Sepracor Announces Third Quarter 1999 Financial Results
MARLBOROUGH, Mass., Oct. 22 /PRNewswire/ -- Sepracor Inc. (Nasdaq: SEPR)
today announced its consolidated financial results for the third quarter of
1999. For the three months ended September 30, 1999, Sepracor's consolidated
revenues from continuing operations were $2.5 million, of which revenues from
pharmaceutical product sales were approximately $1.8 million. The net loss
was $55.7 million, or $1.68 per share. These consolidated results compare
with consolidated revenues from continuing operations of $1.5 million, and a
net loss of $29.6 million, or $1.05 per share for the three months ended
September 30, 1998.
For the nine months ended September 30, 1999, Sepracor's consolidated
revenues from continuing operations were $10.2 million, and the net loss was
$122.7 million, or $3.73 per share. This compares with consolidated revenues
from continuing operations of $9.0 million, and a net loss of $58.9 million,
or $2.10 per share, for the nine months ended September 30, 1998. Financial
results for the three and nine month periods ended September 30, 1999, and
1998 have been reclassified to record discontinued operations of BioSphere
Medical, Inc. (formerly BioSepra Inc.), a subsidiary of Sepracor.
As of September 30, 1999, Sepracor had approximately $378 million in
consolidated cash, cash equivalents and marketable securities.
Sepracor recently announced that it has entered into an agreement with
Rhone-Poulenc Rorer SA (RPR), a unit of Rhone-Poulenc SA, whereby the Company
has exclusively licensed RPR's preclinical, clinical and post-marketing
surveillance data package relating to zopiclone, its isomers and metabolites,
to develop, make, use and sell (+)-zopiclone in the United States. Under the
licensing agreement, RPR will assign all U.S. patent applications relating to
(
zopiclone to Sepracor. Zopiclone, marketed by RPR under the brand names of
Imovane(R) and Amoban(R), is available in approximately 80 countries worldwide
and has never been registered for the U.S. market. Pursuant to the agreement,
RPR retains the right under the licensed data package to manufacture (+)-
zopiclone in the U.S. for non-U.S. markets.
Zopiclone is a non-benzodiazepine rapid-acting hypnotic indicated for the
treatment of sleep disorders. Zopiclone rapidly induces sleep while its
optimal duration of action prevents nocturnal awakenings. In preclinical and
clinical studies, Sepracor has shown that the isomer, (+)-zopiclone, is
predominately responsible for the hypnotic effect of the parent drug and has
the potential to reduce certain side effects.
This quarter, Sepracor filed an Investigational New Drug Application (IND)
for (+)-zopiclone with the U.S. Food and Drug Administration (FDA). The
Company also initiated a Phase I clinical study during the quarter and is
currently completing the trial. Sepracor plans to initiate a large-scale
pivotal study in the first half of 2000.
Sleep disorders affect approximately 80 million people in the United
States. The U.S. market for prescription sleep products is currently over $600
million and growing at a rate of 20 percent per year.
Also this quarter, Sepracor and Hoechst Marion Roussel, the pharmaceutical
company of Hoechst AG, announced that they have amended an existing business
arrangement related to fexofenadine. The amended arrangement settles all
patent issues between the two companies involving the nonsedating
antihistamine developed and marketed by Hoechst Marion Roussel. Sepracor will
receive royalties on fexofenadine sales in the U.S. upon expiration of Hoechst
Marion Roussel's composition of matter patent in mid-February 2001.
Under the terms of a separate ex-U.S. agreement, Hoechst Marion Roussel
has obtained an exclusive license to Sepracor's patents that had been the
subject of litigation in Europe, as well as various other patent oppositions
between the two companies outside the U.S. Under this agreement, all legal
actions outside the U.S. have been settled and Sepracor will receive royalties
on fexofenadine products effective March 1, 1999 in countries where it has
patents in place.
Sepracor also announced the appointment of James O'Shea to the newly
created position of President and Chief Operating Officer. Mr. O'Shea was
previously Senior Vice President of Sales, Marketing and Medical Affairs for
Zeneca, Inc., the $2.2 billion U.S. unit of the former Zeneca Group plc, which
merged with Astra AB in 1999 to form AstraZeneca plc. At Zeneca, Mr. O'Shea
was responsible for all commercial and medical operations of the U.S.
subsidiary.
This news release contains forward-looking statements that involve risks
and uncertainties, including statements with respect to the safety, efficacy
and potential benefits of the Company's ICE Pharmaceuticals under development.
Among the factors that could cause actual results to differ materially from
those indicated by such forward-looking statements are: the timing of filing
and approval of NDAs, the results of the Company's clinical trials with
respect to its products under development; the scope of the Company's patent
protection with respect to such product candidates; the availability of
sufficient funds to continue research and development efforts; and certain
other factors that may affect future operating results and are detailed in the
Company's periodic reports filed with the Securities and Exchange Commission.
