-----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, OBcgT2Hcoh/5paY2RVRmUC5KDcB1H+ZObxyJ5gXtJwQCF0Ef105GFi5wmKHIKFPC KjmNmfIVClah/zJvFap/yQ== 0000912057-01-007026.txt : 20010307 0000912057-01-007026.hdr.sgml : 20010307 ACCESSION NUMBER: 0000912057-01-007026 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20010221 ITEM INFORMATION: ITEM INFORMATION: FILED AS OF DATE: 20010301 FILER: COMPANY DATA: COMPANY CONFORMED NAME: BIO TECHNOLOGY GENERAL CORP CENTRAL INDEX KEY: 0000722104 STANDARD INDUSTRIAL CLASSIFICATION: MEDICINAL CHEMICALS & BOTANICAL PRODUCTS [2833] IRS NUMBER: 133033811 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: SEC FILE NUMBER: 000-15313 FILM NUMBER: 1558745 BUSINESS ADDRESS: STREET 1: 70 WOOD AVE S CITY: ISELIN STATE: NJ ZIP: 08830 BUSINESS PHONE: 9086328800 MAIL ADDRESS: STREET 1: 70 WOOD AVENUE SOUTH CITY: ISELIN STATE: NJ ZIP: 08830 8-K 1 a2040377z8-k.txt 8-K SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): February 21, 2001 Bio-Technology General Corp. (Exact name of issuer as specified in its charter) Delaware 0-15313 13-3033811 (State or Other Jurisdiction (Commission File Number) (IRS Employer of Incorporation) Identification No.) 70 Wood Avenue Iselin, N.J. 08830 (Address of Principal Executive Offices) (Zip Code) Registrant's telephone number, including area code: (732) 632-8800 None. (Former address, if changed since last report) ITEM 5. OTHER EVENTS. On February 21, 2001 Bio-Technology General Corp. (the "Company") entered into a definitive agreement to acquire Myelos Corporation, a privately held biopharmaceutical company. On February 22, 2001 the Company announced the definitive agreement to acquire Myelos and its results of operations for the quarter and the year ended December 31, 2000. Copies of the press releases announcing the agreement to acquire Myelos Corporation and the Company's results of operations are filed as an exhibit to this report and are hereby incorporated by reference. ITEM 7. FINANCIAL STATEMENTS AND EXHIBITS. (a) Financial Statements None. (b) Pro Forma Financial Information None. (c) Exhibits 99.1. Press release of the Company issued on February 22, 2001 relating to the Company's entering into a definitive agreement to acquire Myelos Corporation. 99.2 Press release of the Company issued on February 22, 2001 relating to the Company's fourth quarter and year end earnings. 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 hereunto duly authorized. BIO-TECHNOLOGY GENERAL CORP. (Registrant) By: /s/ ROBERT SHAW ------------------------------------------ Robert Shaw Senior Vice President-General Counsel Dated: February 28, 2001 EX-99.1 2 a2040377zex-99_1.txt EX-99.1 EXHIBIT 99.1 FOR IMMEDIATE RELEASE INVESTOR RELATIONS CONTACT Don Weinberger Leah Berkovits Wolfe Axelrod Weinberger Associates Bio-Technology General Corp. 212-370-4500 732-632-8800 - -------------------------------------------------------------------------------- BIO-TECHNOLOGY GENERAL TO ACQUIRE MYELOS CORPORATION -- PROMISING NEW DRUG FOR DIABETIC NEUROPATHIC PAIN IN CLINICAL DEVELOPMENT -- Iselin, New Jersey, February 22, 2001 -- Bio-Technology General Corp. (NASDAQ:BTGC) today announced it has entered into a definitive agreement to acquire Myelos Corporation, a privately-held biopharmaceutical company focused on the development of novel therapeutics to treat diseases of the nervous system. Myelos' technology platform enables the isolation of stimulatory peptides (short chains of amino acids) derived from growth factors. This has led to the development of Prosaptide-TM-, a promising new compound for the treatment of neuropathic pain associated with diabetic peripheral neuropathy. A Phase II human clinical trial in Type I and Type II diabetes mellitus already completed by Myelos demonstrated that Prosaptide effectively decreases pain associated with diabetic peripheral neuropathy without deleterious side effects. Diabetic peripheral neuropathy is a serious and debilitating complication of Type I and Type II diabetes mellitus that usually affects the feet and legs. Symptoms include pain, numbness, and tingling. An estimated 8.8 million diabetics have peripheral neuropathy, while approximately 2.6 million of them have been diagnosed and are symptomatic. Due to the fact that available treatment options for pain