-----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, DciYVQxQrhh4KlqvQ4D87DKA2I81tX3bac/e1WqauacLE5eRJnAhfEf7XOMssAZN e3YKKRlTZvkgWnTSrY1/sw== 0000912057-00-004278.txt : 20000208 0000912057-00-004278.hdr.sgml : 20000208 ACCESSION NUMBER: 0000912057-00-004278 CONFORMED SUBMISSION TYPE: 10-K405 PUBLIC DOCUMENT COUNT: 7 CONFORMED PERIOD OF REPORT: 19991231 FILED AS OF DATE: 20000207 FILER: COMPANY DATA: COMPANY CONFORMED NAME: SCIOS INC CENTRAL INDEX KEY: 0000726512 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 953701481 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-K405 SEC ACT: SEC FILE NUMBER: 000-11749 FILM NUMBER: 525818 BUSINESS ADDRESS: STREET 1: 820 W MAUDE AVE CITY: SUNNYVALE STATE: CA ZIP: 94086 BUSINESS PHONE: 4159661550 MAIL ADDRESS: STREET 1: 820 WEST MAUDE AVENUE CITY: SUNNYVALE STATE: CA ZIP: 94086 FORMER COMPANY: FORMER CONFORMED NAME: SCIOS INC DATE OF NAME CHANGE: 19920703 FORMER COMPANY: FORMER CONFORMED NAME: CALIFORNIA BIOTECHNOLOGY INC DATE OF NAME CHANGE: 19920302 10-K405 1 10-K405 - -------------------------------------------------------------------------------- - -------------------------------------------------------------------------------- SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 ------------------------ FORM 10-K (MARK ONE) /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 OR / / TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
FOR THE TRANSITION PERIOD FROM ______________ TO ______________ COMMISSION FILE NUMBER 0-11749 ------------------------ SCIOS INC. (Exact name of registrant as specified in its charter) ------------------------ DELAWARE 95-3701481 (State or other jurisdiction of (I.R.S. Employer incorporation or organization) Identification No.)
820 WEST MAUDE AVENUE, SUNNYVALE, CALIFORNIA 94086 (Address of principal executive offices) Registrant's telephone number, including area code: (408) 616-8200 SECURITIES REGISTERED PURSUANT TO SECTION 12(b) OF THE ACT: NONE SECURITIES REGISTERED PURSUANT TO SECTION 12(g) OF THE ACT: Common Stock, $0.001 par value Contingent Payment Rights Common Share Purchase Rights 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/ The approximate aggregate market value of voting stock held by nonaffiliates of the registrant as of January 11, 2000 was $224,803,100. As of January 11, 2000, 38,468,652 shares of the registrant's Common Stock were outstanding (net of Treasury Shares). DOCUMENTS INCORPORATED BY REFERENCE
DOCUMENTS FORM 10-K PART - --------- -------------- Definitive Proxy Statement with respect to the 2000 Annual Meeting of Stockholders................................... III
- -------------------------------------------------------------------------------- - -------------------------------------------------------------------------------- THE FOLLOWING DISCUSSION CONTAINS FORWARD-LOOKING STATEMENTS ABOUT PLANS, OBJECTIVES AND FUTURE RESULTS OF SCIOS INC. ("SCIOS" OR THE "COMPANY"). THESE FORWARD-LOOKING STATEMENTS ARE BASED ON THE CURRENT EXPECTATIONS OF THE COMPANY, AND THE COMPANY ASSUMES NO OBLIGATION TO UPDATE THIS INFORMATION. REALIZATION OF THESE PLANS AND RESULTS INVOLVES RISKS AND UNCERTAINTIES, AND THE COMPANY'S ACTUAL RESULTS COULD DIFFER MATERIALLY FROM THOSE DISCUSSED HERE. FACTORS THAT COULD CAUSE OR CONTRIBUTE TO SUCH DIFFERENCES INCLUDE, BUT ARE NOT LIMITED TO, THOSE DISCUSSED BELOW IN THIS FORM 10-K FOR THE YEAR ENDED DECEMBER 31, 1999. PART I ITEM 1. BUSINESS OVERVIEW Scios Inc. is a biopharmaceutical company engaged in the discovery, development, and commercialization of novel human therapeutics based upon its capabilities in both protein-based and small-molecule drug discovery and development. The Company currently focuses its proprietary research and development efforts primarily in the areas of cardiorenal and inflammatory disorders, and Alzheimer's disease. The Company has research and development collaborations with Chiron Corporation, DuPont Pharmaceuticals Company, Eli Lilly and Company, GenVec, Inc., Kaken Pharmaceutical Co., Ltd. and Novo Nordisk A/S. More detail regarding the Company's research and development program and its relationships with partner companies is provided below in "Business--Products in Development." The Company also operates a Psychiatric Sales and Marketing Division ("PSMD") which provides operating cash that funds the other activities of the Company, principally research and development efforts. More detail is provided below in "Business--Marketing and Sales." Scios is well funded, with approximately $100.7 million in cash and marketable securities as of December 31, 1999. 1999 was the first full year of the Company's operation under the leadership of Richard Brewer, who became President and Chief Executive Officer of the Company in September 1998. During 1999 the Company's Board of Directors and management revised the Company's business plan and created and implemented a significant restructuring plan (the "Restructuring Plan"). The Restructuring Plan included a 30% employee reduction following the closing of Scios' protein manufacturing facility, the sale of the Company's Mountain View campus and a building in Baltimore yielding net proceeds of more than $21.0 million, and consolidation of the Company's operations into less expensive facilities leased by the Company in Sunnyvale, California. In 1999, the Company recorded a one-time restructuring charge of approximately $6.4 million for the disposition of certain assets and severance costs under the Restructuring Plan. Elimination of the manufacturing operation in Mountain View was due mainly to the facility's low capacity and high operating expense and the Company's belief that recombinant protein manufacturing is available from third parties. Scios will maintain process science personnel and pilot scale manufacturing capability in order to support its research programs. Scios' revised business plan includes two primary elements: (1) focusing the Company's research and development efforts on Natrecor-Registered Trademark- (nesiritide), the p38 kinase inhibitor program, and the Alzheimer's disease program; and (2) expanding the business of the Company's PSMD. The decision to focus on certain research and development efforts led to a determination to outlicense the Company's growth factor programs, which include work on VEGF(121) and Fiblast-Registered Trademark-(trafermin) which is the human form of fibroblast growth factor ("FGF"). See "Business--Products in Development" below. Scios is seeking to reach profitability in the next several years through the launch of Natrecor(-Registered Trademark-), the cost reductions under the Restructuring Plan, funding from collaborations with corporate partners on other products and the acquisition of late stage products that the Company's PSMD can market. OVERVIEW OF STATUS OF LEAD DEVELOPMENT PROGRAMS Natrecor-Registered Trademark- (nesiritide) is the Company's product for the short-term management of acute decompensated congestive heart failure ("CHF"), Natrecor-Registered Trademark- is currently being evaluated in a Phase III clinical trial across the 1 United States in a study that the Company has named the "VMAC Trial" (Vasodilation in the Management of Acute Congestive Heart Failure). The VMAC Trial was initiated following the April 1999 decision by the U.S. Food and Drug Administration ("FDA") to require that the Company conduct a further clinical trial before the FDA would consider approving Natrecor-Registered Trademark- for marketing in the United States. In January 29, 1999, the Cardiovascular and Renal Drugs Advisory Committee of the FDA had recommended approval of Natrecor-Registered Trademark- for sale in the United States. Scios and a steering committee made up of clinical researchers expert in the cardiovascular field recruited by the Company designed the VMAC trial to provide the further information on the pharmacodynamic profile of Natrecor-Registered Trademark- requested by the FDA. From enrollment of the first patient on October 27, 1999 through February 2, 2000, the Company has enrolled 131 of the approximately 500 patients expected to be enrolled in the VMAC trial. Scios' p38 kinase inhibitor program is developing new pharmaceutical agents to treat inflammatory disorders. Scios has developed promising lead compounds that inhibit p38 kinase, a key factor in the intracellular pathway that stimulates the synthesis of tumor necrosis factor ("TNF"). The Company is developing small molecule agents that can be taken orally, which is expected to give them advantages over certain currently marketed therapies, which are administered by injection. The Company has selected rheumatoid arthritis as its initial target indication. The Arthritis Foundation estimates that currently 2.1 million people in the United States suffer from rheumatoid arthritis. Scios' goal is to begin human clinical trials of a p38 kinase inhibitor in rheumatoid arthritis in 2000. Certain of the Company's product candidates, for example, Fiblast-Registered Trademark-, VEGF(121) gene therapy, and GLP-1, have been licensed to corporate partners who are now responsible for product development. Under its arrangements with corporate partners, Scios typically receives signing and/or milestone payments upon the partners' achievement of scientific and clinical benchmarks. Generally, the Company is also entitled to royalties on commercial sales of products by its partner or will share in profits. In some cases, Scios may receive all or part of its compensation in the form of payments for the supply of the product. Until the FDA's non-approval decision on Natrecor-Registered Trademark- in 1999, the Company had expected to achieve profitability in 2000 based on development milestone and supply payments which the Company expected to receive from its former partner for Natrecor-Registered Trademark-, Bayer AG. As these events demonstrate, the Company's goal for achieving profitability, as well as other statements in this Annual Report on Form 10-K concerning matters like the results and timing of product development, future revenues, operations and expenditures, regulatory approval and market introduction of the Company's products are "FORWARD-LOOKING STATEMENTS" which are subject to change. Each statement is based on current expectations of the Company at the time the statement is made. These forward-looking statements are subject to the risks and uncertainties inherent in the Company's business. In accordance with the Private Securities Litigation Reform Act of 1995 ("PSLRA-95"), the Company reminds investors that all such "FORWARD-LOOKING STATEMENTS" are only estimates of future results and that the actual results achieved by the Company may differ materially from these projections due to a number of factors, including: (1) the demonstration of the safety and efficacy of its products at each stage of clinical development; (2) timely regulatory approval and patent and other proprietary rights protection for the Company's products; (3) the actions of third parties, including collaborators, licensees, manufacturing partners, and competitors; (4) market acceptance of the Company's products; (5) the ability to secure and retain third party manufacturers to produce the Company's products in commercial quantities at reasonable cost and in a manner acceptable to various regulatory authorities; (6) the Company's ability to identify and then acquire products that will contribute to the profitable growth of the Company; and (7) the accuracy of the Company's information concerning the products and resources of competitors and potential competitors. Factors creating uncertainty are discussed in more detail in individual sections of this Annual Report on Form 10-K. In particular see "Business--Product Development Activities and Risks" below and the "Outlook and Risks", "Outlook and Risks For Liquidity and Capital Resources" and "Financial Risk Management" sections of "Management's Discussion and Analysis of Financial Condition and Results of Operations." The Company was incorporated in California in 1981 under the name California Biotechnology Inc. and reincorporated in Delaware in 1988. The Company changed its name to Scios Inc. in February 1992, to Scios 2 Nova Inc. in September 1992 following acquisition of Nova Pharmaceuticals, Inc., and returned to using the name Scios Inc. in March 1996. Since September 1999, the principal executive offices of the Company have been located at 820 West Maude Avenue, Sunnyvale, California 94086. The Company's telephone number is (408) 616-8200. PRODUCT DEVELOPMENT ACTIVITY TABLE The following table summarizes certain information concerning Scios' principal product development programs and product partnerships with other pharmaceutical companies. The information in the table is qualified in its entirety by reference to the more detailed information concerning the Company's products that is set forth elsewhere in this report:
POTENTIAL APPLICATIONS/ DEVELOPER/ PRODUCT STATUS (TERRITORY) INDICATIONS CORPORATE PARTNER - ------- ------------------ ---------------------------------------------------- -------------------------------- PARTNERED Fiblast-Registered Trademark- NDA filed (Japan) Recalcitrant dermal wounds Kaken Pharmaceutical Co., Ltd. (trafermin) Fiblast-Registered Trademark- Phase II Coronary artery disease Chiron Corporation (trafermin) Fiblast-Registered Trademark- Phase II Peripheral vascular disease Chiron Corporation (trafermin) VEGF(121) Phase II Cardiovascular disease: gene therapy GenVec, Inc. GLP-1 Phase I Type 2 diabetes Novo Nordisk A/S (insulinotropin) Beta-amyloid Research Alzheimer's disease Eli Lilly and Company modulators Beta-amyloid Research Alzheimer's disease DuPont Pharmaceuticals Company modulators BNP diagnostic assay Marketed (Japan & Diagnosis/monitoring of heart failure Shionogi & Co., Ltd. Europe) BNP diagnostic assay PMA filed (United Diagnosis/monitoring of heart failure Biosite Diagnostics Inc. States) BNP diagnostic assay Development Diagnosis/monitoring of heart failure Abbott Laboratories UNPARTNERED Natrecor-Registered Trademark- Phase III Acute congestive heart failure Seeking partner (nesiritide) VEGF(121) Preclinical Cardiovascular disease: protein therapy Seeking licensee p38 kinase inhibitors Preclinical Inflammatory disease --
- ------------------------------ * "Research" denotes discovery research and initial bench scale production. "Preclinical" denotes studies in animal models necessary to support an application to the FDA and foreign health registration authorities to commence clinical testing in humans. Clinical trials for pharmaceutical products are conducted in three phases. In Phase I, studies are conducted to determine safety. In Phase II, studies are conducted to gain additional safety information, as well as preliminary evidence as to the efficacy and appropriate doses of the product. In Phase III, studies are conducted to provide sufficient data for the statistical proof of safety and efficacy, including dosing regimen. Phase III is the final stage of such clinical studies prior to the submission of an application for approval of a new drug or licensure of a biological product. "NDA filed" means an application for commercial sale of a new drug has been filed in the indicated country seeking approval to market the product in that country for the covered indication. "PMA filed" means a pre-market approval application in the indicated country seeking approval to market the diagnostic product in that country. PRODUCT DEVELOPMENT ACTIVITIES AND RISKS Scios currently focuses its product research and development efforts on proprietary novel therapeutics, principally in the areas of cardiorenal and inflammatory disorders, and Alzheimer's disease. The Company's 3 success will depend on its ability to achieve scientific and technological advances and to translate such advances into commercially competitive products on a timely basis. As described in "Business--Products In Development," Scios' products are at various stages of research and development, and in most cases further development and testing will be required to determine their technical feasibility and commercial viability. THE COMPANY REPEATS THE CAUTION GIVEN TO ITS INVESTORS IN EARLIER ANNUAL REPORTS ON FORM 10-K THAT THE DEVELOPMENT OF PHARMACEUTICALS IS SUBJECT TO SIGNIFICANT RISKS AND UNCERTAINTIES. In particular, the proposed development schedules for the Company's products may be affected by a wide variety of factors, such as technological difficulties, proprietary technology and rights developed by others, reliance on third parties to perform certain activities or provide certain resources, and changes in governmental regulation. Many of the factors affecting development of the Company's products will not be within the control of Scios. As a result, there can be no assurance that any of the products described in this Item 1 or resulting from Scios' research programs will be successfully developed, proved to be safe and effective, meet applicable regulatory standards, be capable of being produced in commercial quantities at reasonable costs, or be successfully marketed. In developing pharmaceutical products, the Company faces critical challenges in at least three broad areas: the discovery and development of novel compounds that are worth developing; the successful clinical testing in humans of candidate compounds that the Company and its collaborators deem worthy of development; and competition in many forms and areas. The discovery process in pharmaceutical development often involves doing or understanding what has not previously been done or understood, while working in biological systems that are not always predictable or predictive. Pharmaceutical drug discovery is an inherently challenging and risky undertaking in which numerous factors come into play in determining success or failure. Some of the key factors include the ability to identify appropriate targets and models to use in understanding complex disease processes, to comprehensively screen many compounds under consistent conditions in order to identify those which show promise, to build on insights gained from numerous and frequently imperfect data points in selecting the compounds most likely to treat the target disease, even though the target disease itself is not completely understood (both as to what causes that disease and how the disease manifests itself), and to avoid being misled by false indicators. These efforts all take place in increasingly competitive environments in which several companies are often simultaneously trying to apply their resources and insights to the same targets and challenges. The Company attempts to address these challenges by incorporating new techniques as they become available in the industry. Greater use of genomics, bioinformatics, microarray-based gene expression analysis and high throughput screening are examples of new technologies adopted by the Company in the last several years to improve its pharmaceutical research and development discovery process. How well a particular company marshals its resources to attack an issue will often determine its success. Because it is impractical, if not impossible, for any company to do everything imaginable to acquire sufficient knowledge to better assure success in meeting these challenges, intuition, untested assumptions and luck can sometimes play a significant role in determining a particular company's success in pharmaceutical discovery and development. The Company particularly cautions investors that any decision to commence or continue clinical trials in humans based on the results of preclinical work in cell-based assays and animal models or an earlier clinical study does not necessarily mean that the results achieved in subsequent human clinical studies will be similar to those achieved in the earlier studies. A central issue in all pharmaceutical development is how well a particular cell-based assay or preclinical animal model selected by the investigator predicts the effectiveness of a drug candidate in treating the target disorder in humans. While well-developed and well-tested models exist for some disorders, often it is not possible to know with certainty the predictive quality of a model until results in humans are obtained. In some cases, it turns out that the selected model does not accurately predict the effect of a drug candidate in humans or whether the product is safe to use in humans at all. In clinical testing of compounds selected for development, the Company, as well as every other company in the biopharmaceutical and pharmaceutical industries, faces challenges in several areas. In the clinical trial initiation phase, these factors include creating a sound study design that will, as effectively and efficiently as 4 possible, reveal the safety and efficacy of a particular compound and then finding appropriate clinical investigators who can identify and recruit patients and follow the clinical protocol. Each clinical trial itself contains the risk that a compound will not produce positive clinical results in the specific subjects included in that study population or that it will produce ambiguous or mixed results in which the benefits of the compound do not clearly enough outweigh any adverse side effects, or that judgments will have been incorrect about how large the study population needed to be to demonstrate the effects of the compound. Uncertainty as to the outcome is inherent in every clinical trial, even when a previous clinical study has produced a favorable result. This was demonstrated in the Company's experience with Auriculin-Registered Trademark- (anaritide) for the treatment of acute renal failure and with the clinical trials of Fiblast-Registered Trademark- for the treatment of stroke. See "Business--Products in Development" below. When clinical trials for a compound are completed, a vast quantity of data on a wide range of topics must be assembled in a manner that will give regulatory authorities the basis, following intense review by the FDA and comparable regulators in other countries, to decide whether or not to approve the product for marketing. Inherent in the regulatory review process is the risk that the particular regulatory agency or its advisors will not find sufficiently reliable the methods that the company selected or that such agency will place different weight on various factors and results than the developing company did. In addition, when another company's product is already on the market to treat the target indication, the company developing a new drug for the same indication faces additional challenges, which may include demonstrating that the new product has superior properties or economic benefit. Because the regulators in various countries operate under different regulatory systems and approaches, the decisions and requirements with respect to the clinical testing of a compound may vary from one country to another. These issues and a company's inability to address them adequately may lead the regulatory authority to put limits on how or for what indication a compound may be marketed, thereby directly affecting a product's commercial success. Failure to deal with these factors to the satisfaction of the regulatory authority can also lead to the denial or delay of approval to market a product. The intellectual property rights of third parties can also affect the Company's development of its products. For instance, patent rights of other companies may need to be licensed in order for the Company to commercialize a product. These third party patent rights may not be available for license by the Company or may be available only at a high cost to the Company. See "Business--Patents and Proprietary Rights" for a discussion of the patent positions that the Company is endeavoring to establish for its products and information on some of the competing patent positions of third parties. The Company plans to continue the development of selected products primarily under the sponsorship of corporate partners. The Company's alliances with Eli Lilly and Company and The DuPont Pharmaceuticals Company in the Alzheimer's field, with Novo Nordisk A/S on GLP-1 and with Kaken Pharmaceuticals Co., Ltd. and Chiron Corporation on Fiblast-Registered Trademark- are examples. The Company is also seeking a partner with whom to co-promote Natrecor-Registered Trademark- in the United States. Continued funding and participation by the Company's corporate partners under joint marketing, joint development or licensing agreements will depend not only on the timely achievement of research and development objectives by the Company, which cannot be assured, but also on each corporate partner's own financial, competitive, marketing and strategic considerations and overall attitude towards engaging in outside collaborations. Under several of its joint development or license agreements, Scios relies on its corporate partners to conduct all or a portion of preclinical and clinical trials, to obtain regulatory approvals, and to manufacture and market products. Although the Company believes that its corporate partners will have an economic incentive to meet their contractual responsibilities, the amount and timing of resources devoted to these activities generally will be controlled by the corporate partner. The wave of mergers among the established pharmaceutical companies over the last few years and the downsizing and shift in research strategy that often follows these mergers have underscored the fact that corporate partners can change their strategy, and may sometimes drop entirely the collaborations they or their predecessor have established with other companies. All of these factors combine to make drug development extremely risky, challenging and competitive. At the same time, these factors contribute to the significant rewards and satisfaction that can accrue to the 5 stockholders and personnel of a company that successfully overcomes the challenges of drug discovery and development and succeeds in creating and marketing a new pharmaceutical agent. PRODUCTS IN DEVELOPMENT NATRECOR-REGISTERED TRADEMARK- (NESIRITIDE). Episodes of acute decompensated CHF require hospitalization of approximately one million people annually in the United States. In the Company's clinical studies, Natrecor-Registered Trademark- has produced improvements in important measures of heart function: pulmonary capillary wedge pressure ("PCWP") and cardiac index. The Company filed a new drug application ("NDA") for Natrecor-Registered Trademark- with the FDA in April 1998. In January 1999, the Cardiovascular and Renal Advisory Committee to the FDA recommended by a 5 to 3 vote that Natrecor-Registered Trademark- be approved by the FDA for sale in the United States for the short-term management of CHF. However, in April 1999 the FDA advised the Company that it was not approving Natrecor-Registered Trademark- and requested that the Company conduct an additional study to define the consequences of the pharmacodynamic profile of Natrecor-Registered Trademark-, specifically as it relates to the onset of effect and the recovery from hypotension if it occurs. Following the FDA's action, the Company met several times with the FDA to discuss the FDA's concerns and the design of the VMAC Trial, an additional Phase III clinical trial being conducted in approximately 500 patients. The first patient was enrolled in the study in late October and 131 patients had been enrolled in the study as of February 2, 2000. The trial design includes the evaluation of Natrecor-Registered Trademark- and nitroglycerin, an existing therapy, compared to placebo. In hemodynamically monitored patients, the principal endpoint of the study is the change from baseline in PCWP. In patients not hemodynamically monitored, the principal endpoint is improvement in shortness of breath in Natrecor-Registered Trademark- patients compared with those treated with placebo, after three hours of treatment. Secondary endpoints of the VMAC Trial include speed of improvement in hemodynamics and symptoms, duration and adequacy of effect, and adverse effects in the Natrecor-Registered Trademark- and nitroglycerin groups respectively over the course of treatment. Not including patients in the VMAC Trial, over 650 patients have previously received Natrecor-Registered Trademark- as part of Scios' clinical program to study this drug. The pivotal efficacy study in the Company's 1998 NDA application was a randomized, double blind, placebo-controlled Phase III study that studied 127 patients with acutely decompensated CHF requiring hospitalization. Patients received an infusion of either Natrecor-Registered Trademark- (0.015 or 0.03mg/kg/min) or placebo. The primary endpoint of the study was a reduction in PCWP. Secondary endpoints included cardiac index and symptom improvement. With respect to the primary endpoint, the analysis indicates that Natrecor-Registered Trademark- reduced PCWP by 20% (p=0.003) and 31% (pgreater than0.001) in the 0.015 and 0.03mg/kg/min dose groups, respectively, compared to placebo. Symptom scores and cardiac index also improved compared to placebo at a statistically significant level. In May 1998, the Company entered into an agreement with Bayer establishing a collaboration for the worldwide development and commercialization of Natrecor-Registered Trademark-. On signing the contract, the Company received a payment of $20.0 million. In May 1999, Bayer terminated the agreement following the FDA non-approval letter and all rights in Natrecor-Registered Trademark- reverted to Scios without any payment being due from Scios. Scios is now seeking a co-promotion partner with which to commercialize Natrecor-Registered Trademark- in the United States and partner(s) to license Natrecor-Registered Trademark- for sale in other countries. A number of low cost pharmaceutical products are already being used by physicians to treat acute episodes of CHF. Hence, the Company and its Natrecor-Registered Trademark- partner will need to demonstrate positive clinical benefits of Natrecor-Registered Trademark- in order to successfully introduce Natrecor-Registered Trademark- into this competitive market. This discussion of Natrecor-Registered Trademark- includes forward-looking statements within the meaning of the PSLRA-95, which are based on current information. Many factors could influence the commercial success of Natrecor-Registered Trademark-, principally including the reaction of various regulatory agencies, including the FDA, to the additional data Scios will develop concerning the degree of efficacy and safety of Natrecor-Registered Trademark-, the scope of any approval such agencies may grant for the product, and the ability of Scios and a commercial partner to successfully exploit the opportunity. See "Business--Product Development Activities and Risks" for a further discussion of factors that can impact the Company's commercialization of its products, including Natrecor-Registered Trademark-. 