Taro Pharmaceuticals Reports Record Second Quarter and Six Month Financial Results.Business Editors & Health/Medical Writers HAWTHORNE, N.Y.--(BUSINESS WIRE)--July 19, 2001 Taro Pharmaceuticals (Nasdaq/NMS:TARO) Second Quarter Highlights:
-- Q2 Sales Increase to a Record $36.4 Million, a 49% Gain Over Q2 2000
-- Q2 Net Income Increases to a Record $6.1 Million, or $0.48 Per Diluted
Share, from $2.1 Million, or $0.18 Per Diluted Share in Q2 2000
-- Q2 Operating Income Before R&D Expense Increases 86% to $12.3 Million from
$6.7 Million in Q2 2000
-- Gross Profit Margin Increases to 65% from 60% in Q2 2000
-- Taro Receives Three ANDA Approvals in Q2 2001
-- Taro Receives First Generic Approval for Clotrimazole and Betamethasone
Dipropionate Cream, USP ("CB Cream")
-- 100% Stock Dividend Announced in Q2 2001
Taro Pharmaceutical Industries Ltd. (Nasdaq/NMS:TARO) today reported record results for the Company's second quarter and six months ended June 30, 2001. The Company's results for the second quarter and six-month period do not reflect the stock dividend announced on June 28, 2001. Second Quarter Results Second quarter 2001 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 49% to $36.4 million from $24.4 million in the second quarter of 2000. Net income for the quarter increased 192% to $6.1 million, or $0.48 per diluted di·lute tr.v. di·lut·ed, di·lut·ing, di·lutes 1. To make thinner or less concentrated by adding a liquid such as water. 2. To lessen the force, strength, purity, or brilliance of, especially by admixture. share, compared with $2.1 million, or $0.18 per diluted share, for the second quarter of 2000. The Company's gross profit increased in the second quarter of 2001 to $23.8 million, or 65% of sales, up from $14.6 million, or 60% of sales, for the second quarter of the prior year. The increase in gross profit primarily reflects the Company's introduction of CB Cream in late May 2001. 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 expense increased 86% to $12.3 million from $6.7 million in the second quarter of 2000. Selling, general and administrative expenses increased to $11.4 million, or 31% of sales, from $7.9 million, or 33% of sales, for the second quarter of 2000. SG&A increased as the result of increased promotional expenses Noun 1. promotional expense - the cost of promoting a product business expense, trade expense - ordinary and necessary expenses incurred in a taxpayer's business or trade related to the introduction of CB Cream and expanding distribution of the Company's full product line in the U.S. R&D expenses were $4.9 million, or 13% of sales, versus $3.4 million, or 14% of sales, for the second quarter of 2000. "This is our twenty-second consecutive quarter of record sales and our twelfth consecutive quarter of record earnings," stated Barrie Levitt, M.D., Chairman of the Company. "Receiving the first generic approval for Lotrisone(R) Cream is another milestone in maintaining Taro's position as a leader in the U.S. topical dermatological dermatological, dermatologic pertaining to dermatology; of or affecting the skin. market." Six Month Results For the six-month period ended June 30, 2001, sales increased 39% to $64.7 million, compared with $46.6 million for the same period in 2000. Net income for the six-month period increased 139% to $8.8 million, or $0.70 per diluted share, compared with $3.7 million, or $0.32 per diluted share, for the same period in 2000. Selling, general and administrative expenses for the six-month period were $20.3 million, or 31% of sales, compared with $14.7 million, or 32% of sales, for the same period in 2000. R&D expenses were $8.9 million, or 14% of sales, compared with $6.9 million, or 15% of sales, for the same period in 2000. The Company's gross profit increased to $40.8 million, or 63% of sales, for the six months ended June 30, 2001, compared with $28.0 million, or 60% of sales, for the same period in 2000. Operating income before R&D expense was $20.6 million, or 32% of sales, compared to $13.3 million, or 29% of sales, for the same period of 2000. Three Approvals in the Second Quarter The Company received three Abbreviated New Drug Application 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 (ANDA ANDA abbr. abbreviated new drug application ) approvals during the second quarter of 2001, two for solid 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. cardiovascular products and one for a topical dermatological product. In April of 2001, Taro received approval from 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. of its ANDA for Amiodarone Hydrochloride a·mi·o·da·rone hydrochloride n. A vasodilator for the heart used to control ventricular and supraventricular arrhythmias and to manage stenocardia. Tablets, 200 mg, 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 Wyeth-Ayerst Laboratories' Cordarone(R). Amiodarone is a cardiovascular drug indicated for life-threatening ventricular arrhythmias ventricular arrhythmia An abnormal, usually rapid, heart rhythm that arises