-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, VdEGeHtxQ52a0sLP9msipXGOilHHMBk8PYIJOXREJIuSUlim/0t45Q/iGATV/S7l eVONepa/OKcXj96ZyVUdzA== 0000950135-00-001901.txt : 20000331 0000950135-00-001901.hdr.sgml : 20000331 ACCESSION NUMBER: 0000950135-00-001901 CONFORMED SUBMISSION TYPE: 10-K405 PUBLIC DOCUMENT COUNT: 7 CONFORMED PERIOD OF REPORT: 19991231 FILED AS OF DATE: 20000330 FILER: COMPANY DATA: COMPANY CONFORMED NAME: AMERICAN BIOGENETIC SCIENCES INC CENTRAL INDEX KEY: 0000856984 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 112655906 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-K405 SEC ACT: SEC FILE NUMBER: 000-19041 FILM NUMBER: 588549 BUSINESS ADDRESS: STREET 1: 1375 AKRON STREET STREET 2: P O BOX 1001 CITY: COPIAGUE STATE: NY ZIP: 11726 BUSINESS PHONE: 5167892600 10-K405 1 AMERICAN BIOGENETIC SCIENCES, INC. 1 SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K [X] ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE FISCAL YEAR ENDED DECEMBER 31, 1999 [ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM _______ TO _______ COMMISSION FILE NUMBER 0-19041 AMERICAN BIOGENETIC SCIENCES, INC. ------------------------------------------------------ (EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER) DELAWARE 11-2655906 - ------------------------------- ------------------------------------ (STATE OR OTHER JURISDICTION OF (I.R.S. EMPLOYER IDENTIFICATION NO.) INCORPORATION OR ORGANIZATION) 1375 AKRON STREET, COPIAGUE NEW 11726 --------------------------------------------------- (ADDRESS OF PRINCIPAL EXECUTIVE OFFICES) (ZIP CODE) 631-789-2600 ---------------------------------------------------- (REGISTRANT'S TELEPHONE NUMBER, INCLUDING AREA CODE) SECURITIES REGISTERED PURSUANT TO SECTION 12(b) OF THE ACT: NONE SECURITIES REGISTERED PURSUANT TO SECTION 12(g) OF THE ACT: CLASS A COMMON STOCK -------------------- (TITLE OF CLASS) Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes _X_ No ___ Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of registrant's knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. [X] As of the close of business on March 17, 2000, there were outstanding 40,486,865 shares of the registrant's Class A Common Stock and 3,000,000 shares of its Class B Common Stock. The approximate aggregate market value (based upon the closing price on the OTC Bulletin Board) of shares held by non-affiliates of the registrant as of March 17, 2000 was $94,986,000. DOCUMENTS INCORPORATED BY REFERENCE Portions of the registrant's Proxy Statement relating to its 2000 Annual Meeting of Stockholders are incorporated by reference into Part III of this report. 2 CAUTIONARY STATEMENT FOR THE PURPOSES OF THE "SAFE HABOR" PROVISIONS OF THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995 This Report contains forward-looking statements. The words "believe," "expect," "anticipate," "estimate," "may," "will," "plan," "intend," "could," "estimate," "is being," "goal" and other expressions which are predictions of or indicate future events and trends and which do not relate to historical matters identify forward-looking statements. Such forward-looking statements are subject to a number of known and unknown risks and uncertainties that, in addition to general economic and business conditions (both in the United States and in the overseas markets where the Company intends to distribute products), could cause the Company's anticipated results, performance and achievements to differ materially from those described or implied in the forward-looking statements. Examples of these risks and uncertainties include, without limitation, the Company's ability to complete products under development and to maintain superior technological capability, foresee changes and identify, develop and commercialize innovative and competitive products (see "--Products Under Development"), obtain widespread acceptance of its products by the medical community, including the reliability, safety and effectiveness of such products (see "--Marketing and Sales"), meet competition (see "--Competition"), comply with various governmental regulations related to the Company's products and obtain government clearance to market its products (see "--Government Regulation"), successfully expand its manufacturing capability (see "--Manufacturing"), attract and retain technologically qualified personnel (see "--Personnel"), and generate cash flows and obtain collaborative or other arrangements with pharmaceutical companies or obtain other financing to support its product development testing and marketing operations and growth (see "Management's Discussion and Analysis of Financial Condition and Results of Operations" in Item 7 of this Report). In addition to the foregoing, the Company's actual future results could differ materially from those projected in the forward-looking statements as a result of the risk factors set forth in the Company's various filings with the Securities and Exchange Commission and of changes in general economic conditions, changes in interest rates and changes in the assumptions used in making such forward-looking statements. The Company undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise. 3 PART I ITEM 1. BUSINESS SUMMARY American Biogenetic Sciences, Inc. ("ABS" or the "Company") is engaged in researching, developing and marketing cardiovascular and neurobiology products for commercial development. The Company commenced selling its products during the last quarter of 1997. The Company's products are designed for in vitro and in vivo diagnostic procedures and therapeutic drugs. In vitro diagnostic procedures are those in which blood, urine or other bodily fluid or tissue is extracted from the body and diagnostic tests are performed in a test tube or other laboratory equipment. In vivo diagnostic procedures are those in which proteins or compounds are injected directly into the body or bloodstream to assess abnormal reactions or conditions. The Company's therapeutic products have been identified for the treatment of epilepsy, migraine and mania and neurodegenerative diseases. At the present time ABS' principal products or activities are: - THROMBUS PRECURSOR PROTEIN DIAGNOSTIC TEST (TpP(TM)). This is an in vitro diagnostic test used to assess the risk of blood clots in the veins or arteries. This test is also used to monitor the performance of anti-clotting therapy or drugs used in the prevention of blood clots. - FUNCTIONAL INTACT FIBRINOGEN DIAGNOSTIC TEST (FiF(R)). This is an in vitro diagnostic test which measures the levels of fibrinogen in blood. Fibrinogen is a protein used in the blood-clotting process. - THERAPEUTIC NEUROCOMPOUNDS. These are chemical compounds which have been identified for the treatment of epilepsy, migraine and mania and neurodegenerative diseases. - IN VITRO DIAGNOSTIC PRODUCTS FOR INFECTIOUS AND AUTO-IMMUNE DISEASE. These can determine the status of such diseases as human herpes and lupus. - MOUSE SERUM. This is a blood component that lacks blood cells which is used in diagnostic tests by major in vitro diagnostic product manufacturers for a variety of purposes. ABS was incorporated in Delaware in September 1983. The Company's principal executive offices are located at 1375 Akron Street, Copiague, New York 11726 and its telephone number is 631-789-2600. 4 CORE TECHNOLOGIES THE ANTIGEN-FREE MOUSE COLONY - MONOCLONAL ANTIBODIES One of the Company's core technologies is a patented antigen-free mouse colony which allows the generation of highly specific monoclonal antibodies that are difficult to obtain from conventional systems. The Company utilizes this technology to supply antibodies for its in vitro and in vivo diagnostic products. The proprietary antigen-free mouse colony is maintained in a germ-free environment and fed a chemically defined and ultrafiltered diet. When the antigen-free mice are challenged with a foreign entity, there is a large immune response that eventually results in the proliferation of a large number of antibody secreting cells with a spectrum of specificities to the foreign entity. The Company holds several United States patents covering the antigen-free mouse colony and methods of producing antibodies relating to it. See "--Intellectual Property." THERAPEUTIC NEUROCOMPOUNDS The Company has developed a series of neurocompounds for possible treatment of epilepsy, migraine, mania and neurodegeneration diseases. CURRENT PRODUCTS MEDICAL BACKGROUND FOR CARDIOVASCULAR PRODUCTS Using its antigen-free mouse colony, the Company developed patented two antibodies, 45J and MH1. These antibodies react specifically with both fibrinogen (a blood protein) and fibrin (a component of blood clots). These antibodies are used in two of ABS' main products, the FiF and TpP tests. These tests assist doctors in diagnosing blood clots lodged in the legs and the lungs, known as thrombosis. Blood clots that form in the bloodstream consist of two major parts: - a cellular component made up of platelets; and - a meshwork of fibrin fibers that cements the platelets into an insoluble mass which has the mechanical strength to withstand the pressure of blood in the circulation. The fibrin component is insoluble and is derived from fibrinogen, a blood protein that is manufactured in the liver. When thrombin, an enzyme produced in response to injury of a blood vessel, is present in blood, it converts soluble fibrinogen into fibrin at the site of vascular injury. Similarly, the generation of plasmin plays the major role in fragmentation of the fibrin meshwork, a process known as fibrinolysis. Like thrombin, plasmin does not ordinarily circulate in plasma but is derived from the circulating protein plasminogen when the fibrinolytic system is activated. In addition to causing fragmentation of fibrin, plasmin also attacks fibrinogen and 2 5 institutes changes in its structure that prevent its polymerization to fibrin. In extreme cases, this process, called fibrinogenolysis, can lead to bleeding caused by lack of clottable fibrinogen. Fragmentation of fibrin leads to the production of soluble fibrin degradation products that circulate in plasma and are generally elevated in patients following a thrombotic event. Since all these products are proteins, it is possible to produce antibodies that can react specifically with individual fibrin degradation products. Electrophoretic techniques have identified soluble fibrin polymers in the plasma of patients with different clinical conditions, including myocardial infarction and deep vein thrombosis. Laboratory tests have also reported elevated soluble fibrin levels in other clinical intravascular fibrin formation conditions, including disseminated intravascular coagulation and patients undergoing surgical procedures who are experiencing thrombotic complications. Thrombosis itself can be fatal. It is also associated with a number of other medical conditions, such as heart attack, stroke, and complications from pregnancy. Some of the most hazardous sites for blood clot formation include the coronary arteries where a blood clot can lead to myocardial infarction (heart attack); the arteries leading to the brain, where a blood clot can cause stroke; and the veins of the legs which can lead to a pulmonary embolism. There are approximately 12 million surgical procedures performed each year in the United States alone which put patients at risk of forming a blood clot. Approximately 10 million people in the United States go to emergency rooms each year due to chest pain. However, as many as 80% of these individuals are not suffering heart attacks and may have from some less serious conditions. An early warning test that establishes those patients that are not having a heart attack will eliminate expensive diagnostic procedures and unnecessary hospital admissions. Furthermore, the early identification of those patients who are forming life threatening blood clots or suffering from a heart attack would permit earlier use of clot dissolving drugs or anticoagulants. Current biochemical tests for acute myocardial infarction measure cardiac muscle proteins which leak out as a result of dying heart muscle. This release of cardiac specific proteins only occurs 4-6 hours after the onset of clinical symptoms. There is a strong clinical need for an earlier warning of myocardial infarction. The detection of blood clot formation early in the clinical event should facilitate proper identification and treatment of myocardial infarction patients with life saving, clot dissolving drugs. Several epidemiological studies have revealed a significant causal relationship between high fibrinogen levels and coronary artery disease. It is widely accepted that events leading to coronary artery disease are caused as much by biochemical processes in the coagulation (blood-clotting) system as by the metabolism of cholesterol. The most important landmark trial to show a causal relationship between high fibrinogen and coronary artery disease is the Framingham epidemiology study (1985) conducted at the Institute for Prevention of Cardiovascular Disease at 3 6 the Deaconess Hospital, Harvard Medical School. That study concluded that elevated levels of fibrinogen "exceeded that of all risk factors except elevated systolic blood pressure." Other studies indicate that individuals with elevated levels of fibrinogen are predisposed to thrombosis. On the other hand, diminished levels may result in hemorrhage. Thus, reagents that can be used to measure fibrinogen can play a vital role in determining the appropriate level of thrombolytic therapy, as well as determine an individual's risk of coronary artery disease. THROMBUS PRECURSOR PROTEIN ASSAY (TpP) The Company's Thrombus Precursor Protein Assay (TpP) is an in vitro diagnostic enzyme test using the Company's patented monoclonal antibodies MH1 and 45J to measure soluble fibrin polymers in blood to indicate active blood clot formation (thrombosis) in individuals with possible myocardial infarction and other clinical conditions precipitated by clot formation. TpP provides a means to measure intravascular coagulation (fibrin formation) in post-operative patients to determine the risk of deep vein thrombosis and its clinical sequelae, pulmonary embolism. It has also been demonstrated that thrombosis precursor protein levels are significantly lower in patients who are undergoing invasive surgical procedures and have been adequately anticoagulated. TpP relies on the measurement of soluble fibrin polymers which are produced and circulate freely when a clot starts to form, even before the onset of clinical symptoms, and is elevated when the patient first begins to experience chest pain. TpP is also expected to offer physicians a screening tool to monitor patients post-operatively for blood clot formation and to effect therapeutic intervention if required and monitor their response to anticoagulant therapy. A study using TpP to monitor patients post-operatively was conducted at Johns Hopkins School of Medicine and a second at the University of Perugia, Italy in 1997. These studies showed that thrombosis precursor protein was elevated post operatively. The Company has patented: - the TpP test kit itself; - the antibodies used to recognize the presence of thrombosis precursor protein in blood; and - the use of TpP to measure intravascular fibrin polymer formation in patients with symptoms indicating a blood clotting event. See "--Intellectual Property." In October 1996, ABS received 510(k) clearance from the FDA to market TpP to aid in the risk assessment of blood clot formation and the monitoring of anticoagulant therapy. See "--Government Regulation." The Company began to market TpP in late 1997 through independent distributors. 4 7 In 1998 and 1999, ABS put additional effort into clinical evaluation of TpP with the goal to characterize the most promising applications and demonstrate the advantages of TpP over competitor products. Dr. Yale Arkel was appointed as the Company's Coordinator of Clinical Development for TpP. Dr. Arkel is an outside consultant to the Company. In addition, ABS has developed a hand-held, disposable, rapid assay device which measures TpP levels in plasma. The prototype of a hand-held device for obtaining semi-quantitative test results (i.e. qualitative test results derived from numerical data) has been produced and the Company plans to submit a 510(k) to the FDA for marketing approval of the rapid assay format TpP test in 2000. The Company believes that the more user-friendly and rapid point-of-care format will greatly enhance the market opportunity for the TpP test. The Company intends to seek outside sources for the manufacture of its point-of-care device and corporate partners to market this product. FUNCTIONAL INTACT FIBRINOGEN ASSAY (FiF) The Company's Functional Intact Fibrinogen Assay (FiF) is an in vitro diagnostic tool using the Company's patented monoclonal antibody, 45J, to provide a direct and accurate quantitative measurement of the amount of fibrinogen present in plasma. FiF has received FDA approval for use. See "--Intellectual Property." Traditional clotting tests are an indirect measure of fibrinogen, estimated by the amount of time that passes before a clot is formed, which can be influenced by the presence of degradation products of fibrin/fibrinogen. FiF, on the other hand, is a direct measure of fibrinogen that is not adversely influenced by these products. In May 1996, a research group of the Framingham Heart Study reported that FiF is an accurate method of detecting elevated fibrinogen levels, a risk factor for cardiovascular disease. Furthermore, the findings demonstrated that the fibrinogen levels measured by FiF were correlated with the prevalence of cardiovascular disease both by itself and when adjusted for age, weight, smoking and diabetes. The Company has been marketing FiF in a manual format kit since late 1997 and continues to seek corporate partners to include FiF on automated diagnostic testing equipment. THERAPEUTIC NEUROCOMPOUNDS The Company has developed a series of neurocompounds for possible treatment of epilepsy, migraine, mania and neurodegenerative diseases. Epilepsy; Migraine; Mania. ABS is developing a series of anticonvulsant compounds which have improved properties compared to valproate, a significant drug which is currently used for the treatment of epilepsy, migraine and mania. In pre-clinical trials in Germany, one of these compounds, ABS-103, has been shown to control seizure activity without any of the sedative action or side effects commonly associated with other anticonvulsants. 5 8 Scientists have recently discovered that, many drugs exist as two forms, enantiomers, which are mirror images of each other and where one of the enantiomers is responsible for the therapeutic effects and the other enantiomer may be inactive or cause unwanted side effects. R-103 is the preferred chemical entity for commercial development. The Company has isolated the R- enantiomer (R-103) of ABS-103. ABS scientists were able to isolate the R (right) enantiomer from the S (left) to produce R-103. The value of isolating R-103 lies in its superior safety and efficacy profile. The Company has patented the use of ABS-103 as an anticonvulsant in the U.S. and in Europe and additional applications relating to this technology are pending. See "--Intellectual Property." In January 2000, ABS entered into a license agreement with Abbott Laboratories ("Abbott") granting Abbott exclusive worldwide rights to ABS-103 for certain applications. See "--Marketing and Sales." Neurodegenerative Diseases. The Company, in collaboration with the National University of Ireland, Dublin, University of Hanover, Germany, University of Notre Dame, United States and fellow researchers within the Global Scientific Network(R), has identified certain chemical compounds for the potential treatment of neurodegenerative diseases, designated as the ABS 200 series. See"--Research and Development Agreements -Global Scientific Network." The ABS 200 series of compounds are putative neuroprotectants designed to treat and halt the progression of neurodegenerative diseases. The compounds have been evaluated in cells where they exhibit nerve growth factor-like activity. The ABS 200 series of compounds can penetrate the blood-brain barrier, unlike nerve growth factor, which requires specific development of a delivery system. One of the ABS 200 Series compounds, ABS-205, has been shown to induce the expression of a protein known as neural cell adhesion molecule in vitro. Neural cell adhesion molecule is involved in memory, neurodevelopment and other neuroplastic events. ABS-205 also has been shown to enhance neural cell adhesion molecule function in the rat hippocampus and cortex, areas known to be involved in memory formation. Moreover, ABS-205 protects against chemical induced memory loss (amnesia) in animals. The Company has patented this technology in the United States. See "--Intellectual Property." The Company has also developed the ABS 300 series of compounds relating to small molecules which may be useful for enhancing memory. It has filed two United States patent applications relating to this series of compounds. IN VITRO DIAGNOSTIC PRODUCTS FOR INFECTIOUS AND AUTO-IMMUNE DISEASE The Company also owns a series of in vitro diagnostic products for infectious and auto-immune disease. These products are manufactured and distributed by the Company's wholly owned subsidiary, Stellar Bio Systems, Inc. ("Stellar"). Stellar manufactures in vitro 6 9 immunodiagnostic assays utilizing an immunofluorescent antibody assay format. These assays determine the presence of various infectious diseases and autoimmune conditions. including: - - human herpes simplex virus 1; - human parvovirus B-19; - - human herpes simplex virus 2; - measles virus; - - Epstein-Barr virus; - rubella virus; - - cytomegalovirus; - adenovirus; - - varicella zoster virus; - mumps virus; - - respiratory syncytial virus; - antinuclear bodies Hep-2; - - human herpes virus 6; - anti-nuclear bodies KB; - - human herpes virus 7; - anti- mitochondrial bodies; and - anti-native DNA bodies. MOUSE SERUM; RESEARCH REAGENTS Stellar also is the largest domestic provider of high quality mouse serum. Stellar's mouse serum is used as an assay component by in vitro diagnostic assay manufacturers. Stellar additionally provides contract services for the development, process scale up, manufacture and purification of research reagents such as monoclonal and polyclonal antibodies. Research reagents are individual components of diagnostic products, such as antibodies, calibrators and serum used in the biotechnology industry. PRODUCTS UNDER DEVELOPMENT MH1 MH1 as an Imaging Agent. ABS has labeled an antibody fragment of its MH1 antibody that contains the binding site for fibrin with a radioisotope for use as an in vivo imaging agent to show the size and location of blood clots. Images have been generated in pre-clinical animal studies and clinical human studies with the resolution required for commercial use. The product is intended to permit the rapid imaging of blood clots in the lungs, a condition known as pulmonary embolism, and the detection of blood clots in the legs (deep vein thrombosis). The primary protein component of a thrombus is fibrin, and an antibody that can differentiate fibrin from its plasma precursor, fibrinogen, can be used when, appropriately labeled with a radioisotope, to image the site and extent of an occlusion and to carry thrombolytic reagents to the site. Traditional methods for detecting a thrombus in the circulatory system have consisted of angiography, venography, duplex doppler and monitoring radio labeled blood clot components, derived from a human donor, injected into the circulatory system and then absorbed by the clot. These procedures are costly, often may lack sensitivity and some can pose potential risks to the patient. The large quantity of dye required in angiography and venography may cause kidney problems and may irritate the walls of blood vessels. Also, in angiography a catheter is used for delivery of the dye into the arterial system which adds further to the risk of the patient. In contrast, only a minimum quantity of ABS' radio labeled MH1 need be used, and since the 7 10 antibody is not derived from man, there is no risk of human blood-borne disease. However, whenever a foreign substance is introduced into the human body, there is the risk of an immune reaction and cases of reactions to mouse-derived antibody have been reported. In January 1995, ABS completed Phase I testing of MH1 in imaging blood clots for pulmonary embolism and deep vein thrombosis. The final Phase I report was submitted to the FDA in October 1995. The Company has compiled all necessary information regarding the Phase I/II clinical trials for MH1 imaging that were subsequently conducted and submitted a final report to the FDA in 1998. Clinical trial results demonstrated that MH1 is effective and safe as an imaging agent for pulmonary embolism and deep vein thrombosis. ABS is seeking corporate partners to fund, collaborate, license and to conduct full Phase II and Phase III trials and market the product. MH1 as a Delivery Vehicle for Thrombolytic Therapy. The Company is seeking to develop a product using MH1 as a delivery-vehicle for known thrombolytics (drugs that dissolve blood clots). Tests by the Company have demonstrated the ability to link MH1 to a known thrombolytic agent to form a potent, fibrin specific, therapeutic agent which, in animals, has demonstrated superior clot dissolving properties. In March 1998, ABS obtained a United States patent for this application. See "--Intellectual Property." MH1 as an Antithrombotic. The Company is also investigating the utility of MH1 as an antithrombotic agent (to prevent clot formation) for the interference and/or inhibition of excess fibrin deposition in surgical procedures such as angioplasty. In January 1996, ABS obtained a United States patent for this application. See "--Intellectual Property." NEUROBIOLOGY PROGRAM The goal of this longer term program is to develop fine chemical compounds for use in the treatment of epilepsy, migraine and mania and to treat and halt the progression of neurodegenerative diseases such as Alzheimer's, Parkinson's, neuropathy, trauma and stroke. Most of the applications developed to date have been developed in conjunction with scientists in the Company's Global Scientific Network. See "--Research and Development Agreements Global Scientific Network." There can be no assurance that the Company's products in development will prove to be commercially viable, that any of the products will receive regulatory clearance or clearance for particular indications, or that ABS will successfully market any products or achieve significant revenues or profitable operations. The Company is seeking to enter into additional collaborative, licensing, distribution, and/or co-marketing arrangements with third parties to expedite the commercialization of its products. However, there can be no assurance that ABS will be able to enter into any such additional arrangements or, if it does, that any such arrangements will be on terms that will be favorable to ABS. RESEARCH AND DEVELOPMENT AGREEMENTS GLOBAL SCIENTIFIC NETWORK 8 11 The Company formed its Global Scientific Network to promote and facilitate collaborative research leading to product development. The network is comprised of certain of the members of the Company's Scientific Advisory Committee and additional scientists from various disciplines. See "--Scientific Advisory Committee." The network is a joint effort to expedite the research, development and commercialization of ABS' diagnostic and therapeutic products. Though the network does not hold meetings, communication among its participants is facilitated through the Company. The network offers the Company's management an opportunity to review and evaluate new technologies. In addition, it offers a network of scientific leaders who can offer advice and direction. To facilitate the identification and screening of new technologies, the Company has scientific coordinators in St. Petersburg, Russia; and Beijing, China. These activities are coordinated from the Company's office in Dublin, Ireland. The Company is currently collaborating with leading medical and scientific institutions worldwide including University College Dublin, Ireland; University of Hanover, Germany; William Harvey Research Institute, London, England. Through its Global Scientific Network, ABS has entered into various agreements which generally grant the Company an exclusive license to the results of the research, as discussed below. AGREEMENTS FOR NEUROSCIENCE PROGRAMS ABS has entered into various agreements with universities and/or individual scientists who are part of the Global Scientific Network. These agreements generally grant the Company an exclusive license to the results of the research for use in various neuroscience applications, which may include compounds and antibodies. In general, the agreements are for a term equal to the duration of any patents that may be granted, with a minimum term of 10 years. In exchange for a license, ABS is obligated to pay certain research expenses and the costs of filing and processing patent applications in the United States and any other countries that ABS may select. Pursuant to these agreements, ABS is also required to pay the inventors or the university a royalty, typically 5% of net product sales. The Company is seeking to commercialize the products under development by entering into collaborative arrangements, licensing agreements and/or through research and development partners. ABS has also entered into development agreements with the National Institutes of Health (NIH) for some of its neurobiology products, including an agreement with the NIH (epilepsy branch) in 1998 to evaluate ABS-103 and R-103. These evaluations have been completed and have demonstrated anticonvulsant activity with little or no toxicity. In addition, results of an evaluation under a Phase I Small Business Innovation Research (SBIR) grant from the NIH, have demonstrated that ABS-205 can enhance learning and memory in pre-clinical models. There can be no assurance that the Company's neurobiology products will prove to be commercially viable, or that ABS will successfully market the products or achieve significant revenues or profitable operations or enter into any arrangements with third parties for 9 12 development of the neurobiology products, or if it does, that any such arrangements will be on terms that will be favorable to ABS. OTHER RESEARCH AND DEVELOPMENT AGREEMENTS As part of its development stage activities, ABS, in the ordinary course of business, enters into various agreements that provide for the expenditure by the Company of funds for research and development activities. These agreements typically provide for the payment of royalties (typically 2% to 8% of net sales) by ABS if any products are successfully developed and marketed as a result of the work being performed under the agreement. Reference is made to Note 10 of the Notes to Consolidated Financial Statements for a discussion of various arrangements which the Company has entered into for collaborative research and development projects (including arrangements for the use of space and services) and technology license arrangements for the development and prospective manufacturing and sale of products being developed. MARKETING AND SALES MARKETS The Company's commercial sales of its in vitro test kits are directed to hospitals, laboratories, clinical laboratories and physicians in large group medical practices. The Company believes that sales to hospitals and clinical laboratories will be dependent upon physician general acceptance of use of direct fibrinogen level measurement as part of routine and special blood analyses. MARKETING AND SALES During fiscal year 1999, the Company had one customer account for 30% of the Company's revenue, while another customer accounted for 20% and a third customer accounted for 11% of the Company's revenues. The Company does not believe that the loss of any of these customers would have a material adverse effect on the Company. Sales of ABS' proposed products on a commercial basis will be substantially dependent on widespread acceptance by the medical community. The use of any products that the Company may develop for diagnosis and therapy will require educating the medical community as to their reliability, safety and effectiveness. The Company, and any pharmaceutical company with which it may collaborate, may use several approaches to obtain general acceptance in the medical community of the Company's proposed products. Such promotional approaches may include: publicizing existing studies; offering the products to current practitioners and researchers who are leaders in their fields for their use and publication of their findings; conducting comparative studies with competitive products and methodologies and publishing the results of the studies; and sponsoring professional symposia and seminars. The Company has begun marketing its TpP diagnostic kit through distributors. This approach requires the Company to pay the expenses of developing promotional literature and 10 13 aids, hiring sales support personnel and completing studies to support clinical use of the product. The independent distributors that ABS uses also market similar products produced by others. ABS intends to rely on collaborative arrangements with pharmaceutical firms to conduct and fund the major portion of the human clinical trials that are necessary to obtain regulatory approval for any in vivo products it may develop. The Company also intends to rely on these firms to market and sell the products exclusively, especially during the first few years of the collaboration. While arrangements may vary, the Company intends to require payments of a royalty based on sales of the product, with an amount to be paid "up front" upon entering into the arrangement. The personnel and financial resources of the Company are not sufficient to permit the Company to alone gain the acceptance of the medical community for ABS' proposed in vivo pharmaceutical products or vaccines. Accordingly, the Company may be required to collaborate with one or more pharmaceutical companies, which will provide the necessary financing and expertise, in order to obtain medical community's acceptance. Such arrangements are likely to entail, among other things, the sharing of revenue or profits with such companies. The Company continues to seek arrangements with large pharmaceutical companies to market its products. In the event ABS is unable to enter into arrangements or if the arrangements into which it enters are not successful, the Company will likely seek to market such products through distributors. This would require ABS to develop a marketing program to support sales. In January 1992, the Company entered into an agreement with Yamanouchi Pharmaceutical Co., Ltd. ("Yamanouchi") of Japan granting Yamanouchi the exclusive right to manufacture, use and sell in Japan and Taiwan diagnostic test kits which utilize 45J. The Company received an initial payment of $900,000 (net of Japanese taxes). The license agreement requires Yamanouchi to purchase its 45J requirements from ABS. The agreement is for a period of fifteen years, provided that if any of the Company's patent rights for 45J have not yet expired at the end of that period, the agreement will continue until such expiration. The Company has filed a patent application in Japan relating to 45J. To date, Yamanouchi has not made any sales of the diagnostic tests covered by this agreement. The Company does not have any further obligations and could terminate the agreement. In October 1995, ABS entered into a license and collaboration agreement with F. Hoffmann-La Roche, Ltd. ("Hoffman-La Roche") for the co-development and marketing of the Company's TpP test for the detection of active blood clot formation (thrombosis). The agreement grants Hoffmann-La Roche a worldwide license to market the TpP test in a latex based particle agglutination format, but does not obligate Hoffman-La Roche to do so. Under the agreement, the Company received a $60,000 non-refundable development payment to adapt the TpP test in the latex based particle agglutination format to Hoffmann-La Roche's automated diagnostic systems. The Company may also receive milestone payments upon achievement of certain commercialization goals. The TpP test is to be manufactured by the Company for use on Hoffmann-La Roche's instruments. Prior to marketing the test, Hoffman-La Roche must obtain 510(k) clearance. See "--Government Regulation." ABS is to receive a percentage of Hoffmann-La Roche's net selling price for the Company's manufacturing of the TpP test plus a 5% royalty on net sales made by Hoffmann-La Roche. Under the agreement, the TpP test is also 11 14 to be sold by ABS and Hoffmann-La Roche to other diagnostic companies using similar particle agglutination technology. On these sales, gross profit is to be shared equally between the Company and Hoffmann-La Roche. To date, ABS has not received any milestone or royalty payments. In December 1995, ABS entered into a license agreement with Abbott for the marketing of the Company's TpP assay. The license agreement grants Abbott a worldwide license to market the TpP test for Abbott's immunoassay formats, but does not obligate Abbott to do so. The Company received a $100,000 non-refundable up-front payment and is to receive milestone payments upon achievement of certain development and commercialization goals. The Company is to receive a 5% royalty on net sales made by Abbott. In addition, the reagent for the TpP test is to be manufactured by the Company for use by Abbott. Prior to marketing the test, Abbott must obtain 510(k) clearance. See "--Government Regulation." To date, ABS has not received any milestone or royalty payments. In January 2000, ABS entered into a license agreement with Abbott granting Abbott exclusive worldwide rights to its ABS-103 compound, related technology and patent rights. The license gives Abbott the exclusive rights to develop and market the compound which presently is in the pre-clinical stage. Abbott will complete development of the product and conduct appropriate clinical trials to test for safety and effectiveness. In consideration for the license and in addition to customary royalties on net sales, Abbott paid the Company non-refundable up-front license fee of $500,000 and agreed to pay additional milestone payments aggregating up to $17 million depending upon successfully reaching development milestones, generally by indication. There can be no assurance that these milestones will be achieved. In conjunction with entering into the license, Abbott made an additional $1,500,000 equity investment in ABS. There can be no assurance that any future marketing arrangements will be entered into or, that if entered into, they will be on terms similar to those discussed above or on terms that will be favorable to the Company. If no arrangements are entered into, ABS will require substantial alternative financing in order to market its products. There can be no assurance that any such financing arrangements will be available to the Company or, if available to, it will be available on terms acceptable or favorable to the Company. There can be no assurance that any of the Company's products will be accepted in the medical community, and ABS is unable to estimate whether it will be able, and if so the length of time it would take, to gain such acceptance. COMPETITION The biotechnology industry is characterized by rapid technological advances, evolving industry standards and technological obsolescence. ABS has numerous competitors, none of whom is believed to be dominant, and it is likely that others may enter the field. Competitors may develop products which may render ABS' products obsolete or which have advantages over ABS' products, such as greater accuracy and precision or greater acceptance by the medical community. ABS' inability to meet and surpass its competitors' technological advances could have a material adverse effect on the Company's business, financial condition and results of 12 15 operations. Competing products may also get through