6 The Company believes that it was the first to discover human b-type natriuretic peptide ("BNP"), whose gene it cloned in 1988 as a part of its cardiorenal research program in natural human peptides. BNP is made in the heart and is part of the body's natural response to a failing heart. Preclinical studies at the Company and elsewhere suggest that BNP has the biological effects of increasing the elimination of salt and water from the body, dilating blood vessels, and decreasing the secretion of other hormones which lead to blood vessel constriction and elevated blood pressure. The Company holds issued United States and European patents covering human BNP, which currently expire in mid-May 2009. These patents issued to Scios are subject to possible extension of several years due to time taken up in the regulatory approval process. The Company also has the exclusive right to develop therapeutic products using BNP under certain patents and applications on BNP originally filed by Daiichi Pharmaceutical Co., Ltd. which were subsequently acquired by Shionogi & Co., Ltd. ("Shionogi"). All issued patents are subject to the risk that they may be challenged by another entity, which may result in a court invalidating or limiting the patent. See "Business--Patents and Proprietary Rights." P38 KINASE INHIBITORS. The goal of Scios' p38 kinase inhibitor program is to establish and develop a potent, orally available treatment for rheumatoid arthritis and other inflammatory disorders. p38 kinases stimulate tumor necrosis factor (TNF) production and biosynthesis of the proinflammatory enzyme cyclooxygenase-2 (COX-2), leading to inflammation. Inhibitors of p38 kinases could be useful to treat certain inflammatory and cardiovascular conditions. Current development plans anticipate the nomination of a development candidate shortly and the initiation of preclinical development to support an IND filing allowing the start of clinical tials in the second half of 2000. The treatment of rheumatoid arthritis has recently made striking advances with the discovery that proteins that antagonize the inflammatory cytokine TNF markedly relieve the symptoms and retard the progression of rheumatoid arthritis. These existing protein-based products, either neutralizing antibodies or soluble receptors, have to be given by injection on a repeated basis. A potent inhibitor of TNF in tablet form should permit the effective treatment of rheumatoid arthritis with a much more convenient and tolerable form of administration. An additional benefit of inhibiting p38 kinase is the inhibition of COX-2 in white blood cells. Since COX-1 is not regulated by p38 kinase, inhibitors of p38 kinase provide a selective inhibition of COX-2, which has already been demonstrated by selective COX-2 inhibitors to be highly effective in relieving the symptoms of many forms of arthritis. Thus, patients being treated with a p38 kinase inhibitor could experience a reduction in both the symptoms of rheumatoid arthritis and the progression of the disease. The clinical plan for Scios' p38 kinase inhibitor is to treat moderate to severe rheumatoid arthritis to initially reduce signs and symptoms and, secondarily, to retard joint structural damage in patients who are not responding to current treatment. FIBLAST-REGISTERED TRADEMARK- (TRAFERMIN). Fiblast-Registered Trademark- (trafermin) is Scios' form of human basic fibroblast growth factor (FGF), an agent that has been shown to promote angiogenesis (the growth of new blood vessels), to directly stimulate the growth of connective tissue, and to possess certain neuroprotective properties, the mechanisms of which are not yet fully understood. As described below, Scios has licensed Fiblast-Registered Trademark- to two key partners for the development in a variety of indications. Since 1988, Scios has worked with Kaken Pharmaceutical Co., Ltd. ("Kaken"), the Company's corporate partner for Fiblast-Registered Trademark- in Japan. Pursuant to a 1988 agreement, Kaken has exclusive rights to develop and market Fiblast-Registered Trademark- for all indications in Japan, Korea, Taiwan, Hong Kong and the People's Republic of China. Scios has received research and development support payments, is entitled to receive additional payments as regulatory milestones are met, and will receive royalties on any sales of Fiblast-Registered Trademark- products by Kaken. Under a series of agreements between Scios and Kaken entered into in 1994, Scios has manufactured a specified quantity of Fiblast-Registered Trademark- for Kaken, following which Kaken will arrange its own supply. The agreements also established a collaboration on manufacturing process development between the companies and provided Kaken with a license to Scios' manufacturing technology for Fiblast-Registered Trademark-. However, the timing for Kaken to assume this responsibility has not been determined. Under the 1994 agreements, Kaken made a series of payments to Scios from 1994 through 1998 for the supply of material, the process development collaboration, and the license to Fiblast-Registered Trademark- know-how, patents and manufacturing technology. As of December 31, 1999 the total of these payments (not previously applied to Kaken's purchases from the Company) has been recorded 7 as deferred revenue in the amount of $15,908,000. Prior to closing its Mountain View manufacturing facility in May 1999, Scios produced the amount of material due to Kaken and Scios now holds it for delivery to Kaken upon regulatory approval in Japan. Once the supply of material produced by Scios has been used to produce commercial products, Kaken will arrange for the manufacture of Fiblast-Registered Trademark- for its future needs. Kaken conducted two Phase III trials in Japan for evaluation of Fiblast-Registered Trademark- in recalcitrant wounds. Based on the results of these studies, in June 1996 Kaken filed an NDA in Japan for this indication. Before it may begin to market Fiblast-Registered Trademark- in Japan, Kaken must obtain approvals from the Japanese authorities with respect to the NDA for Fiblast-Registered Trademark- in the target indication and also for importation of Fiblast-Registered Trademark- in bulk form from Scios into Japan and for product pricing in Japan. Obtaining these approvals is a complex process involving a thorough review of the comprehensive set of data that Kaken is required to submit. Approval for Kaken to market the product in Japan will require that the Japanese authorities reach the conclusion that such data demonstrate to the regulators' satisfaction that Fiblast-Registered Trademark- is safe and effective in the treatment of recalcitrant wounds, and that the processes and facilities used by Scios for manufacturing the bulk drug substance used in Fiblast-Registered Trademark- were satisfactory. Although Japanese regulators will apply Japanese standards and practices in reviewing Kaken's NDA, Kaken faces many of the same challenges and factors that are discussed in "Business--Product Development Activities and Risks." In 1996, Scios signed a Collaboration Agreement with the Wyeth-Ayerst Laboratories division of American Home Products Corporation ("Wyeth-Ayerst") creating a joint development and commercialization program to examine the use of Fiblast-Registered Trademark- in the treatment of stroke and cardiovascular disorders. In extensive preclinical studies, Fiblast-Registered Trademark- had been shown to protect neurons from damaging effects associated with stroke, including oxygen and glucose deprivation, and glutamate release. Fiblast-Registered Trademark- also demonstrated a reduction of neuronal death in both permanent occlusion and reperfusion animal models of stroke. Early in 1996, Scios began a Phase I/II study of Fiblast-Registered Trademark- for the treatment of stroke. This study was concluded in 1997, ultimately enrolling 66 patients and further demonstrating the safety of Fiblast-Registered Trademark- after systemic administration. In 1997, Wyeth-Ayerst assumed the responsibility of lead development party for Fiblast-Registered Trademark- in stroke and the Company and Wyeth-Ayerst announced the initiation of two 900-patient Phase II/III clinical trials of Fiblast-Registered Trademark- in stroke. In July 1998, Wyeth-Ayerst and Scios announced termination of the stroke clinical trial in the United States for safety reasons. The stroke clinical trial in Europe, which used a different dosing regimen, was continued into mid-1999 after Wyeth-Ayerst conducted an interim analysis of the data from the European trial. While the data from the European trial did not repeat the safety issues that led to the halting of the North American stroke trial, Wyeth-Ayerst elected to terminate its agreement with Scios in the second half of 1999 based on its assessment of the expense of additional trials and likelihood of success. All rights in Fiblast-Registered Trademark- reverted to Scios. As of December 31,1999 the Company has recorded $300,000 in connection with the share of clinical trial expenses that the Company is to reimburse Wyeth-Ayerst under the agreement. In November 1999, Scios announced the granting of a license to Chiron Corporation ("Chiron") covering rights in Fiblast-Registered Trademark- not previously licensed by the Company, including the rights returned by Wyeth-Ayerst. Chiron has had a long-term interest in FGF research, particularly in FGF's potential use to treat coronary artery disease. This proposed use is based on FGF's ability to induce angiogenesis, the growth of new blood vessels. Chiron has held since the 1980's, a license from the Salk Institute under a patent covering the bovine form of FGF. See "Business--Patents and Proprietary Rights--Fiblast-Registered Trademark-" for a discussion of a U.S. patent interference that the Company had with Salk. In 1999, under the Agreement with Chiron, Scios received $12.5 million in licensing fees in the form of cash and a forgivable loan to Scios. In addition, milestone payments totaling $12.0 million will also be made by Chiron to Scios upon completion of certain development objectives. Scios will receive royalties based on sales of FGF products (human or bovine) in countries where Scios holds patents. Under the agreement, Chiron has assumed full responsibility for product development. Scios has also granted licenses under its Fiblast-Registered Trademark- patents and technology to companies working to develop products in other areas. These include a non-exclusive license to Orquest, Inc., a company developing products for the treatment of bone fractures, and a license to Selective Genetics Incorporated (formerly Prizm Pharmaceuticals, Inc.), a company using bFGF for the targeted delivery of other pharmaceutical agents. Scios is supplying Orquest with Fiblast-Registered Trademark- for incorporation into Orquest's product. 8 Scios is obligated to make payments to Organon International ("Organon") based on amounts received by Scios upon commercialization of Fiblast-Registered Trademark-. Approximately $218,000 remains to be paid under the obligation, which stems from the Company's 1989 reacquisition of certain Fiblast-Registered Trademark- rights previously licensed to Organon. The basic research on Fiblast-Registered Trademark- was funded by Biotechnology Research Partners, Ltd. See Note 12 of Notes to Consolidated Financial Statements. See also "Business--Patents and Proprietary Rights" for a discussion of Fiblast-Registered Trademark- patent issues. VASCULAR ENDOTHELIAL GROWTH FACTOR (VEGF(121)). Scios conducted pre-clinical studies of its proprietary 121 amino acid form of VEGF ("VEGF(121)"), another potent angiogenic substance. The company has shown that VEGF(121) is effective in an animal model of peripheral vascular disease following several different modes of administration, including intravenous and subcutaneous administration. The Company has granted a license to GenVec, Inc. for the use of the gene encoding VEGF(121) in gene therapy paradigms. GenVec is conducting clinical testing of VEGF(121) gene therapy in the U.S. in collaboration with its partner, Parke-Davis. Scios has been awarded U.S. and European patents covering VEGF(121). Other companies hold patents on competing forms of VEGF. See "Business--Patents and Proprietary Rights--VEGF(121)" for a discussion of patent issues. As part of the Restructuring Plan, the Company has decided to seek a licensee for its VEGF(121) protein technology. ALZHEIMER'S DISEASE. For many years, the Company has conducted a basic research program to develop new therapies for Alzheimer's disease primarily based on the investigation of the beta-amyloid precursor protein. During this time, the Company has collaborated with a variety of pharmaceutical company partners. In 1997, Scios formed separate research collaborations with Eli Lilly and Company ("Lilly") and with DuPont Pharmaceuticals Corporation. Each of these collaborations provides funding to Scios for the research it conducts, potential milestone payments to Scios by the partner if certain events are achieved and the right of the partner to commercialize resulting products subject to royalty payments to Scios. In 1998, Lilly expanded the scope and funding of the primary programs in the collaboration and extended it through April 2001. Previously, Scios had a research alliance on Alzheimer's disease with Marion Merrell Dow, Inc. which merged with Hoechst Roussel in 1995 to form Hoechst Marion Roussel, Inc. ("HMR"). HMR terminated the collaboration in 1996, and in early 1997, the parties clarified certain issues concerning the rights of each party to use the technology developed in the program. Among other terms, the resolution included certain payments by HMR to Scios. HMR's decision to terminate its collaboration with the Company represents an example of how a change in the priorities of a corporate sponsor, such as HMR, can impact Scios. This risk is discussed in the section "Business--Product Development Activity and Risks." ADDITIONAL PROJECTS The Company has from time to time pursued product development activities outside of the focus areas described above. In the past, Scios divested or otherwise leveraged certain technologies that were not central to its long-term business strategy and may continue to do so in the future. Some of these programs are discussed below. GLP-1(INSULINOTROPIN). In 1996, Scios granted Novo Nordisk A/S of Denmark ("Novo Nordisk"), a world leader in insulin and diabetes care products, an exclusive license to the Company's GLP-1 technology. The Company formerly referred to the GLP-1 technology as its "insulinotropin project". Under the agreement Scios has received payments totaling $10.0 million, of which the final $4.0 million milestone payment was received in 1999. Novo Nordisk is responsible for development activities for GLP-1 and is currently conducting Phase I human clinical trials. GLP-1 is a potent peptide that stimulates insulin release when blood sugar levels are above normal. Type 2 diabetics do not release enough insulin from the pancreas when blood glucose levels rise in response to eating a meal and they become progressively more resistant to insulin action in stimulating glucose uptake by muscle and fat tissue. GLP-1 controls blood glucose levels in Type 2 diabetics by stimulating insulin release and perhaps by overcoming insulin resistance. Present therapies for Type 2 9 diabetics include insulin injections and oral hypoglycemic agents, which can induce dangerously low blood sugar levels. Since GLP-1 appears to stimulate insulin release only when blood sugar levels are above normal, it may have a lower risk of this serious side effect. The Company holds an exclusive royalty bearing license to patent applications covering GLP-1 and certain analogs held by Massachusetts General Hospital, which rights were licensed to Novo Nordisk. Scios will receive royalties on product sales made by Novo Nordisk. BNP DIAGNOSTICS. Independent researchers have determined that the level of circulating BNP may be a good basis for a diagnostic to identify and track patients suffering from congestive heart failure. Scios has granted Abbott Laboratories and Biosite Diagnostics Incorporated ("Biosite") non-exclusive rights under the Company's BNP patents to develop BNP diagnostics. In December 1999, Biosite filed its pre-market approval application with the FDA seeking approval to market Biosite's Triage(-Registered Trademark-) BNP Test. The test measures BNP as an aid in the basis of diagnosis of patients with congestive heart failure. In 1998, Scios and Shionogi entered into a cross-license of their respective BNP patent rights for the diagnostic field. The diagnostic cross-license is royalty free. Shionogi also granted Scios a royalty-bearing, exclusive license under its BNP patents to develop therapeutic products. Shionogi has begun marketing a radioimmunoassay (RIA)-BNP diagnostic in Japan and Europe. CNS DISORDERS. In 1993, Scios founded Guilford Pharmaceuticals Inc. ("Guilford") to develop pharmaceutical products for the treatment of diseases of the central nervous system ("CNS"). In its initial years, Guilford operated as a majority-owned subsidiary of Scios. Following various equity offerings by Guilford, including its initial public offering and Scios' subsequent sale of a portion of its holdings, Scios' ownership interest in Guilford was reduced to approximately 7% as of December 31, 1998. In 1999, Scios sold all of its position in Guilford. Scios had previously transferred to Guilford certain neuroscience technology, and had licensed to Guilford the Gliadel(-Registered Trademark-) implant project and related drug delivery technology described below for application in the treatment of tumors of the central nervous system and cerebral edema. DRUG DELIVERY SYSTEMS. Prior to Scios' acquisition of Nova in 1992, Nova had been developing certain drug delivery systems, including the Gliadel(-Registered Trademark-) implant to treat primary brain cancer and the Septacin(-Registered Trademark-) implant for the treatment of osteomyelitis, a serious bone infection. These projects were developed pursuant to a license agreement with the Massachusetts Institute of Technology ("MIT") relating to MIT's Biodel(-Registered Trademark-) drug delivery technology. As noted above, the Company licensed a portion of the drug delivery technology, including Gliadel(-Registered Trademark-), to Guilford in 1992. Gliadel(-Registered Trademark-) was approved for marketing in the United States in 1996. In 1994, the Company licensed to another third party the drug delivery technology, including Septacin(-Registered Trademark-), for all uses outside the area licensed to Guilford. Scios thereafter assigned its Biodel(-Registered Trademark-) license rights back to MIT, which will administer these licenses. The Company and MIT are receiving royalty and milestone payments under the license agreements with Guilford and other licensees as products are developed. The licensees are also obligated to meet certain diligence standards in pursuing development of their respective product candidates. The Gliadel(-Registered Trademark-) and Septacin(-Registered Trademark-) projects were undertaken by the Company on behalf of Nova Technology Limited Partnership, the limited partnership that funded Nova's research and development on these projects. See Note 4 of Notes to Consolidated Financial Statements for a description of the Company's payment obligations to former limited partners. MARKETING AND SALES PROPRIETARY PRODUCTS. Once they have been approved for marketing, the Company ultimately intends to promote certain of its proprietary products in the United States through its own sales force for some or all approved indications. This could be done by the Company alone or jointly with its commercial partner(s) for any such product. As discussed above, the Company has decided to seek a co-promotion partner in the United States for Natrecor(-Registered Trademark-) and a partner(s) to commercialize Natrecor(-Registered Trademark-) in other countries. Scios believes that its experience in marketing certain psychiatric products under arrangements such as those described below in "Psychiatric Sales and Marketing Division" will prove useful as it prepares to participate in marketing its own products. However, to date, Scios' marketing experience has been limited to 10 psychiatric products, and the Company does not currently have in place all of the resources to market the products it is seeking to develop or that it may acquire. The commercialization of the Company's major products will require significant financial resources, as well as sales, marketing and distribution capabilities. In order to provide funds and expertise to meet these requirements, particularly outside of North America, the Company has determined to seek established pharmaceutical companies as commercialization partner(s). There can be no assurance that the Company will be able to enter into such partnerships on favorable terms or to develop such a marketing capability on its own. Scios believes that such collaborations may enable it to speed the timing of product launch and increase market penetration of selected new therapies. When entering into agreements with partners for the purpose of obtaining sales and marketing expertise and services, the Company incurs the additional risk that the partner's level of effort or marketing approach may differ from that which the Company might choose if operating solely on its own behalf. The Company tries to structure its agreements to provide for Scios' participation in the planning of sales and marketing strategies and to align the interests of both parties to product success. However, changes in priorities or other circumstances at the partner company could have an adverse effect on achieving potential levels of product sales. See "Business--Product Development Activities and Risks." The Company's ability to commercialize its products successfully may depend in part on the extent to which reimbursement for the cost of such products and related treatment will be available from government health administration authorities, private health coverage insurers and other organizations. Government and other third-party payors are increasingly attempting to contain healthcare costs by limiting both coverage and the level of reimbursement for new therapeutic products. Market acceptance of Scios' products would be adversely affected if adequate coverage and reimbursement levels are not provided for approved uses of Company products. In addition, in view of expressed governmental concerns over drug prices and other healthcare costs, there can be no assurance that future government and private cost control initiatives will not adversely affect the Company's ability to maintain price levels on its products sufficient to realize an appropriate return on development efforts. PSYCHIATRIC SALES AND MARKETING DIVISION. In 1999 the Company's Psychiatric and Sales Marketing Division generated approximately $10.0 million in operating profit (calculated with no allocation of corporate overhead) by marketing products that were developed by others. In this division, the Company has a field sales force of approximately 90 representatives who are employed on a part-time basis marketing psychiatric products. The Company currently markets in the United States five psychiatric products discussed below under license from SmithKline Beecham Corporation ("SB") and in mid-1998 began co-promoting two additional products: Risperdal(-Registered Trademark-) (risperidone), the most frequently prescribed antipsychotic under a co-promotion agreement with Janssen Pharmaceutica and Paxil(-Registered Trademark-) (paroxetine HCL), which participates in both the selective serotonin reuptake inhibitor (SSRI) antidepressant and antianxiety markets, under a co-promotion agreement with SB. Prior to entering into the co-promotion agreements on Risperdal(-Registered Trademark-) and Paxil(-Registered Trademark-), the Company had agreements to co-promote Haldol(-Registered Trademark-) Decanoate (haloperidol), a depot injection product to treat schizophrenia that was distributed by Ortho-McNeil Pharmaceutical, and Effexor(-Registered Trademark-) (venlafaxine HCl), an antidepressant that is marketed by Wyeth-Ayerst. The Haldol(-Registered Trademark-) agreement was terminated by mutual agreement in April 1998 when generic competition entered the market. The Effexor(-Registered Trademark-) agreement was also terminated by mutual agreement in April 1998. Generally, the various companies with whom Scios enters into co-promotion agreements for psychiatric products remain responsible for the manufacture and distribution of the product and these companies generally indemnify Scios against product liability claims. In its current co-promotion arrangements, Scios is compensated at a fixed level for performing detailing activity for the product to selected groups of psychiatrists and other prescribers, with Scios having the opportunity to earn additional incentive compensation based on increasing sales of the product over targets established for the prescribers to whom Scios details the product. The Company has exclusive rights to market the following SB products in the United States: Eskalith(-Registered Trademark-) and Eskalith CR(-Registered Trademark-) (lithium) for the treatment of manic depressive illness, Thorazine(-Registered Trademark-) (chlorpromazine) and Stelazine(-Registered Trademark-) (trifluoperazine) for the treatment of schizophrenia, and Parnate(-Registered Trademark-) (tranylcypromine) for the treatment of 11 depression (collectively, the "SB Products"). Eskalith CR(-Registered Trademark-) 450 is the largest selling of the SB Products. SB currently manufactures and distributes the SB Products. In 1999, SB changed its site of manufacture of the two Eskalith(-Registered Trademark-) products. In December 1999 Scios announced that it had been advised by SB that a product outage could develop in 2000 for Eskalith CR(-Registered Trademark-) 450 mg while SB responds to questions raised by the FDA concerning the change of manufacturing location. Since December, the Company and SB have reached an agreement with the FDA allowing product shipments from the new manufacturing facility beginning in February 2000. The initial shipments will have six month expiration dating, which will be extended as additional stability data is developed. As a result, while the Company may experience some reduction in revenues on this product in 2000, it is not expected to be material. In February 1999, the FDA approved the change of manufacturing site for Eskalith(-Registered Trademark-) (lithium carbonate) immediate release capsules after a brief shortage. SB may discontinue manufacturing one or more of the products if it gives the Company at least 12 months notice, in which case Scios has the right to manufacture such product(s). SB is responsible for all ancillary matters relating to sales of the SB Products (including various administrative tasks) and for the maintenance in good standing of all NDAs with respect to the SB Products. The agreement also grants Scios certain rights to indemnification from SB for product liability claims. The Company is obligated to spend certain amounts for marketing support based on the prior year's net sales and to reimburse SB for certain third-party royalty payments. Scios pays SB 40% of the Company's net profits (as defined in the Company's agreement with SB) from United States sales of the SB Products. See Note 3 of Notes to Consolidated Financial Statements. Risperdal(-Registered Trademark-), Paxil(-Registered Trademark-) and the SB Products all face competition which is likely to become greater over time. For several of the SB Products, unit volume for certain products have been eroding and can be expected to continue to erode due to competition from generic products sold at substantially lower prices. These statements are forward-looking within the meaning of the PSLRA-95. Numerous factors will influence the impact that competitive products will have on the Company's revenues from the SB Products and the Company's co-promotion activities. These factors include the success of the Company's and its partners' marketing strategies and efforts, the actual and perceived features of competing products, the amount of the difference in price of competing products, the continued availability of product from SB, and the marketing effort by third parties on competing products. Although past decreases in unit sales of the SB Products have been partially offset by price increases, there can be no assurance that the market will accept any additional price increases. Among the SB Products, the Company has placed particular marketing emphasis on those product formulations, such as Eskalith CR(-Registered Trademark-) (a controlled release formulation), where generic equivalents are less available. From time to time, the Company may seek to acquire the right to market additional or replacement products. Numerous factors will determine whether and when the Company is able to do so and then the degree to which the Company realizes net revenue contribution from marketing such additional products. Factors influencing the availability of such additional products on terms favorable to the Company include the ability of the Company to demonstrate success under its current agreements, the willingness of other companies to enter into such agreements with the Company, which will be based in part on where such companies elect to deploy their own marketing resources, and competition from other companies offering sales and marketing assistance similar to that offered by the Company. MANUFACTURING Prior to March 1999, the Company produced only the bulk active ingredient in Fiblast(-Registered Trademark-) in its own facility and relied on third parties for the manufacture of other products, including Natrecor(-Registered Trademark-) and the final product form