in a ventricle; VAs are often life threatening and 2º to myocardial infarction Examples V tach, V fib . The U.S. market for Amiodarone Tablets, 200 mg is estimated by industry sources to be over $100 million. Also in April, the Company received a tentative approval from the FDA of its ANDA for Enalapril Maleate e·nal·a·pril maleate n. An angiotensin-converting enzyme inhibitor used as an antihypertensive agent. enalapril maleate (enal´ and Hydrochlorothiazide hydrochlorothiazide /hy·dro·chlo·ro·thi·a·zide/ (-klor?o-thi´ah-zid) a thiazide diuretic, used for treatment of hypertension and edema. hy·dro·chlo·ro·thi·a·zide n. Abbr. Tablets USP USP - unique sales point ("Enalapril HCTZ HCTZ abbr. hydrochlorothiazide "), in two strengths. Enalapril HCTZ is a cardiovascular drug used in the treatment of hypertension hypertension or high blood pressure, elevated blood pressure resulting from an increase in the amount of blood pumped by the heart or from increased resistance to the flow of blood through the small arterial blood vessels (arterioles). , with a diuretic diuretic (dī'yərĕt`ĭk), drug used to increase urine formation and output. Diuretics are prescribed for the treatment of edema (the accumulation of excess fluids in the tissues of the body), which is often the result of underlying component. The U.S. market for Enalapril HCTZ is estimated by industry sources to be over $50 million. In late May, Taro received FDA approval for CB Cream, the first generic equivalent in the U.S. market for Schering Plough's Lotrisone(R)Cream. CB Cream is a combination antifungal/corticosteroid and is used to treat a variety of dermatological conditions. The U.S. market for CB Cream is estimated by industry sources to be over $100 million. "We expect that 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. and Betamethasone betamethasone /be·ta·meth·a·sone/ (ba?tah-meth´ah-son) a synthetic glucocorticoid, the most active of the antiinflammatory steroids; used topically as the benzoate, dipropionate, or valerate salts as an antiinflammatory, topically or Dipropionate Cream will have a significant impact on our 2001 results, despite the entry of an additional generic competitor," stated Dr. Levitt. Proprietary Research Taro continues to work on NonSpil(TM), a patented, spill-resistant liquid delivery system which has potential applications in a wide variety of both prescription and over-the-counter pharmaceutical products. The Company holds several patents relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc the delivery system and has additional patents pending in the U.S. and worldwide. The Company also continues development of T2000, its patented novel 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. . Taro is currently in Phase I clinical testing for T2000, which is a non-sedating, long-acting barbiturate barbiturate (bärbĭch`ərāt'), any one of a group of drugs that act as depressants on the central nervous system. High doses depress both nerve and muscle activity and inhibit oxygen consumption in the tissues. that may require less frequent administration than other commonly used treatments for epilepsy epilepsy, a chronic disorder of cerebral function characterized by periodic convulsive seizures. There are many conditions that have epileptic seizures. Sudden discharge of excess electrical activity, which can be either generalized (involving many areas of cells in and seizure disorders Seizure Disorder Definition A seizure is a sudden disruption of the brain's normal electrical activity accompanied by altered consciousness and/or other neurological and behavioral manifestations. . 100% Stock Dividend On June 28, the Company announced a two-for-one stock split to be effected in the form of a stock dividend. Shareholders of record at the close of business on Thursday, July 12, 2001 will receive one Ordinary Share for each Ordinary Share then held. The stock dividend will be paid at the close of business on Thursday, July 26, 2001 and trading will begin on a post-dividend basis on Friday, July 27, 2001. Future Outlook "Taro will continue to expand its generic product offering while investing in its branded and proprietary initiatives," stated Dr. Levitt. "We remain committed to our R&D programs and our global marketing organization for the expansion of our presence in existing markets, and to establish ourselves in new markets as well." The Company has multiple regulatory filings in Canada and Israel, and ten current submissions to the FDA, including one tentative approval. The market size of the branded products targeted by these ten ANDA filings is estimated by industry sources to be over $500 million. 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. Certain statements in this release 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. Factors that could cause actual results to differ include industry and market conditions, slower than anticipated penetration of new markets, additional competition in 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, 2000.