associated with diabetic peripheral neuropathy are often unsatisfactory and frequently accompanied by unacceptable side effects, only approximately one-third of patients who are diagnosed and symptomatic are currently treated. BTG believes that the annual worldwide market potential for Prosaptide in the treatment of diabetic neuropathic pain may be in excess of $800 million. Moreover, in a series of animal studies, Prosaptide was shown to not only alleviate peripheral neuropathic pain but also to reverse the underlying neuropathy, thereby inducing neuronal regeneration and preventing neuronal death. The data from these studies strongly suggest that if these findings are replicated in human clinical trials, there may well be additional potential for Prosaptide in the treatment of diabetic peripheral neuropathy, over and above its demonstrated ability to decrease neuropathic pain. No approved drugs are available to prevent or reverse the neuropathy itself. Under the terms of the agreement, BTG will pay Myelos stockholders $35 million in a combination of cash and stock ($14 million in cash and $21 million in equity (approximately 2.3 million shares of common stock)). As a result of the transaction, shares outstanding will increase by approximately 4%. Despite this increase in shares, BTG should be able to achieve EPS growth in 2001 over 2000. The shares being issued to Myelos are unregistered. Although BTG has agreed to register the shares under the Securities Act, each principal stockholder of Myelos has agreed to limit their sale of BTG shares in any three-month period. This lockup agreement expires after two years. An additional future payment of $30 million in a combination of cash and stock is contingent upon BTG being in position to file a New Drug Application for FDA approval of Prosaptide in the treatment of neuropathic pain. A final payment of 15% of worldwide net sales in the third year of commercialization will be made in a combination of cash and stock. The consummation of the acquisition is subject to customary closing conditions including approval by the stockholders of Myelos. The Company expects to close the acquisition during March 2001. Sim Fass, Chairman and CEO of Bio-Technology General Corp., stated: "The acquisition of Myelos enhances our prospects for future growth by the addition of an exciting proprietary product with large market potential to our pipeline of drugs in development. Based on the data from Myelos' pre-clinical and clinical program, we believe that Prosaptide is a drug that can make a much-needed contribution to the treatment of diabetic peripheral neuropathy, and that it may one day prove to be effective in the treatment of peripheral neuropathy associated with other medical conditions. In addition, beyond Prosaptide's potential, the Myelos technology platform could lead to the development of new peptides to treat other diseases of the nervous system." Bio-Technology General Corp., a leading biopharmaceutical company, develops, manufactures and markets genetically engineered and other products for human health care. BTG's products are marketed worldwide. Products sold in the United States are Oxandrin-Registered Trademark- (oxandrolone, USP), marketed by BTG and by the Ross Products Division of Abbott Laboratories under a co-marketing agreement, Delatestryl-Registered Trademark- (testosterone enanthate), marketed by BTG, Mircette-TM- (oral contraceptive), marketed by Organon, Inc., and BioLon-TM- (sodium hyaluronate), marketed by Akorn, Inc. Products sold internationally are Bio-Tropin-TM-(recombinant human growth hormone), BioLon-TM- (sodium hyaluronate), Bio-Hep-B-TM- (hepatitis B vaccine), and Silkis-Registered Trademark- (vitamin D derivative). BTG's news releases and other information are available on the Company's website at www.btgc.com. BTG will be offering a live webcast of a discussion by BTG management of the earnings and the Company's business on Thursday, February 22, 2001, at 10:30 a.m. (EST). The webcast can be accessed by going to BTG's website at www.btgc.com. It will be archived and available after the discussion via our website through March 1, 2001. A replay will also be available for one week by calling 888-203-1112 (US) or 719-457-0820 (from overseas), passcode 771458. #### STATEMENTS IN THIS