8-K 1 h00962e8vk.txt TEXAS BIOTECHNOLOGY CORPORATION - DATED 11/6/02 SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 -------------------------- FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities and Exchange Act of 1934 Date of Report: (Date of earliest event reported): November 6, 2002 TEXAS BIOTECHNOLOGY CORPORATION (Exact name of registrant as specified in its charter) DELAWARE 0-20017 13-3532643 (State of Incorporation) (Commission File Number) (IRS Employer Identification No.) -------------------------------------------------------------------------------- 7000 FANNIN, 20TH FLOOR HOUSTON, TEXAS 77030 (Address of Registrant's principal executive offices) (713) 796-8822 (Registrant's telephone number, including area code) (NOT APPLICABLE) (Former name or former address, if changed since last report) ITEM 5. OTHER EVENTS THE FOLLOWING STATEMENT WAS RELEASED TO THE PRESS ON NOVEMBER 6, 2002 REGARDING THE THIRD QUARTER 2002 EARNINGS. TEXAS BIOTECHNOLOGY REPORTS THIRD QUARTER 2002 RESULTS ARGATROBAN SALES IN LINE WITH 2002 GUIDANCE RECENTLY COMPLETED STRIDE TRIAL DEMONSTRATES POTENTIAL USE OF SITAXSENTAN AS ONCE A DAY ORAL THERAPY FOR PULMONARY ARTERIAL HYPERTENSION HOUSTON, TX, NOVEMBER 6, 2002 - Texas Biotechnology Corporation (NASDAQ:TXBI) today announced financial results for the third quarter of 2002. Results for the third quarter were in line with management's prior guidance. THIRD QUARTER 2002 FINANCIAL RESULTS o Net loss for the third quarter of 2002 was $5.8 million, or $0.13 per basic and diluted share, compared to a net loss of $4.3 million, or $0.10 per basic and diluted share, for the same period last year. o The increased loss in the current quarter is primarily due to increased research and development costs associated with the clinical trials for the development of Argatroban as a treatment for ischemic stroke and percutaneous coronary intervention, and for sitaxsentan as a treatment for pulmonary arterial hypertension. o Revenue in the third quarter of 2002 was $2.4 million compared to $1.7 million in the comparable quarter of 2001. In the third quarter of 2002, the Company's royalties earned on net sales of Argatroban increased to $676,000 compared to approximately $333,000 in the third quarter of 2001. "We are encouraged by hospital sales data that indicate sales of Argatroban are keeping pace with the overall growth in the direct thrombin inhibitor market," stated Bruce D. Given, M.D., President and CEO of Texas Biotechnology. "Also during the third quarter, GlaxoSmithKline initiated a broad-based HIT Disease Education Media Campaign designed to increase awareness of HIT - a life-threatening reaction to heparin for which Argatroban is approved. As medical education is key to growing Argatroban sales in HIT, we believe this initiative, along with increased direct selling efforts, are likely to have a positive impact on Argatroban sales in 2003." o Cash, cash equivalents and investments at September 30, 2002 were approximately $74.3 million, compared with $95.4 million at December 31, 2001. STRIDE TRIAL UPDATE During the third quarter, the ICOS/Texas Biotechnology L.P. announced positive top-line results from the STRIDE (Sitaxsentan To Relieve ImpaireD Exercise in Pulmonary Hypertension) Phase IIb/III placebo-controlled trial. "As measured by traditional clinical measures, including six-minute walk and change in NYHA class, we are pleased to report that the 100 mg dose of sitaxentan showed maximum benefit with improved safety as compared to the 300 mg dose," stated Dr. Given. "Several regulatory and clinical experts in pulmonary hypertension have now reviewed the data and are confident that the risk/benefit of sitaxsentan at the 100 mg dose level meets, and in certain areas may exceed, what has been shown with other agents." Texas Biotechnology expects to meet with the FDA over the next two to three months to discuss next steps for sitaxsentan. YEAR 2002 FINANCIAL OUTLOOK Guidance for 2002 includes results of Revotar and the ICOS-TBC partnership. o Net sales of Argatroban Unchanged- approximately $22 to $26 million o Revenue Unchanged- approximately $8.5 to $11 million o Investment income Unchanged- approximately $1.8 to $2.5 million o Expenses Reduced from $45 to $48 million to $41 to $44 million The Company expects to provide 2003 guidance in early 2003. Texas Biotechnology management will host a conference call on Thursday, November 7, 2002, at 8:00 AM Eastern. To participate in the call, dial (651) 224-7472 and ask for the Texas Biotechnology conference call. A replay of the conference call will also be available beginning at 10:45 AM Eastern on Thursday, November 7, 2002 and will end on Friday, November 8, 2002 at 11:59 PM Eastern. To access the replay dial (320) 365-3844. The access code for the replay is 657071. In addition, the conference call will be available live on the