Duramed Discusses Continued Progress and Growth at Annual Meeting
CINCINNATI, May 10, 2001 (BUSINESS WIRE) --
Provides Details On Pipeline Expansion; Announces Shipment of Its Oral
Contraceptive Aviane(TM) Into the $130 Million Brand Market
Duramed Pharmaceuticals Inc. (Nasdaq:DRMD) announced today that its chairman and
chief executive officer E. Thomas Arington addressed Duramed shareholders at the
company's 2001 annual meeting. Arington reviewed the progress the company made
in the full year 2000 and in the first quarter of 2001; discussed the approval
and shipment of Aviane(TM) (levonorgestrel and ethinyl estradiol) Tablets,
Duramed's new oral contraceptive product; commented on the company's product
development efforts; and reviewed its outlook. Also presenting at the meeting
were Dr. Raymond Klein, clinical and medical advisor to the chairman, and Kathi
Rinesmith, Duramed's vice president of research and development.
"We are keeping our corporate promises," Arington said at the beginning of the
meeting. "At last year's annual meeting, we stated that our commitments for the
year 2000 would be the continued sales growth and market penetration of Cenestin
and Apri; key new product approvals by mid year 2001; the continued development
of both brand and generic products; improved gross margins; and an improved
bottom line. We are pleased to say that our performance is in keeping with those
commitments."
Improving Financial Condition
For the year 2000, Duramed's net sales were $83.5 million, up 66 percent over
1999. Gross profit for 2000 was $35.1 million, up 235 percent from 1999.
For the first quarter 2001, the company's net sales totaled $27.3 million, up 64
percent from the first quarter 2000. And gross profit for the quarter was $12.8
million, up 129 percent from the same period last year.
The improvements were largely due to the performance of the company's portfolio
of hormone products. Hormone products represented 21 percent of revenue in 1999
and 48 percent in 2000. The company believes hormone products will continue to
grow strongly and account for 65 percent of net sales in 2001.
Arington said, "Our top priority and core business strategy is to provide
pharmaceutical products that address female healthcare needs. Duramed's strength
and focus continues to be on solid oral dose hormones, where we are developing
two separate franchises--hormone replacement therapy and oral contraceptive
products. These franchises will continue to be our major revenue drivers."
Aviane Shipping Commences
Arington also announced that the company began shipping Aviane on May 8, 2001.
Aviane is the first and only product deemed bioequivalent to and therapeutically
interchangeable with Alesse(TM)(a) for all new and refill prescriptions.
According to IMS data for drugstore and non-retail purchases, Alesse sales in
2000 were approximately $130 million, up 35 percent from 1999.
"We are excited that Aviane expands our hormone family to six products, and we
look forward to the revenues it will produce," Arington continued. "With the
success of Apri, our first oral contraceptive, we have proven that we can be
very effective in penetrating the oral contraceptive market."
Like Apri(R) (desogestrel and ethinyl estradiol) Tablets, Aviane will be
marketed as a value brand, meaning that the product can be written as a
prescription by physicians and/or substituted for the brand product by
pharmacists.
Expanding Pipeline
Aviane was Duramed's first product approval in 2001. The company has four
additional Abbreviated New Drug Applications (ANDAs) on file with the U.S. Food
and Drug Administration, including oral contraceptives. In 2001, Duramed expects
to submit eight ANDAs to the FDA, five of which are for hormone products.
Further, the company has recently signed two agreements with product development
companies, and these could produce at least four multi-source, non-hormone
products per year beginning in 2002.
Duramed also has 11 hormone products in various stages of development. Six of
these are for ANDAs, and five are for New Drug Applications (NDAs).
The five NDA items, upon successful completion, will expand the Cenestin(R)
(synthetic conjugated estrogens, A Tablets) family of products. These items
include combining Cenestin with progesterone, with methyltestosterone, and with
both progesterone and methyltestosterone. The development work on the Cenestin
and progesterone combination product is completed, and that product should be in
the clinic within a few weeks.
Formal Business
In the formal business segment of the meeting, Duramed shareholders ratified the
selection of Ernst and Young LLP as the company's independent auditors. As
members of the 2001 Board of Directors, shareholders reelected members of the
2000 Board and also elected Vernon A. Brunner and Gerald L. Wolken. Brunner is
president of Brunner Marketing Solutions and former executive vice president of
marketing at Walgreen Co. Wolken is managing partner of MLE Enterprises, Inc., a
management consulting firm and former chief executive officer of SupeRx Drug
Stores, a spin off of Kroger Co.
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