Taro Pharmaceuticals Reports Record Fourth Quarter, Year-End Results for 2000.Business Editors HAWTHORNE, N.Y.--(BUSINESS WIRE)--Feb. 22, 2001 Taro Pharmaceuticals (Nasdaq/NMS:TARO): Highlights: -- Q4 2000 Sales Increase 34% to $29.9 Million -- Q4 2000 Net Income Increases 105% to $3.5 Million, or $0.29 per Diluted Share, from $1.7 Million, or $0.15 per Diluted Share, in Q4 99 -- Q4 Gross Profit Increases 36% to $18.0 Million -- 2000 Sales up 24% to $103.8 Million -- 2000 Net Income Increases 81% to $10.0 Million, or $0.84 per Diluted Share, from $5.5 Million, or $0.51 per Diluted Share, in 1999 Taro Pharmaceutical Industries Ltd. (Nasdaq/NMS:TARO) today reported record fourth-quarter results and record sales and earnings for the year ended December 31, 2000. The Company reported sales of $29,951,000 for the fourth quarter, a 34% increase from sales of $22,282,000 for the fourth quarter of 1999. Gross profit for the fourth quarter of 2000 was $18,014,000, or 60% of sales, an increase of 36% from $13,199,000, or 59% of sales, for the fourth quarter of 1999. Net income for the fourth quarter was a record $3,514,000, or $0.33 per basic share and $0.29 per diluted share, compared with $1,714,000, or $0.17 per basic share and $0.15 per diluted share, for the fourth quarter of 1999. "Taro continued to reach higher performance levels in 2000, the first year in which we exceeded $100 million in annual sales. The growth was driven by continued success in our U.S. generic pharmaceutical business," stated Barrie Levitt, M.D., Chairman of the Company. "We expanded our U.S. market share of oral prescription products such as carbamazepine carbamazepine /car·ba·maz·e·pine/ (kahr?bah-maz´e-pen) an anticonvulsant and analgesic used in the treatment of pain associated with trigeminal neuralgia and in epilepsy manifested by certain types of seizures. tablets, 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 Novartis' Tegretol(R), and warfarin sodium war·fa·rin sodium n. An anticoagulant with the same actions as dicumarol. warfarin sodium, (wôr´f tablets, bioequivalent to Dupont's Coumadin(R). These gains were achieved while maintaining our position as a leading supplier of topical dermatologic dermatological, dermatologic pertaining to dermatology; of or affecting the skin. products in the North American North American named after North America. North American blastomycosis see North American blastomycosis. North American cattle tick see boophilusannulatus. generic pharmaceuticals market." SG&A expenses in the fourth quarter of 2000 were $8,980,000, or 30% of sales, compared with $7,822,000, or 35% of sales, in the fourth quarter of 1999. SG&A includes a number of marketing campaigns aimed at increasing the generic substitution rate of Taro's warfarin sodium tablets in the U.S. and Canada. In addition, it includes the Company's investment in its UK subsidiary and associated start-up sales & marketing expenses. R&D expenditures in the fourth quarter of 2000 were $3,866,000, or 13% of sales, compared with $3,014,000, or 14% of sales, for the fourth quarter of 1999. Operating income Operating Income The profit realized from a business' own operations. Notes: This would not include income from things such as investments in other firms. Also referred to as operating profit or recurring profit. before R&D expenditures was $9,034,000, or 30% of sales, compared with $5,377,000, or 24% of sales, in the fourth quarter of 1999. "Taro will continue to support its strong R&D program in order to keep introducing new products into the U.S., Israeli, Canadian and European markets," Dr. Levitt stated. Year-End Results The Company reported 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 of $103,797,000 for the year ended December 31, 2000, compared with $83,785,000, a 24% increase from the prior year. R&D expenditures were $14,593,000, or 14% of sales, compared with expenditures of $11,728,000, or 14% of sales, for the previous year. The gross profit margin Gross profit margin Gross profit divided by sales, which is equal to each sales dollar left over after paying for the cost of goods sold. gross profit margin A measure calculated by dividing gross profit by net sales. for the year ended December 31, 2000 was 60%, up from 58% in the prior year. Net income for 2000 was $10,027,000, or $0.94 per basic share and $0.84 per diluted share, compared with $5,539,000, or $0.55 per basic share and $0.51 per diluted share, for 1999. Fully diluted shares increased from 10,762,423 in 1999, to 11,932,010 in 2000. The increase results primarily from the rise in the share price during 2000, which would enable the Company to purchase fewer shares in the open market with the proceeds from options, should they be exercised. Seven 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. Approvals in 2000 During 2000, Taro received seven FDA approvals, including the Company's first New Drug Application approval (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) for Clotrimazole