Faulding reports breakeven result for its 1st quarter.ELIZABETH, N.J.--(BUSINESS WIRE)--Nov. 4, 1996-- - Company has new Clonazepam clonazepam /clo·naz·e·pam/ (klo-naz´e-pam) a benzodiazepine used as an anticonvulsant and as an antipanic agent. clo·naz·e·pam n. approval and 14 submissions pending 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 Following its early 1996 restructuring restructuring - The transformation from one representation form to another at the same relative abstraction level, while preserving the subject system's external behaviour (functionality and semantics). and return to profitability in the quarter ended June 30, Faulding Inc. maintained a profitable course with a small gain in the first quarter of the current fiscal year, it was reported today by Richard F. Moldin, president and chief executive officer. The company had net income of $34,000 on sales of $18.6 million, compared with a restated net loss of $2.8 million on sales of $15.6 million in the prior year's quarter ended September 30, and further compared with earnings of $666,000 on sales of $23.6 million during its fiscal fourth quarter ended June 30, 1996. After payment of preferred dividends preferred dividend n. a payment of a corporation's profits to holders of preferred shares of stock. (See: preferred stock) , there was a loss of 4 cents per common share compared with a restated loss of 22 cents per common share in the prior year's quarter. The Purepac oral generic drug generic drug, a drug sold or prescribed under the nonproprietary name of its active ingredients or under a generally descriptive name rather than under a brand or trade name. line had net income of $1.0 million in the current quarter compared with a net loss of $1.1 million in the 1995 quarter. As anticipated, these gains were offset somewhat by costs associated with the start-up Start-up The earliest stage of a new business venture. businesses acquired in February 1996, which have been included in the 1995 restated results. Moldin stated that the decline in first quarter sales from the immediately preceding quarter resulted from a combination of factors, including expected fall-off from the prior quarter which saw the launch of new diclofenac sodium diclofenac sodium Voltaren, Voltaren XR Pharmacologic class: Cyclooxygenase inhibitor, nonsteroidal anti-inflammatory drug (NSAID) Therapeutic class: Nonopioid analgesic, antiarthritic , diflunisal and indapamide products and the commencement of contract manufacture of the modified release morphine morphine, principal derivative of opium, which is the juice in the unripe seed pods of the opium poppy, Papaver somniferum. It was first isolated from opium in 1803 by the German pharmacist F. W. A. product Kadian(TM), and changes in buying practices by certain of the company's customers. "New products introduced earlier in 1996 boosted our first-quarter sales above the 1995 first-quarter level - particularly our diclofenac sodium tablets for arthritis arthritis, painful inflammation of a joint or joints of the body, usually producing heat and redness. There are many kinds of arthritis. In its various forms, arthritis disables more people than any other chronic disorder. ," said Moldin. "However, the rapid changes in the health-care industry are presenting special challenges to each new quarter." Moldin said Faulding is addressing these challenges by seeking to increase its new product submissions to the Food and Drug Administration (FDA) and investing substantially in its new start-up injectable in·ject·a·ble adj. Capable of being injected. Used of a drug. n. A drug or medicine that can be injected. drug and medical device businesses. On Nov. 1, 1996 the company announced that its wholly-owned subsidiary, Purepac Pharmaceutical Co., had received approval from the FDA to market clonazepam tablets, the generic equivalent of the anti-convulsant drug Klonopin(R), and that it expected to commence shipment of that product to customers early in calendar 1997. Commenting on that approval, Moldin stated that, "One of the positive aspects of this approval was the relatively fast approval time frame of less than 8 months since the filing of the submission with the FDA." "Our new product submissions to the FDA now total 14 - a record level for the company and nearly triple the number of products in the FDA pipeline in mid-1995. We anticipate FDA approval of two more of these drugs in this calendar year. With both of these new products, we importantly could have the potential to participate in the formation of the generic market at patent expiration EXPIRATION. Cessation; end. As, the expiration of, a lease, of a contract, or statute. 2. In general, the expiration of a contract puts an end to all the engagements of the parties, except to those which arise from the non- fulfillment of obligations created of the brand product," Moldin said. "Furthermore," the CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. pointed out, "in the past 10 months Faulding has received FDA approval for and has commercialized a total of four new drugs - double the whole previous year's performance. To meet our customers' demands for a broader product line, we also have an expansion well underway at our injectable drug plant in Puerto Rico Puerto Rico (pwār`tō rē`kō), island (2005 est. pop. 3,917,000), 3,508 sq mi (9,086 sq km), West Indies, c.1,000 mi (1,610 km) SE of Miami, Fla. ." Faulding Inc. develops, manufactures and markets human pharmaceuticals and medical devices. Faulding Inc. is the former Purepac Inc., which changed its name following its recent expansion beyond oral dosage forms A dosage form is the physical form of a dose of medication, such as a capsule or injection. The route of administration is dependent on the dosage form of a given drug. into injectable drugs and drug delivery devices. The shares of Faulding are traded on 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 under the symbol "FAUL FAUL Federação da Área Urbana de Lisboa (Partido Socialista - Portugal) ." Note: Klonopin(R) is a registered trademark of Roche Laboratories.
(Dollars in Millions Except Per Share Earnings)
Three Months Ended
Sept. 30,
Condensed Summary of Operations (Unaudited) 1996 1995(a)
Net sales $18.6 $15.6
Cost of sales 13.0 13.7
Gross profit 5.6 1.9
Expenses:
Selling, general and administrative 3.0 2.9
Research and development 2.5 2.2
Total expenses 5.5 5.1
Income (loss) from operations 0.1 (3.2)
Other income (expense), net (0.1) (0.3)
Income (loss) before income taxes -- (3.5)
Provision (benefit) for income taxes -- (0.7)
Net income (loss) 0.034 (2.8)
Preferred stock dividends 0.7 0.5
Net income (loss), available for common stock $ (0.7) $ (3.3)
Net income (loss) per common share (b) $(0.04) $ (.22)
Weighted average number of common shares
outstanding (thousands) 15,065 15,019
(a) 1995 results restated to reflect businesses acquired Feb. 29, 1996.
(b) Net income (loss) per common share is computed by adjusting for
the company's preferred stock dividend. Fully Diluted Earnings
Per Common Share are not presented as the effect would be
anti-dilutive.
Condensed Consolidated Balance Sheets (Unaudited) (Audited)
9/30/1996 6/30/1996
Assets:
Cash and cash equivalents $ 2.4 $ 1.9
Other current assets 51.7 50.2
Property, plant and equipment, net 42.3 41.5
Other assets 5.5 5.1
Total assets $101.9 $ 98.7
Liabilities and Stockholders' Equity:
Current liabilities $ 19.6 $ 15.8
Long term liabilities -- --
Stockholders' equity 82.3 82.9
Total liabilities and stockholders' equity $ 101.9 $ 98.7
CONTACT: Faulding Inc. Lee Craker, 908/527-9100 |
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