the regulatory approval process sooner than ABS' products, enabling those competitors to market their products earlier than ABS. Usually, the first person to market a product has a significant marketplace advantage. In addition, other products now in use, presently undergoing the regulatory approval process, or under development by others, may perform functions similar to ABS' existing products or those which it has under development. INTELLECTUAL PROPERTY Patents. ABS' policy is to seek patent protection for its proposed products, whether resulting from its own research and development activities or from development and licensing arrangements into which the Company enters. ABS has been issued United States Patents, Nos. 4,870,023 and 5,041,379, which will expire 2006 and 2008, respectively; United States Patent No. 5,294,548, relating to the Hepatitis A vaccine, filed jointly with the University of Iowa, which will expire 2011. In addition, ABS has been issued United States Patent, Nos. 5,091,512 and 5,120,834, each of which will expire in 2009, covering monoclonal antibodies specific for fibrinogen and monoclonal antibodies specific for fibrin, respectively. ABS has also been issued United States Patent No. 5,223,410, which will expire in 2010, covering the use of its antigen-free mouse colony to generate monoclonal antibodies. ABS has also been issued United States Patent No. 5,721,122 which expires in 2015, covering a method of obtaining primed lymphocytes collected from immunized antigen-free mice. ABS has further been issued United States Patent No. 5,453,359, which will expire in 2012, covering an immunoassay for soluble fibrin using the Company's proprietary fibrin-specific monoclonal antibody as a method of detecting a thrombotic event, such as myocardial infarction. ABS has also been issued United States Patent No. 5,487,892, which will expire in 2014, covering use of the Company's proprietary fibrin-specific monoclonal antibody as an antithrombotic agent. ABS has further been issued United States Patent No. 5,723,126, which will expire in 2015, covering the use of the Company's propriety fibrin-specific monoclonal antibody in conjunction with a thrombolytic reagent for the treatment of thrombosis. ABS has been issued United States Patent No. 5,837,540, which will expire in 2016, covering a method of producing fibrin-specific antibody. ABS has also been issued United States Patent No. 5,843,690, which will expire in 2015, covering a method and an assay kit for the in vitro detection of the presence or amount of soluble fibrin polymers in a sample from a subject. ABS has also been issued United States Patent No. 5,871,737, which will expire in 2008, covering a fibrin-specific monoclonal antibody. Additional patent applications are pending covering alternative embodiments of the Company's proprietary fibrin-specific monoclonal antibody, as well as improved methods of raising fibrin specific monoclonal antibodies and of using the soluble fibrin immunoassay. ABS has twenty-two counterpart applications (including designated countries under patent treaties) covering monoclonal antibodies specific for fibrinogen, monoclonal antibodies specific for fibrin, methods for use of the Company's proprietary fibrin-specific monoclonal antibody in a soluble fibrin assay, and as an antithrombotic agent, and the use of the antigen-free mouse colony to generate monoclonal antibodies. ABS presently has issued three patents in Australia covering monoclonal antibodies specific for fibrinogen, monoclonal antibodies specific for 13 16 fibrin, methods for localizing a blood clot in a patient, an immunoassay for determining fibrin levels in a patient's blood, and use of the antigen-free mouse colony to generate monoclonal antibodies. The Company has exclusive worldwide rights in technology relating to certain methods and compositions for treating epilepsy. ABS has the exclusive license for United States Patent No. 5,786,380, which will expire in 2015, covering a method of reducing seizure activity in an individual by administering an anti-epileptic compound that contains ABS-103. Six patents protect this technology on behalf of the Company which include patents in the United States and Europe. The European Patent has been activated in 16 European countries. ABS has filed additional patent applications in the United States and other foreign jurisdictions to further protect this technology. The Company also has exclusive worldwide rights in technology related to certain novel neurotrophic methods and compositions. United States Patent No. 5,672,746 was issued September 30, 1997. A reissue application for this patent is pending. Foreign applications to protect this technology worldwide are pending. ABS is the worldwide exclusive licensee of United States Patent No. 5,492,812, issued to Trinity College (Dublin, Ireland), which will expire in 2013, covering a method for diagnosing Alzheimer's disease, and a corresponding pending European patent application. Ono Pharmaceutical, Ltd., ("Ono"), has filed third party observations to the patent applications relating to the neurotrophic compounds in the Japan and Australian patent offices, as well as the European Patent Office. These applications remain pending and the Company is continuing their prosecution. ABS has filed a reissue application of its United States Patent No. 5,672,746 to provide the United States Patent and Trademark Office an opportunity to examine this patent in light of the issues raised by Ono. On November 30, 1998, the United States Patent and Trademark declared an interference between an application of Ono and one of the Company's applications related to its 5,672,746 patent to determine the priority of invention of commonly claimed subject matter. The Company recently resolved the interference in the United States Patent and Trademark Office. The Company received a judgment that permits it to pursue patent protection relating to the use of ABS-205 as a therapeutic with claims which were previously allowed prior to the interference. There can be no assurance that any of the claims in pending or future applications will issue as patents, that any issued patents will provide ABS with significant competitive advantages, or that challenges will not be instituted against the validity or enforceability of any patent issued to ABS or, if instituted, that such challenges will not be successful. The cost of litigation to uphold the validity of patents and prevent infringement can be substantial. Furthermore, there can be no assurance that others have not independently developed or will not independently develop similar technologies or will not develop distinctively patentable technology duplicating the Company's technology or that they will not design around the patentable aspects of the Company's technology. While obtaining patents is deemed important by ABS, patents are not considered essential to the success of its business. However, if patents do not issue from present or future patent applications, ABS may be subject to greater competition. Moreover, unpatented technology could be independently developed by others who would then be free to use the technology in competition with unpatented technology of ABS. 14 17 Exclusive Licenses. The Company has exclusive worldwide rights in technology relating to certain methods and compositions for treating epilepsy. ABS has the exclusive license for United States Patent No. 5,786,380, which will expire in 2015, covering a method of reducing seizure activity in an individual by administering an anti-epileptic compound that contains ABS-103. Patents protect this technology on behalf of the Company in the United States and the European Patent Office. The European Patent has been activated in 16 European countries. ABS has filed additional patent applications in the United States and other foreign jurisdictions to further protect this technology. The Company also has exclusive worldwide rights in technology related to certain novel neurotrophic methods and compositions (United States Patent No. 5,672,746, issued September 30, 1997). Foreign applications to protect this technology worldwide are pending. ABS is the worldwide exclusive licensee of a United States patent covering a method for diagnosing Alzheimer's disease (United States Patent No. 5,492,812, issued to Trinity College (Dublin, Ireland), expiring in 2013) and a corresponding pending European patent application. Trade Secrets. With respect to certain aspects of its technology, ABS currently relies upon, and intends to continue to rely upon, trade secrets, unpatented proprietary know-how and continuing technological innovation to protect its potential commercial position. Relationships between ABS and its scientific consultants and collaborators may provide access to the Company's know-how, although, ABS has generally entered into confidentiality agreements with the parties involved. Similarly, ABS' employees and consultants have entered into agreements with the Company which require that they forebear from disclosing confidential information of ABS and that they assign to the Company all rights in any inventions made while in ABS' engagement relating to Company activities. However, members of the Company's Scientific Advisory Committee may be employed by or have consulting agreements with third parties, the businesses of which may conflict with or compete with ABS, and any inventions discovered by such individuals as part of their agreement with third parties will not become the property of ABS. There can be no assurance that trade secrets will be developed and maintained, that secrecy obligations will be honored, or that others will not independently develop similar or superior technology. To the extent that consultants, employees, collaborators or other third parties apply technological information independently developed by them or by others to Company projects, disputes may arise as to the ownership of such information which may not be resolved in favor of ABS. See "--Scientific Advisory Committee." Trademarks. ABS owns trademarks registered with the United States Patent and Trademark Office for the names FiF(R), Global Scientific Network(R) and Cadkit(R). Federally registered trademarks have a perpetual life, as long as they are renewed on a timely basis, subject to the rights of third parties to seek cancellation of the marks. ABS has filed other trademark applications, including TpP(TM) and may claim common law trade name rights as to other potential products. It anticipates filing additional trademark applications in the future. ABS does not believe that any of its trademarks (or applied for trademarks) is material to its business. 15 18 GOVERNMENT REGULATION ABS' present and proposed activities are subject to government regulation in the United States and most other countries in which the Company may choose to market its proposed products or conduct product development, research or manufacturing. ABS has not determined those countries, other than the United States, where it will seek regulatory approvals to market its proposed products. The following is a discussion of the processes required in order to obtain FDA approval for marketing a product, which are different for the three types of products being developed by ABS: monoclonal antibodies for in vitro use, monoclonal antibodies for in vivo use and drugs to treat neurological diseases. Regulation of In Vitro Products. Some in vitro diagnostic products are regulated as medical devices and can be approved by the FDA under a process known as a "510(k)." This procedure is available if the proposed product is "substantially equivalent" to another product that was in commercial distribution in the United States before May 28, 1976 or is lawfully marketed under a 510(k) approval (a "predicate device"). When a 510(k) review is used, a sponsor is required to submit a pre-market notification to the FDA. ABS cannot proceed with commercial sales of such products for diagnostic use in the United States until it receives 510(k) clearance from the FDA. In the event that the FDA requests additional information for the pre-market notification, this could result in multiple cycles of submissions, each potentially involving additional review periods until 510(k) clearance is granted or the FDA determines that the device is not substantially equivalent. In cases where ABS' product is determined by the FDA not to be "substantially equivalent" to a predicate device, a pre-market approval application ("PMA") will be required to be submitted and approved before commercial distribution is permitted. There can be no assurance that any present or future in vitro test ABS develops will be determined to be substantially equivalent by the FDA or receive PMA approval by the FDA in a timely manner or at all. A PMA may be required for some or all the Company's future proposed in vitro products. The FDA sometimes requires supporting clinical data for a 510(k) and invariably requires clinical data for a PMA. ABS expects that it will submit clinical data in at least some of its anticipated 510(k) notices. The clinical data must be gathered in accordance with FDA's regulations. Medical devices may be exported before receiving 510(k) clearance or PMA approval under certain conditions. Once cleared for marketing in the United States, a diagnostic device must comply with certain regulatory requirements, such as good manufacturing practices (also known as the Quality System Regulation), medical device reporting, and restrictions on advertising and promotion. Failure to comply with these rules can lead to FDA enforcement actions. The European Union also has developed a structure for the regulation of in vitro diagnostic devices. ABS believes that there are no material regulatory impediments to the sale of its in vitro diagnostic tests presently under development in North Africa and the Middle East. 16 19 Regulation of In Vivo Products. Any products intended for in vivo use, including vaccines, will be subject to regulation by the FDA. The products produced, depending on their characteristics, may be classified as "biologics" or products regulated under the Public Health Service Act (the "PHS Act") and the Federal Food, Drug, and Cosmetic Act (the "FDCA") or may be classified as non-biologic drugs regulated only under the FDCA. Development of a pharmaceutical product for use in humans under either statute is a multistep process. First, laboratory animal testing establishes probable safety and parameters of use of the experimental product for testing in humans and suggests potential effectiveness with respect to a given disease. Once the general investigative plan and protocols for specific human studies are developed, an investigational new drug ("IND") application is submitted to the FDA. FDA clearance of the IND is required before the study can begin. Normally, the initial phase of clinical testing (Phase I) is conducted to evaluate the pharmacological actions and side effects of the experimental product in humans, i.e. the safety of the drug. A demonstration of therapeutic benefit is not required in order to complete such trials successfully. If acceptable product safety is demonstrated, then Phase II trials may be initiated. Phase II trials are designed to evaluate the effectiveness of the product in the treatment of a given disease, and often involve well-controlled, closely monitored studies in a relatively small number of patients. Routes, dosages and schedules of administration may also be studied. If Phase II trials are successfully completed, Phase III trials may be commenced. Phase III trials are expanded, controlled trials which are intended to gather additional information about safety and effectiveness in order to evaluate the overall risk/benefit relationship of the product and provide the evidence of safety and effectiveness necessary for product approval. Although this is the standard drug testing pattern, different approaches are often used, such as combining Phases I and II. It is not possible to estimate the time within which Phase I, II and III studies will be completed with respect to a given product, although the time period to complete all the testing can exceed five years. Following the successful completion of clinical trials, the clinical evidence that has been accumulated is submitted to the FDA as part of a marketingapplication. Approval of the application is necessary before a company may market the product. The approval process can be very lengthy and depends upon the FDA's review of the application and the time required to provide satisfactory answers or additional clinical data when requested. For any given product, there is no assurance that an application will be approved in a timely manner, or at all. Failure to obtain such approvals would prevent ABS from commercializing its products and would have a material adverse effect on the Company's business. The process of seeking and obtaining FDA approval for a new product generally requires substantial funding. ABS anticipates that in most instances where it develops a product, the Company will seek to enter into a joint venture or similar arrangement with an established chemical or pharmaceutical company that will help conduct the required preclinical studies and clinical trials and bear a substantial portion of the expense of obtaining FDA approval. Good Manufacturing Practices. The FDA also has extensive regulations concerning good manufacturing practices applicable to both biologic and non-biologic drug products once they are approved. ABS' compliance with good manufacturing practice, and its ability to assure the 17 20 potency, purity and quality of the drugs and biologics manufactured, must be documented in the applications submitted for the products, and manufacturing facilities will be subject to pre-approval and other inspections by the FDA and other government agencies. Failure to comply with the good manufacturing practice regulations, or to comply with other applicable legal requirements, can lead to seizure of violative products, injunctive actions, other enforcement actions, and potential criminal and civil liability on the part of a Company and of the officers and employees of a Company. In addition to complying with FDA regulations, ABS and the facilities used by it are also required to comply with federal and state environmental, occupational health and other applicable regulations. ABS believes that its facilities comply with such regulations. MANUFACTURING While ABS has produced a limited quantity of monoclonal antibodies for testing and evaluation of its in vitro products, there can be no assurances that ABS will be able to either finance or meet FDA regulations for good manufacturing practices required in order to convert and operate its facility for commercial production of such products. ABS does not intend to establish its own manufacturing operations for its in vivo products unless and until, in the opinion of management of ABS, the size and scope of its business and its financial resources so warrant. It is the Company's intention to enter into manufacturing agreements, joint ventures or license agreements for the manufacture of monoclonal antibodies. Each joint venture partner or contract manufacturer participating in the process of manufacturing the Company's monoclonal antibody must comply with FDA regulations and provide documentation to support that part of the manufacturing process in which it is involved. ABS has contracted with several different GMP manufacturers for the production of antibodies and the TpP and FiF kits. The Company intends that the manufacture and assembly of TpP kits will be performed in house at the Stellar facility in Columbia, Maryland. The Stellar facility presently complies with GMP regulations and has received International Standards Organization ("ISO") 9001 series certification. There is no assurance that the Company will be able to enter into arrangements for the manufacture of sufficient quantities of the Company's in vivo monoclonal antibody necessary to obtain full FDA clearance, that the FDA will accept the Company's manufacturing arrangements, or find the facilities in GMP compliance, or that commercial manufacturing arrangements can be obtained on acceptable terms. PRODUCT LIABILITY The testing, marketing, manufacture and sale of pharmaceutical products entails a risk of product and other liability claims by consumers and others. ABS' monoclonal antibodies are generated from an antigen free mouse colony and there have been clinical reports of instances of the human immune system negatively reacting to mouse derived antibodies. Product and other liability claims may be asserted by physicians, laboratories, hospitals or patients relying upon the results of ABS' diagnostic tests (MH1 imaging). Product liability claims may be asserted by physicians, laboratories, hospitals or patients relying upon the results of the Company's 18 21 diagnostic tests (TpP, FiF and Stellar products). Claims may also be asserted against ABS by end users of the Company's products, including persons who may be treated with any in vivo diagnostic or therapeutics. Certain distributors of pharmaceutical products require minimum product liability insurance coverage as a condition precedent to purchasing or accepting products for distribution. Failure to satisfy these insurance requirements could impede the ability of ABS to achieve broad distribution of its proposed products, which would have a material adverse effect upon the business and financial condition of ABS. ABS has obtained product liability insurance covering its TpP and FiF products. Although ABS will attempt to obtain product liability insurance prior to the marketing of any of its other proposed products, there is no assurance that ABS will be able to obtain such insurance. Also, there can be no assurance that any insurance obtained (including its existing policies) can be maintained or that such insurance can be acquired or maintained at a reasonable cost or will be sufficient to cover all possible liabilities. In the event of a successful suit against ABS, lack or insufficiency of insurance coverage could have a material adverse effect on ABS. SCIENTIFIC ADVISORY COMMITTEE ABS has a Scientific Advisory Committee comprised of scientists and physicians active in the fields of microbiology, immunology and molecular biology and in cardiovascular disease, hepatic disease and drug development. These scientists serve as advisors to the Company. Members of the Scientific Advisory Committee are selected by the Company's management and generally make themselves available on an informal basis for consultations with ABS. Members of the Scientific Advisory Committee review the feasibility of the Company's proposed research and development programs review the progress of programs undertaken and assist in establishing both the scientific goals of ABS and the priorities of its product development. Members of the Scientific Advisory Committee may be employed by or have consulting agreements with third parties, the business of which may conflict or compete with ABS. Any inventions discovered by such individuals as part of their agreements with third parties will not become the property of ABS. These individuals are not required to devote any, and are expected to devote only a small portion, of their time to ABS, and are not expected to actively participate in the development of the Company's technology. It is possible regulations or policies now in effect or adopted in the future might limit the ability of the scientific advisors to continue their relationship with ABS. Members of the Scientific Advisory Committee were used on an informal basis for consultations in 1999. Members are paid $1,000 per meeting attended, plus expenses. Members of the Scientific Advisory Committee have been granted ten year options to purchase from 5,000 to 25,000 shares of Class A Common Stock from the Company. As of December 31, 1999, there were outstanding options for an aggregate of 263,000 shares held by members of the Scientific Advisory Committee (excluding options held by Dr. Born in his capacity as a non-employee director of the Company), at exercise prices ranging from $.28 per share to $7.75 per share. The 1999 cash payments to the advisors for informal meetings and other consultations as a group 19 22 were approximately $65,000. Certain members of the Committee are associated with institutions with which ABS has undertaken or may in the future undertake collaborative research efforts. Arrangements with these institutions may result in a member of the Scientific Advisory Committee receiving royalties or other compensation from that institution or from ABS if such member works as a scientist in the collaborative effort. The members of the Scientific Advisory Committee have no general fiduciary duties to ABS, have entered into limited confidentiality agreements and may, in their discretion, engage in activities which are competitive with those engaged in by the Company. The members of the Committee as of March 17, 2000 are: Giancarlo Agnelli, M.D., is Professor of Internal Medicine at the University of Perugia, Italy, where he received his medical education. Prior to appointment to his present post he was a research fellow and clinical fellow in the Department of Pathology and Department of Medicine at McMaster University, Hamilton, Ontario, Canada. He continues as an associate member of the Hamilton Civic Hospital Research Center at McMaster University. He is co-chairman of the Sub-Committee on Control of Anti-coagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Hemostasis. He has presented lectures at more than 200 international and national meetings and is the author or co-author of more than 200 scientific articles. Denian Ba, M.D., Ph.D., is presently Academician, The Chinese Academy of Engineering; President of the Chinese Academy of Medical Sciences & Peking Union Medical College; Chairman, Chinese Society of Immunology; Vice Chairman, Chinese Medical Association. Dr. Ba was engaged in research on Cancer Immunology as Associate Chief, Chief, Department of Immunology at the Institute of Cancer Research in Harbin Medical University, and Deputy Director, Director at the Institute of Cancer Research in Harbin Medical University. Dr. Ba received his M.D. from the Department of Medicine of Harbin Medical University and received his Ph.D. from the School of Medicine of Hokkaido University, Japan. Konrad T. Beyreuther, Ph.D., is presently professor of Molecular Biology and Head of Laboratory for Molecular Neuropathology at the Center of Molecular Biology, University of Heidelberg, Federal Republic of Germany. His primary research deals with genetics and molecular biology of Alzheimer's disease and related dementia disorders. He earned his doctorate at the Max-Plank Institute for Biochemistry Munich, University of Munich, Germany. Gustav Victor Rudolf Born, M.D., D. Phil., F.R.S., is presently Research Director of The William Harvey Research Institute at St. Bartholomew's Hospital Medical College, London, England, and Emeritus Professor of Pharmacology in the University of London. Among Professor Born's distinctions, appointments and activities are: Fellowship and Royal Medal of the Royal Society; Foundation President of the British Society for Thrombosis and Haemostasis; Corresponding Member of the Belgian Royal Academy of Medicine; Professor of the Foundation de France, Paris; Robert Pfleger, Paul Morawitz and Alexander-von-Humbolst Prizes; Honorary Life Member of the New York Academy of Sciences; Medical Advisor of the Heineman Medical Research Center, Charlotte, North Carolina; Co-Director for Centre for Thrombosis Research, 20 23 Perugia, Italy; Honorary Doctorates from eight universities, including Brown and Loyola. Dr. Born is also a director of the Company. Francis J. Castellino, Ph.D., is Dean of the College of Science, and Kleiderer-Pezold Professor of Biochemistry at the University of Notre Dame. He earned a doctorate in biochemistry at the University of Iowa, and was a postdoctoral fellow at Duke University Medical Center. He maintains a research program studying blood coagulation and fibrinolysis. Jeffrey Ginsberg, M.D., is a hematologist with research training in clinical and laboratory aspects of thrombosis. His current research interests include the clinical development of novel antithrombotic agents, the diagnosis and management of thrombosis during pregnancy, the prevention and treatment of the post- phlebitic syndrome, the investigation of the clinical complications of antiphospholipid antibodies, and the diagnosis of venous thrombosis and pulmonary embolism. He is currently the principal investigator of a number of clinical trials relative to thrombosis. He is the Director of the Thromboembolism Unit at Chedoke-McMaster Hospitals and a Career Investigator of the Heart and Stroke Foundation of Ontario. Lawrence Grossman, Ph.D., is University Distinguished Service Professor of Biochemistry at the Johns Hopkins University School of Hygiene and Public Health, Baltimore, Maryland. He is consultant to Applied DNA Systems, Inc. He earned a Ph.D. degree from the University of Southern California, and subsequently trained and worked thereafter at Johns Hopkins University and Brandeis University. His areas of expertise are in DNA repair, molecular basis of mutagenesis and molecular biology in general. Thomas W. Meade, CBE, DM, FRCP, FRS, is presently Director of the Medical Research Council Epidemiology and Medical Care Unit, Wolfson Institute of Preventive Medicine, St. Bartholomew's and the Royal London Hospital School of Medicine and Dentistry, London, England. Additional appointments include: Professor of Epidemiology at the University of London, Hon. Consultant in Epidemiology, North West London Hospitals NHS Trust, Hon. Consultant in Epidemiology, St. Bartholomew's and Royal London Hospitals NHS Trust. He is: Doctor of Medicine, Fellow of the Royal College of Physicians and Fellow of the Royal Society. Daniel M. Michaelson, Ph.D., is presently Professor of Neurobiology, Department of Neurobiochemistry, Tel Aviv University, Tel Aviv, Israel. He earned a Ph.D. in Biophysics from the University of California, Berkeley. Among Professor Michaelson's distinctions, appointments and activities are: Membership of the International Society of Neurochemistry, International Society for Developmental Neuroscience, International Brain Research Organization, the New York Academy of Sciences, Israel Society of Neurosciences, Israel Biochemical Society and the Israel Society for Pharmacology and Physiology. He is a member of the Scientific Advisory Board of the Alzheimer Foundation, and a board member of Ramot University Authority for Applied Research and Industrial Development Ltd. Peter Victorovich Morozov, M.D., Ph.D., is Professor of Psychiatry at the Russian State Medical University, Moscow. He has served as the Secretary of the International Section of the National Scientific Society of Psychiatrists and is currently secretary of the Russian Section of French-Russian Society of Psychiatrists. Dr. Morozov's primary area of research is 21 24 psychopharmacology, problems of classification and diagnosis, post-traumatic stress disorders. Dr. Morozov graduated from Pirogov II Medical School and received his doctorate from the Institute of Psychiatry AMS USSR. Heinz Nau, Ph.D., is presently Professor and Chairman, Department of Food Toxicology at the School of Veterinary Medicine in Hannover, Germany. He obtained his Ph.D. degree in Chemistry from the University Innsbruck, Austria. He then did post-doctoral work at Massachusetts Institute of Technology, Cambridge, Massachusetts, and was a Professor at the Institute of Toxicology and Embryopharmacology in Berlin, Germany. Dr. Nau holds an Honorary Doctorate from the University of Uppsala, Sweden, and is currently President of the European Teratology Society, and a Member of the Scientific Committee of Food at the European Commission in Brussels, Belgium, as well as a member of the International Federation of Teratological Societies. He has published over 350 scientific papers and is an editor of several books. Alfred Nisonoff, Ph.D., is Professor of Biology (Emeritus) at the Rosenstiel Research Center, Brandeis University, Waltham, Massachusetts. He earned a doctorate in chemistry from Johns Hopkins University, Baltimore, Maryland and was a postdoctoral fellow at the Johns Hopkins Medical School. Dr. Nisonoff is on the Scientific Advisory Committee of the Roswell Park Cancer Institute, Buffalo, New York and was employed by ABS from November 1996 to November 1997 as Research and Development Executive. His expertise is in the field of immunology and idiotypic antibodies. He was also Executive Secretary for the Task Force on Immunology, National Institute of Allergy and Infectious Diseases (1998). Member, United States National Academy of Sciences; Former President, American Association of Immunologists; Member, American Academy of Arts and Sciences; Foreign Correspondent, Belgian Academy of Medicine. Rem V. Petrov, M.D., is currently Vice-President of Russian Academy of Sciences, Moscow, Russia and chief of the Immunology Department of the Institute of Bioorganic Chemistry of the Academy. His main scientific interests are in the fields of Immunogenetics (genetical control of Immune response, interactions of syngeneic and nonsyngeneic cells) and Immunobiotechnology (artificial immunogens and vaccines, immunopharmacology-myelopeptides and other natural immunodulators). Craig M. Pratt, M.D., is currently a Professor of Medicine and Director, Clinical Cardiology Research, Section of Cardiology, Department of Internal Medicine, Baylor College of Medicine, Houston, Texas. Dr. Pratt is currently Director of the Coronary Care Unit and Non-invasive Laboratories at The Methodist Hospital. Nationally, Dr. Pratt is a consultant to the Cardiovascular and Renal Drugs Advisory Board to the Food and Drug Administration. John H. Proctor, Ph.D., Fellow and formerly Secretary General of the World Academy of Art and Science from 1986-1997, Life Fellow and Past President of the Washington Academy of Sciences in Washington, D.C., a full member of the Russian Academy of Sciences and a corresponding member of the Spanish Royal Academy of Sciences. He has facilitated national and international technology transfer, organizational development and productivity improvement 22 25 projects for over thirty years. Dr. Proctor has written three books and has published seventy-eight technical papers. Ciaran M. Regan, Ph.D., D.Sc. is presently Associate Professor of Pharmacology at University College, Dublin, Ireland. Dr. Regan received his B.Sc. and Ph.D. from University College, Dublin. He is a past Postdoctoral Fellow, Department of Biochemistry, University of Nijmegen, The Netherlands and past Scientific Officer of Medical Research Council, Institute of Neurology, London. Dr. Regan has numerous publications. Jacob Szmuszkovicz, Ph.D., is a Professor of Chemistry at the University of Notre Dame, South Bend, Indiana. He earned a doctorate in Chemistry from the Hebrew University, Jerusalem. He served as a Member of Staff at the Weizmann Institute before joining the Upjohn Company where he held the position of a Distinguished Scientist in the CNS (Central Nervous System) Unit from 1954 to 1985. Dr. Szmuszkovicz is co-inventor on over 100 patents. He has served as a Member of the Executive Committee of the Organic Division of the American Chemical Society. PERSONNEL As of March 17, 2000, ABS had 25 full time employees and 3 part-time employees. Of the full-time employees, 5 are research and development personnel, including 3 Ph.D.s, 6 are manufacturing personnel, and the rest are executive and administrative personnel. ABS' President and Chief Executive Officer and its Executive Vice President are parties to employment agreements with the Company ending November 15, 2001 and September 30, 2001, respectively. Those officers also are parties to agreements with ABS to keep corporate information with regard to the business of the Company confidential during and subsequent to their employment with ABS. None of ABS' employees is represented by a labor organization. ABS believes its relationship with its employees is satisfactory. The Company has standardized procedures for recruiting, interviewing and reference checking prospective personnel. ITEM 2. PROPERTIES ABS leases 6,000 square feet of office space in Copiague, New York under a lease expiring July 2000 (with an annual base rent of $39,000), which it intends to renew, and office space in Dublin, Ireland under a short-term arrangement. ABS' subsidiary, Stellar, has a lease covering 16,000 square feet in Columbia, Maryland, with an annual base rent of $136,000 and a term ending March 31, 2001. ABS has terminated its lease with Boston University and has consolidated its research and development activities at Stellar's facility. ITEM 3. LEGAL PROCEEDINGS 23 26 None. ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS None. PART II ITEM 5. MARKET FOR THE REGISTRANT'S COMMON STOCK AND RELATED SECURITY HOLDER MATTERS. The Company's Class A Common Stock (the "Common Stock") was traded on the Nasdaq National Market under the trading symbol "MABXA" until December 6, 1999 and on the Nasdaq Smallcap Market from December 6, 1999 to January 6, 2000 under the trading symbol "MABAC." Since January 6, 2000, the Common Stock has traded on the OTC Bulletin Board under the symbol "MABA." The following table sets forth the high and low closing bid prices for the Company's Common Stock for the periods indicated, as reported by Nasdaq, without retail mark-ups, mark-downs or commissions.
Fiscal Years - ------------ High Low - ------------------------------------------------------------------------------------------------------- 1999 - ---- First Quarter $1 7/16 $ 27/32 Second Quarter 1 7/32 15/16 Third Quarter 1 5/32 1/4 Fourth Quarter 21/32 9/32 1998 - ---- First Quarter $2 3/8 $1 17/32 Second Quarter 2 31/32 Third Quarter 1 3/16 13/32 Fourth Quarter 1 23/32 5/32
24 27 There were approximately 664 holders of record of Common Stock as of March 17, 2000 (exclusive of stockholders whose shares are held in street name by brokers, depositories and other institutional firms). ABS has not paid any cash dividends on its Common Stock since its inception and does not anticipate paying dividends for the foreseeable future. ITEM 6. SELECTED FINANCIAL DATA. The following selected financial data for the periods indicated have been derived from the consolidated financial statements of the Company audited by Arthur Andersen LLP, independent public accountants. This information should be read in conjunction with the related financial statements and notes thereto and management's discussion and analysis of financial conditions and results of operations included elsewhere in this report.
For the Year Ended December 31, 1999 1998 1997 1996 1995 ------------------------------------------------------------------------------------ Operating Results - ----------------- Revenues: Sales $ 1,361,000 $ 1,197,000 $ 150,000 -- -- Royalties/License -- -- -- -- $ 100,000 Collaborative Agreements $ 82,000 -- $ 9,000 $ 54,000 $ 27,000 Net Loss $ (5,351,000) $ (7,548,000) $ (7,147,000) $ (7,700,000) $ (5,607,000) Net Loss Per Share Basic and Diluted $ (.14) $ (.29) $ (.35) $ (.45) $ (.39) Weighted Average Shares 39,266,000 25,740,000 20,223,000 17,209,000 14,455,000
As of December 31, 1999 1998 1997 1996 1995 ------------------------------------------------------------------------------------ Balance Sheet - ------------- Working Capital (Deficit) $ (1,436,000) $ 2,947,000 $ 4,761,000 $ 13,697,000 $ 9,485,000 Total Assets $ 3,938,000 $ 6,514,000 $ 9,388,000 $ 16,473,000 $ 12,521,000 Long-Term Debt $ 33,000 $ 56,000 $ 8,000 $ 10,319,000 $ 7,865,000 Total Liabilities $ 2,360,000 $ 918,000 $ 2,705,000 $ 10,931,000 $ 8,376,000 Accumulated Deficit $(62,314,000) $(56,963,000) $(49,415,000) $(42,268,000) $(34,568,000)
25 28 ABS has not paid any cash dividends on its Common Stock since its inception. The following pro forma data reflects certain transactions which occurred subsequent to December 31 1999. See Note 11 of the Consolidated Financial Statements.
