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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