-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, SJBZMErxR/0PAa6gI5fP+vYzX9MF6/vAwc//mU2nn3vPkfhOwgT73ycJ+dSbeskM uj6+p0MTlNDHd4CnELDexg== 0000950129-03-002557.txt : 20030508 0000950129-03-002557.hdr.sgml : 20030508 20030508164052 ACCESSION NUMBER: 0000950129-03-002557 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20030508 ITEM INFORMATION: Financial statements and exhibits ITEM INFORMATION: Regulation FD Disclosure FILED AS OF DATE: 20030508 FILER: COMPANY DATA: COMPANY CONFORMED NAME: TEXAS BIOTECHNOLOGY CORP /DE/ CENTRAL INDEX KEY: 0000887023 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 133532643 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-20117 FILM NUMBER: 03688438 BUSINESS ADDRESS: STREET 1: 7000 FANNIN STREET 2: 20TH FLR CITY: HOUSTON STATE: TX ZIP: 77030 BUSINESS PHONE: 7137968822 8-K 1 h05674e8vk.txt TEXAS BIOTECHNOLOGY CORPORATION 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): May 8, 2003 TEXAS BIOTECHNOLOGY CORPORATION (Exact name of registrant as specified in its charter)
DELAWARE 0-20117 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 7. FINANCIAL STATEMENTS, PRO FORMA FINANCIAL INFORMATION AND EXHIBITS (a) Financial Statements of Business Acquired None. (b) Pro Forma Financial Information. None. (c) Exhibits. 99.1 Press release issued by Texas Biotechnology Corporation dated May 8, 2003 ITEM 9. REGULATION FD DISCLOSURE In accordance with Securities and Exchange Commission Release Nos. 33-8216 and 34-47583, the following information, which is intended to be furnished under Item 12, "Results of Operations and Financial Condition," is instead being furnished under Item 9, "Regulation FD Disclosure." The information in this Current Report is being furnished and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934 (the "Exchange Act"), or otherwise subject to the liabilities of that Section. The information in this Current Report shall not be incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing. On May 8, 2003, Texas Biotechnology Corporation ("TBC") issued a press release regarding TBC's financial results for its first fiscal quarter ended March 31, 2003. The full text of TBC's press release is furnished herewith as Exhibit 99.1. [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 May 8, 2003 TEXAS BIOTECHNOLOGY CORPORATION /s/ Stephen L. Mueller ------------------------------------------ Stephen L. Mueller Vice-President, Finance and Administration Secretary and Treasurer EXHIBIT INDEX Exhibit No. Description - ----------- ----------- 99.1 Press release issued by Texas Biotechnology Corporation dated May 8, 2003 EX-99.1 3 h05674exv99w1.txt PRESS RELEASE EXHIBIT 99.1 TEXAS BIOTECHNOLOGY REPORTS FIRST QUARTER 2003 RESULTS CONFERENCE CALL SCHEDULED FOR TODAY HOUSTON, TX - May 8, 2003 - Texas Biotechnology Corporation (NASDAQ: TXBI) today announced financial results for the first quarter 2003. Results for the first quarter were in line with prior guidance and sales of Argatroban continued to increase. FIRST QUARTER 2003 FINANCIAL HIGHLIGHTS o For the first quarter of 2003, the Company reported a net loss of approximately $5.0 million, or $0.11 per basic and diluted share, compared to a net loss of $6.8 million, or $0.15 per basic and diluted share, for the same period last year. o The decreased loss in the current quarter compared to last year is primarily due to decreased 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 which completed in 2002. The Company plans to initiate a final pivotal study for sitaxsentan during the second quarter of 2003. o The quarter loss includes a charge of approximately $556,000 in conjunction with a restructuring plan implemented in January 2003, which will reduce future operating expenses. o Revenue in the first quarter of 2003 was $3.2 million compared to $2.6 million in the comparable quarter of 2002. The increased revenue reflects in part increased sales of Argatroban by GlaxoSmithKline. In the first quarter of 2003, the Company's royalties earned on net sales of Argatroban increased to $1,148,000 compared to approximately $965,000 in the first quarter of 2002. o Cash, cash equivalents and investments at March 31, 2003 were approximately $59.8 million, compared with $68.0 million at December 31, 2002. "We are pleased with our progress in the first quarter, particularly in our sitaxsentan development program," said Bruce D. Given, M.D., President and CEO of Texas Biotechnology. "We have set extremely aggressive goals for this year and we appear to be on track to achieve them." SITAXSENTAN DEVELOPMENT HIGHLIGHTS o TBC