IMPAX Reports First Quarter Financial Results; Quarter Highlights Include FDA Approval and Tentative Approval of ANDAs and Higher Revenues.Business Editors & Health/Medical Writers HAYWARD, Calif.--(BW HealthWire)--April 30, 2002 IMPAX Laboratories, Inc. (Nasdaq: 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 terbutaline sulfate (terbū´t  lēn´),n brand names: Brethaire, Brethine, Bricanyl; drug class: Tablets in June 2001 and Fludrocortisone Acetate flu·dro·cor·ti·sone acetate n. A synthetic mineralocorticoid used to increase blood pressure by lowering the amount of salt the body excretes and to treat adrenocortical insufficiency resulting from Addison's disease. 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 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 the expansion of our sales and marketing capabilities, partially offset by higher revenues. The 2002 first quarter net loss was also favorably fa·vor·a·ble adj. 1. Advantageous; helpful: favorable winds. 2. Encouraging; propitious: a favorable diagnosis. 3. impacted by the absence of goodwill amortization expense of approximately $876,000. 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 $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 Net Proceeds The amount received after all costs are deducted from the sale of a piece of property or security. Notes: In the case of an investor selling a security, net proceeds represent the proceeds from the sale minus any trading costs (i.e. commissions). 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 tentative, adj not final or definite, such as an experimental or clinical finding that has not been validated. approval by the U.S. 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. ) of our ANDA ANDA abbr. abbreviated new drug application for a generic version of Tricor TriCor® Fenofibrate Cardiology An adjunct to diet for managing stratospheric serum TG levels in Pts unresponsive to diet or at risk of pancreatitis (R) (Fenofibrate fenofibrate /fen·o·fi·brate/ (fen?o-fi´brat) an antihyperlipidemic agent used to reduce elevated serum lipids. fenofibrate ), Micronized, and the approval by the FDA of our ANDA for a generic version of Florinef Flor·i·nef A trademark for the drug fludrocortisone acetate. fludrocortisone acetate Florinef (UK), Florinef Acetate Pharmacologic class: Adrenocorticoid Therapeutic class: (R) (Fludrocortisone Acetate Tablets). During the quarter, the FDA also accepted the filing of ANDAs for a generic version of Allegra-D Allegra-D® Fexofenadine/pseudoephedrine Allergy medicine A nonsedating antihistamine with a decongestant for relief of seasonal allergic rhinitis. See Allergic rhinitis, Antihistamine. (R) (Fexofenadine HCl/Pseudoephedrine HCl) Extended Release 60mg/120mg Tablets (our eighth Paragraph IV filing) and for a generic version of Oxycontin Ox·y·con·tin A trademark for the drug oxycodone. oxycodone hydrochloride ETH-Oxydose, OxyContin, OxyFast, Oxy-IR, Oxynorm (UK), Roxicodone, Supeudol (CA) Pharmacologic class: Opioid agonist (R) (Oxycodone oxycodone /oxy·co·done/ (-ko´don) an opioid analgesic derived from morphine; used in the form of the hydrochloride and terephthalate salts. ox·y·co·done n. 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 Chief Operating Officer (COO) The officer of a firm responsible for day-to-day management, usually the president or an executive vice-president. , 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 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, 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.
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
------- ------
Gross margin (loss) 293 (504)
Research and development 2,890 2,595
Less: Teva payments (166) -
------ ------
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
------ -----
Net loss from operations (5,289) (5,550)
Interest income 235 262
Interest expense(b) (367) (50)
------ ------
Net loss $ (5,421) $ (5,338)
======= =======
Net loss per share (basic and
diluted) $ (0.12) $ (0.16)
======= =======
Weighted average common shares
outstanding 46,812,977 33,951,876
=========== ==========
(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
--------- --------
Total assets $ 99,041 $ 97,322
--------- --------
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
--------- ---------
Total liabilities and
stockholders'
equity $ 99,041 $ 97,322
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