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.

@@start.t1@@      (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
                                                        =========  =========  =========  =========@@end@@

    "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.

@@start.t2@@      (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)
                                         ========= ========= ========= ========= ==========@@end@@

    (Logo: http://www.newscom.com/cgi-bin/prnh/20040122/LILLYICOSLOGO )

ots Originaltext: Lilly ICOS LLC
Im Internet recherchierbar: http://www.newsaktuell.ch

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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