Taro Pharmaceuticals Reports Second- Quarter, Six-Month Results; ANDA Approval of Hydrocortisone Valerate Cream USP, 0.2% and Hydrocortisone Valerate Ointment 0.2%.HAWTHORNE Hawthorne. 1 City (1990 pop. 71,349), Los Angeles co., S Calif., a suburb of Los Angeles; inc. 1922. Located in an oil- and gas-producing area, Hawthorne manufactures navigation systems, solar panels, electronic components, silicon instruments, and , New York--(BUSINESS WIRE)--Aug. 28, 1998--Taro Pharmaceutical Industries Ltd. (Nasdaq NM:TAROF) Friday Friday: see Sabbath; week. Friday young Indian rescued by Crusoe and kept as servant and companion. [Br. Lit.: Robinson Crusoe] See : Servant reported financial results for the second quarter and the first six months of 1998. Second quarter 1998 net sales Net Sales The amount a seller receives from the buyer after costs associated with the sale are deducted. Notes: This amount is calculated by subtracting the following items from gross sales: merchandise returned for credit, allowances for damaged or missing goods, freight increased to $16,260,000, from $15,570,000 for the second quarter of 1997. Net income for the quarter was $320,000, or $0.03 per share, compared with $407,000, or $0.04 per share, for the second quarter of the prior year. The company's gross profit increased in the second quarter of 1998 to $8,833,000, or 54% of sales, up from $7,751,000, or 50% of sales for the second quarter of 1997. The increase in gross profit reflects increased manufacturing efficiencies resulting from the company's ongoing capital improvement program. Selling, general and administrative expenses increased to $5,303,000, or 33% of sales, for the second quarter of 1998, compared with $4,416,000, or 28% of sales for the second quarter of 1997. The increase in SG&A is partially related to costs associated with the implementation of a new computer system, related hardware, and Year 2000 compliance issues. R&D expenses remained steady as a percentage of sales, at $2,442,000, or 15% of sales for the second quarter of 1998, compared with $2,336,000, or 15% of sales for the second quarter of 1997. Recent Approvals As previously announced, Taro Pharmaceuticals Inc., the company's wholly owned Canadian Canadian (kənā`dēən), river, 906 mi (1,458 km) long, rising in NE New Mexico. and flowing E across N Texas and central Oklahoma into the Arkansas River in E Oklahoma. subsidiary, received notification from 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. ) approving its 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) for Hydrocortisone Valerate hydrocortisone valerate Westcort Pharmacologic class: Short-acting corticosteroid Therapeutic class: Anti-inflammatory (steroidal) Pregnancy risk category C ActionCream USP USP - unique sales point , 0.2% and Hydrocortisone Valerate Ointment ointment /oint·ment/ (oint´ment) a semisolid preparation for external application to the skin or mucous membranes, usually containing a medicinal substance.oint·ment n. 0.2%. The company has started shipping these products. The company believes it is currently the only generic manufacturer of the ointment product. Taro's Hydrocortisone Valerate products are topical corticosteroids Topical corticosteroids Cortisone and related drugs used on the skin and in the eye, usually for allergic conditions. Mentioned in: Corneal Ulcers used in the treatment of a variety of inflammatory dermatologic dermatological, dermatologic pertaining to dermatology; of or affecting the skin. conditions. The products are bioequivalent bi·o·e·quiv·a·lent n. A value indicating the rate at which a substance enters the bloodstream and becomes available to the body. to Westwood Squibb's Westcort Cream and Ointment. The U.S. combined market for Hydrocortisone Valerate Cream and Ointment is estimated by industry sources to be approximately $48 million. In July, the FDA approved the Canadian subsidiary's ANDA ANDA abbr. abbreviated new drug application for Desoximetasone desoximetasone /des·ox·i·met·a·sone/ (des-ok?se-met´ah-son) a synthetic corticosteroid used topically for the relief of inflammation and pruritus in corticosteroid-responsive dermatoses. Gel USP, 0.05%. Taro's Desoximetasone Gel is bioequivalent to Hoechst Marion Roussell's Topicort Top·i·cort A trademark for the drug desoximetasone. Gel. This product is an important extension to Taro's existing line of Desoximetasone Cream and Ointment products. Taro is currently the only generic manufacturer of this dosage form 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. of desoximetasone, and expects to begin shipment in the third quarter of 1998. "In addition to our investments in research and development of novel compounds and delivery systems, Taro is committed to remaining a leader in the dermatologic pharmaceutical market. Among the benefits of our investments in R&D are these valuable additions to our topical topical /top·i·cal/ (top´i-k'l) pertaining to a particular area, as a topical antiinfective applied to a certain area of the skin and affecting only the area to which it is applied. top·i·cal adj. corticosteroid corticosteroid /cor·ti·co·ster·oid/ (-ster´oid) any of the steroids elaborated by the adrenal cortex (excluding the sex hormones) or any synthetic equivalents; divided into two major groups, the glucocorticoids and product line," said Barrie Levitt M.D., chairman of the company. Six-Month Results For the six-month period ended June 30, 1998, sales were $29,759,000, compared with $28,253,000 for the same period in 1997. Net income for the six-month period was $409,000, or $0.04 per share, compared with $482,000, or $0.05 per share for the same period in 1997. Selling, general and administrative expenses for the six-month period were $9,907,000, or 33% of sales, compared with $8,865,000, or 31% of sales for the same period in 1997. R&D expenses were $4,717,000, or 16% of sales, compared with $4,273,000, or 15% of sales for the same period in 1997. The company's gross profit remained high for the six months ended June 30, 1998, at $16,286,000, or 55% of sales, compared with $14,625,000, or 52% of sales for the same period in 1997. Strong Balance Sheet The company maintains a strong balance sheet. As of June 30, 1998, shareholders' equity Shareholders' Equity A firms' total assets minus its total liabilities. Equivalently, it is share capital plus retained earnings minus treasury shares. Shareholders' equity is the amount by which a company is financed through common and preferred shares. was $27,450,000, total assets were $78,009,000 and total liabilities were $50,477,000. Bright Outlook "In the remainder of 1998 and into 1999 the company looks forward to increased sales and profitability from generic products which have already been approved, new packaging sizes, and additional new product introductions," said Levitt. "We are working to achieve further increases in manufacturing and cost efficiencies, and to reduce selling, general, and administrative expenses as well as R&D expenses as a percentage of sales." Taro currently has nine ANDAs submitted to the FDA, in addition to multiple international regulatory filings. Taro Pharmaceutical Industries is a multinational pharmaceutical company whose research and development program has resulted in the company being the first generic marketer of several branded drugs as well as the developer of several novel pharmaceutical compounds. For further information on Taro Pharmaceutical Industries, visit the company's Web site at http://www.taropharma.com. To receive additional information on Taro, via fax at no charge, dial 800/PRO-INFO and enter company code TAROF. Certain statements in this release, including but not limited to success in various markets by the company's products, the results expected from research and development, and expected approvals by the U.S. Food and Drug Administration, are 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. within the meaning of 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. Although Taro Pharmaceutical Industries Ltd. believes the expectations reflected in such forward-looking statements to be based on reasonable assumptions, it can give no assurance that its expectations will be attained at·tain v. at·tained, at·tain·ing, at·tains v.tr. 1. To gain as an objective; achieve: attain a diploma by hard work. 2. . Factors that could cause actual results to differ materially from the company's expectations include industry and market conditions, slower than anticipated penetration of new markets, changes in the company's financial position, regulatory actions, and other risks detailed from time to time in the company's Securities and Exchange Commission reports, including its Annual Report on Form 20-F for the last fiscal year ended Dec. 31, 1997.
TARO PHARMACEUTICAL INDUSTRIES LTD.
SUMMARY CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands)
June 30 Dec. 31
1998 1997
(Unaudited) (Audited)
Assets
Current Assets:
Cash and Cash Equivalents $ 2,546 $ 2,706
Accounts Receivable 22,882 21,443
Inventories 17,291 14,795
Total Current Assets 42,719 38,944
Property, Plant
and Equipment, net 29,970 28,731
Other Assets 5,320 5,415
Total Assets $78,009 $73,090
Liabilities and Shareholders' Equity
Current Liabilities:
Short-Term Bank Credits $16,934 $11,139
Current Maturities
of Long-Term Liabilities 2,133 2,533
Accounts Payable
and Accrued Expenses 13,184 14,852
Total Current Liabilities 32,251 28,524
Long-Term Liabilities 17,170 16,115
Deferred Taxes
and Other Liabilities 1,056 1,043
Total Liabilities 50,477 45,682
Minority Interest 82 100
Shareholders' Equity 27,450 27,308
Total Liabilities
and Shareholders' Equity $78,009 $73,090
TARO PHARMACEUTICAL INDUSTRIES LTD.
SUMMARY CONSOLIDATED STATEMENTS OF INCOME
(US dollars in thousands, except per share data)
(Unaudited)
Three Months Ended Six Months Ended
June 30, June 30,
1998 1997 1998 1997
Sales $ 16,260 $ 15,570 $ 29,759 $ 28,253
Cost of Sales 7,427 7,819 13,473 13,628
Gross Profit 8,833 7,751 16,286 14,625
Operating Expenses:
Selling and
Administrative 5,303 4,416 9,907 8,865
Operating income
before Research
and Development 3,530 3,335 6,379 5,760
Research
and Development 2,442 2,336 4,717 4,273
Operating Income 1,088 999 1,662 1,487
Financial
Expenses - Net 758 445 1,348 903
330 554 314 584
Other Income
- Net 21 2 46 9
351 556 360 593
Taxes on Income 34 146 (32) 121
317 410 392 472
Minority Share
in Profit
(Losses) of
Subsidiaries (3) 3 (17) (10)
Net Income $ 320 $ 407 $ 409 $ 482
Earnings per
Ordinary
Share $ 0.03 $ 0.04 $ 0.04 $ 0.05
Diluted earnings
per Ordinary
Share $ 0.03 $ 0.04 $ 0.04 $ 0.05
Weighted average
number of
shares -
Basic EPS 10,004,081 9,975,081 10,004,081 9,975,081
Diluted EPS 10,115,714 10,395,138 10,109,207 10,610,912
CONTACT: Taro Pharmaceutical Industries Ltd., Hawthorne Kevin Connelly Kevin Connelly was born in Middlesbrough, England. He is an impressionist comedian, and after dinner speaker and is probably most famous for his role on the popular BBC television programme 'Dead Ringers'. , 914/345-9001 or The Financial Relations Board Daniel Saks, General Information, 310/442-0599 Kathy Brunson, Analyst Information, 312/266-7800 |
|
||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion