Great News !!!!!!!!!!!!!
Duramed Pharmaceuticals Reports Q3 2000 EPS of 4 Cents * Sales up 100% from third quarter 1999 * Net income at $1.1 million * Rising contribution from hormone products * Company realizing results of strategic business plan
Conference Call Webcast: Wednesday, October 18, 2000 at 11:00 EST Topic: Duramed Pharmaceuticals Third Quarter 2000 Results as discussed in this release event.videonewswire.com
CINCINNATI, Oct. 18 /PRNewswire/ -- Duramed Pharmaceuticals, Inc. (Nasdaq: DRMD - news) today reported that net sales for its third quarter ended September 30, 2000, were $22.4 million, up 100 percent from last year's third quarter and up from $20.7 million in the second quarter of 2000. Net income for the quarter was $1.1 million, or 4 cents per share (diluted), compared with a net loss of $26.9 million, or $1.24 per share, reported in last year's third quarter. Weighted average shares outstanding (diluted) rose approximately 7.2 million to 29.0 million, due primarily to shares issued to Solvay Pharmaceuticals in the fourth quarter of 1999, the conversion of Preferred Stock, and the exercise of outstanding stock options and warrants.
E. Thomas Arington, Chairman and Chief Executive Officer, stated, ``Duramed's quarter-over-quarter performance improvements since the beginning of this year reflect our commitment to the company's strategic business plan and the importance we are placing on achieving predictable profitability.
``Strategic decisions made and implemented over the past several years are contributing to the underlying strength of our operations. As we enter the fourth quarter, we remain focused on leveraging the personnel, plans, technologies, and expertise that we have in place to achieve continued performance improvements. Duramed has made, and will continue to make, investments in the right projects as part of our ongoing effort to create value for shareholders,'' Arington said.
Sales Growth Reflects Contribution of Recently Approved Products
Jeffrey T. Arington, President and Chief Operating Officer, noted, ``Duramed is committed to investing in the development and marketing of high margin multi-source and branded products in select high-barriers-to-entry categories, focusing on women's health and solid oral dose hormone products. Since the beginning of 1999, Duramed has received approval from the Food and Drug Administration (FDA) for 11 products. In addition, five abbreviated new drug applications (ANDAs) currently are pending with the FDA, four of which are for hormone products, and 19 products are in the development pipeline.''
On a consolidated basis, Duramed's hormone products accounted for $12.4 million of net sales, or 55 percent of total net sales, in this year's third quarter, compared with $0.9 million, or 9 percent, in last year's third quarter and $8.6 million, or 42 percent, in the second quarter of 2000. Duramed's hormone product portfolio includes Cenestin® (synthetic conjugated estrogens, A) Tablets and Apri(TM) (desogestrel and ethinyl estradiol) Tablets as well as estropipate, estradiol and medroxyprogesterone.
J. Arington added, ``Accelerating market penetration for the two hormone products approved in 1999, Cenestin, and Apri, was the primary reason for the growing contribution from this product area. From the final week of the second quarter through the final week of the third, total Cenestin weekly prescriptions were up 28 percent to approximately 14,000 and total weekly Apri prescriptions rose 15 percent to approximately 45,000.''
Improving Sales and Greater Operating Efficiencies Lead to Margin
Improvements
Gross profit for the quarter was $10.1 million, up from $1.9 million in
the third quarter of 1999, and $9.2 million in the second quarter of 2000.
J. Arington observed that growing demand for the company's products is
allowing more efficient use of its manufacturing capacity. That, combined
with a focus on higher margin products, resulted in an improvement in the
gross margin to 44.9 percent from 16.8 percent in last year's third quarter
and 44.4 percent in the second quarter of 2000.
Third quarter selling, general and administrative expense was well-below last year's level, primarily due to the company's heavy Cenestin launch expenses in the third quarter of 1999. In addition, third quarter 1999 operating expenses included accrual of a $15 million charge related to the company's settlement with Schein Pharmaceutical, Inc. Excluding that charge, the net loss in the third quarter of 1999 was $11.9 million, or 55 cents per share.
Nine Month Results
Net sales for the nine months ended September 30, 2000, were $59.7 million, up 74 percent from the comparable period in 1999. For the nine months, the company reported a net loss of $1.4 million, or 5 cents per share, compared with a net loss of $38.9 million, or $1.83 per share, last year.
Strengthening Resources and Positive Outlook
Positive results from the third quarter contributed to continued improvement in the company's financial position, with shareholders' equity at $3.2 million at September 30, 2000.
