Bank of America Merrill Lynch Healthcare Conference. September 13, 2013

Similar documents
LEVERAGING OUR BIOLOGICS EXPERTISE IN BIOSIMILARS SCOTT FORAKER VICE PRESIDENT AND GENERAL MANAGER, BIOSIMILARS

Goldman Sachs Health Care Conference

AMGEN ASTELLAS AND ASTELLAS ANNOUNCE SUBMISSION OF APPLICATION FOR INVESTIGATIONAL OSTEOPOROSIS MEDICATION ROMOSOZUMAB IN JAPAN

Commercial Strategy. Tony Hooper Executive Vice President, Global Commercial Operations

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

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

ANNOUNCEMENT OF MARKETING APPROVAL SUBMISSION TO MHLW (JAPAN) FOR LDL CHOLESTEROL-LOWERING MEDICATION EVOLOCUMAB

HQ/0716/RMZ/ UCB News

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

Teva Pharmaceutical Industries Ltd. J.P. Morgan Healthcare Conference. Kåre Schultz President and CEO January 7, 2019

Forget Heart Disease: 1 Stock to Enjoy a Long, Healthy, Prosperous Retirement

AMGEN SUBMITS APPLICATIONS IN THE US AND EUROPE FOR KYPROLIS (CARFILZOMIB) FOR THE TREATMENT OF RELAPSED MULTIPLE MYELOMA

The industry s largest toolkit with

Mylan. Raymond James 40 th Annual Institutional Investors Conference March 05, 2019

Goldman Sachs Key Debates In Biosimilars Conference

HEAD-TO-HEAD PHASE 3 TRIAL OF KYPROLIS (CARFILZOMIB) VERSUS VELCADE (BORTEZOMIB) MET PRIMARY ENDPOINT OF PROGRESSION-FREE SURVIVAL

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

Jefferies 2016 Healthcare Conference. June 7, 2016

Investor Presentation. October 2018

Eli Lilly and Company

ARIKAYCE U.S. FDA Approval

Innovation and Sustainability: An integrated approach

Pfizer Completes Acquisition of Hospira

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

The Future of Consumer Health Care

Spectrum Pharmaceuticals Jefferies 2015 Global Healthcare Conference

Addressing attrition in neurosciences. Dr Ismail Kola Head UCB NewMedicines

Karyopharm Reports Second Quarter 2016 Financial Results and Highlights Recent Progress

Amgen, Inc. Rating: Buy

Jefferies 2018 Global Healthcare Conference. June 7, 2018

Are Biosimilars the Panacea for High Cost Specialty Drugs?

J.P. Morgan Healthcare Conference

Bringing a successful partnership to the next level

Jefferies 2015 Global Healthcare Conference June 3, 2015

Jefferies 2016 Healthcare Conference. June 8, 2016

Second Quarter 2017 Earnings Teleconference. August 1, 2017

A full-service CRO with integrated early-stage capabilities

University of Connecticut Student Managed Fund 2018 Analyst Report. Jonathan Stryjek & Michael Pehota

Cautions Concerning Forward-looking Statements

psivida Corp PSDV June 2016

ARQULE AND DAIICHI-SANKYO ENTER INTO STRATEGIC R&D PARTNERSHIP TO PROGRESS NOVEL COMPOUNDS TO TARGET CANCER

Investor Presentation RBC Capital Markets Global Healthcare Conference February 22, 2017

Cortendo and Antisense Therapeutics Announce Licensing Agreement for ATL1103 for Acromegaly

PRESS RELEASE. Ipsen delivers strong sales growth of 20.2% 1 for the third quarter of 2018 and confirms full year guidance

Biosimilars Market Update

J.P. Morgan Healthcare Conference January 10, 2018

Amgen, Inc. Rating: Buy

Jefferies 2017 Global Healthcare Conference. June 7, 2017

The Mochida Pharmaceutical Group s Medium Term Management Plan

Pfizer To Acquire Hospira

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

Changing Lives. Daniel Junius, President and CEO June 3, Nasdaq: IMGN

Jefferies Healthcare Conference. June 2016

Second Quarter 2017 Financial Results. August 8, 2017

Investor Day Leading in Next Generation Products. Kingsley Wheaton

Trubion Investor Presentation BioCentury NewsMakers in the Biotech Industry Conference September 6, 2007

AmerisourceBergen. J.P. Morgan Healthcare Conference. Steve Collis, Chairman, President & CEO Tim Guttman, EVP & CFO.

AMGEN AT ASH 2017: DEVELOPING LEADERSHIP IN BISPECIFIC THERAPIES DECEMBER 9, 2017

Corporate Presentation January 2019

Agios Pharmaceuticals, Inc.

Science Applications International Corporation (SAIC) [NYSE: SAIC]

Stephens Fall Investment Conference

REFERENCE CODE GDHC1180DFR PUBLICATION DATE M AY 2013

Biomanufacturing Capacity for Biosimilars: Is there enough?

