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
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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
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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.