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COMPANY CONTACTS: INVESTOR RELATIONS CONTACTS:
IMPAX Laboratories, Inc. Lippert/Heilshorn & Associates, Inc.
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Barry R. Edwards, CEO Kim Sutton Golodetz (kgolodetz@lhai.com)
(215) 289-2220 Ext. 1771 (212) 838-3777
Larry Hsu, Ph.D., President Bruce Voss (bvoss@lhai.com)
(510) 476-2000 Ext. 1111 (310) 691-7100
Cornel C. Spiegler, CFO www.lhai.com
(215) 289-2220 Ext. 1706 ------------
www.impaxlabs.com
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IMPAX POSTS FIRST PROFITABLE QUARTER DRIVEN BY RECORD REVENUES
- RECEIVED FIVE FDA APPROVALS IN FIRST QUARTER -
HAYWARD, CALIF (MAY 5, 2004) - IMPAX LABORATORIES, INC. (NASDAQ NM: 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
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Net sales $ 35,822 $ 11,066
Revenue from reversal of refundable deposit from Teva 2,500 --
Other revenues 531 359
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Total revenues 38,853 11,425
Cost of sales 18,550 8,147
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Gross margin 20,303 3,278
Research and development 6,504 3,755
Less: Teva payments (11) (132)
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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
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Income (loss) from operations 9,740 (3,024)
Interest income 56 42
Interest expense (272) (231)
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Income (loss) before income taxes 9,524 (3,213)
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Provision for income taxes 476 --
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Net income (loss) $ 9,048 $ (3,213)
=========== ===========
Net income (loss) per share
Basic 0.16 (0.07)
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Diluted 0.14 (0.07)
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Weighted average common shares outstanding
Basic 56,978,095 47,876,830
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Diluted 62,465,827 47,876,830
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IMPAX LABORATORIES, INC.
CONDENSED BALANCE SHEET
(IN THOUSANDS)
MARCH 31, DECEMBER 31,
2004 2003
(UNAUDITED) (UNAUDITED)
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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
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Total assets $ 153,854 $ 132,706
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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
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Total liabilities and stockholders' equity $ 153,854 $ 132,706
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(a) Represents cash held as collateral for the $25 million revolving credit
facility and term loan with Congress Financial.
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