NEWS RELEASE CONCERNING THE COMPANY'S BUSINESS OUTLOOK OR FUTURE ECONOMIC PERFORMANCE; ANTICIPATED PROFITABILITY, REVENUES, EXPENSES OR OTHER FINANCIAL ITEMS; AND STATEMENTS CONCERNING ASSUMPTIONS MADE OR EXPECTATIONS AS TO ANY FUTURE EVENTS, CONDITIONS, PERFORMANCE OR OTHER MATTERS, ARE "FORWARD-LOOKING STATEMENTS" AS THAT TERM IS DEFINED UNDER THE FEDERAL SECURITIES LAWS. FORWARD-LOOKING STATEMENTS ARE SUBJECT TO RISKS, UNCERTAINTIES AND OTHER FACTORS THAT COULD CAUSE ACTUAL RESULTS TO DIFFER MATERIALLY FROM THOSE STATED IN SUCH STATEMENTS. SUCH RISKS, UNCERTAINTIES AND FACTORS INCLUDE, BUT ARE NOT LIMITED TO, CHANGES AND DELAYS IN PRODUCT DEVELOPMENT PLANS AND SCHEDULES, CUSTOMER ACCEPTANCE OF NEW PRODUCTS, CHANGES IN PRICING OR OTHER ACTIONS BY COMPETITORS, PATENTS OWNED BY THE COMPANY AND ITS COMPETITORS, AND GENERAL ECONOMIC CONDITIONS, AS WELL AS OTHER RISKS DETAILED IN THE COMPANY'S FILINGS WITH THE SECURITIES AND EXCHANGE COMMISSION. EX-99.2 3 a2040377zex-99_2.txt EX-99.2 EXHIBIT 99.2 FOR IMMEDIATE RELEASE INVESTOR RELATIONS CONTACT Don Weinberger Leah Berkovits Wolfe Axelrod Weinberger Associates Bio-Technology General Corp. 212-370-4500 732-632-8800 - -------------------------------------------------------------------------------- BIO-TECHNOLOGY GENERAL CORP. REPORTS FOURTH QUARTER AND FISCAL YEAR 2000 EARNINGS RESULTS -- DEMAND FOR OXANDRIN GROWING THROUGH ABBOTT CO-MARKETING ACTIVITY -- Iselin, NJ, February 22, 2001 -- Bio-Technology General Corp. (NASDAQ:BTGC) today announced its earnings and financial results for the fourth quarter and full year 2000. Net income for the fourth quarter of 2000 was $4.8 million, or $0.09 per share, compared to a net loss of $2.0 million, or $0.04 per share, in the fourth quarter of 1999. Total revenues for the fourth quarter of 2000 grew 49% to $21.9 million from $14.7 million in the comparable quarter of 1999. Revenues from product sales in the fourth quarter of 2000 increased 43% to $17.4 million, compared to $12.2 million in the fourth quarter of 1999. Year-to-year fourth quarter sales of Oxandrin-Registered Trademark- grew 88%, reflecting the resumption, in June 2000 (following a period of inventory reduction), of purchases of Oxandrin by Gentiva, BTG's distributor, matching Gentiva's sales to pharmacies and distribution outlets. Year-to-year fourth quarter sales of human growth hormone grew 176% due to seasonal variations in orders from BTG's licensees. Sales of BioLon-TM- and Delatestryl-Registered Trademark- in the fourth quarter of 2000, declined by 25% and 69%, respectively, compared to the fourth quarter of 1999. Gentiva reduced its purchases of Delatestryl in anticipation of the reintroduction of a competitor's product. BioLon sales decreased as BTG halted shipments of the product to the United States pending approval of a supplemental application relating to an upgrade in BTG's manufacturing process to conform it to a higher standard of quality implemented by BTG. This resulted in a back order of the product in the United States at the end of 2000. Expenses decreased 12% from $18.8 million in the fourth quarter of 1999 to $16.7 million in the fourth quarter of 2000. This decrease was primarily due to the write-off in 1999 of a previously capitalized expense. Income for the year ended December 31, 2000, before cumulative effect of change in accounting principle related to contract revenues recognized in prior periods, was $15.9 million, or $0.28 per share in 2000, compared to $13.9 million, or $0.26 per share in 1999. Total revenues were $84.9 million in 2000, compared to $85.3 million in 1999. Revenues from product sales were $62.1 million, compared to $62.3 million in 1999. Sales of Oxandrin and human growth hormone in 2000 increased 29% and 14%, respectively, over 1999. The increase in Oxandrin sales in 2000 was partly due to an inventory reduction process completed in the first half of 2000. These sales revenues were largely offset by a reduction in sales of Delatestryl and BioLon, for the reasons noted above. Expenses decreased 3% from $66.6 million in 1999 to $64.6 million in 2000. Expense decreases of 10% and 12% were recorded in general and administrative and cost of product sales, respectively. General and administrative expense was lower largely because a write-off of a previously