Joseph J. Wolk Vice President, Investor Relationsfiles.shareholder.com/.../Joe_Wolk_Slides.pdf ·...

10
Joseph J. Wolk Vice President, Investor Relations

Transcript of Joseph J. Wolk Vice President, Investor Relationsfiles.shareholder.com/.../Joe_Wolk_Slides.pdf ·...

Joseph J. Wolk Vice President, Investor Relations

Today’s Agenda

Pharmaceutical R&D Strategy William N. Hait, Global Head, Janssen Research & Development

Opening Remarks Alex Gorsky Chairman and Chief Executive Officer

Pharmaceutical Business Overview Joaquin Duato, Executive Vice President, Worldwide Chairman, Pharmaceuticals

Closing Remarks Dominic Caruso, Executive Vice President, Chief Financial Officer

Enterprise Q&A Panel

Therapeutic Area Reviews: • Susan B. Dillon, Immunology • Lawrence Blatt, Infectious Disease • Husseini K. Manji, Neuroscience • James F. List, Cardiovascular / Metabolic • Peter F. Lebowitz, Oncology

Therapeutic Area Q&A Panel

The App

AM Presentations

PM Presentations

Survey

Therapeutic Area Exhibits

A World Without Multiple Myeloma

Lung Cancer: Targeting Key Driver Pathways

Vaccines with Transformational Potential

Pioneering the Science in IBD

Cautions Concerning Forward-Looking Statements

These presentations contain “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, future operating and financial performance, product research and development, regulatory submissions and approvals, market position, impact of planned acquisitions, and business strategy. The viewer is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of the Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in new product research and development, including uncertainty of clinical success and decisions of regulatory authorities regarding approval, labeling, and other matters that could affect the availability or commercial potential of product candidates; uncertainty of commercial success for new and existing products; the satisfaction of closing conditions for the acquisition of Actelion Ltd., the possibility that the Actelion acquisition will not be completed in the expected timeframe or at all, and the potential that the expected benefits and opportunities of the Actelion acquisition, if completed, may not be realized or may take longer to realize than expected; the ability of the company to successfully execute strategic plans; challenges to patents; the impact of patent expirations; competition, including technological advances, new products, and patents attained by competitors; future clinical data and analysis, including post marketing surveillance; impact of business combinations and divestitures; significant adverse litigation or government action; changes to applicable laws and regulations, including global health care reforms; trends toward health care cost containment; changes in behavior and spending patterns of purchasers of health care products; manufacturing difficulties or delays; product efficacy or safety concerns resulting in product recalls or regulatory action; and increased scrutiny of the health care industry by government agencies. A further list and descriptions of these risks, uncertainties, and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 1, 2017, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.investor.jnj.com, or on request from Johnson & Johnson. Any forward-looking statement made in these presentations speaks only as of the date of these presentations. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.

Note Regarding Non-GAAP Financial Measures

Notice Regarding Trademarks & Photos Third-party trademarks used herein are trademarks of their respective owners.

Photo disclaimer: Unless otherwise noted, individuals depicted are models for illustrative purposes.

These presentations refer to certain non-GAAP financial measures. These non-GAAP financial measures should not be considered replacements for, and should be read together with, the most comparable GAAP financial measures. A reconciliation of these non-GAAP financial measures to the most directly comparable GAAP financial measures can be found on the Investor Relations section of the company’s website at www.investor.jnj.com

Note: Operational sales growth, a non-GAAP financial measure, excludes the impact of translational currency.

Note Regarding Pending Actelion Ltd. Acquisition

During the first quarter of 2017, we announced a definitive agreement to acquire Actelion Ltd., a leading biopharmaceutical company, for approximately $30 billion. The transaction is expected to close in the second quarter of 2017, subject to the satisfaction of remaining closing conditions, including antitrust approval from the European Commission.

Although the acquisition of Actelion has not been completed, today’s presentations include information and expectations regarding Actelion, its products, and its product pipeline. Projections and expectations provided today are based on Johnson & Johnson’s current knowledge, pending the completion of the Actelion acquisition, which may not be completed in the expected timeframe or at all.

During the course of today’s presentations, we will discuss a number of products and compounds developed in collaboration with strategic partners or licensed from other companies. Following is an acknowledgement of those relationships.

Strategic Partnerships, Collaborations & Licensing Arrangements

Immunology REMICADE® and SIMPONI®/SIMPONI ARIA® marketing partners are Schering-Plough (Ireland) Company, a subsidiary of Merck & Co., Inc. and Mitsubishi Tanabe Pharma Corporation, Sirukumab developed in collaboration with GlaxoSmithKline, Guselkumab discovered using MorphoSys AG antibody technology, JNJ-4447 (VE 202) licensed from Vedanta Biosciences, Inc., JNJ-3133 (FR-104) licensed from Effimune (now OSE Pharma SA), JNJ-3534 developed in collaboration with Phenex Pharmaceuticals AG, JNJ-4500 (NKG2D) licensed from Novo Nordisk, A/S, JNJ-1524 developed in collaboration with Ionis Pharmaceuticals.

Neuroscience INVEGA SUSTENNA®/XEPLION®/INVEGA TRINZA®/TREVICTA® includes technology licensed from Alkermes Pharma Ireland Limited (APIL), RISPERDAL CONSTA® developed in collaboration with Alkermes Pharma Ireland Limited (APIL), JNJ-1911 (BACEi) developed in collaboration with and licensed from Shionogi & Co. and in clinical research trial collaboration with Washington University School of Medicine (DIAN-TU), Tau vaccine developed in collaboration with AC Immune SA, JNJ-4789 (Alpha-2C AR antagonist) licensed from Orion Corporation, JNJ-7922 (Orexin-2 antagonist) developed in collaboration with Minerva Neurosciences, Inc.

