HAYWARD, Calif.--(BUSINESS WIRE)--May 5, 2004--IMPAX Laboratories,
Inc. (Nasdaq:IPXL) today reported financial results for the three
months ended March 31, 2004.
Revenues for the first quarter of 2004 were a record $38,853,000,
up more than 240% compared with revenues of $11,425,000 in the prior
year's first quarter, and up more than 131% over total revenues of
$16,829,000 in the fourth quarter of 2003. The year-over-year increase
for the first quarter was primarily due to shipments of our generic
versions of Wellbutrin(R) SR (Bupropion Hydrochloride) 100 mg and 150
mg Controlled Release Tablets, which were approved by the FDA during
the quarter. During the quarter, upon approval from the FDA, we also
commenced shipments of Demeclocycline Hydrochloride (generic of
Declomycin(R)) 150 mg and 300 mg Tablets. First quarter revenues also
include $2,500,000, representing the reversal of the refundable
deposit from Teva under its strategic alliance agreement related to
its exercise of the exclusivity option for certain products.
Net income for the 2004 first quarter was $9,048,000, or $0.14 per
fully diluted share, compared with a net loss of $3,213,000, or
$(0.07) per share, in the prior year first quarter. Cash, cash
equivalents and short-term investments (unrestricted) were $19.5
million at March 31, 2004, compared to $15.5 million at December 31,
2003. During the first quarter of 2004, we satisfied the remaining
$2.5 million refundable deposit obligation to Teva in full by issuing
160,751 shares of our common stock to Teva. As of March 31, 2004, to
our knowledge, Teva owns 2,511,752 shares of our common stock, or
approximately 4.3% of the outstanding common stock. Also during the
quarter, the holders of Series 2 Preferred Stock converted their
entire 75,000 preferred shares into 1,500,000 shares of common stock.
Subsequent to the end of the quarter, IMPAX closed a private placement
of $95,000,000 aggregate principal amount of 1.250% convertible senior
subordinated debentures due 2024.
"We are delighted to report our first profitable quarter since
IMPAX Laboratories was formed in December 1999," said Barry R.
Edwards, Chief Executive Officer of IMPAX. "Our research and
development team's steady stream of filings, the subsequent FDA
approvals of those ANDAs, positive litigation outcomes, and the
dedication and hard work of our employees in all the functional areas
of the Company made this goal a reality. The convertible debenture
financing completed on April 5, 2004 provides us with additional
financial resources going forward."
Commenting on the Company's product pipeline, Larry Hsu, Ph.D.,
IMPAX's President, said, "The launch of our generic Wellbutrin SR
represents IMPAX's single largest product opportunity to date.
According to NDCHealth, U.S. sales of Wellbutrin SR 100 mg and 150 mg,
marketed by GlaxoSmithKline (NYSE:GSK), were approximately $1.4
billion in the twelve months ended February 29, 2004. In addition to
the generic Wellbutrin SR, our new product pipeline continues to
progress through the FDA. During the quarter, we received final
approvals for generic versions of Declomycin and Claritin(R)-D
24-Hour. Our generic versions of Allegra(R)-D and Tricor(R) Tablets
have also been granted tentative approvals."
IMPAX currently has seventeen applications pending at the FDA,
including five tentatively approved, which address over $5.4 billion
in U.S. branded product sales for the 12 months ended February 29,
2004. Thirteen of these filings were made under Paragraph IV of the
Hatch-Waxman Amendments.
IMPAX Laboratories, Inc. is a technology based specialty
pharmaceutical company applying its formulation expertise and drug
delivery technology to the development of controlled-release and
specialty generics in addition to the development of branded products.
IMPAX markets its generic products through its Global Pharmaceuticals
division and intends to market its branded products through the IMPAX
Pharmaceuticals division. Additionally, where strategically
appropriate, IMPAX has developed marketing partnerships to fully
leverage its technology platform. IMPAX Laboratories is headquartered
in Hayward, California, and has a full range of capabilities in its
Hayward and Philadelphia facilities. For more information, please
visit the Company's Web site at: www.impaxlabs.com.
