Lilly ICOS LLC Reports Second Quarter 2004 Cialis Worldwide Sales
of $137 Million - U.S. sales of Cialis exceed $50 million -
BOTHELL, Wash. and INDIANAPOLIS, Ind., July 22
/PRNewswire-FirstCall/ -- Lilly ICOS LLC (Lilly ICOS)
(NYSE:LLYNYSE:andNYSE:Nasdaq:NYSE:ICOS) is releasing its financial
results for the three-month period ended June 30, 2004. Worldwide
sales of Cialis(R) (tadalafil) in the second quarter of 2004 were
$137.2 million, compared to $108.3 million in the first quarter of
2004 and $37.4 million in the second quarter of 2003. Cialis Net
Product Sales: ------------------------ (in millions) Three Months
Ended Six Months Ended June 30, June 30, ------------------
---------------- 2004 2003 2004 2003 -------- ------- -------
------- Lilly ICOS Territories: United States $50.8 $ -- $83.6 $ --
Europe(1) 45.3 21.9 81.6 38.5 Canada and Mexico 8.9 -- 14.8 --
-------- ------- ------- ------- Total Lilly ICOS 105.0 21.9 180.0
38.5 Lilly Territories 32.2 15.5 65.5 20.4 -------- ------- -------
------- Worldwide Total $137.2 $37.4 $245.5 $58.9 ======== =======
======= ======= (1) Austria, Belgium, Denmark, Finland, France,
Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands,
Norway, Portugal, Spain, Sweden, Switzerland and the United
Kingdom. "Worldwide sales of Cialis were strong in the 2004 second
quarter, exceeding $137 million, and continue on track to achieve
our full year worldwide sales expectation of $500 million to $600
million," observed Paul N. Clark, ICOS Chairman and CEO. "The Lilly
ICOS 2004 second quarter net loss came in lower than previously
contemplated due to the timing of certain expenditures that Lilly
ICOS strategically shifted to later in the year. Full year 2004
results expected for Lilly ICOS continue to be in-line with our
prior guidance." Clark continued, "Worldwide, the PDE5 inhibitor
market is solidly expanding. In the U.S., first-half 2004 PDE5
inhibitor market prescription growth was 13.2%, compared to the
same period in 2003.(2) Also, in the U.S., Cialis share of total
PDE5 inhibitor prescriptions grew to 14.0% for the month of June
2004, up 3.8 percentage points from its March 2004 level.(2)
Patients and physicians continue to embrace Cialis' unique 36-hour
window of opportunity." Bryce Carmine, Lilly's President, Metabolic
Disorders and Specialty Products added, "We are continuing to
invest in Cialis to build on the momentum of the launch, including
our most recent new U.S. initiative, The Cialis Promise. Reflecting
our confidence in this product, we are offering to pay for our
competitors' products if patients are not satisfied after trying
Cialis." Financial Results For the three months ended June 30,
2004, Lilly ICOS reported a net loss of $70.5 million, compared to
a net loss of $40.1 million for the three months ended June 30,
2003. Total Lilly ICOS revenue for the second quarter of 2004 was
$111.4 million, compared to $25.0 million for the second quarter of
2003. Lilly ICOS revenue for the 2004 period includes $6.4 million
in royalties on sales reported by Lilly, compared to $3.1 million
in royalty revenue for the second quarter of 2003. The increase in
Lilly ICOS revenue reflects the global expansion of Cialis
availability, from introduction in Europe, Australia and New
Zealand in February 2003, to approximately 70 countries today. Cost
of sales, including royalties payable by Lilly ICOS equal to 5% of
its net product sales, increased $6.8 million from the second
quarter of 2003, to $9.0 million in the second quarter of 2004. As
a percent of net product sales, cost of sales was 8.6% in the
second quarter of 2004, compared to 9.9% in the second quarter of
2003. Selling, general and administrative expenses increased $109.3
million from the second quarter of 2003, to $157.8 million in the
second quarter of 2004. This increase is primarily due to 2004
sales and marketing costs associated with the launches of Cialis in
the United States, Canada and Mexico. Research and development
expenses were $15.1 million in the second quarter of 2004, compared
to $14.3 million in the second quarter of 2003. For the six months
ended June 30, 2004, Lilly ICOS reported a net loss of $209.3
million, compared to a net loss of $83.2 million for the six months
ended June 30, 2003. The increase is primarily due to sales and
marketing costs associated with the launches of Cialis in the
United States, Canada and Mexico. 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, benign prostatic hyperplasia, 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. Neither ICOS nor Lilly
undertake any obligation to update any forward-looking statements.