Company Profile. German-Taiwan Biotech Seminar 6 November 2017

JP Morgan Healthcare Conference January 9, 2012

Morgan Stanley Conference. November 15, 2017

Datamonitor Healthcare Pharma intelligence informa Datamonitor Healthcare Content Calendar

Taylor Acquisition Overview. May 18, 2018

UBS 2007 Global Life Sciences Conference. September 24, 2007

License Agreement of Tildrakizumab for Psoriasis in Europe

Biopharmaceuticals Investor & Analyst Day

J.P. Morgan Health Care Conference

Eagle Pharmaceuticals NASDAQ: EGRX

Supplemental Financial Schedules May 19, 2015

News For Immediate Release

Sustainable Profitable Growth through Innovation. Pascal Soriot Chief Operating Officer Roche Pharmaceuticals

REFERENCE CODE GDHC1106CFR PUBLICATION DATE M AY 2013

psivida Transforms into Commercial Stage Specialty BioPharmaceutical Company ASCRS April 12, 2018 NASDAQ: EYPT

Raymond James 34th Annual Institutional Investors Conference

PerkinElmer, Inc. Andy Wilson, CFO May 13, 2015 HUMAN HEALTH ENVIRONMENTAL HEALTH. Bank of America Merrill Lynch Global Healthcare Conference

The Growth Strategy of Shionogi. September, 2011

Amgen, Inc. Rating: Buy

Coherus BioSciences 2018 CANTOR GLOBAL HEALTHCARE CONFERENCE OCTOBER 2, Copyright 2018 All Rights Reserved.

14 May Evotec Q1 2013: Driving Innovation Efficiency

FINANCIAL PERSPECTIVES

Health Care Worldwide. Crédit Suisse Global Credit Products Conference October 1, Barcelona

Jefferies TMT Conference

Focusing Our Portfolio & Utilizing Our Financial Strength

Challenges and Opportunities in Pharma: Perspective for an Emerging Middle East April 24th, 2015

Steelcase Inc. Reports Third Quarter Fiscal 2002 Results; Declares Quarterly Dividend of Six Cents Per Share

Quarter End Results. Period Ended September 30, 2018

Value Creation; Eisai Way

Primer: The Biotechnology Industry Han Zhong l September 2011

Improving the standard of care

Jefferies London Healthcare Conference Julie Brown, CFO

Jefferies 2014 Global Healthcare Conference June 3, 2014 NYSE: Q

Global Demand and Utilization of Mammalian Cell Culture Manufacturing Capacity

Capital Market Day June 12, 2012

REFERENCE CODE GDHC1113CFR PUBLICATION DATE M AY 2013

Transcription:

Bank of America Merrill Lynch Healthcare Conference September 13, 2013

Safe Harbor Statement This presentation contains forward-looking statements that are based on management s current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including statements about the planned completion of the tender offer and the merger, estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission (SEC) reports filed by Amgen, including Amgen s most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and Form 8-K. Please refer to Amgen s most recent Forms 10-K, 10-Q and 8-K for additional information on the uncertainties and risk factors related to our business. Unless otherwise noted, Amgen is providing this information as of September 13, 2013 and expressly disclaims any duty to update information contained in this presentation. No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Risks and uncertainties include whether the proposed transaction described in this presentation can be completed in a timely manner, and whether the anticipated benefits of the proposed transaction can be achieved. Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments (domestic or foreign) involving current and future products, sales growth of recently launched products, competition from other products (domestic or foreign) and difficulties or delays in manufacturing our products. Discovery or identification of new product candidates cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. We develop product candidates internally and through licensing collaborations, partnerships, joint ventures and acquisitions. Product candidates that are derived from relationships or acquisitions may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. In addition, sales of our products are affected by reimbursement policies imposed by thirdparty payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment as well as U.S. legislation affecting pharmaceutical pricing and reimbursement. Government and others regulations and reimbursement policies may affect the development, usage and pricing of our products. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. We or others could identify safety, side effects or manufacturing problems with our products after they are on the market. Our business may be impacted by government investigations, litigation and products liability claims. If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. government, we could become subject to significant sanctions. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors. We depend on third parties for a significant portion of our manufacturing capacity for the supply of certain of our current and future products and limits on supply may constrain sales of certain of our current products and product candidate development. In addition, we compete with other companies with respect to some of our marketed products as well as for the discovery and development of new products. Our products may compete against products that have lower prices, established reimbursement, superior performance, are easier to administer, or that are otherwise competitive with our products. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock. 2

We Are Executing on Our Strategy for Growth and Creating Value Expect to deliver attractive EPS and expect dividend increases through 2015 Grow and differentiate our in-market products Deliver increased Enbrel profitability to shareholders Accelerate growth longer term Pending acquisition of Onyx will add a growing multiple myeloma franchise Our pipeline has nine innovative programs with registration enabling data by 2016 We are developing six biosimilars that offer a multi-billion dollar opportunity We have made progress on expanding internationally We are committed to returning capital to shareholders Meaningful dividend increases Return on average > 60% of adjusted net income over 2011 2015 3