"Safe Harbor" statement under the Private Securities Litigation
Reform Act of 1995:
To the extent any statements made in this news release contain
information that is not historical, these statements are
forward-looking in nature and express the beliefs and expectations of
management. Such statements are based on current expectations and
involve a number of known and unknown risks and uncertainties that
could cause Impax's future results, performance or achievements to
differ significantly from the results, performance or achievements
expressed or implied by such forward-looking statements. Such risks
and uncertainties include, but are not limited to, Impax's ability to
obtain sufficient capital to fund its operations, the difficulty of
predicting FDA filings and approvals, consumer acceptance and demand
for new pharmaceutical products, the impact of competitive products
and pricing, Impax's ability to successfully develop and commercialize
pharmaceutical products, Impax's reliance on key strategic alliances,
the uncertainty of patent litigation, the availability of raw
materials, the regulatory environment, dependence on patent and other
protection for innovative products, exposure to product liability
claims, fluctuations in operating results and other risks detailed
from time to time in Impax's filings with the Securities and Exchange
Commission. Forward-looking statements speak only as to the date on
which they are made, and Impax undertakes no obligation to update
publicly or revise any forward-looking statement, regardless of
whether new information becomes available, future developments occur
or otherwise.
IMPAX LABORATORIES, INC.
STATEMENTS OF OPERATIONS
(dollars in thousands, except share and per share data)
Three Months Ended
March 31,
2004 2003
Net sales $35,822 $11,066
Revenue from reversal of refundable
deposit from Teva 2,500 --
Other revenues 531 359
Total revenues 38,853 11,425
Cost of sales 18,550 8,147
Gross margin 20,303 3,278
Research and development 6,504 3,755
Less: Teva payments (11) (132)
Research and development, net 6,493 3,623
Selling expenses 726 568
General and administrative expenses 3,351 2,122
Other operating income 7 11
Income (loss) from operations 9,740 (3,024)
Interest income 56 42
Interest expense (272) (231)
Income (loss) before income taxes 9,524 (3,213)
Provision for income taxes 476 --
Net income (loss) $9,048 $(3,213)
Net income (loss) per share
Basic $0.16 $(0.07)
Diluted $0.14 $(0.07)
Weighted average common shares
outstanding
Basic 56,978,095 47,876,830
Diluted 62,465,827 47,876,830
IMPAX LABORATORIES, INC.
CONDENSED BALANCE SHEET
(in thousands)
March 31, December 31,
2004 2003
(unaudited) (unaudited)
ASSETS
Cash, cash equivalents and short-
term investments $19,491 $15,505
Restricted cash(a) 10,000 10,000
Accounts receivable, net 24,052 9,885
Inventory 30,148 28,479
Property, plant and equipment, net 39,231 38,132
Goodwill and intangibles, net 27,857 27,953
Other assets 3,075 2,752
Total assets $153,854 $132,706
LIABILITIES AND STOCKHOLDERS'
EQUITY
Current liabilities $55,329 $42,365
Long-term debt, net of current
portion 8,489 8,854
Refundable deposit from Teva 0 5,000
Deferred revenues and other
liabilities 2,895 2,879
Mandatory redeemable convertible
preferred stock 0 7,500
Stockholders' equity 87,141 66,108
Total liabilities and stockholders'
equity $153,854 $132,706
(a) Represents cash held as collateral for the $25 million revolving
credit facility and term loan with Congress Financial.
CONTACT: IMPAX Laboratories, Inc.
Barry R. Edwards, 215-289-2220 Ext. 1771
Larry Hsu, 510-476-2000 Ext. 1111
Cornel C. Spiegler, 215-289-2220 Ext. 1706
www.impaxlabs.com
or
Investor Relations Contacts:
Lippert/Heilshorn & Associates, Inc.
Kim Sutton Golodetz, 212-838-3777
kgolodetz@lhai.com
Bruce Voss, 310-691-7100
bvoss@lhai.com
www.lhai.com
SOURCE: IMPAX Laboratories, Inc.