Lilly ICOS LLC Reports Results for 2003
-- Cialis(R) 2003 worldwide sales exceed $200 million --
BOTHELL, Wash. and INDIANAPOLIS, Ind., Jan. 29 /PRNewswire-FirstCall/ --
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(R) (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 62.9 129.8
Sales 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(R)
(sildenafil) and Levitra(R) (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(2) --
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.
About Lilly ICOS LLC
Lilly ICOS LLC is a joint venture between ICOS Corporation and Eli Lilly
and Company.
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.
ICOS Corporation, a biotechnology company, is dedicated to bringing
innovative therapeutics to patients. Headquartered in Bothell, Washington,
ICOS is marketing its first product, Cialis (tadalafil), for the treatment of
erectile dysfunction. ICOS is working to develop treatments for serious unmet
medical conditions such as interstitial cystitis, chronic obstructive
pulmonary disease, cancer and inflammatory diseases.
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. More specifically, there can be no assurance that Cialis will
achieve 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 judgment as of the date of this release. ICOS and Lilly
undertake no obligation to publicly update any forward-looking statements.
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(2) IMS Health. IMS MIDAS, Copyright 2003. Growth rates are based on
three-month moving total tablet inflow to pharmacies.
-Selected financial data follows-
Lilly ICOS LLC
Condensed Consolidated Statements of Operations
(in thousands)
(unaudited)
Three Months Ended Year Ended
December 31, December 31,
2003 2002 2003 2002
Revenue:
Product sales, net $62,911 $ - $129,828 $ -
Royalties 6,263 - 14,705 -
-------- -------- --------- --------
Total revenue 69,174 - 144,533 -
-------- -------- --------- --------
Expenses:
Cost of sales 5,966 - 12,543 -
Selling, general &
administrative 103,025 22,580 243,110 75,697
Research and
development 17,858 19,782 63,622 55,641
-------- -------- -------- --------
Total expenses 126,849 42,362 319,275 131,338
-------- -------- -------- --------
Net loss $(57,675) $(42,362) $(174,742) $(131,338)
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SOURCE Lilly ICOS LLC
