-----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, IAoIaencj39AIhIgo6bLlwzvsfsNMZJprKYeL/VCeE05JEqFzloW/I+0BDY296QD AdyDpBPE3nngNBoovxBmBA== 0000912057-99-008649.txt : 19991209 0000912057-99-008649.hdr.sgml : 19991209 ACCESSION NUMBER: 0000912057-99-008649 CONFORMED SUBMISSION TYPE: DEFA14A PUBLIC DOCUMENT COUNT: 1 FILED AS OF DATE: 19991208 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: DEFA14A SEC ACT: SEC FILE NUMBER: 000-11749 FILM NUMBER: 99770778 BUSINESS ADDRESS: STREET 1: 820 W MAUDE AVE CITY: SUNNYVALE STATE: CA ZIP: 94086 BUSINESS PHONE: 4159661550 MAIL ADDRESS: STREET 1: 2450 BAYSHORE PARKWAY CITY: MOUNTAIN VIEW STATE: CA ZIP: 94043 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 DEFA14A 1 DEFA14A SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant /x/ Filed by a party other than the Registrant / / Check the appropriate box: / / Preliminary Proxy Statement / / Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) / / Definitive Proxy Statement / / Definitive Additional Materials /x/ Soliciting Material Pursuant to Section 240.14a-11(c) or Section 240.14a-12 Scios Inc. - -------------------------------------------------------------------------------- (Name of Registrant as Specified In Its Charter) - -------------------------------------------------------------------------------- (Name of Person(s) Filing Proxy Statement, if other than the Registrant) Payment of Filing Fee (Check the appropriate box): /x/ No fee required / / Fee computed on table below per Exchange Act Rules 14a-6(i)(1) and 0-11 (1) Title of each class of securities to which transaction applies: ------------------------------------------------------------------------ (2) Aggregate number of securities to which transaction applies: ------------------------------------------------------------------------ (3) Per unit price or other underlying value of transaction computed pursuant to Exchange Act Rule 0-11 (set forth the amount on which the filing fee is calculated and state how it was determined): ------------------------------------------------------------------------ (4) Proposed maximum aggregate value of transaction: ------------------------------------------------------------------------ (5) Total fee paid: ------------------------------------------------------------------------ / / Fee paid previously with preliminary materials. / / Check box if any part of the fee is offset as provided by Exchange Act Rule 0-11(a)(2) and identify the filing for which the offsetting fee was paid previously. Identify the previous filing by registration statement number, or the Form or Schedule and the date of its filing. (1) Amount Previously Paid: ------------------------------------------------------------------------ (2) Form, Schedule or Registration Statement No.: ------------------------------------------------------------------------ (3) Filing Party: ------------------------------------------------------------------------ (4) Date Filed: ------------------------------------------------------------------------ Below is a copy of a presentation for use by Scios Inc. with its investors and other parties interested in Scios. SCIOS INC. DECEMBER 1999 1 of 31 SCIOS INC. The statements in this presentation that are not historical facts are forward-looking statements that involve risks and uncertainties, and may include references to the implementation of the Company's strategic plan and the timely development and approval of the Company's products and the receipt of revenue from those products, as well as the other risks detailed from time to time in the Company's SEC reports, including its annual reports on Form 10-K and subsequent reports on Form 10-Q 2 of 31 SCIOS SNAPSHOT EARLY 1999 - - TOTAL CORPORATE RESTRUCTURE: MAR `99 - 40% workforce reduction - Eliminated protein manufacturing - Sold Mountain View campus for net proceeds of $19.2 million - $14 million annual cost savings expected - - NATRECOR-Registered Trademark- ANTICIPATED APPROVAL AND LAUNCH: APR `99 - - MOVE TOWARD PROFITABILITY THROUGH NATRECOR-Registered Trademark- AND RESTRUCTURING 3 of 31 WHAT HAPPENED TO NATRECOR-Registered Trademark- - - JAN 99 Approved by Cardiorenal Advisory Committee - - APR 99 Non-Approval letter - - FDA REQUESTS ADDITIONAL CLINICAL DATA - Onset and offset of hypotension - Clinical utility of Natrecor-Registered Trademark- vs. existing therapy - Sample size 4 of 31 IMPACT ON THE STOCK [Graph of Scios Stock Price in 1999 showing:] Date Stock Price ---- ----------- January 4, 1999 $10.000 February 1, 1999 $10.625 March 1, 1999 $ 9.313 April 1, 1999 $ 9.500 May 3, 1999 $ 4.094 June 1, 1999 $ 3.625 July 1, 1999 $ 3.625 August 2, 1999 $ 4.000 September 1, 1999 $ 3.875 October 1, 1999 $ 3.750 November 1, 1999 $ 3.938 December 1, 1999 $ 4.563 5 of 31 VMAC VASODILATION IN THE MANAGEMENT OF ACUTE CONGESTIVE HEART FAILURE 6 of 31 VMAC STEERING COMMITTEE - - JAMES B. YOUNG, M.D. - Chairman of Steering Committee - Head, Section of Heart Failure and Cardiac Transplant Medicine at the Cleveland Clinic Foundation - - WILLIAM ABRAHAM, M.D. - Director, Section of Heart Failure and Cardiac Transplantation, University of Cincinnati College of Medicine - - CHARLES EMERMAN, M.D. - Chairman, Department of Emergency Medicine at the Cleveland Clinic Foundation - - LYNNE WARNER STEVENSON, M.D. - Clinical Director, Cardiomyopathy and Heart Failure Center, Brigham and Women's Hospital 7 of 31 VMAC [To the left (below) is a graphic portrayal of the heart with the amino acid sequence of Natrecor-Registered Trademark-] - Double-blind, placebo controlled study with Natrecor-Registered Trademark- and nitroglycerin - Primary objective of the study is to compare the effect of Natrecor-Registered Trademark- and placebo on PCWP and symptoms 3 hours after start of study drug - Two arms, catheterized and non-catheterized - Administration of both fixed and adjustable doses of Natrecor-Registered Trademark- 8 of 31 VMAC TRIAL DESIGN [Graphic depicting arms of VMAC trial for Natrecor-Registered Trademark- showing the stratification of the patients between the catheterized and non-catheterized arms of the trial, the randomization of patients between placebo, nitroglycerin and Natrecor-Registered Trademark- during a three hour placebo-controlled period and an active-controlled treatment period.] 9 of 31 NATRECOR-Registered Trademark- MARKET OPPORTUNITY - - National healthcare consulting firm completed intensive U.S. market evaluation - - 80% of patients with CHF are treated in the ER -> ICU - CCU - Telemetry setting: targeted setting for Natrecor-Registered Trademark- as an IV therapeutic - - - National survey of more than 200 physicians - Representing cardiologists and emergency department physicians - interest in prescribing Natrecor-Registered Trademark- as a therapeutic was high: 4.4/5 - - More than two-thirds of CHF patients are in the normotensive or hypertensive category: where Natrecor-Registered Trademark- is expected to be most widely employed. 10 of 31 NATRECOR-Registered Trademark- MARKET OPPORTUNITY - $200 - $300 million peak U.S. annual sales - High physician interest in new vasoactive therapy for acute CHF - Patients are treated for acute CHF in settings appropriate for an IV therapeutic - Physician attitudes are negative toward inotropic agents due to arrhythmia generating potential 11 of 31 SEIZING THE NATRECOR-Registered Trademark- OPPORTUNITY - - Build awareness for the product and its position - - All alternatives considered and priority strategy chosen: SECURE THE RIGHT PARTNER AND CO-PROMOTION AGREEMENT 12 of 31 SCIOS INC. - VALUE BUILDERS - - (2ND HALF 00) P38-Kinase Inhibitor enters clinical trials for rheumatoid arthritis indication - - (3RD Q00) VMAC enrollment complete - - (4TH Q00) Natrecor-Registered Trademark- NDA Amendment filing - - (2000) Fiblast-Registered Trademark- approval in Japan (targeted by Kaken) - - (ONGOING) VEGF(121) partners 13 of 31 SCIOS INC. - A VALUE OPPORTUNITY - - 9/30/99 $96 Million Cash - - NATRECOR-Registered Trademark- A Valuable Product - Committed Course New Natrecor-Registered Trademark- Trial - - P38-KINASE Promising Pipeline - Committed Course Complete toxicology work and move into clinic - - COMPANY Lean and Focused - - RIGHT PEOPLE TO MAKE IT HAPPEN 14 of 31 SCIOS INC. Stay Tuned Assess Performance Over Time See The Value 15 of 31 SCIOS INC. RESEARCH PROGRAMS 16 of 31 SCIOS (NEW): DISEASE-BASED DISCOVERY RESEARCH [FLOWCHART depicting that functional genomics, bioinformatics, computational chemistry and combinational chemistry support gene cloning, protein expression, transcriptional analytics, high throughput screening, and biased chemical library which in turn support development of protein therapeutics and small molecule kinase inhibitors] 17 of 31 EXPRESSION ANALYSIS: CDNA MICROARRAYS [Graphic depicting use of cDNA Microarray technology and how results are displayed: - Individual DNA clones in 96-well format -- > DNAs printed as microarray -- > microscopic slide - Disease tissue and normal tissue: fluorescently labeled cDNAs prepared, then hybridized together on microarray -- > microscopic slide - Fluorescense scanning of microscopic slide reveals hybridization patterns] 18 of 31 SCIOS DISCOVERY MODEL SUCCESS - - P38 Kinase Inhibitor program is the first success story of Scios' new drug discovery model - Combines experience in both proteins and small molecule synthesis - Increases capability for future products 19 of 31 ROLE OF P38 KINASE IN TNF BIOSYNTHESIS AND ACTION [Flowchart depicting that stress causes Target Cells to produce P38-Kinase which in turn causes greater production of TNF which in turn acts on Responder Cells to cause greater production of P38-Kinase that causes further production of TNF, IL-1 and COX-2.] 20 of 31 P38 KINASE INHIBITOR ROLE IN INFLAMMATORY DISEASE [Graphic depicting role of P38 Kinase in triggering inflammation and fibrosis and goal of Scios Kinase Inhibitors to suppress these responses.] 21 of 31 POTENTIAL P38-KINASE INHIBITORS COULD BE THE FIRST ORALLY ADMINISTERED TREATMENT FOR RHEUMATOID ARTHRITIS BY BLOCKING THE BIOSYNTHESIS AND ACTION OF TNF AND INHIBITING COX-2. 22 of 31 SCIOS INC. P38-KINASE INHIBITORS - - Novel chemical classes discovered by Scios research - - Both oral and IV compounds have been defined - - Patents pending - - Development underway 23 of 31 P38-KINASE INHIBITORS: THE LEADING EDGE OF ANTI-INFLAMMATORY THERAPEUTICS - - Lowering TNF represents a paradigm shift in modifying inflammatory diseases - - Injectable protein TNF antagonists have defined the therapeutic mechanism and the market - - Inhibitors of COX-2 have re-defined the optimum approach to symptom relief in arthritis - - Scios' ORALLY ADMINISTERED P38-Kinase inhibitors both lower TNF and inhibit COX-2 24 of 31 P38-KINASE INHIBITORS DISEASE TARGETS: - - Rheumatoid arthritis - - Inflammatory bowel disease - - Heart failure 25 of 31 DEVELOPMENT PROGRAMS [CHART showing status of the following development programs: Scios Programs: Natrecor-Registered Trademark- Actute Congestive Heart Failure: Phase III VEGF-121 Cardiovascular Disease- Protein Therapy: Preclinical P38-Kinase Inhibitors Inflammatory Disease: Preclinical Partnered Programs: B-Amyloid Alzheimer's Disease: Preclinical, Partner: Eli Lilly & Co. Alzheimer's Disease: Preclinical, Partner: DuPont Pharmaceuticals Natrecor-Registered Trademark- BNP