Lehman Brothers Global Healthcare Conference

Similar documents
January 2019 Investor Presentation NASDAQ: ATRS

BUSINESS UPDATE CALL. September 7, 2017

Catching the Bug for Novel Antibiotics: Roundtable Conference

Cowen and Company 34 th Annual Health Care Conference

Japan: Subgroup Report

ImmunoGen, Inc. Reports Fourth Quarter and Fiscal Year 2013 Financial Results and Provides Fiscal Year 2014 Financial Guidance and Corporate Update

Promotion and Development Collaborations Between Established Players

Theravance Biopharma, Inc. Reports Fourth Quarter and Full Year 2016 Financial Results and Provides Business Update

FORWARD LOOKING STATEMENTS

Datamonitor Healthcare Pharma intelligence informa Datamonitor Healthcare Content Calendar

The Growth Strategy of Shionogi. September, 2011

Medical breakthroughs have always driven our business

NASDAQ: ATRS. September 2016

Adam Schechter President, U.S. Human Health

Investor Presentation June 2006

TOKYO, JAPAN AND SOUTH SAN FRANCISCO,

Second Mid-term Business Plan - FY2010 to FY2014 -

Apricus Biosciences, Inc. (NASDAQ:APRI) Corporate Presentation BIO CEO & Investor Conference New York City. Tuesday February 12, 2013

BRINGING SCIENCE AND TECHNOLOGY TO MAKE BETTER PRODUCTS FOR A HEALTHIER LIFE. April 11, 2019

CORPORATE PRESENTATION January 2019

Acting Deputy Commissioner for Operations, U.S. Food and Drug Administration

TELECONFERENCE Q November 2014

Santen Acquisition of InnFocus, Developer of MicroShunt Glaucoma Implant Device

AVEO Oncology Reports Third Quarter 2016 Financial Results and Provides Business Update

Jefferies 2016 Healthcare Conference. June 7, 2016

AltraGen Senior management leadership offsite Day 1: Introduction

Spectrum Pharmaceuticals Jefferies 2015 Global Healthcare Conference

Adam Schechter President, Global Human Health. Merck & Co., Inc. Cowen 2015 Healthcare Conference. March 3, 2015

Pfenex Inc. San Diego, CA NYSE MKT: PFNX. Updated July 2017

NASDAQ: ATRS. Investor Presentation January 2017

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC FORM 8-K

How Competitive Marketing Expenditures Influence the Growth of Markets

HAI event March 2009

Innovative therapies for Alzheimer s disease

Furiex Pharmaceuticals

Market Analysis & Segmentation. Gary Phillips CEO Bioshares 29 July 2016

Corporate Presentation January 2019

Roche Committed to Innovation. Sal. Oppenheim European Healthcare Investors Conference Frankfurt, September 2, 2008

Pfenex Inc. San Diego, CA NYSE MKT: PFNX

Jefferies 2018 Global Healthcare Conference. June 7, 2018

Overview: The future of medicine is personalised. Severin Schwan, CEO

Economic Incentives for Genetic and Genomic Strategies: Stratified Medicines

Agios Pharmaceuticals, Inc. (Exact Name of Registrant as Specified in Charter)

First Quarter 2018 Financial Results & Update

Oryzon Genomics SA ORY.SM MADRID Buy

Immune Design Reports Third Quarter 2017 Financial Results and Provides Corporate Update

Sosei Business Update and Revised Financial Forecast Following Acquisition of Arakis

VISION & STRATEGY FIC LIC. Interview with the President

Personalized Medicine: The Changing Landscape of Health Care

Johan Christenson MD; PhD Partner Farmasidagene 2014 Oslo

QIAGEN Sample & Assay Technologies From Discovery to Patient

UBS 2007 Global Life Sciences Conference. September 24, 2007

Electric Forward Market Report

Important notice. 139 th Ordinary general meeting of shareholders. Christophe Weber President & Chief Executive Officer

INVESTOR PRESENTATION. June 2018

Investor Presentation. October 2018

Fourth Quarter and Full Year Financial and Operational Results Conference Call March 21, 2018

Achillion Reports Third Quarter 2017 Financial Results and Provides Update on Clinical Programs

January (San Francisco, CA) January 8, 2018

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C FORM 8-K

Models of Industry Trials for Regulatory Purposes (Safety) Frank Cerasoli, PhD OREXIGEN Therapeutics

Pain Therapeutics, Inc. Pain Therapeutics Announces Update on Drug Portfolio

Eagle Pharmaceuticals NASDAQ: EGRX

New Ways to Source Innovation in the Healthcare Industry In-licensing needs Oncology of Janssen/Johnson & Johnson Innovation

novel drug molecule for the treatment of Chronic Pain

SYNTHETIC BIOLOGICS, INC.

