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Lilly ICOS LLC (LLY) Reports First Full-Year Profit In Its History



1/20/2006 10:56:43 AM

BOTHELL, Wash. and INDIANAPOLIS, Ind., Jan. 20 /PRNewswire-FirstCall/ -- Lilly ICOS LLC (Lilly ICOS) is releasing its financial results for the fourth quarter and year ended December 31, 2005. For the 2005 year, net income was $37.8 million, compared to a net loss of $262.0 million in 2004. Worldwide sales of Cialis(R) (tadalafil) in 2005 totaled $746.6 million, an increase of 35% compared to $552.3 million in 2004.

Cialis Net Sales: ----------------- (in millions) Three Months Ended Year Ended December 31, December 31, --------------------- ------------------- 2005 2004 2005 2004 ------- ------- ------- ------- Lilly ICOS Territories: United States $81.6 $52.8 $272.9 $206.6 Europe(1) 65.3 52.8 244.5 177.9 Canada and Mexico 18.6 13.1 59.3 37.2 ------- ------- ------- ------- Total Lilly ICOS 165.5 118.7 576.7 421.7 Lilly Territories 45.0 34.0 169.9 130.6 ------- ------- ------- ------- Worldwide Total $210.5 $152.7 $746.6 $552.3 ======= ======= ======= =======

"Lilly ICOS has reached a significant milestone, achieving full-year profitability in the second year following the Cialis launch in the United States," commented Paul N. Clark, ICOS Chairman and CEO. "Since launch, Cialis has delivered solid market share gains and sales growth, while concurrently leveraging early investments in marketing and selling programs."

Lilly ICOS continues to broaden its understanding of tadalafil and explore its potential use in additional indications beyond erectile dysfunction. In 2005, a Phase 3 clinical study was initiated in pulmonary arterial hypertension, a life-threatening disease, and a Phase 2 clinical study began in hypertension, a common disorder which dramatically increases the risk of cardiovascular complications.

In 2005, Lilly ICOS completed a Phase 2 clinical study and reported positive results in the treatment of lower urinary tract symptoms in men with benign prostatic hyperplasia (BPH). The Phase 2 clinical results will be presented at the upcoming meetings of the European Association of Urology and the American Urological Association, in April and May 2006, respectively. Earlier this week Lilly ICOS had a productive meeting with the FDA, in which the results of the study and a clinical plan for BPH were discussed. Based on the discussion, Lilly ICOS plans to proceed with a Phase 2b study this year, which may serve as one of two pivotal studies, to evaluate multiple doses of tadalafil. The results of the multi-dose study will be useful in the design of a Phase 3 study for BPH, expected to begin in 2007.

2005 Full-Year Financial Results

For the year ended December 31, 2005, Lilly ICOS reported net income of $37.8 million, compared to a net loss of $262.0 million for the year ended December 31, 2004, reflecting increased worldwide Cialis revenues and reduced selling and marketing costs.

Total Lilly ICOS revenue for 2005 was $610.7 million, compared to $447.9 million for 2004. Lilly ICOS revenue for 2005 includes $34.0 million in royalties on sales reported by Lilly, compared to $26.1 million in royalty revenue for 2004. The increase in total revenue reflects continued growth of Cialis in the Lilly ICOS territories since its 2003 introduction, as well as its global expansion in countries where Cialis is sold by Lilly.

Cost of sales totaled $47.3 million in 2005, including royalties payable by Lilly ICOS equal to 5% of its net product sales. Cost of sales, as a percentage of net product sales, was 8.2% in 2005, compared to 8.6% in 2004.

Selling, general and administrative expenses decreased $146.7 million from the year ended December 31, 2004, to $459.8 million in 2005. The decrease was primarily due to planned reductions in 2005 selling and marketing expenses in the United States.

2005 Fourth Quarter Financial Results

For the three months ended December 31, 2005, Lilly ICOS reported net income of $61.4 million, compared to a net loss of $31.4 million for the three months ended December 31, 2004. The shift to profitability resulted from an increase of $49.0 million in total revenue and a reduction of $43.8 million in expenses.

Total Lilly ICOS revenue for the fourth quarter of 2005 was $174.5 million, compared to $125.5 million for the fourth quarter of 2004. Lilly ICOS revenue for the fourth quarter of 2005 included $9.0 million in royalties on sales reported by Lilly, compared to $6.8 million in royalty revenue for the fourth quarter of 2004.

Selling, general and administrative expenses decreased $46.0 million from the fourth quarter of 2004, to $84.4 million in the fourth quarter of 2005. The decrease was primarily due to the aforementioned reduced U.S. selling and marketing expenses in the 2005 quarter.

About Lilly ICOS LLC

Lilly ICOS LLC, a joint venture equally owned by ICOS Corporation and Eli Lilly and Company, is marketing Cialis, in North America and Europe, for the treatment of erectile dysfunction.

