ICOS Icos

ICOS Corporation (Nasdaq:ICOS) today announced that Lilly ICOS LLC, its joint venture with Eli Lilly and Company (NYSE:LLY), has submitted a regulatory filing for marketing approval to the European Medicines Agency (EMEA) for Cialis(R) (tadalafil) 2.5 mg and 5 mg once-a-day dosing to treat erectile dysfunction (ED). Lilly ICOS plans to file in the United States and Canada later in 2006. If approved, the first launches could occur in late 2007. "We are very excited about the prospect of bringing Cialis Once-A-Day to the market in North America and Europe," stated Paul Clark, ICOS Chairman and CEO. "Market research revealed that once-a-day therapy could especially appeal to an important segment of the patient population -- the man in his forties or fifties who takes a PDE5 inhibitor more frequently than average." Mr. Clark added, "Importantly, growth in worldwide Cialis sales, including Cialis Once-A-Day beginning in 2008 if approved, are expected to drive accelerated earnings for ICOS Corporation." The recent EMEA filing followed the completion of three Phase 3 clinical studies that evaluated the efficacy and safety of Cialis when administered once-a-day for the treatment of ED. Men with ED taking Cialis 5 mg Once-A-Day experienced significantly improved erectile function compared to those taking placebo. Cialis 5 mg Once-A-Day was generally well-tolerated with most frequently occurring side effects being upset stomach and headache. "Introducing the once-a-day treatment for ED is part of our long range strategic plan for maximizing the value of the tadalafil molecule," added Leonard Blum, Senior Vice President, Sales and Marketing. "The once-a-day dose would be priced less than the Cialis 10 mg or 20 mg tablet, commonly used on-demand and, as a result, could be a financially viable alternative to the current on-demand regimen." Financial Outlook In order to provide some context as to the potential value of Cialis Once-A-Day, ICOS is presenting its expectations for future results. ICOS is assuming that Cialis Once-A-Day will be approved in the United States, Europe, Canada and Mexico, and will generate incremental sales beginning in 2008. On May 4, 2006, ICOS stated its expectation that 2006 worldwide Cialis product sales would be around $900 million, and Lilly ICOS' 2006 net income would be near the upper end of the $210 million to $240 million range previously communicated. The Company also indicated that it expected ICOS' 2006 full year GAAP net loss to be near the low end of the $5.0 million ($0.08 per share) to $25.0 million ($0.39 per share) net loss range that it had previously communicated. "We are delighted to discuss, for the first time, our expected significant acceleration of earnings for ICOS Corporation in 2007 and 2008," said Michael Stein, Senior Vice President and Chief Financial Officer. ICOS Corporation currently expects its 2007 fully-taxed net income to be in the range of $35 million ($0.53 per diluted share) to $45 million ($0.68 per diluted share). For 2008, ICOS Corporation's fully-taxed net income is presently expected to be in the range of $85 million ($1.23 per diluted share) to $100 million ($1.45 per diluted share). The expected 2007 and 2008 results of operations for ICOS Corporation are presented on a fully-taxed basis, assuming a 35% effective income tax rate. However, because of net operating loss carryforwards, the Company does not expect that ICOS Corporation will recognize or pay significant Federal income taxes in those years. ICOS anticipates that 2007 worldwide Cialis product net sales may grow at or greater than a mid-teens percentage rate, to in excess of $1 billion, and expects a greater than 50% increase in Lilly ICOS' 2007 net income compared to 2006. ICOS expects that 2008 worldwide total Cialis net product sales (including once-a-day) may grow 20% to 25% over 2007, and expects a 40% to 50% increase in Lilly ICOS' net income in 2008 compared to 2007. Expected results for Lilly ICOS do not include any costs it might choose to incur as a result of a successful outcome of the currently in process Phase 2 study of tadalafil in hypertension. Conference Call ICOS will host a conference call, on Thursday, June 8, 2006, at 8:30 a.m. Eastern Time, to discuss plans for Cialis Once-A-Day and related matters, including information regarding expected future results of operations. The conference call can be accessed as a webcast at www.icos.com, in the Investor/Events section, or by telephone, using the Passcode 832207, live at 480-629-9025, or as a replay at 320-365-3844. The webcast will be available until June 15, 2006, at 9:30 a.m. Eastern Time. The telephone replay will be available until June 9, 2006, at 8:00 p.m. Eastern Time. About ED ED is defined as the consistent inability to attain and maintain an erection sufficient for sexual intercourse. ED affects an estimated 189 million men worldwide(1). Experts believe that 80-90 percent of ED cases are related to a physical or medical condition, like diabetes, cardiovascular diseases, and prostate cancer treatment, while 10-20 percent are due to psychological causes(2)(3). In many cases, however, both psychological and physical factors contribute to the condition(4). About Cialis Cialis(R) (tadalafil) is approved for the treatment of erectile dysfunction, and is the only oral ED tablet clinically proven to work up to 36 hours. Cialis is