capitalized expense is reflected in the 1999 numbers. Cost of product sales was lower because of a reduction in sales of products with high cost of goods, relative to total sales. Marketing and sales and research and development expense each increased by 6%. ABBOTT LABORATORIES - OXANDRIN CO-MARKETING RELATIONSHIP Commenting on the results, Sim Fass, Chairman and CEO of BTG, stated: "Prescriptions for Oxandrin grew 3% in the fourth quarter of 2000 compared to the third quarter of 2000. However, we are pleased to report that 2001 has begun on a highly promising note, with demand for Oxandrin growing significantly. In late 2000, the Ross Products Division of Abbott Laboratories (NYSE:ABT) launched Oxandrin, through its nutritional support products specialty sales force, under a co-marketing agreement with BTG. In January 2001, prescriptions for Oxandrin increased by 36% compared to December 2000, and by 48% compared to January 2000. We are excited by this indication that Oxandrin is now reaching many more individuals with involuntary weight loss and we believe that if the broader market penetration we are now seeing is sustained, Oxandrin will achieve even greater commercial success." ANTICIPATED DEVELOPMENTS IN 2001 As also announced today, BTG has entered into a definitive agreement to acquire Myelos Corporation, a privately-held biopharmaceutical company focused on the development of novel therapeutics to treat diseases of the nervous system. The consummation of the acquisition is anticipated to occur during March 2001. The Myelos technology platform has led to the development of Prosaptide-TM-, a promising new compound for the treatment of neuropathic pain associated with diabetic peripheral neuropathy. BTG plans to initiate a Phase II(b) clinical trial of Prosaptide in 2001 to supplement the findings of an earlier Phase II clinical trial of the product completed by Myelos. OTHER ANTICIPATED DEVELOPMENTS IN 2001: - - Increase in Oxandrin-Registered Trademark-sales via the co-marketing relationship with Abbott - - Launch of BioHy-TM-(Europe), a royalty-bearing osteoarthritis product, by DePuy Orthopaedics Inc., a Johnson & Johnson company - - Additional launches of Silkis-Registered Trademark- (Europe, Latin America), a royalty-bearing psoriasis product, by Galderma - - Approval and launch of recombinant human insulin (Poland/Eastern Europe), by Ibatech - - Fibrimage-TM- - completion by Draxis of Phase III clinical study in the detection of deep vein thrombosis - - Puricase-TM- - initiation of Phase I clinical study in gout - - Anti-leukemia agent - completion of pre-clinical program in preparation for Phase I clinical study Bio-Technology General Corp., a leading biopharmaceutical company, develops, manufactures and markets genetically engineered and other products for human health care. BTG's products are marketed worldwide. Products sold in the United States are Oxandrin-Registered Trademark- (oxandrolone, USP), marketed by BTG and by the Ross Products Division of Abbott Laboratories under a co-marketing agreement, Delatestryl-Registered Trademark- (testosterone enanthate), marketed by BTG, Mircette-TM- (oral contraceptive), marketed by Organon, Inc., and BioLon-TM- (sodium hyaluronate), marketed by Akorn, Inc. Products sold internationally are Bio-Tropin-TM-(recombinant human growth hormone), BioLon-TM- (sodium hyaluronate), Bio-Hep-B-TM- (hepatitis B vaccine), and Silkis-Registered Trademark- (vitamin D derivative). BTG's news releases and other information are available on the Company's website at www.btgc.com. BTG will be offering a live webcast of a discussion by BTG management of the earnings and the Company's business on Thursday, February 22, 2001, at 10:30 a.m. (EST). The webcast can be accessed by going to BTG's website at www.btgc.com. It will be archived and available after the discussion via our website through March 1, 2001. A replay will also be available for one week by calling 888-203-1112 (US) or 719-457-0820 (from overseas), passcode 771458. ALL EARNINGS-PER-SHARE AMOUNTS IN THE TEXT OF THIS NEWS RELEASE REPRESENT DILUTED EARNINGS PER SHARE AS DEFINED UNDER STATEMENT OF FINANCIAL ACCOUNTING STANDARDS NO. 128, "EARNINGS PER SHARE." ##### STATEMENTS IN THIS NEWS RELEASE CONCERNING THE COMPANY'S BUSINESS OUTLOOK OR FUTURE ECONOMIC