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WSR REPORT
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QUESTCOR PHARMACEUTICALS, INC.
(AMEX: QSC)
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CURRENT PRICE: $ 1.06
AVERAGE DAILY VOLUME: 16,900
OUTSTANDING SHARES: 28.4 million
FLOAT: 14.9 million
RECOMMENDATION: "BUY"
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COMPANY |
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Questcor Pharmaceuticals, Inc., headquartered in Hayward, CA, is a specialty
pharmaceutical company serving the needs of the acute care and critical care hospital
markets. The Company has an extensive pipeline of pharmaceuticals, including four
currently marketed acute care products, two late stage critical care drugs currently under
clinical development, another Phase III medication already being marketed abroad, and
several mid and early stage research developments. Trading on the AMEX under the symbol
QSC since its formation through a merger between RiboGene, Inc. and Cypros Pharmaceutical
Corporation in November 1999, Questcor has emerged as a well-balanced, fully-integrated
pharmaceutical company within the small-cap arena.
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STRATEGY |
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Capitalizing on its diversified product pipeline, Questcor's business model provides great
potential for rapid growth and at the same time preserves the Company's stability and
continuity. The funding for focused development and clinical trials of products in
Questcor's proprietary acute and critical care portfolio is continuously supplemented by
revenues from products already marketed and distributed directly to hospitals by the
Company's in-house sales force or through marketing alliances with leading pharmaceutical
companies. In addition, the Company engages in co-development partnerships in order to
further mitigate the risks and reduce costs. This year the Company has licensed certain
components of its earlier stage antiinfective research technology to Dainippon
Pharmaceutical Co. Ltd. in Osaka, Japan and Rigel Pharmaceuticals, Inc. of South San
Francisco, generating immediate revenue, as well as rights to future milestone and royalty
payments. The creative strategic management of its family of products allows Questcor to
enhance shareholder value by concentrating on development of most advanced and lucrative
drugs, significantly reducing its burn rate and still maintaining tremendous growth
prospects for future products.
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PRODUCTS, MARKETS AND COLLABORATIONS |
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Questcor's impressive drug pipeline includes numerous acute and critical
care pharmaceuticals, some with multiple applications, which face limited competition in
the marketplace and often warrant expedited approval consideration by FDA.
GLOFIL & INULIN Glofil and Inulin allow the direct measurement of
glomerular filtration rate (GFR), a diagnostic parameter of kidney function that can be
utilized to detect disorders such as polcystic kidney disease. Currently, there are over 2
million creatinine tests performed each year to determine GFR, but these measures are
indirect and have been shown to be inaccurate. Glofil is a far more accurate and reliable
test for kidney function. The approved and marketed Glofil technology reduces the test
procedure time from 24 to 3 hours and significantly improves accuracy. With these
attributes, Glofil should gain a powerful position in the market of kidney function
testing, the diseases of which cost the U.S. economy over 12 billion per year.
ETHAMOLIN® Ethamolin addresses the problem of bleeding esophageal
varices, a condition which occurs in cases of advanced liver disease in which hepatic
veins become distended, swollen due to internal pressure and may burst. Ethamolin is a
potentially life-saving drug, and is the only product on the market approved for this
purpose.
DERMAFLO(TM) LINE Questcor has exclusive worldwide rights to a patented
Dermaflo technology, a solid phase system with potential multiple applications that allow
continuous topical release of a particular incorporated drug. Currently, the Dermaflo
technology has been marketed as Neoflo(TM), which delivers the triple antibiotic
Neosporin® for general wound care in the form of a bandage. Questcor is selling to
NutraMax an over-the-counter private label version of Neoflo. NutraMax's channels include
numerous retail pharmacies, including Wal-Mart and Kmart. market of approximately $60
million annually in the U.S.
EMITASOL® Currently in Phase III clinical trials, Emitasol is an
intranasally administered formulation of metaclopramide intended for treating
gastroparesis (stomach paralysis), a prevalent gastrointestinal disorder in diabetic
patients, and the syndrome known as delayed onset emesis, or vomiting and nausea, that is
frequently associated with chemotherapy. Questcor has partnered with Roberts
Pharmaceutical Corp., a subsidiary of Shire Pharmaceuticals, Inc., to co-develop the
patented product for North America. As part of the license agreement, Questcor will
receive up to $10 million milestone payment upon FDA approval, anticipated in 2002, as
well as royalty payments of 12.5% on sales. Roberts Pharmaceutical's public statements
suggest initial annual sales of $25-40 million in the first and second years, and up to
$70 million annually thereafter. However, this estimate only includes the delayed onset
emesis market, in which out of 1.4 million cancer cases reported each year, 60% are
treated with chemotherapy and well over 80% of patients experience symptoms treatable with
Emitasol, which is expected to sell for about $100 per treatment. In addition, out of the
approximately 8 million reported cases of diabetes in the US, up to 50% experience
symptoms or evidence of gastroparesis, which creates a much higher revenue potential for
the product. Currently, the gastroparesis target market is in the $1 billion range. In
addition, the Company distributes Emitasol abroad under licensing agreements in several
countries, including Italy, where it is marketed under the brand name Pramidin®, by
Crinos Industria Farmacobiologica, SpA, in Chile by Laboratorios Silesia and throughout
Eastern Europe by CSC Pharmaceuticals of Vienna, Austria. The management is negotiating
additional agreements covering Australia, New Zealand and Southeast Asia.