available by prescription only and is not for everyone. Men taking nitrates, often used for chest pain, should not take Cialis. Such a combination could cause a sudden, unsafe drop in blood pressure. The most common side effects with Cialis were headache, upset stomach, delayed backache or muscle ache. As with any ED tablet, in the rare event of priapism (an erection lasting more than four hours), men should seek immediate medical attention to avoid long-term injury. Men should not drink alcohol in excess with Cialis. Cialis does not protect a man or his partner from sexually transmitted diseases, including HIV. In rare instances, men taking prescription ED tablets (including Cialis) reported a sudden decrease or loss of vision. It's not possible to determine if these events are related directly to the ED tablets or to other factors. If a man has a sudden decrease or loss of vision, he should stop taking any ED tablet and seek immediate medical attention. Men should discuss their medical conditions and all medications with their doctors to ensure Cialis is right for them and that they are healthy enough for sexual activity. Individual results may vary. Cialis has not been studied for multiple attempts per dose. For full patient information and/or full prescribing information, visit http://www.cialis.com. Tadalafil, the active ingredient in Cialis, is also being evaluated for other medical conditions, such as hypertension, benign prostatic hyperplasia (BPH) and pulmonary arterial hypertension (PAH). About ICOS Corporation 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 conditions such as benign prostatic hyperplasia, hypertension, pulmonary arterial hypertension, cancer and inflammatory diseases. Additional information about ICOS is available at www.icos.com. 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, including statements concerning anticipated regulatory approvals of once-a-day dosing of Cialis and expected future results of operations. In some cases, you can identify forward-looking statements by terminology such as "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "might," "plan," "possible," "potential," "predict," "should" or "will" or the negative of such terms or other comparable terminology. Forward-looking statements are only predictions that provide our current expectations or forecasts of future events. These forward-looking statements involve risks and uncertainties that may cause our results and the timing and outcome of events to differ materially from those expressed in or implied by the forward-looking statements, including risks associated with product commercialization, research and clinical development, regulatory approvals, manufacturing, collaboration arrangements, liquidity, competition, intellectual property claims, litigation and other risks detailed in our latest Quarterly Report on Form 10-Q and our other public filings with the Securities and Exchange Commission. In particular, government regulatory authorities may not approve once-a-day dosing of Cialis or may delay its approval. Any failure to receive the regulatory approvals necessary to commercialize once-a-day dosing of Cialis could harm our business. Human therapeutic products are subject to extensive and rigorous government regulation. In addition, we have only limited experience in filing and pursuing applications necessary to gain regulatory approvals, which may impede our ability to obtain such approvals. The regulatory review and approval process is lengthy, expensive and uncertain. Any FDA or other regulatory approval of our product candidates, once obtained, may be withdrawn. Any or all of our forward-looking statements in this press release and in any other public statements that we make may turn out to be wrong. Inaccurate assumptions we might make and known and unknown risks, uncertainties and other factors may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Although we believe that the expectations reflected in the forward-looking statements are reasonable, based on the information available to us at the time the statements are made, we cannot guarantee future results, performance or achievements. You should not place undue reliance on these forward-looking statements. The forward-looking statements contained in this press release represent our judgment as of the date of this release. Except as required under federal securities laws and regulations, we undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise. The biotechnology and pharmaceutical businesses are risky and there can be no assurance that any of our products or product candidates will achieve commercial success or that competing therapies will not pre-empt market opportunities that might exist for any of our products or product candidates. (1)Data were extrapolated from Feldman HA, Goldstein I, Hatzichristou DG, Krane RJ. Impotence and its Medical and Psychosocial Correlates: Results of the Massachusetts Male Aging Study, Journal of Urology. Vol. 151, 54-61, January 1994 and World Population Projection Program Of United Nations (2002 Revision) with indirect standardization. (2)Shabsigh, R. (2002). Back To Great Sex: Overcome ED and Reclaim Lost Intimacy. New York: Kensington. (3)Diseases and Conditions: Impotence, http://www.impotence.org/FAQ/index.asp. Data accessed 11.20.03 (4)Lue, Tom F. Erectile Dysfunction. N Engl J Med 2000; 342: 1802-1813.