re-acquired all remaining rights from ICOS to sitaxsentan, giving Texas Biotechnology complete development and marketing rights worldwide. o The company announced that data from STRIDE will be presented at the American Thoracic Society Annual Meeting in May. o The company is on track to begin a final Phase III trial in patients with pulmonary arterial hypertension in the second quarter of 2003. ARGATROBAN DEVELOPMENT HIGHLIGHTS o Argatroban was assigned a Medicare billing code for use in hospital outpatient settings. The new code will provide Medicare reimbursement for Argatroban use in patients with or at risk for heparin-induced thrombocytopenia, undergoing hospital outpatient percutaneous coronary interventions (PCI). Argatroban is already reimbursed for most inpatient PCI procedures. o Investigators presented results of ARGIS-I Phase II trial at the International Stroke Conference that supported the tolerability of Argatroban, showing no statistically significant differences between Argatroban and placebo in symptomatic or asymptomatic intracranial hemorrhage, which is a major concern in stroke patients receiving anticoagulants. o Investigators presented at the American College of Cardiology annual meeting the first results of a two part feasibility study of Argatroban in combination with glycoprotein IIb/IIIa inhibitors during percutaneous coronary interventions (PCI) in non-HIT patients. In the study, 100% of patients achieved angiographic success and adequate anticoagulation, while only 2% had an incident of major bleeding. o Texas Biotechnology also received a formal request from FDA that a study be conducted with Argatroban in pediatric patients. Successful completion of this study should result in an additional 6 months of market exclusivity. TEXAS BIOTECHNOLOGY WILL HOST A CONFERENCE CALL TODAY AT 4:30PM EASTERN TIME. TO PARTICIPATE IN THE CALL, DIAL (612) 332-0632; ACCESS CODE TEXAS BIOTECHNOLOGY. A REPLAY OF THE CONFERENCE CALL WILL ALSO BE AVAILABLE UNTIL MONDAY, MAY 12 AT 11:59PM EASTERN TIME. TO ACCESS THE REPLAY, DIAL (320) 365-3844 AND USE ACCESS CODE 683925. 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 TEXAS BIOTECHNOLOGY CORPORATION Texas Biotechnology Corporation, 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. Texas Biotechnology is in Phase III development of the endothelin antagonist, sitaxsentan, for pulmonary arterial hypertension. Its majority owned affiliate, Revotar Biopharmaceuticals AG, is in Phase II development with the selectin antagonist bimosiamose in asthma, psoriasis and atopic dermatitis. Texas Biotechnology has several other research and development programs ongoing for a range of cardiovascular and inflammatory diseases. To learn more about Texas Biotechnology please visit our web site: www.tbc.com. 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 government 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 of revise these forward-looking statements. # # # TEXAS BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES UNAUDITED SELECTED FINANCIAL DATA AMOUNTS IN THOUSANDS (EXCEPT PER SHARE DATA) CONSOLIDATED SUMMARY OF OPERATIONS
Three Months Ended March 31, ----------------------------------- 2003 2002 --------------- --------------- Revenues $ 3,216 $ 2,593 Operating expenses: Research and development 4,219 5,190 Equity in loss of affiliate 2,386 2,510 General and administrative 2,154 2,667 --------------- --------------- Total expenses 8,759 10,367 --------------- --------------- Operating loss (5,543) (7,774) Investment income, net 373 767 Minority interest in Revotar 190 257 --------------- --------------- Net loss $ (4,980) $ (6,750) =============== =============== Net loss per common share: (basic and diluted) $ (0.11) $ (0.15) Weighted average common shares outstanding: (basic and diluted) 43,945 43,613
CONDENSED CONSOLIDATED BALANCE SHEETS
March 31, Dec. 31, 2003 2002 ------------------- ------------------ Cash, cash equivalents and investments $ 59,848 $ 68,005 Other assets 10,943 9,787 ------------------- ------------------ Total assets 70,791 77,792 =================== ================== Total liabilities 5,522 7,388 Deferred income 5,351 5,718 Minority interest in affiliate 2,418 2,608 Stockholders' equity 57,500 62,078 ------------------- ------------------ $ 70,791 $ 77,792 =================== ==================
Note: Certain reclassifications have been made to prior period information to conform with the March 31, 2003 presentation with no effect on net loss or stockholders' equity previously reported. -----END PRIVACY-ENHANCED MESSAGE-----