eli lilly & co (LLY) Key Developments
Eli Lilly and Company Announces Expansion of San Diego Biotechnology Center
Jul 23 15
Eli Lilly and Company announced that it has revealed plans to expand the Lilly Biotechnology Center located in San Diego, Calif. The expansion will effectively double the company's research presence in San Diego as the company seeks to develop new collaborations in one of the world's leading regions for drug research and development. Set to be completed in 2016, the expansion will feature an additional 175,000 square feet of working space and is expected to generate up to 130 potential new job openings, yielding a 140% increase in the center's space and 70% increase in its staff. Importantly, the space will allow for closer collaboration among the company experts in discovery chemistry and research technologies and biotechnology, which will help accelerate the discovery of new medicines within the company's core therapeutic areas, including immunology. The expansion also signifies the company's investment in obtaining additional top scientific talent. Specifically, the company will be recruiting experts in drug discovery in the disciplines of biotechnology, chemistry and immunology and in immunological clinical development.
Eli Lilly and Company Reports Unaudited Earnings Results for the Second Quarter and Six Months Ended June 30, 2015; Revises Earnings Guidance for the Full Year of 2015
Jul 23 15
Eli Lilly and Company reported unaudited earnings results for the second quarter and six months ended June 30, 2015. For the quarter, the company reported revenue of $4,978.7 million against $4,935.6 million a year ago. Operating income was $803.0 million against $886.6 million a year ago. Income before income taxes was $679.7 million against $940.4 million a year ago. Net income was $600.8 million or $0.56 per diluted share against $733.5 million or $0.68 per diluted share a year ago. Non-GAAP adjusted revenue was $4,978.7 million against $5,211.2 million a year ago. Non-GAAP adjusted net income was $954.8 million or $0.90 per diluted share against $798.1 million or $0.74 per diluted share a year ago. Operating income in the second quarter of 2015 decline of 9% compared with the second quarter of 2014, driven by higher acquired in-process research and development charges and asset impairment, restructuring and other special charges, partially offset by lower operating expenses. The declines in net income and earnings per share were driven by charges related to the repurchase of debt and lower operating income, partially offset by a lower effective tax rate.
For the six months, the company reported revenue of $9,623.4 million against $9,618.7 million a year ago. Operating income was $1,328.2 million against $1,721.4 million a year ago. Income before income taxes was $1,297.6 million against $1,831.2 million a year ago. Net income was $1,130.3 million or $1.06 per diluted share against $1,461.4 million or $1.36 per diluted share a year ago. Non-GAAP adjusted revenue was $9,623.4 million against $10,146.1 million a year ago. Non-GAAP adjusted net income was $1,878.5 million or $1.76 per diluted share against $1,595.9 million or $1.48 per diluted share a year ago.
The company has revised certain elements of its 2015 financial guidance on a reported basis and on a non-GAAP basis. Full-year 2015 earnings per share are now expected to be in the range of $2.20 to $2.30 on a reported basis. On a non-GAAP basis, full-year 2015 earnings per share are now expected to be in the range of $3.20 to $3.30. The company now anticipates 2015 revenue of between $19.7 billion and $20.0 billion, reflecting solid underlying performance for the first six months of the year, including the launch trajectories of Jardiance, Trulicity and Cyramza. The company still expects that gross margin as a percent of revenue will be approximately 74.5% on a reported basis. On a non-GAAP basis, gross margin as a percent of revenue is still expected to be approximately 78.0%, reflecting the exclusion of inventory step-up costs associated with the acquisition of Novartis Animal Health as well as amortization of intangibles. The 2015 tax rate is now expected to be approximately 14.5% on a reported basis, primarily due to the tax impact of the net charge related to the repurchase of debt. The non-GAAP tax rate is now expected to be approximately 21.0%. Both rates assume a full-year 2015 benefit of the R&D tax credit and other tax provisions up for extension. If these items are not extended, the non-GAAP 2015 tax rate would be approximately 1.5% points higher. Capital expenditures are still expected to be approximately $1.3 billion.
