IMPAX Reports Third Quarter Financial Results; Two ANDAs Filed with FDA in Quarter; Six ANDAs Filed Year-to-Date.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.--(BW HealthWire)--Oct. 30, 2001 IMPAX Laboratories, Inc. (Nasdaq:IPXL) today reported financial results for the three and nine months ended September September: see month. 30, 2001. Revenues for the third quarter of 2001 were $1,658,000 compared with $2,777,000 in the prior-year third quarter and were approximately 46% higher than revenues of $1,136,000 in the second quarter of 2001. The decline in revenues from the prior year is attributed primarily to the discontinuation dis·con·tin·u·a·tion n. A cessation; a discontinuance. Noun 1. discontinuation - the act of discontinuing or breaking off; an interruption (temporary or permanent) discontinuance of certain products as the Company prepared to shift production to its new 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. from 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. . On a sequential quarter basis however, revenues were higher owing to owing to prep. Because of; on account of: I couldn't attend, owing to illness. owing to prep → debido a, por causa de sales of Terbutaline Sulfate terbutaline sulfate (terbū´t  lēn´),n brand names: Brethaire, Brethine, Bricanyl; drug class: tablets, a generic version of Brethine(R), which began shipment in late June June: see month. and the reintroduction Noun 1. reintroduction - an act of renewed introduction intro, introduction, presentation - formally making a person known to another or to the public of two products which were previously discontinued dis·con·tin·ue v. dis·con·tin·ued, dis·con·tin·u·ing, dis·con·tin·ues v.tr. 1. To stop doing or providing (something); end or abandon: : Methitest(TM), a generic alternative to Android/Testred and Aminobenzoate aminobenzoate /ami·no·ben·zo·ate/ (-ben´zo-at) p- aminobenzoate, any salt or ester of aminobenzoic acid; the potassium salt is used as an antifibrotic in some dermatologic disorders and various esters are used as topical sunscreens. Potassium potassium (pətăs`ēəm), a metallic chemical element; symbol K [Lat. kalium=alkali]; at. no. 19; at. wt. 39.0983; m.p. 63.25°C;; b.p. 760°C;; sp. gr. .862 at 20°C;; valence +1. , a generic alternative to Potaba. The net loss for the 2001 third quarter was $6,769,000, or $0.15 per share, including amortization of intangibles and goodwill of $969,000, or $0.02 per share. This compares with a net loss of $9,618,000, or $0.38 per share, including amortization of intangibles and goodwill of $1,151,000, or $0.05 per share, and the one-time 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 $0.14 per share, in the prior-year third 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 $41.7 million at September 30, 2001 compared with $19.2 million at December 31, 2000. During the quarter, IMPAX issued 238,353 shares of common stock to Teva Pharmaceuticals, 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 approximately $3.75 million. Under the terms of a strategic alliance announced in June 2001, Teva is to make equity investments in IMPAX totaling $15 million under a fixed schedule through June 2002. For the nine months ended September 30, 2001, the Company reported sales of $4,566,000, compared with $8,870,000 in the comparable period the previous year. The net loss through September 30, 2001 was $18,257,000, or $0.46 per share, including amortization of intangibles and goodwill of $2,913,000 or $0.07 per share. This compares with a net loss of $19,157,000, or $0.77 per share, including amortization of intangibles and goodwill of $3,623,000, or $0.15 per share, and one-time restructuring charges and non-recurring items of $3,646,000 or $0.15 per share, in the comparable nine month period. "The third quarter showed a turnaround Turnaround A situation where a company that has had poor performance for an extended period of time experiences a positive reversal. Notes: A speculator may profit from a turnaround if he or she accurately anticipates the improvement of a poorly performing company. in sales," said Barry R. Edwards, Co-CEO. "We expect continued sequential quarter improvement in the fourth quarter and through 2002, as we get marketing approval for new products and bring previously discontinued marketed products, back into production in our California California (kăl'ĭfôr`nyə), most populous state in the United States, located in the Far West; bordered by Oregon (N), Nevada and, across the Colorado River, Arizona (E), Mexico (S), and the Pacific Ocean (W). facility." Larry Hsu, President and COO (Cell Of Origin) See mobile positioning. added: "We filed two more new ANDAs with the U.S. Food and Drug Administration during the quarter, for a total of six this year. We continue to be on track for filing six to eight new ANDAs in 2001." IMPAX currently has 13 ANDA ANDA abbr. abbreviated new drug application filings pending at the 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. that address more than $7.3 billion in annual U.S. branded product sales. Seven 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 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 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. Reform Act 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 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.