PERFORMANCE; ANTICIPATED PROFITABILITY, REVENUES, EXPENSES OR OTHER FINANCIAL ITEMS; AND STATEMENTS CONCERNING ASSUMPTIONS MADE OR EXPECTATIONS AS TO ANY FUTURE EVENTS, CONDITIONS PERFORMANCE OR OTHER MATTERS, ARE "FORWARD-LOOKING STATEMENTS" AS THAT TERM IS DEFINED UNDER THE FEDERAL SECURITIES LAWS. FORWARD-LOOKING STATEMENTS ARE SUBJECT TO RISKS, UNCERTAINTIES AND OTHER FACTORS THAT COULD CAUSE ACTUAL RESULTS TO DIFFER MATERIALLY FROM THOSE STATED IN SUCH STATEMENTS. SUCH RISKS, UNCERTAINTIES AND FACTORS INCLUDE, BUT ARE NOT LIMITED TO, CHANGES AND DELAYS IN PRODUCT DEVELOPMENT PLANS AND SCHEDULES, CUSTOMER ACCEPTANCE OF NEW PRODUCTS, CHANGES IN PRICING OR OTHER ACTIONS BY COMPETITORS, PATENTS OWNED BY THE COMPANY AND ITS COMPETITORS, AND GENERAL ECONOMIC CONDITIONS, AS WELL AS OTHER RISKS DETAILED IN THE COMPANY'S FILINGS WITH THE SECURITIES AND EXCHANGE COMMISSION. TABLE TO FOLLOW BIO-TECHNOLOGY GENERAL CORP. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF OPERATIONS (IN THOUSANDS EXCEPT PER SHARE DATA)
Three Months Ended December 31 ------------------ 2000* 1999 ----------- ------------ Revenues: Product sales $ 17,354 $ 12,168 Contract fees 463 39 Royalties 981 644 Other 762 414 Interest 2,321 1,465 ----------- ----------- Total revenues 21,881 14,730 ----------- ----------- Expenses: Research and development 5,892 5,731 Cost of product sales 2,790 2,237 General and administrative 2,526 5,213 Marketing and sales 4,678 4,817 Other 764 834 ----------- ----------- Total expenses 16,650 18,832 ----------- ----------- Income (loss) before income taxes 5,231 (4,102) Income tax expense (benefit) 438 (2,068) ----------- ----------- Net income (loss) $ 4,793 $ (2,034) =========== =========== Earnings (loss) per common share: Basic $ 0.09 $ (0.04) =========== =========== Diluted $ 0.09 $ (0.04) =========== =========== Weighted average number of shares outstanding: Basic 54,729 52,891 =========== =========== Diluted 55,779 55,690 =========== ===========
*BTG adopted the Securities and Exchange Commission's Staff Accounting Bulletin No. 101 on Revenue Recognition in the fourth quarter of 2000, effective January 1, 2000, and recorded a cumulative effect of change in accounting principle related to contract revenues recognized in prior periods. The related revenue is being recognized over the terms of the agreements. CONSOLIDATED STATEMENTS OF OPERATIONS (IN THOUSANDS, EXCEPT PER SHARE DATA)
Year Ended December 31, -------------------------- 2000* 1999 ----- ---- Revenues: Product sales $ 62,149 $ 62,332 Contract fees 10,229 14,848 Royalties 3,139 1,761 Other 1,931 1,746 Interest 7,496 4,633 ---------- ---------- Total revenues 84,944 85,320 ---------- ---------- Expenses: Research and development 22,360 21,120 Cost of product sales 9,887 11,224 General and administrative 12,685 14,035 Marketing and sales 17,614 16,583 Other 2,028 3,599 ---------- ---------- Total expenses 64,574 66,561 ---------- ---------- Income before income taxes 20,370 18,759 Income taxes 4,475 4,897 ---------- ---------- Income before cumulative effect of change in accounting principle 15,895 13,862 Cumulative effect of change in accounting principle 8,178 -- ---------- ---------- Net income $ 7,717 $ 13,862 ========== ========== Earnings per common share: Basic: Income before cumulative effect of change in accounting principle $ 0.29 $ 0.26 ========== ========== Cumulative effect of change in accounting principle $ 0.15 $ 0.00 ========== ========== Net income $ 0.14 $ 0.26 ========== ========== Diluted: Income before cumulative effect of change in accounting principle $ 0.28 $ 0.26 ========== ========== Cumulative effect of change in accounting principle $ 0.14 $ 0.00 ========== ========== Net income $ 0.14 $ 0.26 ========== ========== Weighted average number of common and common equivalent shares: Basic 54,320 52,348 ========== ========== Diluted 56,885 54,191 ========== ==========
*BTG adopted the Securities and Exchange Commission's Staff Accounting Bulletin No. 101 on Revenue Recognition in the fourth quarter of 2000, effective January 1, 2000, and recorded a cumulative effect of change in accounting principle related to contract revenues recognized in prior periods. The related revenue is being recognized over the terms of the agreements. -----END PRIVACY-ENHANCED MESSAGE-----