Company's web site (www.tbc.com). A replay of the conference call will also be available on the Company's web site. ABOUT SITAXSENTAN Sitaxsentan is a small molecule that blocks the action of endothelin, a potent mediator of blood vessel constriction and growth of smooth muscle in vascular walls. Endothelin receptor antagonists may prove to be effective in the treatment of a variety of diseases where the regulation of vascular constriction is important. In the STRIDE trial, the most frequent adverse events that occurred in patients receiving sitaxsentan, and were more common than in placebo-treated patients, were headache, peripheral edema, nausea, nasal congestion and prolonged clotting time. Incidences of liver abnormalities, which reversed in all cases, were 2% for the placebo group, 0% for the sitaxsentan 100 mg group and 10% for the sitaxsentan 300 mg group. When data from the STRIDE trial are combined with data from the extension trial (patients were exposed to sitaxsentan for a maximum of 55 weeks in both studies combined), the incidences of liver abnormalities, which were all reversible, were 5% for the sitaxsentan 100 mg dose group and 21% for the sitaxsentan 300 mg dose group. ABOUT TEXAS BIOTECHNOLOGY Texas Biotechnology, a biopharmaceutical company focused on the discovery, development and commercialization of novel drugs, is recognized for its expertise in small molecule drug development and vascular biology. Argatroban, its first FDA-approved product, is being marketed by GlaxoSmithKline for heparin-induced thrombocytopenia. Additional studies are seeking to expand use of Argatroban in other therapeutic settings. Texas Biotechnology has several other products in clinical development for cardiovascular and anti-inflammatory diseases. This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements are subject to certain risks, trends and uncertainties that could cause actual results to differ materially from those projected. Among those risks, trends and uncertainties are timing and cost of our clinical trials, attainment of research and clinical goals and milestones of product candidates, attainment of required governmental approvals, sales levels of our products and availability of financing and revenues sufficient to fund development of product candidates and operations. In particular, careful consideration should be given to cautionary statements made in the various reports Texas Biotechnology has filed with the Securities and Exchange Commission. The Company undertakes no duty to update or revise these forward-looking statements. TEXAS BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES SELECTED FINANCIAL DATA AMOUNTS IN THOUSANDS (EXCEPT PER SHARE DATA) UNAUDITED CONSOLIDATED SUMMARY OF OPERATIONS
THREE MONTHS ENDED NINE MONTHS ENDED SEPT. 30, SEPT. 30, ----------------------------- ---------------------------- 2002 2001 2002 2001 ---------- ---------- ---------- ----------- Revenues.................................... $ 2,405 $ 1,704 $ 7,624 $ 6,436 Operating expenses: Research and development................ 5,286 3,776 16,107 11,835 Equity in loss of ICOS-TBC, L.P......... 1,838 2,156 6,305 5,926 General and administrative.............. 2,041 1,479 6,803 4,713 ---------- ---------- ---------- ---------- Total expenses.............................. 9,165 7,411 29,215 22,474 ---------- ---------- ---------- ---------- Operating loss.............................. (6,760) (5,707) (21,591) (16,038) Investment income, net...................... 556 1,152 1,936 4,250 Minority interest in loss of Revotar........ 364 266 844 451 ---------- ---------- ---------- ---------- Net loss.................................... $ (5,840) $ (4,289) $ (18,811) $ (11,337) ========== ========== ========== ========== Net loss per common share: (basic and diluted).................... $ (0.13) $ (0.10) $ (0.43) $ (0.26) Weighted average common shares outstanding: (basic and diluted).................... 43,799 43,608 43,720 43,659
CONDENSED CONSOLIDATED BALANCE SHEETS UNAUDITED
SEPT. 30, DEC. 31, 2002 2001 ---------- ---------- Cash, cash equivalents and investments...... $ 74,316 $ 95,427 Other assets................................ 9,238 8,935 ---------- ---------- Total assets................................ 83,554 104,362 ========== ========== Total liabilities........................... 7,740 9,622 Deferred revenue and credits................ 8,811 9,290 Minority interest in Revotar................ 369 1,213 Stockholders' equity........................ 66,634 84,237 ---------- ---------- $ 83,554 $ 104,362 ========== ==========
[SIGNATURE PAGE FOLLOWS] SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized. Date November 6, 2002 TEXAS BIOTECHNOLOGY CORPORATION /s/ Stephen L. Mueller ------------------------------------------ Stephen L. Mueller Vice-President, Finance and Administration Secretary and Treasurer