Pro Forma Information Dec. 31, 1999 - --------------------- ------------- Working Capital $4,064,000 Total Assets $8,938,000 Total Liabilities $1,860,000 Total Stockholders' Equity $7,078,000
ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS. The following discussion and analysis provides information which ABS' management believes is relevant to an assessment and understanding of the Company's results of operations and financial condition. This discussion should be read in conjunction with the consolidated financial statements and notes appearing elsewhere herein. OVERVIEW ABS is a development stage company incorporated in September 1983. To date, ABS has launched two commercial products ( TpP, ABS' Thrombus Precursor Protein diagnostic test, and FiF, ABS' Functional Intact Fibrinogen diagnostic test), although it has not yet derived any significant revenues from the sale of these products. On April 23, 1998, the Company acquired Stellar Bio Systems, Inc. ("Stellar"), a manufacturer and distributor of in vitro diagnostic products and research reagents. Reagents are individual components of diagnostic products, such as antibodies, calibrators and serum used in the biotechnology industry. The purchase price was $120,000 in cash and $700,000 in Class A Common Stock at the market value on the acquisition date (398,406 shares), plus future contingent payments of $650,000 in Class A Common Stock to be paid over three years based upon future sales levels of Stellar, with the Class A Common Stock to be valued at its market value on the acquisition agreement anniversary dates. On April 23, 1999, the Company made the first contingent payment of $150,000 in Class A Common Stock (131,118 shares) (see Note 5 to the Consolidated Financial Statements). LIQUIDITY AND CAPITAL RESOURCES The Company has funded its research and development activities to date principally from (i) the sale of Common Stock issued in an initial public offering, (ii) the exercise of the Class A and Class B Warrants issued in the initial public offering, (iii) private placements of Convertible Debentures, Convertible Preferred Series A Stock and Class A Common Stock, (iv) the exercise of stock options, (v) capital contributions to ABS by it's Chairman of the Board, (vi) initial license fee payments and fees from collaborative contract services and (vii) the income on funds 26 29 invested in bank deposits, United States Treasury bills and notes and other high grade liquid investments. ABS expects to continue to incur substantial expenditures in research and product development in the neurobiology program and in the development and commercialization of a rapid assay format for TpP, as well as in the FDA approval process relating to additional 510(k) filings for TpP and Stellar's products. As of December 31,1999, ABS, had a negative working capital of $1,436,000; however on a pro forma basis (See Note 11 of the Consolidated Financial Statements), the working capital was $4,064,000, compared to $2,947,000 at December 31, 1998. The Company implemented a cash conservation plan during the second and third quarters of 1999, which included salary deferrals by executive officers and other employees ranging from 5% to 100% of salary. As of December 31, 1999, accounts payable and accrued expenses includes $302,000 of deferred salaries. In addition, non-essential projects and consultants were terminated or agreed to other methods of payment for services, including the issuance of stock or deferral of payments. The Company's Chairman funded operating cash needs between late August 1999 and January 2000 by loaning the Company money. As of December 31, 1999, the Chairman had loaned the Company $695,000 on a demand basis, bearing interest at the rate of 6% per annum. Between January 1, 2000 and January 19, 2000, the Company's Chairman loaned the Company an additional $81,000 (See Note 11 of the Consolidated Financial Statements). ABS' management believes that current pro forma working capital, together with the receipt of additional licensing fees and milestone payments projected to be received within the next 12 months will be sufficient to fund its planned activities through the first quarter of 2001. Currently, product development plans include licensing TpP and the ABS-205 neurobiology compound, to large pharmaceutical companies provide additional funding and clinical expertise, perform additional testing necessary to obtain regulatory approvals, provide manufacturing expertise and market ABS' products. Without such licensing fees, milestone payments or co-marketing arrangements, additional sources of funding will be required to finance ABS beyond the first quarter of 2001. During 1999, the Company's cash and cash equivalents decreased by $2,945,000 to $93,000, primarily because cash used in operations ($3,724,000) and investing activities ($548,000) exceeded net proceeds from financing activities ($1,318,000). Net cash of $3,724,000 was used to fund the Company's cash loss from operations of $4,535,000 (net of non cash expenses of $318,000 for depreciation and amortization, $4,000 gain on sale of fixed asset, and $502,000 incurred in connection with the issuance of stock and warrants). Cash of $811,000 was provided by changes in operating assets, primarily as a result of an increase in accounts payable and accrued expenses ($840,000), a decrease in inventory ($34,000) and a decrease in other assets ($7,000). This was partially offset by higher accounts receivable ($34,000) and an increase in other current assets ($36,000) due to a $100,000 loan made to the Company's President/CEO (of which $50,000 had been forgiven in 1999) as part of the inducement to him to join the Company. Cash was used in investing activities for capitalized patent costs ($539,000) primarily for ABS 103 and ABS 205 and the purchase of equipment ($13,000). This was slightly offset by the proceeds from the sale of fixed asset ($4,000). New financing activities provided 27 30 $1,318,000 as a result of the purchase by the Company's Chairman of 440,000 shares of Class A Common Stock for $495,000, the purchase by the Company's President/CEO of 82,000 shares of Class A Common Stock for $82,000, the issuance of 500,000 shares of Class A Common Stock in lieu of a cash payment of $80,000 for the development and manufacture of the rapid assay format of TpP, loans from the Company's Chairman of $702,000 and the exercise of stock options, offset in part, by payments of $44,000 under capital lease obligations and notes payable. At December 31, 1999, ABS had net operating loss carryforwards of approximately $59,900,000 for income tax purposes. The net operating loss carryforwards will expire in varying amounts through 2019. In addition, ABS has approximately $1,230,000 of available research and development tax credits to offset future taxes. These credits expire through 2019. In accordance with Statement of Financial Accounting Standards No. 109 "Accounting for Income Taxes," ABS has recorded a valuation allowance of $61,130,000 to fully reserve for the deferred tax benefit attributable to its net operating loss and tax credit carryforwards due to the uncertainty as to their ultimate realizability. In accordance with certain provisions of the Tax Reform Act of 1986, a change in ownership of a corporation of greater than 50 percentage points within a three-year period places an annual limitation on the corporation's ability to utilize its existing net operating loss carryforwards, investment tax and research and development credit carryforwards (collectively "tax attributes"). Such a change in ownership was deemed to have occurred in connection with ABS' 1990 initial public offering at which time ABS' tax attributes amounted to approximately $4.9 million. The annual limitation of the utilization of such tax attributes is approximately $560,000. To the extent the annual limitation is not utilized, it may be carried forward for utilization in future years. At December 31, 1999, $4,900,000 million of net operating losses is no longer subject to this limitation. RESULTS OF OPERATIONS ABS has not generated any significant revenues from the sale of any products. Revenues from inception through December 31, 1999 of $4,092,000 are attributable to nonrefundable initial license fees and collaborative research agreements, sales of TpP and FiF and, since April 1998, sales of Stellar products. As a result of ABS' substantial start-up expenses and minimal revenues, ABS had an accumulated deficit of $62,314,000 as of December 31, 1999. ABS' research and development expenses are anticipated to be substantial for the foreseeable future and ABS expects to continue to incur significant operating losses. ABS initiated its marketing efforts for TpP and FiF in the microtiter plate format in November 1997. TpP kits have been marketed through European, Japanese and United States distributors as well as direct sales to specialty laboratories and research hospitals. ABS' efforts in 2000 will be directed toward adding new distributors and specialty labs, completing clinical studies with the rapid assay format (POC) of TpP, filing a 510(k) application for TpP POC format, entering into license agreements for the POC TpP and the ABS-205 therapeutic neurocompound and expanding Stellar's product base through additional 510(k) application filings and product acquisitions. ABS has licenses for TpP with Abbott and Roche in the automated instrument format and a license for 45J with Yamanouchi. ABS does not have any 28 31 performance obligations under these agreements. In order to market the product the licensees will be required to file for the appropriate governmental clearances. ABS has a sufficient quantity of antibodies to initially supply these licensees. Management believes that the POC format will increase the commercial potential of the TpP test and encourage the licensees to complete the commercialization process under these agreements. COMPARISON OF YEARS ENDED DECEMBER 31, 1999 AND 1998 ABS' net loss for the year ended December 31, 1999 was $5,351,000 compared to $7,548,000 for the year ended December 31, 1998. The decrease was primarily the result of the absence of an extraordinary charge for the early retirement of debentures ($1,140,000), a $598,000 decrease in interest expense, a $436,000 decrease in research and development expense and a $246,000 increase in revenues. The Company completed its consolidation of facilities in Maryland which resulted in savings in R&D expenses. Sales during 1999 of $1,361,000 include sales of Stellar products for a full year and sales of TpP. Sales of TpP declined in 1999 due to a slow market acceptance of the current test format. Stellar product sales increased over 1998 due to a full years' operation. Collaborative agreement revenue of $82,000 reflects the earned portion of an NIH National Institute on Aging grant and contract services. The Company obtained a grant of $135,000 from the NIH for additional studies of the Company's ABS-205 therapeutic neurocompound. These studies have been completed and the final report filed at the end of 1999. Cost of sales increased by $133,000 during 1999 compared to 1998 due primarily to increased sales. Cost of sales as a percentage of sales was 43.9% in 1999 and 38.8% in 1998. The percentage increase was due to increased payroll costs and higher fixed TpP costs being absorbed by a lower sales volume. Research and development costs decreased $436,000 from $2,161,000 in 1998 to $1,725,000 in 1999 primarily due to the consolidation of R&D facilities in Columbia, Maryland. This was partially offset by the inclusion of Stellar's costs for the full year of 1999 compared to eight months in 1998, increases in Stellar's post-acquisition research and development costs relating to FDA 510(k) filings, and continued TpP rapid assay POC development and clinical costs. Selling, general and administrative expenses increased by $56,000 from $4,432,000 in 1998 to $4,488,000 in 1999, primarily as a result of the inclusion of Stellar's selling and general expenses for the full year of 1999 compared to eight months in 1998, increased cost of investor relations, and the noncash value of warrants issued for services. This was offset in part by a reduction in other consulting costs. Interest expense was $598,000 lower in 1999 than in 1998, resulting from the repurchase of convertible debentures in the fourth quarter of fiscal 1998. Interest income, net, was $290,000 lower in 1999 than in 1998 due to lower average cash balances. 29 32 COMPARISON OF YEARS ENDED DECEMBER 31, 1998 AND 1997 ABS' net loss was $7,548,000 for the calendar year 1998 compared to $7,147,000 for the calendar year 1997. The increase was primarily the result of an extraordinary chargeof 1,140,000 for the early retirement of the Company's 5% Convertible Debentures. The loss before the extraordinary charge decreased by $739,000. This decrease was due to Stellar operations (included from April 23, 1998), continued sales of TpP and FiF and reduced research and development costs offset, in part, by increased selling, general and administrative and the facility consolidation costs. Sales during 1998 of $1,197,000 include sales of Stellar products since the date of acquisition in late April 1998 and sales of TpP and FiF kits. TpP sales were comparable to the 1997 sales of $150,000. Stellar product sales increased over 1997 (prior to its acquisition and accordingly, prior to the inclusion of it's results in the Company's consolidated results of operations. Cost of sales increased by $433,000 during the twelve months ended December 31, 1998 compared to the twelve months ended December 31, 1997 due primarily to increased sales. Cost of sales as a percentage of sales was 38.8% in 1998 and 21.3% in 1997. The percentage increase was due to Stellar products having a higher cost, plus an increase in the cost of TpP and FiF kits. Research and development costs decreased $1,081,000 from $3,242,000 in 1997 to $2,161,000 in 1998. The decrease was primarily due to the absence of costs incurred during the first six months of 1997 relating to the relocation of ABS' research laboratories from South Bend, Indiana to Boston, Massachusetts. The cost of relocation included severance, relocation and moving costs as well as duplicate facility costs. The decrease was also attributable to a reduction in personnel (FDA filing related) and consulting costs offset, in part, by increases in the cost of TpP clinical studies and the TpP point of care development costs. Selling, general and administrative expenses increased by $765,000 from $3,667,000 in 1997 to $4,432,000 in 1998, primarily as a result of the inclusion of Stellar, selling expenses relating to the marketing and promotion of TpP and increased personnel cost relating to marketing of TpP and business development. Facility consolidation cost of $252,000 includes severance costs, lease termination expenses and a write-down of leasehold improvements. In order to conserve resources and operate more efficiently with less duplication, management decided to close the Boston facility and consolidate the research and development and antigen free mouse colony at the Stellar facilities in Columbia, Maryland. The process of closing the Boston facility was completed in June of 1999. Interest expense was $301,000 lower in 1998 than in 1997 due to a lower average amount of debentures being outstanding during the year, with those being outstanding bearing a lower average interest rate. 30 33 Interest income, net, was $230,000 lower in 1998 than in 1997 due to lower average cash balances. YEAR 2000 State of Readiness: The Year 2000 problem is the result of some computer programs being written using two-digits rather than four to define the applicable year. Therefore, it is possible that programs that have time-sensitive software may recognize a date using "00" as the year 1900 rather than the year 2000, which could result in a system failure or miscalculation. ABS uses software developed and supported by third parties for various applications, including financial reporting, sales, purchasing and inventory. During 1999, ABS assessed the potential impact of the Year 2000 problem issue on its information systems. While it is possible that a problem may yet arise, to date the Company has not experienced any Year 2000 related problems. Management does not expect disruptions caused by the failures of third parties to remediate their year 2000 issues. Costs related to the year 2000 program were not significant. ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK. The Company's available cash is invested in highly liquid investments (primarily United States Treasury Bills) which have a maturity, at the time of purchase, of less than three months. ABS does not have operations subject to risks of foreign currency fluctuations, nor does it use derivative financial instruments in its operations. ABS does not have exposure to market risks associated with changes in interest rates because it has no variable interest rate debt outstanding. ABS does not believe it has any other material exposure to market risks associated with interest rates. ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA. The response to this item is submitted in a separate section of this report, starting on page F-1. ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE. None. PART III The information called for by Part III (Items 10, 11, 12 and 13 of Form 10-K) is incorporated herein by reference to such information which will be contained in ABS' Proxy Statement to be filed pursuant to Regulation 14A of the Securities Exchange Act of 1934 with respect to ABS' 2000 Annual Meeting of Stockholders. PART IV 31 34 ITEM 14. EXHIBITS, FINANCIAL STATEMENTS AND REPORTS ON FORM 8-K. (a) 1. and 2. Financial Statements and Financial Statement Schedules The following consolidated financial statements of ABS are annexed hereto immediately following the signature page of this Report.
Page ---- Index to Consolidated Financial Statements F-1 Report of Independent Public Accountants F-2 Consolidated Balance Sheets F-3 Consolidated Statements of Operations F-4 Consolidated Statements of Cash Flows F-5 Consolidated Statements of Stockholders' Equity F-6 - F-8 Notes to Consolidated Financial Statements F-9 - F-26
Information required by schedules called for under Regulation S-X is either not applicable or the information required therein is included in the consolidated financial statements or notes thereto. (b) Exhibits Exhibit No. Description - -------------------------------------------------------------------------------- 3.1* Restated Certificate of Incorporation of ABS, as filed with the Secretary of State of Delaware on July 30, 1996 and amended through March 3, 2000. 3.2 Amended and Restated By-Laws of ABS. Incorporated herein by reference to Exhibit 4.02 to ABS' Registration Statement on Form S-8, File No. 333-09473. 4.1 Form of Purchase and Investment Agreement executed by ABS and several investors on October 27, 1998. Incorporated herein by reference to Exhibit 99 to ABS' Registration Statement on Form S-3, file number 333-69735, filed with the Commission on December 24, 1998. 4.2 Form of Warrant issued to several individuals under ABS' Financial Advisory Agreement with M.H. Meyerson & Co., Inc., dated as of August 13, 1998 and schedule of holders thereof. Incorporated herein by reference to Exhibit 4.1(e) to 32 35 Exhibit No. Description - -------------------------------------------------------------------------------- ABS' Form 10-K for the fiscal year ended December 31, 1998, File No. 0-19041. 4.3(a) Stock Purchase Agreement, dated as of January 27, 2000, between ABS and Abbott Laboratories. Incorporated herein by reference to Exhibit 99.1 to ABS' Current Report on Form 8-K dated January 27, 2000 (date of earliest event reported), File No. 0-19041. 4.3(b) Registration Rights Agreement, dated as of January 27, 2000, between ABS and Abbott Laboratories. Incorporated herein by reference to Exhibit 4.1 to ABS' Current Report on Form 8-K dated January 27, 2000 (date of earliest event reported), File No. 0-19041. 4.4(a)* Securities Purchase Agreement, dated as of February 3, 2000, among ABS and Biotechnology Value Fund, L.P., Biotechnology Value Fund II, L.P., Investment 10 L.L.C. and Alfred J. Roach. 4.4(b)* Registration Agreement, dated as of March 3, 2000, among ABS and Biotechnology Value Fund, L.P., Biotechnology Value Fund II, L.P., Investment 10 L.L.C. and Alfred J. Roach. 10.1(a)+ Employment Agreement dated October 1, 1996 between ABS and Ellena M. Byrne. Incorporated herein by reference to Exhibit 10.1(b) to ABS' Form 10-K/A, dated April 30, 1997, File No. 0-19041. 10.1(b)+ Employment Agreement dated November 2, 1998 between ABS and Mr. John S. North. Incorporated herein by reference to Exhibit 10.1(b) to ABS' Form 10-K for the fiscal year ended December 31, 1998, File No. 0-19041. 10.2(a)+ ABS' Stock Option Plan, as amended. Incorporated herein by reference to Exhibit 28.1 to ABS' Registration Statement on Form S-8, File No. 33-51240. 10.2(b)+ ABS' 1993 Non-Employee Director Stock Option Plan. Incorporated herein by reference to Exhibit 99.01 to ABS' Registration Statement on Form S-8, File No. 33-65416. 10.2(c)*+ ABS' 1996 Stock Option Plan, as amended. 10.3 Exclusive License Agreement dated January 24, 1992 between ABS and Yamanouchi Pharmaceutical Co., Ltd. Incorporated herein by reference to Exhibit 10.29 to ABS' Current Report on Form 8-K dated January 24, 1992, File No. 0- 19041. 10.4 Warrant dated October 25, 1995 issued to Swartz Investments, Inc. Incorporated herein by reference to Exhibit 10.13 to ABS' Current Report on Form 8-K dated 33 36 Exhibit No. Description - -------------------------------------------------------------------------------- October 12, 1995, File No. 0-19041. 10.5 Exclusive License Agreement, dated as of January 27, 2000, between ABS and Abbott Laboratories. Incorporated herein by reference to Exhibit 10.1 to ABS' Current Report on Form 8-K dated January 27, 2000, File No. 0-19041. 21 List of Subsidiaries. Incorporated herein by reference to Exhibit 21 to ABS' Form 10-K for the fiscal year ended December 31, 1998, File No. 0-19041. 23* Consent of Independent Public Accountants. 27* Financial Data Schedule. *Filed herewith. All other exhibits are incorporated by reference to the document following the description thereof. +Management contract or compensatory plan. (b) Reports on Form 8-K. None 34 37 SIGNATURES Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this Report to be signed on its behalf by the undersigned, thereunto duly authorized. March 29, 2000 AMERICAN BIOGENETIC SCIENCES, INC. -------------- (Registrant) (Date) By: /s/ Josef C. Schoell ----------------------------------- Josef C. Schoell Vice President, Finance (Principal Financial and Accounting Officer) Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the Registrant and in the capacities and on the dates indicated. March 29, 2000 /s/ Alfred J. Roach -------------- -------------------------------- (Date) Alfred J. Roach, Chairman of the Board of Directors March 29, 2000 /s/ Josef C. Schoell -------------- -------------------------------- (Date) Josef C. Schoell Vice President, Finance March 29, 2000 /s/ John S. North -------------- -------------------------------- (Date) John S. North President and Chief Executive Officer March 29, 2000 /s/ Timothy J. Roach -------------- -------------------------------- (Date) Timothy J. Roach, Secretary, Treasurer, and Director March 29, 2000 /s/ Ellena M. Byrne -------------- -------------------------------- (Date) Ellena M. Byrne, Executive Vice President and Director March 29, 2000 /s/ Joseph C. Hogan -------------- -------------------------------- (Date) Joseph C. Hogan, Director March 29, 2000 -------------- -------------------------------- (Date) Gustav Victor Rudolf Born, Director March 29, 2000 /s/ Glenna M. Crooks -------------- -------------------------------- (Date) Glenna M. Crooks, Director 38 AMERICAN BIOGENETIC SCIENCES, INC. AND SUBSIDIARIES (A DEVELOPMENT STAGE COMPANY) INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
Page ---- Report of Independent Public Accountants F-2 Consolidated Balance Sheets F-3 Consolidated Statements of Operations F-4 Consolidated Statements of Cash Flows F-5 Consolidated Statements of Stockholders' Equity F-6 - F-8 Notes to Consolidated Financial Statements F-9 - F-26
Information required by schedules called for under Regulation S-X is either not applicable or the information required therein is included in the consolidated financial statements or notes thereto. F-1 39 REPORT OF INDEPENDENT PUBLIC ACCOUNTANTS To American Biogenetic Sciences, Inc.: We have audited the accompanying consolidated balance sheets of American Biogenetic Sciences, Inc. (a Delaware corporation in the development stage) and subsidiaries as of December 31, 1999 and 1998, and the related consolidated statements of operations, stockholders' equity and cash flows for each of the three years in the period ended December 31, 1999 and for the period from inception (September 1, 1983) to December 31, 1999. These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on these financial statements based on our audits. We conducted our audits in accordance with auditing standards generally accepted in the United States. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion. In our opinion, the financial statements referred to above present fairly, in all material respects, the financial position of American Biogenetic Sciences, Inc. and subsidiaries as of December 31, 1999 and 1998, and the results of their operations and their cash flows for each of the three years in the period ended December 31, 1999 and for the period from inception to December 31, 1999 in conformity with accounting principles generally accepted in the United States. ARTHUR ANDERSEN LLP Melville, New York March 10, 2000 F-2 40 AMERICAN BIOGENETIC SCIENCES, INC. AND SUBSIDIARIES (A DEVELOPMENT STAGE COMPANY) CONSOLIDATED BALANCE SHEETS
December 31, December 31, Assets 1999 1998 ------------ ------------ Current Assets: Cash and cash equivalents $93,000 $3,047,000 Accounts receivable 211,000 177,000 Inventory 511,000 545,000 Other current assets 76,000 40,000 ------------ ------------ Total current assets 891,000 3,809,000 ------------ ------------ Fixed assets, net 476,000 631,000 Patent costs, net of accumulated amortization of $502,000 and $390,000, respectively 1,895,000 1,468,000 Intangible assets, net 657,000 580,000 Other assets 19,000 26,000 ------------ ------------ $3,938,000 $6,514,000 ============ ============ Liabilities and Stockholders' Equity Current Liabilities: Accounts payable and accrued expenses $1,581,000 $797,000 Current portion of capital lease obligation - 8,000 Current portion of notes payable 746,000 57,000 ------------ ------------ Total current liabilities 2,327,000 862,000 ------------ ------------ Long Term Liabilities: Notes payable, less current portion 33,000 56,000 ------------ ------------ Total liabilities 2,360,000 918,000 ------------ ------------ Commitments (Notes 1, 5, 8, 10 and 12) Stockholders' Equity: Class A common stock, par value $.001 per share; 100,000,000 shares authorized; 36,918,510 and 35,559,556 shares issued and outstanding, respectively 37,000 36,000 Class B common stock, par value $.001 per share; 3,000,000 shares authorized; 3,000,000 shares issued and outstanding, respectively 3,000 3,000 Additional paid-in capital 63,852,000 62,520,000 Deficit accumulated during the development stage (62,314,000) (56,963,000) ------------ ------------ Total stockholders' equity 1,578,000 5,596,000 ------------ ------------ $3,938,000 $6,514,000 ============ ============
The accompanying notes are an integral part of these consolidated balance sheets. F-3 41 AMERICAN BIOGENETIC SCIENCES, INC. AND SUBSIDIARIES (a development stage company) CONSOLIDATED STATEMENTS OF OPERATIONS
For the Period From Inception Year Ended December 31, (September 1, ------------------------------------------ 1983) Through December 31, 1999 1998 1997 1999 ------------ ------------ -------------- -------------- Revenues: Sales $1,361,000 1,197,000 150,000 $2,708,000 Royalties / license fees - - - 1,000,000 Collaborative agreements 82,000 - 9,000 384,000 ------------ ------------ -------------- -------------- 1,443,000 1,197,000 159,000 4,092,000 Costs and expenses: Cost of sales 598,000 465,000 32,000 1,095,000 Research and development 1,725,000 2,161,000 3,242,000 30,531,000 Selling, general and administrative 4,488,000 4,432,000 3,667,000 33,581,000 Facility consolidation cost - 252,000 - 252,000 ------------ ------------ -------------- -------------- Loss from operations (5,368,000) (6,113,000) (6,782,000) (61,367,000) ------------ ------------ -------------- -------------- Other Income (Expense): Interest expense (16,000) (614,000) (915,000) (4,372,000) Net gain on sale of fixed assets 4,000 - 1,000 11,000 Investment income, net 29,000 319,000 549,000 4,554,000 ------------ ------------ -------------- -------------- Loss before extraordinary charge (5,351,000) (6,408,000) (7,147,000) (61,174,000) Extraordinary charge for early retirement of debentures, net - (1,140,000) - (1,140,000) ------------ ------------ -------------- -------------- Net loss ($5,351,000) ($7,548,000) ($7,147,000) ($62,314,000) ============ ============ ============== ============== Per Share Information (Note 2): Basic and Diluted loss per share Loss before extraordinary charge ($0.14) ($0.25) ($0.35) ============ ============ ============== Extraordinary charge for early retirement of debentures, net - ($0.04) - ============ ============ ============== Net loss ($0.14) ($0.29) ($0.35) ============ ============ ============== Common shares used in computing per share amounts: Basic and Diluted 39,266,000 25,740,000 20,223,000 ============ ============ ==============
The accompanying notes are an integral part of these consolidated statements. F-4 42 AMERICAN BIOGENETIC SCIENCES, INC. AND SUBSIDIARIES (a development stage company) CONSOLIDATED STATEMENTS OF CASH FLOWS
For the Period From Inception (September 1, Year Ended December 31, 1983) ------------------------------------------ Through December 31, 1999 1998 1997 1999 ------------ ------------ -------------- -------------- Cash Flows From Operating Activities: Net income (loss) ($5,351,000) ($7,548,000) ($7,147,000) ($62,314,000) Adjustments to reconcile net (loss) to net cash used in operating activities: Depreciation and amortization 318,000 497,000 531,000 3,040,000 Net (gain) loss on sale of fixed assets (4,000) - (1,000) (11,000) Net (gain) loss on sale of marketable securities - - - (217,000) Other non-cash expenses accrued primarily for stocks and warrants 502,000 306,000 299,000 2,544,000 Amortization of debt discount included in interest expense - 317,000 492,000 2,160,000 Extraordinary loss on repurchase of debt - 1,140,000 - 1,140,000 Write-off of patent costs - - - 93,000 Changes in operating assets and liabilities: (Increase) decrease in accounts receivable (34,000) (69,000) - (103,000) (Increase) decrease in inventory 34,000 (91,000) (296,000) (353,000) (Increase) decrease in other current assets (36,000) 1,000 487,000 (76,000) (Increase) decrease in other assets 7,000 1,000 (2,000) 80,000 Increase (decrease) in accounts payable and accrued expenses 840,000 265,000 46,000 1,816,000 Increase in interest payable to stockholder - - - 112,000 ------------ ------------ -------------- -------------- Net cash used in operating activities (3,724,000) (5,181,000) (5,591,000) (52,089,000) ------------ ------------ -------------- -------------- Cash Flows From Investing Activities: Capital expenditures (13,000) (41,000) (222,000) (2,056,000) Proceeds from sale of fixed assets 4,000 - 2,000 22,000 Payments for patent costs and other assets (539,000) (229,000) (434,000) (2,467,000) Business acquisition, net of stock issued and cash acquired - (119,000) - (119,000) Proceeds from maturity and sale of marketable securities - - 5,817,000 67,549,000 Purchases of marketable securities - - (2,796,000) (67,332,000) ------------ ------------ -------------- -------------- Net cash provided by (used in) investing activities (548,000) (389,000) 2,367,000 (4,403,000) ------------ ------------ -------------- -------------- Cash Flows From Financing Activities: Payments to debentureholders - (1,000,000) (1,246,000) (2,246,000) Proceeds from issuance of common stock, net 660,000 3,182,000 834,000 40,144,000 Proceeds from issuance of 5% convertible debentures, net - 3,727,000 - 3,727,000 Proceeds from issuance of 7% convertible debentures, net - - - 8,565,000 Proceeds from issuance of 8% convertible debentures, net - - - 7,790,000 Principal payments under capital lease obligation and notes payable (44,000) (61,000) (3,000) (114,000) Redemption of 8% convertible debentures - (500,000) - (500,000) Repurchase of 5% convertible debentures - (3,852,000) - (3,852,000) Capital contributions from chairman - - - 1,000,000 Increase in loans payable to stockholder / affiliates 702,000 - - 3,371,000 Repayment of loans payable to stockholder and affiliates (remainder contributed to capital by the stockholder) - - - (1,300,000) ------------ ------------ -------------- -------------- Net cash provided (used in) by financing activities 1,318,000 1,496,000 (415,000) 56,585,000 ------------ ------------ -------------- -------------- Net Increase (Decrease) in Cash and Cash Equivalents (2,954,000) (4,074,000) (3,639,000) 93,000 Cash and Cash Equivalents at Beginning of Period 3,047,000 7,121,000 10,760,000 - ------------ ------------ -------------- -------------- Cash and Cash Equivalents at End of Period $93,000 $3,047,000 $7,121,000 $93,000 ============ ============ ============== ============== Supplemental Disclosure of Non-cash Activities: Capital expenditure made under capital lease obligation - - - $20,000 ============ ============ ============== ============== Convertible debentures converted into 0, 4,851,618, 2,995,006, and 10,470,853 shares of Common Stock, respectively - $1,447,000 $7,155,000 $14,658,000 ============ ============ ============== ============== Warrants issued to debentureholders and placement agents - $63,000 - $588,000 ============ ============ ============== ============== Conversion of stockholder loan to paid-in capital - - - $1,481,000 ============ ============ ============== ==============
The accompanying notes are an integral part of these consolidated statements. F-5 43 AMERICAN BIOGENETIC SCIENCES, INC. AND SUBSIDIARIES (a development stage company) CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY
Class A Class B Per Common Stock Common Stock Share --------------------------- ------------------------ Amount Shares Dollars Shares Dollars ------- ------------ ------------- ----------- ----------- BALANCE, AT INCEPTION, (SEPTEMBER 1, 1983) $ - $ - - $ - Sale of common stock to chairman for cash .33 78,000 - - - Net (loss) for the period - - - - ------------ ------------- ----------- ----------- BALANCE, DECEMBER 31, 1983 78,000 - - - Sale of common stock to chairman for cash .33 193,500 - - - Net (loss) for the period - - - - ------------ ------------- ----------- ----------- BALANCE, DECEMBER 31, 1984 271,500 - - - Sale of common stock to chairman for cash .33 276,700 1,000 - - Net (loss) for the period - - - - ------------ ------------- ----------- ----------- BALANCE, DECEMBER 31, 1985 548,200 1,000 - - Sale of common stock to chairman for cash .33 404,820 - - - Net (loss) for the period - - - - ------------ ------------- ----------- ----------- BALANCE, DECEMBER 31, 1986 953,020 1,000 - - Sale of common stock to chairman for cash .33 48,048 - - - Net (loss) for the period - - - - ------------ ------------- ----------- ----------- BALANCE, DECEMBER 31, 1987 1,001,068 1,000 - - Exchange of common stock for Class B stock (1,001,068) (1,000) 1,001,068 1,000 Sale of Class B stock to chairman for cash .33 - - 1,998,932 2,000 Net (loss) for the period - - - - ------------ ------------- ----------- ----------- BALANCE, DECEMBER 31, 1988 - - 3,000,000 3,000 Net (loss) for the period - - - - ------------ ------------- ----------- ----------- BALANCE, DECEMBER 31, 1989 - - 3,000,000 3,000 Conversion of loans payable to stockholder into additional paid-in capital - - - - Sale of 1,150,000 Units to public consisting of 3,450,000 shares of Class A common stock and warrants (net of $1,198,000 underwriting expenses) 2.00 3,450,000 3,000 - - Conversion of Class B stock into Class A stock 668,500 1,000 (668,500) (1,000) Net (loss) for the period - - - - ------------ ------------- ----------- ----------- BALANCE, DECEMBER 31, 1990 4,118,500 $4,000 2,331,500 $2,000 ------------ ------------- ----------- -----------
CONTINUED F-6 44
BALANCE, DECEMBER 31, 1990 $ 4,118,500 $4,000 2,331,500 $2,000 Exercise of Class A Warrants (net of $203,000 in underwriting expenses) for cash 3.00 3,449,955 3,000 - - Exercise of Class B Warrants for cash 4.50 79,071 - - - Conversion of Class B stock into Class A stock 850,000 1,000 (850,000) (1,000) Exercise of stock options 2.00 417,750 1,000 - - Expense for warrants issued - - - - Net (loss) for the period - - - - ------------ ------------- ----------- ----------- BALANCE, DECEMBER 31, 1991 8,915,276 9,000 1,481,500 1,000 Exercise of Class B Warrants (net of $701,000 in underwriting expenses) for cash 4.50 3,370,884 3,000 - - Conversion of Class B stock into Class A stock 106,000 - (106,000) - Exercise of stock options 2.49 348,300 1,000 - - Net (loss) for the period - - - - ------------ ------------- ----------- ----------- BALANCE, DECEMBER 31, 1992 12,740,460 13,000 1,375,500 1,000 Sale of common stock to Medeva PLC. 7.50 200,000 - - - Exercise of stock options 2.00 32,700 - - - Net (loss) for the period - - - - ------------ ------------- ----------- ----------- BALANCE, DECEMBER 31, 1993 12,973,160 13,000 1,375,500 1,000 Exercise of stock options 2.16 91,250 - - - Net (loss) for the period - - - - ------------ ------------- ----------- ----------- BALANCE, DECEMBER 31, 1994 13,064,410 13,000 1,375,500 1,000 Conversion of 8% convertible debentures into Class A Common Stock 1.85 354,204 - - - Exercise of stock options 1.82 12,750 - - - Expense for warrants/options issued - - - - Net (loss) for the period - - - - ------------ ------------- ----------- ----------- BALANCE, DECEMBER 31, 1995 13,431,364 $13,000 1,375,500 $1,000 ------------ ------------- ----------- -----------
CONTINUED F-7 45
------------ ------------- ----------- ----------- BALANCE, DECEMBER 31, 1995 $ 13,431,364 $13,000 1,375,500 $1,000 Conversion of 8% Convertible Debentures into Class A Common Stock 2.74 2,269,755 2,000 - - Exercise of stock options 2.53 569,875 1,000 - - Expense for warrants/options issued - - - - Discount on 7% convertible debentures - - - - Net (loss) for the period - - - - ------------ ------------- ----------- ----------- BALANCE, DECEMBER 31, 1996 16,270,994 16,000 1,375,500 1,000 ------------ ------------- ----------- ----------- Conversion of 7% and 8% convertible debentures into Class A Common Stock 2.93 2,995,006 3,000 - - Sale of Class B Common Stock to Chairman for cash 2.23 - - 350,000 1,000 Exercise of stock options 2.00 27,500 - - - Expense for warrants issued - - - - Class A Common Stock issued 3.12 48,117 - - - Net (loss) for the period - - - - ------------ ------------- ----------- ----------- BALANCE, DECEMBER 31, 1997 19,341,617 19,000 1,725,500 2,000 ------------ ------------- ----------- ----------- Conversion of 5%, 7% and 8% convertible debentures into Class A Common Stock 0.32 4,851,618 5,000 - - Sale of Class B Common Stock to Chairman for cash 0.37 - - 1,274,500 1,000 Exercise of stock options 1.75 4,000 - - - Expense for warrants issued - - - - Class A Common Stock issued 1.06 163,915 - - - Class A Common Stock issued for Stellar 1.76 398,406 1,000 - - Class A Common Stock issued for Private Placement 0.25 10,800,000 11,000 - - Discount on 5% convertible debentures - - - - Net (loss) for the period - - - - ------------ ------------- ----------- ----------- BALANCE, DECEMBER 31, 1998 35,559,556 36,000 3,000,000 3,000 ------------ ------------- ----------- ----------- Sale of Class A Common Stock to Chairman for cash 1.13 440,000 - - - Exercise of stock options 0.61 5,250 - - - Expense for warrants issued - - - - Class A Common Stock issued 0.50 913,704 1,000 - - Net (loss) for the period - - - - ------------ ------------- ----------- ----------- BALANCE, DECEMBER 31, 1999 36,918,510 $37,000 3,000,000 $3,000 ============ ============= =========== ===========
The accompanying notes are an integral part of these consolidated statements. F-8 46 AMERICAN BIOGENETIC SCIENCES, INC. AND SUBSIDIARIES (a development stage company) CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY
Deficit Accumulated Additional During the Paid-in Development Capital Stage Total ------------ ------------- ----------- BALANCE, AT INCEPTION, (SEPTEMBER 1, 1983) $ - $ - $ - Sale of common stock to chairman for cash 26,000 - 26,000 Net (loss) for the period - (25,000) (25,000) ------------ ------------- ----------- BALANCE, DECEMBER 31, 1983 26,000 (25,000) 1,000 Sale of common stock to chairman for cash 65,000 - 65,000 Net (loss) for the period - (242,000) (242,000) ------------ ------------- ----------- BALANCE, DECEMBER 31, 1984 91,000 (267,000) (176,000) Sale of common stock to chairman for cash 92,000 - 93,000 Net (loss) for the period - (305,000) (305,000) ------------ ------------- ----------- BALANCE, DECEMBER 31, 1985 183,000 (572,000) (388,000) Sale of common stock to chairman for cash 134,000 - 134,000 Net (loss) for the period - (433,000) (433,000) ------------ ------------- ----------- BALANCE, DECEMBER 31, 1986 317,000 (1,005,000) (687,000) Sale of common stock to chairman for cash 16,000 - 16,000 Net (loss) for the period - (730,000) (730,000) ------------ ------------- ----------- BALANCE, DECEMBER 31, 1987 333,000 (1,735,000) (1,401,000) Exchange of common stock for Class B stock - - - Sale of Class B stock to chairman for cash 664,000 - 666,000 Net (loss) for the period - (1,031,000) (1,031,000) ------------ ------------- ----------- BALANCE, DECEMBER 31, 1988 997,000 (2,766,000) (1,766,000) Net (loss) for the period - (1,522,000) (1,522,000) ------------ ------------- ----------- BALANCE, DECEMBER 31, 1989 997,000 (4,288,000) (3,288,000) Conversion of loans payable to stockholder into additional paid-in capital 1,481,000 - 1,481,000 Sale of 1,150,000 Units to public consisting of 3,450,000 shares of Class A common stock and warrants (net of $1,198,000 underwriting expenses) 5,699,000 - 5,702,000 Conversion of Class B stock into Class A stock - - - Net (loss) for the period - (2,100,000) (2,100,000) ------------ ------------- ----------- BALANCE, DECEMBER 31, 1990 $8,177,000 ($6,388,000) $1,795,000 ------------ ------------- -----------
CONTINUED F-6 (column continuation) 47
BALANCE, DECEMBER 31, 1990 $8,177,000 ($6,388,000) $1,795,000 Exercise of Class A Warrants (net of $203,000 in underwriting expenses) for cash 10,143,000 - 10,146,000 Exercise of Class B Warrants for cash 356,000 - 356,000 Conversion of Class B stock into Class A stock - - - Exercise of stock options 835,000 - 836,000 Expense for warrants issued 900,000 - 900,000 Net (loss) for the period - (4,605,000) (4,605,000) ------------ ------------- ----------- BALANCE, DECEMBER 31, 1991 20,411,000 (10,993,000) 9,428,000 Exercise of Class B Warrants (net of $701,000 in underwriting expenses) for cash 14,465,000 - 14,468,000 Conversion of Class B stock into Class A stock - - - Exercise of stock options 865,000 - 866,000 Net (loss) for the period - (4,016,000) (4,016,000) ------------ ------------- ----------- BALANCE, DECEMBER 31, 1992 35,741,000 (15,009,000) 20,746,000 Sale of common stock to Medeva PLC. 1,500,000 - 1,500,000 Exercise of stock options 65,000 - 65,000 Net (loss) for the period - (6,521,000) (6,521,000) ------------ ------------- ----------- BALANCE, DECEMBER 31, 1993 37,306,000 (21,530,000) 15,790,000 Exercise of stock options 197,000 - 197,000 Net (loss) for the period - (7,431,000) (7,431,000) ------------ ------------- ----------- BALANCE, DECEMBER 31, 1994 37,503,000 (28,961,000) 8,556,000 Conversion of 8% convertible debentures into Class A Common Stock 571,000 - 571,000 Exercise of stock options 23,000 - 23,000 Expense for warrants/options issued 602,000 - 602,000 Net (loss) for the period - (5,607,000) (5,607,000) ------------ ------------- ----------- BALANCE, DECEMBER 31, 1995 $38,699,000 ($34,568,000) $4,145,000 ------------ ------------- -----------
CONTINUED F-7 (column continuation) 48
BALANCE, DECEMBER 31, 1995 $38,699,000 ($34,568,000) $4,145,000 Conversion of 8% convertible debentures into Class A Common Stock 5,483,000 - 5,485,000 Exercise of stock options 1,438,000 - 1,439,000 Expense for warrants/options issued 330,000 - 330,000 Discount on 7% convertible debentures 1,843,000 - 1,843,000 Net (loss) for the period - (7,700,000) (7,700,000) ------------ ------------- ----------- BALANCE, DECEMBER 31, 1996 47,793,000 (42,268,000) 5,542,000 ------------ ------------- ----------- Conversion of 7% and 8% convertible debentures into Class A Common Stock 7,152,000 - 7,155,000 Sale of Class B Common Stock to Chairman for cash 778,000 - 779,000 Exercise of stock options 55,000 - 55,000 Expense for warrants issued 149,000 - 149,000 Class A Common Stock issued 150,000 - 150,000 Net (loss) for the period - (7,147,000) (7,147,000) ------------ ------------- ----------- BALANCE, DECEMBER 31, 1997 56,077,000 (49,415,000) 6,683,000 ------------ ------------- ----------- Conversion of 5%, 7% and 8% convertible debentures into Class A Common Stock 1,442,000 - 1,447,000 Sale of Class B Common Stock to Chairman for cash 465,000 - 466,000 Exercise of stock options 7,000 - 7,000 Expense for warrants issued 205,000 - 205,000 Class A Common Stock issued 174,000 - 174,000 Class A Common Stock issued for Stellar 699,000 - 700,000 Class A Common Stock issued for Private Placement 2,689,000 - 2,700,000 Discount on 5% convertible debentures 762,000 - 762,000 Net (loss) for the period - (7,548,000) (7,548,000) ------------ ------------- ----------- BALANCE, DECEMBER 31, 1998 62,520,000 (56,963,000) 5,596,000 ------------ ------------- ----------- Sale of Class A Common Stock to Chairman for cash 495,000 - 495,000 Exercise of stock options 3,000 - 3,000 Expense for warrants issued 376,000 - 376,000 Class A Common Stock issued 458,000 - 459,000 Net (loss) for the period - (5,351,000) (5,351,000) ------------ ------------- ----------- BALANCE, DECEMBER 31, 1999 $63,852,000 ($62,314,000) $1,578,000 ============ ============= ===========
The accompanying notes are an integral part of these consolidated statements. CONTINUED F-8 (column continuation) 49 AMERICAN BIOGENETIC SCIENCES, INC. AND SUBSIDIARIES (A DEVELOPMENT STAGE COMPANY) NOTES TO CONSOLIDATED FINANCIAL STATEMENTS 1. BUSINESS AND DEVELOPMENT STAGE RISKS: American Biogenetic Sciences, Inc. (together with its subsidiaries (Note 2), the "Company" or "ABS") was incorporated in Delaware on September 1, 1983. The Company was formed to engage in the research, development and production of bio-pharmaceutical products. As a development stage company, the Company has not materially commenced its principal operations. Most of its efforts have been devoted to research and development, acquiring equipment, recruiting and training personnel, and financial planning. The Company's research efforts have been focused on the development of products to diagnose, prevent and treat diseases in humans. The Company has had limited product sales to date and has had limited revenues from collaborative and licensing agreements (Notes 10 and 11). Since its inception, the Company has been dependent upon the receipt of capital investment or other financing to fund its continuing research and commercialization activities. The Company expects to incur substantial expenditures in research and product development and the Food and Drug Administration approval process relating to 510(k) applications for its TpP and other diagnostic tests. Currently product development plans of the Company include entering into additional collaborative, licensing and co-marketing arrangements with large pharmaceutical companies to provide additional funding and clinical expertise to perform tests necessary to obtain regulatory approvals, provide manufacturing expertise and market the Company's products. Without such collaborative, licensing or co-marketing arrangements, additional sources of funding will be required to finance the Company. In addition to the normal risks associated with a business engaged in research and development of new products, there can be no assurance that the Company's research and development will be successfully completed, that any products developed will obtain the necessary U.S. regulatory approvals (principally from the FDA), that any approved product will be a commercial success, that adequate product liability insurance can be obtained or that sufficient capital will be available when required to permit the Company to realize its plans. In addition, the Company operates in an environment of rapid changes in technology and in an industry which has many competitors who have far more resources available to them than does the Company. Further, the Company is dependent upon the services of several key employees and advisors. While losses from development stage activities are expected to continue in 2000, management believes that its liquidity and capital resources at December 31, 1999, including the license and financing transactions that occurred subsequent to year-end as discussed in Note 11, together with the receipt of milestone fees expected to be received within the next year, additional licensing fees will be sufficient to fund its planned activities through the first quarter of 2001. F-9 50 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES: PRINCIPLES OF CONSOLIDATION During 1989, the Company formed a subsidiary, American Biogenetic Sciences (Ireland), Ltd., which is 99% owned by the Company and, to fulfill legal requirements, 1% owned by an officer of the Company. On April 23, 1998, the Company acquired all of the capital stock of Stellar Bio Systems, Inc. ("Stellar") (Note 5). The financial statements reflect the accounts of the Company and these subsidiaries. All significant intercompany transactions and balances have been eliminated in consolidation. CASH EQUIVALENTS Cash equivalents include highly liquid investments which have an original maturity of less than three months from date of purchase. CONCENTRATION OF CREDIT RISK As of December 31, 1999, the Company had two customers whose balances exceeded 10% of the accounts receivable balance. These customers accounted for 35% and 24% of the accounts receivable balance. As of December 31, 1998, the Company had four customers whose balances exceeded 10% of the accounts receivable balance. These customers accounted for 22%, 21%, 18% and 11% of the accounts receivable balance. During fiscal year 1999, one customer accounted for 30% of the Company's revenues, another customer accounted for 20% while a third customer accounted for 11% of the Company's revenues. During fiscal year 1998, one customer accounted for 34% of the Company's revenues, another customer accounted for 17% while a third customer accounted for 10% of the Company's revenues. There were no customers in fiscal year 1997 that exceeded 10% of revenues. INVENTORY Inventory is valued at the lower of cost (first-in, first-out) or market. LONG-LIVED ASSETS In accordance with Statement of Financial Accounting Standards ("SFAS") No. 121, "Accounting for the Impairment of Long-Lived Assets and for Long-Lived Assets to Be Disposed Of," ABS periodically reviews long-lived assets and certain identifiable intangibles for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to the fair value of the asset measured by the future net cash flows (on an undiscounted basis) expected to be generated by the asset. If such assets are considered to be impaired, the impairment to be recognized would be measured by the amount by which the carrying amount of the assets exceeds the underlying fair value of the assets. ABS has performed a review F-10 51 of its long-lived assets and has determined that no impairment of the respective carrying values has occurred as of December 31, 1999. DEPRECIATION AND AMORTIZATION Depreciation and amortization is generally provided for by the straight-line method over the estimated useful lives of the assets. Laboratory equipment, office equipment, furniture and vehicles are depreciated over five years. Leasehold improvements are amortized over the life of the lease, usually five years. PATENT COSTS Costs of certain patent applications are capitalized. Upon issuance of a patent, such costs are charged to operations utilizing the straight-line method over the lesser of the estimated useful life or 17 years. Costs of unsuccessful patent applications or discontinued projects are charged to expense. DEFERRED FINANCING COSTS Deferred financing cost incurred by the Company in connection with the issuance of convertible debentures (Note 7) were capitalized and charged to operations as additional interest expense over the life of the related debt. Upon conversion of the underlying debt, any unamortized deferred financing costs were charged to paid-in capital during 1998. INTANGIBLE ASSETS Intangible assets include goodwill and intellectual know-how relating to the acquisition of Stellar. Intangible assets are being amortized over a 10-year period. FAIR VALUE OF FINANCIAL INSTRUMENTS The Company accounts for the fair value of its financial instruments in accordance with SFAS No. 107, "Disclosures about Fair Value of Financial Instruments." The carrying value of all financial instruments reflected in the accompanying balance sheets approximated fair value at December 31, 1999 and December 31, 1998, respectively. REVENUE RECOGNITION Revenue on product sales is recognized at the time the products are shipped to customers. Revenue from royalties and license fees are recognized when earned, provided that no significant performance obligations remain. F-11 52 RESEARCH AND DEVELOPMENT INCOME AND EXPENSES Revenues from collaborative agreements are recognized as the Company performs research activities under the terms of each agreement, provided that no further performance obligations remain. Research and development costs are charged to expense in the year incurred. STOCK-BASED COMPENSATION The Company follows the provisions of SFAS No. 123, "Accounting for Stock-Based Compensation." This statement establishes financial accounting and reporting standards for stock-based employee compensation plans. SFAS No. 123 encourages entities to adopt a fair value based method of accounting for stock compensation plans. However, SFAS No. 123 also permits the Company to continue to measure compensation costs under pre-existing accounting pronouncements. If the fair value based method of accounting is not adopted, SFAS No. 123 requires pro forma disclosures of net loss and net loss per common share in the notes to consolidated financial statements. The Company has elected to provide the necessary pro forma disclosures (Note 8). NET LOSS PER COMMON SHARE The Company follows the provisions of SFAS No. 128, "Earnings Per Share." Basic net loss per common share ("Basic EPS") is computed by dividing net loss by the weighted average number of common shares outstanding. Diluted net loss per common share ("Diluted EPS") is computed by dividing net loss by the weighted average number of common shares and dilutive potential common shares then outstanding. SFAS No. 128 requires the presentation of both Basic EPS and Diluted EPS on the face of the consolidated statements of operations. The impact of the adoption of this statement was not material to all previously reported EPS amounts. Diluted EPS for 1999, 1998 and 1997 is the same as Basic EPS because the inclusion of stock options and convertible debentures then outstanding would be anti-dilutive. For the purposes of the calculation of both basic and diluted EPS, Class A and Class B Common Stock have been treated as one class. The following equity instruments were not included in the diluted net loss per share calculation as their effect would be anti-dilutive:
DECEMBER 31 ----------------------------------------------- 1999 1998 1997 ---- ---- ---- Stock Options - Exercisable 3,761,132 3,279,334 3,018,543 Conversion of Convertible Debentures -- -- 1,160,000 Exercise of Warrants 1,039,295 709,445 445,216 --------- --------- --------- Total Shares 4,800,427 3,988,779 4,623,759 ========= ========= =========
USE OF ESTIMATES The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial F-12 53 statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. COMPREHENSIVE INCOME In fiscal 1999 the Company adopted SFAS No. 130 "Reporting Comprehensive Income," which establishes new rules for the reporting of comprehensive income and its components. The adoption of this statement had no impact on the Company's net income or shareholders' equity. For the fiscal years ended 1999, 1998 and 1997, the Company's operations did not give rise to items includable in comprehensive income which were not already included in net income. Therefore, the Company's comprehensive income is the same as its net income for all periods presented. DERIVATIVE INSTRUMENTS In June 1998, the Financial Accounting Standards Board issued SFAS No. 133, "Accounting for Derivative Instruments and Hedging Activities". This statement establishes accounting and reporting standards for derivative instruments, including certain derivative instruments embedded in other contracts, and for hedging activities. SFAS No. 133, as amended by SFAS No. 137, is effective for all fiscal years beginning after June 15, 2000 and will not require retroactive restatement of prior period financial statements. This statement requires the recognition of all derivative instruments as either assets or liabilities in the balance sheet measured at fair value. Derivative instruments will be recognized as gains or losses in the period of change. If certain conditions are met where the derivative instrument has been designated as a fair value hedge, the hedge items may also be marked to market through earnings, thus creating an offset. If the derivative is designed and qualifies as a cash flow hedge, the changes in fair value of the derivative instrument may be recorded in comprehensive income. The Company does not presently make use of derivative instruments. 3. INVENTORY INVENTORY CONSISTS OF THE FOLLOWING:
DECEMBER 31, -------------------------- 1999 1998 ---- ---- Raw Materials $334,000 $339,000 Work in Progress 71,000 91,000 Finished Goods 106,000 115,000 -------- -------- $511,000 $545,000 ======== ========
F-13 54 4. FIXED ASSETS FIXED ASSETS CONSISTS OF THE FOLLOWING:
DECEMBER 31, --------------------------------- 1999 1998 ---- ---- Laboratory equipment $ 1,279,000 $ 1,261,000 Office equipment, furniture and vehicles 523,000 554,000 Leasehold improvements 514,000 534,000 ----------- ----------- 2,316,000 2,349,000 Accumulated depreciation and amortization (1,840,000) (1,718,000) ----------- ----------- $ 476,000 $ 631,000 =========== ===========
5. ACQUISITION On April 23, 1998, the Company acquired all of the capital stock of Stellar, a manufacturer of immunodiagnostic kits and reagents. The purchase price was $120,000 in cash and $700,000 in Class A Common Stock (398,406 shares were issued) plus future contingent payments of $650,000 in Class A Common Stock to be paid over three years based upon future sales levels of Stellar, with the Class A Common Stock to be valued at its market value on the acquisition agreement anniversary dates. The Company made a contingent payment of $150,000 in Class A Common Stock (131,118 shares) as of April 23, 1999 representing the first contingent payment. This amount was charged to Intangible Assets and is being amortized over 10 years. The Acquisition was accounted for by the purchase method. Results of operations of Stellar have been included in the Company's consolidated financial statements since the date of acquisition. The excess of the aggregate purchase price over the fair value of net assets acquired of $771,000 has been allocated to intangible assets (intellectual know-how of $100,000 and goodwill of $671,000) and is being amortized over a 10-year period. Any additional future payments required under the contingent earnout provisions of the purchase agreement will be accounted for as additional goodwill and will be amortized over the remaining life of the goodwill. Accumulated amortization of intangible assets was approximately $114,000 and $41,000 as of December 31, 1999 and 1998, respectively. 6. ACCOUNTS PAYABLE AND ACCRUED EXPENSES ACCOUNTS PAYABLE AND ACCRUED EXPENSES CONSIST OF THE FOLLOWING:
DECEMBER 31, ------------------------------ 1999 1998 ---- ---- Accounts Payable $1,117,000 $ 355,000 Professional Fees 98,000 110,000 Payroll and Related Expenses 366,000 85,000 Facility Consolidation Reserve -- 247,000 ---------- ---------- $1,581,000 $ 797,000 ========== ==========
F-14 55 7. LONG TERM DEBT: On May 20, 1998, the Company completed a private placement to three accredited investors of an aggregate of $4,000,000 of 5% Convertible Debentures due May 20, 2001, and three series of Warrants to purchase up to an aggregate of 261,288 shares of the Company's Class A Common Stock. Interest on the Debentures was payable only on maturity, conversion, redemption or when other payment was made on the Debentures in cash or, if registered for resale under the Securities Act of 1933, as amended, in shares of the Company's Class A Common Stock valued at the applicable Debenture conversion price. These debentures were repurchased on November 11, 1998 (see below). The Company also issued to the investors warrants in series entitling the investors to purchase, at an exercise price of $1.9141 per share, an aggregate of 261,228 shares of the Company's Class A Common Stock at any time to and including May 19, 2002. These warrants were cancelled on November 11, 1998 (see below). In conjunction with the private placement, the Company incurred both cash and noncash issuance costs totaling $525,000. These issuance costs were amortized on a straight-line basis as a component of interest expense through November 11, 1998. Upon conversion of the Debentures, the related unamortized deferred financing costs were charged to paid-in capital. The fair value of the warrants as determined using an option-pricing model of $252,000, was recorded as additional paid-in capital and included in the $525,000 total issuance costs related to these Debentures. In addition, the Company recorded additional paid-in capital and debt discount of $762,000 to reflect the intrinsic value of the maximum market price conversion discount (16%) related to these Debentures. The debt discount was amortized and charged to interest expense from May 20, 1998 through November 11, 1998. The unamortized issuance costs and debt discount were included in the extraordinary charge for early extinguishment discussed below. On November 11, 1998, the Company repurchased the then outstanding Debentures for a total of $3,852,000 (principal amount of $3,248,000 plus accrued interest of $79,000 and a $525,000 premium). As a result of the repurchase the Company has recorded a one-time extraordinary charge to earnings of $1,140,000 which represents the loss on early extinguishment. For each of the aforementioned debt instruments and warrants, the fair value of each was estimated on the date of the agreement using an option-pricing model with the following assumptions: dividend yield of 0%; expected volatility of 135% in 1998; risk-free interest rate of range 5.7% to 6.5% and expected lives of 2 to 5 years dependent on the life of the instrument. 8. STOCKHOLDERS' EQUITY: DESCRIPTION OF CLASS A AND CLASS B COMMON STOCK Holders of Class A Common Stock and Class B Common Stock have equal rights to receive dividends, equal rights upon liquidation, vote as one class on all matters requiring stockholder approval, have no preemptive rights, are not redeemable and do not have cumulative voting rights; F-15 56 however, holders of Class A Common Stock have one vote for each share held while holders of the Class B Common Stock have ten votes for each share held on all matters to be voted on by the stockholders. All Class B Common Stock is owned by the Chairman of the Board and may be converted into Class A Common Stock on a share-for-share basis at the option of the holder and generally is automatically converted in the event of sale or, with certain exceptions, transfer. PRIVATE PLACEMENT On October 27, 1998, the Company entered into an agreement to issue an aggregate of 10,800,000 shares of its Class A Common Stock to a group of accredited investors at a price of $.25 per share, a price above the market price of the Company's Class A Common Stock at the time. Of such shares, 4,000,000 shares were purchased by Alfred J. Roach, the Company's Chairman of the Board of Directors and Chief Executive Officer, for an aggregate price of $1,000,000. The Company has registered the shares issued in the private placement under the Securities Act of 1933, as amended. The proceeds from this private placement were used to repurchase the 5% Convertible Debentures (see Note 7). STOCK OPTION PLANS The Company's 1986 Stock Option Plan (the "1986 Plan") provided for the grant of incentive stock options and/or non-qualified options until July 1997 to purchase up to an aggregate of 4,450,000 shares of Class A Common Stock. Options were granted at exercise prices not less than the fair market value at the date of grant and for a term not to exceed ten years from the date of grant; except that an incentive stock option granted under the 1986 Plan to a stockholder owning more than 10% of the outstanding Common Stock of the Company could not have a term which exceeded five years nor have an exercise price of less than 110% of the fair market value of the Class A Common Stock on the date of the grant. The outstanding options have a vesting period ranging two years to four years ratably from the date of grant. Changes in outstanding options and options available for grant under the 1986 Plan, expressed in number of shares, are as follows: F-16 57
FOR THE YEARS ENDED DECEMBER 31, 1999 DECEMBER 31, 1998 ----------------------------- ------------------------------- Shares Weighted Avg. Shares Weighted Avg. Under Option Under Option Option Price Option Price ------ ------------- ------ ------------- Options outstanding, 2,790,500 $ 4.11 2,873,625 $ 4.10 beginning of year Granted -- -- -- -- Exercised -- -- (4,000) $ 1.75 Cancelled 272,250 $ 3.65 (79,125) $ 3.74 Expired 42,000 $ 2.00 -- -- Options outstanding, 2,476,250 $ 4.20 2,790,500 $ 4.11 end of year Options exercisable, 2,453,250 $ 4.21 2,730,750 $ 4.13 end of year Options available -- -- for grant, end of year
The Company's 1993 Non-Employee Director Stock Option Plan (the "1993 Plan") provides for the issuance of stock options for up to 500,000 shares of Class A Common Stock to outside directors of the Company. Options to purchase 10,000 shares of Class A Common Stock are automatically granted immediately following each Annual Meeting of the Company to each outside director elected at the Annual Meeting. The option exercise price is 100% of the fair market value of the Class A Common Stock on the date of grant and the option may be exercised during a period of five years from the date of grant at the rate of 25% each year on a cumulative basis, commencing one year from the date of grant. Changes in outstanding options and options available for grant under the 1993 Plan, expressed in number of shares, are as follows: F-17 58
FOR THE YEARS ENDED DECEMBER 31, 1999 DECEMBER 31, 1998 ----------------------------- ------------------------------- Shares Weighted Avg. Shares Weighted Avg. Under Option Under Option Option Price Option Price ------ ------------- ------ ------------- Options outstanding, 120,000 $ 3.27 110,000 $ 4.05 beginning of year Granted 40,000 $ 1.09 30,000 $ 1.00 Exercised -- -- -- -- Cancelled -- -- -- -- Expired (20,000) $ 3.38 (20,000) $ (4.13) Options outstanding, end of year 140,000 $ 2.63 120,000 $ 3.27 Options exercisable, end of year 57,500 $ 3.76 52,250 $ 3.86 Options available for grant, end of year 347,500 367,500
The Company's 1996 Stock Option Plan, as amended (the "1996 Plan"), which replaced the 1986 plan, provides for the grant of incentive stock options and/or non-qualified options to employees, officers and consultants of the Company to purchase up to an aggregate of 4,000,000 shares of Class A Common Stock. Options may be granted at exercise prices not less than the fair market value at the date of grant and may be exercisable for a period not to exceed ten years from the date of grant; except that the term of an incentive stock option granted under the 1996 Plan to a stockholder owning more than 10% of the outstanding Common Stock of the Company must not exceed five years nor have an exercise price of less than 110% of the fair market value of the Class A Common Stock on the date of the grant. The majority of options outstanding are exercisable 25% each year on a cumulative basis, commencing one year from the date of grant. Changes in outstanding options and options available for grant under the 1996 Plan, expressed in number of shares, are as follows: F-18 59
FOR THE YEARS ENDED DECEMBER 31, 1999 DECEMBER 31, 1998 ----------------------------- ------------------------------- Shares Weighted Avg. Shares Weighted Avg. Under Option Under Option Option Price Option Price ------ ------------- ------ ------------- Options outstanding, 1,487,750 $ 1.99 821,000 $ 3.35 beginning of year Granted 2,255,000 $ .70 741,500 $ .58 Exercised (5,250) $ .61 -- -- Cancelled (448,498) $ 2.40 (74,750) $ 2.95 Options outstanding, end of year 3,289,002 $ 1.05 1,487,750 $ 1.99 Options exercisable, end of year 1,250,382 $ 1.75 496,084 $ 3.41 Options available for grant, end of year 705,748 512,250
The Company has adopted the disclosure-only provisions of SFAS No. 123, "Accounting for Stock-Based Compensation." Accordingly, no compensation cost has been recognized for the stock option plans. Had compensation cost for the Company's stock option plans been determined based on the fair value at the grant date for options granted in 1999, 1998, and 1997 in accordance with the provisions of SFAS No. 123, the Company's net loss and loss per share would have been increased to the pro forma amounts indicated below:
1999 1998 1997 - ------------------------------------------------------------------------------------------------------------------- Net loss - as reported $ (5,351,000) $ (7,548,000) $ (7,147,000) Net loss - pro forma $ (6,130,000) $ (8,243,000) $ (7,522,000) Basic and diluted loss per share - as reported $ (.14) $ (.29) $ (.35) Basic and diluted loss per share - pro forma $ (.16) $ (.32) $ (.37) - -------------------------------------------------------------------------------------------------------------------
The fair value of each option grant is estimated on the date of grant using the Black-Scholes option-pricing model with the following weighted-average assumptions used for grants in 1999, 1998 and 1997: dividend yield of 0%; expected volatility of 106% in 1999, 135% in 1998 and 84% in 1997; risk-free interest rate of range 4.4% to 6.8% and expected lives of seven years. F-19 60 The weighted average fair value of all three option plans for options granted were $.59, $.50 and $2.10 in 1999, 1998 and 1997, respectively. The following table sets forth additional SFAS No. 123 disclosure information as to options outstanding for all three plans at December 31, 1999:
Weighted Average Shares Exercisable Exercise Weighted Average Remaining Outstanding Shares Price Range Exercise Price Contractual Life - --------------------------------------------------------------------------------------------------------------- 1,342,500 137,500 $ .25 - $ .31 $ .26 8.7 160,000 25,000 $ .40 - $ .66 $ .53 9.5 86,250 55,500 $ .61 - $ .85 $ .67 8.8 1,187,502 568,382 $1.00 - $1.50 $ 1.04 8.1 744,750 658,250 $1.52 - $2.25 $ 1.87 4.6 435,500 409,500 $2.38 - $3.50 $ 3.3 6.4 1,490,500 1,460,500 $3.66 - $5.38 $ 4.76 2.5 457,250 445,500 $5.50 - $7.75 $ 5.63 2.3 1,000 1,000 $10.00 $10.00 2.2 - ------------------------------------ 5,905,252 3,761,132
OTHER OPTIONS GRANTED The Company entered into a consulting agreement with an unaffiliated third party to assist in the strategic planning and implementation of the Company's licensing, collaborative and co-marketing plans, which expired February 29, 1996. Pursuant to the agreement, the Company granted an option to purchase 50,000 shares of Class A Common Stock on or before February 28, 2000 at $2.25 per share. The Company also granted performance options to purchase 50,000 shares of Class A Common Stock at $2.25 for licensing or collaborative agreements entered into which met certain criteria. These options are exercisable for five years from the date of grant. The Company has granted an investor relations consultant a warrant to purchase 50,000 shares of Class A Common Stock on or before November 14, 2000 at $3.50 per share pursuant to an agreement dated November 27, 1995. The Company entered into an agreement with an unaffiliated third party dated October 6, 1995 to assist with the marketing of the Company's products and intellectual property, which agreement has expired. Pursuant to this agreement, the Company granted performance options to purchase 25,000 shares of Class A Common Stock and issued 5,000 shares for services rendered under the agreement. Options were granted for 12,500 shares at $3.00 per share and 12,500 shares at $5.50 per share. These options are exercisable for five years from the date of grant. The Company entered into an agreement with an unaffiliated third party to render financial consulting advice, dated August 13, 1998 and amended on October 1, 1998. Pursuant to this agreement, the Company granted performance options to purchase up to 400,000 shares of Class F-20 61 A Common Stock. Options were granted for 150,000 shares at $.75 per share, 150,000 shares at $1.00 per share and 100,000 shares at $1.50 per share. The options are exercisable for four years from the agreement date. The fair value of these options as determined using an option-pricing model was $124,000, which is being recorded as a noncash charge over the vesting/service period of the options. The following assumptions were used for this fair value computation: dividend yield of 0%, volatility of 135%, risk-free interest rate of 4.26% and expected lives of 4 years. The charge was $81,000 in 1999 and $43,000 in 1998. The Company has granted an investor relations consultant a warrant to purchase up to 300,000 shares of Class A Common Stock on or before January 19, 2004 at $1.00 per share pursuant to an agreement dated January 20, 1999. The warrant may be exercised in increments of 50,000 share amounts only if certain milestones are met during the period ending June 30, 2000. The fair value of these warrants as determined using an option-pricing model was $264,000 which was recorded as a noncash charge over the one year service period (fiscal year 1999). The following assumptions were used for this fair value computation: dividend yield of 0%, volatility of 149%, risk-free interest rate of 4.6% and expected lives of 4 years. The Company performed a valuation of the aforementioned options and warrants using an option-pricing model at the date of grant and recorded a charge to operations over the related service period. 9. FEDERAL INCOME TAXES: At December 31, 1999, the Company had net operating loss carryforwards of approximately $59,900,000 for income tax purposes. The net operating loss carryforwards will expire in varying amounts through 2019. In addition, the Company has approximately $1,230,000 of available research and development tax credits to offset future taxes. These credits expire through 2019. In accordance with SFAS No. 109 "Accounting for Income Taxes," the Company has recorded a valuation allowance of $61,130,000 to fully reserve for the deferred tax benefit attributable to its net operating loss and tax credit carryforwards due to the uncertainty as to their ultimate realizability. In accordance with certain provisions of the Tax Reform Act of 1986, a change in ownership of a corporation of greater than 50 percentage points within a three-year period places an annual limitation on the corporation's ability to utilize its existing net operating loss carryforwards, investment tax and research and development credit carryforwards (collectively "tax attributes"). Such a change in ownership was deemed to have occurred in connection with the Company's 1990 initial public offering, at which time the Company's tax attributes amounted to approximately $4.9 million. The annual limitation of the utilization of such tax attributes is approximately $560,000. To the extent the annual limitation is not utilized, it may be carried forward for utilization in future years. At December 31, 1999, $4,900,000 of net operating losses is no longer subject to this limitation. 