In the fourth quarter of 2009, worldwide total revenue was $5.934 billion, an increase of 14 percent compared with the fourth quarter of 2008. This 14 percent revenue growth was comprised of an increase of 7 percent due to higher volume, 3 percent due to higher prices, and 3 percent due to the impact of foreign exchange rates (numbers do not add due to rounding). Total revenue in the U.S. increased 11 percent to $3.261 billion due to higher prices and wholesaler buying patterns. Total revenue outside the U.S. increased 18 percent to $2.673 billion due to increased demand and the positive impact of foreign exchange rates, partially offset by lower prices.
Gross margin as a percent of total revenue decreased by 6.6 percentage points, to 75.9 percent. Cost of sales increased by 57 percent in the fourth quarter of 2009 compared to the fourth quarter of 2008. The decrease in gross margin was due to the impact of changes in foreign currencies compared to the U.S. dollar on international inventories sold during the quarter, which substantially increased cost of sales in the fourth quarter of 2009, but substantially decreased cost of sales in the fourth quarter of 2008.
Marketing, selling and administrative expenses increased 13 percent compared with the fourth quarter of 2008, to $1.953 billion. The increase was driven by higher marketing and selling expenses outside the U.S. and the impact of foreign exchange rates. Research and development expenses were $1.217 billion, or 21 percent of total revenue. Compared with the fourth quarter of 2008, research and development expenses grew 15 percent due primarily to the ImClone acquisition, increased incentive compensation and increased late-stage clinical trial costs. Total operating expenses, defined as the sum of research and development, marketing, selling and administrative expenses, increased 14 percent compared with the fourth quarter of 2008.
In the fourth quarters of 2009 and 2008, the company recognized charges of $37.9 million and $80.0 million, respectively for asset impairments, restructuring and other special charges primarily related to severance costs from previously announced strategic actions that the company is taking to reduce its cost structure and global workforce. In addition, in the fourth quarter of 2009 the company recognized a charge of $90.0 million related to acquired in-process research and development associated with the in-licensing agreement with Incyte Corporation.
Additionally, in the fourth quarter of 2008, the company recognized pre-tax charges totaling $4.730 billion, or $4.46 per share after tax, related to the acquisition of ImClone Systems. This amount includes a charge of $4.685 billion for in-process research and development, as well as ImClone operating results subsequent to the acquisition, incremental interest costs, and amortization of the intangible asset associated with Erbitux(R).
Operating income in the fourth quarter of 2009 rose to $1.205 billion. In the fourth quarter of 2008, the company had reported an operating loss of $3.256 billion, due to the in-process research and development charges associated with the acquisition of ImClone Systems.
Other income (expense) improved $13.4 million, to a net expense of $67.8 million, primarily due to the net loss on investment securities in the fourth quarter of 2008, partially offset by lower net interest income.
The effective tax rate was 19.5 percent in the fourth quarter of 2009. In the fourth quarter of 2008, the company recognized income tax expense of $292.0 million despite having a loss before income taxes of $3.337 billion because the in-process research and development charge related to the ImClone acquisition was not tax deductible. Also in the fourth quarter of 2008, the company recognized a tax benefit of $136.9 million, or $.13 per share, based upon the determination at final resolution of the agreement that a portion of the Zyprexa Eastern District of Pennsylvania settlement charge, taken in the third quarter of 2008, was tax deductible.
Net income and earnings per share increased to $915.4 million and $.83, respectively, compared with fourth-quarter 2008 net loss of $3.629 billion and loss per share of $3.31.
Full Year 2009 Reported Results
For the full-year 2009, worldwide total revenue increased 7 percent to $21.836 billion compared with 2008. This 7 percent revenue growth was comprised of a 7 percent increase due to higher volume and a 3 percent increase due to higher prices, partially offset by a 3 percent decrease due to the impact of foreign exchange rates. Total revenue in the U.S. increased 12 percent to $12.294 billion due to higher prices and higher demand. Total revenue outside the U.S. increased 1 percent to $9.542 billion due to increased demand, partially offset by the negative impact of foreign exchange rates and lower prices.
Gross margin as a percent of total revenue increased by 2.1 percentage points in 2009, to 80.6 percent. This increase was due to the impact of changes in foreign currencies compared to the U.S. dollar on international inventories sold during the year, which decreased cost of sales in 2009, but increased cost of sales in 2008.
Marketing, selling and administrative expenses increased 4 percent in 2009 compared with 2008, to $6.892 billion. Research and development expenses were $4.327 billion in 2009, or 20 percent of total revenue. Compared with 2008, research and development expenses grew 13 percent due primarily to the ImClone acquisition and increased late-stage clinical trial costs. Total operating expenses, defined as the sum of research and development, marketing, selling and administrative expenses, increased 7 percent in 2009, compared with 2008.
In 2009 the company recognized a charge of $90.0 million related to acquired in-process research and development associated with the in-licensing agreement with Incyte Corporation. In 2008, the company recognized charges of $4.835 billion for acquired in-process research and development associated with the ImClone and SGX acquisitions and the in-licensing agreements with BioMS and TransPharma.
In 2009 the company recognized charges of $692.7 million for asset impairments, restructuring and other special charges primarily related to severance costs from previously announced strategic actions and special charges related to Zyprexa litigation with multiple state attorneys general. In 2008, the company recognized charges totaling $1.974 billion for asset impairments, restructuring and other special charges primarily associated with Zyprexa investigations with the U.S. attorney for the Eastern District of Pennsylvania and multiple states.
Operating income in 2009 rose to $5.587 billion. In 2008, the company reported an operating loss of $1.282 billion due to the in-process research and development charges associated with the acquisition of ImClone Systems.
Other income (expense) in 2009 was a net expense of $229.5 million, compared to a net expense of $26.1 million in 2008, primarily due to lower interest income and higher interest expense resulting from the ImClone acquisition.
The effective tax rate was 19.2 percent for the full-year 2009. In 2008, the company recognized income tax expense of $764.3 million despite having a loss before income taxes of $1.308 billion. The in-process research and development charge recorded in 2008 related to the ImClone acquisition was not tax deductible.
For the full-year 2009, net income and earnings per share increased to $4.329 billion and $3.94, respectively, compared a full-year 2008 net loss of $2.072 billion and loss per share of $1.89.
About Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers - through medicines and information - for some of the world's most urgent medical needs. Additional information about Lilly is available at www.lilly.com; Lilly's clinical trial registry is available at www.lillytrials.com.