of Fiblast(-Registered Trademark-). In March 1999, the Company announced its Restructuring Plan that included closure in 1999 of the manufacturing facility where Scios had manufactured Fiblast(-Registered Trademark-). The Company's commercial partners for Fiblast(-Registered Trademark-), principally Kaken, Chiron and Orquest are now responsible for supplying their long-term need for this product. Similarly, Novo Nordisk is responsible for manufacturing the GLP-1 product and GenVec and its commercial partner, Warner Lambert, are responsible for manufacturing any products based on the VEGF(121) gene. 12 The decision to close Scios' own protein manufacturing facility was based on a combination of factors including the low capacity and high operating cost of the facility compared to third-party manufacturing facilities and the availability of third-party recombinant protein manufacturing capacity. The Company is now dependent on third parties to manufacture its products. The strategy of utilizing third-party facilities carries with it certain risks, as there can be no assurance that such facilities can be arranged on commercially acceptable terms or that Scios will be able to meet manufacturing quantity and quality requirements through the use of such arrangements. Scios has in place an agreement providing for manufacture of Natrecor(-Registered Trademark-) by Biochemie Gesellschaft M.B.H. of Austria through 2006. Having a low-cost manufacturing capability for Natrecor(-Registered Trademark-) and smoothly managing third-party manufacturers are expected to be keys to commercializing this and other products successfully and on a timely basis. Failure to do so could adversely impact the commercial success of the product. See "Business--Competition." Janssen manufactures Risperdal(-Registered Trademark-) and SB manufactures Paxil(-Registered Trademark-) and the SB Products. If SB were to discontinue manufacturing the SB Products and the Company wished to continue selling the products, the Company would have to assume management of the manufacturing contracts currently managed by SB. The risk of reliance on a third party to manufacture is demonstrated by SB's recent notice to the Company of a possible out-of-stock situation in 2000 on Eskalith CR(-Registered Trademark-) following changes by SB in the site of manufacturing. See "Business--Marketing and Sales." PATENTS AND PROPRIETARY RIGHTS Scios is seeking patent protection for proprietary technology and products in the United States and abroad to prevent others from unfairly capitalizing on its investment in research. Other companies engaged in research and development of new health care products based on biotechnology also are actively pursuing patents for their technologies, which they consider to be novel and patentable. Scios also relies and will continue to rely upon trade secrets and know-how to develop and maintain its competitive position. There can be no assurance, however, that others will not develop similar technology or that confidentiality agreements on which the Company relies to protect trade secrets will be honored. The Company currently owns or holds exclusive rights to approximately 63 issued United States patents and 49 United States pending patent applications covering its proprietary technology and products. The Company also files foreign applications corresponding to most of its United States applications. Scios' issued patents include patents on Natrecor(-Registered Trademark-), Fiblast(-Registered Trademark-), VEGF(121) and insulinotropin. The Company's patent position with respect to certain principal products under development is described above in the section discussing each product. See "Business--Product Development Activities and Risks." If a patent issues prior to marketing approval, as has been the case with all of the Company's issued patents to date, Scios can apply for extension of the patent term for a limited period of time to make up for a portion of the patent term lost to the regulatory approval period. The actual period of the extension varies but generally cannot exceed five years. In certain of its third-party agreements, the absence of a patent covering a product licensed by Scios could reduce the royalties due to the Company under the agreements. This section entitled "Patents and Proprietary Rights" contains forward-looking statements under the PSLRA-95. Actual results will vary depending on numerous factors, many of which are discussed. Investors should appreciate that the patent position of biotechnology and pharmaceutical firms is generally highly uncertain and involves complex legal and factual questions. Although Scios believes it has strong patent positions on certain of its products, there can be no assurance that any patent will issue on pending applications of the Company, or that any patent issued will afford the Company significant commercial protection against competitors for the technology or product covered by it, or that patents will not be infringed upon or designed around. Third parties have filed applications for, or have been issued patents relating to, products or processes that are similar to or competitive with certain of the Company's products or processes. Scios is incurring and expects to continue to incur substantial costs in interference proceedings and in defending the validity or scope of its patents or in challenging the validity or scope of competing patents. The Company is unable to predict how the courts will resolve issues relating to the validity and scope of such 13 patents. If any such patent were to be interpreted to cover any of the Company's products and could not be licensed, circumvented or shown to be invalid, the results of Scios' future operations could be materially and adversely affected. Described below are patent positions of other companies of which Scios is aware that potentially overlap the Company's principal product development areas discussed above. NATRECOR(-REGISTERED TRADEMARK-). Scios has been issued United States, Canadian, European and Japanese patents covering the endogenous form of Natrecor(-Registered Trademark-), human BNP. An opposition proceeding has been filed against Scios' Japanese patent and the matter is presently before the Japanese courts. Scios has also obtained from Shionogi a worldwide license for therapeutic uses to certain issued BNP patents that are based on work by Daiichi Pharmaceutical Co., Ltd., Tokyo, including a patent issued to Daiichi by the European Patent Office. P38 KINASE INHIBITORS. Scios has filed a series of patent applications in the United States covering the classes of p38 kinase inhibitors that the Company has identified. While the classes of small molecule compounds identified by Scios researchers appear to be unique, the Company is aware that other companies are also working to develop p38 kinase inhibitor compounds, have filed patent applications on and received patents covering certain classes of compounds that these competing companies have identified, and on various aspects of identifying such compounds. Among the companies competing to develop p38 kinase inhibitors are SmithKline Beecham Corporation, G.D. Searle Pharmaceuticals, a division of Monsanto Company, Johnson & Johnson Company and Merck, Inc., each of whom has substantial resources. FIBLAST(-Registered Trademark-). In February 1991, a United States patent with one claim covering a form of FGF protein was issued to Synergen, Inc. ("Synergen"), which was later acquired by Amgen Inc. In June 1991, a United States patent with one claim covering the DNA for the same form of FGF was issued to Synergen. Based on a review of the publicly-available documents relating to these patents, Scios believes that the Synergen form of FGF or DNA differs from the form of FGF produced by the Company. On August 8, 1995, following a decision favorable to Scios in a patent interference proceeding with the Salk Institute for Biological Studies ("Salk"), Scios received a United States patent covering DNA sequences, expression vectors and microorganisms used in the recombinant production of human basic FGF. On May 7, 1996, Scios received a United States patent covering the recombinant production of human basic FGF. On February 18, 1997, Scios received a United States patent covering recombinantly produced human basic FGF. On January 12, 1999, Scios received a United States patent covering a cysteine mutant of human basic FGF. In October 1992, a United States patent was issued to Salk which contains claims directed to substantially pure mammalian basic FGF containing the 146 amino acid sequence of bovine basic FGF or a naturally occurring homologous sequence of another mammalian species. If any claim of this patent were determined to be valid and construed to cover Scios' human basic FGF, the Company's ability to develop basic FGF might be hindered or prevented if it were unable to obtain a license. Scios' outside counsel has reviewed the publicly-available documents relating to the Salk patent. Based upon this review, such counsel has opined that, to the extent any claims of the patent may be interpreted to cover human basic FGF, such claims are overly broad and would likely be held invalid by an informed court. In May 1994, the European Patent Office issued European Patent No. 0 248 819 to Scios covering Scios' form of recombinant basic FGF known by the product name Fiblast(-Registered Trademark-). An opposition proceeding was instituted against this patent by Chiron Corp. and Pharmacia S.p.A. In June 1996, the Opposition Division of the European Patent Office upheld the validity of the Scios patent; however, the opponents have filed an appeal against this ruling. In August 1994, the European Patent Office issued European Patent No. 0 228 449 to Salk covering the 146 amino acid sequence of bovine basic FGF or an equivalent or analog thereof. The Company filed an opposition to this patent and in September 1997, the Opposition Division revoked the patent; however, Salk has filed an appeal against this ruling. As part of the November license agreement with the Company, Chiron has withdrawn its opposition to Scios' European Patent and Scios has withdrawn from the appeal proceedings involving Salk's European patent. 14 In March 1994, the Company obtained a non-exclusive license to make, use and sell Fiblast(-Registered Trademark-) under a United States patent issued to Harvard University containing claims to purified cationic (basic) FGF. The Harvard patent is based on a patent application having a filing date earlier than the application which formed the basis for the Salk patent. Sublicense Rights under this patent are included in the rights granted by the Company to its Fiblast(-Registered Trademark-) licensees, Kaken and Chiron. VEGF(121). VEGF is a highly specific mitogen for vascular endothelial cells. Seven isoforms of human VEGF ("hVEGF") are known, having 121, 145, 148, 165, 183, 189 and 206 amino acids, respectively. Scios believes it was the first to identify, clone and produce by recombinant DNA technology the 121 amino acid form of hVEGF (hVEGF(121)). hVEGF(121) is the only human VEGF isoform known not to bind to heparin. Scios owns two U.S. patents issued in 1993 covering hVEGF(121), and in 1996 received a European patent covering this VEGF isoform. Patent applications are pending in Canada and Japan. Other companies and institutions, including Genentech, Monsanto, and the Regents of the University of California, hold patents and pending patent applications claiming various isoforms of hVEGF and certain VEGF variants. TRADEMARKS. Natrecor(-Registered Trademark-), Fiblast(-Registered Trademark-) and Auriculin(-Registered Trademark-) are registered trademarks of Scios. Paxil(-Registered Trademark-), Eskalith(-Registered Trademark-), Eskalith CR(-Registered Trademark-), Thorazine(-Registered Trademark-), Stelazine(-Registered Trademark- ) and Parnate(-Registered Trademark-) are registered trademarks of SB. Risperdal(-Registered Trademark-) is the registered trademark of Janssen. Haldol(-Registered Trademark-) is a registered trademark of Ortho-McNeil Pharmaceutical, Inc. Effexor(-Registered Trademark-) is a registered trademark of American Home Products Inc. Gliadel(-Registered Trademark-) is the registered trademark of Guilford. Triage(-Registered Trademark- ) is a registered trademark of Biosite Diagnostics Incorporated. COMPETITION Competition is intense in the development of pharmaceutical products. There are numerous companies and academic research groups throughout the world engaged in similar research and development. Some of the Company's competitors, including some of its licensees, are working on products similar to those being developed by Scios. Many of these companies have substantially greater financial, marketing and human resources than Scios. In the case of Natrecor(-Registered Trademark-), a number of products are already clinically accepted for the short-term management of CHF. Hence, the Company will need to demonstrate positive low cost clinical benefits compared to the existing products and an ability to continue to produce Natrecor(-Registered Trademark-) cost-effectively in order to successfully introduce Natrecor(-Registered Trademark-) into this competitive market. There can be no assurance that technological developments or superior marketing capabilities possessed by competitors will not materially adversely affect the commercial potential of the Company's products. In addition, if the Company commences significant commercial sales of products, manufacturing efficiency and marketing capability are likely to be significant competitive factors. With respect to products no longer covered by patents, such as the SB Products, Scios faces, or expects to face, competition from companies offering generic products. The Company believes that the competitive success of the Company will be based primarily on scientific and technological superiority, managerial competence in identifying and pursuing opportunities, operational competence in developing, protecting, producing and marketing products, and obtaining timely regulatory agency approvals and adequate funds. Achieving success in these areas will depend on the Company's ability to attract and retain skilled and experienced personnel, to develop and secure the rights to advanced proprietary technology and to exploit commercially its technology prior to the development of competitive products by others. Scios expects that there will be continued competition for highly qualified scientific, technical and managerial personnel. This section entitled Competition contains forward-looking statements within the meaning of the PSLRA-95. Numerous factors, including the factors identified above, could cause actual results to differ from those described in these forward-looking statements. 15 GOVERNMENT REGULATION The industry in which the Company participates--the development and marketing of pharmaceutical products--is heavily regulated. As is true for all companies developing pharmaceuticals, the Company's research and development activities and the production and marketing of its products are subject to extensive regulation for safety and efficacy by numerous governmental authorities in the United States and other countries. This regulation is a significant factor in the production and marketing of the products resulting from Scios' research and development activities. Testing, production and marketing of pharmaceutical products for human use require approval of the FDA and comparable authorities in other countries. Over the next several years, Scios expects to expend substantial resources to meet these requirements for the products it is developing. See "Business--Product Development Activities and Risks." The procedure for seeking and obtaining the required governmental approvals for a new product involves many steps, beginning with animal testing to determine safety and potential toxicity. In addition, extensive human clinical testing is required to demonstrate the efficacy, optimal dose and safety of each product. The time and expense required to perform clinical testing can far exceed the time and expense of developing the product prior to clinical testing. Whether undertaken by the Company or its commercial partners, the process of seeking and obtaining these approvals for a new product is likely to take a number of years and involves the expenditure of substantial resources. In addition, there can be no assurance that any of the Company's products will receive the necessary approvals on a timely basis, if at all. The regulatory environment is constantly evolving and one of the demands on companies in the pharmaceutical industry is to take account of and anticipate these changes in order to minimize negative impact on the Company or its product development timelines. As a developer of pharmaceutical products, the Company and its commercial partners must also deal with differences in the regulatory requirements of different countries. Although there is an effort at greater harmonization of regulatory standards, differences still impact whether and in what time frame a product may be approved in a particular country, if at all. Because of these differences between countries, approval in one country does not assure approval in another. Even if initial FDA approval is obtained for a product, further studies may be required to provide additional data or to gain approval for the use of a product as a treatment for clinical indications other than those initially targeted. Moreover, the FDA may reconsider its approval of any product at any time and may withdraw such approval. In addition, before the Company's products can be marketed in foreign countries, they are subject to regulatory approval in such countries similar to that required in the United States. Accordingly, numerous factors will impact the timing, extent and value of any regulatory approvals that may be obtained for the Company's products, including changes in regulatory requirements, which may either decrease or increase the burden on the Company, the level of side effects exhibited by the Company's products as compared to their beneficial effects, the availability of adequate resources to regulatory agencies which will impact the speed of regulatory review, and the price the Company is able to charge for its products. FDA regulations require that any drug to be tested in humans must be manufactured according to current Good Manufacturing Practices ("cGMPs"). The cGMPs set certain minimum requirements for procedures, record-keeping and the physical characteristics of the facilities used in the production of these drugs. In addition, various foreign and United States federal, state and local laws and regulations relating to safe working conditions, laboratory practices, the experimental use of animals, and the storage, use and disposal of hazardous or potentially hazardous substances, including radioactive compounds and infectious disease agents, used in connection with the Company's research and manufacturing work are or may be applicable to such activities. They include, among others, the United States Atomic Energy Act, the Clean Air Act, the Clean Water Act, the Occupational Safety and Health Act, the National Environmental Policy Act, the Toxic Substances Control Act, the Resource Conservation and Recovery Act, national restrictions on technology transfer, import, export and customs regulations, and other present and possible future foreign, federal, state and local regulations. Although the Company believes that its safety procedures for handling and disposing of hazardous materials comply with prescribed regulations, the risk of accidental contamination or injury from these materials cannot be completely eliminated. The Company may also incur substantial costs to comply 16 with environmental regulations if the Company develops additional manufacturing capacity or otherwise changes its operations. Furthermore, the Company employs third-party contractors that it believes to be reliable to perform certain work in connection with the disposal of hazardous materials generated in the Company's research in compliance with applicable laws, but it cannot ensure their compliance. Notwithstanding such reliance, the Company may remain responsible for the materials and the actions of its contractors related to such materials. From time to time, the Company has been notified that certain of its contractors may not have disposed of such materials in full compliance with applicable laws and that the Company may be required to contribute to the cost of environmental clean-up efforts. See Item 3 below and Note 11 of Notes to Consolidated Financial Statements. EMPLOYEES The Company had 180 full-time employees as of December 31, 1999 (of which 132 were engaged in research, product and clinical development) and 90 field sales representatives. ITEM 2. PROPERTIES In September 1999, the Company consolidated all of its operations in Sunnyvale, California. The Company has leased a 52,000 square foot building in Sunnyvale, California since 1995 in which the Company's discovery research group is located. In 1999, the Company built out the remaining space in the Sunnyvale facility to consolidate all of its research and development laboratories and headquarter offices in one building. In 1999, the Company also leased a neighboring 33,400 square foot office building to house certain of its employees. The Company's annual lease payments for the Sunnyvale facilities are approximately $1,543,000. The Company expended approximately $5.0 million in capital expenditures in 1999 and anticipates spending approximately $1.0 million in capital expenditures in 2000. In August 1999, the Company completed the sale of the buildings the Company had occupied in Mountain View, California for net proceeds of approximately $19.2 million. The sale of the Mountain View facility was part of the Restructuring Plan announced by the Company in March 1999. The Company leased these facilities back for approximately 6 months as it phased into its Sunnyvale locations. In May, 1999, the Company also sold the administrative and laboratory building in Baltimore, Maryland originally owned by Nova Pharmaceutical Corporation. ITEM 3. LEGAL PROCEEDINGS In November 1995, the Company was notified by the United States Environmental Protection Agency ("EPA") that it may have a liability in connection with the clean-up of a toxic waste site arising out of the alleged disposal of hazardous substances by a subcontractor of Nova Pharmaceutical Corporation, which was acquired by the Company in 1992. The Company has accepted a settlement agreement proposed by the EPA under which the Company has agreed to contribute $90,000 to clean-up costs. This amount has been accrued at December 31, 1999 and is expected to be paid in 2000. The Company is also involved in certain legal proceedings related to patents and patent application covering its products. See "Business--Patents and Proprietary Rights." ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS No matters were submitted to a vote of security holders during the fourth quarter of the fiscal year covered by this report. 17 MANAGEMENT EXECUTIVE OFFICERS The executive officers of the Company and their ages at January 11, 2000 are as follows:
NAME AGE POSITION - ---- -------- ----------------------------------------------- Richard B. Brewer.............................. 48 President and Chief Executive Officer Elliott B. Grossbard, M.D...................... 52 Senior Vice President, Development John H. Newman................................. 49 Senior Vice President, General Counsel and Secretary Lauretta C. Cesario............................ 53 Vice President, Human Resources Jack Cohen, Ph.D............................... 62 Vice President, Quality and Product Development Barbara Cordell, Ph.D.......................... 53 Vice President, Alzheimer's Research Thomas L. Feldman.............................. 49 Vice President, Sales and Marketing David W. Gryska................................ 43 Vice President, Finance and Chief Financial Officer John A. Lewicki, Ph.D.......................... 48 Vice President, Research George F. Schreiner, M.D., Ph.D................ 50 Vice President, Cardiorenal Research
Mr. Brewer is President and Chief Executive Officer of Scios Inc. He joined Scios in September 1998 and has served as a Director since that time. From early 1996 to 1998, he was with Heartport Inc., first as Executive Vice President of Operations and then, Chief Operating Officer. Prior to that, Mr. Brewer served in various capacities with Genentech, Inc. from 1984 to 1995, most recently as Senior Vice President, U.S. Sales and Marketing, Genentech Europe Ltd., and Genentech Canada, Inc. Mr. Brewer earned a B.S. from Virginia Polytechnic Institute and a M.B.A. from Northwestern University. Dr. Grossbard joined Scios in 1991 as Vice President of Medical and Regulatory Affairs and became Senior Vice President in 1996. Immediately prior to joining Scios, he was Vice President of Medical Affairs for HemaGen/PFC, a privately-held company developing perfluorocarbon products for oxygen transport and as blood substitutes. From 1982 to 1990, he was Associate Director and later Director of Clinical Research for Genentech, Inc., in charge of the clinical development of Alteplase(-Registered Trademark-) (TPA). From 1978 to 1980, as an Assistant Attending Physician at Memorial Hospital and Assistant Professor of Medicine at Cornell Medical School, he helped to establish the Bone Marrow Transplant Service at Memorial Hospital. He received his M.D. from the Columbia College of Physicians and Surgeons in 1973, trained in internal medicine at Massachusetts General Hospital in Boston and received subspecialty training in hematology at the Columbia-Presbyterian Medical Center and the Memorial Sloan-Kettering Cancer Center in New York. Mr. Newman joined Scios in 1983 as Vice President, General Counsel and Secretary, and became Vice President of Commercial Development, General Counsel and Secretary in December 1989, Vice President of Legal Affairs, General Counsel and Secretary in March 1992 and Senior Vice President, General Counsel and Secretary in February 1998. Prior to joining Scios, Mr. Newman was an attorney in private practice. Ms. Cesario joined Scios in 1997 as Director, Human Resources. She became Vice President, Human Resources in 1998. Prior to joining the Company, Ms. Cesario was Director, Human Resources at Silicon Graphics, Inc. from 1995 to 1997, Director, Human Resources at National Semiconductor from 1994 to 1995 and Group Director, Human Resources at Syntex Corporation from 1983 to 1994. Dr. Cohen joined Scios in 1992, as Vice President, Quality, and became Vice President, Quality & Regulatory in 1997, and Vice President, Quality and Product Development in 1999. He was with Syntex Corporation from 1965 to 1992, starting in Research in the Institute of Pharmaceutical Sciences. During the latter half of his career at Syntex, he was Vice President, Quality Assurance, for Syntex Laboratories. His 18 education includes a B.S. in Pharmacy from Columbia University, and a M.S. and Ph.D. in Pharmaceutics and Analytical Chemistry from the University of Iowa. Dr. Cordell joined Scios in 1983 as a Founding Senior Scientist. She was promoted to a Vice President, Research position in 1985. Dr. Cordell has headed Scios' Alzheimer's research program for the past twelve years and was promoted to Vice President, Alzheimer's Research in 1996. Prior to joining Scios, Dr. Cordell served on the faculty of Harvard Medical School. Dr. Cordell received her Ph.D. from Indiana University in 1973. Mr. Feldman joined Scios in January 1995 as Vice President of Commercial Operations and in 1999 his title was changed to Vice President, Sales and Marketing. Prior to joining the Company, Mr. Feldman was responsible for sales and marketing activities in two pharmaceutical companies affiliated with Johnson & Johnson. From 1993 through 1994, Mr. Feldman was National Sales Manager at Ortho Pharmaceutical Corporation. From 1973 to 1993, Mr. Feldman held various sales and marketing positions at McNeil Pharmaceutical, where he most recently served as National Sales Manager from 1990 to 1993. Mr. Gryska joined Scios in December 1998 as Vice President of Finance and Chief Financial Officer. Prior to joining Scios, Mr. Gryska was Vice President, Finance and Chief Financial Officer of Cardiac Pathways Corporation since 1993. Mr. Gryska was with Ernst & Young LLP from 1982 to September 1993 and as a partner since 1989. Dr. Lewicki joined Scios in 1983 as a Scientist, and became Senior Scientist in 1984, Vice President, Research in August 1986, Vice President and Deputy Director, Research in March 1987, and Vice President and Director of Research in February 1988. Dr. Lewicki received his Ph.D. in Physiology/Pharmacology from the University of California, San Diego in 1979. From 1979 to 1981, Dr. Lewicki conducted postdoctoral research at the University of Virginia, Department of Internal Medicine, and, from 1981 to 1983, he was a research pharmacologist at Stanford University, Division of Clinical Pharmacology. Dr. Schreiner joined Scios in 1997 as Vice President, Cardiorenal Research. Dr. Schreiner is responsible for directing the disease-based research program focusing on congestive heart failure and progressive renal failure. Prior to joining Scios, Dr. Schreiner served on the faculties of Harvard Medical School and Washington University School of Medicine and then joined CV Therapeutics, Inc. as Vice President, Medical Science and Preclinical Research. Dr. Schreiner obtained a M.D. from Harvard Medical School and a Ph.D. in immunology from Harvard University in 1977. PART II ITEM 5. MARKET FOR REGISTRANT'S COMMON EQUITY AND RELATED STOCKHOLDER MATTERS The Company's Common Stock is traded on the Nasdaq National Market System under the symbol SCIO. The table below sets forth the high and low sales prices as reported by Nasdaq for the Common Stock during the last two fiscal years. Prices represent quotations among dealers without adjustment for retail markups, markdowns or commissions, and may not represent actual transactions. No cash dividends have been paid on Common Stock, and the Company does not anticipate paying cash dividends in the foreseeable future. As 19 of December 31, 1999, there were approximately 4,663 stockholders of record of the Company's Common Stock.