Condensed consolidated statements of operations and consolidated balance
sheets follow.
Sepracor Inc.
Condensed Consolidated Statements of Operations
(Unaudited)
(in thousands, except per share amounts)
Three months ended Nine months ended
September 30, September 30,
1999 1998 1999 1998
Revenues:
Product sales $ 2,392 $34 $ 7,619 $124
R & D, license fees,
royalties 91 1,437 2,602 8,831
Total revenues 2,483 1,471 10,221 8,955
Cost of revenue 906 41 2,227 532
Gross margin 1,577 1,430 7,994 8,423
Operating expenses:
Research and development 34,690 20,151 77,252 43,490
Sales and marketing 15,560 6,460 30,935 11,820
General and administrative 3,512 2,115 10,257 5,918
Patent costs 1,024 476 2,554 1,412
Total operating expenses 54,786 29,202 120,998 62,640
Loss from operations (53,209) (27,772) (113,004) (54,217)
Other income (expense):
Interest income 5,304 3,483 16,975 9,459
Interest expense (8,276) (4,502) (24,834) (12,132)
Other income (expenses), net 70 87 132 (43)
Equity in investee losses(A) -- (600) (2,509) (1,846)
Total other income
(expense) (2,902) (1,532) (10,236) (4,562)
Net loss before minority
interests (56,111) (29,304) (123,240) (58,779)
Minority interests in
subsidiaries 362 134 910 291
Net loss from continuing
operations $(55,749) $(29,170) $(122,330) $(58,488)
Discontinued operations:
Loss from discontinued
operations (net of
minority interest in
subsidiaries)(B) -- (458) (345) (442)
Net loss $(55,749) $(29,628) $(122,675) $(58,930)
Basic and diluted net loss
per common share from
continuing operations $ (1.68) $ (1.03) $ (3.72) $ (2.08)
Basic and diluted net loss
per common share from
discontinued operations $ -- $ (0.02) $ (0.01) $ (0.02)
Basic and diluted net loss
per common share $ (1.68) $ (1.05) $ (3.73) $ (2.10)
Shares used in computing
basic and diluted net loss
per common share: 33,098 28,315 32,873 28,092
Note: Certain amounts have been reclassified as a result of BioSphere
discontinued operations.
(A) Represents Sepracor's portion of Versicor, Inc. and HemaSure, Inc.
losses in 1999 and Sepracor's portion of Versicor, Inc. losses in
1998.
(B) Represents discontinued operations relating to BioSphere Medical Inc.
(formerly BioSepra)
Sepracor Inc.
Condensed Consolidated Balance Sheets
(Unaudited)
(in thousands) September 30, December 31,
1999 1998
ASSETS
Cash and marketable securities $377,798 $499,598
Accounts receivable, net 2,827 --
Inventory, net 6,208 --
Property, plant and equipment, net 18,963 16,508
Investment in affiliates 2,058 1,490
Net assets from discontinued
operations(A) -- 10,325
Other assets(B) 40,744 21,339
Total assets $448,598 $549,260
LIABILITIES AND STOCKHOLDERS' EQUITY
Accounts payable and accrued expenses $51,677 $40,565
Deferred revenue and other
liabilities(C) 7,761 7,502
Debt payable 2,519 4,845
Convertible subordinated debentures(D) 489,475 489,475
Minority interests in subsidiaries 1,462 2,445
Total stockholders' equity (deficit) (104,296) 4,428
Total liabilities and stockholders'
equity $448,598 $549,260
Note: Certain prior period amounts have been reclassified as a result of
BioSphere discontinued operations.
(A) Represents discontinued operations relating to BioSphere Medical Inc.
(formerly BioSepra).
(B) Includes $13,286 and $15,119 in net unamortized deferred financing
costs relating to the convertible debenture offerings and $21,156 and
2,677 of net unamortized intangible assets in 1999 and 1998,
respectively.
(C) Includes $5,000 as an offset to the Investment in HemaSure relating to
a guarantee of a HemaSure line of credit.
(D) Consists of $189,475 in 6 1/4% and $300,000 in 7% convertible
debentures due 2005.
Xopenex is a trademark of Sepracor Inc. Imovane and Amoban are registered
trademarks of Rhone-Poulenc Sante.
To receive a copy of this release or any recent release via fax,
call Sepracor's automated news fax line at 1-800-758-5804 ext. 780960.
SOURCE Sepracor Inc.
CO: Sepracor Inc.
ST: Massachusetts
IN: MTC
SU: ERN
10/22/1999 07:00 EDT prnewswire.com |
