Lilly ICOS LLC Reports Third Quarter 2004 Cialis Worldwide Sales of
$154 Million - Third Quarter 2004 U.S. sales of Cialis exceed $70
million - BOTHELL, Wash. and INDIANAPOLIS, Ind., Oct. 21
/PRNewswire-FirstCall/ -- Lilly ICOS LLC (Lilly ICOS)
(NYSE:LLYNYSE:andNYSE:Nasdaq:NYSE:ICOS) is releasing its financial
results for the three and nine months ended September 30, 2004.
Worldwide sales of Cialis(R) (tadalafil) in the third quarter of
2004 were $154.1 million, compared to $50.2 million in the third
quarter of 2003. Cialis Net Product Sales: (in millions) Three
Months Ended Nine Months Ended September 30, September 30,
--------------------- ---------------------- 2004 2003 2004 2003
--------- --------- --------- --------- Lilly ICOS Territories:
United States $70.2 $-- $153.8 $-- Europe(1) 43.5 26.1 125.1 64.6
Canada and Mexico 9.3 2.3 24.1 2.3 --------- --------- ---------
--------- Total Lilly ICOS 123.0 28.4 303.0 66.9 Lilly Territories
31.1 21.8 96.6 42.2 --------- --------- --------- ---------
Worldwide Total $154.1 $50.2 $399.6 $109.1 ========= =========
========= ========= "We are delighted with the U.S. sales
performance of Cialis in the third quarter of 2004," commented Paul
N. Clark, ICOS Chairman and CEO. "In the U.S., Cialis has gained
market share of total prescriptions of PDE5 inhibitors each month
since it was launched, reaching 17.1% for September 2004.(2) We are
pleased that a Lilly ICOS analysis of IMS data shows that Cialis is
the most widely prescribed PDE5 inhibitor when U.S. patients are
switching from one product to another." Clark added, "At this time,
based on results to date, we expect worldwide 2004 sales of Cialis
to be in the middle of the range of our guidance of $500 million to
$600 million. Third quarter 2004 results reflect a combination of
steady revenue growth, cost management and the timing of certain
marketing and sales initiatives. While we expect costs to moderate
further over time, Lilly ICOS does not expect further cost
decreases in the fourth quarter of 2004." In Canada, Mexico and
across Europe, market share for Cialis also continues to increase.
Among major markets in August 2004, wholesaler to pharmacy market
share of Cialis ranged from 22% in the U.K. to 41% in France.(3)
Third quarter 2004 European sales were reduced slightly, on a
consecutive quarterly basis, due to a temporary closure of a Lilly
European distribution center due to a systems upgrade in July. That
scheduled closure, which was announced to wholesalers in advance,
accelerated some sales into the second quarter. Financial Results
For the three months ended September 30, 2004, Lilly ICOS reported
a net loss of $21.4 million, compared to a net loss of $33.9
million for the three months ended September 30, 2003. Total Lilly
ICOS revenue for the third quarter of 2004 was $129.2 million,
compared to $32.8 million for the third quarter of 2003. Lilly ICOS
revenue for the 2004 period includes $6.2 million in royalties on
sales reported by Lilly, compared to $4.4 million in royalty
revenue for the third quarter of 2003. The increase in Lilly ICOS
revenue reflects the U.S. launch of Cialis in November 2003 as well
as the global expansion of Cialis availability to approximately 100
countries today. Cost of sales, including royalties payable by
Lilly ICOS equal to 5% of its net product sales, increased $7.4
million from the third quarter of 2003, to $10.2 million in the
third quarter of 2004. As a percent of net product sales, cost of
sales was 8.3% in the third quarter of 2004, compared to 9.9% in
the third quarter of 2003. Selling, general and administrative
expenses increased $74.1 million from the third quarter of 2003, to
$123.2 million in the third quarter of 2004. This is primarily due
to increased 2004 sales and marketing costs as Cialis was launched
in August 2003 in Mexico and November 2003 in the United States and
