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Lilly ICOS LLC

Lilly ICOS LLC Reports Results for 2004

Bothell, Washington and Indianapolis, Indiana (ots/PRNewswire)

- 2004 Worldwide Sales of Cialis Top US$550 Million -
Lilly ICOS LLC (Lilly ICOS) (NYSE: LLY and Nasdaq: ICOS) is
releasing its financial results for the fourth quarter and year ended
December 31, 2004. Largely driven by the first year of sales in the
United States, worldwide sales of Cialis(R) (tadalafil) surged 172%
in 2004, to US$552 million, compared to US$203 million in 2003.
    (All amounts are in US Dollars)
        Cialis Net Sales:
     (in millions)
                                    Three Months Ended        Year Ended
                                       December 31,           December 31,
                                   --------------------  --------------------
                                     2004        2003       2004        2003
                                   ---------  ---------  ---------  ---------
     Lilly ICOS Territories:
         United States              $52.8       $27.9     $206.6       $27.9
         Europe(1)                   52.8        30.4      177.9        95.1
         Canada and Mexico           13.1         4.6       37.2         6.8
                                   ---------  ---------  ---------  ---------
            Total Lilly ICOS        118.7        62.9      421.7       129.8
     Lilly Territories               34.0        31.3      130.6        73.5
                                   ---------  ---------  ---------  ---------
            Worldwide Total        $152.7       $94.2     $552.3      $203.3
                                   =========  =========  =========  =========
"We are delighted that Cialis generated 2004 worldwide sales of
US$552 million," commented Paul N. Clark, ICOS Chairman and CEO.
"Sales of Cialis in the U.S. were US$207 million in 2004 and US$53
million in the fourth quarter of 2004. During the 2004 fourth
quarter, Cialis' monthly total U.S. prescriptions increased 18%
sequentially from the third quarter of 2004 and, in December, Cialis
achieved a new high of 20% market share for total prescriptions.(2)
Overall, during 2004, Cialis steadily gained market share in major
Lilly ICOS territories outside of the United States and, for November
2004, market share of Cialis ranged from 22% in Spain to 44% in
France.(3)"
Clark continued, "While our U.S. prescription volume grew
significantly during the 2004 fourth quarter, sequential quarterly
sales, from Lilly ICOS into the wholesale channel, decreased due to
our efforts to reduce channel inventory, beginning in December 2004.
As a result, based on the information available today, we estimate
there was approximately a US$15 million reduction of wholesaler
inventories during December 2004 and we anticipate there will be
further reductions of wholesaler inventories in the first quarter of
2005. There also was some expected reduction in wholesaler
inventories during October 2004, following the 6% price increase
implemented on September 30, 2004. We continue to expect Lilly ICOS
to achieve profitability around mid-2005."
Khoso Baluch, Lilly Vice President, U.S. Diabetes and Family
Health Business Unit stated, "Early in the fourth quarter in the
U.S., we introduced a variety of new marketing initiatives. We
believe we are already seeing the results of those new programs.
Cialis' effective positioning and highly successful launch campaign
earned it the 'Marketing Team of the Year' award from Medical
Marketing and Media in the January 2005 issue."
Baluch added, "We begin 2005 with excitement. We will continue to
invest to support our well-differentiated product and to further grow
Cialis' market share."
2004 Fourth Quarter Financial Results
For the three months ended December 31, 2004, Lilly ICOS reported
a net loss of US$31.4 million, compared to a net loss of US$57.7
million for the three months ended December 31, 2003.
Total Lilly ICOS revenue for the fourth quarter of 2004 was
US$125.5 million, compared to US$69.2 million for the fourth quarter
of 2003. Lilly ICOS revenue for the 2004 period includes US$6.8
million in royalties on sales reported by Lilly, compared to US$6.3
million in royalty revenue for the fourth quarter of 2003. The
increase in Lilly ICOS revenue reflects the U.S. and Canadian
launches of Cialis beginning in November 2003, as well as the global
expansion of Cialis to approximately 100 countries today.
In December 2004, Lilly ICOS took action to reduce channel
inventory to targeted levels. As a result, based on information
currently available, the company estimates that approximately US$15
million of wholesaler inventory reductions occurred during that month
and the company anticipates there will be further reductions of
wholesaler inventories in the first quarter of 2005.
Cost of sales, including royalties payable by Lilly ICOS equal to
5% of its net product sales, was 8.7% in the fourth quarter of 2004,
compared to 9.5% in the fourth quarter of 2003.
Selling, general and administrative expenses increased US$27.4