10. VARIOUS AGREEMENTS AGREEMENTS WITH BOSTON UNIVERSITY F-21 62 On December 1, 1996, the Company entered into a Sublease Agreement and, effective January 1, 1997, an Agreement for Services with Boston University. These two agreements provided for the Company's use of approximately 7,700 square feet of space for laboratories and for its antigen-free technology at a total annual payment of $275,000. The agreements had an initial term of three years. In connection with this lease agreement, the Company may, at its option, pay a portion of the annual lease obligation with Class A Common Stock plus a warrant to purchase shares of Class A Common Stock. The number of shares are computed using the average market price of the Company's Class A Common Stock during the ten days prior to issuance. The warrant shares are to be exercisable at a price equal to the closing price of the underlying Class A Common Stock on the date the warrant is issued and for a period of four years from the date of issuance. During 1997, the Company issued 48,117 shares of Class A Common Stock and warrants to purchase 48,117 shares of Class A Common Stock with the exercise price ranging from $2.13 to $4.75. During 1998, the Company issued 129,847 shares of Class A Common Stock and warrants to purchase 129,847 shares of Class A Common Stock with the exercise price ranging from $.63 to $2.19. During 1999, the Company issued 29,850 shares of Class A Common Stock and warrants to purchase 29,850 shares of Class A Common Stock with the exercise price of $1.28. The fair values of the warrants were calculated using an option-pricing model at the date of issue and recorded a charge to operations of $32,000 in 1999, $99,000 in 1998 and $93,000 in 1997. In the fourth quarter of 1998, the Company implemented a consolidation of its research and development facilities. In 1998, the Company recorded a $252,000 reserve for consolidating facilities which included severance costs, lease termination, and the write-down of leasehold improvements. The Boston facilities were closed in June 1999 and consolidated at the Stellar facilities in Columbia, Maryland. UNIVERSITY OF NOTRE DAME AGREEMENT On December 1, 1983, the Company entered into a lease agreement with the University of Notre Dame ("Notre Dame Agreement") which was amended and extended until November 30, 1993, at which time it was terminated. On December 1, 1993, the Company entered into a lease with Notre Dame ("Notre Dame Lease") for substantially the same premises occupied by the Company under the Notre Dame Agreement for a term ending August 31, 1995. Notre Dame extended the rental of a portion of the space through August 31, 1996. In February 1996, the Company entered into a lease in South Bend, Indiana for approximately 5,200 square feet with an annual base rent of $52,200. This lease commenced on April 1, 1996 for an initial five-year term with three one-year renewal options. In September 1996, the Company entered into a second lease for a three year term in South Bend, Indiana for approximately 3,000 square feet with an annual base rent of $30,400. In 1997, the Company moved its research and development activities from South Bend, Indiana to Boston, Massachusetts. The Company closed both facilities and has terminated both leases. Under the Notre Dame Agreement, the Company was required to pay Notre Dame for the direct and indirect payroll cost of substantially all of the Company's research and development personnel, purchases of laboratory supplies, items of equipment or other costs associated with the research projects. F-22 63 Notre Dame has granted the Company all rights, title and interest in and to any inventions, patents and patent applications for research projects funded by the Company. Inventors of any processes or technology which receive Company support have assigned his or her interest in the product, patent or patent applications to the Company. The Company did not incur costs under the Notre Dame Agreement during the three years ended December 31, 1999, and incurred $6,150,000 for the period from inception (September 1, 1983) through December 31, 1996. The Company has agreed to pay Notre Dame a royalty of 5% of the net income the Company achieves from sales of products resulting from Company-sponsored research activities at Notre Dame. Royalty payments shall continue for a ten-year period from the date of the first commercial sale of a product, regardless of the continuation of the Notre Dame Agreement. EMPLOYMENT AGREEMENTS The President and Chief Executive Officer and the Executive Vice-President are parties to employment agreements with the Company ending November 15, 2001 and September 30, 2001, respectively. The aggregate annual minimum compensation under these agreements as of December 31, 1999 was approximately $350,000. Those officers also are parties to confidentiality agreements with the Company requiring them to maintain certain information in confidence during and subsequent to their employment with the Company. SCIENTIFIC ADVISORY COMMITTEE AGREEMENTS The Company has entered into advisory board agreements with certain research scientists with respect to specific projects in which the Company has an interest. The payments to the advisors for informal meetings and other consultations as a group were approximately $65,000, $115,000 and $87,000, for the three years ended December 31, 1999, 1998 and 1997, respectively. Generally, members of the Company's Scientific Advisory Committee are employed by or have consulting agreements with third parties, the businesses of which may conflict or compete with the Company and any inventions discovered by such individuals will not become the property of the Company. As part of its development stage activities, the Company enters into various agreements that provide for the expenditure of funds for research and development activities and typically provide for the payment of royalties (between 2% to 8% of net sales) by the Company if any products are successfully developed and marketed as a result of the work being performed under the agreement. The following is a summary of significant agreements the Company has entered into: LICENSE AGREEMENTS On January 24, 1992, the Company entered into an exclusive, 15 year license agreement with Yamanouchi Pharmaceutical Co., Ltd. ("Yamanouchi"), a Japanese pharmaceutical company. Under this agreement, Yamanouchi may manufacture, use or market diagnostic assays that contain the Company's monoclonal antibody, 45-J, in Japan and Taiwan. Yamanouchi paid a non-refundable, initial sign-up payment to the Company of $900,000 (net of Japanese taxes). The agreement provides that Yamanouchi is to pay the Company a fixed percentage over the Company's F-23 64 manufacturing costs of the 45-J antibody supplied to Yamanouchi. On an ongoing basis, Yamanouchi is to pay the Company royalties at the rate of 10% of all net sales of diagnostic assays sold by Yamanouchi or its affiliates during each calendar year of the agreement term. Additionally, Yamanouchi is to pay the Company 50% of any initial fees, royalties or other consideration received with respect to any sublicense granted by Yamanouchi. To date, Yamanouchi has not made any sales. On December 10, 1992, the Company entered into an agreement (as amended) with University College Dublin, Ireland granting the Company an exclusive license for drugs/compounds to halt the onset and/or progression of neurodegenerative diseases, in general, and Alzheimer's Disease, in particular. The agreement's term is the duration of any patents that may be granted to the university with a minimum of 10 years. Pursuant to the agreement, the Company is to pay the university a royalty of 5% of net income relating to product sales. The Company expensed $18,000 in 1999, $5,000 in 1998 and $12,000 in 1997 for certain research expenses, supplies and equipment under this agreement. On August 10, 1993, the Company entered into a five-year collaboration agreement with the Free University of Berlin to develop therapeutic compounds. The Company also acquired a series of anticonvulsant compounds. Pursuant to the agreement, the Company is to pay a royalty of 5% of the net product sales. The agreement lasts the life of the patent or a minimum of 10 years. The Company expensed $75,000 in 1999, $103,000 in 1998 and $116,000 in 1997 for research expenses and supplies under this agreement. In October 1995, ABS entered into a license and collaboration agreement with F. Hoffmann-La Roche, Ltd. ("Hoffmann-La Roche") for the co-development and marketing of the Company's TpP test for the detection of active thrombosis (blood clot formation). The agreement grants Hoffmann-La Roche a worldwide license to market the TpP test in a latex based particle agglutination format. Under the agreement, the Company received a $60,000 non-refundable development payment, to adapt the TpP test in the latex based particle agglutination format to Hoffmann-La Roche's automated diagnostic systems. The Company is also to receive milestone payments upon achievement of certain commercialization goals. The TpP test is to be manufactured by the Company for use on Hoffmann-La Roche's instruments. ABS is to receive a percentage of Hoffmann-La Roche's net selling price for the Company's manufacturing of the TpP test plus a 5% royalty on net sales made by Hoffmann-La Roche. Under the agreement, the TpP test is also to be sold by ABS and Hoffmann-La Roche to other diagnostic companies using similar particle agglutination technology. On these sales, gross profit is to be shared equally between the Company and Hoffmann-La Roche. To date, ABS has not received any milestone or royalty payments. In December 1995, ABS entered into a license agreement with Abbott Laboratories ("Abbott") for the marketing of the Company's TpP assay. The license agreement grants Abbott a worldwide license to market the TpP test for Abbott's immunoassay formats. The Company received a $100,000 non-refundable up-front payment and is to receive milestone payments upon achievement of certain development and commercialization goals. The Company is to receive a 5% royalty on net sales made by Abbott. In addition, the reagent for the TpP test is to be manufactured by the Company for use by Abbott. To date, ABS has not received any milestone or royalty payments. F-24 65 11. SUBSEQUENT EVENTS On January 27, 2000, the Company entered into an Exclusive License Agreement with Abbott under which the Company granted to Abbott an exclusive worldwide license to its ABS-103 compound, related technology and patent rights. The Exclusive License Agreement gives Abbott the exclusive right to develop and market the compound, which presently is in the pre-clinical stage. In consideration for the license grant and in addition to customary royalties on sales, Abbott paid the Company an initial license fee of $500,000 and agreed to pay additional milestone payments aggregating up to $17 million depending upon successfully reaching development milestones, generally by indication. In connection with the entering into of the Exclusive License Agreement, the Company and Abbott also entered into a Stock Purchase Agreement dated January 27, 2000 pursuant to which Abbott purchased 2,782,931 shares (the "Abbott Shares") of the Company's Class A Common Stock for $1,500,000. The Company also entered into a Registration Rights Agreement with Abbott pursuant to which, among other things, the Company agreed to register the Abbott Shares under the Securities Act of 1933, as amended upon Abbott's request at any time after the first anniversary of the sale and to include the Abbott Shares in any other registration of the Company's securities under the Securities Act after that date. All expenses of registration of the Abbott Shares, other than underwriting discounts, selling commissions and fees and disbursements of counsel for Abbott, are to be borne by the Company. On December 31, 1999 the Company and Biotechnology Value Fund, L.P. ("BVF") signed a letter agreement, subject to negotiation of definitive agreements, authorization of preferred stock and certain other matters, for BVF to invest between $2 and 3 million for the purchase of between 4,000 and 6,000 shares of Series A Convertible Preferred Stock (the "Preferred Stock") and related Warrants. When the Company and BVF began negotiating the definitive agreements for the sale transaction in January 2000, in order to induce BVF to purchase the full $3 million, at the suggestion of BVF, the Company's Chairman Mr. Roach agreed that rather than demand repayment of his demand notes, he would convert $500,000 of the approximately $776,000 plus accrued interest owed to him into an additional investment in the Company on terms identical to the terms previously negotiated with BVF and that the balance of the amount owed him (approximately $276,000 of principal) could be repaid at the rate of $100,000 of principal and interest per month until repaid in full. Accordingly, $500,000 of the amount owed Mr. Roach was converted into 1,000 shares of Preferred Stock and 1,000,000 Warrants. The Company entered into a Securities Purchase Agreement dated as of February 3, 2000 with BVF and Mr. Roach relating to the issuance of the 7,000 shares of Preferred Stock and Warrants for 7,000,000 shares of Class A Common Stock. On February 7, 2000, BVF loaned $3,000,000 to the Company, equaling the purchase price for 6,000 shares of Preferred Stock and 6,000,000 Warrants. On March 3, 2000, after receiving stockholder consent to the proposed sale, the Company repaid BVF's loan and $500,000 of the Company's indebtedness to Mr. Roach by issuing F-25 66 6,000 shares of Preferred Stock and 6,000,000 Warrants to BVF and 1,000 shares of Preferred Stock and 1,000,000 Warrants to Mr. Roach. The Shares of Preferred Stock: (i) have the right to participate with dividends declared on the Common Stock, if, as and when declared, on an as-converted basis; (ii) contain customary anti-dilution adjustments for mechanical adjustments in the event of stock splits and similar transactions; (iii) contain restrictions on subsequent issuances of other preferred stock ranking equal to or superior to the Preferred Stock without the consent of the holders of a majority of such Preferred Stock; (iv) have a liquidation preference equal to the original issue price of the Preferred Stock, plus any accrued and unpaid dividends; (v) will not be entitled to vote except as a separate class when its rights are affected; and (vi) will be convertible at any time after the original issue date at the option of the holder. Each share of Preferred Stock initially will be convertible into 1,000 shares of Class A Common Stock, or a conversion price of $.50 per share of Class A Common Stock. Under the terms of the Securities Purchase Agreement, the Company also entered into a Registration Agreement under which it agreed to file a registration statement within 60 days after closing, registering the Class A Common Stock issuable upon conversion of the Preferred Stock or exercise of the Warrants and to use its best efforts to cause that registration to become effective within 120 days after closing. The Company will bear the expenses of such registration. The following table summarizes the pro forma financial impact of the previously described subsequent events upon the balance sheet of the company as of December 31, 1999:
Condensed Balance Sheet Pro Forma Pro Forma (in Thousands) 12/31/99 Adjustments 12/31/99 ----------------------- -------- ----------- --------- Total current assets $ 891 $5,000 $5,891 Total assets 3,938 5,000 8,938 Total current liabilities 2,327 (500) 1,827 Total stockholders' equity 1,578 5,500 7,078 Total liabilities and stockholders' Equity 3,938 5,000 8,938
Adjustments include: 1) Receipt of a $500,000 upfront license fee plus $1,500,000 for issuance Class A Common Stock under agreements with Abbott. 2) Receipt of $3,000,000 investment in Preferred Stock and warrants by BVF. 3) Conversion of $500,000 of Notes payable to Mr. Roach into Preferred Stock and warrants. 12. COMMITMENTS ABS leases 6,000 square feet of office space in New York under a lease expiring July 2000 (with an annual base rent of $39,000), which it intends to renew. ABS' subsidiary, Stellar, has a lease covering 16,000 square feet in Maryland, with an annual base rent of $136,000 and a term ending March 31, 2001. F-26 67 Commission File No. 0-19041 SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 EXHIBITS TO FORM 10-K ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE FISCAL YEAR ENDED DECEMBER 31, 1999 AMERICAN BIOGENETIC SCIENCES, INC. 68 Exhibit No. Document - ----------- -------- 3.1* Restated Certificate of Incorporation of ABS, as filed with the Secretary of State of Delaware on July 30, 1996 and amended through March 3, 2000. 3.2 Amended and Restated By-Laws of ABS. Incorporated herein by reference to Exhibit 4.02 to ABS' Registration Statement on Form S-8, File No. 333-09473. 4.1 Form of Purchase and Investment Agreement executed by ABS and several investors on October 27, 1998. Incorporated herein by reference to Exhibit 99 to ABS' Registration Statement on Form S-3, file number 333-69735, filed with the Commission on December 24, 1998. 4.2 Form of Warrant issued to several individuals under ABS' Financial Advisory Agreement with M.H. Meyerson & Co., Inc., dated as of August 13, 1998 and schedule of holders thereof. Incorporated herein by reference to Exhibit 4.1(e) to ABS' Form 10-K for the fiscal year ended December 31, 1998, File No. 0-19041. 4.3(a) Stock Purchase Agreement, dated as of January 27, 2000, between ABS and Abbott Laboratories. Incorporated herein by reference to Exhibit 99.1 to ABS' Current Report on Form 8-K dated January 27, 2000 (date of earliest event reported), File No. 0-19041. 4.3(b) Registration Rights Agreement, dated as of January 27, 2000, between ABS and Abbott Laboratories. Incorporated herein by reference to Exhibit 4.1 to ABS' Current Report on Form 8-K dated January 27, 2000 (date of earliest event reported), File No. 0-19041. 4.4(a)* Securities Purchase Agreement, dated as of February 3, 2000, among ABS and Biotechnology Value Fund, L.P., Biotechnology Value Fund II, L.P., Investment 10 L.L.C. and Alfred J. Roach. 4.4(b)* Registration Agreement, dated as of March 3, 2000, among ABS and Biotechnology Value Fund, L.P., Biotechnology Value Fund II, L.P., Investment 10 L.L.C. and Alfred J. Roach. 10.1(a)+ Employment Agreement dated October 1, 1996 between ABS and Ellena M. Byrne. Incorporated herein by reference to Exhibit 10.1(b) to ABS' Form 10-K/A, dated April 30, 1997, File No. 0-19041. 10.1(b)+ Employment Agreement dated November 2, 1998 between ABS and Mr. John S. North. Incorporated herein by reference to Exhibit 10.1(b) to ABS' Form 10-K for the fiscal year ended December 31, 1998, File No. 0-19041. 69 Exhibit No. Document - ----------- -------- 10.2(a)+ ABS' Stock Option Plan, as amended. Incorporated herein by reference to Exhibit 28.1 to ABS' Registration Statement on Form S-8, File No. 33-51240. 10.2(b)+ ABS' 1993 Non-Employee Director Stock Option Plan. Incorporated herein by reference to Exhibit 99.01 to ABS' Registration Statement on Form S-8, File No. 33-65416. 10.2(c)*+ ABS' 1996 Stock Option Plan, as amended. 10.3 Exclusive License Agreement dated January 24, 1992 between ABS and Yamanouchi Pharmaceutical Co., Ltd. Incorporated herein by reference to Exhibit 10.29 to ABS' Current Report on Form 8-K dated January 24, 1992, File No. 0- 19041. 10.4 Warrant dated October 25, 1995 issued to Swartz Investments, Inc. Incorporated herein by reference to Exhibit 10.13 to ABS' Current Report on Form 8-K dated October 12, 1995, File No. 0-19041. 10.5 Exclusive License Agreement, dated as of January 27, 2000, between ABS and Abbott Laboratories. Incorporated herein by reference to Exhibit 10.1 to ABS' Current Report on Form 8-K dated January 27, 2000, File No. 0-19041. 21 List of Subsidiaries. Incorporated herein by reference to Exhibit 21 to ABS' Form 10-K for the fiscal year ended December 31, 1998, File No. 0-19041. 23* Consent of Independent Public Accountants. 27* Financial Data Schedule. *Filed herewith. All other exhibits are incorporated by reference to the document following the description thereof. +Management contract or compensatory plan.
EX-3.1 2 RESTATED CERTIFICATE OF INCORPORATION 1 Exhibit 3.1 RESTATED CERTIFICATE OF INCORPORATION OF AMERICAN BIOGENETIC SCIENCES, INC. It is hereby certified that: 1. The present name of the Corporation (hereinafter called the "Corporation") is American Biogenetic Sciences, Inc., which is the name under which the Corporation was originally incorporated. The date of filing the original Certificate of Incorporation of the Corporation with the Secretary of State of the State of Delaware is September 1, 1983. 2. The provisions of the Certificate of Incorporation of the Corporation, as heretofore amended and/or supplemented, are hereby restated and integrated into the single instrument without further amendment and without any discrepancy between the provisions of the Certificate of Incorporation as heretofore amended and supplemented and the provisions of the said single instrument hereinafter set forth. 3. The Board of Directors of the Corporation has duly adopted this Restated Certificate of Incorporation pursuant to the provisions of Section 245 of the General Corporation Law of the State of Delaware in the form set forth as follows: 2 "RESTATED CERTIFICATE OF INCORPORATION OF AMERICAN BIOGENETIC SCIENCES. INC. ***** 1. The name of the Corporation is AMERICAN BIOGENETIC SCIENCES, INC. 2. The address of its registered office in the State of Delaware is 1209 Orange Street, in the City of Wilmington, County of New Castle. The name of its registered agent at such address is The Corporation Trust Company. 3. The nature of the business or purposes to be conducted or promoted is to engage in any lawful act or activity for which corporations may be organized under the General Corporation Law of Delaware. 4. The aggregate number of shares which the Corporation shall have authority to issue is 53,000,000, of which (i) 50,000,000 shares, having a par value of $.001 per share, shall be Class A Common Stock, and (ii) 3,000,000 shares, having a par value of $.00l per share, shall be Class B Common Stock The following sets forth the relative rights, powers, preferences and limitations of the shares of each class of stock. (a) The holders of Class A Common Stock and the holders of Class B Common Stock shall be entitled to the same rights and privileges, and shall share equally, share and share alike, in the distribution of any funds which the Board of Directors may declare or set aside or pay out as -2- 3 dividends, and shall share equally, share and share alike, in the distribution of any and all dividends and in the distribution of assets in the event of liquidation, whether voluntary or involuntary, and after the payment of all debts of the Corporation, and shall be alike in all other respects, except that each holder of Class B Common Stock shall be entitled to ten votes for each share of Class B Common Stock held by such holder, and each holder of Class A Common Stock shall be entitled to one vote for each share of Class A Common Stock held by such holder. The holders of the Class A Common Stock and Class B Common Stock shall vote as one class. (b) Each share of Class B Common Stock may be converted into one share of Class A Common Stock at the option of the bolder thereof. (c) No person holding shares of Class B Common Stock of record (hereinafter called a "Class B Holder") may transfer, and the Corporation shall not register the transfer of, such shares of Class B Common Stock, as Class B Common Stock, whether by sale, assignment, gift, bequest, appointment or otherwise, except to a Permitted Transferee, and upon any attempted transfer of shares not permitted hereunder said shares of Class B Common Stock shall be converted into Class A Common Stock. A Permitted Transferee shall mean, with respect to each person from time to time shown as the record holder of shares of Class B Common Stock: (i) a trust principally for the benefit of the Class B Stockholder; and (ii) a partnership or corporation a majority of the beneficial ownership of which is owned by the Class B Stockholder. (d) Notwithstanding anything to the contrary set forth herein, any Class B Holder may pledge such Holder's shares of Class B Common Stock to a pledgee pursuant to a bona fide pledge of such shares as collateral security for indebtedness due to the pledgee, provided that such shares shall -3- 4 not be transferred to or registered in the name of the pledgee and shall remain subject to the provisions of this Article 4. In the event of foreclosure or other similar action by the pledgee, such pledged shares of Class B Common Stock may only be converted into shares of Class A Common Stock. (e) At any time when the number of outstanding shares of Class B Common Stock as reflected on the stock transfer books of the Corporation falls below 5% of the aggregate number of the issued and outstanding shares of the Class A Common Stock and Class B Common Stock of the Corporation, or the Board of Directors and the holders of a majority of the outstanding shares of Class B Common Stock approve the conversion of all of the Class B Common Stock into Class A Common Stock, then, immediately upon the occurrence of either such event, the outstanding shares of Class B Common Stock shall be converted into shares of Class A Common Stock. In the event of such a conversion, certificates formerly representing outstanding shares of Class B Common Stock shall thereupon and thereafter be deemed to represent the like number of shares of Class A Common Stock. (f) Shares of Class B Common Stock shall be registered in the names of the beneficial owners thereof and not in "street" or "nominee" name. For this purpose, a "beneficial owner" of any shares of Class B Common Stock shall mean a person who, or an entity which, possess the power, either singly or jointly, to direct the voting or disposition of such shares. The Corporation shall note on the certificates for shares of Class B Common Stock the restrictions on transfer and registration of transfer imposed by this Article 4. (g) The Corporation shall, at all times, reserve and keep available out of authorized but unissued shares of Class A Common Stock, solely for the purpose of effecting the conversion of Class B Common Stock, such number of shares of Class A Common Stock as shall from time to time be sufficient to effect the conversion of all outstanding shares of Class B Common Stock. -4- 5 5. The Corporation is to have perpetual existence. 6. In furtherance and not in limitation of the powers conferred by statute, the Board of Directors is expressly authorized to make, alter or repeal the by-laws of the Corporation. 7. Elections of Directors need not be by written ballot unless the by-laws of the Corporation shall so provide. Meetings of stockholders may be held within or without the State of Delaware, as the by-laws may provide. The books of the Corporation may be kept (subject to any provision contained in the statutes) outside the State of Delaware at such place or places as may be designated from time to time by the Board of Directors or in the by-laws of the Corporation. 8. The Corporation reserves the right to amend, alter, change or repeal any provision contained in this Certificate of Incorporation, in the manner now or hereafter prescribed by statute, and all rights conferred upon stockholders herein are granted subject to this reservation. 9. No Director of the Corporation shall be liable to the Corporation or any of its stockholders for monetary damages for breach of fiduciary duty as a Director, except for liability (1) for any breach of the Director's duty of loyalty to the Corporation or its stockholders, (2) for acts or omissions not in good faith or which involve intentional misconduct or a knowing violation of law, (3) under Section 174 of the Delaware General Corporation Law, or (4) for any transaction from which the Director derived an improper personal benefit." Signed on July 29, 1996 /s/ Alfred J. Roach --------------------------------------------------- Alfred J. Roach, Chairman of the Board of Directors -5- 6 CERTIFICATE OF AMENDMENT OF CERTIFICATE OF INCORPORATION OF AMERICAN BIOGENETIC SCIENCES, INC. It is hereby certified that: 1. The name of the corporation (hereinafter called the "Corporation") is American Biogenetic Sciences, Inc. 2. The Certificate of Incorporation of the Corporation if hereby amended by striking out Article 4. thereof and by substituting in lieu of said Article the following new Article: "4. The aggregate number of shares which the Corporation shall have authority to issue is 103,000,000, of which (i) 100,000,000 shares, having a par value of $.001 per share, shall be Class A Common Stock, and (ii) 3,000,000 shares, having a par value of $.001 per share, shall be Class B Common Stock. The following sets forth the relative rights, powers, preferences and limitations of the shares of each class of stock. (a) The holders of Class A Common Stock and the holders of Class B Common Stock shall be entitled to the same rights and privileges, and shall share equally, share and share alike, in the distribution of any funds which the Board of Directors may declare or set aside or pay out as dividends, and shall share equally, share and share alike, in the distribution of any and all dividends and in the distribution of assets in the event of liquidation, whether voluntary or involuntary, and after the payment of all debts of the Corporation, and shall be alike in all other respects, except that each holder of Class B Common Stock shall be entitled to ten votes for each share of Class B Common Stock held by such holder, and each holder of Class A Common Stock shall be entitled to one vote for each share of Class A Common Stock held by such holder. The holders of the Class A Common Stock and Class B Common Stock shall vote as one class. (b) Each share of Class B Common Stock may be converted into one share of Class A Common Stock at the option of the holder thereof. (c) No person holding shares of Class B Common Stock of record (hereinafter called a "Class B Holder") may transfer, and the Corporation shall not register the transfer of, such shares of Class B Common Stock, as Class B Common Stock, whether by sale, assignment, gift, bequest, appointment or otherwise, except to a Permitted Transferee, and upon any attempted transfer of shares not permitted 7 hereunder said shares of Class B Common Stock shall be converted into Class A Common Stock. A Permitted Transferee shall mean, with respect to each person from time to time shown as the record holder of shares of Class B Common Stock: (i) a trust principally for the benefit of the Class B Stockholder; and (ii) a partnership or corporation a majority of the beneficial ownership of which is owned by the Class B Stockholder. (d) Notwithstanding anything to the contrary set forth herein, any Class B Holder may pledge such Holder's shares of Class B Common Stock to a pledge pursuant to a bona fide pledge of such shares as collateral security for indebtedness due to the pledge, provided that such shares shall not be transferred to or registered in the name of the pledge and shall remain subject to the provisions of this Article 4. In the event of foreclosure or other similar action by the pledgee, such pledged shares of Class B Common Stock may only be converted into shares of Class A Common Stock. (e) At any time when the number of outstanding shares of Class B Common Stock as reflected on the stock transfer books of the Corporation falls below 5% of the aggregate number of the issued and outstanding shares of the Class A Common Stock and Class B Common Stock of the Corporation, or the Board of Directors and the holders of a majority of the outstanding shares of Class B Common Stock approve the conversion of all of the Class B Common Stock into Class A Common Stock, then, immediately upon the occurrence of either such event, the outstanding shares of Class B Common Stock shall be converted into shares of Class A Common Stock. In the event of such a conversion, certificates formerly representing outstanding shares of Class B Common Stock shall thereupon and thereafter be deemed to represent the like number of shares of Class A Common Stock. (f) Shares of Class B Common Stock shall be registered in the names of the beneficial owners thereof and not in "street" or "nominee" name. For this purpose, a "beneficial owner" of any shares of Class B Common Stock shall mean a person who, or an entity which, possess the power, either singly or jointly, to direct the voting or disposition of such shares. The Corporation shall note on the certificates for shares of Class B Common Stock the restrictions on transfer and registration of transfer imposed by this Article 4. (g) The Corporation shall, at all times, reserve and keep available out of authorized but unissued shares of Class A Common Stock, solely for the purpose of effecting the conversion of Class B Common Stock, such number of shares of Class A Common Stock as shall from time to time be sufficient to effect the conversion of all outstanding shares of Class B Common Stock." -2- 8 3. The amendment of the Certificate of Incorporation herein certified has been duly adopted in accordance with the provisions of Section 242 of the General Corporation Law of the State of Delaware. Signed on June 15, 1999 /s/ John S. North ------------------------ John S. North, President -3- 9 STATE OF DELAWARE SECRETARY OF STATE DIVISION OF CORPORATIONS FILED 10:00 AM 03/03/2000 001108829 - 2015219 CERTIFICATE OF AMENDMENT TO THE RESTATED CERTIFICATE OF INCORPORATION OF AMERICAN BIOGENETIC SCIENCES, INC. AMERICAN BIOGENETIC SCIENCES, INC., a corporation organized and existing under the laws of the State of Delaware (the "Corporation"), pursuant to Section 242 of the Delaware General Corporation Law, hereby certifies as follows: 1. The Board of Directors of the Corporation by unanimous written consent dated as of January 20, 2000, duly adopted the following resolutions in accordance with the provisions of Sections 141 and 242 of the Delaware General Corporation Law; RESOLVED: The first two paragraphs of Article 4 of the Company's Restated Certificate of Incorporation, as amended, are to be deleted in their entirety and replaced with the following: "4. The aggregate number of shares which the Corporation shall have authority to issue is 113,000,000, of which (i) 100,000,000 shares, having a par value of $.001 per share, shall be Class A Common Stock (ii) 3,000,000 shares, having a par value of $.001 per share, shall be Class B Common Stock and (iii) 10,000,000 shares, having a par value of $.001 per share, shall be Preferred Stock. PART A - COMMON STOCK --------------------- The relative rights, powers, preferences and limitations of the Corporation's classes of Common Stock are as follows:" RESOLVED: Article 4 of the Company's Restated Certificate of Incorporation, as amended. is further amended by adding a new Part B immediately after the present paragraph 14(g) thereof: PART B - PREFERRED STOCK ------------------------ SECTION 1. GENERAL. The Preferred Stock may consist of one or more series. The Board of Directors may, from time to time, establish and designate the different series and the variations in the relative rights and preferences as between the different series provided Part B, Section 2 of this Article 4, but in all other respects all shares of the Preferred Stock shall be identical. In the event that at any time the Board of Directors 10 shall have established and designated one or more series of Preferred Stock consisting of a number of shares less than all of the authorized number of shares of Preferred Stock, the remaining authorized shares of Preferred Stock shall be deemed to be shares of undesignated series of Preferred Stock until designated by the Board of Directors as being a part of a series previously established or a new series then being established by the Board of Directors. SECTION 2. ESTABLISHMENT OF A SERIES. Subject to the provisions of this Article 4, the Board of Directors is authorised to establish one or more series of Preferred Stock and, to the extent now or hereafter permitted by the laws of the State of Delaware, to fix and determine the voting powers, designations preferences, and relative, participating, optional, or other special rights and qualifications, limitations or restrictions of each series, including but not limited to: (a) the number of shares to constitute such series and the distinctive designation of such series; (b) the dividend rate on the shares of such series and preferences, if any, and the special and relative rights of such shares of such series as to dividends; (c) whether or not the shares of such series shall be redeemable, and, if redeemable, the price, terms and manner of redemption; (d) the preferences, if any, and the special and relative rights of the shares of such series upon liquidation of the corporation; (e) whether or not the shares of such series shall be subject to the operation of a sinking or purchase fund and, if so, the terms and provisions of such fund; (f) whether or not the shares of such series shall be convertible into shares of any other class or of any other series of the same or any other class of stock of the corporation and, if so, the conversion price or ratio and other conversion rights; (g) the conditions under which the shares of such series shall have separate voting rights or no voting rights; and (h) such other designations, preferences and relative, participating, optional or other special rights and qualifications, limitations 11 or restrictions of such series to the full extant now and hereafter permitted by the laws of the State of Delaware. Notwithstanding the fixing of the number of shares constituting a particular series, the Board of Directors may at any time authorize the issuance of additional shares of the same series. SECTION 3. DIVIDENDS. Holders of Preferred Stock shall be entitled to receive, when and as declared by the Board of Directors, but only out of funds legally available for the payment of dividends, cash dividends at the rates fixed by the Board of Directors for the respective series, payable on such dates in each year as the Board of Directors shall fix for the respective series as provided in Part B, Section 2 (hereinafter referred to as "dividend dates"). Until all accrued dividends on each series of Preferred Stock shall have been paid through the last preceding dividend date of each such series, no dividend or distribution shall be made to holders of Common Stock other than a dividend payable in Common Stock of the corporation. Dividends on shares of any cumulative series of Preferred Stock shall accumulate from and after the day on which such shares are issued, but arrearages in the payment thereof shall not bear interest. Nothing herein contained shall be deemed to limit the right of the corporation to purchase or otherwise acquire at any time any shares of its capital stock. For purposes of this Article 4, the amount of dividends "accrued" on any shares of any cumulative series of Preferred Stock us at any dividend date shall be deemed to be the amount of any unpaid dividends accumulated thereon to and including such dividend date, whether or not earned or declared. The amount of dividends "accrued" on any noncumulative series of Preferred Stock shall mean only those dividends declared by the Board of Directors, unless otherwise specified for such series by the Board of Directors pursuant to Part B, Section 2. SECTION 4. LIQUIDATION. Upon the voluntary or involuntary liquidation of the corporation, before any payment or distribution of the assets of the corporation shall be made to or set apart for any other class of stock, the holders of Preferred Stock shall be entitled to payment of the amount of the preference payable upon such liquidation of the corporation fixed by the Board of Directors for the respective series as provided in Part B, Section 2. If, upon any such liquidation, the assets of the corporation shall be insufficient to pay in full to the holders of the Preferred Stock the preferential amount aforesaid, then such assets, or the proceeds thereof, shall be distributed among the holders at each series of Preferred Stock ratably in accordance with the sums which would be payable on such distribution of all sums payable were discharged in full. The voluntary 12 sale, conveyance, exchange or transfer of all or substantially all of the property and assets of the corporation, the merger or consolidation of the corporation into or with any other corporation, or the merger of any other corporation into it, shall not be deemed to be a liquidation of the corporation for the purpose of this Section 4. SECTION 5. RETIREMENT. Any shares of Preferred Stock which shall at any time have been redeemed, or which shall at any time have been surrendered for conversion or exchange or for cancellation pursuant to any sinking or purchase fund provisions with respect to any series of Preferred Stock, shall be retired and shall thereafter have the status of authorized and unissued shares of Preferred Stock undesignated as to series. SECTION 6. VOTING RIGHTS. The Common Stock shall have exclusive voting power except as required by law and except to the extent the Board of Directors shall, at the time any series of Preferred Stock is established, determine that the shares of such series shall vote (a) together as a single class with shares of Common Stock and/or with shares of Preferred Stock (or one or more other series thereof) on all or certain matters presumed to the stockholders and/or upon the occurrence of any specified event or condition, and/or (b) exclusively on certain matters, or, upon the occurrence of any specified event or condition, on all or certain matters. The Board of Directors, in establishing a series of Preferred Stock and fixing the voting rights thereof, may determine that the voting power of each share of such series may be greater or less than the voting power of each share of the Common Stock or of other series of Preferred Stock notwithstanding that the shares of such series of Preferred Stock may vote as a single class with the shares of other series of Preferred Stock and/or with the shares of Common Stock 2. The foregoing amendment to the Certificate of Incorporation was duly adopted by the stockholders by written consent given in accordance with Section 228 of the Delaware General Corporation Law in accordance with the provision of Section 242 of the General Corporation Law of Delaware as of March 2, 2000 and written notice of the adoption of this amendment to the Restated Certificate of Incorporation has been given as provided in Section 228 of the Delaware General Corporation Law to every stockholder entitled so such notice. 