Bio-Technology General Corp. Reports Fourth Quarter and Fiscal Year 2000 Earnings Results; Demand for Oxandrin Growing Through Abbott Co-Marketing Activity.Business Editors ISELIN, N.J.--(BUSINESS WIRE)--Feb. 22, 2001 Bio-Technology General Corp. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :BTGC BTGC Bio-Technology General (stock symbol) BTGC Bukit Tinggi Golf Club (Malaysia) ) 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(R) grew 88%, reflecting the resumption RESUMPTION. To reassume; to promise again; as, the resumption of payment of specie by the banks is general. It also signifies to take things back; as the government has resumed the possession of all the lands which have not been paid for according to the requisitions of the law, and the , 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 human growth hormone (HGH): see growth hormone. grew 176% due to seasonal variations in orders from BTG's licensees. Sales of BioLon(TM) and Delatestryl(R) 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 Noun 1. reintroduction - an act of renewed introduction intro, introduction, presentation - formally making a person known to another or to the public of a competitor's product. BioLon sales decreased as BTG BTG BIT (Built-In Test) Target Generator BTG Bridging the Gap BTG British Technology Group BtG Betreuungsgesetz (Germany) BTG Biomass Technology Group BV BTG Begbies Traynor Group halted shipments of the product to the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. pending approval of a supplemental application A Supplemental Application Is A Type Of Application Used By universities and Colleges From the State University Of New York(SUNY). The Supplemental Application is A common 2nd part of The 1st State-wide Application. relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc 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 Abbott Laboratories (NYSE: ABT) is a diversified pharmaceuticals and health care company. It has over 65,000 employees and operates in 130 countries. The corporate headquarters are in Abbott Park, Illinois, a neighborhood of North Chicago, Illinois. - Oxandrin Co-marketing Relationship Commenting on the results, Sim (1) (Society for Information Management, Chicago, IL, www.simnet.org) Founded in 1968 as the Society for MIS, it is a membership organization made up of corporate and division heads of IT organizations. Fass, Chairman and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. 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 NYSE See: New York Stock Exchange :ABT ABT About ABT Abteilung (German: Department) ABT Abbott Laboratories (stock symbol) ABT American Ballet Theatre ABT Associação Brasileira de Telemarketing ABT Abort ABT Availability Based Tariff ) launched Oxandrin, through its nutritional support nutritional support, n the supply of foods and liquids necessary to advance healing and support health. 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 Noun 1. market penetration - the extent to which a product is recognized and bought by customers in a particular market penetration - the act of entering into or through something; "the penetration of upper management by women" 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 therapeutics Treatment and care to combat disease or alleviate pain or injury. Its tools include drugs, surgery, radiation therapy, mechanical devices, diet, and psychiatry. to treat diseases of the nervous system. The consummation CONSUMMATION. The completion of a thing; as the consummation of marriage; (q.v.) the consummation of a contract, and the like. 2. A contract is said to be consummated, when everything to be done in relation to it, has been accomplished. 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 neuropathic /neu·ro·path·ic/ (-path´ik) pertaining to or characterized by neuropathy. neuropathic pertaining to disease of the nervous system. pain associated with diabetic peripheral neuropathy Diabetic peripheral neuropathy A condition where the sensitivity of nerves to pain, temperature, and pressure is dulled, particularly in the legs and feet. Mentioned in: Diabetes Mellitus . 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 Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored phase II of the product completed by Myelos. Other anticipated developments in 2001: -- Increase in Oxandrin(R) 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(R) (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 genetically engineered adjective Recombinant, see there and other products for human health care. BTG's products are marketed worldwide. Products sold in the United States are Oxandrin(R) (oxandrolone, USP USP - unique sales point ), marketed by BTG and by the Ross Products Division of Abbott Laboratories under a co-marketing agreement, Delatestryl(R) (testosterone enanthate testosterone enanthate Warning - Hazardous drug! Delatestryl Pharmacologic class: Hormone Therapeutic class: Androgenic and anabolic steroid, antineoplastic ), marketed by BTG, Mircette(TM) (oral contraceptive oral contraceptive n. A pill, typically containing estrogen or progesterone, that prevents conception or pregnancy. Also called birth control pill. ), marketed by Organon or·ga·non or or·ga·num n. pl. or·ga·nons or or·ga·nums or or·ga·na 1. An organ. 2. A set of principles for use in scientific investigation. organon pl. organa [Gr.] organ. , Inc., and BioLon(TM) (sodium hyaluronate hyaluronate /hy·al·uro·nate/ (hi?ah-ldbobr´ro-nat) a salt, anion, or ester of hyaluronic acid. The sodium salt and a derivative of it are used as analgesics in the treatment of osteoarthritis of the knee. ), marketed by Akorn, Inc. Products sold internationally are Bio-Tropin(TM) (recombinant recombinant /re·com·bi·nant/ (re-kom´bi-nant) 1. the new entity (e.g., gene, protein, cell, individual) that results from genetic recombination. 2. pertaining or relating to such an entity. See also under DNA. human growth hormone), BioLon(TM) (sodium hyaluronate), Bio-Hep-B(TM) (hepatitis B vaccine hepatitis B vaccine n. Abbr. HB A vaccine prepared from the inactivated surface antigen of the hepatitis B virus and used to immunize against hepatitis B. ), and Silkis(R) (vitamin D vitamin D Any of a group of fat-soluble alcohols important in calcium metabolism in animals to form strong bones and teeth and prevent rickets and osteoporosis. It is formed by ultraviolet radiation (sunlight) of sterols (see steroid) present in the skin. 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 EST electroshock therapy. EST abbr. electroshock therapy ). 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 diluted earnings per share An earnings measure calculated by dividing net income less preferred stock dividends for a period by the average number of shares of common stock that would be outstanding if all convertible securities were converted into shares of 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 forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. " 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.
BIO-TECHNOLOGY GENERAL CORP. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands except per share data)
Three Months Ended
December 31
------------------
2000(a) 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
====== ======
(a) 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(a) 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
====== ======
(a) 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.
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