Actualizado 29/01/2004 14:00
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COMUNICADO DE LILLY ICOS LLC (1)

Lilly ICOS LLC Reports Results for 2003

Cialis 2003 worldwide sales exceed $200 million

BOTHELL (USA), 29 (PRNewswire)

Lilly ICOS LLC (Lilly ICOS), a 50/50 joint venture between ICOS Corporation (Nasdaq: ICOS) and Eli Lilly and Company (NYSE: LLY), which is marketing Cialis (tadalafil) for the treatment of erectile dysfunction (ED), is releasing its financial results for the year and fourth quarter ended December 31, 2003.

During 2003, Cialis was launched around the world. The commercial launches began in Europe in early February and continued throughout the year. U.S. approval occurred on November 21, 2003, and physician detailing and pharmacy stocking began immediately thereafter. Cialis also became available in pharmacies in Mexico, in August 2003, and in Canada late in November 2003.

Cialis Product Sales Highlights for 2003 (in millions):

Fourth Quarter Full Year Sales in Lilly ICOS Joint Venture Territories: United States $27.9 $27.9 Europe(1) 30.4 95.1 Canada and Mexico 4.6 6.8 Total Lilly ICOS 62.9 129.8Sales in Lilly-Only Territories 31.3 73.5 Worldwide Total $94.2 $203.3

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

"The first phase of the U.S. launch was executed with speed and precision. Sales representatives met with physicians the first business day after approval. Product was shipped from the manufacturing facility within two business days, and Cialis was on the shelves in most pharmacies within two weeks," stated Khoso Baluch, Lilly's U.S. Business Unit Leader for Cialis. "Building awareness and motivating men with ED to ask for Cialis are now the top priorities. Brand awareness advertising was rolled out in mid-January 2004. Consumer advertising with the profile and benefits of Cialis -- critical in reaching ED patients and emphasizing Cialis' unique profile -- will debut at the Super Bowl."

"Patients tell us that they value the distinctive attributes of Cialis, particularly that it has been shown to improve erectile function, compared to placebo, for up to 36 hours following dosing," commented Leonard Blum, ICOS Corporation Vice President of Sales and Marketing. "Cialis provides the patient and his partner the freedom to choose the time for intimacy that is right for them."

2003 Full-Year Financial Results

For the year ended December 31, 2003, Lilly ICOS reported a net loss of $174.7 million, compared to a net loss of $131.3 million for the year ended December 31, 2002.

In its first year on the market, 2003 worldwide net product sales of Cialis totalled $203.3 million, of which $129.8 million represent sales in Lilly ICOS joint venture territories and $73.5 million represent sales in Lilly-only territories. Total Lilly ICOS revenue was $144.5 million, including $14.7 million in royalties on Cialis sales reported by Lilly.

Cialis has successfully captured a significant share of unit (tablet) sales in Europe among the three PDE5 inhibitors [Cialis, Viagra (sildenafil) and Levitra (vardenafil)]. For November 2003, based on pharmacy purchases from wholesalers(2), Cialis had a 35% share in France, 30% in Germany, 27% in Italy and 16% in both Spain and the United Kingdom. And, through November 2003, those markets continue to grow at healthy rates -- ranging from 22% in Italy up to 40% in Germany.

Cost of sales totalled $12.5 million in 2003, including royalties payable by Lilly ICOS equal to five percent of its net product sales.

Selling, general and administrative expenses increased $167.4 million, from $75.7 million in 2002, to $243.1 million in 2003. The increase primarily reflects the substantial selling and marketing activities associated with the 2003 launches of Cialis in Europe, beginning in early February, and North America later in the year.

Research and development expenses increased $8.0 million, to $63.6 million, in 2003, primarily related to post-marketing clinical studies in Europe, and clinical pharmacology studies in the U.S.

2003 Fourth Quarter Financial Results

For the three months ended December 31, 2003, Lilly ICOS reported a net loss of $57.7 million, compared to a net loss of $42.4 million for the three months ended December 31, 2002.

Worldwide net sales of Cialis totalled $94.2 million in the fourth quarter of 2003, of which $62.9 million represent sales in Lilly ICOS joint venture territories and $31.3 million represent sales in Lilly-only territories. Total Lilly ICOS revenue was $69.2 million, including $6.3 million in royalties on Cialis sales reported by Lilly.

Total expenses increased $84.5 million, to $126.8 million, in the fourth quarter of 2003, reflecting the cost of selling and marketing activities associated with the 2003 launches of Cialis in North America and Europe.

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