COMMON STOCK -------------------------------------------------- FY 1999 FY 1998 ----------------------- ------------------------ HIGH LOW HIGH LOW ----------- --------- ------------ --------- Q1........................................................ 12- 1/2 8- 1/8 13- 5/8 8- 1/8 Q2........................................................ 9- 5/16 2- 7/8 13- 1/4 8 Q3........................................................ 5- 1/4 3- 1/4 9- 1/8 4- 1/8 Q4........................................................ 5- 5/32 3- 3/8 10- 13/16 3- 1/2 Year...................................................... 12- 1/2 2- 7/8 13- 5/8 3- 1/2
ITEM 6. SELECTED FINANCIAL DATA
YEAR ENDED DECEMBER 31, ---------------------------------------------------- 1999 1998 1997 1996 1995 -------- -------- -------- -------- -------- (DOLLARS IN THOUSANDS, EXCEPT PER SHARE AMOUNTS) Revenues.......................................... $ 60,787 $ 73,715 $ 47,429 $ 64,223 $ 49,187 Loss from operations.............................. (24,333) (11,911) (39,737) (22,020) (28,175) Other income...................................... 4,283 11,122 2,254 4,497 5,049 Net loss.......................................... (20,064) (2,363) (38,667) (18,403) (26,382) Net loss per common share and per common share assuming dilution............................... (0.53) (0.06) (1.07) (0.51) (0.74) Cash and securities............................... 100,712 97,311 64,700 62,170 87,069 Working capital................................... 1,706 8,083 4,524 (5,838) 11,642 Total assets...................................... 118,272 138,829 116,871 113,961 131,550 Long-term obligations............................. 42,866 34,573 31,919 426 1,082 Stockholders' equity.............................. 42,787 74,926 60,142 93,628 109,394 Employees at year end............................. 180 279 258 256 216 Field sales representatives....................... 90 98 92 79 85
ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS THE FOLLOWING DISCUSSION CONTAINS FORWARD-LOOKING STATEMENTS ABOUT PLANS, OBJECTIVES AND FUTURE RESULTS OF SCIOS INC. (THE "COMPANY"). THESE FORWARD-LOOKING STATEMENTS ARE BASED ON THE CURRENT EXPECTATIONS OF THE COMPANY, AND THE COMPANY ASSUMES NO OBLIGATION TO UPDATE THIS INFORMATION. REALIZATION OF THESE PLANS AND RESULTS INVOLVES RISKS AND UNCERTAINTIES, AND THE COMPANY'S ACTUAL RESULTS COULD DIFFER MATERIALLY FROM THOSE DISCUSSED HERE. FACTORS THAT COULD CAUSE OR CONTRIBUTE TO SUCH DIFFERENCES INCLUDE, BUT ARE NOT LIMITED TO, THOSE DISCUSSED BELOW IN THIS FORM 10-K FOR THE YEAR ENDED DECEMBER 31, 1999. OPERATING RESULTS (1999, 1998 AND 1997) Total revenues for the Company were $60.8 million in 1999, $73.7 million in 1998 and $47.4 million in 1997. The revenue decline from 1998 to 1999 and increase from 1997 to 1998 was principally due to changes in the level of research and development contract revenues. Revenue from product sales of certain psychiatric products ("SB Products") under license from SmithKline Beecham Corporation ("SB") was $33.8 million, $29.1 million and $35.2 million in 1999, 1998 and 1997, respectively. The product sales increase of 16% from 1998 to 1999 was mainly attributed to improved customer targeting and new marketing programs. Product sales declined 17% from 1997 to 1998 due to competition from generic drugs and new competing products. 20 Co-promotion commissions were $8.6 million, $6.5 million, and $5.8 million in 1999, 1998 and 1997, respectively. In 1999 and 1998, the Company received co-promotion commissions under agreements with SB for the co-promotion of its drug Paxil(-Registered Trademark-) (paroxetine HCl) ("Paxil(-Registered Trademark-)") for the treatment of depression, panic disorder, social anxiety disorder and obsessive-compulsive disorder and with Janssen Pharmaceutica Inc. ("Janssen") for the co-promotion of its anti-psychotic drug Risperdal(-Registered Trademark-) (risperidone) ("Risperdal(-Registered Trademark-)"). In 1998 and 1997 the Company received co-promotion commissions under agreements with Ortho-McNeil Pharmaceutical ("Ortho-McNeil"), an affiliate of Johnson & Johnson, for the co-promotion of the psychiatric product Haldol(-Registered Trademark-) Decanoate ("Haldol(-Registered Trademark-)"), and with Wyeth-Ayerst Laboratories ("Wyeth-Ayerst"), a division of American Home Products Corporation, for the co-promotion of its psychiatric product Effexor(-Registered Trademark-) (venlafaxine HCl) ("Effexor(-Registered Trademark-)"). In April 1998, the respective agreements with Ortho-McNeil and Wyeth-Ayerst to co-promote Haldol(-Registered Trademark-) and Effexor(-Registered Trademark-) were terminated by mutual agreement. Co-promotion commissions increased from 1998 to 1999 and from 1997 to 1998 due to the changes in the product lines promoted by the Company and to better terms under the new agreements. Revenue from research and development contracts was $18.4 million in 1999, $38.1 million in 1998, and $6.4 million in 1997. The decrease in revenue from 1998 to 1999 was mainly due to $20.0 million received from Bayer AG ("Bayer") in 1998 for commercialization of Natrecor(-Registered Trademark-) (nesiritide). The agreement was dissolved in May 1999 after non-approval of the drug by the FDA. The increase in revenue from 1997 to 1998 was primarily due to: receipt of the Bayer $20.0 million payment and $4.5 million from Bayer in additional development funding; milestone payments of $5.0 million from Novo Nordisk A/S for development of GLP-1; and additional contract funding from Eli Lilly and Company ("Lilly") and DuPont Pharmaceuticals Company ("DuPont") for the Company's Alzheimer's research program. Revenues from Chiron Corporation ("Chiron") for rights to Fiblast(-Registered Trademark-) accounted for 27% of contract revenues in 1999. Revenue from Bayer accounted for 11% of contract revenue in 1999 and 64% in 1998. Novo Nordisk accounted for 22% and 13% of contract revenues in 1999 and 1998, respectively. Revenues from Lilly for the Company's Alzheimer's research program comprised 20% of 1999, 8% of 1998 and 28% of 1997 contract revenue. Revenues from the collaboration with Hoechst Marion Roussel to study Alzheimer's disease comprised approximately 3% and 16% of contract revenue in 1998 and 1997, respectively; this collaboration was terminated by mutual agreement in 1997. Revenues under the collaboration with Kaken Pharmaceutical Co., Ltd. ("Kaken") to develop Fiblast(-Registered Trademark-) in Japan for the treatment of dermal ulcers, were less than 1% in 1999, 2% and 3% of contract revenue in 1998 and 1997, respectively. Cost of goods sold for the SB Products was $18.5 million, $16.6 million and $20.2 million in 1999, 1998 and 1997, respectively. The 1999 increase in cost of goods is due to the increase in product sales. The decline from 1997 to 1998 was principally the result of lower unit sales. Gross margins were 45% in 1999 compared to 43% in 1998 and 1997. Future changes in gross margins will be principally dependent upon the effects of price increases, competition in the marketplace and changes in the product lines. Research and development expenses were $34.3 million in 1999, $46.6 million in 1998 and $41.9 million in 1997. The decrease in spending in 1999 was primarily due to the corporate restructuring that included layoff of personnel and closure of the manufacturing facility. The increase from 1997 to 1998 was the result of higher staffing levels, greater expenses for the purchase of drug supply to support further development of the Company's lead products, and increased clinical trials expenses. Marketing, general and administrative expenses were $21.0 million in 1999, $19.4 million in 1998 and $20.7 million in 1997. The increase from 1998 to 1999 is mainly the result of increased outside consulting fees related to marketing of Natrecor(-Registered Trademark-), the corporate reorganization and product licensing. The decreased spending from 1997 to 1998 was mainly due to lower depreciation expenses. The profit distribution to third parties of $4.9 million, $3.1 million and $4.4 million in 1999, 1998 and 1997, respectively, represents SB's share of the net profits from sales of the SB Products. The increase in 1999 and the decrease from 1997 to 1998 were principally due to changing product sales levels. 21 On March 1, 1999, the Company announced a $6.4 million restructuring plan that included reduction of the Company's full-time workforce by approximately 30% or 80 employees and the consolidation of its headquarters, development and research staff into leased facilities in Sunnyvale, California. After the manufacture of the amount of Fiblast(-Registered Trademark-) required for delivery under its contract with Kaken, the Company discontinued using its manufacturing facility due to its low capacity and high operating expenses and the ready availability of third party recombinant protein manufacturing capacity. In the second half of 1999, the Company sold the Mountain View facility. A portion of the Mountain View facility will continue to be leased back through April 2000 to fulfill the Company's obligation to Kaken associated with their drug approval application for Fiblast(-Registered Trademark-) in Japan. The restructuring and consolidation is expected to create improved management and operational synergies and save approximately $14.0 million annually. Other income was $4.3 million in 1999, $11.1 million in 1998 and $2.3 million in 1997. The decrease from 1998 to 1999 was mainly due to a reduction in realized gains on the sale of securities in Guilford Pharmaceuticals Inc. ("Guilford") and increase in royalty expense to the Biotechnology Research Partners on licensing of FGF to Chiron. The increase from 1997 to 1998 was due to the gain on the sale of the Company's entire interest in its subsidiary Karo Bio AB, 70,000 shares of the common stock of Guilford, and other marketable securities in the Company's portfolio. The Company had $1.3 million in equity in net loss of affiliate in both 1998 and 1997 which was the result of Guilford's losses in those respective years. The Company's ownership in Guilford declined from 62% in May 1994 to 7% at December 31, 1998 as a result of Guilford's public stock offerings and the sales of Guilford stock by the Company. In the fourth quarter of 1998, the Company reclassified the Company's investment in Guilford's stock to marketable securities. In 1999 the Company sold its entire holdings of Guilford stock. From June of 1994, the date of Guilford's initial public stock offering, until the fourth quarter of 1998, the Company used the equity method of accounting for its investment in Guilford. Prior to the public stock offering, the financial results of Guilford were consolidated with those of the Company. OUTLOOK AND RISKS The Company is striving to achieve profitability in the next several years. The ability of the Company to achieve sustainable profitability depends principally upon the success of the Company in achieving regulatory approvals and generating sales from Natrecor(-Registered Trademark-). Profitability will also depend on the Company's ability to generate additional revenues through the development and commercialization of its products such as Natrecor(-Registered Trademark-) and p38 kinase inhibitor either through its own efforts or in collaboration with partners. The Company expects to continue to generate revenue from the sale and co-promotion of the psychiatric drugs it currently sells, or of other third party product rights which it may acquire as additions to or replacements for existing products. In addition, the Company expects to continue to rely on outside partners to fund certain research activities such as its ongoing Alzheimer's research program. Such funding will depend, in part, upon priorities set by the sponsors in relation to the sponsor's other product opportunities and their assessment of the continued benefit of sponsoring a particular program at the Company. As a result of closing its manufacturing facility, the Company is wholly dependent upon third party suppliers for the manufacture of drugs for sale and is evaluating additional supply sources for its other products in development. Before closing its manufacturing facility, the Company produced all of the Fiblast(-Registered Trademark-) drug supply necessary to fulfill its contractual agreement with Kaken. Although the Company does not currently foresee a supply problem, future product supply and the Company's profitability could be affected by events at these suppliers over which the Company has limited control. Profitability may also be affected by any merger or acquisition activity undertaken by the Company to expand its portfolio of drugs in development. Further development of the Company's products will require substantial additional investment to cover, among other things, the costs of marketing and sales expenses associated with product introductions, the securing of commercial-scale manufacturing capability and the completion of clinical trials for new and expanded indications. While market introduction of new products may require considerable expenditures by 22 the Company, revenues generated from such products, assuming they are successfully developed, may not be realized for several years. Principal factors that could affect the level of new product revenues will include the rate of market penetration, the availability of alternative therapies, the price charged by the Company per course of therapy, the breadth of the approved indication allowed by the Food and Drug Administration and what, if any, income can be obtained from potential third-party licensees. Sales of the SB Products, in total, are likely to continue to decline during the next few years because of continuing or new competition from generic products or new market entrants. The Company hopes to offset any such decrease with payments received for the co-promotion of other third party products such as Risperdal(-Registered Trademark-) and Paxil(-Registered Trademark-) that are currently being co-promoted. Factors influencing the availability of additional products on terms favorable to the Company include the ability of the Company to demonstrate success under its current agreements and the willingness of other companies to enter into such agreements. For the reasons stated above, the operating results of the Company are expected to fluctuate from period to period. Inflation is not expected to have a significant effect upon the business of the Company. In addition, because the Company participates in a highly dynamic industry, the Company's common stock price is subject to significant volatility as a result of developments at both the Company and in the biopharmaceutical industry in general. LIQUIDITY AND CAPITAL RESOURCES Combined cash, cash equivalents and marketable securities (both current and non-current) totaled $100.7 million at December 31, 1999, an increase of $3.4 million from December 31, 1998. The increase was mainly attributable to favorable investing activities that included the sale of the Mountain View facilities and the sale of Guilford stock. The Company also received $12.5 million in licensing fees and a forgivable loan from Chiron in 1999. The increases were partially offset by $5.0 million used for property and equipment purchases and $1.0 million used in repurchases of the Company's stock in the public market. In addition, in 1999 the Company entered into a $4.0 million equipment operating lease line that expires December 31, 2001. At December 31, 1999 approximately $612,000 had been drawn against the line. In November 1995, the Company authorized the expenditure of up to $6.0 million for the repurchase of shares of the Company's common stock. In October 1998 the Company increased the amount by an additional $5.0 million. As of December 31, 1999, the Company had purchased 1,563,000 shares at an aggregate price of $7.3 million since the inception of the repurchase program. The Company purchased 206,500 treasury stock shares for $1.0 million in 1999 and 327,000 shares for $1.5 million in 1998. To date, the Company's operations and capital requirements have been financed primarily from the proceeds of public and private sales of common stock, research and development partnerships, collaborative agreements with pharmaceutical firms, product sales, equipment lease financing and investment income. The Company's net operating losses and credit carryforwards will provide an additional source of liquidity only to the extent that profitable operations are achieved prior to the expiration of carryforward periods. The utilization of losses generated through the date of the 1992 merger with Nova Pharmaceutical Corporation will be subject to annual limitations. OUTLOOK AND RISKS FOR LIQUIDITY AND CAPITAL RESOURCES The Company's cash, cash equivalents and marketable securities of approximately $100.7 million at December 31, 1999, together with revenues from product sales, royalties, collaborative agreements, equipment lease financing and interest income, will be used to fund new and continuing research and development programs, expand clinical trials for its products under development and for other general purposes. The Company believes its cash resources will be sufficient to meet its capital requirements for the next several years. Key factors that will affect future cash use and the timing of the Company's need to seek additional financing include the Company's decision concerning the degree to which it will incur expenses to launch its products following the necessary regulatory approvals, the results of the Company's partnering 23 efforts and the timing and amounts realized from licensing and partnering activities, the rate of spending required to develop the Company's products and respond to changing business conditions and the net contribution produced by the Psychiatric Sales and Marketing Division from co-promoting and marketing products for third parties. Over the long term, the Company may need to arrange additional financing for the future operation of its business, including the commercialization of its products currently under development, and will consider collaborative arrangements and additional public or private financings, including additional equity financings. Factors influencing the availability of additional funding include the Company's progress in product development, investor perception of the Company's prospects and the general conditions of the financial markets. IMPACT OF YEAR 2000 The Year 2000 Issue was the result of computer programs being written using two digits rather than four to define the applicable year. Any of the Company's computer programs or hardware that have date-sensitive software or embedded chips may recognize a date using "00" as the year 1900 rather than the year 2000. This could result in a system failure or miscalculations causing disruptions of operations, including, among other things, a temporary inability to process transactions, send invoices, or engage in similar normal business activities. In 1999 the Company formulated a plan to resolve the Year 2000 Issue that included the following four phases: assessment, remediation, testing and implementation. The Company's assessment indicated that most of the Company's significant information technology systems were Year 2000 compliant. The assessment indicated, however, that certain systems were at risk. Affected systems included chromatography, clinical case report forms tracking and statistical analysis software. The Company remediated or replaced the equipment at risk, tested and then implemented the equipment. The Company queried its important suppliers and contractors (external agents) regarding their year 2000 remediation activities and developed a contingency plan for both external and internal sources of non-compliance. The Company incurred approximately $85,000 in expenses for all phases of the Year 2000 project. As of February 3, 2000, the Company has had no significant Year 2000 issues from either internal or external sources. However, not all external vendors or all systems have been used at this date and future problems could develop. FINANCIAL RISK MANAGEMENT The Company is exposed to a variety of risks, including changes in interest rates affecting the return on its investments, interest expense on notes and foreign currency fluctuations. In the normal course of business, the Company employs established policies and procedures to manage its exposures to fluctuations in interest rates and foreign currency values. The Company's exposure to market rate risk for changes in interest rates relates primarily to the Company's investment portfolio and its long-term debt instruments. The Company places its investments with high quality issuers and, by policy, limits the amount of credit exposure to any one issuer and does not use derivative financial instruments in its investment portfolio. The Company maintains an investment portfolio of various issuers, types and maturities, which consist of both fixed and variable rate financial instruments. These securities are classified as available-for-sale, and consequently, are recorded on the balance sheet at fair value with unrealized gains or losses reported as a separate component in stockholders' equity, net of applicable taxes. At any time, sharp changes in interest rates can affect the fair value of the investment portfolio and its interest earnings. Currently the Company does not hedge these interest rate exposures. In addition, the interest rates on the Company's long term debt instruments are tied to the prime rate and therefore subject to fluctuations. 24 The Company's exposure to foreign currency fluctuations is currently limited to its supply contract for Natrecor(-Registered Trademark-), which is denominated in German marks. Changes in the exchange rate between German marks and the U.S. dollar could adversely affect the Company's manufacturing costs. All of the Company's other contracts are denominated in U.S. dollars. Exposure to foreign currency exchange rate risk may change over time as the business evolves and the Company's products are introduced into international markets. Currently, the Company does not hedge against any foreign currencies and, as a result, could incur unanticipated gains or losses. RECENT PRONOUNCEMENTS In June 1998, the FASB issued Statement of Financial Accounting Standards No. 133, ("SFAS 133"), "Accounting for Derivative Instruments and Hedging Activities." SFAS 133 establishes new standards of accounting and reporting for derivative instruments and hedging activities. SFAS 133 will be effective for fiscal years beginning in 2000. The Company does not currently hold derivative instruments or engage in hedging activities. In December 1999, the staff of the Securities and Exchange Commission issued Staff Accounting Bulletin No. 101 (SAB 101), REVENUE RECOGNITION IN FINANCIAL STATEMENTS. SAB 101 requires that license and other upfront fees received from research collaborators be recognized over the term of the agreement unless the fee is in exchange for products delivered or services performed that represent the culmination of a separate earnings process. The Company has not yet determined the impact of its implementation on the reporting of the Company's contract revenue. ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA See Index to Financial Statements appearing on page F-1 of this Form 10-K. ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE None. 25 PART III ITEM 10. DIRECTORS AND EXECUTIVE OFFICERS OF THE REGISTRANT IDENTIFICATION OF DIRECTORS. The information required by Item 10 of Form 10-K with respect to identification of directors is incorporated by reference to the information contained in the section captioned "Election of Directors" of the Company's definitive Proxy Statement for the 2000 Annual Meeting of Stockholders. IDENTIFICATION OF EXECUTIVE OFFICERS. See page 18 of this Form 10-K. ITEM 11. EXECUTIVE COMPENSATION The information required by Item 11 of Form 10-K is incorporated by reference to the information contained in the sections captioned "Executive Compensation" and "Stock Option Grants and Exercises" of the Company's definitive Proxy Statement for the 2000 Annual Meeting of Stockholders. ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT The information required by Item 12 of Form 10-K is incorporated by reference to the information contained in the section captioned "Security Ownership of Management and Principal Stockholders" of the Company's definitive Proxy Statement for the 2000 Annual Meeting of Stockholders. ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS The information required by Item 13 of Form 10-K is incorporated by reference to the information contained in the section captioned "Certain Relationships and Transactions" of the Company's definitive Proxy Statement for the 2000 Annual Meeting of the Stockholders. PART IV ITEM 14. EXHIBITS, FINANCIAL STATEMENT SCHEDULES AND REPORTS ON FORM 8-K (a) (1) FINANCIAL STATEMENTS. See Index to Financial Statements at page F-1 of this Form 10-K. (2) FINANCIAL STATEMENT SCHEDULES. Omitted because they are not required, are not applicable, or the information is included in the consolidated financial statements or notes thereto. (3) EXHIBITS. See Exhibit Index at page 27 of this Form 10-K. (b) REPORTS ON FORM 8-K. None. 26 EXHIBIT INDEX
EXHIBIT NUMBER REFERENCE - --------------------- --------- 3.1 Certificate of Incorporation................................ Q 3.2 Bylaws...................................................... J 10.1 Biotechnology Research Partners, Ltd. Agreement of Limited Partnership dated October 29, 1982; Development Contract, Technology License Agreement and Joint Venture Agreement between Biotechnology Research Partners, Ltd. and the Registrant dated December 29, 1982; Promissory Note dated December 29, 1982; and Memorandum of Understanding between Battery Park Credit Company and Biotechnology Research Partners, Ltd. dated December 28, 1982...................... A 10.2* 1983 Incentive Stock Option Plan, as amended, and form of Stock Option Agreement, Promissory Note and Pledge Agreement................................................... E 10.3 Common Stock Purchase Agreement dated April 15, 1985 between the Registrant and American Home Products Corporation....... B 10.5* 1986 Supplemental Stock Option Plan, as amended, and form of Stock Option Agreement, Promissory Note and Pledge Agreement................................................... E 10.6 Rights Exercise Agreement between the Registrant and American Home Products Corporation dated February 28, 1986 and Letter of March 26 and May 16, 1986..................... B 10.9 Rights Agreement dated as of June 18, 1990 between the Registrant and The First National Bank of Boston............ F 10.11* 1992 Equity Incentive Plan.................................. H 10.18 Form of Purchase Option Agreement between each of the limited partners of Nova Technology Limited Partnership and Nova........................................................ I 10.19* Nonemployee Director Stock Option Plan...................... G 10.27 Purchase Agreement dated as of July 29, 1988 between Nova and SKB Properties, Ltd..................................... M 10.29 CNS Psychiatric Products Agreement dated June 30, 1990 between SmithKline Beecham Corporation and Nova............. N 10.32 Collaboration Agreement dated December 30, 1994 between the Registrant and Genentech, Inc............................... Q 10.33 Preferred Stock Purchase Agreement dated December 30, 1994 between the Registrant and Genentech, Inc................... Q 10.34 Note Agreement dated December 30, 1994 between the Q Registrant and Genentech, Inc. (See Exhibit Number 10.41 below amending the Note Agreement).................................................. 10.35 Assignment of Lease dated March 22, 1995 for premises located at 820 West Maude Avenue, Sunnyvale, California..... R 10.38* Employment Letter dated September 8, 1998 between the Registrant and Richard B. Brewer............................ T 10.39 Purchase and Sale Agreement and Joint Escrow Instructions (Mountain View Real Estate Sale) dated May 24, 1999 between Alexandria Real Estate Equities, Inc. and Registrant's wholly owned Subsidiary Bio-Shore Holdings, Ltd. Portions of the exhibit have been omitted pursuant to a request for confidential treatment...................................... U 10.40 Biotech Equipment Schedule No. 003 dated September 17, 1999 to Master Lease Agreement dated as of July 16, 1993 between the Registrant and General Electric Capital Corporation..... V
27
EXHIBIT NUMBER REFERENCE - --------------------- --------- 10.41 First Amendment to Note Agreement and Preferred Stock dated November 3, 1999 between the Registrant and Genentech, Inc. (See Exhibit 10.34 above)................................... V 10.42 Promissory Note dated December 27, 1999 by the Registrant to Chiron Corporation.......................................... V 10.43* Change of Control Severance Plans with Employees, Officers and Chief Executive Officer................................. W 21.2 Subsidiaries of the Registrant.............................. V 23.1 Consent of PricewaterhouseCoopers LLP....................... V 24.1 Powers of Attorney. Reference is made to page 25.
