common stock and 375 shares of common stock subject to common stock purchase warrants.
 
  90   
Includes 37,500 shares of common stock and 5,625 shares of common stock subject to common stock purchase warrants.
 
  91   
Includes 10,000 shares of common stock and 1,500 shares of common stock subject to common stock purchase warrants.
 
  92   
Includes 20,000 shares of common stock and 3,000 shares of common stock subject to common stock purchase warrants.
 
19
 
  93   
Includes 112,500 shares of common stock and 16,875 shares of common stock subject to common stock purchase warrants.
 
  94   
Includes 2,500 shares of common stock and 375 shares of common stock subject to common stock purchase warrants.
 
  95   
Includes 2,500 shares of common stock and 375 shares of common stock subject to common stock purchase warrants.
 
  96   
Includes 2,500 shares of common stock and 375 shares of common stock subject to common stock purchase warrants.
 
  97   
Includes 11,000 shares of common stock and 1,500 shares of common stock subject to common stock purchase warrants.
 
  98   
Includes 3,000 shares of common stock and 450 shares of common stock subject to common stock purchase warrants.
 
  99   
Includes 7,000 shares of common stock and 1,050 shares of common stock subject to common stock purchase warrants.
 
100   
Includes 2,500 shares of common stock and 375 shares of common stock subject to common stock purchase warrants.
 
101   
Includes 6,000 shares of common stock and 750 shares of common stock subject to common stock purchase warrants.
 
102   
Includes 12,000 shares of common stock and 1,800 shares of common stock subject to common stock purchase warrants.
 
103   
Includes 31,000 shares of common stock and 4,650 shares of common stock subject to common stock purchase warrants.
 
104   
Includes 15,000 shares of common stock and 2,250 shares of common stock subject to common stock purchase warrants.
 
105   
Includes 32,000 shares of common stock and 4,800 shares of common stock subject to common stock purchase warrants.
 
106   
Includes 8,000 shares of common stock and 1,200 shares of common stock subject to common stock purchase warrants.
 
107   
Includes 2,500 shares of common stock and 375 shares of common stock subject to common stock purchase warrants.
 
108   
Includes 2,500 shares of common stock and 375 shares of common stock subject to common stock purchase warrants.
 
109   
Includes 5,000 shares of common stock and 7,50 shares of common stock subject to common stock purchase warrants.
 
110   
Includes 3,500 shares of common stock and 375 shares of common stock subject to common stock purchase warrants.
 
111   
Includes 50,000 shares of common stock and 7,500 shares of common stock subject to common stock purchase warrants.
 
112   
Includes 12,000 shares of common stock and 1,050 shares of common stock subject to common stock purchase warrants.
 
113   
Includes 2,500 shares of common stock and 375 shares of common stock subject to common stock purchase warrants.
 
114   
Includes 2,500 shares of common stock and 375 shares of common stock subject to common stock purchase warrants.
 
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        Leerink Swann & Company (“Leerink”) acted as placement agent for the Company in connection with the private placements of Common Stock in May and June 2001. Leerink received fees of approximately $1.1 million and warrants to purchase an aggregate of 130,400 shares of Common Stock in connection with these services. In addition, MedaCorp, Inc., an affiliate of Leerink, is providing consulting services to Bioject pursuant to a consulting agreement under which MedaCorp, Inc. is paid $7,500 per month and has received warrants to purchase 20,000 shares of Common Stock.
 
        On September 30, 1997, the Company entered into an agreement with Elan Corporation, plc (“Elan”) to develop and commercialize Elan’s blood glucose monitoring technology, as well as to collaborate on further development of the Company’s jet injection technology. In order to accomplish these goals, Marathon Medical Technologies Inc. (“Marathon”) was formed, which was owned 80.1% by Bioject and 19.9% by Elan International Services, Ltd. (“EIS”), an affiliate of Elan. In accordance with the agreement and the formation of Marathon, EIS contributed capital to the Company and received shares of the Company’s common and preferred stock as follows:
 
Ÿ  
In October 1997, EIS invested $2.8 million in Bioject in exchange for 545,455 shares of common stock and a five year warrant to purchase 350,000 shares of common stock at $12.50 per share;
 
Ÿ  
In February 1998, in exchange for the cancellation of a long-term promissory note due EIS for $12.015 million, the Company issued 692,694 shares of its Series A Convertible Preferred Stock for $10 million of the note plus accrued interest and 134,333 shares of its Series B Convertible Preferred Stock for $2.015 million of the note, with the Series A Convertible Preferred Stock accruing dividends at the rate of 9% per annum (compounded semi-annually) and the Series B Convertible Preferred Stock accruing no mandatory dividends.
 
Ÿ  
The issuance of $2.4 million of Series C Convertible Preferred Stock in March 1999 in exchange for additional funding for Marathon.
 