Canada. Research and development expenses were $17.2 million in the
third quarter of 2004, compared to $14.7 million in the third
quarter of 2003. For the nine months ended September 30, 2004,
Lilly ICOS reported a net loss of $230.6 million, compared to a net
loss of $117.1 million for the nine months ended September 30,
2003. The increase is primarily due to sales and marketing costs
associated with the timing of 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 headquartered in Bothell, Washington, is
dedicated to bringing innovative therapeutics to patients. ICOS is
marketing its first product, Cialis, through Lilly ICOS LLC. 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. -Selected financial data follows-
Lilly ICOS LLC Condensed Consolidated Statements of Operations (in
thousands) (unaudited) Three Months Ended Nine Months Ended
September 30, September 30, 2004 2003 2004 2003 -----------
----------- ---------- --------- Revenue: Product sales, net
$123,020 $28,449 $303,037 $66,917 Royalties 6,210 4,352 19,311
8,442 ---------- ---------- ---------- ---------- Total revenue
129,230 32,801 322,348 75,359 ---------- ---------- ----------
---------- Expenses: Cost of sales 10,173 2,803 25,728 6,577
Selling, general and administrative 123,222 49,145 476,113 140,085
Research and development 17,203 14,735 51,149 45,764 ----------
---------- ---------- ---------- Total expenses 150,598 66,683
552,990 192,426 ---------- ---------- ---------- ---------- Net
loss $(21,368) $(33,882) $(230,642) $(117,067) ==========
========== ========== ========== Lilly ICOS LLC SUMMARIZED
OPERATING RESULTS (in thousands) (unaudited) 2004
------------------------------------------ Q1 Q2 Q3 TOTAL
---------- ---------- ---------- --------- Revenue: Product sales,
net: United States $32,807 $50,768 $70,226 $153,801 Europe 36,356
45,301 43,414 125,071 Canada and Mexico 5,854 8,931 9,380 24,165
------------------------------------------ 75,017 105,000 123,020
303,037 Royalties 6,652 6,449 6,210 19,311 ---------- ----------
---------- --------- Total revenue 81,669 111,449 129,230 322,348
---------- ---------- ---------- --------- Expenses: Cost of sales
6,573 8,982 10,173 25,728 Selling, general and administrative
195,053 157,838 123,222 476,113 Research and development 18,827
15,119 17,203 51,149 ---------- ---------- ---------- ---------
Total expenses 220,453 181,939 150,598 552,990 ----------
---------- ---------- --------- Net loss $(138,784) $(70,490)
$(21,368) $(230,642) ========== ========== ========== =========
2003 --------------------------------------------------- Q1 Q2 Q3
Q4 TOTAL ---------- --------- --------- --------- ----------
Revenue: Product sales, net: United States $- $- $- $27,922 $27,922
Europe 16,615 21,853 26,154 30,442 95,064 Canada and Mexico - -
2,295 4,547 6,842
--------------------------------------------------- 16,615 21,853
28,449 62,911 129,828 Royalties 975 3,115 4,352 6,263 14,705
---------- --------- --------- --------- ---------- Total revenue
17,590 24,968 32,801 69,174 144,533 ---------- --------- ---------
--------- ---------- Expenses: Cost of sales 1,604 2,170 2,803
5,966 12,543 Selling, general and administrative 42,396 48,544
49,145 103,025 243,110 Research and development 16,685 14,344
14,735 17,858 63,622 ---------- --------- --------- ---------
---------- Total expenses 60,685 65,058 66,683 126,849 319,275
---------- --------- --------- --------- ---------- Net loss
$(43,095) $(40,090) $(33,882) $(57,675) $(174,742) ==========
========= ========= ========= ========== (1) Austria, Belgium,
Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy,
Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden,
Switzerland and the United Kingdom. (2) IMS National Prescription
Audit Plus(TM), October 2004. (3) IMS Health. IMS MIDAS, Copyright
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
Copyright