Lilly ICOS LLC Reports First Quarter 2004 Global Cialis Sales of $108 million
-- Cialis surpasses Levitra in new and total U.S. prescriptions --
-- Nearly two million patients treated with Cialis --
BOTHELL, Wash. and INDIANAPOLIS, Ind., April 19 /PRNewswire-FirstCall/ --
Lilly ICOS LLC (Lilly ICOS) (NYSE: LLY and Nasdaq: ICOS) is releasing its
financial results for the three-month period ended March 31, 2004. Worldwide
sales of Cialis(R) (tadalafil) in the first quarter of 2004 were $108.3
million, compared to $21.5 million in the first quarter of 2003. As of March
31, 2004, nearly two million men around the world have been treated with
Cialis.
Cialis Net Product Sales (in millions):
Three Months Ended
March 31,
2004 2003
Lilly ICOS Territories:
United States $32.8 $ -
Europe (1) 36.3 16.6
Canada and Mexico 5.9 -
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Total Lilly ICOS 75.0 16.6
Lilly Territories 33.3 4.9
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Worldwide Total $108.3 $21.5
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(1) Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland,
Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden and
the United Kingdom.
"We are delighted with the favorable response by physicians and patients
since the U.S. launch of Cialis began, in late 2003," commented Paul Clark,
ICOS Chairman and Chief Executive Officer. "Cialis continues to post strong
gains in market share and the U.S. PDE5 inhibitor market growth has
accelerated. As mentioned in ICOS' February 3, 2004 conference call, the
Cialis marketing and selling investment is heavily front-ended relative to the
expected revenue trajectory. The Lilly ICOS results reported today are
consistent with our expectation, communicated on February 3, that more than
half of the 2004 net loss would occur in the first quarter."
"We are pleased with how our U.S. launch is proceeding and the rapid
uptake of Cialis," commented Khoso Baluch, Lilly's U.S. Group Brand Leader for
Endocrinology and Urology. "After only four months on the U.S. market, Cialis
has surpassed Levitra(R) (vardenafil HCl) in weekly market share of new and
total prescriptions written."
For the week ended April 2, 2004, Cialis captured 19.5% and 11.1% of new
and total U.S. PDE5 inhibitor prescriptions, respectively, compared to
Levitra's 14.2% and 10.3%, respectively.(2)
Leonard Blum, ICOS Vice President, Sales and Marketing, added, "Cialis is
the only oral ED treatment to give couples up to 36 hours to choose the moment
for intimacy that is right for them. Physicians have reported to us that
patients appreciate the benefits of Cialis and frequently, after a sample
period, request a prescription. This is consistent with a head to head study,
recently published in European Urology, showing that 73% of men preferred
Cialis compared to Viagra(R) (sildenafil citrate) for treatment of their ED
after receiving treatment with both products."(3)
Financial Results
For the three months ended March 31, 2004, Lilly ICOS reported a net loss
of $138.8 million, compared to a net loss of $43.1 million for the three
months ended March 31, 2003.
Total Lilly ICOS revenue for the first quarter of 2004 was $81.7 million,
compared to $17.6 million for the first quarter of 2003. Lilly ICOS revenue
for the 2004 period includes $6.7 million in royalties on sales reported by
Lilly, compared to $1.0 million in royalties for the first quarter of 2003.
The increase in Lilly ICOS revenue reflects the global expansion of Cialis
availability, from introduction in Europe in February 2003, to more than 55
countries today.
Cost of sales increased $5.0 million from the first quarter of 2003, to
$6.6 million in the first quarter 2004, including royalties payable by Lilly
ICOS equal to 5% of its net product sales. As a percent of net product sales,
cost of sales was 8.8% in the first quarter of 2004, compared to 9.7% in the
first quarter of 2003.
Selling, general and administrative expenses increased $152.7 million from
the first quarter of 2003, to $195.1 million in the first quarter of 2004.
This increase is primarily due to (i) 2004 sales and marketing costs
associated with the U.S. launch of Cialis, including a substantial direct to
consumer program, and (ii) the fact that 2003 includes only a partial quarter
of post-launch marketing and sales activities in Europe.
Research and development expenses were $18.8 million in the first quarter
of 2004, compared to $16.7 million in the first quarter of 2003. The increase
in research and development expenses is primarily due to postmarketing trials,
partially offset by reduced clinical activity associated with seeking FDA
approval for Cialis.
About Lilly ICOS LLC
Lilly ICOS LLC, a 50/50 joint venture between ICOS Corporation and Eli
Lilly and Company, is marketing Cialis for the treatment of erectile
dysfunction in North America and Europe.
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(R) (tadalafil), for the treatment
of erectile dysfunction. ICOS is working to develop treatments for serious
unmet medical conditions such as 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 National Prescription Audit Plus 7(TM), April 2004.
(3) A Multicenter, Randomized, Double-Blind, Crossover Study to Evaluate
Patient Preference between Tadalafil and Sildenafil. Alexander Von Keitz, MD;
Jacob Rajfer, MD; Scott Segal, MD; Aileen Murphy, MPH: Jonathan Denne, PhD;
Timothy Costigan, PhD; Daniel Lockhart, PhD; Charles Beasley, MD; Jeffrey T.
Emmick, MD, PhD. European Urology (Vol. 45, issue 4)
-Selected financial data follows-
Lilly ICOS LLC
Condensed Consolidated Statements of Operations
(in thousands)
(unaudited)
Three Months Ended
March 31,
------------------------
2004 2003
----------- -----------
Revenue:
Product sales, net $75,017 $16,615
Royalties 6,652 975
----------- -----------
Total revenue 81,669 17,590
----------- -----------
Expenses:
Cost of sales 6,573 1,604
Selling, general and administrative 195,053 42,396
Research and development 18,827 16,685
----------- -----------
Total expenses 220,453 60,685
----------- -----------
Net loss $(138,784) $(43,095)
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SOURCE Lilly ICOS LLC