E.T. Arington concluded, ``We are beginning to realize a return on the investments we have made over the past several years, not only in the creation of greater corporate value but also in the improvement of our bottom line. We anticipate that our investments will provide additional, increased value to shareholders going forward.''
About Duramed Pharmaceuticals
Duramed Pharmaceuticals develops, manufactures and markets prescription drug products. The company's business strategy emphasizes products with attractive market opportunities and potentially limited competition due to technological barriers to entry, focusing on women's health and the hormone replacement therapy market. On March 24, 1999, the FDA approved the company's first branded product, Cenestin® (synthetic conjugated estrogens, A) Tablets, for the treatment of moderate-to-severe vasomotor symptoms associated with menopause.
Duramed's containment manufacturing facility for the production of hormones distinguishes the company from most competitors. The facility incorporates enclosed product flow and state-of-the-art environmental controls to ensure purity, stability, and tablet uniformity for Cenestin and other hormone products. While Duramed's primary focus will be solid oral dose hormones, the company's other areas of concentration -controlled release technology and oncology -- continue to represent attractive market opportunities.
The company's stock is traded on Nasdaq using the symbol DRMD. Additional information about the company can be found on the World Wide Web at www.duramed.com and www.cenestin.com .
Like all estrogen drug products, CENESTIN® (synthetic conjugated estrogens, A) Tablets should not be used in women with known or suspected pregnancy, breast cancer, or estrogen-dependent neoplasia, undiagnosed abnormal genital bleeding, active thrombophlebitis, or thromboembolic disorders. Estrogens have been reported to increase the risk of endometrial carcinoma in postmenopausal women with an intact uterus. The most common adverse events reported in clinical experience with CENESTIN included headache, insomnia, asthenia, nervousness, paresthesia, and depression. For additional information on CENESTIN, please see full prescribing information.
The Securities and Exchange Commission (SEC) encourages companies to disclose forward-looking information so that investors can better understand a company's future prospects and make informed investment decisions. Due to changing market conditions, product competition, the nature of product development and regulatory approval processes, the achievement of forward- looking statements contained in this press release are subject to risks and uncertainties. For further details and a discussion of these risks and uncertainties, see Duramed's SEC filings, including its annual report on Form 1O-K.
Duramed Pharmaceuticals, Inc.
Income Statement
(in thousands except per share amounts and shares outstanding)
Third Quarter Ended Nine Months Ended
September 30, September 30,
2000 1999 2000 1999
Net sales $22,445 $11,138 $59,706 $34,354
Cost of goods sold 12,372 9,262 34,845 29,172
Gross profit 10,073 1,876 24,861 5,182
Operating expenses:
Product development 1,003 1,916 2,855 5,527
Selling, general &
administrative 6,595 10,823 19,047 21,010
Litigation settlement --- 15,000 --- 15,000
Operating income (loss) 2,475 (25,863) 2,959 (36,355)
Interest expense 1,273 986 4,093 2,401
Income (loss) before income
tax and dividends 1,202 (26,849) (1,134) (38,756)
Income tax provision 24 --- 31 ---
Net income (loss) 1,178 (26,849) (1,165) (38,756)
Preferred stock dividends 128 63 214 193
Net income (loss) applicable
to common shareholders $1,050 $(26,912) $(1,379) $(38,949)
Income (loss) per average
common and common equivalent
shares (basic and diluted): $0.04 $(1.24) $(0.05) $(1.83)
Weighted average number of
common and common equivalent
shares outstanding:
Basic 26,967,513 21,735,515 26,124,112 21,278,715
Diluted 28,943,797 21,735,515 26,124,112 21,278,715
Note: Outstanding stock options and warrants are recognized for the
purpose of computing the weighted average number of diluted common shares
only when their effect would be dilutive. In the period in which Duramed
reported a profit, the resulting difference in basic and diluted common
shares outstanding was immaterial in the calculation of earnings per
share. In periods in which Duramed reported a loss, no stock options or
warrants were recognized as their effect would be anti-dilutive.
Balance Sheet
(in thousands) September 30, December 31,
2000 1999
Current Assets $47,620 $49,207
Property, Plant and Equipment and Other 31,229 31,566
Total Assets $78,849 $80,773
Current Liabilities $27,948 $46,627
Long Term Debt 37,711 31,556
Total Liabilities $65,659 $78,183
Mandatory Redeemable Convertible
Preferred Stock 10,000 4,900
Shareholders' Equity 3,190 (2,310)
Total Liabilities and Equity $78,849 $80,773
SOURCE: Duramed Pharmaceuticals, Inc. |
