IMPAX Reports Fourth Quarter And Year-End Financial Results.Business Editors HAYWARD Hayward, city (1990 pop. 111,498), Alameda co., W Calif.; settled 1851, inc. 1876. It is an important commercial and distribution center for farm products. Manufactures include wire, plastics, metal and paper products, textiles, machinery, and motor vehicles. , Calif.--(BUSINESS WIRE)--Feb. 8, 2001 -Company Files Eight ANDAs in 2000, Exceeding Goal- -Plans 6-8 ANDA ANDA abbr. abbreviated new drug application Filings in 2001- IMPAX Laboratories, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on NM: IPXL) today reported financial results for the three and twelve months ended December December: see month. 31, 2000. Revenues for the fourth quarter of 2000 were $1,300,000 compared with $1,240,000 in the fourth quarter of 1999. Net loss for the 2000 fourth quarter was $5,804,000 or $(0.20) per share, including amortization of intangibles and goodwill of $981,000 or $(0.03) per share. This compares with a net loss of $3,491,000 or $(0.35) per share in the prior year fourth quarter. Cash, cash equivalents and short-term Short-term Any investments with a maturity of one year or less. short-term 1. Of or relating to a gain or loss on the value of an asset that has been held less than a specified period of time. investments were $19,228,000 at December 31, 2000, compared with $7,413,000 at December 31, 1999. Revenues for the twelve months ended December 31, 2000, were $10,170,000, compared with $1,240,000 for the twelve months ended December 31,1999. Net loss was $24,961,000 or $(0.91) per share, and reflects restructuring charges restructuring charge The expense of reorganizing a company's operations. A restructuring charge is an infrequent expense that generally results from asset writedowns or facility closings. and non-recurring items of $3,646,000 or $(0.13) per share due to cessation cessation Vox populi The stopping of a thing. See Smoking cessation. of manufacturing at the Company's Philadelphia Philadelphia, ancient cities Philadelphia, name of several ancient cities. One was in Lydia, W Asia Minor (now W Turkey). At the foot of Mt. Tmolus and near the location of modern Alaşehir, it was founded in the 2d cent. B.C. facility, as well as rationalizing the product line, and amortization of intangibles and goodwill of $4,604,000 or $(0.17) per share. This compares with a net loss of $8,949,000 or $(1.12) per share recorded in the comparable period last year. In the fourth quarter of 2000, IMPAX modified its revenue recognition policy to conform with the guidance set forth under the SEC Staff Accounting Bulletin (SAB SAB Spontaneous abortion. See Abortion. ) 101. The application of the SAB 101 guidance to the Company's previous revenue recognition policy requires IMPAX to defer de·fer 1 v. de·ferred, de·fer·ring, de·fers v.tr. 1. To put off; postpone. 2. To postpone the induction of (one eligible for the military draft). v.intr. revenue recognition from the sale of product until the shipment of product is received and accepted by the customer, rather than recognizing revenue only upon shipment. The change in accounting policy resulted in a cumulative effect adjustment at January January: see month. 1, 2000 of $288,000 and also resulted in an increase in revenue and gross margin of $667,000 and $288,000, respectively, for the twelve months period ended December 31, 2000. "The fourth quarter capped a very active year for IMPAX," said Barry R. Edwards Co-Chief Executive Officer. "We now have filed three Abbreviated New Drug Applications abbreviated new drug application Pharmacology An application made in the US by a pharmaceutical company requesting authority to market a 'new' drug for which both its therapeutic indications and formulation were previously approved by the FDA in another similar (ANDAs) with the US Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) for generic versions of Claritin Clar·i·tin A trademark for the drug loratadine. loratadine Alavert, Claritin, Claritin RediTabs, Clarityn (UK) Pharmacologic class: Histamine1-receptor antagonist (second-generation) (R) that address almost $1 billion in total U.S. brand product sales," continued Mr. Edwards. "Other highlights for the year include the Company's move to the Nasdaq National Market in September and successful completion a $16.5 million private placement of common stock in November." "We began the year with a goal for the year to file six ANDAs with the FDA and exceeded this goal by filing eight," added Larry Hsu, PhD, IMPAX's President and Chief Operating Officer Chief Operating Officer (COO) The officer of a firm responsible for day-to-day management, usually the president or an executive vice-president. . "We also received FDA approval for marketing of Sotalol Hydrochloride sotalol hydrochloride Beta-Cardone (UK), Betapace, Betapace AF, Sotacor (CA) (UK) Pharmacologic class: Beta-adrenergic blocker (nonselective) Therapeutic class: Antiarrhythmic (classes II and III) , a generic version of Betapace Betapace® Sotalol, see there (R), for the treatment of documented ventricular arrhythmias ventricular arrhythmia An abnormal, usually rapid, heart rhythm that arises in a ventricle; VAs are often life threatening and 2º to myocardial infarction Examples V tach, V fib , our second ANDA approval for the year." Dr. Hsu continued, "Looking at the coming year, we plan to file 6 to 8 more ANDAs. We also plan to continue to develop our branded product pipeline, working on three development projects directed toward the central nervous system (CNS See Continuous net settlement. CNS See continuous net settlement (CNS). ) disorders, one of which we plan to file in the second half of 2001." IMPAX currently has eight ANDA filings pending at the FDA that address more than $5.6 billion in U.S. branded product sales. Seven of these filings were made under Paragraph IV of the Hatch-Waxman Amendments. IMPAX Laboratories, Inc. was formed as the result of a business combination by merger on December 14, 1999, of IMPAX Pharmaceuticals, Inc., a privately held drug delivery company and Global Pharmaceutical Corporation, a specialty generic pharmaceutical company. The merger was accounted for as a reverse acquisition of Global by IMPAX Pharmaceuticals, with IMPAX Pharmaceuticals deemed the acquirer under the purchase accounting method for financial reporting purposes. Accordingly, the financial results for 1999 include those of IMPAX Pharmaceuticals, Inc. through December 14, 1999, and for the combined company for the period between December 15 and December 31, 1999. On a pro-forma basis, if the merger had occurred on January 1, 1999, IMPAX Laboratories, Inc would have reported revenues of $10,170,000 for the year ended December 31, 2000 compared to $9,446,000 for the year ended December 31, 1999. "As we previously indicated," Mr. Edwards stated, "we are in a transitional period as we transfer the manufacturing operations Manufacturing operations concern the operation of a facility, as opposed to maintenance, supply and distribution, health, and safety, emergency response, human resources, security, information technology and other infrastructural support organizations. from Philadelphia to Hayward. Because we also made the decision to eliminate products that accounted for approximately 35% of sales, the fourth quarter results reflect these changes as compared to previous quarters. These products do not support the long term view of our strategy and opportunities for the Company." IMPAX Laboratories, Inc. is a technology based specialty pharmaceutical company applying its formulation formulation /for·mu·la·tion/ (for?mu-la´shun) the act or product of formulating. American Law Institute 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 Hayward is a city located in the East Bay in Alameda County. The sixth largest city in the San Francisco Bay Area, it is one of the larger suburbs of Oakland. As of the 2000 census, the city population was 140,030. The estimated population in 2007 is 155,312. , 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. "Safe Harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. " statement under the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and To the extent any statements made in this news release contain information that is not historical, these statements are essentially forward-looking and are subject to risks and uncertainties, including the difficulty of predicting FDA filings and approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, uncertainty of patent litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. filed against us, availability of raw materials, the regulatory environment, fluctuations in operating results and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission.
IMPAX LABORATORIES, INC.
CONDENSED BALANCE SHEETS
(in thousands)
December 31, December 31,
2000 1999
(Unaudited)
Assets
Cash, cash equivalents
and short-term investments $ 19,228 $ 7,413
Accounts receivable, net 1,762 3,973
Inventories, net 2,949 2,022
Property, plant and equipment, net 9,699 8,128
Goodwill and intangibles, net 32,609 39,250
Other assets 1,062 919
------------- ------------
Total assets $ 67,309 $ 61,705
------------- ------------
Liabilities and Stockholders' Equity
Current liabilities $ 6,507 $ 7,417
Long-term debt net of current portion 1,345 1,490
Other liabilities 400 520
Mandatorily redeemable convertible
Preferred Stock 28,303 22,000
Stockholders' equity 30,754 30,278
------------ ------------
Total liabilities and
stockholders' equity $ 67,309 $ 61,705
------------ ------------
IMPAX LABORATORIES, INC.
STATEMENT OF OPERATIONS
(unaudited)
(dollars in thousands, except share and per share data)
NOTE: The financial results, including the effect of conforming to
SAB101, are as follows:
Three Months Ended Twelve Months Ended
December 31, December 31,
2000 1999 2000 1999
---- ---- ---- ----
Net sales $ 1,300 $ 1,240 $ 10,170 $ 1,240
Cost of sales 1,857 925 9,716 925
---------- ---------- ----------- ----------
Gross margin (loss) (557) 315 454 315
Research and
development 2,651 1,659 11,096 6,479
Acquired in-process
research and
development - 1,379 - 1,379
Selling, general
and
administrative(a) 2,800 838 11,110 1,833
Other operating
income, net 91 - 306 43
Restructuring charges
and non-recurring
items(b) - - 3,646 -
---------- ---------- ----------- ---------
Net loss from
operations (5,917) (3,561) (25,092) (9,333)
Interest income,
net 113 70 419 384
----------- ---------- ----------- ----------
Net loss before
cumulative
effect of
accounting
change $ (5,804) $ (3,491) $ (24,673) $ (8,949)
Cumulative
effect of
accounting
change (SAB101) - - (288) -
Net loss after
cumulative effect
of accounting
change $ (5,804) $ (3,491) $ (24,961) $ (8,949)
=========== ========== =========== ==========
Net loss per
share
(basic and
diluted) $ (0.20) $ (0.35) $ (0.91) $ (1.12)
========== ========== ============ ==========
Weighted average
common shares
outstanding 29,544,225 10,112,567 27,538,989 7,998,665
=========== ============ ============ ===========
(a) Includes amortization of intangibles and goodwill of $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 recorded and reported in September 2000.
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