- ------------------------ * Management contract or compensatory plan or arrangement. A Filed as an exhibit to Form S-1 Registration Statement (File No. 2-86086), as amended, and incorporated herein by reference. B Filed as an exhibit to Form S-1 Registration Statement (File No. 33-3186), as amended, and incorporated herein by reference. E Filed as an exhibit to Annual Report on Form 10-K for fiscal year 1988 and incorporated herein by reference. F Filed as an exhibit to Form 8-K filed on June 19, 1990 and Form 8-A Registration Statement filed on June 20, 1990 and incorporated herein by reference. G Filed as an exhibit to Form S-8 Registration Statement (File No. 33-39878) filed on April 8, 1991 and incorporated herein by reference. H Filed as an exhibit to Annual Report on Form 10-K for fiscal year 1991 and incorporated herein by reference. I Filed as an exhibit to Form S-1 Registration Statement (File No. 33-14937) filed on behalf of Nova Technology Limited Partnership and incorporated herein by reference. J Filed as an exhibit to Form S-4 Registration Statement (File No. 33-49846) filed on July 22, 1992 and incorporated herein by reference. M Filed as an exhibit to Nova's Report on Form 8-K dated July 29, 1988 and incorporated herein by reference. N Filed as an exhibit to Nova's Annual Report on Form 10-K for fiscal year 1990 and incorporated herein by reference. Q Filed as an exhibit to Annual Report on Form 10-K for fiscal year 1994 and incorporated herein by reference. R Filed as an exhibit to Quarterly Report on Form 10-Q for the quarter ended March 31, 1995 and incorporated herein by reference. T Filed as an exhibit to Annual Report on Form 10-K for fiscal year 1998 and incorporated herein by reference. U Filed as an exhibit to Quarterly Report on Form 10-Q for the quarter ended September 30, 1999 and incorporated herein by reference. V Filed as exhibits herewith. W Filed as exhibits to Report on Form 8-K dated January 24, 2000 and incorporated herein by reference. 28 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. SCIOS INC. Date: February 7, 2000 By: /s/ RICHARD B. BREWER --------------------------------------------------- Richard B. Brewer PRESIDENT AND CHIEF EXECUTIVE OFFICER
POWER OF ATTORNEY KNOW ALL MEN BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Richard B. Brewer his attorney-in-fact, with the power of substitution, for him in any and all capacities, to sign any amendments to this Annual Report on Form 10-K, and to file the same, with exhibits thereto and other documents in connection therewith, with the Securities and Exchange Commission, hereby ratifying and confirming all that the said attorney-in-fact, or his substitute or substitutes, may do or cause to be done by virtue hereof. 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.
SIGNATURE TITLE DATE --------- ----- ---- /s/ RICHARD B. BREWER President and Chief Executive Officer - --------------------------------------- (Principal Executive Officer) Richard B. Brewer February 7, 2000 /s/ DAVID W. GRYSKA Chief Financial Officer - --------------------------------------- (Principal Accounting Officer) David W. Gryska February 7, 2000 /s/ DONALD B. RICE Chairman of the Board - --------------------------------------- Donald B. Rice, Ph.D. February 7, 2000 /s/ SAMUEL H. ARMACOST Director - --------------------------------------- Samuel H. Armacost February 7, 2000 /s/ MYRON DU BAIN Director - --------------------------------------- Myron Du Bain February 7, 2000 /s/ CHARLES A. SANDERS, M.D. Director - --------------------------------------- Charles A. Sanders, M.D. February 7, 2000 /s/ SOLOMON H. SNYDER, M.D. Director - --------------------------------------- Solomon H. Snyder, M.D. February 7, 2000 /s/ BURTON E. SOBEL, M.D. Director - --------------------------------------- Burton E. Sobel, M.D. February 7, 2000 /s/ EUGENE L. STEP Director - --------------------------------------- Eugene L. Step February 7, 2000
29 INDEX TO FINANCIAL STATEMENTS Report of Independent Accountants........................... F-2 Consolidated Balance Sheets at December 31, 1999 and December 31, 1998......................................... F-3 Consolidated Statements of Operations and Comprehensive Income (Loss) for the years ended December 31, 1999, 1998 and 1997.................................................. F-4 Consolidated Statements of Cash Flows for the years ended December 31, 1999, 1998 and 1997.......................... F-5 Consolidated Statements of Stockholders' Equity for the years ended December 31, 1999, 1998, and 1997............. F-6 Notes to Consolidated Financial Statements.................. F-7
Financial Statement Schedules (Omitted because they are not required, are not applicable, or the information is included in the consolidated financials statements or notes thereto.) F-1 REPORT OF INDEPENDENT ACCOUNTANTS To the Board of Directors and Stockholders of Scios Inc.: In our opinion, the accompanying consolidated balance sheets and the related consolidated statements of operations and comprehensive income (loss) and statements of changes in stockholders' equity and of cash flows present fairly, in all material respects, the financial position of Scios Inc. and it subsidiaries at December 31, 1999 and 1998, and the results of their operations and comprehensive income (loss) and their cash flows for each of the three years in the period ended December 31, 1999 in conformity with accounting principles generally accepted in the United States. 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 of these statements in accordance with auditing standards generally accepted in the United States which require that we plan and perform the audits to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements, assessing the accounting principles used and significant estimates made by management, and evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for the opinion expressed above. PricewaterhouseCoopers LLP San Jose, California January 31, 2000 F-2 CONSOLIDATED BALANCE SHEETS
DECEMBER 31, --------------------- 1999 1998 --------- --------- (IN THOUSANDS, EXCEPT SHARE DATA) ASSETS Current assets: Cash and cash equivalents................................. $ 11,582 $ 6,683 Marketable securities..................................... 18,776 23,394 Accounts receivable....................................... 3,068 6,768 Prepaid expenses.......................................... 899 568 --------- --------- Total current assets.................................... 34,325 37,413 Marketable securities, non-current.......................... 70,354 67,234 Property and equipment, net................................. 11,534 32,214 Other assets................................................ 2,059 1,968 --------- --------- TOTAL ASSETS................................................ $ 118,272 $ 138,829 ========= ========= LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable.......................................... $ 1,572 $ 2,327 Other accrued liabilities................................. 11,157 10,107 Deferred contract revenue................................. 17,890 16,896 Current portion of long term debt......................... 2,000 -- --------- --------- Total current liabilities............................... 32,619 29,330 Long-term debt.............................................. 42,866 34,573 --------- --------- Total liabilities....................................... 75,485 63,903 --------- --------- Commitments and contingencies (Notes 10, 11 and 12) Stockholders' equity: Preferred stock; $.001 par value; 20,000,000 shares authorized; none issued and outstanding................. -- -- Common stock; $.001 par value; 150,000,000 shares authorized; issued and outstanding 38,468,652 and 38,468,652 shares, respectively......................... 38 38 Additional paid-in capital................................ 416,600 416,428 Treasury stock; 735,036 and 754,199 shares, respectively............................................ (3,458) (3,481) Notes receivable from stockholders........................ (108) (145) Deferred compensation, net................................ (340) (505) Accumulated other comprehensive income (loss)............. (1,060) 11,412 Accumulated deficit....................................... (368,885) (348,821) --------- --------- Total stockholders' equity.............................. 42,787 74,926 --------- --------- TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY.................. $ 118,272 $ 138,829 ========= =========
The accompanying notes are an integral part of these consolidated financial statements. F-3 CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)
YEAR ENDED DECEMBER 31, ------------------------------------------------ 1999 1998 1997 -------------- -------------- -------------- (IN THOUSANDS, EXCEPT PER SHARE AND SHARE DATA) Revenues: Product sales............................................. $ 33,824 $ 29,101 $ 35,193 Co-promotion commissions.................................. 8,561 6,513 5,822 Research & development contracts.......................... 18,402 38,101 6,414 ----------- ----------- ----------- 60,787 73,715 47,429 ----------- ----------- ----------- Costs and expenses: Cost of goods sold........................................ 18,470 16,606 20,179 Research and development.................................. 34,305 46,637 41,907 Marketing, general and administration..................... 21,044 19,407 20,720 Profit distribution to third parties...................... 4,901 3,056 4,360 Restructuring charges..................................... 6,400 -- -- ----------- ----------- ----------- 85,120 85,706 87,166 ----------- ----------- ----------- Loss from operations........................................ (24,333) (11,991) (39,737) Other income (expense): Investment income......................................... 4,828 4,154 3,966 Interest expense.......................................... (2,793) (2,685) (2,229) Realized gains on securities.............................. 4,933 9,003 -- Other income (expense).................................... (2,685) 630 594 ----------- ----------- ----------- 4,283 11,102 2,331 Equity in net loss of affiliate............................. -- (1,343) (1,261) ----------- ----------- ----------- Loss before provision for income taxes...................... (20,050) (2,232) (38,667) Provision for income taxes.................................. (14) (131) -- ----------- ----------- ----------- Net Loss.................................................. (20,064) (2,363) (38,667) ----------- ----------- ----------- Other comprehensive income (loss): Change in unrealized gains (losses) on securities......... (12,472) 11,124 358 ----------- ----------- ----------- Comprehensive income (loss)................................. $ (32,536) $ 8,761 $ (38,309) ----------- ----------- ----------- Loss per common share: Basic and diluted......................................... $ (0.53) $ (0.06) $ (1.07) =========== =========== =========== Weighted average number of common shares outstanding used in calculation of: Basic and diluted......................................... 37,730,048 37,694,358 36,105,797 =========== =========== ===========
The accompanying notes are an integral part of these consolidated financial statements. F-4 CONSOLIDATED STATEMENTS OF CASH FLOWS
YEAR ENDED DECEMBER 31, --------------------------------- 1999 1998 1997 --------- --------- --------- (IN THOUSANDS) Cash flows from operating activities: Net loss.................................................. $ (20,064) $ (2,363) $ (38,667) Adjustments to reconcile net loss to net cash provided by (used in) operating activities: Depreciation and amortization........................... 3,473 3,845 5,740 Accrued interest payable................................ 2,793 2,577 1,919 Loss on disposal of property and equipment.............. 429 -- -- Equity in net loss of affiliate......................... -- 1,343 1,261 Amortization of deferred compensation................... 317 92 -- Change in assets and liabilities: Accounts receivable................................... 3,700 (1,553) (407) Accounts payable...................................... (754) 642 (822) Other accrued liabilities............................. (2) (950) 1,046 Deferred contract revenue............................. 994 5,244 7,986 Restructuring charges................................. 1,052 -- -- Other................................................. (422) 168 370 --------- --------- --------- Net cash provided by (used in) operating activities........................................ (8,484) 9,045 (21,574) --------- --------- --------- Cash flows from investing activities: Purchases of property and equipment....................... (4,975) (2,476) (2,490) Proceeds from sale of investment in affiliate............. -- 459 90 Proceeds from sale of facilities.......................... 21,754 -- 6 Sales/maturities of marketable securities................. 105,240 260,388 264,745 Purchases of marketable securities........................ (116,368) (276,654) (258,307) --------- --------- --------- Net cash provided by (used in) investing activities........................................ 5,651 (18,283) 4,044 --------- --------- --------- Cash flows from financing activities: Issuance of common stock and collection of notes receivable from stockholders, net....................... 1,280 7,572 1,641 Purchase of treasury stock................................ (1,048) (1,509) (1,767) Payment of notes payable.................................. -- (339) (3,734) Proceeds from notes payable............................... 7,500 -- 30,000 --------- --------- --------- Net cash provided by financing activities........... 7,732 5,724 26,140 --------- --------- --------- Net increase (decrease) in cash and cash equivalents........ 4,899 (3,514) 8,610 Cash and cash equivalents at beginning of year.............. 6,683 10,197 1,587 --------- --------- --------- Cash and cash equivalents at end of year.................... $ 11,582 $ 6,683 $ 10,197 --------- --------- --------- Supplemental cash flow data: Cash paid during the year for interest.................... $ -- $ 21 $ 309 Supplemental disclosure of non-cash investing and financing: Change in net unrealized gains(losses) on securities...... $ (12,472) $ 11,124 $ 358 Investment in affiliate................................... -- $ 1,343 $ 4,949 Write off of fully depreciated assets..................... $ 13,407 $ 143 $ 39
The accompanying notes are an integral part of these consolidated financial statements. F-5 CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY
NOTES COMMON COMMON ADDITIONAL RECEIVABLE PREFERRED STOCK STOCK PAID-IN TREASURY FROM SHARES SHARES PAR VALUE CAPITAL STOCK STOCKHOLDERS --------- ---------- ---------- ---------- --------- ------------- (IN THOUSANDS, EXCEPT SHARE DATA) Balances at January 1, 1997.......... 12,632 36,506,297 $37 $404,456 $(2,991) $ (13) ------- ---------- --- -------- ------- ----- Conversion of preferred.............. (12,632) 1,263,200 1 (1) Purchase of treasury stock........... (1,767) Options exercised.................... 262,621 1,641 Stock issued for services............ 2 Changes in unrealized gains on available-for-sale securities...... Investment in Guilford............... 4,949 Net loss............................. ------- ---------- --- -------- ------- ----- Balances at December 31, 1997........ -- 38,032,120 38 411,045 (4,758) (13) ------- ---------- --- -------- ------- ----- Common stock issued.................. 262,283 3,048 Purchase of treasury stock........... (1,509) Options exercised.................... 677,249 4,524 Treasury stock reissued.............. (603,000) (2,786) 2,786 Notes receivable from stockholders... (132) Deferred Compensation................ 100,000 597 Amortization of deferred compensation....................... Changes in unrealized gains (losses) on available-for-sale securities... Net loss............................. ------- ---------- --- -------- ------- ----- Balances at December 31, 1998........ -- 38,468,652 38 416,428 (3,481) (145) ------- ---------- --- -------- ------- ----- Purchase of treasury stock........... (1,048) Options exercised.................... 185,163 1,243 Treasury stock reissued.............. (225,163) (1,223) 1,071 Notes receivable from stockholders... 37 Deferred Compensation................ 40,000 152 Amortization of deferred compensation....................... Changes in unrealized gains (losses) on available-for-sale securities... Net loss............................. ------- ---------- --- -------- ------- ----- Balances at December 31, 1999........ -- 38,468,652 $38 $416,600 $(3,458) $(108) ------- ---------- --- -------- ------- ----- ACCUMULATED OTHER DEFERRED COMPREHENSIVE ACCUMULATED COMPENSATION INCOME (LOSS) DEFICIT TOTAL -------------- --------------- ------------- -------- (IN THOUSANDS, EXCEPT SHARE DATA) Balances at January 1, 1997.......... $ -- $ (70) $(307,791) $93,628 ----- -------- --------- ------- Conversion of preferred.............. -- Purchase of treasury stock........... (1,767) Options exercised.................... 1,641 Stock issued for services............ -- Changes in unrealized gains on available-for-sale securities...... 358 358 Investment in Guilford............... 4,949 Net loss............................. (38,667) (38,667) ----- -------- --------- ------- Balances at December 31, 1997........ -- 288 (346,458) 60,142 ----- -------- --------- ------- Common stock issued.................. 3,048 Purchase of treasury stock........... (1,509) Options exercised.................... 4,524 Treasury stock reissued.............. -- Notes receivable from stockholders... (132) Deferred Compensation................ (597) -- Amortization of deferred compensation....................... 92 92 Changes in unrealized gains (losses) on available-for-sale securities... 11,124 11,124 Net loss............................. (2,363) (2,363) ----- -------- --------- ------- Balances at December 31, 1998........ (505) 11,412 (348,821) 74,926 ----- -------- --------- ------- Purchase of treasury stock........... (1,048) Options exercised.................... 1,243 Treasury stock reissued.............. (152) Notes receivable from stockholders... 37 Deferred Compensation................ (152) -- Amortization of deferred compensation....................... 317 317 Changes in unrealized gains (losses) on available-for-sale securities... (12,472) (12,472) Net loss............................. (20,064) (20,064) ----- -------- --------- ------- Balances at December 31, 1999........ $(340) $ (1,060) $(368,885) $42,787 ----- -------- --------- -------
The accompanying notes are an integral part of these consolidated financial statements. F-6 NOTES TO CONSOLIDATED FINANCIAL STATEMENTS 1. BUSINESS OF THE COMPANY Scios Inc. (the "Company") is a biopharmaceutical company engaged in the discovery, development and commercialization of novel human therapeutics. The Company's research and development efforts are primarily focused on cardiorenal disorders, inflammatory disorders and Alzheimer's disease. The Company has research and development collaborations with a number of other biopharmaceutical companies under which it may share costs and revenues. The Company's psychiatric sales and marketing division also markets seven psychiatric products in the United States in co-operation with the Company's partners. In the course of its development activities, the Company has sustained operating losses and expects such losses to continue through fiscal 2000. 2. RESTRUCTURING CHARGES AND EXPENSES In March 1999, the Company announced a restructuring plan that included reduction of the Company's full-time workforce by approximately 30% and the consolidation of its headquarters, development and research staff into leased facilities in Sunnyvale, California. In the first quarter of 1999, the Company recorded a restructuring charge of approximately $6.7 million for the disposal of certain excess assets and severance costs. In the fourth quarter the restructuring expense was reduced to $6.4 million primarily due to the decrease in estimated loss on asset disposals. Selected information related to the restructuring plan follows:
WORKFORCE ASSET LEASE CONTRACTUAL 1999 RESTRUCTURING CHARGES REDUCTIONS DISPOSALS EXIT COSTS COMMITMENTS FACILITIES TOTAL - -------------------------- ---------- --------- ---------- ----------- ---------- -------- Restructuring provisions at March 1,........... $ 2,819 $ 1,800 $ 581 $ 1,110 $ 360 $ 6,670 First quarter activity....................... (781) (144) (925) Second quarter activity...................... (1,024) (1,273) (309) (137) (256) (2,999) Third quarter activity....................... (395) 1,347 31 (31) (48) 904 Fourth quarter activity...................... (93) (474) (1,517) (243) (1) (2,328) ------- ------- ------- ------- ----- ------- Charges to restructure in 1999................. (2,293) (400) (1,795) (555) (305) (5,348) Fourth quarter changes in estimate........... 233 (1,400) 1,507 (555) (55) (270) ------- ------- ------- ------- ----- ------- Restructuring liability at December 31, 1999... $ 759 $ -- $ 293 $ -- $ -- $ 1,052 ======= ======= ======= ======= ===== =======
3. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES PRINCIPLES OF CONSOLIDATION The consolidated financial statements include the accounts of the Company and its wholly-owned and majority-owned subsidiaries. Other affiliates, more than 20% but less than 50% owned, are accounted for on the equity basis. Intercompany transactions and balances are eliminated on consolidation. The Company accounted for its 7% ownership in Guilford Pharmaceuticals Inc. ("Guilford") under the equity method through September 1998 because it had representation on Guilford's Board of Directors. In October 1998, the Company reclassified its Guilford investment to marketable securities because of a change in the Company's representation on Guilford's Board of Directors. As of December 31, 1999, the Company had no ownership in Guilford. F-7 NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) 3. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (CONTINUED) USE OF ESTIMATES The preparation of financial statements in conformity with generally accepted accounting principals 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 statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. CASH EQUIVALENTS The Company considers all highly liquid investments with maturities of less than 90 days, at the time acquired, to be cash equivalents. Cash equivalents are stated at cost, which approximates market value. MARKETABLE SECURITIES All marketable securities at December 31, 1999 and 1998 were deemed by management to be available-for-sale and are stated at fair value with net unrealized gains or losses reported in stockholders' equity. Realized gains and losses on sales of all such securities are reported in earnings and computed using the specific identification cost method. BUSINESS RISK AND CREDIT CONCENTRATION Approximately 56% of the Company's total revenues in 1999 were derived from product sales, which consist entirely of sales in the U.S. under a license agreement with SmithKline Beecham Corp. ("SB") (see Note 4). Any factor adversely affecting demand for, or supply of, the psychiatric products covered by the license agreement could materially adversely affect the Company's business and financial performance. In December 1999, the Company announced a possible temporary shortage of Eskalith CR(-Registered Trademark-) (lithium carbonate), one of five products developed and manufactured by SB that are sold by the Company. In 1999, license revenues from Chiron Corporation ("Chiron) accounted for 27%, milestone payments from Novo Nordisk A/S accounted for 22% and Alzheimer's research reimbursement from Eli Lilly and Company ("Lilly") accounted for 21% of total research and development contract revenue. Approximately 11% of 1999 and 64% of 1998 research and development contract revenues were from the agreement with Bayer AG ("Bayer") for commercialization of Natrecor(-Registered Trademark-)(nesiritide). The agreement with Bayer was terminated in May 1999 after non-approval of Natrecor(-Registered Trademark-) by the Food and Drug Administration. In 1997, no individual customer or partner contributed more than 10% to total revenues. At December 31, 1999, the $3.1 million in accounts receivable included $1.4 million from SB, $1.1 million from Janssen Pharmaceutica Inc. ("Janssen"), and $0.3 million from the National Institutes of Health. At December 31, 1998, the $6.8 million in accounts receivable included $3.3 million from Bayer, $1.0 million from Janssen and $2.1 million from SB. The Company's excess cash is invested in a diversified portfolio of securities consisting of U.S. Treasury Notes, deposits with five major banks and financial institutions, and investment-grade interest-bearing corporate securities issued by companies in a variety of industries. In addition, the Company owned 1,367,500 shares of Guilford stock that was recorded on December 31, 1998 at fair value as an available-for-sale marketable security. All the Guilford shares were sold in 1999. F-8 NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) 3. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (CONTINUED) Certain of the Company's products require approval from the Food and Drug Administration and foreign regulatory agencies prior to commercialized sales and are subject to continued regulations once approved. There can be no assurances that the Company's new products will receive any of these required approvals. If the Company were denied such approvals or such approvals were delayed, it could have a materially adverse impact on the Company. DEPRECIATION AND AMORTIZATION Buildings and equipment are stated at cost and are depreciated using the straight-line method over the estimated useful lives of the assets (3 to 7 years for equipment and 40 years for buildings). Leasehold improvements are amortized on a straight-line basis over the shorter of the asset life or fixed-lease term. Upon sale or retirement of assets, the cost and related accumulated depreciation or amortization are removed from the balance sheet, and the resulting gain or loss is reflected in operations. In March 1999, the Company announced a restructuring plan that included consolidation of its headquarters, development and research staff into leased facilities in Sunnyvale, California. On a prospective basis the Company changed its estimate for the amortization of the Sunnyvale leasehold improvements to conform with the Company's intentions for future use of the leased premises. The effect of this change in estimate on net loss for the year ended December 31, 1999 was to increase the net loss by approximately $956,000 or $0.02 per share. PRODUCT SALES Revenue from product sales is recognized in the period in which the products are shipped. Provision is made for estimated returns and allowances, cash discounts and rebates attributable to Medicaid programs related to sales of the SB Products. CO-PROMOTION COMMISSIONS Revenue from co-promotion commissions (see Note 4) is recognized based on estimated sales levels of Janssen's psychiatric product Risperdal(-Registered Trademark-)(risperidone) ("Risperdal(-Registered Trademark-)") and SB's psychiatric product Paxil(-Registered Trademark-) (paroxetine HCl) ("Paxil(-Registered Trademark-)") for their respective contract years. CONTRACT REVENUES Research and development contract revenues from cost-reimbursement agreements are recorded as the related expenses are incurred, up to contractual limits. Payments received that are related to future performance are deferred and recorded as revenues as they are earned over specified future performance periods. Research and development payments for which no services are required to be performed in the future, license payments irrevocably received and royalty payments based on sales to third parties are recognized as revenues upon receipt. Research and development expenses in 1999, 1998, and 1997 include approximately $5.2 million, $4.9 million and $2.1 million, respectively, incurred in connection with programs subject to cost reimbursement, collaborative or other performance agreements. TREASURY STOCK Treasury stock is stated at cost and is considered issued and outstanding. F-9 NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) 3. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (CONTINUED) FAIR VALUE OF FINANCIAL INSTRUMENTS Carrying amounts of certain of the Company's financial instruments including cash and cash equivalents, accounts receivable, accounts payable and other accrued liabilities approximate fair value due to their short maturities. Based on borrowing rates currently available to the Company for loans with similar terms, the carrying value of notes payable approximates fair value. Estimated fair values for marketable securities, which are separately disclosed elsewhere, are based on quoted market prices for the same or similar instruments. COMPUTATION OF NET LOSS PER SHARE Basic net loss per share is calculated using the weighted average number of common shares outstanding for the period. Diluted net loss is calculated using the weighted average number of common and dilutive common equivalent shares outstanding during the period. The outstanding options to purchase common stock were excluded from diluted earnings calculations for 1999, 1998, and 1997 because inclusion of the options would have been anti-dilutive. COMPREHENSIVE INCOME (LOSS) The Company's unrealized gains (losses) on marketable securities represent the only component of comprehensive income, that is excluded from net loss for 1999 and prior years. The Company's comprehensive income (loss) has been presented in the consolidated financial statements. As the Company is in a loss position tax effects have not been allocated to the components of other comprehensive income (loss). Accumulated other comprehensive income (loss) balances are as follows for the years ended (in thousands):
ACCUMULATED UNREALIZED OTHER GAINS (LOSSES) COMPREHENSIVE ON SECURITIES INCOME (LOSS) -------------- ------------- Balance, December 31, 1997............................... $ 288 $ 288 Current period change.................................... 11,124 11,124 Balance, December 31, 1998............................... 11,412 11,412 Current period change.................................... (12,472) (12,472) Balance, December 31, 1999............................... $ (1,060) $ (1,060)
INCOME TAXES The Company accounts for income taxes under Statement of Financial Accounting Standard No. 109, "Accounting for Income Taxes," which prescribes the use of the liability method whereby deferred tax asset or liability account balances are calculated at the balance sheet date using current tax laws and rates in effect for the year in which the differences are expected to affect taxable income. Valuation allowances are established when necessary to reduce deferred tax assets to the amounts expected to be realized. RECLASSIFICATION Certain amounts in the financial statements have been reclassified to conform with the current year's presentation. The reclassifications had no impact on previously reported net loss. F-10 NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) 3. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (CONTINUED) RECENT PRONOUNCEMENTS In June 1998, the FASB issued Statement of Financial Accounting Standards No. 133, ("SFAS 133"), "Accounting for Derivative Instruments and Hedging Activities." SFAS 133 establishes new standards of accounting and reporting for derivative instruments and hedging activities. SFAS 133 will be effective for fiscal years beginning in 2000. The Company does not currently hold derivative instruments or engage in hedging activities. In December 1999, the staff of the Securities and Exchange Commission issued Staff Accounting Bulletin No. 101 (SAB 101), REVENUE RECOGNITION IN FINANCIAL STATEMENTS. SAB 101 requires that license and other upfront fees received from research collaborators be recognized over the term of the agreement unless the fee is in exchange for products delivered or services performed that represent the culmination of a separate earnings process. The Company has not yet determined the impact of its implementation on the reporting of the Company's contract revenue. 4. JOINT BUSINESS ARRANGEMENTS A. AGREEMENT WITH CHIRON CORPORATION In November 1999, the Company signed a license agreement with Chiron for the rights to Fiblast(-Registered Trademark- ) (trafermin). Fiblast(-Registered Trademark-) is a human basic fibroblast growth factor. The Company received $5.0 million in license fees and $7.5 million from a Promissory Note due on December 31, 2006. The note and related interest is forgiven if Fiblast(-Registered Trademark-) is approved by the Food and Drug Administration before December 31, 2006. The Company will also receive royalties based on sales of Fiblast(-Registered Trademark-) products. B. AGREEMENT WITH JANSSEN PHARMACEUTICA INC. The Company entered into a three-year agreement, effective in April 1998, with Janssen to jointly promote the anti-psychotic, Risperdal(-Registered Trademark-), in the United States. Under the agreement, the Company receives base payments plus incentive compensation on achieving specified sales levels over a contract year beginning in April and ending in March. Janssen manufactures and distributes the product. The agreement may be extended by mutual agreement for additional periods of at least 12 months each. C. AGREEMENT WITH SMITHKLINE BEECHAM CORPORATION Under the terms of an agreement with SB, the Company has the exclusive rights to market certain SB Products in the U.S. SB is fully responsible for ancillary matters relating to sales of the SB Products (including various administrative tasks), for the maintenance in good standing of all New Drug Applications with respect to the SB Products and for the maintenance of certain product liability insurance. The Company pays SB 40% of net profits, as defined in the agreement, from sales of the SB Products. In September 1998, the Company entered into an agreement with SB to co-promote Paxil(-Registered Trademark-) in the United States. Paxil(-Registered Trademark-), which regulates the brain chemical serotonin, is currently approved to treat depression, panic disorder, social anxiety and obsessive-compulsive disorder. Under the agreement, the Company receives base payments plus incentive compensation on achieving specified sales levels during a specified term. The companies are currently in discussions on revising the incentive compensation structure. F-11 NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) 4. JOINT BUSINESS ARRANGEMENTS (CONTINUED) D. AGREEMENT WITH DUPONT PHARMACEUTICALS COMPANY In December 1997, the Company entered into an agreement with DuPont Pharmaceuticals Company ("DuPont") establishing a research collaboration in the area of Alzheimer's disease with the goal of developing pharmaceuticals that prevent or retard the disease. Under the terms of the agreement, DuPont will fund research at the Company and will have responsibility to develop and commercialize products from this collaboration. DuPont also purchased $3.0 million of the Company's common stock in 1998 and will make milestone and royalty payments to the Company as products advance through development. E. AGREEMENT WITH ELI LILLY AND COMPANY In May 1997, the Company entered into a research collaboration with Lilly for the development of drugs to prevent or retard the progression of Alzheimer's disease. Under the terms of the agreement, Lilly will fund research and will have the first opportunity to develop products from the collaboration. The Company may elect to develop other products from the collaboration. The commercialization partner will make milestone and royalty payments to the other partner. In 1998, the agreement was amended to increase the funding for additional research staff to facilitate future product completions. F. AGREEMENTS WITH KAKEN PHARMACEUTICAL CO., LTD. In September 1994, the Company entered into a series of agreements with Kaken Pharmaceutical Co., Ltd. ("Kaken") to expand a previous agreement signed in 1988 for Fiblast(-Registered Trademark-). Under the 1994 agreements, the Company will collaborate with Kaken to further develop the Fiblast(-Registered Trademark-) manufacturing process, provide Kaken a license to the Company's Fiblast(-Registered Trademark-) manufacturing technology and supply a specified amount of Fiblast(-Registered Trademark-) product. In return, the Company has received milestone payments, which are contingent on Kaken's continuing development of the product. On December 31, 1999, $15.9 million of the Company's deferred revenue consisted of payments received for the supply of Fiblast(-Registered Trademark-) material. Prior to closing its Mountain View manufacturing facility in May 1999, the Company produced the amount of Fiblast(-Registered Trademark-) due to Kaken and the Company now holds it for delivery to Kaken upon regulatory approval of the product in Japan. G. AGREEMENTS WITH WYETH-AYERST LABORATORIES In October 1996, the Company entered into a collaboration agreement with Wyeth-Ayerst, an affiliate of American Home Products Corp., for the joint development and commercialization of Fiblast(-Registered Trademark-) for the treatment of neurological and cardiovascular disorders. The two companies shared development costs. Wyeth-Ayerst terminated its agreement with the Company in the second half of 1999. All rights in Fiblast(-Registered Trademark-) reverted to the Company. In April 1996, the Company entered into an agreement with Wyeth-Ayerst to promote the antidepressant Effexor(-Registered Trademark-) (venlafaxine hydrochloride) to selected psychiatrists in the U.S. Under the agreement, the Company received payments based on achieving specified increases in sales to the selected psychiatrists over an adjusted base level during each contract year beginning in June 1996. Wyeth-Ayerst manufactured and distributed the product. The agreement was terminated by mutual agreement in April 1998. F-12 NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) H. AGREEMENT WITH GENENTECH, INC. In December 1994, the Company entered into a collaboration agreement with Genentech, Inc. ("Genentech") for the development and commercialization of Auriculin(-Registered Trademark-) (anaritide) for the treatment of acute renal failure. Concurrent with the collaboration agreement, Genentech purchased $20.0 million of the Company's preferred stock, convertible into approximately 2.1 million shares of common stock and provided a $30.0 million loan to the Company in the form of a letter of credit (see Note 10), which the Company drew down in March of 1997. As of December 31, 1997, Genentech had converted all shares of preferred stock into common stock. In 1997, the Company and Genentech discontinued development of Auriculin(-Registered Trademark-) based upon negative results of a clinical study. I. AGREEMENT WITH ORTHO-MCNEIL PHARMACEUTICAL In July 1993, the Company entered into a five-year agreement with Ortho-McNeil, an affiliate of Johnson & Johnson, to jointly promote the injectable antipsychotic Haldol(-Registered Trademark-) Decanoate (haloperidol) in the U.S. Under the agreement, the Company received payments based on achieving specified sales levels over a contract year beginning in August and ending in July. Ortho-McNeil manufactured and distributed the product. The agreement was terminated by mutual agreement in April 1998. J. AGREEMENT WITH BAYER AG In May 1998, the Company entered into an agreement with Bayer for the commercialization of Natrecor(-Registered Trademark-), a new drug for the short-term management of congestive heart failure (CHF). Upon signing the contract, the Company received a payment of $20.0 million. In May 1999, Bayer terminated the agreement after the drug was not approved by the Food and Drug Administration. All rights to Natrecor(-Registered Trademark-) reverted to the Company without any payment being due from the Company. 5. AFFILIATE In June 1994, Guilford, then a fully consolidated subsidiary of the Company, completed an initial public offering, which decreased the Company's percentage ownership from 62% to 29%. As a result, the equity method of accounting was adopted by the Company. Prior to the date of the public offering, the financial results of Guilford were fully consolidated with those of the Company. Due to subsequent public stock offerings, and the sale by the Company of 200,000 shares of Guilford stock in 1996, 12,500 shares in 1997, and 70,000 shares in 1998, the Company's ownership in Guilford was reduced to 7%. The Company continued to use the equity method of accounting for its investment in Guilford through September 1998 because it had representation on Guilford's Board of Directors. In October 1998, the Company reclassified its Guilford investment to marketable securities because of a change in the Company's representation on Guilford's Board of Directors. At December 31, 1999, the Company had no ownership in Guilford. F-13 NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) 6. MARKETABLE SECURITIES Unrealized gains and losses on marketable securities at December 31, 1999 by classification were as follows:
ACCRUED UNREALIZED UNREALIZED COST BASIS INTEREST GAINS LOSSES FAIR VALUE ---------- -------- ---------- ---------- ---------- (IN THOUSANDS) Debt securities: U.S. Government & Government Agency Securities.............. $46,083 $457 $-- $ (688) $45,852 Corporate Bonds.................... 43,142 508 5 (377) 43,278 ------- ---- --- ------- ------- Total............................ $89,225 $965 $ 5 $(1,065) $89,130 ======= ==== === ======= =======
Unrealized gains and losses on marketable securities at December 31, 1998 by classification were as follows:
ACCRUED UNREALIZED UNREALIZED COST BASIS INTEREST GAINS LOSSES FAIR VALUE ---------- -------- ---------- ---------- ---------- (IN THOUSANDS) Debt securities: U.S. Government & Government Agency Securities.............. $32,722 $286 $ 346 $ (7) $33,347 Corporate Bonds.................... 37,117 355 260 (21) 37,711 Equity Investments................. 8,736 -- 10,834 -- 19,570 ------- ---- ------- ---- ------- Total............................ $78,575 $641 $11,440 $(28) $90,628 ======= ==== ======= ==== =======
The scheduled maturities for marketable securities at December 31, 1999 by classification were as follows:
MATURITY MATURITY 1 YEAR OR LESS GREATER THAN 1 YEAR -------------- ------------------- (IN THOUSANDS) Debt securities: U.S. Government & Government Agency Securities....... $ 4,741 $41,111 Corporate Bonds........................................ 14,035 29,243 ------- ------- Total................................................ $18,776 $70,354 ======= =======
The Company realized gains of $5,192,055 and losses of $259,402 on the disposal of marketable securities during 1999 and gains of $9,099,000 and losses of $96,000 on the disposal of marketable securities during 1998. F-14 NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) 7. PROPERTY AND EQUIPMENT
DECEMBER 31, ------------------- 1999 1998 -------- -------- (IN THOUSANDS) Laboratory equipment........................................ $ 7,197 $ 12,802 Computer and related equipment.............................. 2,260 4,780 Furniture and other......................................... 1,202 2,519 Buildings and building improvements......................... 8,334 49,878 ------- -------- 18,993 69,979 Accumulated depreciation and amortization................... (8,938) (38,827) ------- -------- 10,055 31,152 Construction in progress.................................... 1,479 1,062 ------- -------- Total....................................................... $11,534 $ 32,214 ======= ========
8. OTHER ASSETS
DECEMBER 31, ------------------- 1999 1998 -------- -------- (IN THOUSANDS) Deposits.................................................... $ 354 $ 229 Other assets................................................ 1171 304 Equity investments.......................................... -- 1,067 Employee notes receivable................................... 534 368 ------ ------ Total....................................................... $2,059 $1,968 ====== ======
9. OTHER ACCRUED LIABILITIES
DECEMBER 31, ------------------- 1999 1998 -------- -------- (IN THOUSANDS) Accrued contract payable.................................... $ -- $ 1,220 Accrued Medicaid rebates.................................... 1,688 781 Accrued payroll............................................. 2,619 3,566 Profit distribution to third parties........................ 723 1,212 Accrued clinical trial expenses............................. 608 1,231 Restructure reserve......................................... 1,052 -- Accrued Biotechnology Research Partners, Ltd. royalties..... 1,657 -- Other....................................................... 2,810 2,097 ------- ------- Total....................................................... $11,157 $10,107 ======= =======
F-15 NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) 10. LEASE AND DEBT COMMITMENTS A. OPERATING LEASES The Company leases two facilities in Sunnyvale, California; these facilities leases expire in 2001 and 2002 with an option to extend. In addition, the Company has entered into operating leases covering certain laboratory and computer equipment. Future minimum payments under these leases are as follows:
FACILITIES EQUIPMENT OPERATING OPERATING LEASES LEASES ---------- --------- (IN THOUSANDS) 2000........................................................ $1,534 $452 2001........................................................ 1,646 201 2002........................................................ 139 151 ------ ---- Total....................................................... $3,319 $804 ====== ====
Rent expenses for all facilities operating leases were approximately $2,170,000, $963,000, and $1,112,000 in 1999, 1998 and 1997, respectively. In 1999, the Company entered into a $4.0 million equipment operating lease line that expires December 2001. At December 31, 1999, approximately $612,000 had been drawn against the line of credit. B. BORROWING ARRANGEMENTS As part of the Auriculin(-Registered Trademark-) agreement, Genentech committed to loan the Company up to $30.0 million. The $30.0 million was drawn down in March of 1997, and bears interest at the prime rate (8.5% at December 31, 1999). In 1999 the terms of the loan were amended. The loan is repayable in the Company's preferred stock up to a maximum of $25.0 million at the Company's option at any time through December 31, 2002. In the event the Company converts the loan to preferred stock, the stock cannot be sold or registered by Genentech until December 30, 2002. In addition, if the Company should decide to convert the loan to preferred stock, a portion of the loan that is not convertible will become due and payable before December 31, 2002. The amount of the loan that is due before the maturity date is based on a formula that considers the amount of loan converted to stock and the outstanding loan balance. In addition, as part of the amendment $2.0 million of the loan was classified as current at December 31, 1999. As part of the Fiblast(-Registered Trademark-) agreement, Chiron loaned the Company $7.5 million in December 1999. The loan bears interest at the prime rate (8.5% at December 31, 1999) and is due December 31, 2006. The note and related interest are forgiven if Fiblast(-Registered Trademark-) is approved by the Food and Drug Administration before December 31, 2006. In 1998, the Company's paid off two five-year notes that were secured by equipment. C. NATRECOR(-REGISTERED TRADEMARK-) SUPPLY CONTRACT In November 1995, the Company has entered into a long-term supply agreement with a manufacturer for the supply of bulk Natrecor(-Registered Trademark-). The contract provides for the purchase of at least 25 kg of bulk solution over an eight-year period after the first delivery of commercialized quantities at a price of approximately 48.0 million German marks (U.S. equivalent at December 31, 1999, $24.6 million). F-16 NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) 11. LITIGATION On November 29, 1995, the Company was notified by the United States Environmental Protection Agency ("EPA") that it may have a liability in connection with the clean-up of a toxic waste site arising out of the alleged disposal of hazardous substances by a subcontractor of Nova Pharmaceutical Corporation, which the Company acquired in 1992. The Company is one of many potentially responsible parties that have been identified as associated with this specific site. The Company had discussions with the EPA and finalized the amount of potential liability. The Company has accrued $90,000 at December 31, 1999 as provision for the settlement thereof. 12. RESEARCH AND DEVELOPMENT COMMITMENTS A. RESEARCH COMMITMENTS The Company's commitments for payments to research consultants and institutions are $75,000 in 2000, $75,000 in 2001, and $58,000 in 2002. B. COMMITMENTS TO RESEARCH PARTNERSHIPS Under the Company's collaboration agreement with Wyeth-Ayerst for the development and commercialization of Fiblast(-Registered Trademark-), the Company was obligated to pay 30% of the joint development expenses, with Wyeth-Ayerst responsible for the remaining 70%. The collaboration was dissolved in the second half of 1999. At December 31,1999, $300,000 was accrued for the final payment of joint development expenses to Wyeth-Ayerst. In 1988, the Company purchased the interests of Biotechnology Research Partners, a limited partnership in a joint venture, and made a down payment of $575,000. The balance of the purchase price is to be paid in quarterly installments in accordance with the following formula: (i) until the minority partners have received payments of approximately $22.8 million, the Company will pay approximately 37% of the royalty income from third-party licenses and approximately 3.7% of the Company's gross sales of Partnership products; (ii) thereafter, until the minority partners have received aggregate payments of approximately $34.1 million, the Company will pay approximately 31% of the royalty income and approximately 3.1% of the Company's gross sales of Partnership products; and (iii) thereafter, until the earlier of September 30, 2008 or the time all patents relating to the Partnership's technology expire and all information relating to that technology becomes part of the public domain, the Company will pay to the minority partners approximately 20.5% of the royalty income and approximately 2% of the Company's gross sales of Partnership products. Partnership products for which minority partners will receive payments include Fiblast(-Registered Trademark-). The Company has accrued $1.7 million at December 31, 1999 as the partnership's share of license fees received from Fiblast(-Registered Trademark-) in 1999. In December 1992, the Company exercised its option to acquire all interests in Nova Technology Limited Partnership for $20.4 million. The Company also issued contingent payment rights to all limited partners of the partnership, pursuant to which the Company is obligated until January 15, 2008 to pay royalties on the sale or license of certain products that were under development by the partnership. As of December 31, 1999, $190,444 was accrued in 2000 primarily as a result of royalties associated with the commercialization of Guilford's Gliadel(-Registered Trademark-) wafer. 13. STOCKHOLDERS' EQUITY Warrants to purchase approximately 789,000 shares of the Company's common stock at $26.74 per share expired unexercised in June 1998. At December 31, 1999, there were no warrants outstanding. F-17 NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) 13. STOCKHOLDERS' EQUITY (CONTINUED) A. CONVERTIBLE PREFERRED STOCK The Company's convertible preferred stock may be issued in series that have such rights as may be designated by the Board of Directors from time to time. There were no shares of preferred stock issued and outstanding at December 31, 1999. B. COMMON STOCK The Company has a Common Share Purchase Rights Plan under which stockholders have a right to purchase for each share held, one share of the Company's common stock at a 50% discount and, in certain circumstances, a share of common stock of an acquirer at a similar discount. The rights become exercisable, at $55.00 per right, in the event of an acquisition or tender offer, which results in the acquisition of 20% or more of the Company's common stock. The rights may be redeemed, in certain circumstances, at $0.01 per right and expire on July 31, 2000. C. DEFERRED COMPENSATION In August 1999, the Company granted shares of restricted stock to an officer. The shares vest over a three-year period provided that the recipient is still employed by the Company. The market value of the shares awarded was $152,480 and has been recorded as a separate component of stockholders' equity. In September 1998, the Company granted shares of restricted stock to an officer and director. The shares vest over a two-year period provided that the recipient is still employed by the Company. The market value of the shares awarded was $597,000 and has been recorded as a separate component of stockholders' equity. Deferred compensation for both of these share grants is being amortized over the applicable period of the vesting. The restricted stock was granted under the 1992 Incentive Stock Plan. 14. EMPLOYEE 401(k) BENEFIT PLAN The Company has a qualified profit sharing plan and trust under Internal Revenue Service Code sections 401(a) and 401(k). Employees are eligible to participate in the plan the first day of the month after hire and can elect to contribute to the plan up to 15% of their salary subject to current statutory limits. The Company contribution is 100% vested at the end of an employee's third year of employment. Company contributions to the plan totaled approximately $779,000 in 1999, $838,000 in 1998 and $664,000 in 1997. 15. STOCK OPTION PLANS Under the Company's stock option plans, the Board of Directors has the authority to determine to whom options will be granted, the number of shares, the vesting period and the exercise price (which cannot be less than fair market value ("FMV") at date of grant for incentive stock options or 85% of FMV for nonstatutory options). The options are exercisable at times and in increments as specified by the Board of Directors, F-18 NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) 15. STOCK OPTION PLANS (CONTINUED) generally expire ten years from date of grant and fully vest over periods from three to five years. The following shares are authorized and available for grant as of December 31, 1999:
PLAN SHARES OPTIONS AVAILABLE TITLE AUTHORIZED OUTSTANDING FOR GRANT OPTION PRICE - --------------------- ---------- ----------- --------- ------------- 1983/86 2,200,000 401,615 -- Not less than 85% of FMV* 1989 170,000 10,000 -- FMV 1992 5,000,000 2,959,510 768,786 Not less than 85% of FMV 1996 2,475,000 2,200,736 221,878 Not less than 85% of FMV NQ 443,161 -- -- Not less than 85% of FMV
- ------------------------ * FMV = fair market value Additional information with respect to the activity of outstanding options is summarized in the following table:
