ICOS Intercos Spa

- Cialis Attains Leading ED Market Share Position in Eleven Countries - BOTHELL, Wash. and INDIANAPOLIS, Ind., April 20 /PRNewswire-FirstCall/ -- Lilly ICOS LLC (Lilly ICOS) (NYSE:LLYNYSE:andNYSE:Nasdaq:NYSE:ICOS) is releasing its financial results for the 2006 first quarter, ended March 31. Worldwide sales of Cialis(R) (tadalafil) in the first quarter of 2006 totaled $222.7 million, an increase of 48% compared to $150.1 million in the first quarter of 2005. Cialis Net Sales: (in millions) Three Months Ended March 31, ------------------- 2006 2005 --------- --------- Lilly ICOS Territories: United States $82.5 $42.7 Europe(1) 67.6 56.3 Canada and Mexico 17.2 12.2 --------- --------- Total Lilly ICOS 167.3 111.2 Lilly Territories 55.4 38.9 --------- --------- Worldwide Total $222.7 $150.1 ========= ========= In February 2006, Cialis had achieved market share leadership in eleven countries, including France, Portugal, Saudi Arabia, South Africa and Venezuela. In France, Cialis has been the market leader for 14 consecutive months and held a 51% share for February 2006.(2) "We are proud of the market share leadership Cialis has achieved," stated Gaetano Crupi, Cialis Global Brand Development Leader for Lilly. "This time last year, Cialis was the share leader in just five countries. As 2006 unfolds, we expect Cialis to emerge as the category leader in additional markets as share gains continue and overall sales continue to grow." Lilly ICOS is evaluating the use of tadalafil, the active ingredient in Cialis, for its potential use in a number of medical indications in addition to erectile dysfunction. Paul Clark, ICOS Chairman and CEO, added, "At this time, we are finalizing the design of a Phase 2b clinical study to evaluate several doses of tadalafil for symptoms of benign prostatic hyperplasia. Patient enrollment in a multi- national Phase 3 study in pulmonary arterial hypertension continues. And, in the second half of 2006, we expect to announce the results of the Phase 2 proof of concept study in hypertension. We are excited that tadalafil might benefit patients in additional indications." 2006 First Quarter Financial Results For the three months ended March 31, 2006, Lilly ICOS reported net income of $65.0 million, compared to a net loss of $41.7 million for the three months ended March 31, 2005, primarily due to the $72.6 million increase in worldwide sales of Cialis and a $50.5 million reduction in selling, general and administrative expenses. Total Lilly ICOS revenue for the 2006 first quarter was $178.4 million, compared to $119.0 million for the first quarter of 2005. Lilly ICOS revenue for the 2006 period included $11.1 million in royalties on sales reported by Lilly, compared to $7.8 million in royalty revenue for the first quarter of 2005. The increase in net sales of Cialis in the U.S. includes the impact of an estimated $27 million aggregate reduction in U.S. wholesaler inventories of Cialis in the 2005 first quarter. Cost of sales, including royalties payable equal to 5% of net product sales, was 8.0% of net product sales in the 2006 first quarter, compared to 8.8% in the 2005 first quarter. The percentage decrease was primarily due to price increases since the beginning of 2005. The $50.5 million decrease in selling, general and administrative expenses, in 2006 compared to 2005, was primarily due to refinements to our U.S. sales force configuration and lower direct to consumer marketing expenditures in the 2006 first 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 benign prostatic hyperplasia, hypertension, pulmonary arterial 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. (2) IMS Health, IMS MIDAS (based on PDE5 inhibitor tablets from wholesalers to pharmacies) February 2006. Lilly ICOS LLC Condensed Consolidated Statements of Operations (in thousands) (unaudited) Three Months Ended March 31, ----------------------------- 2006 2005 Revenue ------------ ----------- Product sales, net $167,274 $111,194 Royalties 11,088 7,790 ------------ ----------- Total revenue 178,362 118,984 ------------ ----------- Expenses Cost of sales 13,382 9,752 Selling, general and administrative 86,517 137,027 Research and development 13,502 13,874 ------------ ----------- Total expenses 113,401 160,653 ------------ ----------- Net income (loss) $64,961 $(41,669) ============ =========== Lilly ICOS LLC SUMMARIZED OPERATING RESULTS (in thousands) (unaudited) 2006 2005 ----------- ---------------------- Q1 Q1 Q2 ----------- ---------- ---------- Revenue: Product sales, net: United States $82,537 $42,744 $71,118 Europe 67,586 56,264 60,925 Canada and Mexico 17,151 12,186 13,839 ----------- ---------- ---------- 167,274 111,194 145,882 Royalties 11,088 7,790 9,010 ----------- ---------- ---------- 178,362 118,984 154,892 ----------- ---------- ---------- Expenses: Cost of sales 13,382 9,752 11,934 Selling, general and administrative 86,517 137,027 126,232 Research and development 13,502 13,874 18,413 ----------- ---------- ---------- 113,401 160,653 156,579 ----------- ---------- ---------- Net income (loss) $64,961 $(41,669) $(1,687) =========== ========== ========== Lilly ICOS LLC SUMMARIZED OPERATING RESULTS (in thousands) (unaudited) 2005 ----------------------------------- Q3 Q4 TOTAL ----------- ---------- ---------- Revenue: Product sales, net: United States $77,438 $81,615 $272,915 Europe 61,992 65,311 244,492 Canada and Mexico 14,727 18,575 59,327 ----------- ---------- ---------- 154,157 165,501 576,734 Royalties 8,172 8,997 33,969 ----------- ---------- ---------- 162,329 174,498 610,703 ----------- ---------- ---------- Expenses: Cost of sales 12,378 13,200 47,264 Selling, general and administrative 112,152 84,416 459,827 Research and development 18,035 15,494 65,816 ----------- ---------- ---------- 142,565 113,110 572,907 ----------- ---------- ---------- Net income (loss) $19,764 $61,388 $37,796 =========== ========== ========== (Logo: http://www.newscom.com/cgi-bin/prnh/20040122/LILLYICOSLOGO ) http://www.newscom.com/cgi-bin/prnh/20040122/LILLYICOSLOGO DATASOURCE: Lilly ICOS LLC CONTACT: Terra Fox of Lilly, +1-317-276-5795; or Lacy Fitzpatrick of ICOS, +1-425-415-2207

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