Eli Lilly Mulls Acquisitions
Jul 23 15
Eli Lilly and Company (NYSE:LLY) intends to look at acquisition opportunities. John Lechleiter, Chairman/Chief Executive Officer of the company told Bloomberg: “We're going to do it mainly through organic growth. So we said the Eli Lilly that is emerging from this period of patent expirations has a strong presence in diabetes, a strong presence in oncology. We aim to grow a presence in neurology with our Alzheimer's molecules. Pain is another area that we're interested in. And then the autoimmune space, we filed with the FDA for approval of a new medicine for psoriasis. In all of those areas we feel we have a good organic base. We will make acquisitions if we see an opportunity to enhance our presence in any one of those areas.”
Eli Lilly and Company Announces Results Suggesting the Treatment Effect of Solanezumab in Patients with Mild Alzheimer's Disease
Jul 22 15
Eli Lilly and Company announced results suggesting the treatment effect of solanezumab was preserved within a pre-specified amount in patients with mild Alzheimer's disease who received solanezumab earlier in the disease compared to patients who began treatment at a later point. These results were from a pre-specified secondary analysis of the Phase 3 EXPEDITION, EXPEDITION2 and EXPEDITION-EXT studies, and were presented at the Alzheimer's Association International Conference® 2015 (AAIC®) in Washington, D.C.1, 2 These results support the use of the 'delayed-start' method for assessing the potential effects of a treatment on the underlying disease progression of Alzheimer's disease. The objective of the delayed-start analysis was to assess a possible disease-modifying effect of solanezumab in patients with mild Alzheimer's disease. These results were obtained from a pre-specified secondary analysis of the Phase 3 EXPEDITION, EXPEDITION2 and EXPEDITION-EXT studies. EXPEDITION and EXPEDITION2 had identical study protocols, which included an 18-month randomized, double-blind, placebo-controlled period, after which a two- year delayed-start period occurred (EXPEDITION-EXT), where the placebo-treated patients from the placebo-controlled period began treatment with solanezumab. Results from EXPEDITION and EXPEDITION2 were pooled and only patients with mild dementia at the beginning of the study were included in this analysis. During the delayed-start period, the original treatment assignment remained blinded to patients and sites. When considering the placebo-controlled period and delayed-start period together, all patients were randomized to the same active treatment (solanezumab) but starting at different times, resulting in two treatment regimens: early-start and delayed-start. The primary analysis was at 108 weeks after the beginning of the placebo-controlled period (28 weeks after the beginning of the delayed-start period) among the subgroup of patients with mild Alzheimer's disease at baseline. To assess whether the benefits of early treatment can be matched by later treatment (that is, whether delayed-start patients can "catch up" with early-start patients), a noninferiority test was conducted. Key results highlights include: Treatment differences in cognition and function between early-start and delayed-start groups at the end of the placebo-controlled period (80 weeks since randomization) were preserved at the primary time point of 108 weeks (28 weeks after the start of EXPEDITION-EXT) within a pre-defined margin. This difference at 108 weeks remained statistically significant; and Treatment differences in cognition and function between early-start and delayed-start groups at the end of the placebo-controlled period (80 weeks since randomization) were also preserved at an additional time point of 132 weeks (52 weeks after the start of EXPEDITION-EXT) within a pre-defined margin. This difference at 132 weeks was statistically significant.
Eli Lilly Enters into Clinical Trial Collaboration with Immunocore
Jul 6 15
Eli Lilly and Company and Immunocore Limited have entered into an immunotherapy-based clinical trial collaboration to explore the utility of Immunocore's T cell receptor-based investigational therapeutic, IMCgp100, in combination with Lilly's galunisertib and merestinib for the treatment of melanoma. The goal of the collaboration is to identify combination regimens that provide synergies in efficacy and durability in patients with metastatic cutaneous and uveal melanomas. Under the terms of the agreement, Immunocore and Lilly will conduct a Phase Ib/II clinical study evaluating the safety and preliminary efficacy of IMCgp100 in combination with galunisertib in metastatic cutaneous melanoma. A second Phase Ib/II study will be conducted combining IMCgp100 with merestinib in metastatic uveal melanoma. Lilly will act as trial sponsor. These studies are anticipated to begin in 2016.