Roche: adapting to the changing environment. Severin Schwan, CEO Roche Group London, 15 September 2010

Synthetic Biologics Reports Year End 2012 Financial Results

Strategic trends facing the pharmaceutical industry and their implications for marketing skills development Received: 4th September, 2002

Roche in Australia Innovation Leader

Parameters of Development - Drug Delivery Enabled/Enhanced Products (DDEP ) A Review (Chapter 7)

1 st Quarter 2007 Earnings. April 19, 2007

WITA/GWU TRADE SEMINAR September 29, 2016 Washington D.C. RICHARD KJELDGAARD INTELLECTUAL PROPERTY AND TRADE CONSULTANT

University of Michigan Eco-Driving Index (EDI) Latest data: August 2017

JEFFERIES 2015 GLOBAL HEALTHCARE CONFERENCE JUNE 4, 2015 VINCENT J. ANGOTTI, CHIEF OPERATING OFFICER

For personal use only

Valuing and Licensing Intellectual Property. Richard Williams

35 th Annual J.P. Morgan Healthcare Conference. Gwan Sun Lee. President & CEO

Investor Presentation: Phase II Data for LCP Tacro. March 3, 2008

Venture Philanthropy Models: The Leukemia & Lymphoma Society's Therapy Acceleration Program. A FasterCures Webinar June 19, 2013

2016 Summary Financial Results

Small-Cap Research OUTLOOK. V.DMA: Zacks Company Report

About the Healthcare Strategic Analysis Team Geographic specific reports: Global issue reports: 1. About This Report Chapter structure Executive

Pharmaceutical Innovation at a Crossroads

AMGEN AND CENTOCOR ORTHO BIOTECH PRODUCTS FINALIZE ESA RISK EVALUATION AND MITIGATION STRATEGY (REMS) WITH FDA

CENTRAL NERVOUS SYSTEM (CNS) BIOMARKERS: TECHNOLOGIES AND GLOBAL MARKETS

GLOBAL MARKETS AND MANUFACTURING TECHNOLOGIES FOR PROTEIN DRUGS

INVESTOR PRESENTATION 2018

JP Morgan Healthcare Conference

Allergan to Acquire Naurex

Jefferies 2015 Global Healthcare Conference June 3, 2015

trial. Key trial data points:

Global Pharmaceutical Industry Profile 2012

ARIKAYCE U.S. FDA Approval

Arthur P. Bedrosian, Chief Executive Officer Brian Kearns, Chief Financial Officer. Investor Presentation February 2009

The Current Status at Shionogi

FIGURE 2 GLOBAL MARKET FORECAST FOR ALS THERAPEUTICS, ($ MILLIONS) THE U.S. MARKETS (CONTINUED) ALS: BACKGROUND INFORMATION...

Important Update on EpiPen (epinephrine injection, USP) 0.3 mg Auto-Injectors from Mylan and Pfizer

Company Report Daring to be different

Moderna Therapeutics Announces Transition to a Clinical Stage Company, Provides Business Update and Outlines 2016 Strategic Priorities

Transcription:

Lehman Brothers Global Healthcare Conference Lawrence S. Olanoff - MD, Ph.D President and Chief Operating Officer March 20, 2007

Safe Harbor Except for the historical information contained herein, this presentation contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because these statements involve a number of risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to the difficulty of predicting FDA approvals, acceptance and demand for new pharmaceutical products, challenges relating to intellectual property protection, the impact of competitive products and pricing, the timely development and launch of new products and the risk factors listed from time to time in the Company s SEC reports, including the Company s Annual Report on Form 10-K for the fiscal year ended March 31, 20.