clotrimazole /clo·trim·a·zole/ (klo-trim´ah-zol) an imidazole derivative used as a broad-spectrum antifungal agent. clo·trim·a·zole n. Three-Day Cream 2%, an over-the-counter treatment for vaginal yeast infections Vaginal yeast infection An overgrowth of fungus in the vaginal area. Mentioned in: Jock Itch . Taro markets Clotrimazole Three-Day Cream 2% under its own label and as a private-label product. The Company also received six approvals for 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 two topical products and four oral 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. products. The topical products were Diflorasone Diacetate di·flo·ra·sone diacetate n. A corticosteroid used in topical preparations to control or prevent inflammation. diflorasone diacetate (dif´lor Cream, bioequivalent to Dermik Laboratories' Psorcon(R) Cream, with a U.S. market estimated at $15 million, and Clobetasol Propionate clobetasol propionate (klōbā´t 1. softening or soothing. 2. an agent that softens or soothes the skin, or soothes an irritated internal surface. e·mol·lient adj. Cream, bioequivalent to Glaxo Wellcome, Inc.'s Temovate(R) E Cream, with a U.S. market estimated at $17 million. These two products were important line extensions that contributed to the Company's increased distribution and sales in 2000. Two of the oral dosage form products were Carbamazepine Suspension and Carbamazepine Chewable Tablets, bioequivalent to Novartis' Tegretol(R) Suspension and Chewable Tablets, respectively. The combined market for these two line extension products is estimated by industry sources to be $32 million. The Company will begin marketing these products in 2001. The additional oral product approvals were for Clorazepate Dipotassium clorazepate dipotassium (klor´ n. A tricyclic compound used as an antidepressant. nortriptyline hydrochloride Allegron (UK), Aventyl, Norventyl (CA), Pamelor, PMS-Nortriptyline (CA) Capsules in four strengths, bioequivalent to Sandoz Pharmaceuticals' Pamelor(R) Capsules, with the U.S. market size estimated at $34 million. First Generic Warfarin warfarin (wôr`fərĭn), anticoagulant used to treat blood clots. In large doses it causes bleeding. Warfarin, mixed with bait, is used in rodent control. warfarin Anticoagulant drug, marketed as Coumadin. Approval in Canada In the third quarter of 2000, Taro received approval from the Therapeutic Products Program of Health Canada Health Canada (French: Santé Canada) is the department of the government of Canada with responsibility for national public health. Health Canada's goal is to improve Canadian life by improving Canadian longevity, lifestyle and use of public healthcare. (TPP TPP thiamine pyrophosphate. Thiamine pyrophosphate (TPP) The coenzyme containing thiamine that is essential in converting glucose to energy. Mentioned in: Beriberi TPP 1. total plasma protein. 2. ) for its Abbreviated New Drug Submission (ANDS) for nine strengths of Warfarin Sodium Tablets. Taro's Warfarin Sodium Tablets are bioequivalent to DuPont Pharma's Coumadin(R) and its market in Canada is estimated at CDN (Content Delivery Network) A system of distributed content on a large intranet or the public Internet in which copies of content are replicated and cached throughout the network. $42 million (US$28 million). Taro's Warfarin Sodium Tablets are the first generic warfarin sodium tablets to receive approval from Canada's TPP. Proprietary R&D Program Taro's NonSpil(TM) spill-resistant delivery system was granted its second U.S. patent during the second quarter of 2000. This patent strengthens Taro's existing U.S. patent protection for the technology, and was issued less than a month after the Company received an Israeli patent for the delivery system. Patents for the NonSpil(TM) technology have also been issued to Taro in Australia and South Africa South Africa, Afrikaans Suid-Afrika, officially Republic of South Africa, republic (2005 est. pop. 44,344,000), 471,442 sq mi (1,221,037 sq km), S Africa. , with additional patent applications pending that relate to the delivery system in the U.S. and worldwide. The Company continues to work towards the commercialization of the delivery system, which has applications in a multitude of OTC OTC See: Over-the-counter. OTC See over-the-counter market (OTC). and prescription products in pediatrics, geriatrics geriatrics (jĕrēă`trĭks), the branch of medicine concerned with conditions and diseases of the aged. Many disabilities in old age are caused by or related to the deterioration of the circulatory system (see arteriosclerosis), e.g. , and other clinical applications. T2000, Taro's non-sedating anticonvulsant anticonvulsant /an·ti·con·vul·sant/ (-kon-vul´sant) inhibiting convulsions, or an agent that does this. an·ti·con·vul·sant n. A drug that prevents or relieves convulsions. for the treatment of epilepsy, was granted an additional U.S. patent during the third quarter of 2000, providing for new compounds and more efficient processes for the