Diagnostic: Regulatory, Partner: Shionogi & Co., Ltd. BNP Diagnostic: Regulatory, Partner: Biosite Diagnostics Inc. BNP Diagnostic: Preclinical, Partner: Abbott Laboratories Fiblast Recalcitrant Dermal Wounds: Regulatory, Partner: Kaken (Japan) Coronary Artery Disease: Phase II, Partner: Chiron Peripheral Vascular Disease: Phase II, Partner: Chiron VEGF-121 Coronary Artery Disease - Gene Therapy: Phase I, Partner: GenVec GLP-1 Type 2 Diabetes: Phase I, Partner: Novo Nordisk] 26 of 31 SCIOS INC. OPERATIONS AND FINANCIAL UPDATE 27 of 31 CASH PICTURE - - Start FY 2000 with approximately $100 Million in cash - - Initial revenue expected in FY 2000 from Fiblast wound healing in Japan - - Cash use in FY 2000 operations expected to be approximately $27 million 28 of 31 FIBLAST-Registered Trademark- HUMAN BASIC FIBROBLAST GROWTH FACTOR (bFGF) - - Licensed to Chiron for $25 million + royalties - Scios to receive payments based on any commercialized form (human or bovine) - Chiron has ongoing Phase II trials in CAD and PVD 29 of 31 PSYCHIATRIC SALES & MARKETING DIVISION - - Dedicated to psychiatric product sales - - $9 million net contribution (cash flow) expected in 1999 - - Fully integrated and experienced marketing/sales organization - - Expansion capability - - Line reorganization expected in 2000 30 of 31 CERTAIN INFORMATION CONCERNING PARTICIPANTS The following individuals, all of whom are directors of Scios Inc., may be deemed participants in the solicitation of proxies on behalf of the Company's Board of Directors: Donald B. Rice, Ph.D. (Chairman of the Board of the Company; President and Chief Executive Officer of Urogenesys, Inc.); Richard B. Brewer (Chief Executive Officer and President of the Company); Samuel H. Armacost (Chairman, SRI International); Myron Du Bain (Chairman and Chief Executive Officer (Retired), Fireman's Fund Corporation); Charles A. Sanders, M.D. (Chairman and Chief Executive Officer (Retired), Glaxo Inc.); Solomon H. Snyder, M.D. (Director, Department of Neuroscience, and Distinguished Service Professor of Neuroscience, Pharmacology and Molecular Sciences and Psychiatry, The Johns Hopkins University); Burton E. Sobel, M.D. (E.L. Amidon Professor and Chair, Department of Medicine, The University of Vermont College of Medicine); and Eugene L. Step (Executive Vice President, President of the Pharmaceutical Division (Retired), Eli Lilly and Company). The following executives of the Company may also be deemed participants: Thomas L. Feldman (Vice President of Commercial Operations); Elliott B. Grossbard, M.D. (Senior Vice President of Development); David W. Gryska (Vice President of Finance and Chief Financial Officer); John A. Lewicki, Ph.D. (Vice President of Research); John H. Newman (Senior Vice President, General Counsel & Secretary); George F. Schreiner, M.D., Ph.D. (Vice President, Cardiorenal Research) and Wendy Carhart (Senior Manager of Investor Relations). In the aggregate, these individuals beneficially own 1,622,257 shares of the Company's Common Stock, including 1,267,332 shares subject to stock options exercisable within 60 days of December 6, 1999. None of these individuals beneficially owns more than 1% of the Company's Common Stock. In addition to customary cash compensation payable to non-employee directors, under the Company's Equity Incentive Plan each non-employee director receives an automatic grant of a stock option to acquire 10,000 shares of the Company's Common Stock at each annual meeting where the director is elected to the Company's Board of Directors. Mr. Brewer's employment agreement with the Company provides for, among other things, severance payments to Mr. Brewer in the event of termination of his employment "without cause" or "for good reason." 31 of 31 -----END PRIVACY-ENHANCED MESSAGE-----