10-QPeriod: Q3 FY2013

ELI LILLY & Co Quarterly Report for Q3 Ended Sep 30, 2013

Filed October 30, 2013For Securities:LLY

Summary

Eli Lilly and Company (LLY) reported solid revenue growth for the first nine months of 2013, with total revenue increasing by 4% to $17.3 billion. This growth was primarily driven by key products like Cymbalta, insulins, animal health products, Alimta, Cialis, and Trajenta. However, the company experienced a 9% decrease in net income for the third quarter of 2013, largely due to a significant one-time income recognized in the prior year related to the exenatide revenue-sharing obligation. For the nine-month period, net income increased by 21% to $3.96 billion. The company is facing upcoming patent expirations for key drugs like Cymbalta and Evista, which are expected to materially impact future results due to anticipated generic competition. Lilly is actively managing these upcoming patent cliffs through a new $5 billion share repurchase program and continued investment in its R&D pipeline.

Financial Statements
Beta
Revenue$5.77B
Cost of Revenue$1.20B
Gross Profit$4.57B
R&D Expenses$1.38B
SG&A Expenses$1.65B
Operating Expenses$3.03B
Interest Expense$39.80M
Net Income$1.20B
EPS (Basic)$1.11
EPS (Diluted)$1.11
Shares Outstanding (Basic)1.08B
Shares Outstanding (Diluted)1.08B

Key Highlights

  • 1Total revenue for the nine months ended September 30, 2013, increased 4% to $17.3 billion, driven by strong performance in key products and animal health.
  • 2Third-quarter net income decreased 9% year-over-year to $1.20 billion, primarily due to the absence of a large one-time income recognized in Q3 2012 from the exenatide collaboration termination payment.
  • 3Research and development expenses increased 6% year-over-year for the nine-month period, reflecting ongoing investment in early-stage discovery and late-stage clinical trials.
  • 4The company announced a new $5.00 billion share repurchase program in October 2013, indicating confidence and a commitment to returning capital to shareholders.
  • 5Eli Lilly faces significant near-term patent expirations for Cymbalta (December 2013) and Evista (March 2014), which are expected to lead to substantial revenue declines due to generic competition.
  • 6The company is advancing its late-stage pipeline with multiple New Molecular Entities (NMEs) in regulatory review or Phase III trials, including treatments for diabetes, cancer, and autoimmune diseases.
  • 7Effective tax rate decreased significantly to 20.5% in Q3 2013 and for the nine months, compared to 29.2% and 25.8% in the prior year periods, respectively, benefiting from the R&D tax credit reinstatement and prior year one-time income tax impacts.

Frequently Asked Questions

The primary driver of the decrease in net income for the third quarter of 2013 was the absence of a significant one-time income of $787.8 million recognized in the third quarter of 2012, related to the early payment of the exenatide revenue-sharing obligation following Amylin's acquisition.

The most significant near-term risk is the upcoming loss of patent exclusivity for key products, notably Cymbalta in December 2013 and Evista in March 2014. The introduction of generic versions of these drugs is expected to cause a rapid and severe decline in their respective revenues.

Eli Lilly is focusing on mitigating the impact of these patent expirations by emphasizing growth in its patent-protected products, expanding in emerging markets, and continuing to launch new products. The company also announced a new $5.00 billion share repurchase program, signaling confidence and a commitment to shareholder returns.

Eli Lilly has a robust late-stage pipeline with approximately 60 potential new drugs in human testing or under regulatory review. Key developments include regulatory submissions for dulaglutide and ramucirumab, and ongoing Phase III trials for several other promising compounds targeting diseases such as diabetes, cancer, and autoimmune disorders.