synthesis of certain compounds. T2000 is currently in Phase I clinical testing in humans in Canada. The Company emphasizes that most drugs that enter clinical trials do not ultimately obtain regulatory approval, and there can be no assurance that T2000 will ever be of medical or commercial value. Only if Phase II and III clinical studies are successfully completed can Taro submit a New Drug Application in the U.S. and its equivalents elsewhere. This process will last at least several years. Establishment of UK Subsidiary In the first quarter of 2000, Taro established a company in the UK, which serves as Taro's European headquarters. Taro has assembled a team of experienced pharmaceutical executives to manage the UK operation. Taro currently markets several products in the UK, with many products in its pipeline for the UK and Europe. Future Outlook "Taro is currently creating a business development infrastructure that will allow the Company to pursue opportunities for growth and expansion in the U.S. and worldwide," stated Dr. Levitt. "During 2001, Taro will continue to focus on its core competencies, maintaining its position as a leading manufacturer of topical dermatological dermatological, dermatologic pertaining to dermatology; of or affecting the skin. products in the U.S. market, while continuing to support its growing oral prescription business. We will continue to invest in our generic and proprietary R&D programs which are the foundation for further international expansion." Taro has multiple regulatory filings in Canada and Israel, and nine ANDAs currently submitted to the FDA. Industry sources estimate the current annual markets in the U.S. for the drugs targeted by these ANDAs have an aggregate value exceeding $750,000,000. Taro Pharmaceutical Industries Ltd. is a multinational, science-based pharmaceutical company dedicated to meeting the needs of its customers through the discovery, development, manufacturing and marketing of the highest quality healthcare products. For further information on Taro Pharmaceutical Industries Ltd., please visit the Company's website at www.taro.com. For further information on Taro Pharmaceutical Industries Ltd., at no charge, dial 1-800-PRO-INFO and enter company code 104 or ticker symbol Ticker Symbol An arrangement of characters (usually letters) representing a particular security listed on an exchange or otherwise traded publicly. When a company issues securities to the public marketplace, it selects an available ticker symbol for its securities which investors TARO. Certain statements in this release are forward-looking statements 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. Factors that could cause actual results to differ 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 SEC reports, including its Annual Report on Form 20-F for the last fiscal year ended December 31, 1999.
TARO PHARMACEUTICAL INDUSTRIES LTD.
SUMMARY CONSOLIDATED BALANCE SHEETS
(US dollars in thousands)
December 31, December 31,
2000 1999
Assets
Current Assets:
Cash and Cash Equivalents $ 7,245 $ 3,003
Restricted Short-Term Bank Deposits 2,307 2,109
Accounts Receivable 42,576 27,405
Inventories 19,618 18,208
Total Current Assets 71,746 50,725
Property, Plant and Equipment, net 41,827 34,624
Other Assets 6,899 5,608
TOTAL ASSETS $ 120,472 $ 90,957
Liabilities and Shareholders' Equity
Current Liabilities:
Short-Term Bank Credits $ 2,170 $ 6,204
Current Maturities of Long-Term Liabilities 6,321 5,192
Accounts Payable and Accrued Expenses 19,686 13,365
Total Current Liabilities 28,177 24,761
Long-Term Liabilities 38,250 23,328
Deferred Taxes and Other Liabilities 3,664 2,168
Total Liabilities 70,091 50,257
Minority Interest 168 148
Shareholders' Equity 50,213 40,552
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY $ 120,472 $ 90,957
TARO PHARMACEUTICAL INDUSTRIES LTD.
SUMMARY CONSOLIDATED STATEMENTS OF INCOME
(US dollars in thousands, except per share data)
Three Months Ended Year Ended
December 31, December 31,
2000 1999 2000 1999
SALES $ 29,951 $ 22,282 $103,797 $ 83,785
Cost of Sales 11,937 9,083 41,206 35,314
Gross Profit 18,014 13,199 62,591 48,471
Operating Expenses:
Selling and Administrative 8,980 7,822 31,902 25,933
Operating Income before
Research and Development 9,034 5,377 30,689 22,538
Research and Development 3,866 3,014 14,593 11,728
Operating Income 5,168 2,363 16,096 10,810
Financial Expenses - Net 1,199 1,062 3,859 3,869
3,969 1,301 12,237 6,941
Other Income - Net 173 62 344 94
4,142 1,363 12,581 7,035
Taxes on Income 651 (355) 2,538 1,471
3,491 1,718 10,043 5,564
Minority Share in profits
(losses) of Subsidiaries (23) 4 16 25
NET INCOME $ 3,514 $ 1,714 $ 10,027 $ 5,539
Earnings per Ordinary Share $ 0.33 $ 0.17 $ 0.94 $ 0.55
Diluted earnings per
Ordinary Share $ 0.29 $ 0.15 $ 0.84 $ 0.51
Weighted average number
of shares-
BASIC EPS 10,732,091 10,176,663 10,709,905 10,075,349
DILUTED EPS 12,289,282 11,968,961 11,932,010 10,762,423
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