STATEMENT OF OPERATIONS
(unaudited)
(dollars in thousands, except share and per share data)
Three Months Ended Nine Months Ended
September 30, September 30,
2001 2000 2001 2000(aa)
----------- ----------- ----------- -----------
Net sales $ 1,658 $ 2,777 $ 4,566 $ 8,870
Cost of sales 2,247 2,921 6,515 7,859
----------- ----------- ----------- -----------
Gross margin (loss) (589) (144) (1,949) 1,011
Research and development 3,673 2,958 8,983 8,445
Less: TEVA payments (399) -- (699) --
----------- ----------- ----------- -----------
Research and
development, net 3,274 2,958 8,284 8,445
Selling expenses 592 401 1,715 1,061
General and
administrative(a) 2,269 2,617 6,664 7,249
Other operating
income, net -- 61 64 215
Restructuring charges
and non-recurring items(aaa) -- 3,646 -- 3,646
----------- ----------- ----------- -----------
Net loss from operations (6,724) (9,705) (18,548) (19,175)
Interest income 412 198 835 560
Interest expense (457) (111) (544) (254)
----------- ----------- ----------- -----------
Net loss before
cumulative effect
of accounting change (6,769) (9,618) (18,257) (18,869)
Cumulative effect
of accounting
change (SAB101) -- -- -- (288)
----------- ----------- ----------- -----------
Net loss $ (6,769)$ (9,618)$ (18,257)$ (19,157)
=========== =========== =========== ===========
Net loss per share before
cumulative effect of
accounting change $ -- $ -- $ -- $ (0.76)
=========== =========== =========== ===========
Net loss per share
(basic and diluted) $ (0.15)$ (0.38)$ (0.46)$ (0.77)
=========== =========== =========== ===========
Weighted average
common shares
outstanding ----------- ----------- ----------- -----------
45,943,604 25,094,236 39,932,294 24,843,452
=========== =========== =========== ===========
(a) Includes amortization of intangibles and goodwill of $969K in
the quarter ended September 30, 2001, and $2,913K in the nine
months ended September 30, 2001, compared to $1,151K in the
quarter ended September 30, 2000, and $3,623K in the nine
months ended September 30, 2000.
(aa) Includes the effects of SAB 101. Excluding the impact of SAB
101, amounts previously reported for net sales and gross
margin were $8,203K and $723K, respectively.
(aaa) 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.
SELECTED BALANCE SHEET
(unaudited)
(in thousands)
Sept. 30, Dec. 31,
2001 2000
--------- ---------
ASSETS
Cash, cash equivalents
and short-term investments $ 41,744 $ 19,228
Accounts receivable, net 3,282 1,762
Inventory 3,556 2,949
Property, plant
and equipment, net 15,820 9,699
Goodwill and intangibles, net 29,693 32,609
Other assets 1,804 1,062
--------- ---------
Total assets $ 95,899 $ 67,309
--------- ---------
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities $ 6,507 $ 6,507
Long-term debt, net
of current portion 26,131(a) 1,345
Other liabilities 400 400
Mandatorily redeemable
convertible preferred stock 7,500 28,303
Stockholders' equity 55,361 30,754
--------- ---------
Total liabilities and
stockholders' equity $ 95,899 $ 67,309
--------- ---------
(a) Includes refundable deposit from TEVA and related accrued
interest payable of $22,438,000
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