Quarter Highlights Include FDA Approval and Tentative Approval
of ANDAs and Higher Revenues
April 30, 2002 -- IMPAX Laboratories, Inc. (Nasdaq NM: IPXL) today reported
financial results for the three months ended March 31, 2002.
The revenues for the first quarter of 2002 were $3,432,000 compared to $1,772,000
in the prior year's first quarter and $2,025,000 in the fourth quarter of 2001.
The increase in revenue by approximately 94% over the prior year was primarily
due to the introduction of two new products: Terbutaline Sulfate Tablets in
June 2001 and Fludrocortisone Acetate Tablets in March 2002.
The net loss for the 2002 first quarter was $5,421,000 or $(0.12) per share.
This compares with a net loss of $5,338,000 or $(0.16) per share in the prior
year first quarter. The increase in the net loss from last year comparable period
was primarily due to higher research and development and infrastructure costs
related to the new manufacturing facility in Hayward, California and the expansion
of our sales and marketing capabilities, partially offset by higher revenues.
The 2002 first quarter net loss was also favorably impacted by the absence of
goodwill amortization expense of approximately $876,000.
Cash, cash equivalents and short-term investments were $30.7 million at March
31, 2002, compared with $13.8 million at March 31, 2001. During the quarter,
IMPAX issued 419,933 shares of common stock to a subsidiary of Teva Pharmaceuticals
Industries, Ltd., for net proceeds to the Company of $3.75 million. Under the
terms of a strategic alliance announced in June 2001, TEVA has invested $11.25
million in Impax Laboratories to date, and is required to make a further investment
of approximately $3.75 million in June 2002.
"The first quarter revenues continue our sequential quarter improvement
and the significant increase over last year's comparable quarter," said
Barry R. Edwards, Co-Chief Executive Officer. "The first quarter highlights
also include the tentative approval by the U.S. Food and Drug Administration
(FDA) of our ANDA for a generic version of Tricor® (Fenofibrate), Micronized,
and the approval by the FDA of our ANDA for a generic version of Florinef®
(Fludrocortisone Acetate Tablets). During the quarter, the FDA also accepted
the filing of ANDAs for a generic version of Allegra-D® (Fexofenadine HCl/Pseudoephedrine
HCl) Extended Release 60mg/120mg Tablets (our eighth Paragraph IV filing) and
for a generic version of Oxycontin® (Oxycodone HCl) Extended Release 80mg
Tablets (our ninth Paragraph IV filing)."
Regarding progress on brand development projects, Larry Hsu, Ph.D., President
and Chief Operating Officer, stated, "Our first application for a central
nervous system brand product was recently submitted to the FDA as an ANDA. This
brand product application marks the first milestone in the development of our
brand product strategy."
IMPAX currently has 15 ANDAs pending at the FDA that address more than $8 billion
in 2001 U.S. branded product sales. Nine of these filings were made under Paragraph
IV of the Hatch-Waxman Amendments, one of which has received tentative approval
from the FDA.
IMPAX Laboratories, Inc. is a technology focused specialty pharmaceutical company
applying its formulation expertise and drug delivery technology to the development
of controlled-release and niche 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. 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.
IMPAX LABORATORIES, INC.
IMPAX Laboratories, Inc.
Statements of Operations
(unaudited)
(dollars in thousands, except share and per share data)
Three Months Ended
March 31,
2002 2001
------ ------
Net sales $ 3,432 $ 1,772
Cost of sales 3,139 2,276
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Gross margin (loss) 293 (504)
Research and development 2,890 2,595
Less: Teva payments (166) -
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Research and development, net 2,724 2,595
Selling 658 317
General and administrative(a) 2,170 2,159
Other operating income (expense), net (30) 25
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Net loss from operations (5,289) (5,550)
Interest income 235 262
Interest expense(b) (367) (50)
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Net loss $ (5,421) $ (5,338)
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Net loss per share (basic and
diluted) $ (0.12) $ (0.16)
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Weighted average common shares
outstanding 46,812,977 33,951,876
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(a) Includes amortization of intangibles of $96K in the quarter ended
March 31, 2002, and amortization of intangibles and goodwill of
$972K in the quarter ended March 31, 2001.
(b) The total interest of $539K for the quarter ended March 31, 2002,
which was reduced by $172K in capitalized interest, included
interest of $438K on refundable deposit from Teva.
IMPAX Laboratories, Inc.
Condensed Balance Sheet
(in thousands)
March 31, December 31,
2002 2001
(unaudited)
ASSETS
Cash, cash equivalents and
short-term investments $ 30,675 $ 35,466
Accounts receivable, net 3,422 3,433
Inventory 3,897 3,488
Property, plant and equipment, net 29,518 24,134
Goodwill and intangibles, net 28,625 28,721
Other assets 2,904 2,080
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Total assets $ 99,041 $ 97,322
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LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities $ 10,177 $ 7,803
Long-term debt, net of current
portion 6,796 6,868
Refundable deposit and related
accrued interest 23,314 22,876
Other liabilities 101 117
Mandatorily redeemable convertible
preferred stock 7,500 7,500
Stockholders' equity 51,153 52,158
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Total liabilities and
stockholders'
equity $ 99,041 $ 97,322
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