Strategically Focused Supporting growth of in-market products while building the pipeline to deliver long-term earnings performance License promising new products from innovative companies worldwide at virtually every stage of development Conduct rigorous and aggressive scientific development programs for drug therapies that can make a unique contribution to the field of healthcare and the lives of patients Execute focused marketing and sales initiatives to firmly establish our products in the marketplace

Feb- Jun- Oct- Feb-07 Oct-05 Jun-05 Feb-05 2,700 2,600 2,500 2,400 2,300 2,200 2,100 Core Business Strength Monthly Total Prescriptions (TRx,000) 550 475 400 325 250 175 100 Oct-04 Feb-05 Jun-05 Oct-05 Feb- Jun- Oct- Feb-07 Jun-04 Oct-04 1,200 1,100 1,000 900 800 700 600 500 Source: IMS Feb-07 Oct- Jun- Jun-04 Oct-04 Feb-05 Jun-05 Oct-05 Feb- Jun-04

Nov- Feb-07 14,500 14,000 13,500 13,000 12,500 12,000 11,500 11,000 SSRI Market Monthly TRx Volume 03 Δ 8.4% 04 Δ 2.8% 05 Δ -2.3% 03-Feb 03-MayAug-03 Nov-03 Feb-04May-04 Aug-04 Nov-04Feb-05 May-05 Aug-05Nov-05 Feb- May-Aug- SSRI TRx 3 Mo Av Avg. Δ 6.4%

SRI Market: Category Leadership in Detailing Detailing Investment ($,000) 14,000 12,000 Three Key Players 10,000 8,000 6,000 4,000 2,000 0 Jan- 05 Mar- 05 May- 05 Jul- 05 Sep- 05 Nov- 05 Jan- Mar- May- Jul- Sep- Nov- Jan- 07 LEXAPRO PAXIL+CR ZOLOFT CYMBALTA EFFEXOR/XR Source: IMS Integrated Promotional Services

Alzheimer s Market Growing Prevalence of Combination Therapy Network: Neurologist Mild Moderate Severe Namenda + AChE Inhibitor Combo Therapy Namenda Monotherapy AChE Inhibitor Monotherapy 16% 16% 16% 20% 18% 6% 7% 7% 4% 9% 11% 3% 41% 49% 44% 44% 47% 49% 62% 50% 73% 69% 62% 10% 8% 9% 9% 12% 9% 87% 12% 77% 77% 77% 76% 73% 10% 14% 2% 50% 42% 5% 10% 42% 42% 48% 47% 38% 30% 28% 24% 21% 21% n=142 126 140 112 89 119 389 333 386 325 277 370 69 58 56 61 63 64 69% Mar- Apr- May- Jun- Jul- Aug- Mar- Apr- May- Jun- Jul- Aug- Mar- Apr- May- Jun- Jul- Aug-

Aug- Nov- Feb-07 Monthly Market Share 35.00% 30.00% 25.00% 20.00% 15.00% 10.00% 5.00% 0.00% Feb-04 May-04 Aug-04 Nov-04 Feb-05 May-05 Aug-05 Nov-05 Feb- May- NRx Share TRx Share 32.9% N 32.4% T

Monthly NRx Share ARB + Combo Market 40% 35% 30% 25% 20% 15% 10% 5% 0% 7 th entry Feb- Jun- 03 03 Oct- 03 Feb- 04 Jun- 04 Oct- 04 Feb- 05 Jun- 05 Oct- 05 Feb- Jun- BENICAR + HCT COZAAR + HYZAAR DIOVAN+DIOVAN HCT Oct- Feb- 07 16.2% 3 rd in market share AVAPRO+AVALIDE ATACAND+ATACAND HCT MICARDIS+MICARDIS HCT Benicar is a registered trademark of Sankyo Pharma

Competitive Sales Force Ranked 14 th by Salesforce Size in US Source: Verispan 1 st Productivity 2 nd Forest 3 rd 4 th 5 th 2 nd Forest 1 st Sales Call Quality 2 nd 3 rd 4 th 5 th Forest 2 nd Forest Sensitivity to Time Constraints - GP 1 st 2 nd 3 rd 4 th 5 th Forest 2 nd Forest Unbiased Product Comparisons - GP 1 st 2 nd 3 rd 4 th Forest 4 th 5 th Forest

