Lilly ICOS LLC

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.

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

    "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.

@@start.t2@@      (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 )@@end@@

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; FCMN Contact:
terrafox@lilly.com



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