million from the fourth quarter of 2003, to US$130.4 million in the
fourth quarter of 2004. This is primarily due to increased 2004 sales
and marketing costs as Cialis was launched in the United States and
Canada in November 2003.
Research and development expenses were US$16.2 million in the
fourth quarter of 2004, compared to US$17.9 million in the fourth
quarter of 2003.
2004 Full-Year Financial Results
For the year ended December 31, 2004, Lilly ICOS reported a net
loss of US$262.0 million, compared to a net loss of US$174.7 million
for the year ended December 31, 2003. As expected, the increased loss
in 2004 was a result of the costs associated with launching Cialis in
North America.
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.
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.
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. F-LLY
BOTHELL, Washington and INDIANAPOLIS, Indiana, January 26
/PRNewswire/ --
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.
(1) Austria, Belgium, Denmark, Finland, France, Germany, Greece,
Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal,
Spain, Sweden, Switzerland and the United Kingdom.
(2) Based on calculations using IMS National Prescription Audit
Plus(TM), December 2004.
(3) IMS Health. IMS MIDAS, Copyright 2004.
    (All amounts are in US Dollars)
                                 Lilly ICOS LLC
               Condensed Consolidated Statements of Operations
                                (in thousands)
                                 (unaudited)
                               Three Months Ended          Year Ended
                             ----------------------- ------------------------
                                   December 31,            December 31,
                                2004        2003        2004         2003
                             ----------- -----------  ----------- -----------
    Revenue
      Product sales, net       $118,705     $62,911    $421,742     $129,828
      Royalties                   6,809       6,263      26,120       14,705
                             ----------- -----------  ----------- -----------
        Total revenue           125,514      69,174     447,862      144,533
                             ----------- -----------  ----------- -----------
    Expenses
      Cost of sales              10,338       5,966      36,066       12,543
      Selling, general and
       administrative           130,398     103,025     606,511      243,110
      Research and
       development               16,169      17,858      67,318       63,622
                             ----------- -----------  ----------- -----------
        Total expenses          156,905     126,849     709,895      319,275
                             ----------- -----------  ----------- -----------
    Net loss                   $(31,391)   $(57,675)  $(262,033)   $(174,742)
                             =========== ===========  =========== ===========
                                Lilly ICOS LLC
                         SUMMARIZED OPERATING RESULTS
                                (in thousands)
                                 (unaudited)
                                               2004
                            Q1        Q2        Q3         Q4       TOTAL
                          --------- --------- --------- --------- ----------
     Revenue:
      Product sales, net:
       United States       $32,807   $50,768   $70,226   $52,783   $206,584
       Europe               36,356    45,301    43,414    52,859    177,930
       Canada and Mexico     5,854     8,931     9,380    13,063     37,228
                          --------- --------- --------- --------- ----------
                            75,017   105,000   123,020   118,705    421,742
      Royalties              6,652     6,449     6,210     6,809     26,120
                          --------- --------- --------- --------- ----------
       Total revenue        81,669   111,449   129,230   125,514    447,862
                          --------- --------- --------- --------- ----------
     Expenses:
      Cost of sales          6,573     8,982    10,173    10,338     36,066
      Selling, general
       and administrative  195,053   157,838   123,222   130,398    606,511
      Research and
       development          18,827    15,119    17,203    16,169     67,318
                          --------- --------- --------- --------- ----------
       Total expenses      220,453   181,939   150,598   156,905    709,895
                          --------- --------- --------- --------- ----------
     Net loss            $(138,784) $(70,490) $(21,368) $(31,391) $(262,033)
                          ========= ========= ========= ========= ==========
                                               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)
                          ========= ========= ========= ========= ==========
(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

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