Pharmaceutical company Eli Lilly & Co. (LLY) Thursday confirmed its earnings and revenue forecast for fiscal 2009. The company also provided its outlook for fiscal 2010, expecting to deliver strong sales with earnings growth. In addition, Eli Lilly affirmed its long-term guidance of low double-digit compound annual earnings growth.
The drug maker said it continues to expect full-year 2009 earnings in the range of $3.90 - $4.00 per share on a reported basis, or $4.30 - $4.40 per share on a pro forma non-GAAP basis.
Further, the company still expects low- to mid-single digit total revenue growth on a pro-forma basis and mid-single digit revenue growth on a reported basis for fiscal 2009.
Analysts polled by Thomson Reuters currently expect the company to report earnings of $4.42 per share for fiscal 2009 on revenues of $21.54 billion. Analysts' estimates typically exclude special items.
The company has also forecast gross margin as a percent of total revenue to increase for the full year, driven by favorable foreign exchange impact in the first nine months of 2009. Additionally, the company expects fourth-quarter gross margin as a percent of total revenue to decrease compared with the fourth quarter of 2008.
Eli Lilly also provided financial guidance for fiscal 2010 that excludes the potential impact of health care reform in the U.S. The company expects full-year 2010 earnings of $4.65 to $4.85 per share on both a reported and pro-forma non-GAAP basis. Meanwhile, analysts are currently of the view that the company will report earnings of $4.73 per share for fiscal 2010.
At the company's annual meeting today, Eli Lilly also detailed the progress being made in its labs and across its five new business units. According to the company, its R&D pipeline includes more than 60 molecules in clinical development, including 25 in Phases II and III. The company expects 10 Phase III molecules in 2011 and plans to launch 2 new medicines per year beginning in 2013.
Eli Lilly also reaffirmed its commitment to deliver low double-digit compound annual earnings per share growth between 2007 and 2011, excluding the potential impact of health care reform in the U.S. The company also foresees annual revenue of at least $20 billion during the major patent expiry years of 2012 to 2014 and beyond.
Detailing its operations in Established Markets, Eli Lilly said that the established markets business unit is the largest, accounting for more than half of the company's revenues and more than half of its clinical stage pipeline. The company's two best-selling drugs, Zyprexa and Cymbalta, are part of this business unit.
Cymbalta sales for the first three quarters of 2009 have grown 13% in the U.S. and 15% internationally. Cymbalta is under regulatory review for chronic pain in the U.S. and was recently approved by both Mexico and Brazil for this indication. The company expects additional international regulatory submissions in 2010.
In the U.S., Zyprexa sales grew 4% in the first nine months of 2009 and more than half of Zyprexa's sales now come from international markets. Market share is stable in other EU countries and continues to grow in Japan. In other Asian nations, including China, the current strong sales trend is expected to continue, Eli Lilly noted.
The company's Cialis worldwide sales rose 4% to $1.1 billion in the first three quarters of 2009. The benign prostatic hyperplasia, or BPH, Phase III program for Tadalafil is ongoing and will complete recruitment late next year. The company expects to submit for approval of the BPH indication in the U.S. and Japan in 2011, and in the EU in 2012.
Eli Lilly and Daiichi-Sankyo anticipate Efient launches in France, Italy and Spain in 2010. The drug is also expected to be launched in 24 other countries outside the U.S. and Europe in 2010.
Key molecules in the established markets business unit pipeline include gamma secretase inhibitor Semagacestat, monoclonal antibody Solanezumab, potential schizophrenia compound mGlu 2/3 Prodrug, pain compound iGluR5 Receptor Antagonist, Insomnia Compound LY2624803, IL-17 antibody and BAFF antagonist.
Eli Lilly's three key cancer medicines within the oncology business unit, Alimta, Gemzar and Erbitux, account for 14% of its worldwide revenue. Over the first three quarters of 2009, Alimta has been the company's fastest growing product, reaching worldwide sales of $1.2 billion. The company plans to pursue additional indications for Alimta, either as monotherapy, or in combination with other oncolytics.
Gemzar sales exceeded $1 billion in the first three quarters of 2009. The drug, which continues to grow in other markets, including Japan and China, has lost patent exclusivity in Europe in March of 2009, resulting in rapid generic penetration.
Eli Lilly also said that Erbitux is currently approved in certain indications for colorectal cancer, as well as head and neck cancer. It is being studied for additional indications for these cancers, as well as lung cancer, gastric cancer and others.
The company's key molecules in the oncology business unit pipeline include Ramucirumab, Necitumumab, Cixutumumab, Enzastaurin, Tasisulam, Survivin ASO, and IMC-3G3.
In diabetes arena, Eli Lilly's Humalog grew 12% worldwide for the three quarters of 2009, including a 21% growth in the U.S. market. Key molecules in the diabetes business unit pipeline include Exenatide once weekly, GLP-Fc and Teplizumab.
Eli Lilly said the emerging markets business unit will include many of the world's fastest-growing markets, including six of the so-called "pharmerging markets" such as China, Russia, Brazil, Mexico, South Korea, and Turkey. Currently, these markets accounted for 9% of the company's revenue in the first nine months of 2009. The company also said that its top emerging market priority is China. The company is currently building a second manufacturing plant in Suzhou to produce insulin.
In the Animal Health business, Elanco is planning for 7 new product launches and expanded indications, including two new companion animal products in 2010. As per the company, Elanco is positioned to double revenue in five years with five strategic initiatives.
Citing IMS Health data, Eli Lilly is indicated to have moved into the ninth spot among the top 10 companies ranked by worldwide pharmaceutical sales for the 12 months ended in June 2009.
For the recently closed third quarter, Eli Lilly had reported a profit of $941.8 million, or $0.86 per share, compared with a loss of $465.6 million, or $0.43 per share last year, helped by lower charges related to the litigation involving its antipsychotic drug Zyprexa, as well as higher sales for Alimta and Cymbalta. Total revenue increased 7% in the third quarter to $5.562 billion from $5.210 billion a year ago.
LLY is trading at $35.37, down $1.19, on a volume of 11.14 million shares.
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June 05, 2026 16:18 ET A busy week for economic news flow saw a slew of reports being released that reflected the trends in the U.S. labor market. In Europe, economic growth and inflation data gained attention as the European Central Bank and Bank of England head for policy session later in the month. In Asia, the monetary policy session of the Indian central bank was in focus as the country, a major oil importer, reels under the pressures of a weaker rupee and rising inflation.