Lilly ICOS LLC Reports Third Quarter 2004 Cialis Worldwide Sales of US$154 Million
Bothell, Washington and Indianapolis, Indiana (ots/PRNewswire)
- Third Quarter 2004 U.S. sales of Cialis exceed US$70 million -
Lilly ICOS LLC (Lilly ICOS) (NYSE: LLY and Nasdaq: 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 US$154.1 million, compared to US$50.2 million in the third quarter of 2003.
(All figures in US Dollars)
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 US$500 million to US$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 US$21.4 million, compared to a net loss of US$33.9 million for the three months ended September 30, 2003.
Total Lilly ICOS revenue for the third quarter of 2004 was US$129.2 million, compared to US$32.8 million for the third quarter of 2003. Lilly ICOS revenue for the 2004 period includes US$6.2 million in royalties on sales reported by Lilly, compared to US$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 US$7.4 million from the third quarter of 2003, to US$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 US$74.1 million from the third quarter of 2003, to US$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 US$17.2 million in the third quarter of 2004, compared to US$14.7 million in the third quarter of 2003.
For the nine months ended September 30, 2004, Lilly ICOS reported a net loss of US$230.6 million, compared to a net loss of US$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.
(All figures in US Dollars)
-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 )Contact:
Terra Fox of Lilly, +1-317-276-5795; or Lacy Fitzpatrick of ICOS,
+1-425-415-2207; Photo:
http://www.newscom.com/cgi-bin/prnh/20040122/LILLYICOSLOGO , PRN
Photo Desk, photodesk@prnewswire.com; FCMN Contact:
terrafox@lilly.com