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January 31, 2014
11:32 EDTLLY, SNYEli Lilly does not believe new insulin glargine product infringes Sanofi patents
Eli Lilly (LLY) provided a statement regarding a lawsuit filed by Sanofi (SNY) in the United States District Court for the District of Delaware alleging patent infringement with respect to LY2963016, a new insulin glargine product for which Lilly is currently seeking approval from the U.S. Food and Drug Administration. Lilly's general patent counsel said, "Lilly respects the intellectual property of others and does not believe the application for approval of its new insulin glargine product infringes any valid claim of the asserted patents." Lilly, and its alliance partner Boehringer Ingelheim, recently announced the FDA had accepted the filing of the New Drug Application for LY2963016, an investigational basal insulin, the company noted.
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October 23, 2014
06:35 EDTLLYEli Lilly backs FY14 EPS view of $2.72-$2.80, consensus $2.75
Sees FY14 revenue $19.4B-$19.8B, consensus $19.77B. Due to the strengthening of the U.S. Dollar, as well as competitive pressures and market dynamics in the U.S. animal health business, the company now anticipates 2014 revenue between $19.4B-$19.8B. Patent expirations have led to a rapid and severe decline in U.S. Cymbalta and U.S. Evista sales. These revenue declines are expected to be partially offset by growth from a portfolio of other products including Humalog, Humulin, Trajenta, Cialis, Forteo and Alimta, as well as the animal health business and new product launches. In addition, strong revenue growth is expected in China, while a weaker Japanese yen will dampen revenue growth in Japan. The company now anticipates gross margin as a percent of revenue will be approximately 74.5% in 2014 driven by recent strengthening of the U.S. Dollar versus the Euro. Gross margin in 2014 is now also expected to benefit from a decision to delay until 2015 the shutdown at one of the company's bulk insulin plants to implement production changes. Total operating expenses in 2014 are still expected to decrease substantially compared to 2013. On a reported basis marketing, selling and administrative expenses are now expected in the range of $6.4B-$6.6B, which includes the Branded Prescription Drug Fee. On a non-GAAP basis, marketing, selling and administrative expenses are now expected to be in the range of $6.3B-$6.5B. Research and development expenses are now expected to be in the range of $4.6B-$4.8B. Other income is now expected to be in the range of $200M-$250M of income.
06:32 EDTLLYEli Lilly reports Q3 EPS 66c, consensus 67c
Reports Q3 revenue $4.88B, consensus $4.83B.
October 22, 2014
17:48 EDTLLYCANDA NK-2 files motion to dismiss patent infringement suit
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16:23 EDTLLYEli Lilly expands collaboration with Zymeworks by up to $375M
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15:37 EDTLLYNotable companies reporting before tomorrow's open
Notable companies reporting before tomorrow's market open, with earnings consensus, include Comcast (CMCSA), consensus 71c; Union Pacific (UNP), consensus $1.52; 3M (MMM), consensus $1.96; AbbVie (ABBV), consensus 77c; Celgene (CELG), consensus 95c; Eli Lilly (LLY), consensus 67c; Occidental Petroleum (OXY), consensus $1.57; Caterpillar (CAT), consensus $1.36; Alexion Pharmaceuticals (ALXN), consensus $1.16; Precision Castparts (PCP), consensus $3.32; Raytheon (RTN), consensus $1.60; American Electric Power (AEP), consensus $1.02; Southwest Airlines (LUV), consensus 53c; Lorillard (LO), consensus 90c; T. Rowe Price (TROW), consensus $1.15; Mead Johnson (MJN), consensus 91c; Zimmer Holdings (ZMH), consensus $1.30; Nucor (NUE), consensus 73c; Nielsen (NLSN), consensus 65c; Prologis (PLD), consensus 46c; Sigma-Aldrich (SIAL), consensus $1.06; Under Armour (UA), consensus 40c; EQT (EQT), consensus 56c; Dr Pepper Snapple (DPS), consensus 88c; Cameron International (CAM), consensus $1.10; Coca-Cola Enterprises (CCE), consensus 89c; Quest Diagnostics (DGX), consensus $1.08; CMS Energy (CMS), consensus 41c; Airgas (ARG), consensus $1.29; PulteGroup (PHM), consensus 36c; Diamond Offshore (DO), consensus 79c; Bemis (BMS), consensus 67c.
