IMPAX Reports Record First Quarter Results; Quarter Highlighted by Record Revenues and Litigation Progress.Business Editors/Health/Medical Writers 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)--April 30, 2003 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 :IPXL) today reported financial results for the three months ended March 31, 2003. Revenues for the first quarter of 2003 were $11,425,000, up more than 232% compared with revenues of $3,432,000 in the prior year's first quarter, and up more than 36% over total revenues of $8,400,000 in the fourth quarter of 2002. The significant year-over-year increases came primarily on Claritin-D(R) 12-hour over-the-counter (OTC OTC See: Over-the-counter. OTC See over-the-counter market (OTC). ) Tablets shipped to Schering-Plough during the first quarter of 2003; higher sales of 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, introduced at the end of the first quarter of 2002; higher Lipram sales; sales of Minocycline Hydrochloride min·o·cy·cline hydrochloride n. A broad-spectrum antibiotic derived from tetracycline. minocycline hydrochloride Capsules launched in the third quarter of 2002; and lower product returns. The net loss for the 2003 first quarter was $3,213,000, or $(0.07) per share, compared with a net loss of $5,421,000, or $(0.12) per share, in the prior year first quarter. Net loss narrowed due to increased sales, which was partially offset by increases in research and development expenses. 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 (unrestricted) were $11.2 million at March 31, 2003, compared to $10.2 million at December 31, 2002. "We continue our rapid sequential quarter improvement as we execute on our commercial strategy," commented Barry R. Edwards, Co-Chief Executive Officer of IMPAX Laboratories. "In addition, we have made progress in resolving much of the outstanding 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. which stood in the way of obtaining final 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. approval for two of our products. We recently prevailed in Abbott's patent infringement patent infringement n. the manufacture and/or use of an invention or improvement for which someone else owns a patent issued by the government, without obtaining permission of the owner of the patent by contract, license or waiver. lawsuit lawsuit: see procedure; tort. regarding our ANDA ANDA abbr. abbreviated new drug application filing for generic 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) capsules, and Merck withdrew its lawsuit related to our ANDA filing for generic Sinemet Sin·e·met A trademark for the drug combination of carbidopa and L-dopa. carbidopa-levodopa Co-carledopa (UK), Half Sinemet (UK), Sinemet, Sinemet CR, Tilolec (UK) Pharmacologic class: (R) CR tablets." IMPAX has 19 applications pending at the FDA, including three tentatively ten·ta·tive adj. 1. Not fully worked out, concluded, or agreed on; provisional: tentative plans. 2. Uncertain; hesitant. approved, that address approximately $6.0 billion in U.S. branded product sales for the twelve months ended December 31, 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 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 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 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. As previously announced, the Company has scheduled a conference call to discuss this announcement beginning at 8:00 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 April 30, 2003 through midnight Eastern Time May 2, 2003, by dialing (800) 642-1687 in the U.S. or (706) 645-9291 for international callers, and entering access code 9890648. Alternatively, individuals may listen to the call by visiting the investor relations Investor relations The process by which the corporation communicates with its investors. section of the Company's website at www.impaxlabs.com. To listen to the live call, please go to the website 15 minutes prior to its start to register, download To receive a file transmitted over a network. In any communications session, "download" means receive, and "upload" means send. The download/upload often implies a big/little scenario, in which data is being downloaded from the "big" server into the "little" user's computer. and install the necessary audio software. A recording of the call will be available for 14 days on the site beginning on April 30, 2003. "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 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 forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. . 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
(dollars in thousands, except share and per share data)
Three Months Ended
March 31,
2003 2002
Net sales $ 11,066 $ 3,432
Other revenues 359 --
Total revenues 11,425 3,432
Cost of sales 8,147 3,139
Gross margin 3,278 293
Research and development 3,755 2,890
Less: Teva payments (132) (166)
Research and development, net 3,623 2,724
Selling expenses 568 658
General and administrative expenses 2,122 2,170
Other operating income (expense), net 11 (30)
Net loss from operations (3,024) (5,289)
Interest income 42 235
Interest expense (231) (367)
Net loss $ (3,213) $ (5,421)
Net loss per share (basic and diluted) $ (0.07) $ (0.12)
Weighted average common shares outstanding 47,876,830 46,812,977
IMPAX LABORATORIES, INC.
CONDENSED BALANCE SHEET
(in thousands)
March 31, December 31,
2003 2002
(unaudited) (unaudited)
ASSETS
Cash, cash equivalents and short-term
investments $ 11,224 $ 10,219
Restricted cash(a) 10,000 10,000
Accounts receivable, net 5,734 6,524
Inventory 12,788 10,478
Property, plant and equipment, net 36,974 37,065
Goodwill and intangibles, net 28,241 28,337
Other assets 1,730 1,780
Total assets $ 106,691 $ 104,403
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities $ 27,144 $ 23,248
Long-term debt, net of current portion 9,643 9,105
Refundable deposit 22,000 22,000
Deferred revenues and other liabilities 2,419 1,486
Mandatory redeemable convertible preferred stock 7,500 7,500
Stockholders' equity 37,985 41,064
Total liabilities and stockholders' equity $ 106,691 $ 104,403
(a) Represents cash held as collateral for the $25 million revolving
credit facility and term loan with Congress Financial.
|
|
||||||||||||

Printer friendly
Cite/link
Email
Feedback
Reader Opinion