| Investors: | Media: | |
| Ann Tanabe | Dan Budwick | |
| VP, Investor Relations and Corporate Communications | BMC Communications | |
| Encysive Pharmaceuticals | (212) 477-9007 ext. 14 | |
| (713) 796-8822 | ||
| Marcy Strickler | ||
| The Trout Group | ||
| (212) 477-9007 ext. 27 |
| • | Revenues in the second quarter of 2006 were $3.7 million, as compared to $3.0 million for the second quarter of 2005. This increase was due to higher royalties on sales of Argatroban by GlaxoSmithKline. Royalty income increased 23% to $3.3 million, as compared to $2.7 million earned in the same period last year. | ||
| • | For the second quarter of 2006, the Company reported a net loss of $28.0 million, or $0.48 per basic and diluted share, compared to a net loss of $19.2 million, or $0.33 per basic and diluted share, for the second quarter of 2005. The increased loss in the current quarter, as compared to the second quarter of 2005, was primarily the result of the investment in the U.S. sales force and increased commercialization-related expenses. | ||
| • | Cash, cash equivalents and accrued interest at June 30, 2006, were $75.4 million, compared to $127.9 million at December 31, 2005, and $100.5 million at March 31, 2006. Due to the delay in the approval of THELIN™ (sitaxsentan sodium), the Company now anticipates the need to raise additional cash and is exploring various financing options. |
| • | On May 25, 2006, the Company submitted its complete response to the U.S. Food and Drug Administration (FDA), to address the issues and concerns detailed in the March 24, 2006, approvable letter for THELIN. The FDA, in turn, designated the review as a Class 1 resubmission. A new Prescription Drug User Fee Act (PDUFA) target action date of July 24, 2006, was established. | ||
| • | On July 24, 2006, Encysive received a second approvable letter from the FDA for THELIN. One of the substantive items raised in the March 24 approvable letter remains unresolved. The FDA acknowledged that the unresolved item is a matter of judgment and expressed a willingness to consider new arguments to address this remaining item. The FDA again offered the alternative of conducting additional clinical work. The Company has initiated active |
| discussions with the Agency, and is in the process of setting up a face-to-face meeting with the goal of attempting to resolve the remaining item. |
| • | On June 2, 2006, the Company announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Agency for the Evaluation of Medicinal Products (EMEA) issued a positive opinion recommending the approval of THELIN™ 100 mg tablets as a once daily oral treatment for patients with pulmonary arterial hypertension. The CHMP’s positive opinion will be considered by the European Commission, and a final decision regarding marketing approval for THELIN is expected within approximately 90 days from the opinion date. Under the EMEA’s centralized licensing procedure, if approved, Encysive would be granted marketing authorization for THELIN in all 25 member states of the European Union. | ||
| • | In preparation for the launch of THELIN in Europe, Encysive has established a European commercial organization, headquartered in London. Sales and marketing organizations are currently being developed in the United Kingdom, Germany and France, with other countries to follow. | ||
| • | The Company presented new THELIN data from the STRIDE-2X trial at the European League Against Rheumatism (EULAR) Annual European Congress of Rheumatology in June 2006. |
| • | Sept. 2-6 World Congress of Cardiology Barcelona, Spain | ||
| • | Sept. 2-6 European Respiratory Society 16th Annual Congress Munich, Germany | ||
| • | Sept. 11-14 ThinkEquity Partners 4th Annual Growth Conference San Francisco* | ||
| • | Sept. 25-28 UBS Global Life Sciences Conference New York City* |
| Three Months Ended | Six Months Ended | |||||||||||||||
| June 30, | June 30 | |||||||||||||||
| 2006 | 2005 | 2006 | 2005 | |||||||||||||
| Revenues | $ | 3,662 | $ | 2,976 | $ | 7,223 | $ | 5,462 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 14,676 | 17,366 | 33,055 | 33,681 | ||||||||||||
| Sales and marketing | 11,767 | 3,263 | 21,603 | 4,380 | ||||||||||||
| General and administrative | 5,364 | 3,605 | 11,106 | 6,199 | ||||||||||||
| Total expenses | 31,807 | 24,234 | 65,764 | 44,260 | ||||||||||||
| Operating loss | (28,145 | ) | (21,258 | ) | (58,541 | ) | (38,798 | ) | ||||||||
| Investment income | 1,085 | 1,339 | 2,384 | 1,933 | ||||||||||||
| Interest expense | (978 | ) | (976 | ) | (1,958 | ) | (1,147 | ) | ||||||||
| Loss from continuing operations | (28,038 | ) | (20,895 | ) | (58,115 | ) | (38,012 | ) | ||||||||
| Income from discontinued operations | — | 1,661 | — | 1,335 | ||||||||||||
| Loss before cumulative effect of change in accounting principle | $ | (28,038 | ) | $ | (19,234 | ) | $ | (58,115 | ) | $ | (36,677 | ) | ||||
| Cumulative effect of change in accounting principle | — | — | 107 | — | ||||||||||||
| Net loss | $ | (28,038 | ) | $ | (19,234 | ) | $ | (58,008 | ) | $ | (36,677 | ) | ||||
| Net loss per common share | ||||||||||||||||
| Basic and diluted | $ | (0.48 | ) | $ | (0.33 | ) | $ | (0.99 | ) | $ | (0.63 | ) | ||||
| Weighted average common shares | ||||||||||||||||
| Outstanding: basic and diluted | 58,465 | 57,895 | 58,368 | 57,776 | ||||||||||||
| June 30, | June 30, | |||||||
| 2006 | 2005 | |||||||
| Assets: | ||||||||
| Cash, cash equivalents and Accrued interest | $ | 75,417 | $ | 127,913 | ||||
| Other assets | 17,727 | 18,789 | ||||||
| Total assets | 93,144 | 146,702 | ||||||
| Liabilities and stockholders’ deficit | ||||||||
| Current liabilities | 26,664 | 26,151 | ||||||
| Deferred revenue, long-term | 642 | 1,286 | ||||||
| Long-term debt | 130,000 | 130,000 | ||||||
| Total liabilities | 157,306 | 157,437 | ||||||
| Stockholders’ deficit | (64,162 | ) | (10,735 | ) | ||||
| Liabilities and stockholders’ deficit | $ | 93,144 | $ | 146,702 | ||||