13:49 EDTLLYEarnings Preview: Lilly looks to rebound from recent patent expirations
Eli Lilly and Company (LLY) is scheduled to report third quarter earnings before the market open on Thursday, October 23 with a conference call scheduled for 9:00 am ET. Lilly is a global pharmaceutical manufacturer that also has an animal health business segment. EXPECTATIONS: Analysts are looking for earnings per share of 67c on revenue of $4.83B, according to First Call. The consensus range for EPS is 60c-77c on revenue of $4.75B-$4.92B. LAST QUARTER: Eli Lilly reported second quarter EPS of 68c, which beat consensus estimates, on revenue of $4.94B against estimates of $4.9B. Lilly reaffirmed its FY14 EPS and revenue view at the time. The company said it sees FY14 EPS of $2.72-$2.80 on revenue of $19.4B-$20.0B, against consensus estimates of $2.78 and $19.93B respectively. Lilly's CEO John Lechleiter commented on the quarter, "Lilly's second-quarter results reflect a substantial decline in revenue and earnings resulting from recent patent expirations. At the same time, new product approvals and impending launches give us great confidence that Lilly is poised for growth in the years ahead. We have stayed the course with our innovation-based strategy, replenishing and advancing our pipeline. We remain firm in our commitment to sustain and accelerate a flow of important new medicines that make life better for people around the world." STREET RESEARCH: In late August, Deutsche Bank initiated coverage of the name with a Buy rating and a $71 price target. PRICE ACTION: Lilly shares are relatively flat since the company's last earnings report on July 24, and they are trading up fractionally to $64.95 in midday trading ahead of tomorrow's earnings release.
07:35 EDTLLY, SNYCardiometabolic Health Congress to hold annual meeting
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October 21, 2014
08:32 EDTLLYFDA accepted NDA for empagliflozin plus
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07:15 EDTLLYFDA to hold workshop on breast cancer drug development
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07:06 EDTSNYFierce Biotech to hold a breakfast meeting
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06:44 EDTSNYActavis among bidders for Omega Pharma, Bloomberg reports
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October 20, 2014
10:37 EDTSNYSanofi unit announces Aubagio gains FDA approval due to study data
Genzyme, a Sanofi company, announced that the Food and Drug Administration has approved the inclusion of efficacy and safety data from the TOWER and TOPIC studies of once-daily, oral Aubagio in the productís U.S. label. In the TOWER study, patients with relapsing MS receiving Aubagio 14 mg had a statistically significant reduction in annualized relapse rate and relative risk of sustained disability progression compared to placebo. In addition, a significant reduction in annualized relapse rate was observed in patients treated with Aubagio 7 mg compared to placebo. The TOPIC study was designed to assess whether initiation of Aubagio in patients who experienced their first neurological symptoms suggestive of MS could prevent or delay a second clinical attack. In this study, the proportion of patients free of relapse was statistically significantly greater for Aubagio 14 mg and 7 mg, compared to placebo. Results of the TOPIC study were published in The Lancet Neurology in September.
