Two ANDAs Filed with FDA in Quarter for a Total of Eight
in 2001 -- Expects to File 6 to 8 ANDAs in 2002
February 7, 2002 -- IMPAX Laboratories, Inc. (Nasdaq NM: IPXL) today reported
financial results for the three and twelve months ended December 31, 2001.
Revenues for the fourth quarter of 2001 were $2,025,000, up 22% on a sequential
quarter basis and up from $1,300,000 in the prior-year fourth quarter. Higher
revenues came on sales of Terbutaline Sulfate tablets, a generic version of
Brethine®, and on the reintroduction of products that had been discontinued
in August 2000 when production was shifted from Philadelphia to Hayward, California.
The company anticipates that its new, state-of-the-art manufacturing facility
in Hayward will be completed by the end of the second quarter of 2002, by which
time additional products are expected to have been reintroduced and/or launched
to the marketplace.
The net loss for the 2001 fourth quarter was $6.9 million, or $(0.15) per share,
including amortization of intangibles and goodwill of $972,000, or $(0.02) per
share. This compares with a net loss of $5.8 million, or $(0.20) per share,
including amortization of intangibles and goodwill of $981,000, or $(0.03) per
share in the prior year fourth quarter. The increase in net loss from last year
comparable period was primarily due to the interest expense on the refundable
deposit from Teva Pharmaceutical Industries, Ltd. (TEVA) and additional infrastructure
costs related to the new manufacturing facility and sales and marketing areas.
Cash, cash equivalents and short-term investments were $35.5 million at December
31, 2001 compared with $19.2 million at December 31, 2000. During the quarter,
IMPAX issued 340,662 shares of common stock to TEVA, for net proceeds to the
Company of approximately $3.75 million. Under the terms of a strategic alliance
announced in June 2001, Teva has invested $7.5 million in IMPAX Laboratories
to date, and will make further investments totaling $7.5 million through June
2002.
For the 12 months ended December 31, 2001, the Company reported sales of $6,591,000,
compared with $10,170,000 in the comparable period the previous year; the lower
sales were due to discontinued products and sales returns. The net loss through
December 31, 2001, was $25,111,000, or $(0.60) per share, including amortization
of intangibles and goodwill of $3,885,000 or $(0.09) per share and interest
expense of $876,000 or $(0.02) per share on the refundable deposit from TEVA.
This compares with a net loss of $24,961,000, or $(0.91) per share, including
amortization of intangibles and goodwill of $4,604,000, or $(0.17) per share,
and one-time restructuring charges and non-recurring items of $3,646,000 or
$(0.13) per share, in the comparable 12 month period last year.
The Company noted that a recent Section 382 Net Operating Loss (NOL) limitation
study conducted by its tax accountants indicated that NOL amounts of approximately
$51 million as of December 31, 2000, will be available to offset future taxable
profits. Of the $51 million NOL, approximately $33 million will be currently
available as of December 31, 2001, to offset taxable profits, with the remainder
being fully available by December 31, 2004.
``The fourth quarter continues our sequential quarter improvement,'' said Barry
R. Edwards, Co-CEO. ``We are looking forward to increasing sales throughout
2002, as we receive U.S. Food and Drug Administration (FDA) marketing approval
for new products and bring previously discontinued products back into production
in our California facility. We anticipate that our new state-of-the-art facility
in Hayward will be fully operational by June of this year and will have the
capacity to support the additional anticipated product requirements in the coming
years.''
Larry Hsu, President and COO added, ``We are very pleased that our development
team reached the high end of our goal of filing six to eight ANDAs in 2001.
During the past quarter we filed two additional ANDAs for controlled release
products with the FDA, for a total of eight ANDAs this year. In addition, we
were issued U.S. Patent No. 6,333,332 for Pharmaceutical Stabilization System
(PSS), which continues to build our proprietary technology base. We anticipate
that we will file 6 to 8 new ANDAs in 2002.''
IMPAX currently has 15 ANDAs pending at the FDA that address more than $8 billion
in annual U.S. branded product sales. Nine 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 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.
STATEMENT OF OPERATIONS
(dollars in thousands, except share and per share data)
Three Months Ended Twelve Months Ended
December 31, December 31,
2001 2000 2001 2000
(unaudited) (unaudited)
Net sales $ 2,025 $ 1,300 $ 6,591 $ 10,170
Cost of sales 3,154 1,857 9,669 9,716
-------- -------- --------- ---------
Gross margin (loss) (1,129) (557) (3,078) 454
Research and development 2,907 2,651 11,890 11,096
Less: TEVA payments (219) - (918) -
-------- -------- --------- ---------
Research and development, net 2,688 2,651 10,972 11,096
Selling expenses 471 285 2,186 1,346
General and administrative (a) 2,594 2,515 9,258 9,764
Other operating income, net 100 91 164 306
Restructuring charges and
non-recurring items (b) - - - 3,646
-------- -------- --------- ---------
Net loss from operations 6,782 (5,917) (25,330) (25,092)
Interest income 313 198 1,148 758
Interest expense (c) (385) (85) (929) (339)
-------- -------- --------- ---------
Net loss before cumulative
effect of accounting change (6,854) (5,804) (25,111) (24,673)
Cumulative effect of accounting
change (SAB101) - - - (288)
-------- -------- --------- ---------
Net loss $ (6,854) $(5,804) $(25,111) $(24,961)
======== ======== ========= =========
Net loss per share before
cumulative effect of
accounting change $ - $ - $ - $ (0.90)
======== ======== ========= =========
Net loss per share
(basic and diluted) $ (0.15) $ (0.20) $ (0.60) $ (0.91)
======== ======== ========= =========
Weighted average common
shares outstanding 46,680,047 29,544,225 41,555,818 27,538,989
=========== ========== ========== ==========
(a) Includes amortization of intangibles and goodwill of $972K in the
quarter ended December 31, 2001, and $3,885K in the twelve months
ended December 31, 2001, compared to $981K in the quarter ended
December 31, 2000, and $4,604K in the twelve months ended
December 31, 2000.
(b) Includes one time write-off of $2,037K in intangibles, $957K in
inventory and $652K in assets impairment due to ceasing of
manufacturing in the Philadelphia facility and rationalizing the
product line.
(c) Includes interest on refundable deposit from TEVA of $438K in the
quarter ended December 31, 2001, and $876K in the twelve months
ended December 31, 2001, respectively.
IMPAX LABORATORIES, INC.
CONDENSED BALANCE SHEET
(in thousands)
December 31, December 31,
2001 2000
(unaudited)
ASSETS
Cash, cash equivalents
and short-term investments $ 35,466 $ 19,228
Accounts receivable, net 3,523 1,581
Inventory 3,488 2,949
Property, plant and equipment, net 24,334 9,699
Goodwill and intangibles, net 28,721 32,609
Other assets 2,080 1,062
-------- ---------
Total assets $ 97,612 $ 67,128
-------- ---------
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities $ 7,803 $ 6,326
Long-term debt, net of current portion 6,868 1,345
Refundable deposit and related
accrued interest 22,876 -
Other liabilities 117 400
Mandatorily redeemable convertible
preferred stock 7,500 28,303
Stockholders' equity 52,448 30,754
-------- --------
Total liabilities and
stockholders' equity $ 97,612 $ 67,128
--------- --------