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June 16, 2014
18:19 EDTLLYEli Lilly reports results from Phase 3 trials of Dulaglutide
Eli Lilly and Company released detailed results from two AWARD trials that showed treatment with once-weekly dulaglutide 1.5 mg resulted in superior reductions in HbA1c from baseline compared to insulin glargine, with a lower risk for hypoglycemia. Dulaglutide is an investigational glucagon-like peptide-1 receptor agonist being studied for the treatment of type 2 diabetes. Results were presented at the 74th American Diabetes Association Scientific Sessions in San Francisco. "Many patients with type 2 diabetes reach a point when oral medicines alone may no longer be effective enough. In these cases, many healthcare professionals choose to intensify treatment with an injectable medicine," said Francesco Giorgino, MD, professor of endocrinology and metabolism, University of Bari, Italy. "Data from these two studies comparing once-weekly dulaglutide with insulin glargine, in combination with other diabetes treatments, provide important information about a GLP-1 receptor agonist that, if approved, may be appropriate for patients with type 2 diabetes." Results from the AWARD-2 trial, which evaluated the safety and efficacy of two doses of once-weekly dulaglutide compared to insulin glargine as add on to combination therapy with sulfonylurea and metformin, showed that once-weekly dulaglutide 1.5 mg provided superior blood sugar control at 52 and 78 weeks. Significantly more dulaglutide 1.5 mg-treated patients reached target HbA1c levels of less than 7 percent. Further, once-weekly dulaglutide 0.75 mg was non-inferior to insulin glargine in reducing HbA1c levels. Both doses of dulaglutide were associated with sustained weight loss, while insulin glargine showed weight gain. Results from the AWARD-4 trial the first Phase III study to evaluate a GLP-1 receptor agonist in combination with a mealtime insulin showed that once-weekly dulaglutide 1.5 mg and 0.75 mg combined with mealtime insulin lispro provided superior blood sugar control at 26 and 52 weeks compared to the traditional basal/bolus combination of insulin glargine and mealtime insulin lispro. Further, at the 26-week primary endpoint, significantly more dulaglutide-treated patients reached target HbA1c levels of less than 7%, and patients treated with the dulaglutide-mealtime insulin lispro combination had 30% less total insulin dose. Both doses of dulaglutide, in combination with mealtime insulin lispro, were associated with relative weight benefit compared to the basal/bolus therapy of insulin glargine and mealtime insulin lispro. Hypoglycemia rates were lower in dulaglutide 1.5 mg-treated patients compared to insulin glargine in both studies. In AWARD-2, the 0.75 mg dose also had a lower rate of hypoglycemia compared to insulin glargine. Adverse events were similar for dulaglutide-treated patients in both studies. The most frequently reported events were gastrointestinal-related, including nausea, diarrhea and vomiting. Nausea, which was mostly mild to moderate, was the most commonly reported event. These findings are consistent with prior studies of once-weekly dulaglutide.
News For LLY From The Last 14 Days
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October 23, 2014
12:20 EDTLLYOn The Fly: Midday Wrap
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07:25 EDTLLYEli Lilly CEO says economic outlook 'won't affect Eli Lilly negatively'
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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 EDTLLYCardiometabolic 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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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
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.
October 14, 2014
07:15 EDTLLYBiotech Industry Organization to hold a summit
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October 10, 2014
10:03 EDTLLYEli Lilly olaratumab granted orphan designation as soft tissue sarcoma treatment
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