NUMBER OF AGGREGATE COMMON STOCK SHARES OPTION PRICE PRICE - ------------ --------- ------------ -------------- (IN THOUSANDS) Balances at December 31, 1996.................. 3,776,323 $3.50-$21.13 $28,210 Granted........................................ 819,740 $ 6.06-$8.13 5,266 Exercised...................................... (262,621) $ 4.13-$9.13 (1,641) Canceled....................................... (347,300) $5.44-$15.06 (2,491) --------- ------------ ------- Balances at December 31, 1997.................. 3,986,142 $3.50-$21.13 $29,344 Granted........................................ 1,515,475 $5.19-$12.75 13,245 Exercised...................................... (677,249) $ 3.50-$9.13 (4,524) Canceled....................................... (318,533) $3.50-$20.54 (2,502) --------- ------------ ------- Balances at December 31, 1998.................. 4,505,835 $3.69-$21.13 $35,563 Granted........................................ 2,119,200 $ 3.81-$8.75 12,638 Exercised...................................... (185,163) $ 5.13-$9.63 (1,243) Canceled....................................... (868,011) $3.81-$15.06 (6,592) --------- ------------ ------- Balances at December 31, 1999.................. 5,571,861 $3.69-$21.13 $40,366 ========= ============ =======
F-19 NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) 15. STOCK OPTION PLANS (CONTINUED) In 1998 and 1999, two officers were granted a total of 140,000 shares of restricted stock under the 1992 Incentive Stock Plan (see Note 13-c). The options outstanding by range of exercise price at December 31, 1999 are as follows:
WEIGHTED AVERAGE NUMBER OF REMAINING WEIGHTED OPTIONS CONTRACTUAL LIFE AVERAGE EXERCISE PRICE OUTSTANDING (IN YEARS) EXERCISE PRICE - -------------- ----------- ---------------- -------------- $3.69-$3.81...................................... 801,050 9.58 $ 3.81 $3.88-$5.44...................................... 743,796 7.58 $ 4.42 $5.56-$6.12...................................... 663,109 7.63 $ 6.00 $6.25 -$6.81..................................... 156,499 6.37 $ 6.42 $7.73-$7.13...................................... 613,527 2.26 $ 7.13 $7.21-$7.75...................................... 595,502 5.08 $ 7.54 $7.88-$8.90...................................... 707,982 8.60 $ 8.75 $9.00-$9.19...................................... 234,166 3.14 $ 9.07 $9.63-$21.13..................................... 1,056,230 5.83 $10.65 --------- ---- ------ $3.69-$21.13..................................... 5,571,861 6.62 $ 7.12 ========= ==== ======
The options currently exercisable by range of exercise price at December 31, 1999 are as follows:
NUMBER OF WEIGHTED OPTIONS AVERAGE EXERCISE PRICE EXERCISABLE EXERCISE PRICE - -------------- ----------- -------------- $3.69-$3.81................................................. 5,708 $ 3.70 $3.88-$5.44................................................. 212,486 $ 4.57 $5.56-$6.12................................................. 467,162 $ 6.00 $6.25 -$6.81................................................ 115,371 $ 6.47 $7.73-$7.13................................................. 608,027 $ 7.13 $7.21-$7.75................................................. 505,707 $ 7.52 $7.88-$8.90................................................. 224,137 $ 8.60 $9.00-$9.19................................................. 227,832 $ 9.07 $9.63-$21.13................................................ 728,179 $11.09 --------- ------ $3.69-$21.13................................................ 3,094,609 $ 8.00 ========= ======
STOCK BASED COMPENSATION The Company accounts for stock based compensation using the intrinsic value method prescribed by APB Opinion No. 25, "Accounting for Stock Issued to Employees." Accordingly, compensation cost for stock options is measured as the excess, if any, of the quoted market price of the Company's stock at the date of the grant over the amount an employee must pay to acquire the stock. The Company has adopted the disclosure-only provisions of Statement of Financial Accounting Standards No. 123, "Accounting for Stock-Based Compensation" ("SFAS 123"). F-20 NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) 15. STOCK OPTION PLANS (CONTINUED) The following pro forma information has been prepared following the provisions of SFAS No. 123:
DECEMBER 31, ------------------------------ 1999 1998 1997 -------- -------- -------- (IN THOUSANDS, EXCEPT PER SHARE AMOUNTS) Net loss--as reported................................... $(20,064) $(2,363) $(38,667) Net loss--pro forma..................................... (25,449) (6,331) (40,163) Net loss per common share and per common share-- assuming dilution--as reported........................ $ (0.53) $ (0.06) $ (1.07) Net loss per common share--pro forma and per common share--assuming dilution--pro forma................... $ (0.67) $ (0.17) $ (1.10)
The fair value of each option grant is estimated on the date of grant using the Black-Scholes single option pricing method assuming the following parameters:
1999 1998 1997 -------- -------- -------- Risk free interest rate..................................... 5.5% 5.29% 5.87% Expected life (years)....................................... 5.4 4.8 5.0 Volatility.................................................. 0.9121 0.7916 0.792 Dividend yield.............................................. -- -- --
The weighted average fair value of options granted in 1999, 1998 and 1997 was $4.11, $5.71 and $4.33, respectively. The impact on pro forma loss per share and net loss in the table above may not be indicative of the effect in future years as options vest over several years and the Company continues to grant stock options to employees. This policy may or may not continue. 16. INCOME TAXES The Company's deferred tax assets and liabilities are determined based on the difference between the financial statement and tax bases of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to affect taxable income. Valuation allowances are established when necessary to reduce deferred tax assets to the amounts expected to be realized. The Company has federal and state income tax net operating loss ("NOL") and research credit carryforwards at December 31, 1999 for tax purposes available as follows: Federal NOL................................................. $295,416,000 State NOL................................................... 11,754,000 Federal Research Credit..................................... 8,788,000 State Research Credit....................................... 7,628,000
These federal and state NOL carryforwards expire in the years 2000 through 2019 and 2000 through 2004, respectively. The federal research credit carryforwards expire in the years 2000 through 2014. F-21 NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) 16. INCOME TAXES (CONTINUED) Due to a change in the ownership of the Company, as defined, a portion of the federal and state NOL carryover is subject to an annual utilization limitation. Should another change in ownership occur, future utilization of the Company's NOL carryforwards may be subject to additional limitations. The tax effects of temporary differences that give rise to significant portions of the deferred tax assets are presented below:
DECEMBER 31, --------------------- 1999 1998 --------- --------- IN THOUSANDS Net operating loss carryforwards............................ $ 100,440 $ 94,000 State (net of federal benefit).............................. 15,250 13,800 Credits..................................................... 15,240 15,200 Assets subject to depreciation and amortization............. 4,520 9,100 Deferred Revenue............................................ 6,080 Other accrued liabilities................................... 6,140 1,300 --------- --------- Total deferred tax assets................................. 147,670 133,400 Valuation allowance......................................... (147,670) (133,400) --------- --------- Net deferred tax assets................................... $ -- $ --
Due to the uncertainty surrounding the realization of the favorable tax attributes in future tax returns, the Company has placed a valuation allowance against its otherwise recognizable net deferred tax assets. 17. INDUSTRY AND GEOGRAPHIC SEGMENT INFORMATION Management uses one measurement of profitability for its business. The Company receives revenue from product sales and from licensing and development of products. The Company markets its products in the United States and Japan and received licensing revenue from partners in the United States, Europe and Asia Pacific and operates in one business segment. F-22 NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED) 17. INDUSTRY AND GEOGRAPHIC SEGMENT INFORMATION (CONTINUED) Revenue and long-lived assets by geographic area as of and for the year ended:
LONG LIVED REVENUES ASSETS -------- ---------- (IN THOUSANDS) December 31, 1999: U.S....................................................... $54,434 $11,534 International............................................. 6,353 -- ------- ------- Total..................................................... $60,787 $11,534 December 31, 1998: U.S....................................................... $42,243 $32,214 International............................................. 31,472 -- ------- ------- Total..................................................... $73,715 $32,214 December 31, 1997: U.S....................................................... $46,609 $33,583 International............................................. 820 -- ------- ------- Total..................................................... $47,429 $33,583
18. SUBSEQUENT EVENT In December 1999 the Company received a notice that Randal J. Kirk and certain investors were nominating a slate of directors for election at the 2000 Annual Stockholders Meeting of the Company in competition with the slate proposed by the Board of Directors of the Company. In order to promptly resolve this contest, the Company's Board moved the Year 2000 annual meeting date forward to February 28, 2000 from its typical May time period. In January 2000 the Company and Mr. Kirk jointly announced a definitive agreement which ended Mr. Kirk's proxy solicitation to elect a new slate of directors. Under the agreement, Mr. Kirk has been added to the slate of candidates nominated by the Company's Board for election as directors at the 2000 annual meeting of stockholders. This raised the number of Board candidates to eight, including the seven current Company Board members who are standing for re-election. If elected, Mr. Kirk as well as all other directors will serve for a one-year term. F-23
EX-10.40 2 EXHIBIT 10.40 EXHIBIT 10.40 SLB/CS(R062599) BIOTECH EQUIPMENT SCHEDULE SCHEDULE NO.003 DATED THIS 09-17-99 TO MASTER LEASE AGREEMENT DATED AS OF July 16, 1993 Lessor & Mailing Address: Lessee & Mailing Address Scios, Inc. General Electric Capital Corporation 820 West Maude Avenue 65 Water Street Sunnyvale, CA 94086 South Norwalk, CT 06854 This Schedule is executed pursuant to, and incorporates by reference the terms and conditions of, and capitalized terms not defined herein shall have the meanings assigned to them in, the Master Lease Agreement identified above ("Agreement" said Agreement and this Schedule being collectively referred to as "Lease"). This Schedule, incorporating by reference the Agreement, constitutes a separate instrument of lease. A. Equipment: Subject to the terms and conditions of the Lease, Lessor agrees to Lease to Lessee the Equipment described below (the "Equipment"). B.
Number Capitalized Manufacturer Serial Number Model & Type of Equipment of Units Lessor's Cost $611,579.20 Various Scientific Laboratory Equipment
Equipment immediately listed above is located at: 820 West Maude Avenue, Sunnyvale, SANTA CLARA County, CA 94086 B. Financial Terms 1. Advance Rent (if any): $16,754.26 5. Basic Term Commencement Date: October 1, 1999 2. Capitalized Lessor's Cost $611,579.20 6. Lessee Federal Tax ID No.: 953701481 3. Basic Term (No. of Months): 36 Months 7. Last Delivery Date: September 30, 1999 4. Basic Term Lease Rate Factor: 2.739508 8. Daily Lease Rate Factor: .09131933
9. First Termination Date: Thirty-six (36) months after the Basic Term Commencement Date. 10. Interim Rent: For the period from and including the Lease Commencement Date to but not including the Basic Term Commencement Date ("Interim Period"), Lessee shall pay as rent ("Interim Rent") for each unit of Equipment, the product of the Daily Lease Rate Factor times the Capitalized Lessor's Cost of such unit times the number of days in the Interim Period. Interim Rent shall be due on September 30, 1999. 11. Basic Term Rent. Commencing on October 1, 1999 and on the same day of each month thereafter (each, a "Rent Payment Date") during the Basic Term, Lessee shall pay as rent ("Basic Term Rent") the product of the Basic Term Lease Rate Factor times the Capitalized Lessor's Cost of all Equipment on this Schedule. 12. Secondary Term Rent. Unless the Schedule has been earlier terminated as provided therein, commencing on October 1, 2002 (the "Secondary Term Commencement Date") and on the same day of each month thereafter (each, a "Rent Payment Date") for 12 months (the "Secondary Term"), Lessee shall pay as rent ("Secondary Term Rent") the product of 1.764763 0 (the "Secondary Term Lease Rate Factor") times the Capitalized Lessor's Cost of all Equipment on this Schedule. 13. Adjustment to Capitalized Lessor's Cost. Lessee hereby irrevocably authorizes Lessor to adjust the Capitalized Lessor's Cost up or down by no more than ten percent (10%) to account for equipment change orders, equipment returns, invoicing errors and similar matters. Lessee acknowledges and agrees that the Rent shall be adjusted as a result of such change in the Capitalized Lessor's Cost. Lessor shall send Lessee a written notice stating the final Capitalized Lessor's Cost, if different from that disclosed on this Schedule. C. Tax Benefits Depreciation Deductions: 1. Depreciation method is the 200% declining balance method, switching to straight line method for the 1st taxable year for which using the straight line method with respect to the adjusted basis as of the beginning of such year will yield a larger allowance. 2. Recovery Period: 5 years. 3. Basis: 100% of the Capitalized Lessor's Cost. D. Property Tax APPLICABLE TO EQUIPMENT LOCATED IN SUNNYVALE, CA 94086: Lessee agrees that it will (a) list all such Equipment (b) report all property taxes assessed against such Equipment and (c) pay all such taxes when due directly to the appropriate taxing authority until Lessor shall otherwise direct in writing. Upon request of Lessor, Lessee shall promptly provide proof of filing and proof of payment to Lessor. Lessor may notify Lessee (and Lessee agrees to follow such notification) regarding any changes in property tax reporting and payment responsibilities. E. Insurance 1. Public Liability: At least $1,000,000 total liability per occurrence. 2. Casualty and Property Damage: An amount equal to the higher of the Stipulated Loss Value or the full replacement cost of the Equipment. F. Article 2A Notice IN ACCORDANCE WITH THE REQUIREMENTS OF ARTICLE 2A OF THE UNIFORM COMMERCIAL CODE AS ADOPTED IN THE APPLICABLE STATE, LESSOR HEREBY MAKES THE FOLLOWING DISCLOSURES TO LESSEE PRIOR TO EXECUTION OF THE LEASE, (A) THE PERSON(S) SUPPLYING THE EQUIPMENT IS Various (THE "SUPPLIER(S)"), (B) LESSEE IS ENTITLED TO THE PROMISES AND WARRANTIES, INCLUDING THOSE OF ANY THIRD PARTY, PROVIDED TO THE LESSOR BY SUPPLIER(S), WHICH IS SUPPLYING THE EQUIPMENT IN CONNECTION WITH OR AS PART OF THE CONTRACT BY WHICH LESSOR ACQUIRED THE EQUIPMENT AND (C) WITH RESPECT TO SUCH EQUIPMENT, LESSEE MAY COMMUNICATION WITH SUPPLIER(S) AND RECEIVE AN ACCURATE AND COMPLETE STATEMENT OF SUCH PROMISES AND WARRANTIES, INCLUDING ANY DISCLAIMERS AND LIMITATIONS OF THEM OR OF REMEDIES. TO THE EXTENT PERMITTED BY APPLICABLE LAW, LESSEE HEREBY WAIVES ANY AND ALL RIGHTS AND REMEDIES CONFERRED UPON A LESSEE IN ARTICLE 2A AND ANY RIGHTS NOW OR HEREAFTER CONFERRED BY STATUTE OR OTHERWISE WHICH MAY LIMIT OR MODIFY ANY OF LESSOR'S RIGHTS OR REMEDIES UNDER THE DEFAULT SECTION OF THE AGREEMENT. G. Stipulated Loss and Termination Value Table*
stipulated termination loss # of value value payments % of cost % of cost 1 102.875 107.150 2 101.048 105.671 3 99.194 104.166 4 97.315 102.635 5 95.413 101.082 6 93.490 99.507 7 91.544 97.910 8 89.577 96.291 9 87.587 94.650 10 85.575 92.986 11 83.541 91.300 12 81.484 89.592 13 79.404 87.861 14 77.302 86.106 15 75.176 84.329 16 73.028 82.530 17 70.856 80.706 18 68.661 78.859 19 66.448 76.995 20 64.217 75.112 21 61.968 73.212 22 59.701 71.293 23 57.410 69.350 24 55.100 67.389 25 52.772 65.409 26 50.423 63.409 27 48.070 61.404 28 45.694 59.377 29 43.297 57.328 30 40.877 55.257 31 38.436 53.164 32 35.972 51.048 33 33.485 48.910 34 30.976 46.749 35 28.443 44.565 36 25.887 42.357 37 23.316 40.135 38 21.706 38.873 39 20.081 37.596 40 18.441 36.305 41 16.786 34.998 42 15.115 33.676 43 13.429 32.339 44 11.728 30.986 45 10.011 29.617 46 8.278 28.233 47 6.530 26.833 48 4.765 25.416
*The Stipulated Loss Value or Termination Value for any unit of Equipment shall be the Capitalized Lessor's Cost of such unit multiplied by the appropriate percentage derived from the above table. In the event that the Lease is for any reason extended, then the last percentage figure shown above shall control throughout any such extended term. H. Modifications and Additions for This Schedule Only For purposes of this Schedule only, the Agreement is amended as follows: 1. The LEASING Section of the Lease is hereby deleted in its entirety and the following substituted in its stead: a) Subject to the terms and conditions set forth below, Lessor agrees to lease to Lessee, and Lessee agrees to lease from Lessor, the equipment ("Equipment") described in Annex A to any schedule hereto ("Schedule") or, if applicable, to Section A of any Schedule. Terms defined in a Schedule and not otherwise defined herein shall have the meanings ascribed to them in such Schedule. b) The obligation of Lessor to purchase the Equipment from Lessee and to lease the same to Lessee shall be subject to receipt by Lessor, on or prior to the earlier of the Lease Commencement Date or Last Delivery Date therefor, of each of the following documents in form and substance satisfactory to Lessor: (i) a Schedule for the Equipment (ii) evidence of insurance which complies with the requirements of the INSURANCE Section of the Lease, and (iii) such other documents as Lessor may reasonably request. Once the Schedule is signed, the Lessee may not cancel the Lease. 2. The DELIVERY, USE AND OPERATION Section subsection (a) of the Lease shall be deleted and the following substituted in its stead: The parties acknowledge that this is a sale/lease back transaction and the Equipment is in Lessee's possession as of the Lease Commencement Date. 3. BILL OF SALE Lessee, in consideration of the Lessor's payment of the amount set forth in B 2. above, which includes any applicable sales taxes (which payment Lessee acknowledges), hereby grants, sells, assigns, transfers and delivers to Lessor the Equipment along with whatever claims and rights Seller may have against the manufacturer and/or Supplier of the Equipment, including but not limited to all warranties and representations. At Lessors request Lessee will cause Supplier to deliver to Lessor a written statement wherein the Supplier (i) consents to the assignment to Lessor of whatever claims and rights Lessee may have against the Supplier, (ii) agrees not to retain any security interest, lien or other encumbrance in or upon the Equipment at any time, and to execute such documents as Lessor may request to evidence the release of any such encumbrance, and (iii) represents and warrants to Lessor (x) that Supplier has previously conveyed full title to the Equipment to Lessee, (y) that the Equipment was delivered to Lessee and installation completed, and (z) that the final purchase price of the Equipment (or a specified portion of such purchase price) has been paid by Lessee. Lessor is purchasing the Equipment for leasing back to Lessee pursuant to the Lease. Lessee represents and warrants to Lessor that (i) Lessor will acquire by the terms of this Bill of Sale good title to the Equipment free from all liens and encumbrances whatsoever; (ii) Lessee has the right to sell the Equipment; and (iii) the Equipment has been delivered to Lessee in good order and condition, and conforms to the specifications, requirements and standards applicable thereto; and (iv) the equipment has been accurately labeled, consistent with the requirements of 40 CFR part 82 Subpart E, with respect to products manufactured with a controlled (ozone-depleting) substance. Lessee agrees to save and hold harmless Lessor from and against any and all federal, state, municipal and local license fees and taxes of any kind or nature, including, without limiting the generality of the foregoing, any and all excise, personal property, use and sales taxes, and from and against any and all liabilities, obligations, losses, damages, penalties, claims, actions and suits resulting therefrom and imposed upon, incurred by or asserted against Lessor as a consequence of the sale of the Equipment to Lessor. 4. ACCEPTANCE Pursuant to the provisions of the Lease, as it relates to this Schedule, Lessee hereby certifies and warrants that (i) all Equipment listed above has been delivered and installed (if applicable); (ii) Lessee has inspected the Equipment, and all such testing as it deems necessary has been performed by Lessee, Supplier or the manufacturer; and (iii) Lessee accepts the Equipment for all purposes of the Lease, the purchase documents and all attendant documents. Lessee does further certify, and Lessor hereby waives any requirement of a separate Certificate of Acceptance, that as of the date hereof (i) Lessee is not in default under the Lease; (ii) the representations and warranties made by Lessee pursuant to or under the Lease are true and correct on the date hereof and (iii) Lessee has reviewed and approves of the purchase documents for the Equipment, if any. 5. EQUIPMENT SPECIFIC PROVISIONS The SERVICE Section of the Lease is amended by adding the following as the third sentence in subsection (a): Lessee agrees that upon return of the Equipment, it will comply with all original manufacturer's performance specifications for new Equipment without expense to Lessor. Lessee shall, if requested by Lessor, obtain a certificate or service report from the manufacturer attesting to such condition. Each reference contained in this Agreement to: (a) "Adverse Environmental Condition" shall refer to (i) the existence or the continuation of the existence, of an Environmental Emission (including, without limitation, a sudden or non-sudden accidental or non-accidental Environmental Emission), of, or exposure to, any substance, chemical, material, pollutant, Contaminant, odor or audible noise or other release or emission in, into or onto the environment (including, without limitation, the air, ground, water or any surface) at, in, by, from or related to any Equipment, (ii) the environmental aspect of the transportation, storage, treatment or disposal of materials in connection with the operation of any Equipment or (iii) the violation, or alleged violation of any statutes, ordinances, orders, rules regulations, permits or licenses of, by or from any govemmental authority, agency or court relating to environmental matters connected with any Equipment. (b) "Affiliate" shall refer, with respect to any given Person, to any Person that directly or indirectly through one or more intermediaries, controls, or is controlled by, or is under common control with, such Person. (c) "Contaminant" shall refer to those substances which are regulated by or form the basis of liability under any Environmental Law, including, without limitation, asbestos, polychlorinated biphenyls ("PCB's"), and radioactive substances, or other material or substance which has in the past or could in the future constitute a health, safety or environmental hazard to any Person, property or natural resources. (d) "Environmental Claim" shall refer to any accusation, allegation, notice of violation, claim, demand, abatement or other order on direction (conditional or otherwise) by any govemmental authority or any Person for personal injury (including sickness, disease or death), tangible or intangible property damage, damage to the environment or other adverse effects on the environment, or for fines, penalties or restrictions, resulting from or based upon any Adverse Environmental Condition. (e) "Environmental Emission" shall refer to any actual or threatened release, spill, emission, leaking, pumping, injection, deposit, disposal, discharge, dispersal, leaching or migration into the indoor or outdoor environment, or into or out of any of the Equipment, including, without limitation, the movement of any Contaminant or other substance through or in the air, soil, surface water, groundwater or property. (f) "Environmental Law" shall mean any federal, foreign, state or local law, rule or regulation pertaining to the protection of the environment, including, but not limited to, the Comprehensive Environmental Response, Compensation, and Liability Act ("CERCLA") (42 U.S.C. Section 9601 et seq.), the Hazardous Material Transportation Act (49 U.S.C. Section 1801 et seq .), the Federal Water Pollution Control Act (33 U.S.C. Section 1251 et seq .), the Resource Conservation and Recovery Act (42 U.S.C. Section 6901 et seq .), the Clean Air Act (42 U.S.C. Section 7401 et seq .), the Toxic Substances Control Act (15 U.S.C. Section 2601 et seq .), the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. Section 1361 et seq .), and the Occupational Safety and Health Act (19 U.S.C. Section 651 et seq .), as these laws have been amended or supplemented, and any analogous foreign, federal, state or local statutes, and the regulations promulgated pursuant thereto. (g) "Environmental Loss" shall mean any loss, cost, damage, liability, deficiency, fine, penalty or expense (including. without limitation, reasonable attomeys' fees, engineering and other professional or expert fees), investigation, removal, cleanup and remedial costs (voluntarily or involuntarily incurred) and damages to, loss of the use of or decrease in value of the Equipment arising out of or related to any Adverse Environmental Condition. (h) "Person" shall include any individual, partnership, corporation, trust, unincorporated organization, government or department or agency thereof and any other entity. Lessee shall fully and promptly pay, perform, discharge, defend, indemnify and hold harmless Lessor and its Affiliates, successors and assigns, directors, officers, employees and agents from and against any Environmental Claim or Environmental Loss. The provisions of this Schedule shall survive any expiration or termination of the Lease and shall be enforceable by Lessor, its successors and assigns. The SERVICE Section subsection (a) of the Lease shall be amended by adding the following at the end thereof: RETURN PROVISIONS: In addition to the provisions provided for in the RETURN OF EQUIPMENT Section of the Lease, and provided that Lessee has elected not to exercise its option to purchase the Equipment Lessee shall, at its expense: (a) at least one hundred eighty (180) days and not more than two hundred seventy (270) days prior to expiration or earlier termination of the Lease, provide to Lessor a detailed inventory of all components of the Equipment The inventory should include, but not be limited to, a listing of model and serial numbers for all components comprising the Equipment; (b) at least one hundred eighty (180) days prior to expiration or earlier termination of the Lease, with reference to computer based equipment comprising the Equipment, provide to Lessor a detailed