13 IN WITNESS WHEREOF, American Biogenetic Sciences, Inc. has caused this Certificate of Amendment of its Restated Certificate of Incorporation to be signed by Timothy J. Roach, its Secretary, as of this 2nd day of March, 2000. AMERICAN BIOGENETIC SCIENCES, INC. By: /s/ Timothy J. Roach --------------------------------------- Timothy J. Roach, Secretary 14 CERTIFICATE OF DESIGNATION, NUMBER, VOTING POWERS, PREFERENCES AND RIGHTS OF THE SERIES OF THE PREFERRED STOCK OF AMERICAN BIOGENETIC SCIENCES, INC. TO BE DESIGNATED SERIES A CONVERTIBLE PREFERRED STOCK American Biogenetic Sciences, Inc., a Delaware corporation (the "Corporation"), pursuant to authority conferred on the Board of Directors of the Corporation by the Restated Certificate of Incorporation and in accordance with the provisions of Section 151 of the General Corporation Law of the State of Delaware, certifies that the Board of Directors of the Corporation, by written consent dated January 20, 2000, duly adopted the following resolution providing for the establishment and issuance of a series of Preferred Stock to be designated "Series A Convertible Preferred Stock" and to consist of 7,000 shares, as follows: RESOLVED, that, pursuant to the authority expressly granted and vested in the Board of Directors of this Corporation in accordance with the provisions of its Restated Certificate of Incorporation, of the 10,000,000 shares of Preferred Stock authorized under the Restated Certificate of Incorporation, 7,000 shares are hereby designated as Series A Convertible Preferred Stock (the "Series A Preferred Stock"); the Board of Directors be and hereby is authorized to issue such shares of Series A Preferred stock from time to time and for such consideration and on such terms as the Board of Directors shall determine; and subject to the limitations provided by law and by the Restated Certificate of Incorporation, the powers, designations, preferences and relative, participating, optional or other special rights of, and the qualifications, limitations or restrictions upon, the Series A Preferred Stock shall be as follows: SECTION 1. DEFINITIONS. For the purposes hereof, the following definitions shall apply: "Average Market Price" means the arithmetic average (rounded to the nearest cent) of the Market Price per share of the Class A Common Stock for the twenty (20) consecutive trading days ending on the second trading day prior to the date of determination. "Board of Directors" means the Board of Directors of this corporation. STATE OF DELAWARE SECRETARY OF STATE DIVISION OF CORPORATIONS FILED 10:05 AM 03/03/2000 001108832 - 2016219 15 "Common Stock" means the Class A Common Stock or the Class B Common Stock of the corporation. "Conversion Price" means the amount set forth in Section 4(a), as adjusted pursuant to Section 5. "Convertible Securities" means any evidence of indebtedness, stock (other than Common Stock or the Series A Preferred Stock) or other securities convertible into or exchangeable for Common Stock. "Junior Shares" means all shares of Common Stock of this corporation or any other stock ranking junior to the Series A Preferred Stock in dividends or liquidation rights. "Market Price" means on any particular date (a) if the Common Stock is then principally traded on any national securities exchange or the Nasdaq National Market, the closing sale price per share of the Common Stock on such date on the principal market on which the Common Stock is then traded, or if there is no such sale price on such date then the closing sale price on the date nearest preceding such date, or (b) if the Common Stock is not then listed on a national securities exchange or the Nasdaq National Market, the average of the bid and asked price for a share of Common Stock on the Nasdaq SmallCap Market or in the over-the-counter market as reported by the Nasdaq Bulletin Board or National Quotation Bureau Incorporated (or similar organization or agency succeeding to its functions or reporting prices), or (c) if the Common Stock is not publicly traded, the fair market value of a share of Common Stock as determined by an Appraiser (which shall conduct a good faith appraisal) selected by the Holders of a majority in interest of the shares of the Series A Preferred Stock; provided, however, that the Company, after receipt of the determination by such Appraiser, shall have the right to select an additional Appraiser (which shall conduct a good faith appraiser), in which case, the fair market value shall be equal to the average of the determinations by each such Appraiser. "Options" means rights, options or warrants to subscribe for, purchase or otherwise acquire either Common Stock or Convertible Securities. "Original Issue Date" means the date on which a share of Series A Preferred Stock was first issued. "Subsidiary" means any corporation at least 50% of whose outstanding voting shares shall at the time be owned directly or indirectly by this corporation or by one or more subsidiaries, or by this corporation and one or more subsidiaries. SECTION 2. DIVIDEND RIGHTS. In each fiscal year of the corporation, the holders of shares of Series A Preferred Stock shall be entitled to receive, before any cash dividends shall be declared and paid upon or set aside for the Junior Shares in such fiscal year, when and as declared by the Board of Directors of the corporation out of the funds legally available for that purpose, dividends payable in cash in an amount per share for such fiscal year at least equal to the product of (i) the per share amount, if any, of the cash dividend declared, paid or set aside for the Class A Common Stock during such fiscal year, multiplied by (ii) the number of whole 2 16 shares of Class A Common Stock into which each share of Series A Preferred Stock is then convertible. SECTION 3. LIQUIDATION PREFERENCE. (a) PREFERENCE. In the event of any liquidation, dissolution or winding up of the affairs of the corporation, voluntarily or involuntarily, the holders of each share of Series A Preferred Stock, prior to any distribution to the holders of Junior Shares, shall be entitled to receive pro rata a preferential amount equal to $500 per share (adjusted to reflect any stock split, stock dividend, combination, recapitalization or reorganization) of Series A Preferred Stock held by them (the "Series A Preferred Stock Liquidation Preference"). After payment or setting apart for payment of the Series A Preferred Stock Liquidation Preference, the remaining assets of the corporation, if any, shall be distributed among the holders of the Junior Shares. If, upon such liquidation, dissolution or winding up, the assets of the corporation are insufficient (after payment of the liquidation preference of any class of preferred stock ranking senior on liquidation to the Series A Preferred Stock) to provide for the payment of the Series A Preferred Stock Liquidation Preference for each share of Series A Preferred Stock outstanding, such assets as are available shall be paid out pro rata among the shares of Series A Preferred Stock. (b) MERGER OR ACQUISITION. A merger or consolidation of the corporation with or into another corporation or entity (whether or not the corporation is the surviving entity if, after the merger or consolidation, more than 50% of the voting stock of the surviving corporation is owned by persons who were not holders of voting stock of this corporation prior to the merger or consolidation), or the sale of all or substantially all the assets of the corporation, shall be deemed to be a liquidation, dissolution or winding up the Corporation for purposes of this Section 3 if the holders of at least a majority of the then outstanding shares of Series A Preferred Stock and of any class or series of stock ranking on liquidation on a parity with the Series A Preferred Stock, acting together as a single class, so elect by giving written notice thereof to the corporation at least three days before the effective date of such event. If no such notice is given, the provisions of Section 4(c) shall apply. The amount deemed distributed to the holders of Series A Preferred Stock upon any such merger or consolidation shall be the cash or the value of the property, rights or other securities received in the merger or consolidation which shall be determined in good faith by the Board of Directors of the corporation. SECTION 4. CONVERSION OF SERIES A PREFERRED STOCK. The holders of the Series A Preferred Stock shall have conversion rights in accordance with the following provisions: (a) RIGHT TO CONVERT AND CONVERSION PRICE. If the holders of at least a majority of Series A Preferred Stock so elect at any time after the Original Issue Date, all shares Series A Preferred Stock shall be converted, at the office of the corporation or any transfer agent for the Series A Preferred Stock, into such number of fully paid and non-assessable shares of Class A Common Stock as is determined by dividing $500 by the Conversion Price, determined and adjusted as hereafter provided, in effect at the time of conversion. The initial Conversion Price 3 17 shall be $500 per share, and it shall be subject to adjustment upon certain events as provided in this Section 4. (b) MANDATORY CONVERSION. The corporation at its option may elect to have all the shares of Series A Preferred Stock automatically converted into shares of Class A Common Stock at the then effective Conversion Price if the Market Price at any time exceeds $5.00. All holders of record of shares of Series A Preferred Stock will be given at least 20 days' prior written notice of the date fixed and place designated for mandatory conversion of the Series A Preferred Stock. Such notice shall be sent by certified mail, postage prepaid, to each record holder of Series A Preferred Stock at such holder's address appearing on the stock register of the corporation. On or before the date so fixed for conversion, each holder of shares of Series A Preferred Stock shall surrender his or its certificate or certificates for all such shares to the corporation at the place designated in exchange for the number of shares of Class A Common Stock to which such holder is entitled. The mechanics for conversion and other provisions relating to conversion of Series A Preferred Stock into Class A Common Stock and payments in lieu of fractions set forth elsewhere in this Section 4 shall apply to the mandatory conversion of the Series A Preferred Stock. (c) EFFECT OF ACQUISITION ON SERIES A PREFERRED STOCK. In the event of a merger or consolidation of the corporation with or into another corporation or entity or a sale by the corporation of all or substantially all of its assets, and in the case of successive such mergers, consolidations or sales except for any such transactions as are treated as a liquidation under Section 3(b) hereof, thereafter the shares of Series A Preferred Stock then outstanding shall be convertible into the number and kind of securities of the acquiring or surviving corporation (or such other entity whose securities are delivered in exchange for the Class A Common Stock of the corporation) to which the holders of the Series A Preferred Stock would have been entitled if such holders had converted their Series A Preferred Stock into Class A Common Stock or the common stock of any successor to the corporation upon the consummation of such sale, merger or consolidation; and, in such case, appropriate adjustment (as determined in good faith by the Board of Directors) shall be made in the application of the provisions in this Section 4 and Section 5 with respect to the rights and interest thereafter of the holders of the Series A Preferred Stock, to the end that the provisions set forth in this Section 4 and Section 5 (including provisions with respect to changes in and other adjustments of the Conversion Price) shall thereafter be applicable, as nearly as reasonably may be, in relation to any shares of stock or other property thereafter deliverable upon the conversion of the Series A Preferred Stock. (d) MECHANICS OF CONVERSION. No fractional shares of Class A Common Stock shall be issued upon conversion of Series A Preferred Stock. In lieu of any fractional share to which a holder of Series A Preferred Stock would otherwise be entitled, the corporation shall pay cash equal to such fraction multiplied by the then effective Conversion Price. Before any holder of Series A Preferred Stock shall be entitled to convert the same into full shares of Class A Common Stock, the holder shall surrender the certificate or certificates therefor, duly endorsed for transfer, at the office of the corporation or of any transfer agent for the Series A Preferred Stock, and shall give written notice to the corporation at such office that he elects to convert the same. The corporation shall, as soon as practicable thereafter, issue and deliver at such office to 4 18 such holder of Series A Preferred Stock a certificate or certificates for the number of shares of Class A Common Stock to which he shall be entitled as aforesaid and a check payable to the holder in the amount of any such amounts payable in order to avoid a conversion into fractional shares of Class A Common Stock, except as provided in paragraphs (b) and (c), such conversion shall be deemed to have been made immediately prior to the close of business on the date of such surrender of the shares of Bonus A Preferred Stock to be converted, and the person or persona entitled to receive the shares of Class A Common Stock issuable upon such conversion shall be treated for all purposes as the record holder or holders of such shares of Class A Common Stock on such date. (e) NO IMPAIRMENT. The corporation will not, by amendment of its Restated Certificate of Incorporation or through any reorganization, transfer of assets, consolidation, merger, dissolution, issue or sale of securities or any other voluntary action, avoid or seek to avoid the observance or performance of any of the terms to be observed or performed hereunder by the corporation, but will at all times in good faith assist in the carrying out of all the provisions of this Section 4 and in the taking of all such action as may be necessary or appropriate in order to protect the conversion rights of the holders of the Series A Preferred Stock against impairment. (f) NOTICES OF RECORD DATE, ETC. In the event that the corporation shall propose at any time: (i) to declare any dividend or distribution upon its Common Stock, whether in cash, property, stock or other securities, whether or not a regular cash dividend and whether or not out of earnings or earned surplus; (ii) to offer for subscription pro rata to the holders of any class of its stock any additional shares of stock of any class or other rights; (iii) to subdivide, or combine its outstanding Common Stock; (iv) so effect any reclassification or recapitalization of its Common Stock outstanding involving a change in the Common Stock; or (v) to merge or consolidate with or into any other corporation, or sell, lease or convey all or substantially all its property or business, or so liquidate, dissolve or wind up; then, in connection with each such event, the corporation shall send to the holders of the Series A Preferred Stock: (A) at least 20 days' prior written notice of the date on which a record shall be taken for such dividend, distribution, subscription rights, subdivision or combination (and specifying the date on which the holders of Common Stock shall be entitled thereto) or for 5 19 determining rights to vote in respect of the matters referred to in clauses (iv) and (v) above; and (B) in the case of the matters referred to in clauses (iv) and (v) above, at least 20 days' prior written notice of the date when the same shall take place (specifying the date on which the holders of Common Stock shall be entitled to exchange their Common Stock for securities or other property deliverable upon the occurrence of such event). Each such written notice shall be given by certified mail, postage prepaid, addressed to the holders of Series A Preferred Stock at the address for each such holder as shown on the books of the corporation. (g) ADJUSTMENT FOR COMBINATION OR CONSOLIDATION OF COMMON STOCK. In the event the outstanding shares of Class A Common Stock shall be combined or consolidated, by reclassification or otherwise, into a lesser number of shares of Class A Common Stock, the Conversion Price in effect immediately prior to such combination or consolidation shall, concurrently with the effectiveness of such combination or consolidation, be proportionately increased. (h) ADJUSTMENT FOR STOCK DIVIDEND OR SUBDIVISION. In the event the corporation at any time or from time to time after the Original Issue Date shall declare or pay any dividend on the Common Stock payable in Class A Common Stock, or effect a subdivision of the outstanding shares of Class A Common Stock into a greater number of shares of Class A Common Stock by reclassification or otherwise than by payment of a dividend in Class A Common Stock, then and in any such event, the Conversion Price in effect immediately prior to such subdivision or stock dividend shall forthwith be proportionately reduced. (i) RESERVATION OF COMMON STOCK. The corporation shall, at all times when the Series A Preferred Stock shall be outstanding, reserve and keep available out of its authorized but unissued stock, for the purpose of effecting the conversion of the Series A Preferred Stock, such number of its duly authorized shares of Class A Common Stock as shall from time to time be sufficient to effect the conversion of all outstanding Series A Preferred Stock. Before taking any action which would cause an adjustment reducing she Conversion Price below the then par value of the shares of Class A Common Stock issuable upon conversion of the Series A Preferred Stock, the corporation will take any corporate action which may in the opinion of its counsel, be necessary in order that the corporation may validly and legally issue fully paid and nonassessable shares of such Class A Common Stock at such adjusted Conversion Price. (j) CANCELLATION OF SERIES A PREFERRED STOCK. All shares of Series A Preferred Stock which shall have been surrendered for conversion as herein provided shall no longer be deemed to be outstanding and all rights with respect to such shares, including the rights, if any, to receive notice and to vote, shall forthwith cease and terminate except only the rights of the holders thereof to receive shares of Class A Common Stock in exchange therefor and payment of any accrued amid unpaid dividends thereon. Any shares of Series A Preferred Stock so converted 6 20 shall be retired and cancelled, and shall not be reissued, and the corporation may from time to time take such appropriate action as may be necessary to reduce the authorized Series A Preferred Stock accordingly. SECTION 5. VOTING RIGHTS OF SERIES A PREFERRED STOCK. (a) GENERAL. Except as expressly set forth in this Section and except as otherwise required by law, the Series A Preferred Stock shall have no voting rights. (b) MATTERS AFFECTING SERIES A PREFERRED STOCK. So long as any Series A Preferred Stock shall be outstanding, the corporation shall not, without first obtaining the affirmative vote or written consent of the holders of not less than a majority of the outstanding shares of Series A Preferred Stock, take any of the following actions: (i) amend or repeal any provision of, or add any provision to the corporation's Restated Certificate of Incorporation or By-laws if such action would alter or change the preferences, rights, privileges or powers of, or the restrictions provided for the benefit of, such Series A Preferred Stock; (ii) authorize or issue shares of any class of stock having any preference or priority as to dividends or users superior to or on a parity with any such preference or priority of the Series A Preferred Stock; (iii) reclassify any Junior Shares into shares having any preference to, or priority as to dividends or assets superior to or on a parity with any such preference or priority of the Series A Preferred Stock; (iv) declare any dividend or distribution upon any class of its stock, whether in cash, property, stock or other securities, whether or not a regular cash dividend and whether or not out of earnings or earned surplus; or (v) repurchase or redeem any class of its stock. (c) SPECIAL VOTE FOR LIQUIDATIONS. The corporation may not liquidate, dissolve or wind up if the assets of the corporation then available for distribution to its stockholders shall be insufficient to pay the holders of shares of Series A Preferred Stock the full amount to which they shall be entitled upon such liquidation, dissolution or winding up under section 3(a), without the prior written approval of the holders of a majority of the then outstanding shares of Series A Preferred Stock. In the event such approval has been obtained, and the amount distributed to holders of Series A Preferred Stock shall be less than the full amount provided under section 3(a), the holders of Series A Preferred Stock shall share ratably in any distribution of assets according to the respective amounts which would be payable with respect to the shares held by then upon such distribution if such amounts payable on or with respect to such shares were paid in full. 7 21 IN WITNESS WHEREOF, the corporation has caused its corporate seal to be affixed hereto and this Certificate of Designation to be signed by its Chairman of the Board and attested to by its Secretary this 2nd day of March, 2000. AMERICAN BIOGENETIC SCIENCES, INC. By: /s/ Alfred J. Roach ------------------------ Alfred J. Roach Chairman of the Board ATTEST /s/ Timothy J. Roach - -------------------------- Timothy J. Roach Secretary 8 EX-4.4(A) 3 SECURITIES PURCHASE AGREEMENT 1 Exhibit 4.4(a) ================================================================================ SECURITIES PURCHASE AGREEMENT 7,000 SHARES OF SERIES A CONVERTIBLE PREFERRED STOCK WARRANTS TO PURCHASE 7,000,000 SHARES OF CLASS A COMMON STOCK OF AMERICAN BIOGENETIC SCIENCES, INC. AS OF FEBRUARY 3,2000 ================================================================================ 2 TABLE OF CONTENTS Page ---- ARTICLE I - ISSUANCE AND TERMS OF WARRANTS AND PREFERRED SHARES ............ 1 1.1 AUTHORIZATION OF SECURITIES ......................................... 1 1.2 PURCHASE AND SALE OF PREFERRED SHARES ............................... 2 1.4 PAYMENT ............................................................. 2 1.4 AGREEMENT REGARDING WARRANTS ........................................ 3 ARTICLE II- CLOSING 2.1 CLOSING ............................................................. 3 2.2 LEGEND .............................................................. 3 ARTICLE III - REPRESENTATIONS AND WARRANTIES OF THE COMPANY ................ 4 3.1 ORGANIZATION AND STANDING OF THE COMPANY ............................ 4 3.2 CAPITALIZATION 4 3.3 VALIDITY OF THIS AGREEMENT .......................................... 5 3.4 GOVERNMENTAL CONSENT, ETC ........................................... 5 3.5 VALID ISSUANCE OF SECURITIES ........................................ 5 3.6 FINANCIAL STATEMENTS ................................................ 6 3.7 ACCURACY AND COMPLETENESS OF INFORMATION ............................ 6 3.8 ADVERSE CHANGES ..................................................... 6 3.9 NO VIOLATION ........................................................ 6 3.10 ALL NECESSARY PERMITS ............................................... 7 3.11 TITLE TO PROPERTIES ................................................. 7 3.10 SECURITIES LAWS ..................................................... 7 ARTICLE IV - REPRESENTATIONS AND WARRANTIES OF THE INVESTORS ............... 7 4.1 AUTHORITY OF INVESTORS, VALIDITY OF THIS AGREEMENT .................. 7 4.2 INVESTMENT REPRESENTATIONS .......................................... 8 ARTICLE V - CONDITIONS TO INVESTORS' OBLIGATIONS ........................... 8 5.1 CONDITIONS TO CLOSING ON CLOSING DATE ............................... 9 ARTICLE VI - CONDITIONS TO THE COMPANY'S OBLIGATIONS ....................... 10 6.1 CONDITIONS TO CLOSING ............................................... 10 ARTICLE VII- COVENANTS OF THE COMPANY ...................................... 11 7.1 FURNISHING OF INFORMATION ........................................... 11 7.2 INFORMATION WITH RESPECT TO THE SECURITIES .......................... 11 7.3 SHAREHOLDER APPROVAL ................................................ 11 7.4 LICENSE AGREEMENT ................................................... 11 7.5 INVESTOR'S RIGHTS ................................................... 11 ARTICLE VIII - SURVIVAL AND INDEMNIFICATION ................................ 11 8.1 SURVIVAL ............................................................ 11 8.2 INDEMNIFICATION ..................................................... 12 ARTICLE IX - MISCELLANEOUS ................................................. 13 9.1 NOTICES ............................................................. 13 - -------------------------------------------------------------------------------- Securities Purchase Agreement ii 3 9.2 ENTIRE AGREEMENT .................................................... 14 9.3 AMENDMENTS .......................................................... 14 9.4 ASSIGNMENT .......................................................... 14 9.5 BENEFIT ............................................................. 14 9.6 GOVERNING LAW ....................................................... 15 9.7 SEVERABILITY ........................................................ 15 9.8 HEADINGS AND CAPTIONS ............................................... 15 9.9 NO WAIVER OF RIGHTS, POWERS AND REMEDIES ............................ 15 9.10 EXPENSES ............................................................ 15 9.11 BROKERS ............................................................. 16 9.12 CONFIDENTIALITY ..................................................... 16 9.13 COUNTERPARTS ........................................................ 16 9.14 FURTHER ASSURANCES .................................................. 16 - -------------------------------------------------------------------------------- Securities Purchase Agreement iii 4 SECURITIES PURCHASE AGREEMENT THIS SECURITIES PURCHASE AGREEMENT (this "Agreement"), is made as of this 3rd day of February, 2000, by and among AMERICAN BIOGENETIC SCIENCES, INC., a Delaware corporation (the "Company") and the investors listed on EXHIBIT A hereto (collectively, the "Investors", and the Investors, excluding Alfred J. Roach, his heirs and assigns, the "BVF Investors"). WITNESSETH: WHEREAS, the Company intends to amend its Certificate of Incorporation to authorize a class of Preferred Stock, par value $.001 per share (the "Preferred Stock"), and to thereafter designate 7,000 shares of the Preferred Stock as the Series A Convertible Preferred Stock, convertible into shares of the Company's Class A Common Stock, par value $.001 per share (the "Common Stock"), and otherwise having the designations, powers, preferences, and other terms set forth on EXHIBIT B hereto (the "Preferred Shares"); WHEREAS, the Investors desire to invest $3,500,000 in the Company in exchange for the Preferred Shares and the Company's common stock purchase warrants substantially in the form of EXHIBIT C hereto (each, a "Warrant" and collectively, the "Warrants") entitling the holders to purchase 7,000,000 shares of the Common Stock (the "Warrant Shares"); WHEREAS, in connection with the transactions contemplated by this Agreement, each of the BVF Investors has made a loan to the Company in a principal amount equal to the purchase price of the Preferred Shares and Warrants to be purchased by such BVF Investor hereunder and evidenced by Promissory Notes, dated February 7, 2000, made by the Company and payable to the order of (i) Biotechnology Value Fund, L.P. in the principal amount of $1,050,000 (the "First Note"); (ii) Biotechnology Value Fund II, L.P. in the principal amount of $1,800,000 (the "Second Note"); and (iii) to Investment 10 L.L.C. in the principal amount of $150,000 (the "Third Note", and collectively with the First Note and the Second Note, the "Notes"); and WHEREAS, the Company and the Investors desire to set forth certain matters to which they have agreed relating to the Warrants and the Preferred Shares. NOW THEREFORE, in consideration of the premises and the mutual covenants contained in this Agreement, the parties agree as follows: ARTICLE I. ISSUANCE AND TERMS OF WARRANTS AND PREFERRED SHARES 1.1 AUTHORIZATION OF SECURITIES. Subject to the terms and conditions of this Agreement, the Company has authorized, or prior to the Closing (as hereinafter defined) will have authorized, the issuance of the Preferred Shares, the Common Stock and the Warrants pursuant to this Agreement. 5 1.2 PURCHASE AND SALE OF PREFERRED SHARES, WARRANTS AND COMMON STOCK. Subject to the terms and conditions of this Agreement and in reliance upon the representations and warranties of the Company contained herein, the Investors agree to purchase from the Company and the Company agrees to sell to the Investors on the Closing Date (as hereinafter defined) for an aggregate purchase price of three million five hundred thousand dollars ($3,500,000) (i) the number of Preferred Shares set forth opposite each Investor's name on EXHIBIT A attached hereto, aggregating 7,000 Preferred Shares, or, upon the occurrence of the event described in Section 1.3(b) or (d) hereof, the number of shares of Common Stock described in such Sections, respectively; and (ii) the number of Warrants set forth opposite each Investor's name on EXHIBIT A attached hereto, aggregating Warrants to purchase 7,000,000 Warrant Shares. 1.3 PAYMENT. (a) On the Closing Date, (i) the entire principal amount of the Notes plus accrued interest shall become due and payable; (ii) the BVF Investors shall accept the number of Preferred Shares and Warrants set forth opposite the BVF Investors' names in EXHIBIT A attached hereto as payment in full of all the Company's obligations under the Notes; (iii) the Company shall pay the entire principal amount plus accrued interest under the Notes to the BVF Investors in the form of such Preferred Shares and Warrants; and (iv) thereupon, the BVF Investors shall have satisfied their obligations under Section 1.2 hereof and the Company shall have satisfied all of its obligations under the Notes. (b) In the event that the Closing Date shall not have occurred on or prior to March 15, 2000 due to the Company's failure to satisfy any of the conditions set forth in Article V hereof, then (i) the entire principal amount of the Notes plus accrued interest shall become due and payable; (ii) the BVF Investors shall accept the number of shares of Common Stock into which the number of Preferred Shares set forth opposite the BVF Investors' names in EXHIBIT A attached hereto would otherwise have been convertible and the number of Warrants set forth opposite the BVF Investors' names in EXHIBIT A attached hereto as payment in full of all the Company's obligations under the Notes; (iii) the Company shall pay the entire principal amount plus accrued interest under the Notes to the BVF Investors in the form of such Common Stock and Warrants; and (iv) thereupon, the BVF Investors shall have satisfied their obligations under Section 1.2 hereof and the Company shall have satisfied all of its obligations under the Notes. (c) On the Closing Date, (i) Alfred J. Roach shall accept the number of Preferred Shares and Warrants set forth opposite his name on EXHIBIT A attached hereto as payment of $500,000 of the Company's indebtedness to him; (ii) the Company shall pay such indebtedness in the form of such Preferred Shares and Warrants; and (iii) thereupon, Alfred J. Roach shall have satisfied his obligations under Section 1.2 hereof and the Company shall have satisfied $500,000 of such indebtedness. (d) In the event that the Closing Date shall not have occurred on or prior to March 15, 2000, then (i) Alfred J. Roach shall accept the number of shares of Common Stock equal to the number of Preferred Shares set forth opposite his name on EXHIBIT A attached hereto and the number of Warrants set forth opposite his name in EXHIBIT A attached hereto as payment of - -------------------------------------------------------------------------------- Securities Purchase Agreement 2 6 $500,000 of the Company's indebtedness to him; (ii) the Company shall pay such indebtedness in the form of such Common Stock and Warrants; and (iii) thereupon, Alfred J. Roach shall have satisfied his obligations under Section 1.2 hereof and the Company shall have satisfied $500,000 of such indebtedness. 1.4 AGREEMENT REGARDING WARRANTS. After the Closing, upon the request of the BVF Investors, the Company and the BVF Investors agree to negotiate in good faith commercially reasonable provisions permitting the "cashless exercise" of the Warrants, provided, that, at such time each of such parties determines in good faith that the addition of such provisions would be in such party's best interests. ARTICLE II. CLOSING 2.1 CLOSING. Subject to the satisfaction of the conditions set forth in Articles VI and VII hereof, the closing (the "Closing") shall take place at a place and time (the "Closing Date") mutually agreed by the Company and the Investors, but in any event no later than March 15, 2000. At the Closing, (a) the Company shall deliver to the Investors one or more stock certificates registered in their names for an aggregate of 7,000 Preferred Shares, or the applicable number of shares of Common Stock, as the case may be, against payment to the Company of the purchase price therefor pursuant to Section 1.3, and (b) the Company shall deliver to the Investors one or more Warrants registered in their names to purchase the number of shares indicated therein. 2.2 LEGEND. The certificates representing the Warrants and the Preferred Shares, or the Common Stock, as the case may be, shall be subject to a legend restricting transfer under the Securities Act of 1933, as amended (the "Securities Act"), such legend to be substantially as follows: "THE SECURITIES EVIDENCED HEREBY HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933. THESE SECURITIES MAY NOT BE SOLD OR OTHERWISE TRANSFERRED BY ANY PERSON UNLESS (1) EITHER (A) A REGISTRATION STATEMENT WITH RESPECT TO SUCH SECURITIES SHALL BE EFFECTIVE UNDER THE SECURITIES ACT OF 1933 ("ACT"), OR (B) THE COMPANY SHALL HAVE REASONABLY REQUESTED AND RECEIVED AN OPINION OF COUNSEL SATISFACTORY TO IT THAT AN EXEMPTION FROM REGISTRATION UNDER SUCH ACT IS THEN AVAILABLE, AND (2) THERE SHALL HAVE BEEN COMPLIANCE WITH ALL APPLICABLE STATE SECURITIES LAWS." - -------------------------------------------------------------------------------- Securities Purchase Agreement 3 7 ARTICLE III. REPRESENTATIONS AND WARRANTIES OF THE COMPANY The Company hereby represents and warrants to the Investors that, as of the date of this Agreement, the following are true and correct: 3.1 ORGANIZATION AND STANDING OF THE COMPANY. The Company is a corporation duly organized, validly existing and in good standing under the laws of the State of Delaware. The Company has full corporate power and authority to enter into, deliver, and perform its obligations and undertakings under this Agreement. The Company is duly authorized to conduct its business and is in good standing under the laws of each jurisdiction where such qualification is required, except where the lack of such qualification would not have a material adverse effect on the business, financial condition, operations, results of operations, or future prospects of the Company. The Company has full corporate power and authority to carry on the business in which it is engaged and to own and use the properties owned and as used by it. 3.2 CAPITALIZATION. The Company's entire authorized capital stock consists of: (i) 100,000,000 shares of Class A Common Stock. par value $.00l per share, of which 39,708,907 shares are validly issued and outstanding; and (ii) 3,000,000 shares of Class B Common Stock, par value $.00l per share (the "Class B Common Stock"), all of which are validly issued and outstanding on the date hereof. On or before the Closing, the Company's Restated Certificate of Incorporation will have been amended to authorize 10,000,000 shares of the Preferred Stock and to designate 7,000 shares of the Preferred Stock as Series A Convertible Preferred Stock having the preferences, voting powers, qualifications and special or relative rights or privileges set forth in EXHIBIT B. The issuance of all presently issued and outstanding shares was duly authorized and all such shares are fully paid and non-assessable. All such issued and outstanding shares have the preferences, voting powers, qualifications and special or relative rights or privileges set forth in the Company's Restated Certificate of Incorporation, as amended as in effect on the date hereof, and as of the Closing Date the Preferred Stock will have the preferences, voting powers, qualifications and special or relative rights or privileges set forth in EXHIBIT B. The Preferred Shares will be senior in liquidation preference to all outstanding shares of the Common Stock and the Class B Common Stock. Other than as indicated on SCHEDULE 3.2 hereto or in the SEC Reports (as hereinafter defined), the Company does not have outstanding any option, warrant, purchase right, subscription right, stock appreciation right, phantom stock right, profit participation right, agreement or other commitment to issue or to acquire any shares of its capital stock, or any securities or obligations convertible into or exchangeable for its capital stock, and the Company has not given any person any right to acquire from the Company or sell to the Company any shares of its capital stock. There are no voting trusts, proxies, or other agreements or understandings with respect to the voting of the capital stock of the Company. 3.3 VALIDITY OF THIS AGREEMENT. Subject to shareholder approval, the execution and delivery by the Company of this Agreement and the performance by the Company of its obligations under this Agreement, and - -------------------------------------------------------------------------------- Securities Purchase Agreement 4 8 the issuance, sale and delivery of the Preferred Shares, the Common Stock issuable upon conversion of the Preferred Shares, the Warrants, the Warrant Shares, and the Common Stock, if any, issuable pursuant to Section 1.3, have been duly authorized and approved by all necessary corporate action. This Agreement has been duly executed and delivered by the Company and constitutes a valid and binding obligation of the Company, enforceable in accordance with its terms. The execution and delivery by the Company of this Agreement and the performance by the Company of its obligations under this Agreement and the issuance, sale and delivery of the Preferred Shares, the Common Stock issuable upon conversion of the Preferred Shares, the Warrants, the Warrant Shares and the Common Stock, if any, issuable pursuant to Section 1.3, will not (i) conflict with, or result in any breach of any of the terms of, or constitute a default under, the Restated Certificate of Incorporation when the same will have been amended to designate the Preferred Shares, or By-laws of the Company, (ii) conflict with, result in a breach of or violation or imposition of any lien, charge or encumbrance upon any property or assets of the Company or any of its subsidiaries pursuant to, constitute a default under, result in the acceleration of, create in any party the right to accelerate, terminate, modify, or cancel, or require any notice under, any agreement, instrument, covenant or other restriction or arrangement to which the Company is a party or by which it or any of its properties or assets is bound or any statute law, rule, regulation, judgment, order or decree applicable to the Company or any of its subsidiaries of any court, regulatory body, administrative agency, governmental body, arbitrator or other authority having jurisdiction over the Company or any of its subsidiaries or any of its or their properties. 3.4 GOVERNMENTAL CONSENT, ETC. Except for filings, consents, permits, approvals and authorizations which will be obtained by the Company prior to the Closing and which are set forth in SCHEDULE 3.4, no consent, approval, authorization or other order of, action by, filing with, or notification to any governmental authority is required under existing law or regulation in connection with the execution, delivery and performance of the Agreement or the offer, issuance, sale or delivery of the Preferred Shares, the Common Stock issuable upon conversion of the Preferred Shares, the Warrants, the Warrant Shares and the Common Stock issuable pursuant to Section 1.3 pursuant to the Agreement or the consummation of any other transactions contemplated thereby. 3.5 VALID ISSUANCE OF SECURITIES. When issued and delivered against payment therefor in accordance with the terms and conditions of this Agreement and EXHIBIT B hereto, the Preferred Shares, the Common Stock issuable upon conversion of the Preferred Shares, the Warrants, the Warrant Shares and the Common Stock, if any, issuable pursuant to Section 1.3, shall be (i) duly authorized and validly issued, fully paid and non-assessable and (ii) not subject to any preemptive rights, liens, claims or encumbrances, or other restrictions on transfer or other agreements or understandings with respect to the voting of the Common Stock or the Warrant Shares, except as set forth in this Agreement or EXHIBIT B hereto. - -------------------------------------------------------------------------------- Securities Purchase Agreement 5 9 3.6 FINANCIAL STATEMENTS. The audited financial statements of the Company contained in the Company's Annual Report on Form 10-K for the year ended December 31, 1998, including the notes relating thereto, and the unaudited financial statements of the Company contained in the Company's Quarterly Reports on Form l0-Q for the quarters ended March 31, 1999, June 30, 1999 and September 30, 1999, including the notes thereto, disclose all material liabilities of the Company as of such dates, except as set forth on SCHEDULE 3.6 hereto. Such financial statements, including the notes relating thereto, have been prepared in accordance with generally accepted accounting principles consistently applied throughout the periods involved. Said financial statements and related notes fairly present the financial position and the results of operations and cash flow of Company as of the respective dates thereof and for the periods indicated. 3.7 ACCURACY AND COMPLETENESS OF INFORMATION. The Common Stock is registered pursuant to Section 12(g) of Exchange Act. Copies of all reports filed by the Company with the United States Securities and Exchange Commission (the "Commission") pursuant to the Securities Exchange Act of 1934, as amended (the "Exchange Act") during the period from December 31, 1998 to the date of this Agreement (the "Furnished SEC Reports") have been furnished to the Investors. Since January 1, 1997, the Company has filed each statement, annual, quarterly, and other report, registration statement and definitive proxy statement required to be filed (other than preliminary material) by the Company with the Commission (the "SEC Reports"). As of their respective filing dates, the SEC Reports complied in all material respects with the requirements of the Securities Act or the Exchange Act, as the case may be, and none of the SEC Reports contained any untrue statement of a material fact or omitted to state a material fact required to be stated therein or necessary to make the statements made therein, in light of the circumstances in which they were made, not misleading. 3.8 ADVERSE CHANGES. Since September 30, 1999, except as set forth on SCHEDULE 3.8 hereto, there has not been any Material Adverse Change. For purposes of this Agreement, a "Material Adverse Change" means a material adverse change in the business, earnings, financial condition, results of operations, assets, employee relations, or customer or supplier relations (in each case whether or not arising in the ordinary course of business) or presently foreseeable prospects of the Company and its subsidiaries on an aggregate basis. 3.9 NO VIOLATION. Neither the execution and delivery by the Company of this Agreement, nor the consummation of the transactions contemplated hereby will violate any constitution, statute, rule, injunction, judgment, order, decree, ruling, charge or other restriction of any government, governmental agency, or court known to the Company to which the Company is subject, or, after obtaining shareholder approval and amending the Restated Certificate of Incorporation to designate the Preferred Shares, any provision of its Restated Certificate of Incorporation or By-Laws. - -------------------------------------------------------------------------------- Securities Purchase Agreement 6 10 3.10 ALL NECESSARY PERMITS, ETC. The Company and each subsidiary possesses such valid and current certificates, authorizations or permits issued by the appropriate state, federal or foreign regulatory agencies or bodies as are necessary to conduct their respective businesses, and neither the Company nor any subsidiary has received any notice of proceedings relating to the revocation or modification of, or non-compliance with, any such certificate authorization or permit which, singly or in the aggregate, if the subject of an unfavorable decision, ruling or finding, would result in a Material Adverse Change. 