Cardiovascular/ Metabolism

INVOKANA® and INVOKAMET®/VOKANAMET® fixed-dose combination licensed from Mitsubishi Tanabe Pharma Corporation, XARELTO® co-developed with Bayer HealthCare AG, JNJ-5111 licensed from Hanmi Pharmaceutical Co., Ltd, JNJ-2463 developed in collaboration with Bird Rock Bio, Inc.

Oncology IMBRUVICA® developed in collaboration and co-marketed with Pharmacyclics LLC an AbbVie company, ZYTIGA® licensed from BTG International Ltd., VELCADE® developed in collaboration with Millennium: The Takeda Oncology Company, DACOGEN® developed in collaboration with Eisai Corporation of North America, DARZALEX® developed in collaboration with Genmab A/S, YONDELIS® developed in collaboration with Pharma Mar S.A., PROCRIT®/EPREX® licensed from Amgen Inc ., Erdafitinib discovered in collaboration with Astex Pharmaceuticals, Inc., Imetelstat licensed from Geron Corporation, JNJ 7107 (CD40) licensed from Alligator BioScience AB, JNJ-9588 (VISTA) licensed from ImmuNext, Inc., Duvortuxizumab and JNJ-9383 licensed from Macrogenics, Inc., Talacotuzumab licensed from CSL Limited, JNJ-1809 and JNJ-1757 licensed from Aduro Biotech, Inc., Niraparib licensed from TESARO, Inc., JNJ-7564, JNJ-0819, JNJ-7957, JNJ-9178 and JNJ-6372 include technology licensed from Genmab A/S, SubQ (ENHANZE™ platform) licensed from Halozyme Therapeutics, Inc.

During the course of today’s presentations, we will discuss a number of products and compounds developed in collaboration with strategic partners or licensed from other companies. Following is an acknowledgement of those relationships.

Additional Strategic Partnerships, Collaborations and Other Acknowledgments

Infectious Diseases &

Virology

INCIVO® developed in collaboration with Vertex Pharmaceuticals, OLYSIO® developed in collaboration with Medivir AB, COMPLERA®/EVIPLERA®/ ODEFSEY®, PREZCOBIXTM/ REZOLSTATM fixed-dose combination developed in collaboration with Gilead Sciences, Inc., Rilpivirine + dolutegravir FDC developed in collaboration with ViiV Healthcare UK, Pimodivir licensed from Vertex Pharmaceuticals, Inc. (this project has received federal funding from the Office of the Assistant Secretary of Preparedness and Response, BARDA, under Contract Number HHSO100201500014C), JNJ-1860 licensed and in collaboration with GlycoVaxyn AG, Odalasvir developed in collaboration with Achillion Pharmaceuticals, Inc., JNJ-9220 developed in collaboration with Beth Israel Deaconess Medical Center (BIDMC)/Harvard, HIV Vaccine Trial Network (HVTN), International AIDS Vaccine Initiative (IAVI), National Institute of Allergy and Infectious Diseases (NIH), Ragon Institute of Massachusetts General Hospital, United States Military HIV Research Program (MHRP). Since 2005, Janssen Vaccines & Prevention B.V. has been participating in the National Institutes of Health (NIH) supported Integrated Preclinical/Clinical AIDS Vaccine Development (IPCAVD) program under grants AI066305. AI078526, AI096040 to evaluate HIV-1 vaccine candidates to address the epidemic. The pre-clinical study was supported by grants from the NIH: AI060354; AI078526; AI0080280; AI084794; AI095985; AI096040; AI102660; AI102691; OD011170; HHSN261200300001E, as well as funding from the Bill & Melinda Gates Foundation, Ragon, MIT, and Harvard. Ad 26 (National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH); BIDMC). MVA (Military HIV Research Program (MHRP), Laboratory of Viral Diseases at NIAID/NIH. TLR7 agonist GS-986 (Gilead). Funding: U.S. Army Medical Research and Materiel Command, MHRP, Walter Reed Army Institute of Research through agreement with Henry M. Jackson Foundation (W81XWH-11-2-0174); NIH (AI096040, AI124377, AI126603); Ragon Institute of MGH, MIT, and Harvard, VAC69120 (Filovirus multivalent vaccine) developed in collaboration with Bavarian Nordic; funding: NIH Division of Microbiology and Infectious Diseases (DMID), JNJ-1623 VAC81623 (HPV vaccine) developed in collaboration with and licensed from Bavarian Nordic A/S, JNJ-0535 developed in collaboration with Ichor Medical Systems, JNJ-4964 (TLR Agonist) licensed from Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Global Public Health

Monovalent Ebola Vaccine is developed in collaboration with Bavarian Nordic A/S and has received direct funding and preclinical services from the National Institute of Allergy and Infectious Diseases (NIAID), part of NIH, under Contract Numbers HHSN272200800056C, and HHSN272201000006I and HHSN272201200003I, respectively. This program is also receiving funding from the IMI2 Joint Undertaking under EBOVAC1 (grant nr. 115854), EBOVAC2 (grant nr. 115861), EBOMAN (grant nr. 115850) and EBODAC (grant nr. 115847). This IMI2 Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation program and the European Federation of Pharmaceutical Industries and Associations. In addition, this program is also receiving funding from BARDA, under grant no HHSO100201500008C. MVA-BN licensed from Bavarian Nordic A/S.