        In May 1999, rather than continue to fund the cost of its development, the Company entered into negotiations to sell Marathon’s blood glucose monitoring technology, and certain fixed assets related to developing the technology, to a third party. The sale was completed on June 30, 1999. In connection with the sale and the Company’s related purchase of EIS’ interest in Marathon at June 30, 1999, the Company and EIS agreed to certain changes in the terms of EIS’ Series A and Series B Convertible Preferred Stock (“Series A Stock” and “Series B Stock”), including modifying the conversion price of the Series A Stock and giving the Company the right to redeem the Series A Stock. EIS also exchanged its Series B Stock, which would have been convertible into a minimum of 268,000 shares of the Company’s common stock without additional cash payments, for a warrant that expires June 30, 2006 to purchase 758,000 shares of Bioject’s common stock for $7.50 per share. EIS subsequently assigned its warrants and preferred stock to Elan Pharmaceutical Investments, Ltd. (“EPI”).
 
        Pursuant to the Securities Purchase Agreement dated October 15, 1997, between EIS and the Company, EIS has the right to designate one director to be nominated for election so long as it owns 5% of the Company’s common stock on a fully diluted basis (10% after October 15, 2004). EIS has assigned its rights under this agreement to EPI. Sandra Panem is EPI’s designee.
 
        No other Selling Shareholder has held any position or office, or other material relationship with Bioject or any of its predecessors or affiliates within the past three years.
 
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PLAN OF DISTRIBUTION
 
        We are registering shares of common stock on behalf of the Selling Shareholders. “Selling Shareholders” includes donees, pledgees, transferees or successors-in-interest selling securities received from a named Selling Shareholder as a gift, pledge, partnership distribution or other non-sale related transfer after the date of this Prospectus. The Selling Shareholders will offer and sell the securities to which this Prospectus relates for their own accounts. We will not receive any proceeds from the sale of the securities. All costs, expenses and fees in connection with the registration of the securities offered hereby will be borne by us. Brokerage commissions and similar selling expenses, if any, attributable to the sale of securities will be borne by the Selling Shareholders. Sales of the securities may be effected by Selling Shareholders from time to time in one or more types of transactions, including block transactions,
 
Ÿ  
on the Nasdaq SmallCap Market,
 
Ÿ  
in the over-the-counter market,
 
Ÿ  
in negotiated transactions,
 
Ÿ  
through put or call options transactions relating to the shares, and
 
Ÿ  
through short sales of shares,
 
or a combination of these methods of sale or through any lawful manner, at market prices prevailing at the time of sale, or at negotiated prices. These transactions may or may not involve brokers or dealers. The Selling Shareholders have advised us that they have not entered into any agreements, understandings or arrangements with any underwriters or broker-dealers regarding the sale of their securities, nor is there an underwriter or coordinating broker acting in connection with the proposed sale of securities by the Selling Shareholders.
 
        The Selling Shareholders may sell securities directly to purchasers or to or through broker-dealers, which may act as agents or principals. The broker-dealers may receive compensation in the form of discounts, concessions, or commissions from the Selling Shareholders and/or the purchasers of shares for whom such broker-dealers may act as agents or to whom they sell as principal, or both. This compensation as to a particular broker-dealer might be in excess of customary commissions.
 
        The Selling Shareholders and any broker-dealers that act in connection with the sale of securities might be deemed to be “underwriters” within the meaning of Section 2(11) of the Securities Act, and any commissions received by these broker-dealers and any profit on the resale of the securities sold by them while acting as principals might be deemed to be underwriting discounts or commissions under the Securities Act. We have agreed to indemnify each Selling Shareholder against specified liabilities, including liabilities arising under the Securities Act. The Selling Shareholders may agree to indemnify any agent, dealer or broker-dealer that participates in transactions involving sales of the securities against certain liabilities, including liabilities arising under the Securities Act.
 
        Because Selling Shareholders may be deemed to be “underwriters” within the meaning of Section 2(11) of the Securities Act, the Selling Shareholders will be subject to the prospectus delivery requirements of the Securities Act. We have informed the Selling Shareholders that the anti-manipulative provisions of Regulation M promulgated under the Exchange Act may apply to their sales in the market.
 
        Selling Shareholders also may resell all or a portion of the securities in open market transactions in reliance upon Rule 144 under the Securities Act, provided they meet the criteria and conform to the requirements of that rule.
 
        If we are notified by a Selling Shareholder that any material arrangement has been entered into with a broker-dealer for the sale of securities through a block trade, special offering, exchange distribution or secondary
 
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distribution or a purchase by a broker or dealer, a supplement to this Prospectus will be filed, if required, under Rule 424(b) under the Act, disclosing
 
Ÿ  
the name of each such Selling Shareholder and of the participating broker-dealer(s),
 
Ÿ  
the number of securities involved,
 
Ÿ  
the price at which such securities were sold,
 
Ÿ  
the commissions paid or discounts or concessions allowed to such broker-dealer(s), where applicable,
 
Ÿ  
that such broker-dealer(s) did not conduct any investigation to verify the information set out or incorporated by reference in this prospectus and
 
Ÿ  
other facts material to the transaction.
 
        In addition, if we are notified by a Selling Shareholder that a donee, pledgee, transferee or other successor-in-interest intends to sell more than 500 shares of common stock or preferred stock, a supplement to this Prospectus will be filed.
 
LEGAL MATTERS
 
        The validity of the issuance of the shares of Common Stock offered hereby will be passed upon for us by Stoel Rives LLP, Portland, Oregon.
 
EXPERTS
 
        The financial statements and schedules 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.
 
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