Lilly ICOS LLC Condensed Consolidated Statements of Operations (in
thousands) (unaudited) Three Months Ended Six Months Ended June 30,
June 30, ------------------ ---------------- 2004 2003 2004 2003
------- ------- ------- ------- Revenue: Product sales, net
$105,000 $21,853 $180,017 $38,468 Royalties 6,449 3,115 13,101
4,090 ------- ------- ------- ------- Total revenue 111,449 24,968
193,118 42,558 ------- ------- ------- ------- Expenses: Cost of
sales 8,982 2,170 15,555 3,774 Selling, general and administrative
157,838 48,544 352,891 90,940 Research and development 15,119
14,344 33,946 31,029 ------- ------- ------- ------- Total expenses
181,939 65,058 402,392 125,743 ------- ------- ------- ------- Net
loss $(70,490) $(40,090) $(209,274) $(83,185) ======= =======
======== ======= Lilly ICOS LLC SUMMARIZED OPERATING RESULTS (in
thousands) (unaudited) 2004 -------------------------------- Q1 Q2
TOTAL ------- -------- -------- Revenue: Product sales, net $75,017
$105,000 $180,017 Royalties 6,652 6,449 13,101 ------- --------
-------- Total revenue 81,669 111,449 193,118 ------- --------
-------- Expenses: Cost of sales 6,573 8,982 15,555 Selling,
general and administrative 195,053 157,838 352,891 Research and
development 18,827 15,119 33,946 ------- -------- -------- Total
expenses 220,453 181,939 402,392 ------- -------- -------- Net loss
$(138,784) $(70,490) $(209,274) ======= ======== ======== Lilly
ICOS LLC SUMMARIZED OPERATING RESULTS (in thousands) (unaudited)
2003 -------------------------------- Q1 Q2 Q3 ------- --------
-------- Revenue: Product sales, net $16,615 $21,853 $28,449
Royalties 975 3,115 4,352 ------- -------- -------- Total revenue
17,590 24,968 32,801 ------- -------- -------- Expenses: Cost of
sales 1,604 2,170 2,803 Selling, general and administrative 42,396
48,544 49,145 Research and development 16,685 14,344 14,735 -------
-------- -------- Total expenses 60,685 65,058 66,683 -------
-------- -------- Net loss $(43,095) $(40,090) $(33,882) =======
======== ======== Lilly ICOS LLC SUMMARIZED OPERATING RESULTS (in
thousands) (unaudited) 2003 -------------------------- Q4 TOTAL
-------- -------- 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 and administrative 103,025 243,110 Research and
development 17,858 63,622 -------- -------- Total expenses 126,849
319,275 -------- -------- Net loss $(57,675) $(174,742) ========
======== (2) Based on calculations using IMS National Prescription
Audit Plus(TM), June 2004. (Logo:
http://www.newscom.com/cgi-bin/prnh/20040122/LILLYICOSLOGO )
http://www.newscom.com/cgi-bin/prnh/20040122/LILLYICOSLOGO
DATASOURCE: Lilly ICOS LLC CONTACT: Terra Fox of Lilly,
+1-317-276-5795; or Lacy Fitzpatrick of ICOS, +1-425-415-2207
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