At a meeting this week with the investment community, Eli Lilly and Company announced its 2019 financial guidance, updated certain elements of its 2018 guidance and 2020 minimum financial expectations, reviewed the performance of recently launched medicines, and highlighted numerous potential new medicines in its clinical pipeline.
R&D Transformation
Recent measures to improve R&D productivity and create new medicines were highlighted:
- The company is reshaping its drug discovery engine, with the dual goal of decreasing the time from target identification to clinical testing to approximately three years, while also increasing the use of externally-derived innovation to access novel targets, modalities, and discovery tools.
- Lilly has significantly improved the speed of its development activities and reduced the average time from first human dose of a potential new medicine to commercial launch by more than two years.
- There has been a steady improvement in the success rate of Phase 3 molecules in Lilly’s clinical pipeline due to a greater emphasis on target validation, patient population, molecule optimization, more robust Phase 2 data, and better Phase 3 design.
Development plans and therapeutic potential for promising opportunities and new indications for approved medicines:
- Oncology – Verzenio, pegilodecakin
- Pain – Emgality, lasmiditan, tanezumab
- Neurodegeneration – N3pG antibody, tau antibody, D1PAM
- Immunology – Olumiant, mirikizumab
- Diabetes – Insulins and Connected Care, Trulicity, tirzepatide
“With an attractive clinical pipeline, two new molecules achieving regulatory submissions and three entering Phase 3 in 2018, we are continuing an impressive period of productivity for Lilly Research Labs, and are on pace to deliver on the company’s goal to launch 20 new medicines in 10 years,” said Daniel Skovronsky, M.D., Ph.D., chief scientific officer and president of the research laboratories.
New Medicines
Strong U.S. performance and market share gains of several of medicines, were noted at the meeting, including Trulicity, Jardiance, Taltz, and Verzenio, as well as the early progress for Emgality and international growth opportunities across the portfolio.
“Lilly has dramatically upgraded the quality of its revenue base over the past five years through the launch and uptake of 10 new medicines, which together are expected to account for over 45 percent of human pharmaceutical sales in 2019,” Joshua Smiley, Lilly senior vice president and chief financial officer, told investors. “These 10 medicines are launching in some of the fastest growing categories and continue to deliver growth through increased volume, not price, meaning more and more people around the world are benefiting from Lilly medicines.”
Based on the growth prospects, Smiley announced a 15 percent increase in company dividend.
Revenue Expectations
Lilly executives anticipate 2019 revenue between $25.3 billion and $25.8 billion. Revenue growth is expected to be driven by volume from newer medicines, including Trulicity, Taltz, Basaglar, Jardiance, Verzenio, Cyramza, Olumiant, and Lartruvo.
Revenue growth is also expected to benefit from the recent launch of Emgality, and could benefit from the potential approval and launch of nasal glucagon and lasmiditan. The revenue growth is expected to be partially offset by lower revenue for Cialis and other products that have lost patent exclusivity. It also is expected to be partially offset by the negative impact of foreign exchange rates, as well as continued price pressures in the U.S. and some international markets.
Additional information and details from the meeting, including minimum financial expectations for 2020, are available by clicking here.
(Source: Eli Lilly and Company)
