Lilly ICOS LLC

Lilly ICOS LLC Reports First Full-Year Profit in its History

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

                - 2005 Fourth Quarter Net Income Surges to US$61.4 Million
                                  - 2005 Worldwide Sales Grow 35%
                      - Company Provides Update on Clinical Plan for BPH

    Lilly ICOS LLC (Lilly ICOS) (NYSE: LLY and Nasdaq: ICOS) is releasing its financial results for the fourth quarter and year ended December 31, 2005. For the 2005 year, net income was US$37.8 million, compared to a net loss of US$262.0 million in 2004. Worldwide sales of Cialis(R) (tadalafil) in 2005 totaled US$746.6 million, an increase of 35% compared to US$552.3 million in 2004.

@@start.t1@@      Cialis Net Sales:
        -----------------
        (in millions USD)
                                                          Three Months Ended            Year Ended
                                                              December 31,                  December 31,
                                                        ---------------------    ------------------
                                                          2005            2004            2005            2004
                                                      -------        -------        -------        -------
        Lilly ICOS Territories:
                United States                    $81.6          $52.8         $272.9         $206.6
                Europe(1)                            65.3            52.8          244.5          177.9
                Canada and Mexico                18.6            13.1            59.3            37.2
                                                      -------        -------        -------        -------
                    Total Lilly ICOS          165.5          118.7          576.7          421.7
        Lilly Territories                        45.0            34.0          169.9          130.6
                                                      -------        -------        -------        -------
                    Worldwide Total          $210.5         $152.7         $746.6         $552.3
                                                      =======        =======        =======        =======@@end@@

    "Lilly ICOS has reached a significant milestone, achieving full-year profitability in the second year following the Cialis launch in the United States," commented Paul N. Clark, ICOS Chairman and CEO. "Since launch, Cialis has delivered solid market share gains and sales growth, while concurrently leveraging early investments in marketing and selling programs."

    Lilly ICOS continues to broaden its understanding of tadalafil and explore its potential use in additional indications beyond erectile dysfunction. In 2005, a Phase 3 clinical study was initiated in pulmonary arterial hypertension, a life-threatening disease, and a Phase 2 clinical study began in hypertension, a common disorder which dramatically increases the risk of cardiovascular complications.

    In 2005, Lilly ICOS completed a Phase 2 clinical study and reported positive results in the treatment of lower urinary tract symptoms in men with benign prostatic hyperplasia (BPH). The Phase 2 clinical results will be presented at the upcoming meetings of the European Association of Urology and the American Urological Association, in April and May 2006, respectively. Earlier this week Lilly ICOS had a productive meeting with the FDA, in which the results of the study and a clinical plan for BPH were discussed. Based on the discussion, Lilly ICOS plans to proceed with a Phase 2b study this year, which may serve as one of two pivotal studies, to evaluate multiple doses of tadalafil. The results of the multi-dose study will be useful in the design of a Phase 3 study for BPH, expected to begin in 2007.

    2005 Full-Year Financial Results

    For the year ended December 31, 2005, Lilly ICOS reported net income of US$37.8 million, compared to a net loss of US$262.0 million for the year ended December 31, 2004, reflecting increased worldwide Cialis revenues and reduced selling and marketing costs.

    Total Lilly ICOS revenue for 2005 was US$610.7 million, compared to US$447.9 million for 2004. Lilly ICOS revenue for 2005 includes US$34.0 million in royalties on sales reported by Lilly, compared to US$26.1 million in royalty revenue for 2004. The increase in total revenue reflects continued growth of Cialis in the Lilly ICOS territories since its 2003 introduction, as well as its global expansion in countries where Cialis is sold by Lilly.

    Cost of sales totaled US$47.3 million in 2005, including royalties payable by Lilly ICOS equal to 5% of its net product sales. Cost of sales, as a percentage of net product sales, was 8.2% in 2005, compared to 8.6% in 2004.

    Selling, general and administrative expenses decreased US$146.7 million from the year ended December 31, 2004, to US$459.8 million in 2005. The decrease was primarily due to planned reductions in 2005 selling and marketing expenses in the United States.

    2005 Fourth Quarter Financial Results

    For the three months ended December 31, 2005, Lilly ICOS reported net income of US$61.4 million, compared to a net loss of US$31.4 million for the three months ended December 31, 2004. The shift to profitability resulted from an increase of US$49.0 million in total revenue and a reduction of US$43.8 million in expenses.