08:06 EDTSNYMerck, Sanofi unit announce pediatric hexavalent vaccine BLA
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07:19 EDTSNYIBC Life Sciences to hold a conference
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07:10 EDTSNYAmerican Society of Human Genetics to hold annual meeting
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07:02 EDTSNYRegeneron Sanofi begins dosing in Phase 3 study of dupilumab
Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced that the first patients have been dosed in a Phase 3 clinical study of dupilumab, an investigational therapy that blocks IL-4 and IL-13 signaling, in adults with moderate-to-severe atopic dermatitis, or AD, that is not adequately controlled with topical AD medications. LIBERTY AD CHRONOS, the first trial in the Phase 3 clinical program for dupilumab, is a randomized, double-blind, placebo-controlled, multi-national study with the primary objective of demonstrating the efficacy of dupilumab in adults with moderate to severe AD when administered concomitantly with topical corticosteroids through 16 weeks.
October 17, 2014
10:51 EDTLLYOptions with increasing implied volatility
Options with increasing implied volatility: COV DISH HLT QEP GREK BKW BYI LLY DTV TIBX
09:06 EDTSNYAmgen files patent infringement lawsuit against Sanofi, Regeneron
Amgen (AMGN) announced that it filed a lawsuit in the United States District Court of Delaware against Sanofi (SNY), Aventisub, formerly doing business as Aventis Pharmaceuticals, and Regeneron Pharmaceuticals (REGN) for patent infringement of U.S. Patent Numbers 8,563,698, 8,829,165, and 8,859,741. These patents, which are owned by Amgen, describe and claim monoclonal antibodies to proprotein convertase subtilisin/kexin type 9, or PCSK9. By its complaint, Amgen seeks an injunction to prevent the infringing manufacture, use and sale of Sanofi and Regeneron's alirocumab, a monoclonal antibody targeting PCSK9. Sanofi and Regeneron recently announced that they have completed Phase 3 clinical trials on alirocumab and intend to pursue regulatory approval to market alirocumab in the U.S. Amgen previously announced submission of a Biologics License Application to the FDA for evolocumab, its own investigational human monoclonal antibody to PCSK9, for the treatment of high cholesterol, on Aug. 28.
October 16, 2014
14:36 EDTLLYLilly to close Guayama facility, will take 16c charge in Q4
Eli Lilly announced plans to conclude production and pursue a sale of one of its three manufacturing plants in Puerto Rico. The manufacturing site, located in Guayama, Puerto Rico, will remain in operation until the end of 2015. All of the approximately 100 full-time non-contracted employees currently working in Guayama will be offered employment at Lilly's Carolina, Puerto Rico, location. As a result of this action, the company expects to record a charge of approximately $170M or approximately 16c per share, after tax, in Q414. While Lilly will initiate efforts to sell the Guayama site, the company will continue to invest in two manufacturing plants at Carolina. In November 2013, Lilly announced a $200M investment to increase capacity in its Carolina-based insulin active ingredient manufacturing plant. In July, Lilly announced an additional $40M in investments to increase capabilities at its Carolina-based drug product site as part of a rebalancing of Lilly's oral solid dosage network.
08:19 EDTSNYSanofi Pasteur, Immune Design enter collaboration HSV therapy
Immune Design (IMDZ) announced that it has entered into a broad collaboration for the development of a herpes simplex virus, or HSV, immune therapy with Sanofi Pasteur, the vaccines division of Sanofi (SNY). Sanofi Pasteur and Immune Design will each contribute product candidates to the collaboration: Sanofi Pasteur will contribute HSV-529, a clinical-stage replication-defective HSV vaccine product candidate, and Immune Design will contribute G103, its preclinical trivalent vaccine product candidate. The collaboration will explore the potential of various combinations of agents, including leveraging Immune Design's GLAASTM platform, with the goal to select the best potential immune therapy for patients. The two companies will develop the products jointly through Phase 2 clinical trials, at which point Sanofi Pasteur intends to continue development of the most promising candidate and be responsible for commercialization. Sanofi Pasteur will bear the costs of all preclinical and clinical development, with Immune Design providing a specific formulation of GLA from the GLAAS platform at its cost through Phase 2 studies. Immune Design will be eligible to receive future milestone and royalty payments on any product developed from the collaboration; other financial terms of the agreement have not been disclosed.
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