3.11 TITLE TO PROPERTIES. The Company and each of its subsidiaries has good and marketable title to all the properties and assets reflected as owned by it in the financial statements referred to in Section 3.6 in each case free and clear of any security interests, mortgages, liens, encumbrances, equities, claims and other defects, except (i) as set forth on SCHEDULE 3.11, or (ii) such as do not materially and adversely affect the value of such property and do not materially interfere with the use made or proposed to be made of such property by the Company or such subsidiary. The real property, improvements, equipment and personal property held under lease by the Company or any subsidiary are held under valid and enforceable leases, with such exceptions as are not material and do not materially interfere with the use made or proposed to be made of such real property, improvements, equipment or personal property by the Company or such subsidiary. 3.12 SECURITIES LAWS. All notices, filings, registrations or qualifications under state securities or "blue sky" laws which are required in connection with the offer, issue and delivery of the Preferred Shares, the Warrants, the Common Stock into which such Preferred Shares and Warrants are convertible pursuant to this Agreement and the Common Stock issuable pursuant to Section 1.3, if any, have been or will be timely completed by the Company. ARTICLE IV. REPRESENTATIONS AND WARRANTIES OF THE INVESTORS Each of the Investors hereby acknowledges, represents, warrants and agrees as follows: 4.1 AUTHORITY OF INVESTORS, VALIDITY OF THIS AGREEMENT. Each of the Investors has all requisite power and authority to enter into this Agreement and perform its obligations hereunder. The execution, delivery and performance by each of the Investors of this Agreement, and the purchase of the Warrants and the Preferred Shares pursuant hereto have been duly authorized and approved by all necessary corporate action. This Agreement has been duly executed and delivered and constitutes a valid and binding obligation of each of the Investors, enforceable in accordance with its terms. The execution, delivery and performance of this Agreement and the purchase of the Warrants and the Preferred Shares will not conflict with, or result in a material breach of any of the terms of, or constitute a material default under, any charter, by-law, agreement, instrument, covenant or other restriction to which any of the Investors is a party or by which it or any of its properties or assets is bound. - -------------------------------------------------------------------------------- Securities Purchase Agreement 7 11 4.2 INVESTMENT REPRESENTATIONS. Each of the Investors hereby acknowledges, represents, warrants and agrees as follows: (a) Each of the Investors has had the opportunity to review the Furnished SEC Reports and the financial statements contained therein. Each of the Investors acknowledges that the Company has made available to the Investors documents and information that it has requested relating to the Company and has provided answers to the Investors' questions concerning the Company, the Preferred Shares and the Warrants. (b) Each of the Investors is an "accredited investor" as defined in Rule 501(a)(3) of the Securities Act. (c) Each of the Investors understands that the offering of the Warrants and the Preferred Shares has not been registered under the Securities Act or the securities laws of any state or other jurisdiction and that such Warrants and the Preferred Shares must be held indefinitely unless an exemption from registration is available. Each of the Investors understands that the offering and sale of the Warrants and the Preferred Shares is intended to be exempt from registration under the Securities Act based, in part, upon the representations, warranties and agreements of the Investors contained in this Section 4.2, and the Company may rely on such representations, warranties and agreements in connection therewith. Each of the Investors covenants that it will not transfer the Warrants or the Preferred Shares in violation of the provisions of any applicable Federal or state securities statute. (d) Subject to the Investors' registration rights relating to the Common Stock underlying the Warrants and Preferred Shares and the Common Stock issuable pursuant to Section 1.3, in each case, pursuant to the terms of the Registration Agreement referred to in Section 5.1(j) hereof, each of the Investors is acquiring the Warrants and the Preferred Shares for investment, and not with a view to the resale or distribution thereof; it has no present intention of selling, negotiating, or otherwise disposing of the Warrants and the Preferred Shares. Each of the Investors' financial condition and investments are such that it is in a financial position to hold the Warrants and the Preferred Shares for an indefinite period of time and to bear the economic risk of, and withstand a complete loss of, such Warrants and the Preferred Shares. In addition, by virtue of its expertise, the advice available to it, and its previous investment experience, each of the Investors has sufficient knowledge and experience in financial and business matters, investments, securities, and private placements and the capability to evaluate the merits and risks of the transactions contemplated by this Agreement. ARTICLE V. CONDITIONS TO BVF INVESTORS' OBLIGATIONS 5.1 CONDITIONS TO CLOSING ON CLOSING DATE. The obligation of the BVF Investors to purchase and pay for the Warrants and the Preferred Shares and the Common Stock, if any, issuable pursuant to Section 1.3, on the Closing Date is subject to the following: - -------------------------------------------------------------------------------- Securities Purchase Agreement 8 12 (a) REPRESENTATIONS AND WARRANTIES. The representations and warranties of the Company made herein shall be true, correct and complete on and as of the Closing Date with the same force and effect as if they had been made on and as of the Closing Date. (b) PERFORMANCE. All covenants, agreements and conditions contained in this Agreement to be performed or complied with by the Company on or prior to the Closing Date shall have been performed or complied with. (c) OPINION OF COMPANY'S COUNSEL. The BVF Investors shall have received an opinion of Brown, Rudnick, Freed & Gesmer, counsel for the Company, in form and substance reasonably satisfactory to the BVF Investors. (d) CORPORATE PROCEEDINGS, CONSENTS, ETC. All corporate and other proceedings to be taken and all waivers and consents to be obtained in connection with the transactions contemplated by this Agreement shall have been taken or obtained and all documents incident thereto shall be reasonably satisfactory in form and substance to the BVF Investors and their counsel, each of whom shall have received all such originals or certified or other copies of such documents as each may reasonably request. (e) SHAREHOLDER APPROVAL. The Company shall have obtained the approval of shareholders representing at least a majority of the votes by all then outstanding shares of the Common Stock and the Class B Common Stock, voting together as one class, to the authorization of the Preferred Stock. (f) NO PROCEEDING. No action, suit, investigation or proceeding shall be pending or threatened before any court or governmental agency to restrain, prohibit, collect damages as a result of or otherwise challenge this Agreement or any transaction contemplated hereby or thereby. (g) NO LAW PROHIBITING OR RESTRICTING SUCH SALE. There shall not be in effect any law, rule or regulation prohibiting or restricting such sale, or requiring any consent or approval of any person which shall not have been obtained to issue the Warrants, the Preferred Shares, the Common Stock into which the Warrants and Preferred Shares are convertible and the Common Stock issuable pursuant to Section 1.3. (h) OFFICER'S CERTIFICATE DELIVERED BY COMPANY. The Company shall have delivered to the Investors a certificate, dated the Closing Date and signed by the Chief Executive Officer or the President of the Company, to the effect that each of the conditions to be satisfied by the Company pursuant to this Section 5.1 on or before the Closing Date has been duly satisfied. (i) AMENDMENT TO RESTATED CERTIFICATE OF INCORPORATION. The Company's Restated Certificate of Incorporation shall have been amended to authorize the issuance of Preferred Stock, and either that amendment or a separate Certificate of Designation establishing the Preferred Shares having the terms set forth on EXHIBIT B hereto shall have been filed with the Secretary of State of the State of Delaware. - -------------------------------------------------------------------------------- Securities Purchase Agreement 9 13 (j) REGISTRATION AGREEMENT. The Company and the Investors shall have executed and delivered a Registration Agreement in the form of EXHIBIT D hereto. (k) ABBOTT LICENSE AND INVESTMENT. The Company shall have entered into the Exclusive License Agreement, dated as of January 27, 2000 (the "License Agreement"), with Abbott Laboratories related to the marketing of the Company's ABS-103 Compound and a Stock Purchase Agreement, dated as of January 27, 2000 (the "Stock Purchase Agreement), with Abbott Laboratories pursuant to which Abbott Laboratories shall have purchased 2,782,931 shares of Class A Common Stock of the Company for $1.5 million in cash in accordance with the terms thereof. The License Agreement and the Stock Purchase Agreement are attached hereto as EXHIBITS E and F, respectively. (l) NO MATERIAL ADVERSE CHANGE. There shall have been no Material Adverse Change in the Company since the date of signing of this Agreement. (m) LEGAL MATTERS. All material matters of a legal nature which pertain to this Agreement and the transactions contemplated hereby shall have been reasonably approved by counsel to the BVF Investors. ARTICLE VI. CONDITIONS TO THE COMPANY'S OBLIGATIONS 6.1 CONDITIONS TO CLOSING. The obligation of the Company to issue the Warrants and the Preferred Shares, respectively, to the Investors on the Closing Date is subject to the following: (a) REPRESENTATIONS AND WARRANTIES. The representations and warranties of the Investors made herein shall be true, correct and complete in all respects on and as of the Closing Date with the same force and effect as if they had been made on and as of the Closing Date. (b) NO PROCEEDING. No action, suit, investigation or proceeding shall be pending or threatened before any court or governmental agency to restrain, prohibit, collect damages as a result of or otherwise challenge this Agreement or any transaction contemplated hereby or thereby. (c) NO LAW PROHIBITING OR RESTRICTING SUCH SALE. There shall not be in effect any law, rule or regulation prohibiting or restricting such sale, or requiring any consent or approval of any person which shall not have been obtained to issue the Warrants and the Preferred Shares. - -------------------------------------------------------------------------------- Securities Purchase Agreement 10 14 ARTICLE VII. COVENANTS OF THE COMPANY For so long as the BVF Investors continue to hold not less than 50% of the Preferred Shares held by such Investors on the Closing Date, the Company hereby covenants to such Investors as follows: 7.1 FURNISHING OF INFORMATION. The Company covenants to timely file (or obtain extensions in respect thereof) all reports required to be filed by the Company after the date hereof pursuant to Section 13(a) or 15(d) of the Exchange Act and to promptly furnish the Investors with true and complete copies of all such filings. If the Company is not at the time required to file reports pursuant to such sections, it will prepare and furnish to the Investors annual and quarterly reports comparable to those required by Section 13(a) or 15(d) of the Exchange Act in the time period that such filings would have been required to have been made under the Exchange Act. 7.2 INFORMATION WITH RESPECT TO THE SECURITIES. The Company covenants to provide such information as is reasonably requested by any of the Investors related to the terms of the Preferred Shares, the Common Stock, Warrants or Warrant Shares. 7.3 SHAREHOLDER APPROVAL. The Company shall use its best efforts to obtain the shareholder approval described in Section 5.1(e) hereof prior to the Closing Date. 7.4 LICENSE AGREEMENT. The Company covenants that it will not reduce, assign, transfer or otherwise convey all or any portion of the royalties under the License Agreement without the consent of the BVF Investors; provided, that nothing in the foregoing shall prohibit the Company from causing or permitting liens or security interests upon such royalties in connection with a financing for borrowed money from a financial institution. 7.5 INVESTOR'S RIGHTS. Notwithstanding anything to the contrary in the foregoing, the Investors shall be entitled to such information, privileges, rights and benefits accorded to them as holders of the Preferred Shares under applicable law and under the Company's Restated Articles of Incorporation, as amended, and By-laws. ARTICLE VIII. SURVIVAL AND INDEMNIFICATION 8.1 SURVIVAL. Notwithstanding any examination made by or on behalf of any party hereto, the knowledge of any party or the acceptance by any party of any certificate or opinion, each - -------------------------------------------------------------------------------- Securities Purchase Agreement 11 15 representation, warranty contained herein shall survive the Closing for a period of two years, and each covenant shall survive for the period indicated therein. 8.2 INDEMNIFICATION. (a) The Company shall indemnify and hold harmless each Investor, its shareholders, officers, directors, employees, agents and representatives against any damage, claim, loss, liability and expense (including reasonable counsel fees and expenses) which may be suffered or incurred by any of them as a result of a breach of any representation or warranty or covenant made by the Company in this Agreement, provided that, solely with respect to such representation or warranty, a claim is asserted within the time provided in Section 8.1. (b) The Investors, jointly and severally, agree to indemnify the Company and its shareholders, officers, directors, employees, agents and representatives against any damages, claims, losses, liabilities and expenses (including reasonable counsel fees and other expenses) which may be suffered or incurred by it as a result of any breach of any representation, warranty, or covenant made by the Investors in this Agreement, provided that a claim is asserted within the time provided in Section 8.1. (c) In case any proceeding (including any governmental investigation) shall be instituted involving any person in respect of which indemnity may be sought pursuant to this Section, such person (the "indemnified party") shall promptly notify the person against whom such indemnity may be sought (the "indemnifying party") in writing of the occurrence of the facts and circumstances giving rise to such claim. The failure of any person to deliver the notice required by this Section 8.2(c) shall not in any way affect the indemnifying party's indemnification obligation hereunder except and only to the extent that the indemnifying party is actually prejudiced thereby. In case any such proceeding shall be brought against any indemnified party and it shall notify the indemnifying party of the commencement thereof, the indemnifying party shall be entitled to participate therein and, to the extent that it shall wish, jointly with any other indemnifying party similarly notified, to assume the defense thereof, with counsel satisfactory to such indemnified party and shall pay as incurred the fees and expenses of such counsel related to such proceeding. In any such proceeding, any indemnified party shall have the right to retain its own counsel or pay its own expenses. Notwithstanding the foregoing, the indemnifying party shall pay as incurred the fees and expenses of the counsel retained by the indemnified party in the event (i) the indemnifying party and the indemnified party shall have mutually agreed to the retention of such counsel or (ii) the named parties to any such proceedings (including any impleaded parties) include both the indemnifying party and the indemnified party and representation of both parties by the same counsel would be inappropriate due to actual or potential differing interests between them. The indemnifying party shall not be liable for any settlement of any proceeding effected without its written consent but if settled with such consent or if there be a final judgment for the plaintiff, the indemnifying party agrees to indemnify the indemnified party from and against any loss or liability by reason of such settlement or judgment and the indemnifying party shall obtain a full release of the indemnified party. - -------------------------------------------------------------------------------- Securities Purchase Agreement 12 16 ARTICLE IX. MISCELLANEOUS 9.1 NOTICES. All notices, requests, consents and other communications hereunder shall be in writing, shall be addressed to the receiving party's address set forth below or to such other address as a party may designate by notice hereunder, and shall be either (i) delivered by hand, (ii) made by telecopy or facsimile transmission, (iii) sent by overnight courier, or (iv) sent by registered mail, return receipt requested, postage prepaid. If to the BVF Investors: c/o BVF Partners, L.P. One Sansome Street, 39th Floor San Francisco, CA 94104 Attn: Mr. Mark Lampert Fax: (415) 288-2394 With a copy to: Sidley & Austin 875 Third Avenue New York, NY 10022 Attn: Paul K. Risko, Esq. Fax: (212) 906-2021 If to Alfred J. Roach: c/o American Biogenetic Sciences, Inc. 1375 Akron Street Copiague, New York 11726 Attn: Chief Executive Officer Fax:(516) 789-1661 With a copy to Brown, Rudnick, Freed & Gesmer One Financial Center Boston, Massachusetts 02111 Attn: David H. Murphree, Esq. Fax:(617) 856-8201 If to the Company: American Biogenetic Sciences, Inc. 1375 Akron Street Copiague, New York 11726 Attn: Chief Executive Officer Fax: (516) 789-1661 With a copy to Brown, Rudnick, Freed & Gesmer One Financial Center Boston, Massachusetts 02111 Attn: David H. Murphree, Esq. Fax: (617) 856-8201 - -------------------------------------------------------------------------------- Securities Purchase Agreement 13 17 All notices, requests, consents and other communications hereunder shall be deemed to have been given either (i) if by hand, at the time of the delivery thereof to the receiving party at the address of such party set forth above, (ii) if made by telecopy or facsimile transmission, one (1) day after the time that receipt thereof has been acknowledged by electronic confirmation or otherwise, (iii) if sent by overnight courier, on the next business day following the day such notice is delivered to the courier service, or (iv) if sent by registered mail, on the 5th business day following the day such mailing is made. 9.2 ENTIRE AGREEMENT. This Agreement, including exhibits, or other documents referred to herein, embodies the entire agreement and understanding between the parties hereto with respect to the subject matter hereof and supersedes all prior oral or written agreements and understandings relating to the subject matter hereof. No statement, representation, warranty, covenant or agreement of any kind not expressly set forth in this Agreement shall affect, or be used to interpret, change or restrict, the express terms and provisions of this Agreement. 9.3 AMENDMENTS. On or prior to the Closing Date, the terms and provisions of the Agreement may be modified, amended or waived, or consent for the departure therefrom granted, only by written agreement of the Company, the BVF Investors and Alfred J. Roach. After the Closing Date, the terms and provisions of the Agreement may be modified, amended or waived, or consent for the departure therefrom granted, only by written agreement of the Company and Investors holding Preferred Shares, Warrants or Common Stock issued pursuant to this Agreement, upon conversion of the Preferred Shares or exercise of the Warrants equal to 50% or more of the Common Stock issuable upon conversion of the Preferred Shares and upon exercise of the Warrants, on a fully converted, fully exercised basis.. No such waiver or consent, in either case, shall be deemed to be or shall constitute a waiver or consent with respect to any other terms or provisions of this Agreement, whether or not similar. Each such waiver or consent, in either case, shall be effective only in the specific instance and for the purpose for which it was given, and shall not constitute a continuing waiver or consent. 9.4 ASSIGNMENT. Neither this Agreement nor any or all of the rights and obligations of a party hereunder shall be assigned, delegated, sold, transferred or otherwise disposed of by operation of law or otherwise, to any third person without the prior written consent of the other party, and any attempted assignment, delegation, sale, transfer, or other disposition, by operation of law or otherwise, of this Agreement or of any rights or obligations hereunder contrary to this Section 9.4 shall be void and without force or effect. Each party shall be responsible for the compliance by its Affiliates with the terms and conditions of this Agreement. 9.5 BENEFIT. All statements, representations, warranties, covenants and agreements in this Agreement shall be binding on the parties hereto and shall inure to the benefit of the respective successors and permitted assigns of each party hereto. Nothing in this Agreement shall be construed to - -------------------------------------------------------------------------------- Securities Purchase Agreement 14 18 create any rights or obligations except among the parties hereto, and no person or entity shall be regarded as a third-party beneficiary of this Agreement. 9.6 GOVERNING LAW. This Agreement and the rights and obligations of the parties hereunder shall be construed in accordance with and governed by the law of the State of New York. 9.7 SEVERABILITY. In the event that any court of competent jurisdiction shall determine that any provision, or any portion thereof, contained in this Agreement shall be unreasonable or unenforceable in any respect, then such provision shall be deemed limited to the extent that such court deems it reasonable and enforceable, and as so limited shall remain in full force and effect. In the event that such court shall deem any such provision, or portion thereof, wholly unenforceable, the remaining provisions of this Agreement shall be interpreted as if such provision were so excluded and shall nevertheless remain in full force and effect. 9.8 HEADINGS AND CAPTIONS. The headings and captions of the various subdivisions of this Agreement are for convenience of reference only and shall in no way modify, or affect the meaning or construction of any of the terms or provisions hereof. 9.9 NO WAIVER OF RIGHTS, POWERS AND REMEDIES. No failure or delay by a party hereto in exercising any right, power or remedy under this Agreement, and no course of dealing between the parties hereto, shall operate as a waiver of any such right, power or remedy of the party. No single or partial exercise of any right, power or remedy under this Agreement by a party hereto, nor any abandonment or discontinuance of steps to enforce any such right, power or remedy, shall preclude such party from any other or further exercise thereof or the exercise of any other right, power or remedy hereunder. The election of any remedy by a party hereto shall not constitute a waiver of the right of such party to pursue other available remedies. No notice to or demand on a party not expressly required under this Agreement shall entitle the party receiving such notice or demand to any other or further notice or demand in similar or other circumstances or constitute a waiver of the rights of the party giving such notice or demand to any other or further action in any circumstances without such notice or demand. 9.10 EXPENSES. Except as provided in Section 8.2, each of the parties shall pay its own fees and expenses (including the fees of any attorneys, accountants, appraisers or others engaged by such party) in connection with this Agreement and the transactions contemplated hereby whether or not the transactions contemplated hereby are consummated; provided, that, the Company shall pay such fees and expenses (including attorney's fees) of the BVF Investors up to $5,000. - -------------------------------------------------------------------------------- Securities Purchase Agreement 15 19 9.11 BROKERS. Each of the parties hereto represents and warrants to the other that no broker, finder or financial consultant has acted on its behalf in connection with this Agreement or the transactions contemplated hereby in such a way as to create any liability on the other. Each of the parties hereto agrees to indemnify and save the other harmless from any claim or demand for commission or other compensation by any other broker, finder, financial consultant or similar agent claiming to have been employed by or on behalf of such party and to bear the cost of legal expenses incurred in defending against any such claim. 9.12 CONFIDENTIALITY. The Investors acknowledge and agree that any information or data they have acquired from the Company, which is clearly designated in writing as confidential and is not otherwise properly in the public domain, was received in confidence. Each of the Investors agrees not to divulge, communicate or disclose, except as may be required by law or upon the advice of its accountants or for the performance of this Agreement, or use to the detriment of the Company or for the benefit of any other person or persons, or misuse in any way, any confidential information of the Company. 9.13 COUNTERPARTS. This Agreement may be executed in one or more counterparts, and by different parties hereto on separate counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. 9.14 FURTHER ASSURANCES. In case at any time after the Closing any further action is necessary or desirable to carry out the purposes of this Agreement, the Company and the Investors will take such further action as the other party may reasonably request, all at the sole cost and expense of the requesting party (unless the requesting party is entitled to indemnification therefor under Article VIII). [REMAINDER OF PAGE IS INTENTIONALLY BLANK] - -------------------------------------------------------------------------------- Securities Purchase Agreement 16 20 IN WITNESS WHEREOF, the undersigned have executed this Stock Purchase Agreement this 3rd day of February, 2000. AMERICAN BIOGENETIC SCIENCES, INC. By: /s/ Josef C. Schoell --------------------------------------------- Name: Josef C. Schoell Title: Vice President Finance INVESTORS: /s/ Alfred J. Roach ------------------------------------------------- Alfred J. Roach BIOTECHNOLOGY VALUE FUND, L.P. By: BVF PARTNERS L.P., its General Partner By: BVF, INC., its General Partner By: ------------------------------------- Mark N. Lampert President BIOTECHNOLOGY VALUE FUND II, L.P. By: BVF PARTNERS L.P., its General Partner By: BVF, INC., its General Partner By: ------------------------------------- Mark N. Lampert President INVESTMENT 10 L.L.C. By: BVF PARTNERS, L.P., its Investment Advisor By: BVF, INC., its General Partner By: ------------------------------------- Mark N. Lampert President - -------------------------------------------------------------------------------- Securities Purchase Agreement 1 21 IN WITNESS WHEREOF, the undersigned have executed this Stock Purchase Agreement as of this 3rd day of February, 2000. AMERICAN BIOGENETIC SCIENCES, INC. By: --------------------------------------------- Name: Title: INVESTORS: ------------------------------------------------- Alfred J. Roach BIOTECHNOLOGY VALUE FUND, L.P. By: BVF PARTNERS L.P., its General Partner By: BVF, INC., its General Partner By: /s/ Mark N. Lampert ------------------------------------- Mark N. Lampert President BIOTECHNOLOGY VALUE FUND II, L.P. By: BVF PARTNERS L.P., its General Partner By: BVF, INC., its General Partner By: /s/ Mark N. Lampert ------------------------------------- Mark N. Lampert President INVESTMENT 10 L.L.C. By: BVF PARTNERS, L.P., its Investment Advisor By: BVF, INC., its General Partner By: /s/ Mark N. Lampert ------------------------------------- Mark N. Lampert President - -------------------------------------------------------------------------------- Securities Purchase Agreement 1 EX-4.4(B) 4 REGISTRATION AGREEMENT 1 Exhibit 4.4(b) AMERICAN BIOGENETIC SCIENCES, INC. REGISTRATION AGREEMENT THIS AGREEMENT, is made as of March 3, 2000, among AMERICAN BIOGENETIC SCIENCES, a Delaware corporation (the "Company") and the investors listed on Exhibit A attached hereto (collectively referred to as the "Investor"). The parties to this Agreement are parties to a Securities Purchase Agreement, dated as of February 3, 2000 (the "Purchase Agreement"). In order to induce the Investor to enter into the Purchase Agreement, the Company has agreed to provide the registration rights set forth in this Agreement. The execution and delivery of this Agreement is a condition to the Closing under the Purchase Agreement. Unless otherwise provided in this Agreement, capitalized terms used herein shall have the meanings set forth in paragraph 5 hereof. The parties hereto agree as follows: 1. REGISTRATION AFTER CLOSING. (a) Within 60 days after the Closing, the Company shall file a registration statement on the appropriate form, under the Securities Act covering the Registrable Securities, including a prospectus for the purpose of offering for resale the Registrable Securities (the "Registration Statement"). The Company shall use its best efforts to cause the Registration Statement to be declared effective by the Securities and Exchange Commission within 120 days after the Closing. (b) The Company shall use its best efforts to cause the Registration Statement to remain effective until the first to occur of (i) two years (excluding any period during which the Registration Statement is suspended pursuant to Section 2(d)) after the date it is declared effective, (ii) the date on which all Registrable Securities are sold; and (iii) the date that such share cease to be treated as Registrable Securities because they are eligible be sold without delay under Rule 144 under the Securities Act. 2. REGISTRATION PROCEDURES. (a) The Company shall: (1) notify each holder of Registrable Securities of the filing of the Registration Statement with the Securities and Exchange Commission and of the effectiveness of the Registration Statement; (2) prepare and file with the Securities and Exchange Commission such amendments and supplements to the Registration Statement and the prospectus used in - -------------------------------------------------------------------------------- Registration Agreement -1- 2 connection therewith as may be necessary to keep the Registration Statement effective for the period set forth in Section 1(b) hereof; (3) comply with the provisions of the Securities Act with respect to the disposition of all securities covered by the Registration Statement during such period in accordance with the intended methods of disposition by the sellers thereof set forth in the Registration Statement; (4) furnish to each seller of Registrable Securities such number of copies of the Registration Statement, each amendment and supplement thereto, the prospectus included in the Registration Statement (including each preliminary prospectus) and such other documents as such seller may reasonably request in order to facilitate the disposition of the Registrable Securities owned by such seller; (5) use its best efforts to register or qualify such Registrable Securities under such other securities or blue sky laws of such jurisdictions as any seller reasonably requests and do any and all other acts and things which may be reasonably necessary or advisable to enable such seller to consummate the disposition in such jurisdictions of the Registrable Securities owned by such seller (provided that the Company shall not be required to (i) qualify generally to do business in any jurisdiction where it would not otherwise be required to qualify but for this subparagraph, (ii) subject itself to taxation in any such jurisdiction or (iii) consent to general service of process in any such jurisdiction); (6) notify each seller of such Registrable Securities, at any time when a prospectus relating thereto is required to be delivered under the Securities Act, of the happening of any event as a result of which the prospectus included in the Registration Statement contains an untrue statement of a material fact or omits any fact necessary to make the statements therein not misleading, and, subject to the right of the Company to suspend sales under Section 2(d) below, at the request of any such seller, the Company shall prepare a supplement or amendment to such prospectus so that, as thereafter delivered to the purchasers of such Registrable Securities, such prospectus shall not contain an untrue statement of a material fact or omit to state any fact necessary to make the statements therein not misleading; (7) use its reasonable efforts to cause all such Registrable Securities to be listed on the securities exchange on which similar securities issued by the Company are then listed; (8) provide a transfer agent and registrar for all such Registrable Securities not later than the effective date of the Registration Statement; (9) if the Registrable Securities are to be sold in a firm commitment underwritten offering, enter into a customary underwriting agreement and take all such other actions as the holders of a majority of the Registrable Securities being sold or the underwriters reasonably request in order to expedite or facilitate the disposition of such Registrable Securities; (10) make available for inspection by any seller of Registrable Securities, any underwriter participating in any disposition pursuant to the Registration - -------------------------------------------------------------------------------- Registration Agreement -2- 3 Statement, and any attorney, accountant or other agent retained by any such seller or underwriter, all financial and other records, pertinent corporate documents and properties of the Company, and cause the Company's officers, directors, employees and independent accountants to supply all information reasonably requested by any such seller, underwriter, attorney, accountant or agent in connection with such registration statement; PROVIDED, HOWEVER, that any information that is determined in good faith by the Company to be of a confidential nature at the time of delivery of such information shall be kept confidential by such persons, unless (i) disclosure of such information is required by court or administrative order or is necessary to respond to inquiries of regulatory authorities; (ii) disclosure of such information, in the opinion of counsel to such person, is required by law; (iii) such information becomes generally available to the public other than as a result of a disclosure or failure to safeguard by such person; or (iv) such information becomes available to such person from a source other than the Company and such source is not known by such person to be bound by a confidentiality agreement with the Company; (11) in the event of the issuance of any stop order suspending the effectiveness of the Registration Statement, or of any order suspending or preventing the use of any related prospectus or suspending the qualification of any Common Stock included in the Registration Statement for sale in any jurisdiction, the Company shall use its reasonable best efforts promptly to obtain the withdrawal of such order; (12) the Company may require each seller of the Registrable Securities to furnish to the Company such information regarding the distribution of such Registrable Securities as is required by law to be disclosed in the Registration Statement, and the Company may exclude from such registration the Registrable Securities of any such holder who unreasonably fails to furnish such information within a reasonable time after receiving such request; (b) The holders of any Registrable Securities covenant and agree that (i) they will not sell any Registrable Securities under the Registration Statement until they have received copies of the prospectus as then amended or supplemented as contemplated in Section 4(b) and notice from the Company that the Registration Statement and any post-effective amendments thereto have become effective and (ii) each such holder and its officers, directors or Affiliates, if any, will comply with the prospectus delivery requirements of the Securities Act as applicable to them in connection with sales of Registrable Securities pursuant to the Registration Statement. (c) Each holder of Registrable Securities agrees by its acquisition of such Registrable Securities that, upon receipt of a notice from the Company of the occurrence of any event of the kind described in Subsections 2(a)(6) or 2(a)(11), such holder will forthwith discontinue disposition of such Registrable Securities until such holder's receipt of the copies of the supplemented prospectus and/or amended Registration Statement contemplated by Subsection 2(a)(4), or until it is advised in writing by the Company that the use of the applicable prospectus may be resumed, and, in either case, has received copies of any additional or supplemental filings that are incorporated or deemed to be incorporated by reference in such prospectus or Registration Statement. - -------------------------------------------------------------------------------- Registration Agreement -3- 4 (d) If a event occurs which would otherwise require the filing of an amendment to the Registration Statement or a prospectus supplement under Subsection 2(a) (6) above so as permit the proposed sale without a violation of securities laws, if the in the good faith judgment of the Board of Directors of the Company, after consultation with counsel, such disclosure would materially adversely affect a pending or scheduled public offering, or an acquisition, merger, or similar transaction, or negotiations of either of the foregoing, or would require the disclosure of another material development prior to the time it would otherwise be required to be disclosed in a manner adverse to the best interests of the Company, then it may decline to permit the resale of any Registrable Securities pursuant to the Registration Statement for up to a maximum of ninety (90) days, provided that it may not exercise this right more than twice in any twelve (12) month period. Each Investor hereby covenants and agrees that it will not sell any Shares pursuant to the Registration Statement during the periods sales in reliance upon the Registration Statement are prohibited as set forth in this Section 2(d). 3. REGISTRATION EXPENSES. (a) All expenses incident to the Company's performance of or compliance with this Agreement, including without limitation all registration and Securities and Exchange Commission and National Association of Securities Dealers, Inc. filing fees and expenses, fees and expenses of compliance with securities or blue sky laws, printing expenses, messenger and delivery expenses, fees and disbursements of custodians, the expense of any audit of financial data required to be included in the Registration Statement, and fees and disbursements of counsel for the Company and fees and disbursements of not more than one counsel to the holders of Registrable Securities up to a maximum of $5,000 and fees and disbursements of all independent certified public accountants, and other persons retained by the Company (all such expenses being herein called "Registration Expenses"), shall be borne by the Company; PROVIDED, HOWEVER, that the Company shall have no obligation to pay or otherwise bear any portion of (i) the underwriter's commissions or discounts or transfer taxes attributable to the Registrable Securities being offered and sold by the holders of such Registrable Securities, or (ii) the fees and expenses of advisors, professionals or agents for the holders of Registrable Securities in connection with the registration of Registrable Securities (other than as above provided), or (iii) the fees and expenses of any counsel or accounting firm retained by the underwriters in connection with an underwritten offering of the Registrable Securities and the costs of any determination (but not filing) by the underwriters of the eligibility of the Registrable Securities for investment under the applicable state securities law. (b) To the extent Registration Expenses are not required to be paid by the Company, each holder of securities included in any registration hereunder shall pay those Registration Expenses allocable to the registration of such holder's securities so included, and any Registration Expenses not so allocable shall be borne pro rata by all sellers of securities included in such registration in proportion to the aggregate selling price of the securities to be so registered. 