Lilly Details Robust R&D Pipeline to Investment Community

Company has potential to launch 20 new products in 10 years

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May 24, 2016, 06:30 ET

INDIANAPOLIS, May 24, 2016 /PRNewswire/ -- In a presentation to the investment community today, Eli Lilly and Company (NYSE: LLY) stated it has the potential to launch 20 new products in the 10 years beginning in 2014 and extending through 2023. In addition, Lilly could launch an average of two new indications or line extensions for already-approved products per year during that same time period.

"We're pleased to share with investors the breadth and depth of the Lilly pipeline, which showcases our progress across our key therapeutic areas. This includes recent launches as well as a robust lineup of assets in late-stage development or already under regulatory review," said John C. Lechleiter, Ph.D., Lilly's chairman, president and chief executive officer. "There are no guarantees given the nature of science and of our business; however, in looking at our recent launches and current pipeline, we believe we are in the midst of the most prolific period of new launches in our company's 140-year history."

Lilly's R&D efforts focus on five therapeutic areas where the company has assets and capabilities that enable it to compete successfully. These include four core areas—diabetes, oncology, immunology and neurodegeneration—and one emerging area—pain. Building upon a similar investment community meeting in December 2015 focused on neurodegeneration – specifically Alzheimer's disease – as well as animal health, today's presentation highlighted the company's R&D strategy and progress in diabetes, oncology, immunology and pain.

"We have improved the productivity and success of our pipeline through discrete actions aimed at enhancing focus, quality and speed, and by positioning ourselves as an attractive partner for external innovation opportunities," said Jan Lundberg, Ph.D., executive vice president of science and technology and president of Lilly Research Laboratories. "These improvements have led to the potential for unprecedented R&D output."

Diabetes
Lilly's long-standing commitment to diabetes care dates to 1923, when it was the first company to bring insulin to patients. Today, the company has the broadest range of diabetes therapies in the industry. Lilly's R&D efforts in diabetes focus on differentiated therapeutics and delivery devices within three key areas of unmet need: glucose control, metabolic control and end-organ protection. The company aims to combine its strong in-house diabetes R&D capabilities with a comprehensive external network to deliver continued innovation in this important area of therapy.

Oncology
Lilly has a long history of leadership in oncology. The company has a balanced R&D approach across three key areas of disease modification: tumor cell signaling, tumor microenvironment and immuno-oncology. This approach allows for testing of combinations of internally-derived agents to address tumor heterogeneity and drug resistance. Lilly has a portfolio of differentiated assets across these approaches, including Cyramza^® (ramucirumab), Portrazza™ (necitumumab), olaratumab and abemaciclib. Lilly's immuno-oncology portfolio will have five differentiated molecules in clinical testing by the end of 2016, and as many as 11 by the end of 2018.

Immunology
With the recent launch of Taltz^® (ixekizumab) and the submission of baricitinib for regulatory review, Lilly has designated immunology as the company's newest core therapeutic area. While these assets represent the foundational first wave of innovation, Lilly has built a robust emerging pipeline of both internal assets and partnered molecules focusing on key pathways and interventions in multiple autoimmune diseases.

Neurodegeneration
Lilly's commitment to Alzheimer's disease is demonstrated by its more than 25 years of research and development in the field. As a result of this sustained effort and deep understanding of the disease, Lilly today has one of the industry's most comprehensive Alzheimer's portfolios, with seven molecules already in human testing. The company's Alzheimer's research includes disease prevention, detection and treatment.

Pain
Pain is an emerging research area for Lilly, focusing on non-opioid treatment for chronic pain. The two late-stage innovative medicines currently in development are galcanezumab (CGRP Ab), being studied for cluster headache and migraine, and tanezumab, being studied for osteoarthritis pain, chronic lower back pain and cancer pain in partnership with Pfizer.

A live audio webcast of today's presentation is available on the "Webcasts & Presentations" section of Lilly's investor website at http://investor.lilly.com/events.cfm. A replay will be available for approximately 90 days.

About Eli Lilly and Company
Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com and newsroom.lilly.com/social-channels. F-LLY

This press release contains management's current intentions and expectations for the future, all of which are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements include all statements that do not relate solely to historical or current facts, and can generally be identified by the use of words such as "may," "will," "estimate," "project," "intend," "expect," "believe," "target," "anticipate," "plan," and similar expressions. Actual results may differ materially due to various factors. There are significant risks and uncertainties in pharmaceutical research and development. Among other things, there can be no guarantees that pipeline products will succeed in clinical testing, will receive the necessary clinical and manufacturing regulatory approvals or will prove to be commercially successful. The company's results may also be affected by such factors as the timing of anticipated regulatory approvals and launches of new products; market uptake of recently launched products; competitive developments affecting current products; the expiration of intellectual property protection for certain of the company's products; the company's ability to protect and enforce patents and other intellectual property; the impact of governmental actions regarding pricing, importation, and reimbursement for pharmaceuticals, including U.S. health care reform; regulatory compliance problems or government investigations; regulatory actions regarding currently marketed products; unexpected safety or efficacy concerns associated with the company's products; issues with product supply stemming from manufacturing difficulties or disruptions; regulatory changes or other developments; changes in patent law or regulations related to data-package exclusivity; litigation involving current or future products; the extent to which third-party indemnification obligations relating to product liability litigation and similar matters will be performed; unauthorized disclosure of trade secrets or other confidential data stored in the company's information systems and networks; changes in tax law and regulations; changes in inflation, interest rates, and foreign currency exchange rates; asset impairments and restructuring charges; changes in accounting standards promulgated by the Financial Accounting Standards Board and the U.S. Securities and Exchange Commission (SEC); acquisitions and business development transactions and related integration considerations; and the impact of exchange rates and global macroeconomic conditions. For further discussion of these and other risks and uncertainties, see Lilly's most recent Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.