Lilly ICOS LLC Reports First Quarterly Profit In Its History

BOTHELL, Wash. and INDIANAPOLIS, Ind., Oct. 20 /PRNewswire-FirstCall/ -- Lilly ICOS LLC (Lilly ICOS) is releasing its financial results for the third quarter ended September 30, 2005, proudly reporting net income of $19.8 million, compared to a net loss of $21.4 million in the 2004 third quarter. Worldwide sales of Cialis(R) (tadalafil)(1) in the third quarter of 2005 totaled $195.1 million, an increase of 27% compared to $154.1 million in the third quarter of 2004.

Cialis Net Sales (unaudited): ----------------------------- (in millions) Three Months Ended Nine Months Ended September 30, September 30, ------------------ ------------------ 2005 2004 2005 2004 -------- -------- -------- -------- Lilly ICOS Territories: United States $77.5 $70.2 $191.3 $153.8 Europe(2) 62.0 43.5 179.2 125.1 Canada and Mexico 14.7 9.3 40.7 24.1 -------- -------- -------- -------- Total Lilly ICOS 154.2 123.0 411.2 303.0 Lilly Territories 40.9 31.1 124.9 96.6 -------- -------- -------- -------- Worldwide Total $195.1 $154.1 $536.1 $399.6 ======== ======== ======== ========

"Lilly ICOS has been steadily approaching profitability as a result of sustained top-line growth and planned reductions in marketing and selling expenses," stated Paul Clark, ICOS Chairman, President and Chief Executive Officer. "We are delighted to have achieved this important milestone and look forward to growing Lilly ICOS profitability in the years ahead."

John Bamforth, Lilly Global Marketing Director, added "Cialis continues to perform well, achieving solid market share across the Lilly ICOS territories. In the U.S., market share of total prescriptions of Cialis reached 24.8% in September 2005, an increase of 150 basis points from June 2005.(3) Across Europe, Canada and Mexico, Cialis captured 32.4% of aggregate market share in August 2005."(4)

Tadalafil, the active ingredient in Cialis, is also being evaluated for medical conditions other than erectile dysfunction (ED). During the third quarter of 2005, a clinical study was completed in benign prostatic hyperplasia (BPH), a condition which can cause a number of troublesome urinary tract symptoms as a man ages. Also, studies were initiated in hypertension and pulmonary arterial hypertension.

The recently completed study in BPH demonstrated a clinically meaningful and statistically significant improvement in the primary endpoint, a reduction in lower urinary tract symptoms, as measured by the International Prostate Symptom Score. Results from the study will be presented at an upcoming medical congress. Planning is underway for a Phase 3 clinical program in BPH.

Financial Results

For the three months ended September 30, 2005, Lilly ICOS reported net income of $19.8 million, compared to a net loss of $21.4 million for the three months ended September 30, 2004. The shift to profitability results from an increase of $33.1 million in total revenue and a reduction of $8.0 million in expenses.

Total revenue for the third quarter of 2005 was $162.3 million. Revenue for the 2005 period includes $8.2 million in royalties on sales reported by Lilly, compared to $6.2 million in royalty revenue for the third quarter of 2004. The increase in total revenue reflects the 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. On a sequential basis, excluding the impact of changes in foreign exchange rates, third quarter 2005 European revenues increased approximately six percent over the 2005 second quarter amount.

Selling, general and administrative expenses were $112.2 million in the third quarter of 2005, down from $123.2 million in the third quarter of 2004. Research and development expenses were $18.0 million in the third quarter of 2005, compared to $17.2 million in the third quarter of 2004.

For the nine months ended September 30, 2005, Lilly ICOS reported a net loss of $23.6 million, compared to a net loss of $230.6 million for the nine months ended September 30, 2004. The decrease is primarily due to $113.9 million of increased revenues and a $100.7 million reduction of selling, general and administrative expenses.

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.

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 management 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. There can be no assurance that tadalafil will sustain 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. F-LLY -Selected financial data follows- Lilly ICOS LLC Condensed Consolidated Statements of Operations (in thousands) (unaudited) Three Months Ended Nine Months Ended ------------------ ------------------- September 30, September 30, ------------------ ------------------- 2005 2004 2005 2004 -------- -------- -------- -------- Revenue Product sales, net $154,157 $123,020 $411,233 $303,037 Royalties 8,172 6,210 24,972 19,311 -------- -------- -------- -------- Total revenue 162,329 129,230 436,205 322,348 -------- -------- -------- -------- Expenses Cost of sales 12,378 10,173 34,064 25,728 Selling, general and administrative 112,152 123,222 375,411 476,113 Research and development 18,035 17,203 50,322 51,149 -------- -------- -------- -------- Total expenses 142,565 150,598 459,797 552,990 -------- -------- -------- -------- Net income (loss) $19,764 $(21,368) $(23,592) $(230,642) ======== ========= ========= ========== Lilly ICOS LLC SUMMARIZED OPERATING RESULTS (in thousands) (unaudited) 2005 --------------------------------------- Q1 Q2 Q3 TOTAL --------- --------- -------- --------- Revenue: Product sales, net: United States $42,744 $71,118 $77,438 $191,300 Europe 56,264 60,925 61,992 179,181 Canada and Mexico 12,186 13,839 14,727 40,752 --------- --------- -------- --------- 111,194 145,882 154,157 411,233 Royalties 7,790 9,010 8,172 24,972 --------- --------- -------- --------- Total revenue 118,984 154,892 162,329 436,205 --------- --------- -------- --------- Expenses: Cost of sales 9,752 11,934 12,378 34,064 Selling, general and administrative 137,027 126,232 112,152 375,411 Research and development 13,874 18,413 18,035 50,322 --------- --------- -------- --------- Total expenses 160,653 156,579 142,565 459,797 --------- --------- -------- --------- Net income (loss) $(41,669) $(1,687) $19,764 $(23,592) ========= ========= ======== ========= 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) ========== ========= ========= ========= ========== (1) Cialis(R) is a registered trademark of Lilly ICOS LLC.

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

(3) IMS Health, IMS National Prescription Audit Plus(TM), September 2005.

(4) Based on PDE5 inhibitor tablets from wholesalers to pharmacies, IMS Health, IMS MIDAS August 2005.

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CONTACT: Phil Belt of Lilly, +1-317-376-2506; or Lacy Fitzpatrick of ICOS,+1-425-415-2207