Tuesday September 12, 10:48 am Eastern Time
Press Release
SOURCE: Duramed Pharmaceuticals, Inc.
Duramed Chairman Enthusiastic about Company's Progress and Outlook
* Highlights profitability and increased sales of Cenestin(R) (synthetic conjugated estrogens, A) Tablets and Apri(TM)(desogestrel and ethinyl estradiol) Tablets * Explains Duramed's concurrent brand and generic initiatives * Discusses future value of corporate capabilities
CINCINNATI, Sept. 12 /PRNewswire/ -- Duramed Pharmaceuticals, Inc. (Nasdaq: DRMD - news) Chairman and Chief Executive Officer E. Thomas Arington today addressed Duramed shareholders at the 2000 annual meeting, reviewing the company's progress, noting its challenges, and commenting on its future.
The theme of value creation ran throughout Arington's speech. ``The creation of value has been a continuous goal at Duramed, and we know this process is a marathon, not a sprint,'' he stated. ``Duramed is committed to this marathon and conditioned for it. We are confident in our capabilities and see steadily increasing performance.''
Record Sales Result in Return to Profitability
Duramed achieved record net quarterly sales of $20.7 million in the second quarter of 2000, up from $9.9 million in the second quarter 1999 and up from $16.6 million in the first quarter of 2000. This resulted in operating income of $1.7 million for the quarter and net income of $273,000.
``We were pleased to return to profitable operations in the second quarter of 2000, and we anticipate achieving predictable profitability on a growing base of sales,'' Arington remarked. ``Our five hormone products -- estropipate, estradiol, medroxyprogesterone, Apri, and Cenestin -- alone generated $16.2 million in sales for the six months ended June 30, 2000.
``Total weekly Cenestin prescriptions were 13,106 for the week ended September 1, 2000. This represents a 26 percent increase from the week ended June 30, 2000. New weekly Apri prescriptions were 15,000, and total Apri prescriptions were 45,000. Both new and total weekly Apri prescriptions have risen 15 percent since the week ended June 30, 2000.''
Duramed Business Focus
Arington reviewed and clearly defined Duramed's two-pronged business approach. ``We are a healthcare company focused on both the branded and generic segments of the pharmaceutical industry. We want our shareholders to understand that both segments are important to us and that we have different strategies and goals for each.''
Duramed's overall business focus is on female healthcare, but the company has a specific, tailored mission and vision for the generic segment. Arington added, ``Our new vision concerning the generic segment is to establish marketing dominance in selected high-barriers-to-entry categories, and our mission is to create new products, new partnerships, and new markets by leveraging corporate capabilities.''
Some of the company's corporate capabilities Arington listed include its formulation technology, production capability, and regulatory reputation.
Antitrust Lawsuit
Arington's discussion of the complaint Duramed filed against Wyeth-Ayerst Laboratories, Inc. was limited to the content contained within the lawsuit.
``The factual allegations are that Wyeth-Ayerst's 'pervasive pattern of misconduct has allowed it to maintain is predominance in the market by monopolizing the conjugated estrogens market with its exclusionary and anti- competitive conduct that continues to the present day,''' Arington reminded shareholders.
The complaint further alleges that Wyeth has ``entered into contracts with health plans and PBMs (pharmacy beneficiary managers) that provide that Premarin®(1) shall be the sole and exclusive conjugated estrogens on formulary. These exclusive contracts target the exclusion of Cenestin from the market.''
This is significant because nearly 79 percent of conjugated estrogens are distributed through managed care organizations.
Arington also reviewed the merits of Duramed's lead counsel for the case, Stephen D. Susman, and reported that the company anticipated the litigation to have no adverse material effect on Duramed's business plan.
Comments on Future Value
In concluding his official comments, Arington offered a future outlook, highlighted by the expectation of continued sales growth and increased market penetration for Cenestin, Apri, and Duramed's current generic products. Increased sales should result in an improved gross margin and growing profit for the company.
The company currently has five abbreviated new drug applications (ANDAs) on file with the U.S. Food and Drug Administration (FDA); four of these are for hormone products. Additionally, Duramed has 19 products in the developmental stage.
``We anticipate key new Duramed product approvals in the first half of 2001, continued development of ANDAs and NDAs (new drug applications), and new partnerships,'' Arington declared.
``We believe we have in place personnel, plans, technologies, and expertise that will contribute significantly to our future financial performance, even though income from these sources is not being fully realized today. Duramed has made, and will continue to make, investments in the right projects as part of our ongoing effort to create value for shareholders.''
About Duramed Pharmaceuticals, Inc.
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.
On October 6, 1999, Duramed entered into an alliance with Solvay Pharmaceuticals, Inc. to jointly promote three of the companies' hormone products to obstetricians and gynecologists across the United States: Duramed Pharmaceuticals' Cenestin and Solvay Pharmaceuticals' Estratest®(2) and Prometrium®(3).
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 .
(1) Premarin is a trademark of Wyeth-Ayerst Laboratories, Inc.
(2) Estratest is a trademark of Solvay Pharmaceuticals.
(3) Prometrium is a trademark of Solvay Pharmaceuticals.
Like all estrogen drug products, CENESTIN® 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.
SOURCE: Duramed Pharmaceuticals, Inc.
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