TARO PHARMACEUTICAL INDUSTRIES LTD.
SUMMARY CONSOLIDATED STATEMENTS OF INCOME
(US dollars in thousands, except per share data)
Three Months Ended Six Months Ended
June 30, June 30,
2001 2000 2001 2000
SALES $ 36,360 $ 24,412 $ 64,728 $ 46,644
Cost of Sales 12,582 9,814 23,927 18,603
Gross Profit 23,778 14,598 40,801 28,041
Operating Expenses:
Selling and
Administrative 11,432 7,943 20,250 14,699
Operating income
before Research
and Development 12,346 6,655 20,551 13,342
Research and
Development 4,898 3,395 8,912 6,927
Operating Income 7,448 3,260 11,639 6,415
Financial Expenses
-- Net 1,090 710 1,832 1,668
6,358 2,550 9,807 4,747
Other Income
-- Net 184 160 161 163
6,542 2,710 9,968 4,910
Taxes on Income 469 628 1,134 1,183
6,073 2,082 8,834 3,727
Minority Share in
profits of
Subsidiary 13 8 3 25
NET INCOME $6,060 $2,074 $8,831 $3,702
Earnings per
Ordinary Share $0.56 $0.19 $0.82 $0.35
Diluted earnings per
Ordinary Share $0.48 $0.18 $0.70 $0.32
Weighted average
number of shares-
BASIC EPS 10,861,200 10,709,664 10,823,479 10,702,127
DILUTED EPS 12,686,984 11,632,153 12,593,776 11,737,061
TARO PHARMACEUTICAL INDUSTRIES LTD.
SUMMARY CONSOLIDATED BALANCE SHEETS
(US dollars in thousands)
JUNE 30 DECEMBER 31
2001 2000
Assets
Current Assets:
Cash and Cash Equivalents $3,108 $7,245
Restricted short-term bank
deposits 2,362 2,307
Accounts Receivable -- Trade 46,849 38,670
Accounts Receivable -- Other
and prepaid expenses 5,429 3,898
Inventories 29,077 19,618
Total Current Assets 86,825 71,738
Property, Plant and
Equipment, net 47,318 41,827
Other Assets 6,816 6,881
TOTAL ASSETS $140,959 $120,446
Liabilities and Shareholders' Equity
Current Liabilities:
Short-Term Bank Credits $4,883 $2,170
Current Maturities of
Long-Term Liabilities 5,946 6,321
Accounts Payable and
Accrued Expenses 19,561 19,659
Total Current Liabilities 30,390 28,150
Long-Term Liabilities 47,729 38,250
Deferred Taxes and Other
Liabilities 3,572 3,664
Total Liabilities 81,691 70,064
Minority Interest 171 168
Shareholders' Equity 59,097 50,214
TOTAL LIABILITIES AND
SHAREHOLDERS' EQUITY $140,959 $120,446
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