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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