4. INDEMNIFICATION. (a) The Company agrees to indemnify and hold harmless, to the extent permitted by law, each holder of Registrable Securities, its officers and directors and each person - -------------------------------------------------------------------------------- Registration Agreement -4- 5 who controls such holder (within the meaning of the Securities Act or the Exchange Act) (each, an "Indemnitee") against any loss, claim, damage, liability or expense, as incurred, to which such Indemnitee may be subject under the Securities Act, the Exchange Act, or other federal or state statutory law or regulation, at common law or otherwise (including in settlement of any litigation, if such settlement is effected with the written consent of the Company, which consent shall not be unreasonably withheld), insofar as such loss, claim, damage, liability or expense (or action in respect thereof) arises out of or is based (i) upon any untrue or alleged untrue statement of material fact contained in any registration statement, prospectus or preliminary prospectus or any amendment thereto (including any information deemed to be part thereof pursuant to Rule 430A of the Securities Act) or supplement thereto or any omission or alleged omission of a material fact required to be stated therein or necessary to make the statements therein not misleading; or (ii), in whole or in part upon any failure of the Company or any controlling person to the Company to perform its obligations hereunder, in each case except insofar as the same are caused by or contained in any information furnished to the Company by such holder expressly for use therein or by such holder's failure to deliver a copy of the registration statement or prospectus or any amendments or supplements thereto after the Company has furnished such holder with copies of the same. In connection with an underwritten offering, the Company shall indemnify such underwriters, their officers and directors and each person who controls such underwriters (within the meaning of the Securities Act or the Exchange Act) to the same extent as provided above with respect to the indemnification of the holders of Registrable Securities. (b) In connection with the Registration Statement in which a holder of Registrable Securities is participating, each such holder shall furnish to the Company in writing such information and affidavits as the Company reasonably requests for use in connection with any the Registration Statement or prospectus and, to the extent permitted by law, shall indemnify the Company, its directors, officers, agents and employees and each person who controls the Company (within the meaning of the Securities Act) and the directors, officers, agents and employees of such controlling persons against any losses, claims, damages, liabilities and expenses resulting from any untrue or alleged untrue statement of material fact contained in the Registration Statement, prospectus or preliminary prospectus or any amendment thereof or supplement thereto or any omission or alleged omission of a material fact required to be stated therein or necessary to make the statements therein not misleading, but only to the extent that such untrue statement or omission is contained in any information or affidavit so furnished by such holder; provided that the obligation to indemnify shall be individual, not joint and several, for each holder and shall be limited to the amount of proceeds received by such holder from the sale of Registrable Securities pursuant to the Registration Statement. (c) Any person entitled to indemnification hereunder shall (i) give prompt written notice to the indemnifying party of any claim with respect to which it seeks indemnification (provided that the failure to give prompt notice shall not impair any such person's right to indemnification hereunder to the extent such failure has not prejudiced the indemnifying party) and (ii) unless in such indemnified party's reasonable judgment a conflict of interest between such indemnified and indemnifying parties may exist with respect to such claim, permit such indemnifying party to assume the defense of such claim with counsel reasonably satisfactory to the indemnified party. If such defense is assumed, the indemnifying party shall not be subject to any liability for any settlement made by the indemnified party without its consent - -------------------------------------------------------------------------------- Registration Agreement -5- 6 (but such consent shall not be unreasonably withheld). An indemnifying party who is not entitled to, or elects not to, assume the defense of a claim shall not be obligated to pay the fees and expenses for more than one counsel for all parties indemnified by such indemnifying party with respect to such claim or related claims. (d) The indemnification provided for under this Agreement shall remain in full force and effect regardless of any investigation made by or on behalf of the indemnified party or any officer, director or controlling person of such indemnified party and shall survive the transfer of securities. The parties also agree to make such provisions as are reasonably requested by any indemnified party in the event that indemnification hereunder is unavailable for any reason. 5. DEFINITIONS. (a) "REGISTRABLE SECURITIES" means (i) any Class A Common Stock, par value $.001 per share ("Common Stock"), of the Company (x) to be issued upon the conversion of the Series A Convertible Preferred Stock, $.001 par value per share ("Preferred Stock"), of the Company acquired by the Investor pursuant to the Purchase Agreement or (y)otherwise issued pursuant to Section 1.3(b) of the Purchase Agreement, (ii) any Common Stock issued upon exercise of the Warrants acquired by the Investor pursuant to the Purchase Agreement; and (iii) any Common Stock issued or issuable with respect to the securities referred to in clauses (i) and (ii) by way of a stock dividend or stock split or in connection with a combination of shares, recapitalization, merger, consolidation or other reorganization. As to any particular Registrable Securities, such securities shall cease to be Registrable Securities when they have been distributed to the public pursuant to an offering registered under the Securities Act or sold to the public through a broker or dealer or to a market maker in compliance with Rule 144 under the Securities Act (or any similar rule then in force) or repurchased by the Company or any Subsidiary, or when they are eligible to be sold in compliance with Rule 144 under the Securities Act. For purposes of this Agreement, a person shall be deemed to be a holder of Registrable Securities, and the Registrable Securities shall be deemed to be in existence, whenever such person has the right to acquire directly or indirectly such Registrable Securities (upon conversion or exercise in connection with a transfer of securities or otherwise), whether or not such acquisition has actually been effected, and such person shall be entitled to exercise the rights of a holder of Registrable Securities hereunder. (b) Unless otherwise stated, other capitalized terms contained herein have the meanings set forth in the Purchase Agreement. 6. MISCELLANEOUS. (a) NO INCONSISTENT AGREEMENTS. The Company shall not hereafter enter into any agreement with respect to its securities which is inconsistent with or violates the rights granted to the holders of Registrable Securities in this Agreement. (b) NO ADVERSE ACTION. The Company shall not take any action, or permit any change to occur, with respect to its securities which would adversely affect the ability - -------------------------------------------------------------------------------- Registration Agreement -6- 7 of the holders of Registrable Securities to include such Registrable Securities in the registration undertaken pursuant to this Agreement. (c) REMEDIES. Any person having rights under any provision of this Agreement shall be entitled to enforce such rights specifically to recover damages caused by reason of any breach of any provision of this Agreement and to exercise all other rights granted by law. The parties hereto agree and acknowledge that money damages may not be an adequate remedy for any breach of the provisions of this Agreement and that any party may in its sole discretion apply to any court of law or equity of competent jurisdiction (without posting any bond or other security) for specific performance and for other injunctive relief in order to enforce or prevent violation of the provisions of this Agreement. (d) AMENDMENTS AND WAIVERS. Except as otherwise provided herein, the provisions of this Agreement may be amended or waived only upon the prior written consent of the Company and Investors. (e) SUCCESSORS AND ASSIGNS. All covenants and agreements in this Agreement by or on behalf of any of the parties hereto shall bind and inure to the benefit of the respective successors and assigns of the parties hereto whether so expressed or not. In addition, whether or not any express assignment has been made, the provisions of this Agreement which are for the benefit of purchasers or holders of Registrable Securities are also for the benefit of, and enforceable by, any subsequent holder of Registrable Securities who is an affiliate of the Investor. (f) INCORPORATION OF PURCHASE AGREEMENT PROVISIONS. The paragraphs of Article IX of the Purchase Agreement are hereby incorporated in this Agreement by reference and made a part hereof; except that the provisions of such paragraphs shall refer to this Agreement rather than the Purchase Agreement and shall continue to apply hereto regardless of whether the Purchase Agreement is any longer in effect. (g) NON-TRANSFERABILITY. The Investors' rights and obligations under this Agreement shall not be transferable to an other party under any circumstances, whether by operation of law or otherwise (other than to an entity into which an Investor has been merged or which has acquired substantially all of the assets of the Investor); provided that the Investor shall have the right to transfer its rights and obligations hereunder to its affiliates (as such term is defined in Rule 144 under the Securities Act) in connection with a permitted transfer of Registrable Securities to such affiliates, so long as such affiliates agree in writing to be bound by the terms of this Agreement. - -------------------------------------------------------------------------------- Registration Agreement -7- 8 IN WITNESS WHEREOF, the parties have executed this Registration Agreement as of the date first written above. AMERICAN BIOGENETIC SCIENCES, INC. By: /s/ Josef C. Schoell --------------------------------------------- Name: Josef C. Schoell Title: V. P. Finance INVESTORS: /s/ Alfred J. Roach ------------------------------------------------- Alfred J. Roach BIOTECHNOLOGY VALUE FUND, L.P. By: BVF PARTNERS L.P., its General Partner By: BVF, INC., its General Partner By: ---------------------------------- Mark N. Lampert President BIOTECHNOLOGY VALUE FUND II, L.P. By: BVF PARTNERS L.P., its General Partner By: BVF, INC., its General Partner By: ---------------------------------- Mark N. Lampert President INVESTMENT 10 L.L.C. By: BVF PARTNERS, L.P., its Investment Advisor By: BVF, INC., its General Partner By: ---------------------------------- Mark N. Lampert President - -------------------------------------------------------------------------------- Registration Agreement -8- 9 IN WITNESS WHEREOF, the parties have executed this Registration Agreement as of the date first written above. AMERICAN BIOGENETIC SCIENCES, INC. By: /s/ --------------------------------------------- Name: Title: INVESTORS: ------------------------------------------------- Alfred J. Roach BIOTECHNOLOGY VALUE FUND, L.P. By: BVF PARTNERS L.P., its General Partner By: BVF, INC., its General Partner By: /s/ Mark N. Lampert ---------------------------------- Mark N. Lampert President BIOTECHNOLOGY VALUE FUND II, L.P. By: BVF PARTNERS L.P., its General Partner By: BVF, INC., its General Partner By: /s/ Mark N. Lampert ---------------------------------- Mark N. Lampert President INVESTMENT 10 L.L.C. By: BVF PARTNERS, L.P., its Investment Advisor By: BVF, INC., its General Partner By: /s/ Mark N. Lampert ---------------------------------- Mark N. Lampert President - -------------------------------------------------------------------------------- Registration Agreement -8- EX-10.2(C) 5 1996 STOCK OPTION PLAN 1 Exhibit 10.2(c) 1996 STOCK OPTION PLAN OF AMERICAN BIOGENETIC SCIENCES, INC. (AS AMENDED EFFECTIVE JUNE 15, 1999) 1. PURPOSES OF THE PLAN. This stock option plan (the "Plan") is designed to provide an incentive to employees (including directors and officers who are employees) and to consultants who are not employees of American Biogenetic Sciences, Inc., a Delaware corporation (the "Company"), and its present and future subsidiary corporations, as defined in Paragraph 19 ("Subsidiaries"), and to offer an additional inducement in obtaining the services of such employees and consultants. The Plan provides for the grant of "incentive stock options" ("ISOs") within the meaning of Section 422 of the Internal Revenue Code of 1986, as amended (the "Code"), and nonqualified stock options which do not qualify as ISOs ("NQSOs"), but the Company makes no representation or warranty, express or implied, as to the qualification of any option as an "incentive stock option" under the Code. 2. STOCK SUBJECT TO THE PLAN. Subject to the provisions of Paragraph 12, the aggregate number of shares of Class A Common Stock, $.001 par value per share, of the Company ("Common Stock") for which options may be granted under the Plan shall not exceed 4,000,000. Such shares of Common Stock may, in the discretion of the Board of Directors of the Company (the "Board of Directors"), consist either in whole or in part of authorized but unissued shares of Common Stock or shares of Common Stock held in the treasury of the Company. Subject to the provisions of Paragraph 13, any shares of Common Stock subject to an option which for any reason expires, is canceled or is terminated unexercised or which ceases for any reason to be exercisable shall again become available for the granting of options under the Plan. The Company shall at all times during the term of the Plan reserve and keep available such number of shares of Common Stock as will be sufficient to satisfy the requirements of the Plan. 3. ADMINISTRATION OF THE PLAN. The Plan shall be administered by the Board of Directors or, to the extent the Board of Directors may determine, a committee of the Board of Directors (the "Committee") consisting of not less than two directors, each of whom shall be a "non-employee director" within the meaning of Rule 16b-3 (or any successor rule or regulation) promulgated under the Securities Exchange Act of 1934, as amended (as the same may be in effect and interpreted from time to time, "Rule 16b-3"). A majority of the members of the Committee shall constitute a quorum, and the acts of a majority of the members present at any meeting at which a quorum is present, and any acts approved in writing by all members without a meeting, shall be the acts of the Committee. All references in the Plan to determinations or actions of the Committee shall be deemed to include determinations and actions by the Committee or the Board of Directors. Subject to the express provisions of the Plan, the Committee shall have the authority, in its sole discretion, to determine the employees and the consultants who shall be granted options; the times when options shall be granted; whether an option granted to an employee shall be an ISO or a NQSO; the number of shares of Common Stock to be subject to each option; the term of each option, the date each option shall become exercisable; whether an option shall be exercisable in whole, in part or in installments and, if in installments, the number of shares of Common Stock to be subject to each installment, whether the installments shall be cumulative, the date each installment shall become exercisable and the term of each installment; whether to accelerate the date of exercise of any option or installment; whether shares of Common Stock may be issued upon the exercise of an option as partly paid and, if so, the dates when future installments of the exercise price shall become due and the amounts of such installments; the exercise price of each option; the form of payment of the 2 exercise price; the fair market value of a share of Common Stock; whether to restrict the sale or other disposition of the shares of Common Stock acquired upon the exercise of an option and, if so, whether to waive any such restriction; whether to subject the exercise of all or any portion of an option to the fulfillment of contingencies as specified in the contract referred to in Paragraph 11 (the "Contract"), including without limitation, contingencies relating to entering into a covenant not to compete with the Company, any of its Subsidiaries or a Parent (as defined in Paragraph 19), to financial objectives for the Company, any of its Subsidiaries or a Parent, a division of any of the foregoing, a product line or other category, and/or the period of continued employment of the optionee with the Company, any of its Subsidiaries or a Parent, and to determine whether such contingencies have been met; the amount, if any, necessary to satisfy the Company's obligation to withhold taxes or other amounts; whether an optionee is Disabled (as defined in Paragraph 19); to construe the respective Contracts and the Plan; with the consent of the optionee, to cancel or modify an option, PROVIDED such modified provision would be permitted to be included in an option on the date of modification, and FURTHER, PROVIDED, that, in the case of a modification (within the meaning of Section 424(h) of the Code) of an ISO, such option as modified would be permitted to be granted on the date of such modification under the terms of the Plan; to prescribe, amend and rescind rules and regulations relating to the Plan; and to make all other determinations necessary or advisable for administering the Plan. Any controversy or claim arising out of or relating to the Plan, any option granted under the Plan or any Contract shall be determined unilaterally by the Committee in its sole discretion. The determinations of the Committee on the matters referred to in this Paragraph 3 shall be conclusive and binding on the parties. No member or former member of the Committee shall be liable for any action, failure to act or determination made in good faith with respect to the Plan or any option hereunder. 4. ELIGIBILITY. The Committee may from time to time, in its sole discretion, consistent with the purposes of the Plan, grant options to employees (including officers and directors who are employees) of, and to consultants to, the Company or any of its Subsidiaries. Such options granted shall cover such number of shares of Common Stock as the Committee may determine in its sole discretion; PROVIDED, HOWEVER, that the maximum number of shares subject to options that may be granted to any employee during any calendar year under the Plan (the "162(m) Maximum") shall not exceed 500,000 shares; and FURTHER, PROVIDED, that the aggregate market value (determined at the time the option is granted in accordance with Paragraph 5) of the shares of Common Stock for which any eligible employee may be granted ISOs under the Plan or any other plan of the Company, or of a Parent or a Subsidiary of the Company, which are exercisable for the first time by such optionee during any calendar year shall not exceed $100,000. Such limitation shall be applied by taking ISOs into account in the order in which they were granted. Any option (or the portion thereof) granted in excess of such amount shall be treated as an NQSO. 5. EXERCISE PRICE. The exercise price of the shares of Common Stock under each option shall be determined by the Committee in its sole discretion, PROVIDED, HOWEVER, the exercise price of an ISO shall not be less than the fair market value of the Common Stock subject to such option on the date of grant; and FURTHER, PROVIDED, that if, at the time an ISO is granted, the optionee owns (or is deemed to own under Section 424(d) of the Code) stock possessing more than 10% of the total combined voting power of all classes of stock of the Company, of any of its Subsidiaries or of a Parent, the exercise price of such ISO shall not be less than 110% of the fair market value of the Common Stock subject to such ISO on the date of grant. The fair market value of a share of Common Stock on any day shall be (a) if the principal market for the Common Stock is a national securities exchange, the average of the highest and lowest sales prices per share of Common Stock on such day as reported by such exchange or on a composite tape reflecting transactions on such exchange, (b) if the principal market for the Common Stock is not a national securities exchange and the -2- 3 Common Stock is quoted on The Nasdaq Stock Market ("Nasdaq"), (i) if closing bid and asked price information is available with respect to the Common Stock, the average of the closing bid and asked prices per share of Common Stock on such day on Nasdaq, or (ii) if such information is not available, the average of the highest bid and lowest asked prices per share of Common Stock on such day on Nasdaq, or (c) if the principal market for the Common Stock is not a national securities exchange and the Common Stock is not quoted on Nasdaq, the average of the highest bid and lowest asked prices per share of Common Stock on such day as reported on the OTC Bulletin Board Service or by National Quotation Bureau, Incorporated or a comparable service; PROVIDED, HOWEVER, that if clauses (a), (b) and (c) of this Paragraph are all inapplicable, or if no trades have been made or no quotes are available for such day, the fair market value of the Common Stock shall be determined by the Board by any method consistent with applicable regulations adopted by the Treasury Department relating to stock options. 6. TERM. The term of each option granted pursuant to the Plan shall be such term as is established by the Committee, in its sole discretion; PROVIDED, HOWEVER, that the term of each ISO granted pursuant to the Plan shall be for a period not exceeding 10 years from the date of grant thereof; and FURTHER, PROVIDED, that if, at the time an ISO is granted, the optionee owns (or is deemed to own under Section 424(d) of the Code) stock possessing more than 10% of the total combined voting power of all classes of stock of the Company, of any of its Subsidiaries or of a Parent, the term of the ISO shall be for a period not exceeding five years from the date of grant. Options shall be subject to earlier termination as hereinafter provided. 7. EXERCISE. An option (or any part or installment thereof), to the extent then exercisable, shall be exercised by giving written notice to the Company at its principal office stating which option is being exercised, specifying the number of shares of Common Stock as to which such option is being exercised and accompanied by payment in full of the aggregate exercise price therefor (or the amount due on exercise if the Contract permits installment payments) (a) in cash or by certified check or (b) if the applicable Contract permits, with previously acquired shares of Common Stock having an aggregate fair market value on the date of exercise (determined in accordance with Paragraph 5) equal to the aggregate exercise price of all options being exercised, or with any combination of cash, certified check or shares of Common Stock. The Committee may, in its sole discretion, permit payment of the exercise price of an option by delivery by the optionee of a properly executed notice, together with a copy of the optionee's irrevocable instructions to a broker acceptable to the Committee to deliver promptly to the Company the amount of sale or loan proceeds sufficient to pay such exercise price. In connection therewith, the Company may enter into agreements for coordinated procedures with one or more brokerage firms. A person entitled to receive Common Stock upon the exercise of an option shall not have the rights of a stockholder with respect to such shares of Common Stock until the date of issuance of a stock certificate to him for such shares; PROVIDED, HOWEVER, that until such stock certificate is issued, any optionee using previously acquired shares of Common Stock in payment of an option exercise price shall continue to have the rights of a stockholder with respect to such previously acquired shares. In no case may a fraction of a share of Common Stock be purchased or issued under the Plan. 8. TERMINATION OF RELATIONSHIP. Except as may otherwise be expressly provided in the applicable Contract, any optionee whose relationship with the Company, its Subsidiaries and Parent as an employee or consultant has terminated for any reason (other than his death or Disability) may exercise such option, to the extent exercisable on the date of such termination, at any time within three months -3- 4 after the date of termination, but not thereafter and in no event after the date the option would otherwise have expired; PROVIDED, HOWEVER, that if such relationship is terminated either (a) for cause, or (b) without the consent of the Company, such option shall terminate immediately. For the purposes of the Plan, an employment relationship shall be deemed to exist between an individual and a corporation if, at the time of the determination, the individual was an employee of such corporation for purposes of Section 422(a) of the Code. As a result, an individual on military, sick leave or other bona fide leave of absence shall continue to be considered an employee for purposes of the Plan during such leave if the period of the leave does not exceed 90 days, or, if longer, so long as the individual's right to reemployment with the Company (or a related corporation) is guaranteed either by statute or by contract. If the period of leave exceeds 90 days and the individual's right to reemployment is not guaranteed by statute or by contract, the employment relationship shall be deemed to have terminated on the 31st day of such leave. Notwithstanding the foregoing, except as may otherwise be expressly provided in the applicable Contract, options granted under the Plan shall not be affected by any change in the status of the optionee so long as the optionee continues to be an employee of, or a consultant to, the Company, any of its Subsidiaries or a Parent (regardless of having changed from one to the other or having been transferred from one corporation to another). Nothing in the Plan or in any option granted under the Plan shall confer on any optionee any right to continue in the employ of, or as a consultant to, the Company, its Parent or any of its Subsidiaries, or interfere in any way with any right of the Company, its Parent or any of its Subsidiaries to terminate the optionee's relationship at any time for any reason whatsoever without liability to the Company, its Parent or any of its Subsidiaries. 9. DEATH OR DISABILITY OF AN OPTIONEE. Except as may otherwise be expressly provided in the applicable Contract, if an individual optionee dies (a) while he is an employee of; or a consultant to, the Company, any of its Subsidiaries or a Parent, (b) within three months after the termination of such relationship (unless such termination was for cause or without the consent of the Company) or (c) within one year following the termination of such relationship by reason of Disability, his option may be exercised, to the extent exercisable on the date of his death, by his Legal Representative (as defined in Paragraph 19) at any time within one year after death, but not thereafter and in no event after the date the option would otherwise have expired. Except as may otherwise be expressly provided in the applicable Contract, any optionee whose relationship as an employee of, or a consultant to, the Company, its Parent or any Subsidiary has terminated by reason of Disability may exercise his option, to the extent exercisable upon the effective date of such termination, at any time within one year after such date, but not thereafter and in no event after the date the option would otherwise have expired. 10. COMPLIANCE WITH SECURITIES LAWS. It is a condition to the exercise of any option that either (a) a Registration Statement under the Securities Act of 1933, as amended (the "Securities Act"), with respect to the shares of Common Stock to be issued upon such exercise shall be effective and current at the time of exercise, or (b) there be an exemption from registration under the Securities Act for the issuance of the shares of Common Stock upon such exercise. Nothing herein shall be construed as requiring the Company to register shares subject to any option under the Securities Act or to keep any Registration Statement effective or current. -4- 5 The Committee may require, in its sole discretion, as a condition to the exercise of any option that the optionee execute and deliver to the Company his representations and warranties, in form, substance and scope satisfactory to the Committee, which the Committee determines are necessary or convenient to facilitate the perfection of an exemption from the registration requirements of the Securities Act or other legal requirement, including without limitation that (a) the shares of Common Stock to be issued upon the exercise of the option are being acquired by the optionee for his own account, for investment only and not with a view to the resale or distribution thereof; and (b) any subsequent resale or distribution of shares of Common Stock by such optionee will be made only pursuant to (i) a Registration Statement under the Securities Act which is effective and current with respect to the shares of Common Stock being sold, or (ii) a specific exemption from the registration requirements of the Securities Act, but in claiming such exemption, the optionee shall prior to any offer of sale or sale of such shares of Common Stock provide the Company with a favorable written opinion of counsel satisfactory to the Company, in form, substance and scope satisfactory to the Company, as to the applicability of such exemption to the proposed sale or distribution. In addition, if at any time the Committee shall determine, in its sole discretion, that the listing or qualification of the shares of Common Stock subject to such option on any securities exchange, Nasdaq or under any applicable law, or the consent or approval of any governmental regulatory body, is necessary or desirable as a condition to, or in connection with, the granting of an option or the issue of shares of Common Stock thereunder, such option may not be exercised in whole or in part unless such listing, qualification, consent or approval shall have been effected or obtained free of any conditions not acceptable to the Committee. 11. STOCK OPTION CONTRACTS. Each option shall be evidenced by an appropriate Contract which shall be duly executed by the Company and the optionee, and shall contain such terms, provisions and conditions not inconsistent herewith as may be determined by the Committee. 12. ADJUSTMENTS UPON CHANGES IN COMMON STOCK. Notwithstanding any other provision of the Plan, in the event of a stock dividend, split-up, combination, reclassification, recapitalization, spin-off, merger in which the Company is the surviving corporation, or exchange of shares or the like which results in a change in the number or kind of those shares of Common Stock which are outstanding immediately prior to such event, the aggregate number and kind of shares subject to the Plan, the aggregate number and kind of shares subject to each outstanding option and the exercise price thereof, and the 162(m) Maximum shall be appropriately adjusted by the Board of Directors, whose determination shall be conclusive and binding on all parties. Such adjustment may provide for the elimination of fractional shares which might otherwise be subject to options without payment thereto. In the event of (a) the liquidation or dissolution of the Company, or (b) a merger in which the Company is not the surviving corporation or a consolidation, any outstanding options shall terminate upon the earliest of any such event, unless other provision is made therefor in the transaction. 13. AMENDMENTS AND TERMINATION OF THE PLAN. The Plan was adopted by the Board of Directors on March 29, 1996. No option may be granted under the Plan after March 28, 2006 The Board of Directors, without further approval of the Company's stockholders, may at any time suspend or terminate the Plan, in whole or in part, or amend it from time to time in such respects as it may deem advisable, including, without limitation, in order that ISOs granted hereunder meet the requirements for "incentive stock options" under the Code, to comply with, conform to or adopt the provisions of Rule 16b-3, Section 162(m) of the Code or any change in applicable law, regulations, rulings or interpretations of administrative agencies; provided, however, that no amendment shall be effective without the requisite prior or subsequent stockholder -5- 6 approval which would (a) except as contemplated in Paragraph 12, increase the maximum number of shares of Common Stock for which options may be granted under the Plan or the 162(m) Maximum, (b) materially increase the benefits accruing to participants under the Plan or (c) change the eligibility requirements to receive options hereunder. No termination, suspension or amendment of the Plan shall, without the consent of the holder of an existing and outstanding option affected thereby, adversely affect his rights under such option. The power of the Committee to construe and administer any options granted under the Plan prior to the termination or suspension of the Plan nevertheless shall continue after such termination or during such suspension. 14. NON-TRANSFERABILITY OF OPTIONS. No option granted under the Plan shall be transferable otherwise than by will or the laws of descent and distribution, and options may be exercised, during the lifetime of the optionee, only by the optionee or his Legal Representatives. Except to the extent provided above, options may not be assigned, transferred, pledged, hypothecated or disposed of in any way (whether by operation of law or otherwise) and shall not be subject to execution, attachment or similar process, and any such attempted assignment, transfer, pledge, hypothecation or disposition shall be null and void ab initio and of no force or effect. 15. WITHHOLDING TAXES. The Company shall withhold cash in an amount equal to the amount determined necessary to satisfy the Company's obligation to withhold Federal, state and local income taxes or other amounts incurred by reason of the grant or exercise of an option or the disposition of the underlying shares of Common Stock except to the extent that, with the specific authorization of the Committee, in the Contract or otherwise, the optionee is permitted to pay such amounts by (a) the delivery or withholding of shares of Common Stock having an aggregate fair market value on the exercise date (determined in accordance with Paragraph 5) or (b) any combination of cash and such shares. Alternatively, the Company may require the holder to pay to the Company such amount, in cash, promptly upon demand. The Company shall not be required to issue any shares of Common Stock pursuant to any such option until all required payments have been made. 16. LEGENDS; PAYMENT OF EXPENSES. The Company may endorse such legend or legends upon the certificates for shares of Common Stock issued upon exercise of an option under the Plan and may issue such "stop transfer" instructions to its transfer agent in respect of such shares as it determines, in its discretion, to be necessary or appropriate to (a) prevent a violation of, or to perfect an exemption from, the registration requirements of the Securities Act and any applicable state securities laws, (b) implement the provisions of the Plan or any agreement between the Company and the optionee with respect to such shares of Common Stock, or (c) permit the Company to determine the occurrence of a "disqualifying disposition," as described in Section 421(b) of the Code, of the shares of Common Stock issued or transferred upon the exercise of an ISO granted under the Plan. The Company shall pay all issuance taxes with respect to the issuance of shares of Common Stock upon the exercise of an option granted under the Plan, as well as all fees and expenses incurred by the Company in connection with such issuance. 17. USE OF PROCEEDS. The cash proceeds from the sale of shares of Common Stock pursuant to the exercise of options under the Plan shall be added to the general funds of the Company and used for such corporate purposes as the Board of Directors may determine. 18. SUBSTITUTIONS AND ASSUMPTIONS OF OPTIONS OF CERTAIN CONSTITUENT CORPORATIONS. Anything in this Plan to the contrary notwithstanding, the Board of Directors may, without further approval by the stockholders, substitute new options for prior options of a -6- 7 Constituent Corporation (as defined in Paragraph 19) or assume the prior options of such Constituent Corporation. 19. DEFINITIONS. For purposes of the Plan, the following terms shall be defined as set forth below: (a) Constituent Corporation. The term "Constituent Corporation" shall mean any corporation which engages with the Company, any of its Subsidiaries or a Parent in a transaction to which Section 424(a) of the Code applies (or would apply if the option assumed or substituted were an ISO), or any Parent or any Subsidiary of such corporation. (b) Disability. The term "Disability" shall mean a permanent and total disability within the meaning of Section 22(e)(3) of the Code. (c) Legal Representative. The term "Legal Representative" shall mean the executor, administrator or other person who at the time is entitled by law to exercise the rights of a deceased or incapacitated optionee with respect to an option granted under the Plan. (d) Parent. The term "Parent" shall have the same definition as "parent corporation" in Section 424(e) of the Code. (e) Subsidiary. The term "Subsidiary" shall have the same definition as "subsidiary corporation" in Section 424(f) of the Code. 20. GOVERNING LAW; CONSTRUCTION. The Plan, such options as may be granted hereunder and all related matters shall be governed by, and construed in accordance with, the laws of the State of Delaware, without regard to conflict of law provisions. Neither the Plan nor any Contract shall be construed or interpreted with any presumption against the Company by reason of the Company causing the Plan or Contract to be drafted. Whenever from the context it appears appropriate, any term stated in either the singular or plural shall include the singular and plural, and any term stated in the masculine, feminine or neuter gender shall include the masculine, feminine and neuter. 21. PARTIAL INVALIDITY. The invalidity, illegality or unenforceability of any provision in the Plan or any Contract shall not affect the validity, legality or enforceability of any other provision, all of which shall be valid, legal and enforceable to the fullest extent permitted by applicable law. 22. STOCKHOLDER APPROVAL. The Plan shall be subject to approval by a majority of the votes present in person or by proxy at the next duly held meeting of the Company's stockholders at which a quorum is present. No options granted hereunder may be exercised prior to such approval; PROVIDED, HOWEVER, that the date of grant of any option shall be determined as if the Plan had not been subject to such approval. Notwithstanding the foregoing, if the Plan is not approved by a vote of the stockholders of the Company on or before March 28, 1997, the Plan and any options granted hereunder shall terminate. -7- EX-23 6 CONSENT OF ARTHUR ANDERSEN LLP 1 Exhibit 23 CONSENT OF INDEPENDENT PUBLIC ACCOUNTANTS As independent public accountants, we hereby consent to the incorporation of our report dated March 22, 2000 included in this Form 10-K, into American Biogenetic Sciences, Inc.'s previously filed Registration Statements on Form S-8 (File Nos. 33-35992, 33-39683, 33-51240, 33-65416, 333-09473, 333-59351 and 333-93071), and previously filed Registration Statements on Form S-3 (File Nos. 333-13615, 333-13619, 333-13623, 333- 14447, 333-59345, 333-60117 and 333-69735). /s/ Arthur Andersen LLP Melville, New York March 29, 2000 EX-27 7 FINANCIAL DATA SCHEDULE
5 THIS SCHEDULE CONTAINS TWELVE MONTHS YEAR-TO-DATE SUMMARY FINANCIAL INFORMATION EXTRACTED FROM AMERICAN BIOGENETIC SCIENCES, INC. 1999 10-K FOR THE YEAR ENDED DECEMBER 31, 1999. 12-MOS DEC-31-1999 DEC-31-1999 93,000 0 211,000 0 511,000 76,000 2,316,000 1,840,000 3,938,000 2,327,000 0 0 0 40,000 1,538,000 3,938,000 1,361,000 1,443,000 598,000 598,000 1,725,000 0 16,000 (5,351,000) 0 (5,351,000) 0 0 0 (5,351,000) (.14) (.14)
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