Ability to Compete Against Large Pharma Prozac (Eli Lilly) Zoloft (Pfizer) Paxil (Glaxo-SmithKline) Effexor (Wyeth) Cymbalta (Eli Lilly) Aricept (Pfizer) Exelon (Novartis) Razadyne (Johnson & Johnson) Diovan (Novartis) Cozaar (Merck) Avapro (Bristol-Myers Squibb)

Looking Forward

Licensing Criteria Late Phase Development Projects (Phase II POC and after) Opportunistic Individual Product Licenses/Acquisitions Co-Development and/or Co-Marketing Arrangements Follow-on Products from Established Partners Early Phase or Preclinical Projects (Pre-Phase II Results) Specific Therapeutic Targets of Interest Joint Venture or Portfolio Licensing Agreements Forest Development or Shared Development Discovery Projects/Target Identification (No Lead Candidate at Initiation)

Partner of Choice Products with potential peak sales of less than $1 Billion are attractive to Forest. Do not compete with our ex-us partners in their home markets, comfortable with both US-only or global license distribution agreements. We do not have a traditional drug discovery component that generates competitive drug candidates to partner projects. Partners can see Forest as their mirror image in terms of structure and size. Senior Management, including CEO, are involved in the deal agreement and in actively managing the project post agreement. No history of acquiring partners, whereas we frequently have the opportunity to review and sometimes license newly offered products from established partners.

The Forest Pipeline: Pre-Clinical/Phase I The Forest Pipeline Phase II Phase III NDA/sNDA mglur-5 for various CNS conditions ME1036 Broad spectrum carbapenem RGH-188 for schizophrenia and bipolar mania RGH-896 for chronic pain and other CNS conditions milnacipran for fibromyalgia ceftaroline for CAP, csssi Aclidinium for COPD Namenda QD for Alzheimer s disease nebivolol for hypertension Metabolic Target Lead project Obesity/Diabetes GRC-3886 (oglemilast) for COPD and asthma nebivolol- CHF neramexane for Alzheimer s disease desmoteplase for acute stroke Lexapro Pediatric indication

Pipeline: Key Initiatives Nebivolol Licensed January 11, 20 from Mylan Laboratories Novel beta blocker for hypertension Most highly selective beta blocker Has favorable differentiating characteristics, based on the Phase III studies Mylan Received FDA Approvable Letter May 31, 2005 Expect to submit response to Approvable Letter around the end of Fiscal Year 2007 Plans to submit a separate NDA for the treatment of congestive heart failure

Pipeline: Key Initiatives Milnacipran Dual Serotonin Norepinephrine Reuptake Inhibitor investigated for fibromyalgia (Cypress) Encouraging results from first Phase III Study: n=888 Predefined Primary Composite Endpoint which includes Pain and Patient Global Assessment yield p-value=0.058 LOCF analysis, Dropouts analyzed by BOCF yielded p-value=0.048. Enrollment in second Phase III study increased to 1,200 patients from 800 patients Topline Results to be reported during 2Q-calendar year 2007. Three-month endpoint. Ongoing discussions with FDA regarding analysis plan for second study Third Phase III Study enrolling targeted at 800 patients Significant market opportunity

Pipeline: Key Initiatives Ceftaroline Lead compound from acquisition of Cerexa, Inc. completed in January 2007 Broad-spectrum fifth generation Cephalosporin entering Phase III trials for csssi and CAP in 2007. (Active against MRSA) Injectable antibiotic for future sale by FRX Hospital Salesforce Hospital Infections kill 90,000/yr: excess costs of $4.5B (CDC est. WSJ 12/26/). Experienced antibiotic development team from Cerexa

Upcoming Clinical Data Topline Results 2007 2008 Milnacipran Second Phase III Study Desmoteplase DIAS 2 Memantine Phase III AD - MR RGH-188 Phase II Bipolar Mania Ceftaroline CSSSI- Phase III (2 Studies) RGH-188 Phase II Schizophrenia Lexapro Phase III Pediatric/Adolescent Depression Milnacipran Third Phase III Study Aclidinium - Phase III COPD (2 Studies)

Corporate Overview Lawrence S. Olanoff - MD, Ph.D President and Chief Operating Officer