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Company Contacts: Investor Relations Contacts:
IMPAX Laboratories, Inc. Lippert/Heilshorn & Associates, Inc.
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Barry R. Edwards, Co-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 REPORTS THIRD QUARTER FINANCIAL RESULTS
Company Continues to Post Record Quarterly Revenues
- Four FDA Approvals Received in the Quarter -
HAYWARD, California (November 5, 2003) - IMPAX Laboratories, Inc. (NASDAQ
NM: IPXL) today reported financial results for the three months and nine months
ended September 30, 2003.
Total revenues for the third quarter of 2003 were $16,497,000, up more than 119%
compared with revenues of $7,538,000 in the prior year's third quarter, and up
more than 17% compared with total revenues of $14,067,000 in the second quarter
of 2003. The significant year-over-year increases were primarily due to
shipments of over-the-counter (OTC) Loratadine and Pseudoephedrine Sulfate
(5mg/120mg) 12-hour Extended Release Tablets to Schering-Plough and to Wyeth
during the third quarter of 2003; and higher sales of Fludrocortisone Tablets,
Minocycline Capsules, and the LIPRAM product family.
The net loss for the 2003 third quarter was $3,608,000, or $(0.07) per share,
compared with a net loss of $5,210,000, or $(0.11) per share, in the prior year
third quarter and a net loss of $2,284,000, or $(0.05) per share, in the 2003
second quarter. The year-over-year net loss narrowed due to higher sales, but
increased on a sequential quarter basis due to increased expenses related to
ramping up production for upcoming new product introductions including, but not
limited to, additional personnel, supplies and training costs.
For the nine months ended September 30, 2003, the Company reported total
revenues of $41,989,000 compared with $16,115,000 in the comparable period of
the previous year. The net loss through the third quarter of 2003 was
$9,105,000, or $(0.18) per share. This compares with a net loss of $16,569,000,
or $(0.35) per share, in the nine months ended September 30, 2002.
Unrestricted cash, cash equivalents and short-term investments were $22.5
million at September 30, 2003, compared to $10.2 million at December 31, 2002.
The increase in the cash balance was primarily due to a $25 million private
placement completed in May of this year.
"We are delighted to report that this is our fifth consecutive quarter of record
revenues," said Barry R. Edwards, Co-Chief Executive Officer of IMPAX. "In
addition to receiving final U.S. Food and Drug Administration (FDA) approval for
our generic versions of Urispas(R), Claritin(R) Reditabs and Aralen(R), we also
received tentative approvals of a generic version of OxyContin(R) Controlled
Release Tablets, 80mg."
Mr. Edwards continued, "Also in the quarter, we entered into an Exclusivity
Transfer Agreement with Andrx Corporation (NASDAQ: ADRX) and a subsidiary of
Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) pertaining to pending
Abbreviated New Drug Applications (ANDAs) for bioequivalent versions of
Wellbutrin(R) SR and Zyban(R) (Bupropion Hydrochloride) 100mg and 150mg Extended
Release Tablets filed by Andrx, as well as by IMPAX. We believe that this
agreement with Andrx and Teva will provide us with an opportunity to bring our
products to the market earlier than would be possible alone."
"We filed two ANDAs, as well as one Investigational New Drug application (IND),
with the FDA during the quarter and we remain comfortable that we will meet our
goal of filing at least six applications this year," said Larry Hsu, PhD,
President of IMPAX. "This, our first IND filing, represents a significant
milestone in the development of our branded pharmaceuticals program for products
intended to treat disorders of the Central Nervous System ("CNS").
IMPAX has eighteen applications pending at the FDA, including three tentatively
approved, that address approximately $7 billion in U.S. branded product sales
for the twelve months ended August 31, 2003. Fourteen 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.
As previously announced, the Company has scheduled a conference call to discuss
this announcement beginning at 9:00 a.m. Eastern Time today. To participate in
the call, a few minutes prior to the start time, please dial (888) 803-7396 in
the U.S. or (706) 634-1052 for international callers. Those unable to
participate are invited to listen to a recording of the call and Question and
Answer session from 10:00 a.m. Eastern Time November 5, 2003 through 11:59 p.m.
Eastern Time November 7, 2003, by dialing (800) 642-1687 in the U.S. or (706)
645-9291 for international callers, and entering reservation code 3626714.
Alternatively, individuals may listen to the call by visiting the investor
relations section of the Company's website at www.impaxlabs.com. To listen to
the live call, please go to the website 15 minutes prior to its start to
register, download, and install the necessary audio software. A recording of the
call will be available for 14 days on the site beginning on November 5, 2003.
"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.
(Tables to follow)
# # #
IMPAX LABORATORIES, INC.
STATEMENTS OF OPERATIONS
(unaudited)
(dollars in thousands, except share and per share data)
Three Months Ended Nine Months Ended
September 30, September 30,
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2003 2002 2003 2002
----------- ----------- ----------- -----------
Net Sales $ 15,908 $ 7,283 $ 40,434 $ 15,860
Other revenues 589 255 1,555 255
----------- ----------- ----------- -----------
Total revenues 16,497 7,538 41,989 16,115
----------- ----------- ----------- -----------
Cost of sales 12,976 5,153 30,444 12,274
----------- ----------- ----------- -----------
Gross margin 3,521 2,385 11,545 3,841
Research and development 4,203 4,533 12,305 11,899
Less: Teva payments (93) (182) (247) (486)
----------- ----------- ----------- -----------
Research and development, net 4,110 4,351 12,058 11,413
Selling expenses 546 697 1,552 2,001
General and administrative expenses 2,321 2,084 6,526 6,193
Other operating income (expense), net 4 (30) 25 (39)
----------- ----------- ----------- -----------
Net loss from operations (3,452) (4,777) (8,566) (15,805)
Interest income 87 138 199 540
Interest expense (243) (571) (738) (1,304)
----------- ----------- ----------- -----------
Net loss (3,608) (5,210) (9,105) (16,569)
=========== =========== =========== ===========
Net loss per share (basic and diluted) $ (0.07) $ (0.11) $ (0.18) $ (0.35)
=========== =========== =========== ===========
Weighted average
common shares outstanding 52,610,356 47,778,512 50,382,455 47,302,950
=========== =========== =========== ===========
IMPAX LABORATORIES, INC.
CONDENSED BALANCE SHEET
(unaudited)
(in thousands)
September 30, December 31,
2003 2002
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ASSETS
Cash and cash equivalents $ 22,482 $ 10,219
Accounts receivable, net 7,899 6,524
Inventory 19,863 10,478
Restricted cash (a) 10,000 10,000
Property, plant and equipment, net 37,696 37,065
Goodwill and intangibles, net 28,049 28,337
Other assets 2,067 1,780
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Total assets $128,056 $104,403
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LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities $ 30,955 $ 23,248
Refundable deposit (b) 8,500 22,000
Long-term debt, net of current portion 9,035 9,105
Deferred revenues and other liabilities 2,441 1,486
Mandatorily redeemable convertible preferred stock 7,500 7,500
Stockholders' equity 69,625 41,064
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Total liabilities and stockholders' equity $128,056 $104,403
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(a) Represents cash held as collateral for the $25 million revolving credit
facility and term loan with Congress Financial.
(b) As of the date of this press release, we expect to pay the refundable
deposit to Teva in IMPAX common stock. In September 2003, we issued 888,918
shares of common stock to Teva, paying $13.5 million of the original $22
million refundable deposit.