Files Four ANDAs in Quarter
February 12, 2003--IMPAX Laboratories, Inc. (Nasdaq NM: IPXL) today reported
financial results for the three and twelve months ended December 31, 2002.
Revenues for the fourth quarter of 2002 were $8,400,000, up more than 400%
compared with total revenues of $2,025,000 in the prior year's fourth quarter,
and up more than 11% compared with total revenues of $7,538,000 in the third
quarter of 2002. The significant year-over-year increase came on additional
sales of Fludrocortisone Acetate Tablets, introduced at the end of the first
quarter of 2002, Minocycline Hydrochloride Capsules launched in the third quarter
of 2002, Rimantadine Hydrochloride Tablets launched in the fourth quarter of
2002, higher Lipram sales, and lower product returns.
The net loss for the 2002 fourth quarter was $3,471,000, or $(0.07) per share,
compared with a net loss of $6,854,000, or $(0.15) per share in the prior year
fourth quarter, which included goodwill amortization of approximately $876,000,
or $(0.02) per share. Net loss narrowed due to increased sales, which partially
offset increases in research and development and operating expenses. Further,
results included a benefit from the reversal of the interest expense on the
refundable deposit from Teva under its strategic alliance agreement, of approximately
$1,595,000, or $(0.03) per share.
For the twelve months ended December 31, 2002, the Company reported total revenues
of $24,515,000, up more than 370%, compared with total revenues of $6,591,000
in the previous year. The significant year-over-year increase came on the ramp
up of sales of Fludrocortisone Acetate Tablets, introduced at the end of the
first quarter of 2002, Minocycline Hydrochloride Capsules launched in the third
quarter of 2002, Rimantadine Hydrochloride Tablets launched in the fourth quarter
of 2002, Terbutaline Sulfate Tablets introduced since July 2001, higher Lipram
sales, and lower product returns.
The net loss for the twelve months ended December 31, 2002, was $20,040,000,
or $(0.42) per share, compared with a net loss of $25,111,000, or $(0.60) per
share, in the previous year, which included goodwill amortization of $3,504,000,
or $(0.08) per share. Net loss narrowed due to increased sales, which partially
offset increases in research and development and operating expenses. Further,
results included a benefit from the reversal of the interest expense on the
refundable deposit from Teva of approximately $675,000, or $(0.01) per share.
Cash, cash equivalents and short-term investments were $20.2 million at December
31, 2002, compared with $35.5 million at December 31, 2001. The balance at December
31, 2002 included $10 million in restricted cash that serves as collateral for
the $25 million revolving credit facility and term loan agreement signed with
Congress Financial in October 2002.
"The fourth quarter continues our sequential quarter improvement,"
said Barry R. Edwards, Co-CEO. "We are looking forward to increasing sales
throughout 2003, as we receive U.S. Food and Drug Administration (FDA) marketing
approval for new products."
Larry Hsu, Ph.D., President, added: "We are very pleased that our development
team reached the high end of our goal by filing eight applications in 2002,
four of which were filed in the fourth quarter. This marks the third year in
a row that we have filed eight applications. Once again, for 2003, we expect
to be able to file at least six new applications with the FDA."
IMPAX has 19 applications pending at the FDA, including three tentatively approved,
that address more than $5.8 billion in U.S. branded product sales for the 12
months ended September 30, 2002. 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.
IMPAX LABORATORIES, INC.
STATEMENTS OF OPERATIONS
(unaudited)
(dollars in thousands, except share and per share data)
Three Months Ended Twelve Months Ended
December 31, December 31,
(unaudited) (unaudited)
2002 2001 2002 2001
Net sales $ 7,998 $ 2,025 $ 23,758 $ 6,591
Other revenues 402 -- 757 --
Total revenues 8,400 2,025 24,515 6,591
Cost of sales 6,218 3,154 18,492 9,669
Gross profit (loss) 2,182 (1,129) 6,023 (3,078)
Research and development 4,355 2,907 16,254 11,890
Less: Teva reimbursements (219) (219) (705) (918)
Research and development, net 4,136 2,688 15,549 10,972
Selling expenses 835 471 2,836 2,186
General and Administrative(a) 2,203 2,594 8,396 9,258
Other operating income
(expense), net 3 100 (36) 164
Net loss from operations (4,989) (6,782) (20,794) (25,330)
Interest income 104 313 644 1,148
Interest expense(b) 1,414 (385) 110 (929)
Net loss $(3,471) $(6,854) $(20,040) $(25,111)
Net loss per share
(basic and diluted) $ (0.07) $ (0.15) $ (0.42) $ (0.60)
Weighted average common
shares outstanding 47,867,379 46,680,047 47,444,364 41,555,818
(a)Includes amortization of goodwill of $876,000 in the quarter ended
December 31, 2001 and $3,504,000 in the twelve months ended
December 31, 2001. There was no amortization of goodwill in 2002.
(b) The interest expense for the quarter and twelve months ended
December 31, 2002, included the reversal of the interest on the
refundable deposit from Teva, as follows:
Q-4 2002 Year 2002
Reversal of Interest on Refundable Deposit $ 2,190,000 $ 876,000
Other Interest (181,000) (565,000)
Less: Amounts Previously Capitalized (595,000) (201,000)
Total Interest Expense $ 1,414,000 $ 110,000
IMPAX LABORATORIES, INC.
CONDENSED BALANCE SHEETS
(in thousands)
December 31, December 31,
2002 2001
(unaudited) (unaudited)
ASSETS
Cash, cash equivalents and short-term
investments $ 10,219 $ 35,466
Restricted cash(a) 10,000 --
Accounts receivable, net 6,524 3,523
Inventory 10,478 3,488
Property, plant and equipment, net 37,065 24,334
Goodwill and intangibles, net 28,337 28,721
Other assets 1,780 2,080
Total assets $ 104,403 $ 97,612
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities $ 23,248 $ 7,803
Long-term debt, net of current portion 9,105 6,868
Refundable deposit and related accrued
interest 22,000 22,876
Other liabilities 1,486 117
Mandatorily redeemable convertible
preferred stock 7,500 7,500
Stockholders' equity 41,064 52,448
Total liabilities and stockholders' equity $ 104,403 $ 97,612
(a) Collateral for the $25 million revolving credit facility and term
loan with Congress Financial.