HAYWARD, Calif.--(BUSINESS WIRE)--Nov. 5, 2003--IMPAX
Laboratories, Inc. (Nasdaq: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, Ph.D., 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, Calif., 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 Web site at
www.impaxlabs.com. To listen to the live call, please go to the
Web site 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.
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,
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)
Sept. 30, Dec. 31,
2003 2002
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
Total assets $ 128,056 $ 104,403
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
Total liabilities and stockholders'
equity $ 128,056 $ 104,403
(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.
CONTACT: IMPAX Laboratories, Inc.
Barry R. Edwards, Co-CEO, 215-289-2220, Ext. 1771
Larry Hsu, Ph.D., President, 510-476-2000, Ext. 1111
Cornel C. Spiegler, CFO, 215-289-2220, Ext. 1706
www.impaxlabs.com
or
Lippert/Heilshorn & Associates, Inc.
Kim Sutton Golodetz ([email protected]), 212-838-3777
Bruce Voss ([email protected]), 310-691-7100
www.lhai.com
SOURCE: IMPAX Laboratories, Inc.