    Total Lilly ICOS revenue for the fourth quarter of 2005 was US$174.5 million, compared to US$125.5 million for the fourth quarter of 2004. Lilly ICOS revenue for the fourth quarter of 2005 included US$9.0 million in royalties on sales reported by Lilly, compared to US$6.8 million in royalty revenue for the fourth quarter of 2004.

    Selling, general and administrative expenses decreased US$46.0 million from the fourth quarter of 2004, to US$84.4 million in the fourth quarter of 2005. The decrease was primarily due to the aforementioned reduced U.S. selling and marketing expenses in the 2005 quarter.

    About Lilly ICOS LLC

    Lilly ICOS LLC, a joint venture equally owned by ICOS Corporation and Eli Lilly and Company, is marketing Cialis, in North America and Europe, for the treatment of erectile dysfunction.

    ICOS Corporation, a biotechnology company headquartered in Bothell, Washington, is dedicated to bringing innovative therapeutics to patients. ICOS is working to develop treatments for serious unmet medical needs such as pulmonary arterial hypertension, benign prostatic hyperplasia, hypertension, 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

    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 managements 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 tadalafil will achieve sustained 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 judgments 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.

@@start.t2@@                                          Lilly ICOS LLC
                  Condensed Consolidated Statements of Operations
                                            (in thousands USD)
                                                (unaudited)
                                                      Three Months Ended                 Year Ended
                                                            December 31,                    December 31,
                                                  ----------------------  --------------------
                                                        2005              2004            2005          2004
                                                  ---------    ----------    ---------  --------
      Revenue
         Product sales, net              $165,501        $118,705      $576,734  $421,742
         Royalties                                 8,997            6,809         33,969      26,120
                                                  ---------    ----------    ---------  --------
            Total revenue                    174,498         125,514        610,703    447,862
                                                  ---------    ----------    ---------  --------
      Expenses
         Cost of sales                         13,200          10,338         47,264      36,066
         Selling, general and
          administrative                      84,416         130,398        459,827    606,511
         Research and development        15,494          16,169         65,816      67,318
                                                  ---------    ----------    ---------  --------
            Total expenses                  113,110         156,905        572,907    709,895
                                                  ---------    ----------    ---------  --------
      Net income (loss)                    $61,388        $(31,391)      $37,796 $(262,033)
                                                  =========    ==========    =========  ========
                                                 Lilly ICOS LLC
                                      SUMMARIZED OPERATING RESULTS
                                                 (in thousands)
                                                    (unaudited)
                                                                                    2005
                                                  ---------------------------------------------
                                                        Q1            Q2          Q3          Q4         TOTAL
                                                  --------  -------  -------  -------  --------
         Revenue:
            Product sales, net:
                United States                $42,744  $71,118  $77,438  $81,615  $272,915
                Europe                            56,264    60,925    61,992    65,311    244,492
                Canada and Mexico          12,186    13,839    14,727    18,575      59,327
                                                  --------  -------  -------  -------  --------
                                                    111,194  145,882  154,157  165,501    576,734
            Royalties                            7,790      9,010      8,172      8,997      33,969
                                                  --------  -------  -------  -------  --------
                Total revenue                118,984  154,892  162,329  174,498    610,703
                                                  --------  -------  -------  -------  --------
         Expenses:
            Cost of sales                      9,752    11,934    12,378    13,200      47,264
            Selling, general and
              administrative                137,027  126,232  112,152    84,416    459,827
            Research and
              development                      13,874    18,413    18,035    15,494      65,816
                                                  --------  -------  -------  -------  --------
                Total expenses              160,653  156,579  142,565  113,110    572,907
                                                  --------  -------  -------  -------  --------
         Net income (loss)              $(41,669) $(1,687) $19,764  $61,388    $37,796
                                                  ========  =======  =======  =======  ========
                                                 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 income (loss)      $(138,784) $(70,490) $(21,368) $(31,391) $(262,033)
                                         =========  ========  ========  ========  =========
      (Logo:  http://www.newscom.com/cgi-bin/prnh/20040122/LILLYICOSLOGO )@@end@@

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

Contact:
Lacy Fitzpatrick of ICOS, +1-425-415-2207; or Phil Belt of Lilly,
+1-317-276-2506; Photo:  
http://www.newscom.com/cgi-bin/prnh/20040122/LILLYICOSLOGO
PRN Photo Desk, photodesk@prnewswire.com



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