Lilly ICOS LLC Reports Results for Second Quarter of 2003
Tuesday August 19, 8:09 am ET
Second Quarter Worldwide Cialis Sales Totalled $37.4 Million
BOTHELL, Wash. & INDIANAPOLIS--(BUSINESS WIRE)--Aug. 19, 2003--Lilly ICOS LLC ("Lilly ICOS"), a 50/50 joint venture between ICOS Corporation (Nasdaq:ICOS - News; "ICOS") and Eli Lilly and Company (NYSE:LLY - News; "Lilly"), which is developing Cialis® for the treatment of erectile dysfunction ("ED"), is releasing its financial results for the three- and six-month periods ended June 30, 2003, and summarizing recent events.
Cialis is not yet approved for sale in the United States and is currently under review by the U.S. Food and Drug Administration ("FDA"). Lilly ICOS continues to expect a U.S. regulatory decision regarding Cialis late in 2003. Cialis has been approved in approximately 40 countries worldwide.
Lilly ICOS Financial Results
For the three months ended June 30, 2003, Lilly ICOS reported a net loss of $40.1 million, compared to a net loss of $34.0 million for the three months ended June 30, 2002.
Worldwide product sales of Cialis totalled $37.4 million in the second quarter of 2003, including $21.9 million in the European Union ("EU"), which are reported by Lilly ICOS. Sales in territories outside of North America and the EU, are reported by Lilly, and totalled $15.5 million during the period. Total Lilly ICOS revenue for the second quarter of 2003 was $25.0 million, including $3.1 million in royalties on sales reported by Lilly.
Total expenses were $65.1 million for the three months ended June 30, 2003, compared to $34.0 million for the three months ended June 30, 2002.
Cost of sales totalled $2.2 million in the second quarter of 2003, including royalties payable by Lilly ICOS equal to five percent of its net product sales.
Research and development expenses increased $5.1 million from the second quarter of 2002, to $17.5 million in the second quarter of 2003. The increase primarily reflects incremental costs related to patent litigation, local clinical trials in Europe and clinical pharmacology studies required by the FDA.
Selling, general and administrative expenses increased $23.8 million over the 2002 second quarter, to $45.4 million for the three months ended June 30, 2003. This increase primarily reflects sales and marketing costs associated with the commercial launch of Cialis in Europe and preparations for launch in North America.
For the six months ended June 30, 2003, Lilly ICOS reported a net loss of $83.2 million, compared to a net loss of $62.5 million for the six months ended June 30, 2002.
Worldwide product sales of Cialis totalled $58.9 million for the first six months of 2003, including $38.5 million of sales in the EU and $20.4 million of sales reported by Lilly. Total Lilly ICOS revenue was $42.6 million for the first six months of 2003, including $4.1 million in royalties on sales reported by Lilly. Revenue for the six-month period included initial stocking by European wholesalers and pharmacies during the 2003 first quarter.
Total expenses were $125.7 million for the six months ended June 30, 2003, compared to $62.5 million for the six months ended June 30, 2002. The increase primarily reflects sales and marketing costs associated with the 2003 commercial launch of Cialis in Europe and incremental costs related to patent litigation, local clinical studies in Europe and clinical pharmacology studies required by the FDA.
Cialis Sales Performance
Between its launch in February 2003 and June 2003, Cialis has captured a significant share of ED sales in terms of units (tablets) among the three PDE5 inhibitors (Cialis®, Viagra®(1) and Levitra®(2)) purchased by pharmacies from wholesalers in several EU countries.(3)
During the month of June, Cialis had 30 percent of unit share in Germany, followed by 27 percent in France, and 21 percent in Italy. In the U.K., Cialis has gained 13% share of units. In countries where Lilly has rights to market Cialis, the product had 33 percent of unit share in Australia and 20 percent in Brazil.
Share of Market Wholesaler to Pharmacy (Units/Tablets)
June 2003
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Select countries where Lilly ICOS markets Cialis:
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Country Cialis Viagra Levitra
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Germany 30% 56% 14%
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France 27% 65% 8%
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Italy 21% 69% 10%
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Spain 15% 75% 10%
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United Kingdom 13% 85% 2%
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Select countries where Lilly markets Cialis:
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Country Cialis Viagra Levitra
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Australia 33% 63% 4%
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Brazil 20% 74% 6%
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Source: IMS Health. IMS MIDAS, Copyright, 2003
Independent research shows that France and Italy are the first two European countries where new prescriptions, written by primary care physicians, for Cialis surpassed new prescriptions for Viagra. In France, data on prescriptions written by 1,010 primary care physicians in June show that 45 percent of new PDE5 inhibitor prescriptions were for Cialis, compared to 28 percent for Viagra and 27 percent for Levitra.(4) In Italy, research among 300 pharmacies tracking new prescriptions filled for either Cialis or Viagra, from May 26, 2003 through June 15, 2003, revealed that 56 percent of these prescriptions were for Cialis, compared to 44 percent for Viagra. Data for Levitra were not collected.(5)
"We are delighted with the initial uptake and success achieved by Cialis so soon after its launch," said Mark Barbato, product team leader, Lilly. "We are encouraged that during this period, Cialis sales in Europe and elsewhere began and have remained strong."
About Lilly ICOS LLC
Lilly ICOS LLC, a joint venture between ICOS Corporation and Eli Lilly and Company, is marketing Cialis in the European Union, and pursuing regulatory approvals in North America for the treatment of sexual dysfunction.
Eli Lilly and Company, a leading innovation-driven corporation, is developing a growing portfolio of 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.
ICOS Corporation is a product-driven company that has expertise in both protein-based and small molecule therapeutics. ICOS combines its capabilities in molecular, cellular and structural biology, high-throughput drug screening, medicinal chemistry and gene expression profiling to develop highly innovative products expected to have significant commercial potential. ICOS applies its integrated approach to erectile dysfunction and other urologic disorders, and sepsis and other inflammatory diseases. ICOS' strategy targets multiple therapeutic areas with drugs that act through distinct molecular mechanisms, increasing ICOS' opportunities to market breakthrough products.
Certain of the matters discussed herein with respect to clinical studies and ICOS and Lilly's products may constitute 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. Investors are cautioned that matters subject to forward-looking statements involve risks and uncertainties, including economic, competitive, governmental, technological 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. More specifically, there can be no assurance that this product will receive regulatory approvals or achieve commercial success or that competing products will not pre-empt any market opportunity that might exist for the product.
* (1)The Viagra trademark is the property of Pfizer Inc.
* (2)The Levitra trademark is the property of Bayer AG.
* (3)IMS Health. IMS MIDAS, Copyright 2003.
* (4)Thales prescription tracking data, 2003.
* (5)PiTRE Consulting Market Research Agency, prescription tracking data, 2003.
* Selected financial data follows --
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Lilly ICOS LLC
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands)
(unaudited)
Three Months Ended Six Months Ended
June 30, June 30,
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2003 2002 2003 2002
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Revenue:
Product sales, net $ 21,853 $ - $ 38,468 $ -
Royalties 3,115 - 4,090 -
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Total revenue 24,968 - 42,558 -
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Cost of sales 2,170 - 3,774 -
Research and development 17,509 12,387 35,728 24,410
Selling, general and
administrative 45,379 21,619 86,241 38,056
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Total expenses 65,058 34,006 125,743 62,466
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Net loss $(40,090) $(34,006) $(83,185) $(62,466)
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Contact:
Lilly
Carole Copeland, 317-277-3661
ICOS
Lacy Fitzpatrick, 425-415-2207
Source: Lilly ICOS LLC |
