Lilly Announces Profit Dip, Expands Licensing Deal

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Indianapolis-based Eli Lilly and Co. (NYSE: LLY) is reporting third quarter net income of just over $500 million, compared to more than $1.2 billion during the same period one year ago. Chief Executive Officer John Lechleiter says the results were again affected by patent expirations such as Cymbalta and Evista, as well as charges associated with two big collaboration deals. The company also announced an expanded licensing agreement with Canada-based Zymeworks Inc., which could potentially be valued at $375 million. October 23, 2014

News Release

INDIANAPOLIS, Ind. - Eli Lilly and Company (NYSE: LLY) today announced financial results for the third quarter of 2014.

Certain financial information for 2014 and 2013 is presented on both a reported and a non-GAAP basis. Some numbers in this press release may not add due to rounding. Reported results were prepared in accordance with generally accepted accounting principles (GAAP) and include all revenue and expenses recognized during the period. Non-GAAP measures exclude the items described in the reconciliation tables later in the release. The non-GAAP measures are presented in order to provide additional insights into the underlying trends in the company's business. The company's 2014 financial guidance is also being provided on both a reported and a non-GAAP basis.

"While Lilly's third-quarter financial results continue to reflect the impact of recent patent expirations, our clinical pipeline is now producing strong momentum to drive future growth," said John C. Lechleiter, Ph.D., Lilly's chairman, president and chief executive officer. "In the past quarter alone, three new medicines were approved by the U.S. FDA and several others had positive data readouts. We are focused on successfully launching this new wave of innovative medicines while still sustaining a steady flow of promising assets in our pipeline."

Key Events Over the Last Three Months

The U.S. Food and Drug Administration (FDA) approved Jardiance (empagliflozin) tablets as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Jardiance is part of the company's strategic diabetes collaboration with Boehringer Ingelheim. The companies have launched Jardiance in the U.S. and certain European countries.

The FDA approved Trulicity (dulaglutide) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. The company is launching Trulicity in the U.S. in the fourth quarter of 2014. In addition, the Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending approval of Trulicity to improve glycemic control in adults with type 2 diabetes as monotherapy or in combination with other diabetes medicines, including insulin.

The FDA granted tentative approval for Basaglar (insulin glargine injection), a basal insulin product being developed in collaboration with Boehringer Ingelheim. The FDA has determined that Basaglar meets all of the regulatory requirements for approval, but it is subject to an automatic stay of up to 30 months as a result of litigation filed by Sanofi, claiming patent infringement. In addition, the European Commission granted marketing authorization for this insulin glargine product, indicated to treat diabetes in adults, adolescents and children aged 2 years and above. Lilly and Boehringer Ingelheim will launch the insulin glargine product based on dates that do not infringe valid and enforceable patents.

The company announced that its investigational medicine ixekizumab was statistically superior to etanercept and placebo on all skin clearance measures in Phase III studies in moderate-to-severe plaque psoriasis. Lilly is on track to file a submission with regulatory authorities by the end of the first half of 2015.

The company announced that its investigational basal insulin peglispro demonstrated a statistically significant lower hemoglobin A1c compared with insulin glargine at 26 weeks and 52 weeks, respectively, in Phase III clinical trials in patients with type 1 diabetes. Lilly is on track to file submissions with regulatory authorities by the end of the first quarter in 2015.

The company announced a Phase III study of Cyramza in combination with chemotherapy in patients with metastatic colorectal cancer met its primary endpoint of overall survival. The company expects to initiate regulatory submissions in the first half of 2015.

The company submitted Cyramza to the FDA as a treatment for second-line non-small cell lung cancer. The company expects regulatory action by the end of 2014.

The CHMP issued a positive opinion recommending approval for Cyramza in adults in combination with paclitaxel for the treatment of advanced gastric (stomach) or gastroesophageal junction adenocarcinoma following prior chemotherapy and as a monotherapy in this setting for patients for whom treatment in combination with paclitaxel is not appropriate. The company has also submitted Cyramza for the treatment of second line gastric cancer in Japan and was granted priority review.

The company and AstraZeneca announced an agreement to co-develop and commercialize AZD3293, an oral beta secretase cleaving enzyme (BACE) inhibitor currently in development as a potential treatment for Alzheimer's disease.

The company announced it will discontinue development of tabalumab -- being studied for the treatment of systemic lupus erythematosus (SLE, commonly known as lupus) and multiple myeloma.

The feed additives business acquired from Lohmann Animal Health in the second quarter of 2014 was sold as planned to a Lohmann management-led group.

The company recorded a $119 million non-tax deductible charge in the third quarter of 2014 due to a change created by the IRS final regulations in regard to its administration of the U.S. Branded Prescription Drug Fee. Final regulations modified the timing of when the company must recognize the expense. In addition to accounting for the fee that was imposed and paid in 2014, the company must now also accrue in 2014 for the fee that will be imposed and paid in 2015.

In October the company made the decision and announced plans to close and sell one of its three manufacturing plants located in Puerto Rico. As a result of this action, the company expects to record a charge of approximately $170 million (pre-tax) or approximately $0.16 per share (after tax) in the fourth-quarter of 2014.

The company announced the expansion of its existing licensing and collaboration agreement with Zymeworks Inc. The company will expand the collaboration to include development of additional targets, specifically focused on immuno-modulatory bi-specific antibodies.

Third-Quarter Reported Results

In the third quarter of 2014, worldwide total revenue was $4.876 billion, a decrease of 16 percent compared with the third quarter of 2013. The revenue decline was comprised of 16 percent due to lower volume; the impact of changes in price and foreign exchange rates on worldwide revenue was negligible. The 16 percent decrease in worldwide volume was primarily driven by the loss of U.S. patent exclusivity for Cymbalta, and to a lesser extent Evista, partially offset by volume gains for most other products. Total revenue in the U.S. decreased 33 percent to $2.218 billion, driven primarily by lower demand for Cymbalta and Evista following their patent expirations. Total revenue outside the U.S. increased 8 percent to $2.658 billion, driven by higher volume.

Gross margin decreased 21 percent to $3.609 billion in the third quarter of 2014 compared to the third quarter of 2013, driven by lower sales of Cymbalta and Evista due to the loss of U.S. patent exclusivity. Gross margin as a percent of total revenue was 74.0 percent, a decrease of 5.2 percentage points compared with the third quarter of 2013. The decrease in gross margin percent was primarily due to l