Lilly ICOS LLC

Lilly ICOS LLC Reports First Quarterly Profit in its History

    Bothell, Washington and Indianapolis, Indiana (ots/PRNewswire) - Lilly ICOS LLC (Lilly ICOS) (NYSE: LLY and Nasdaq: ICOS) is releasing its financial results for the third quarter ended September 30, 2005, proudly reporting net income of US$19.8 million, compared to a net loss of US$21.4 million in the 2004 third quarter. Worldwide sales of Cialis(R) (tadalafil)(1) in the third quarter of 2005 totaled US$195.1 million, an increase of 27% compared to US$154.1 million in the third quarter of 2004.

@@start.t1@@        (All figures are in USD)
        Cialis Net Sales (unaudited):
        -----------------------------
        (in millions)
                                                        Three Months Ended         Nine Months Ended
                                                            September 30,                 September 30,
                                                        ------------------         ------------------
                                                          2005         2004                2005         2004
                                                        --------  --------         --------  --------
        Lilly ICOS Territories:
              United States                        $77.5        $70.2            $191.3      $153.8
              Europe(2)                                62.0         43.5              179.2        125.1
              Canada and Mexico                  14.7          9.3                40.7         24.1
                                                        --------  --------         --------  --------
                 Total Lilly ICOS                154.2        123.0              411.2        303.0
        Lilly Territories                         40.9         31.1              124.9         96.6
                                                        --------  --------         --------  --------
                 Worldwide Total                $195.1      $154.1            $536.1      $399.6
                                                        ========  ========         ========  ========@@end@@

    "Lilly ICOS has been steadily approaching profitability as a result of sustained top-line growth and planned reductions in marketing and selling expenses," stated Paul Clark, ICOS Chairman, President and Chief Executive Officer. "We are delighted to have achieved this important milestone and look forward to growing Lilly ICOS profitability in the years ahead."

    John Bamforth, Lilly Global Marketing Director, added "Cialis continues to perform well, achieving solid market share across the Lilly ICOS territories. In the U.S., market share of total prescriptions of Cialis reached 24.8% in September 2005, an increase of 150 basis points from June 2005.(3) Across Europe, Canada and Mexico, Cialis captured 32.4% of aggregate market share in August 2005."(4)

    Tadalafil, the active ingredient in Cialis, is also being evaluated for medical conditions other than erectile dysfunction (ED). During the third quarter of 2005, a clinical study was completed in benign prostatic hyperplasia (BPH), a condition which can cause a number of troublesome urinary tract symptoms as a man ages. Also, studies were initiated in hypertension and pulmonary arterial hypertension.

    The recently completed study in BPH demonstrated a clinically meaningful and statistically significant improvement in the primary endpoint, a reduction in lower urinary tract symptoms, as measured by the International Prostate Symptom Score. Results from the study will be presented at an upcoming medical congress. Planning is underway for a Phase 3 clinical program in BPH.

    Financial Results

    For the three months ended September 30, 2005, Lilly ICOS reported net income of US$19.8 million, compared to a net loss of US$21.4 million for the three months ended September 30, 2004. The shift to profitability results from an increase of US$33.1 million in total revenue and a reduction of US$8.0 million in expenses.

    Total revenue for the third quarter of 2005 was US$162.3 million. Revenue for the 2005 period includes US$8.2 million in royalties on sales reported by Lilly, compared to US$6.2 million in royalty revenue for the third quarter of 2004. The increase in total revenue reflects the 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. On a sequential basis, excluding the impact of changes in foreign exchange rates, third quarter 2005 European revenues increased approximately six percent over the 2005 second quarter amount.

    Selling, general and administrative expenses were US$112.2 million in the third quarter of 2005, down from US$123.2 million in the third quarter of 2004. Research and development expenses were US$18.0 million in the third quarter of 2005, compared to US$17.2 million in the third quarter of 2004.

    For the nine months ended September 30, 2005, Lilly ICOS reported a net loss of US$23.6 million, compared to a net loss of US$230.6 million for the nine months ended September 30, 2004. The decrease is primarily due to US$113.9 million of increased revenues and a US$100.7 million reduction of selling, general and administrative expenses.

    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.

    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. There can be no assurance that tadalafil will sustain 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. F-LLY

@@start.t2@@                                      -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,
                                                    ------------------         -------------------
                                                        2005         2004                2005          2004
                                                    --------  --------         --------    --------
      Revenue
         Product sales, net              $154,157  $123,020         $411,233    $303,037
         Royalties                                 8,172        6,210            24,972        19,311
                                                    --------  --------         --------    --------
            Total revenue                    162,329    129,230          436,205      322,348
                                                    --------  --------         --------    --------
      Expenses
         Cost of sales                         12,378      10,173            34,064        25,728
         Selling, general and
          administrative                    112,152    123,222          375,411      476,113
         Research and development        18,035      17,203            50,322        51,149
                                                    --------  --------         --------    --------
            Total expenses                  142,565    150,598          459,797      552,990
                                                    --------  --------         --------    --------
      Net income (loss)                    $19,764  $(21,368)        $(23,592) $(230,642)
                                                    ========  =========        ========= ==========
                                                  Lilly ICOS LLC
                                      SUMMARIZED OPERATING RESULTS
                                                 (in thousands)
                                                    (unaudited)
                                                                                         2005
                                                            ---------------------------------------
                                                                 Q1            Q2            Q3          TOTAL
                                                            --------- --------- --------  ---------
         Revenue:
              Product sales, net:
                  United States                      $42,744    $71,118    $77,438  $191,300
                  Europe                                  56,264      60,925      61,992    179,181
                  Canada and Mexico                 12,186      13,839      14,727      40,752
                                                            --------- --------- --------  ---------
                                                              111,194    145,882    154,157    411,233
              Royalties                                    7,790        9,010        8,172      24,972
                                                            --------- --------- --------  ---------
                  Total revenue                      118,984    154,892    162,329    436,205
                                                            --------- --------- --------  ---------
         Expenses:
              Cost of sales                              9,752      11,934      12,378      34,064
              Selling, general and
                administrative                        137,027    126,232    112,152    375,411
              Research and development          13,874      18,413      18,035      50,322
                                                            --------- --------- --------  ---------
                  Total expenses                    160,653    156,579    142,565    459,797
                                                            --------- --------- --------  ---------
         Net income (loss)                        $(41,669)  $(1,687)  $19,764  $(23,592)
                                                            ========= ========= ========  =========
                                                                                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)
                                         ========== ========= ========= ========= ==========@@end@@

    (1) Cialis(R) is a registered trademark of Lilly ICOS LLC.

    (2) Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden,  Switzerland and the United Kingdom.

    (3) IMS Health, IMS National Prescription Audit Plus(TM), September 2005.

    (4) Based on PDE5 inhibitor tablets from wholesalers to pharmacies, IMS Health, IMS MIDAS August 2005.

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

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

Contact:
Phil Belt of Lilly, +1-317-376-2506; 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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