ICOS Corporation, a biotechnology company headquartered in Bothell, Washington, is dedicated to bringing innovative therapeutics to patients. ICOS is working to develop treatments for serious unmet medical needs such as pulmonary arterial hypertension, benign prostatic hyperplasia, hypertension, cancer and inflammatory diseases.

Eli Lilly and Company, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Indiana, Lilly provides answers -- through medicines and information -- for some of the world's most urgent medical needs. F-LLY

Except for historical information contained herein, this press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are based on current expectations, estimates and projections about the industry, management beliefs and certain assumptions made by the managements of ICOS and Lilly. Investors are cautioned that matters subject to forward-looking statements involve risks and uncertainties, including economic, competitive, governmental, technological, legal and other factors discussed in the two companies' respective filings with the Securities and Exchange Commission, which may affect the business and prospects of the two companies and Lilly ICOS. Results and the timing and outcome of events may differ materially from those expressed or implied by the forward-looking statements in this press release. More specifically, there can be no assurance that tadalafil will achieve sustained commercial success or that competing products will not pre- empt market opportunities that might exist for the product.

The forward-looking statements contained in this press release represent ICOS' and Lilly's judgments as of the date of this release. Neither ICOS nor Lilly undertake any obligation to update any forward-looking statements.

(1) Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom.

Lilly ICOS LLC Condensed Consolidated Statements of Operations (in thousands) (unaudited) Three Months Ended Year Ended December 31, December 31, ---------------------- --------------------- 2005 2004 2005 2004 --------- ---------- --------- -------- Revenue Product sales, net $165,501 $118,705 $576,734 $421,742 Royalties 8,997 6,809 33,969 26,120 --------- ---------- --------- -------- Total revenue 174,498 125,514 610,703 447,862 --------- ---------- --------- -------- Expenses Cost of sales 13,200 10,338 47,264 36,066 Selling, general and administrative 84,416 130,398 459,827 606,511 Research and development 15,494 16,169 65,816 67,318 --------- ---------- --------- -------- Total expenses 113,110 156,905 572,907 709,895 --------- ---------- --------- -------- Net income (loss) $61,388 $(31,391) $37,796 $(262,033) ========= ========== ========= ======== Lilly ICOS LLC SUMMARIZED OPERATING RESULTS (in thousands) (unaudited) 2005 --------------------------------------------- Q1 Q2 Q3 Q4 TOTAL -------- ------- ------- ------- -------- Revenue: Product sales, net: United States $42,744 $71,118 $77,438 $81,615 $272,915 Europe 56,264 60,925 61,992 65,311 244,492 Canada and Mexico 12,186 13,839 14,727 18,575 59,327 -------- ------- ------- ------- -------- 111,194 145,882 154,157 165,501 576,734 Royalties 7,790 9,010 8,172 8,997 33,969 -------- ------- ------- ------- -------- Total revenue 118,984 154,892 162,329 174,498 610,703 -------- ------- ------- ------- -------- Expenses: Cost of sales 9,752 11,934 12,378 13,200 47,264 Selling, general and administrative 137,027 126,232 112,152 84,416 459,827 Research and development 13,874 18,413 18,035 15,494 65,816 -------- ------- ------- ------- -------- Total expenses 160,653 156,579 142,565 113,110 572,907 -------- ------- ------- ------- -------- Net income (loss) $(41,669) $(1,687) $19,764 $61,388 $37,796 ======== ======= ======= ======= ======== Lilly ICOS LLC SUMMARIZED OPERATING RESULTS (in thousands) (unaudited) 2004 ------------------------------------------------- Q1 Q2 Q3 Q4 TOTAL -------- ------- ------- ------- -------- Revenue: Product sales, net: United States $32,807 $50,768 $70,226 $52,783 $206,584 Europe 36,356 45,301 43,414 52,859 177,930 Canada and Mexico 5,854 8,931 9,380 13,063 37,228 -------- ------- ------- ------- -------- 75,017 105,000 123,020 118,705 421,742 Royalties 6,652 6,449 6,210 6,809 26,120 -------- ------- ------- ------- -------- Total revenue 81,669 111,449 129,230 125,514 447,862 -------- ------- ------- ------- -------- Expenses: Cost of sales 6,573 8,982 10,173 10,338 36,066 Selling, general and administrative 195,053 157,838 123,222 130,398 606,511 Research and development 18,827 15,119 17,203 16,169 67,318 -------- ------- ------- ------- -------- Total expenses 220,453 181,939 150,598 156,905 709,895 -------- ------- ------- ------- -------- Net income (loss) $(138,784) $(70,490) $(21,368) $(31,391) $(262,033) ========= ======== ======== ======== ========= (Logo: http://www.newscom.com/cgi-bin/prnh/20040122/LILLYICOSLOGO )

Photo: http://www.newscom.com/cgi-bin/prnh/20040122/LILLYICOSLOGOPRN Photo Desk, photodesk@prnewswire.comLilly ICOS LLC

CONTACT: Lacy Fitzpatrick of ICOS, +1-425-415-2207; or Phil Belt of Lilly,+1-317-276-2506


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