listing of all internal circuit boards by both the model and serial number for all hardware comprising the Equipment and a listing of all software features listed individually; (c) at least one hundred eighty (180) days prior to expiration or earlier termination of the Lease, upon receiving reasonable notice from Lessor, provide or cause the vendor(s) or manufacturer(s) to provide to Lessor the following documents: (i) one set of service manuals, and operating manuals including replacements and/or additions thereto, such that all documentation is completely up-to-date; (ii) one set of documents, detailing equipment configuration, operating requirements, maintenance records, and other technical data concerning the set-up and operation of the Equipment, including replacements and/or additions thereto, such that all documentation is completely up-to-date; (d) at least one hundred eighty (180) days prior to expiration or earlier termination of the Lease, upon receiving reasonable notice from Lessor, make the Equipment available for on-site operational inspections by potential purchasers, under power, and provide personnel, power and other requirements necessary to demonstrate electrical and mechanical systems for each item of the Equipment; (e) at least one hundred eighty (180) days prior to expiration or earlier termination of the Lease, cause manufacturer's representative or qualified equipment maintenance provider, acceptable to Lessor, (the "Authorized Inspector") to perform a comprehensive physical inspection, including testing all material and workmanship of the Equipment and ensure all Equipment and equipment operations conform to all applicable local, state, and federal laws, health and safety guidelines including the then current FDA regulations; and if during such inspection, examination and test, the Authorized Inspector finds any of the material or workmanship to be defective or the Equipment not operating within manufacturer's specifications and the then current FDA regulations, then Lessee shall repair or replace such defective material and, after corrective measures are completed, Lessee will provide for a follow-up inspection of the Equipment by the Authorized Inspector as outlined in the preceding clause; (f)have each item of Equipment returned with an in-depth field service report detailing said inspection as outlined in Section (e) above. The report shall certify that the Equipment has been properly inspected, examined and tested and is operating within the manufacturer's specifications; (g) provide that all Equipment will be cleaned and cosmetically acceptable, and in such condition so that it may be immediately installed and placed into use in a similar environment; (h) properly remove or treat all rust or corrosion; (i)ensure all items of Equipment will be completely sterilized, steam-cleaned, and de-greased upon redelivery; (j)properly remove all Lessee installed markings which are not necessary for the operation, maintenance or repair of the Equipment, (k) ensure the Equipment shall be mechanically and structurally sound, capable of performing the functions for which the Equipment was originally designed, in accordance with the manufacturer's published and recommended specifications; (l) provide for the deinstallation, packing, transporting, and certifying of the Equipment to include, but not limited to, the following: (i) the manufacturer's representative shall de-install all Equipment (including all wire, cable and mounting hardware) in accordance with the specifications of the manufacturer; (ii) each item of Equipment will be returned with a certificate supplied by the manufacturer's representative qualifying the Equipment to be in good condition and (where applicable) to be eligible for the manufacturer's maintenance plan; the certificate of eligibility shall be transferable to another operator of the Equipment; (iii) the Equipment shall be packed properly and in accordance with the manufacturer's recommendations, free from all contaminants; (iv) Lessee shall provide for transportation of the Equipment in a manner consistent with the manufacturer's recommendations and practices to any locations within the continental United States as Lessor shall direct; and shall have the Equipment unloaded at such locations; (v) Lessee shall obtain and pay for a policy of transit insurance for the redelivery period in an amount equal to the replacement value of the Equipment and Lessor shall be named as the loss payee on all such policies of insurance; and (vi) Lessee shall provide insurance and safe, secure storage for the Equipment for ninety (90) days after expiration or earlier termination of the Lease at accessible locations satisfactory to Lessor. 6 LEASE TERM OPTIONS End or Basic Term Options At the expiration of the Basic Term (the "Basic Term Expiration Date"), so long as no default has occurred and is continuing hereunder and this Agreement has not been earlier terminated, Lessee shall exercise one of the following options. (1) EXTENSION OPTION. Lessee may extend the Lease beyond the Basic Term Expiration Date with respect to all (but not less than all) of the Equipment covered by this Schedule through the Secondary Term set forth in this Schedule and Lessee shall pay Secondary Term Rent as set forth in this Schedule. (2) PURCHASE OPTION. Upon at least one hundred eighty (180) but not more than two hundred seventy (270) days written notice to Lessor prior to the Basic Term Expiration Date, Lessee may purchase all (but not less than all) of the Equipment covered by this Schedule on an AS IS BASIS for cash equal to the greater of (A) twenty percent (20%) of the Capitalized Lessor's Cost (plus all applicable sales taxes) or (B) the then Fair Market Value of the Equipment (plus all applicable sales taxes). On the Basic Term Expiration Date, Lessor shall receive in cash the full purchase price plus all applicable sales taxes) together with any rent or other sums then due under the Lease on such date. Lessee shall be deemed to have waived its purchase option if it fails to (a) timely provide Lessor with the required written notice of its election to exercise the same or (b) provide Lessor with written notice of its irrevocable election to exercise the same within fifteen (15) days after Fair Market Value is determined (by agreement or appraisal). (3) CANCELLATION OPTION. Upon at least one hundred eighty (180) but not more than two hundred seventy (270) days written notice to Lessor prior to the Basic Term Expiration Date (the "Notice Date"), Lessee may cancel the Agreement (the "Cancellation Option") with respect to all (but not less than all) of the Equipment on this Schedule. If all of the terms and conditions of this Section are not fulfilled, this Lease shall continue in fill force and effect and Lessee shall continue to be liable for all obligations thereunder, including, without limitation, the obligation to continue paying rent. Lessee shall be deemed to have waived this option if it fails to timely provide Lessor with the required written notice of its election to exercise the same. (a) Prior to the Basic Term Expiration Date, Lessee shall (i) pay to Lessor, as additional rent, twenty three and three hundred sixteen hundredths percent (23.316%) of the Capitalized Lessor's Cost of the Equipment, plus all rent and all other sums due and unpaid as of the Basic Term Expiration Date (including, but not limited to, any rent payment due and payable on the Basic Term Expiration Date and any sales taxes and property taxes); and (ii) return the Equipment in full compliance with the RETURN OF EQUIPMENT Section of the Lease, such compliance being independently verified by an independent appraiser selected by Lessor (reasonably acceptable to Lessee) to determine that the Equipment is in such compliance, which determination shall be final, binding and conclusive. Lessee shall bear all costs associated with such appraiser's determination and such costs, if any, to cause the Equipment to be in full compliance with the RETURN OF EQUIPMENT Section of the Lease on or prior to such Basic Term Expiration Date. (b) From the applicable Notice Date through the Basic Term Expiration Date, Lessee shall: (i) continue to comply with all of the terms and conditions of the Lease, including, but not limited to, Lessee's obligation to pay rent, and (ii) make the Equipment available to Lessor in such a manner as to allow Lessor to market and demonstrate the Equipment to potential purchasers or lessees from such premises at no cost to Lessor; provided, however, that, subject to Lessor's right to market and demonstrate the Equipment to potential purchasers or lessees from time to time, Lessee may still use the Equipment until the Basic Term Expiration Date. (c) Lessee shall, from the Basic Term Expiration Date through the earlier of the date the Equipment is sold by Lessor to a third party or thirty (30) days following the Basic Term Expiration Date, comply with the following terms and conditions: (i) continue to provide insurance for the Equipment, at Lessee's own expense, in compliance with the terms found in the INSURANCE Section of the Lease, and (ii) make the Equipment available to Lessor and/or allow Lessor to store the Equipment at Lessee's premises, in such a manner as to allow Lessor to market and demonstrate the Equipment to potential purchasers or lessees from such premises at no cost to Lessor. (d) The proceeds of any sale or re-lease of the Equipment after Lessee has exercised its Cancellation Option shall be for the sole benefit of Lessor and Lessee shall have no interest in nor any claim upon any of such proceeds. END OF SECONDARY TERM OPTIONS The PURCHASE OPTION Section subsection (a) of the Lease is hereby deleted in its entirety and the following is substituted therefor: (a) So long as no default exists hereunder and the Lease has not been earlier terminated, Lessee may at the expiration of the Secondary Term upon at least one hundred eighty (180) days but not more than two hundred seventy (270) days written notice to Lessor prior to the end of the Secondary Term, purchase all (but not less than all) of the Equipment in this Schedule on an AS IS, WHERE IS BASIS, without recourse to or warranty from Lessor, express or implied ("AS IS BASIS") for cash equal to its then Fair Market Value (plus all applicable sales taxes). I. Payment Authorization You are hereby irrevocably authorized and directed to deliver and apply the proceeds due under this Schedule as follows:
Company Name Address Amount Scios, Inc. 820 West Maude Ave., Sunnyvale. CA 94086 $611,579.20
This authorization and direction is given pursuant to the same authority authorizing the above-mentioned financing. Except as expressly modified hereby, all terms and provisions of the Agreement shall remain in full force and effect. This Schedule is not binding or effective with respect to the Agreement or Equipment until executed on behalf of Lessor and Lessee by authorized representatives of Lessor and Lessee, respectively. IN WITNESS WHEREOF, Lessee and Lessor have caused this Schedule to be executed by their duly authorized representatives as of the date first above written. LESSOR: LESSEE: (GENERAL ELECTRIC CAPITAL CORPORATION SCIOS, INC. By: /s/ Teresa V. Grace By: /s/ David W. Gryska ---------------------------------- ------------------------------ Teresa V. Grace David W. Gryska Name: Name: -------------------------------- ---------------------------- Credit Manager Chief Financial Officer Title: Title: ------------------------------- ---------------------------
EX-10.41 3 EXHIBIT 10.41 EXHIBIT 10.41 FIRST AMENDMENT TO NOTE AGREEMENT AND PREFERRED STOCK PURCHASE AGREEMENT This First Amendment to Note Agreement and Preferred Stock Purchase Agreement (this "Amendment") is entered into as of November 3, 1999, by and between Scios Inc., a Delaware corporation formerly known as "Scios Nova Inc." (the "Company"), and Genentech, Inc., a Delaware corporation (the "Lender"). RECITALS A. The Company and the Lender entered into a Note Agreement dated as of December 30, 1994 (the "Note Agreement"), pursuant to which Lender has made an interest-bearing loan of $30,000,000 to the Company (the "Loan"). The Loan is due and payable in full on December 31, 2002. B. The Note Agreement authorizes and permits the Company to repay the principal balance of and all accrued and unpaid interest under the Note through cash payments, the Company's issuance to the Lender of shares of the Company's common stock ("Note Shares"), or a combination of both. C. The Company and the Lender also entered into a Preferred Stock Purchase Agreement dated as of December 30, 1994 (the "Stock Agreement"), pursuant to which (among other things) the Company agreed to cause the Note Shares to be registered under the circumstances described therein. D. The parties wish to amend the Note Agreement and the Stock Agreement as set forth herein. AGREEMENT NOW THEREFORE, for good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the parties agree as follows: 1. AMENDMENT OF SECTION 3 OF THE NOTE AGREEMENT The first paragraph of Section 3 of the Note Agreement is hereby amended and restated to read in its entirety as follows: "3. Payment. The principal amount of and interest accrued on this Note shall be payable, at the option of the Company, by either of the following means or a combination thereof: (a) in cash denominated in the currency of the United States of America (a "Cash Payment"); or (b) by the issuance from time to time of Series B Preferred Stock of the Company with the rights and preferences as described in Exhibit 1 hereto and, for Page 1 c) purposes of determining the amount paid against the Note, valuing each share of Series B Preferred Stock as equal to the product of multiplying (X) the average closing price of the Company's Common Stock (as reported by NASDAQ, or as traded on a securities exchange, as applicable) over the thirty-day period ending on the day preceding the payment by (Y) 100, (a "Stock Payment"); PROVIDED, HOWEVER, that: (i) in no event shall the Company repay more than Twenty Five Million Dollars ($25,000,000) of the Note by Stock Payments; (ii) in no event shall Company have the right to apply more than eight (8) separate Stock Payments toward repayment of the Note; (iii) not later than the earlier of the date of the first Stock Payment or January 30, 2000, Company will make a $2,000,000 Cash Payment under the Note; and (iv) contemporaneously with each Stock Payment, the Company will make a Cash Payment determined under the following formula: Amount of Cash Payment = C x (A-B) - B Where: A equals the aggregate amount (principal and interest) outstanding under the Note, calculated immediately prior to such Stock Payment; B equals the amount of the remaining permitted Stock Payments under the Note, calculated immediately prior to such Stock Payment; and C equals the amount of the current Stock Payment. Payments of principal and accrued interest shall be made at the address of the Lender, set forth in the Collaboration Agreement, or such other place as the Lender shall have notified the Company in writing at least five days before such payment is due. All payments in respect of this Note shall be applied first to accrued and unpaid interest hereon, and thereafter to the unpaid principal amount hereof. This Note may be prepaid by the Company without penalty, in whole or in part by any of the means described above at any time." 2. UNDERSTANDINGS WITH RESPECT TO REGISTRATION AND RESALE OF NOTE SHARES The parties agree that the Company's obligation to register any Note Shares is governed by the Stock Agreement. The Lender hereby agrees that notwithstanding any contrary provision of the Stock Agreement or the Note Agreement: (A) none of the Note Shares shall be sold, assigned or transferred prior to December 30, 2002 except with the prior written approval of the Company, which the Company may grant or withhold in its sole discretion; and (B) and the Company shall not be required to file any registration statement prior to December 30, 2002 pursuant to the Stock Agreement to register any of the Note Shares unless, following a written request by the Lender, the Company determines in its sole discretion to effect such registration Page 2 because it believes that market conditions are then suitable for a sale of all or a portion of the Note Shares. The Company agrees that: (A) if after December 30, 2002 and before January 20, 2003 Lender requests the filing of a registration statement covering the Note Shares pursuant to the Stock Agreement, Company will use reasonable efforts to cause such registration statement to become effective not later than February 15, 2003; and (B) in connection with any registration of Note Shares pursuant to the Stock Agreement, the Company will use reasonable efforts (to the extent permitted by applicable securities laws and other legal requirements) to support the sale of the Note Shares by the Lender in the public market through interactions with potential investors and analysts designed to educate them about the Company. 3. AMENDMENT OF SECTION 5 OF THE STOCK AGREEMENT Section 5 of the Stock Agreement is hereby amended by adding the following new subsection (f): "(f) The Purchaser may sell, assign or transfer all or a portion of the Securities and the Note Shares to a third party or related party investor (each, an "Investor"); provided, that such transfers shall not exceed four (4) in total and shall in the aggregate across all transfers be to no more than six (6) separate Investors. In the event of a transfer to one or more Investors under this Section 5(f), the rights granted to the Purchaser under Section 8 of this Agreement to cause the Company to register the Securities and the Note Shares may be transferred or assigned by Purchaser to the Investor(s); provided, that the Company is given written notice of such transfer, stating the name and address of the Investor(s) and identifying the Securities and/or Note Shares with respect to which such registration rights are being transferred or assigned, and provided further, that the Investor(s) assumes the obligations of such Purchaser under Section 8 of this Agreement (in which case, the Investor(s) becomes a "Holder'" as defined under Section 8(a) of this Agreement, for purposes of this Agreement)." Notwithstanding the foregoing, this subsection in no way limits the Purchaser's right to sell any Securities or Note Shares to another party pursuant to the provisions of Rule 144 or an effective registration statement under the Act. 4. MISCELLANEOUS The parties agree and confirm that the Note Agreement and Stock Agreement shall remain in full force and effect in accordance with their original terms except as amended hereby. This Amendment shall be construed and enforced in accordance with the laws of the State of California without regard to principles of conflicts of laws. This Amendment may be executed in counterparts. Page 3 IN WITNESS WHEREOF, this First Amendment to Note Agreement and Preferred Stock Purchase Agreement has been executed and delivered as of the date first above written by duly authorized representatives of the Company and the Lender. SCIOS INC. /s/ Richard B. Brewer By: -------------------------------------------- Richard B. Brewer President and Chief Executive Officer GENENTECH, INC. /s/Brad Goodwin By: -------------------------------------------- Name: Brad Goodwin Its: VP - Finance Doc. # 68727v2 Page 4 EX-10.42 4 EXHIBIT 10.42 EXHIBIT 10.42 PROMISSORY NOTE THE SECURITIES REPRESENTED HEREBY HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED, AND MAY NOT BE SOLD, OFFERED FOR SALE, PLEDGED, HYPOTHECATED OR OTHERWISE TRANSFERRED IN THE ABSENCE OF AN EFFECTIVE REGISTRATION STATEMENT UNDER SAID ACT COVERING THE TRANSFER OF THE SECURITIES OR AN OPINION OF COUNSEL SATISFACTORY TO THE COMPANY THAT SUCH REGISTRATION IS NOT REQUIRED. $7,500,000 Sunnyvale, California December 27, 1999 FOR VALUE RECEIVED, the undersigned, Scios Inc., a Delaware corporation (the "Borrower"), hereby promises to pay to the order of Chiron Corporation, a Delaware corporation ("Chiron"), the principal sum of Seven Million Five Hundred Thousand Dollars ($7,500,000), including interest as hereinafter provided. The entire balance of outstanding principal and accrued and unpaid interest shall be paid in full December 31, 2006, unless the loan has been earlier forgiven as provided below. Interest shall accrue on the unpaid balance of the principal amount at the rate of 8.5% compounded annually on the anniversary date of this Note and calculated on the basis of a 360-day year and the number of days actually elapsed with respect to the outstanding balance from time to time. Interest may be paid from time to time as Scios elects or deferred until the principal is paid in full. Accrued interest, together with all outstanding principal shall be due and payable as set forth in the preceding paragraph. Principal, interest and all other amounts due under this Note shall be payable by wire transfer in accordance with the wire transfer instructions provided by Chiron, or by such other means as the holder of this Note may from time to time designate in writing to the Borrower. The Borrower shall have the right, at any time, to prepay all or any part of the outstanding principal amount without premium or penalty; provided, however, that all payments hereunder shall first be applied to accrued and unpaid interest and thereafter to principal. The Borrower hereby waives presentment, demand, notice, protest and other demands and notices in connection with the delivery, acceptance or enforcement of this Note. No delay or omission on the part of the holder of this Note in exercising any right hereunder shall operate as a waiver of such right or of any other right under this Note, and a waiver, delay or omission on any one occasion shall not be construed as a bar to or waiver of any such right on any future occasion. The Borrower hereby agrees to pay on demand all reasonable costs and expenses, including, without limitation, attorneys' fees and legal expenses, incurred or paid by the holder of this Note in enforcing this Note on default. 1. Upon receipt by the Borrower of evidence reasonably satisfactory to it of the loss, theft, destruction or mutilation of this Note, and indemnity satisfactory to the Borrower (in the case of loss, theft or destruction) or cancellation of the Note (in the case of mutilation), the Borrower will make and deliver to Chiron a new Note of like tenor and principal amount and dated as of the date to which interest has been paid on the unpaid principal balance hereunder. The following events are the Events of Default under this Note: (a) Scios shall (i) voluntarily commence any proceeding or file any petition seeking relief under Title 11 of the United States Code or any other federal, state or foreign bankruptcy, insolvency, liquidation or similar law, (ii) consent to the institution of, or fail to contravene in a timely and appropriate manner, any such proceeding or the filing of any such petition, (ii) apply for or consent to the appointment of a receiver, trustee, custodian, or similar official for Scios or for a substantial part of its property or assets, (iv) file an answer admitting the material allegations of a petition filed against it in any such proceeding, (v) make a general assignment for the benefit of creditors, (vi) become unable, admit in writing its inability or fail generally, to pay its debts as they become due, or (vii) take corporate action for the purpose of effecting any of the foregoing; (b) an involuntary proceeding shall be commenced or an involuntary petition shall be filed in a court of competent jurisdiction seeking (i) relief in respect of Scios' or of a substantial part of its property or assets under Title 11 of the United States Code or any other federal, state or foreign bankruptcy, insolvency, receivership or similar law, (ii) the appointment of a receiver, trustee, custodian, or similar official for Scios or for a substantial part of its property, or (iii) the winding-up or liquidation of Scios; and such proceeding or petition shall continue undismissed for sixty (60) days or an order or decree approving or ordering any of the foregoing shall continue unstayed and in effect for thirty (30) days; and (c) this Note shall for any reason cease to be, or be asserted by Scios not to be, a legal, valid and binding obligation enforceable in accordance with its terms. Upon the happening of an Event of Default described in paragraph (a) or (b) above, this Note shall automatically become due and payable, both as to principal and interest, without presentment, demand, protest or other notice of any kind, all of which are hereby expressly waived by Scios. Upon the happening of an Event of Default described in paragraph (c) above, and at any time thereafter during the continuance of such event, the holder of this Note may, by written or telegraphic notice to Scios, declare the Note to be forthwith due and payable, whereupon the principal of this Note, together with accrued interest thereon and other liabilities of Scios accrued hereunder, shall become due and payable both as to principal and interest, without presentment, demand, protest or any other notice of any kind, all of which are hereby expressly waived by Scios. The obligation of Scios represented by this Note shall be subordinate to all other debt or obligations of Scios regardless of the date that such other debt or obligation may be created. Chiron agrees to execute any document reasonably requested by Scios or another creditor of Scios to evidence the subordination of this Note to other obligations of Scios. 2. This Note shall be deemed to be under seal, and all rights and obligations hereunder shall be governed by the laws of the State of California. This Note, including all outstanding principal and accrued and unpaid interest, shall automatically be forgiven and Scios shall have no further obligation of any kind to Chiron under this Note upon the granting of a New Drug Approval by the United States Food and Drug Administration ) prior to December 31, 2006 authorizing the marketing in the United States of any FGF Product (as defined in the FGF License and Technology Transfer Agreement). AGREED: SCIOS INC. CHIRON CORPORATION /s/ Richard B. Brewer /s/ James R. Sulat By: By: ----------------------------- ----------------------------------- Richard B. Brewer Name: James R. Sulat President and CEO Title: Chief Financial Officer 3. EX-21.2 5 EXHIBIT 21.2 EXHIBIT 21.2 SUBSIDIARIES OF REGISTRANT California Biotechnology Research Inc., a California corporation EX-23.1 6 EXHIBIT 23.1 EXHIBIT 23.1 CONSENT OF INDEPENDENT ACCOUNTANTS We consent to the incorporation by reference in the registration statement of Scios Inc., on Form S-8 (File No. 333-56269) of our report dated January 31, 2000 on our audits of the consolidated financial statements of Scios Inc. and its subsidiaries as of December 31, 1999 and 1998, and the years ended December 31, 1999, 1998 and 1997, which report is included in the Company's Annual Report on Form 10-K. PricewaterhouseCoopers LLP San Jose, California January 31, 2000 EX-27.1 7 EXHIBIT 27.1
5 THIS SCHEDULE CONTAINS SUMMARY FINANCIAL INFORMATION EXTRACTED FROM THE CONSOLIDATED BALANCE SHEET, CONSOLIDATED STATEMENT OF OPERATIONS, AND CONSOLIDATED STATEMENT OF CASH FLOWS INCLUDED IN THE COMPANY'S FORM 10-K FOR THE PERIOD ENDING DECEMBER 31, 1999, AND IS QUALIFIED IN ITS ENTIRETY BY REFERENCE TO SUCH FINANCIAL STATEMENTS. 1,000 12-MOS DEC-31-1999 JAN-01-1999 DEC-31-1999 11,582 89,130 3,068 0 0 34,325 20,472 8,938 118,272 32,619 42,866 0 0 38 42,749 118,272 33,824 60,787 18,470 85,120 0 0 2,793 (20,050) 14 (20,064) 0 0 0 (20,064) (0.53) (0.53)
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