We Have a Diverse Portfolio of Innovative Products For additional information about Amgen products, including important safety information, please visit www.amgen.com 4

Neulasta /NEUPOGEN : Established Track Record of Safety and Efficacy Neulasta is ~ 80% of filgrastim sales with exclusivity through 2015 Potential to expand penetration in breast cancer and NHL patients We will invest in direct-to-patient programs Neulasta is differentiated from short-acting filgrastim competition NHL = non-hodgkin lymphoma 5

Prolia Is Growing Launched in 26 EU countries representing > 90% of the market opportunity Number of repeat visits in the US has increased from ~ 45% to ~ 60% over the past 2 years Most prescribed in osteoporosis patients who are new to therapy in the US In US, unit share has increased from 6% to 10% YOY 6

XGEVA Has a Strong Value Proposition Superior efficacy, safety profile, and convenient sub-q injection In US, dollar share has increased from 50% to 61% YOY Recently launched in key European markets including France, Italy, and Spain Potential for new clinical indications 7

We Will Deliver Enbrel s Increased Profitability to Shareholders Profit share agreement with Pfizer ends October 31, 2013 We expect ~ $800M in operating income benefit in 2014 We are investing in ENBREL given its prolonged exclusivity Renewed direct-to-consumer campaign Developing new devices for patient-friendly experience 8

Onyx Is a Compelling Acquisition for Amgen Innovative oncology medicines with global potential represent excellent strategic fit Attractive time to enter market for the treatment of multiple myeloma Attractive time in lifecycle of Kyprolis Potential to add significant value for Amgen shareholders while maintaining commitment to growing dividend and investment grade balance sheet Improves short- and long-term revenue growth Accretive to adjusted earnings growth rate beginning 2015 9

We Will Be Adding an Important and Growing Multiple Myeloma Franchise Market for multiple myeloma expected to grow from $6.1B in 2012 to $10.4B by 2017 (11% CAGR)* Kyprolis is a differentiated proteasome inhibitor More selective than other proteasome inhibitors resulting in lower peripheral neuropathy Provides a longer duration of inhibition and a consistently deeper response Increasingly viewed by experts as the best-in-class proteasome inhibitor with a superior safety profile Potential in earlier lines of multiple myeloma Expanded global access Oprozomib is an innovative oral proteasome inhibitor in Phase 2 development *Per EvaluatePharma 10

Other Innovative Oncology Products Contributing to Growth Nexavar oral kinase inhibitor Global profit share rights with Bayer (excluding Japan), with a co-promote agreement in the US Stivarga oral kinase inhibitor 20% royalty from Bayer on global sales with a co-promote agreement in the US Palbociclib oral CDK 4/6 inhibitor 8% royalty from Pfizer on global sales CDK = cyclin-dependent kinase 11

Nine Innovative Programs With Registration Enabling Data Product Lead Indication 14 15 16 Talimogene laherparepvec Trebananib (AMG 386) Melanoma Ovarian cancer OS Recurrent OS 1st-line PFS 1st-line OS AMG 145 Brodalumab (AMG 827) Velcalcetide (AMG 416) Blinatumomab (AMG 103) Romosozumab (AMG 785) Rilotumumab (AMG 102) Ivabradine Hyperlipidemia Psoriasis Secondary hyperparathyroidism Relapsed/refractory B-precursor ALL Postmenopausal osteoporosis Gastric cancer Chronic heart failure OS = overall survival; PFS = progression-free survival ALL = acute lymphoblastic leukemia 12 Major Phase 3 Investment Period Projected Data Availability

Our Six Biosimilars in Development Offer a Multi-Billion Dollar Opportunity Originator Worldwide Peak Sales* HUMIRA ~ $11B REMICADE ~ $8B Avastin ~ $7B Herceptin ~ $6B RITUXAN ~ $7B ERBITUX ~ $2B Total ~ $41B We expect to launch the portfolio starting in 2017 *Per EvaluatePharma (8/13/12) 13

We Are Executing on Our Strategy to Enter Japan and China Japan Strategic alliance to commercialize Amgen pipeline products in Japan First potential commercial launch expected as early as 2016 Plan to build dedicated Amgen/Astellas capabilities Will become a wholly-owned Amgen affiliate as early as 2020 Reflects our long-term commitment to the Japanese market China Joint venture agreement with Beta Pharma enables strategy to expand in key, fast-growing emerging markets Aim to deliver Vectibix to Chinese patients as early as 2015 Brings us one step closer to providing Chinese patients with Amgen s medicines 14

We Are Poised to Grow and Create Value Expect to deliver attractive EPS and expect dividend increases through 2015 Multiple levers to accelerate long-term growth Pending acquisition of Onyx adds a growing multiple myeloma franchise Registration enabling data from nine late-stage pipeline molecules expected by 2016 Six biosimilar launches beginning in 2017, representing a multi-billion dollar opportunity Blockbuster revenue opportunity through international expansion Commitment to increase the dividend meaningfully 15

Bank of America Merrill Lynch Healthcare Conference September 13, 2013