CYTOPROTECTANTS Questcor's research efforts concentrate to a large
extent on development of drugs called cytoprotectants, which prevent body cells from
experiencing injury or death during ischemic conditions. Ischemia is characterized by a
lack of glucose and oxygen usually resulting from a decrease in blood flow. Glucose and
oxygen starvation lead to depletion of adenosine triphosphate (ATP), a fuel needed to
perform any cell activity, which in turn causes the death of cells. Ischemia can be
considered the number one cause of death, as it precipitates all heart attacks and
strokes. CordoxTM and CeresineTM are two drugs that use different cell processes to
effectively increase the levels of ATP in an ischemic event. Several applications of these
drugs have been granted an expedited development status by the Food and Drug
Administration (FDA), reserved for drugs, which treat life-threatening or severely
debilitating diseases and for which there is no other adequate therapy. Ceresine, which
can be used for brain related ischemic episodes such as stroke and closed head injury, is
currently undergoing testing at the University of Florida in Gainsville and at the
University of California in San Diego for the treatment of congenital lactic acidosis
(CLA), a unique chronic condition affecting about 5,000 children domestically, which has
been granted an orphan status resulting in tax advantages and seven years of marketing
exclusivity to the first licensed agent. The Company is currently focusing on the ability
of Cordox to improve the biochemical and physical characteristics of stored human red
blood cells, in collaboration with the Hoxworth Blood Center at the University of
Cincinnati in Ohio. The Company expects to complete the in-vitro clinical testing and file
with the FDA before the end of 2001 and, assuming an expedited review, market the product
as a blood preservative the year after. Cordox is expected to increase the shelf-life of
blood from the current maximum level of 42 days to 8-10 weeks, significantly expanding
storage possibilities for transfusions, which exceed 23 million units of blood components
every year in the U.S. alone. Other applications for Cordox include reduction of
complications during coronary bypass surgery and treatment for the sickle cell disease, a
unique red blood cell condition which has also been granted an orphan status. The Company
also has two promising Phase II clinical products, Migrastat® for migraine headache and
Hypnostat® for insomnia.
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COMPETITION |
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Although the pharmaceutical industry is highly competitive and dominated by larger
companies, Questcor's unique product family provides excellent positioning for the
Company. By pursuing products that have no substitutes, such as Ceresine, Cordox or
Ethamolin, products that exhibit a clear competitive advantage, such as Emitasol or
Glofil, and technologies with wide applications, such as Dermaflo, Questcor is effectively
competing with other pharmaceutical firms in the market. Such careful product management
and marketing strategies will likely result in high market penetration. Other growing
pharmaceutical companies with different Phase III and/or market-ready products include
Vical, Inc., Alkermes, Inc. and ImClone Systems, Inc.
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MANAGEMENT |
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MANAGEMENT The well-balanced leadership of the Company abounds in entrepreneurial spirit,
technical expertise and significant managerial and industry experience. Charles J.
Casamento, President, CEO and Chairman of the Board, has held various management positions
at such renowned industry firms as Genzyme Corporation, American Hospital Supply, Johnson
& Johnson, Hoffmann-LaRoche, Inc. and Sandoz, Inc. Subsequently, he co-founded and led
as CEO Interneuron Pharmaceuticals, Inc., a biopharmaceutical company (NASDAQ: IPIC),
which achieved a market cap of $1.6 billion under his leadership. Mr. Casamento joined
RiboGene in 1993 as CEO and President and was instrumental in spearheading the merger with
Cypros Pharmaceutical, which closed in late 1999, resulting in the formation of Questcor.
The Company's key technical processes are directed by Jonathan C. Goldsmith, M.D., VP of
Clinical Research and Regulatory Affairs. Prior to his work within the pharmaceutical
industry he had a twenty-year career in academic medicine which encompassed basic and
clinical research. Previously, Dr. Goldsmith directed research at Centeon, LLC, a
biopharmaceutical company involved in the development and marketing of plasma derivatives
and recombinant coagulation products and was VP of Clinical Affairs with Alpha Therapeutic
Corp., the U.S. subsidiary of Yoshitomi Pharmaceutical Industries, Inc., a large
multinational pharmaceutical company headquartered in Japan. Hans P. Schmid is VP of
Finance & Administration and Chief Financial Officer. Prior to joining Questcor Mr.
Schmid held executive positions at Oread, Inc., a contract drug development and
pharmaceutical manufacturing company from Palo Alto, California, Roche Bioscience, a
division of Hoffmann-LaRoche and Syntex Pharmaceuticals. Kenneth Greathouse, VP of
Marketing & Sales held executive marketing positions at Boron LePore and Elan Corp.,
PLC (NYSE: ELN), and has 18 additional years of experience at Lederle Laboratories, a
division of American Home Products Corporation (NYSE: AHP).
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GROWTH AND FINANCIALS |
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Questcor has cash, cash equivalents and short-term investments of approximately $10
million, which will support aggressive marketing efforts of the four approved acute care
products, as well as expedient progress through the pipeline of its major drug candidates
in development. Intensified marketing of Ethamolin, Glofil and Neoflo, along with the
launch of Sildaflo scheduled within the next 6 months, as well as license cashflow from
its antiinfective research technology, should contribute to immediate revenue growth.
Overall, the current QSC stock price does not reflect the future value of the impressive
pipeline of drug candidates in development, the pharmaceutical value of the products
currently marketed, and the experience value of the Company's management team. Shareholder
value should be enhanced in the near term from increased revenues and in the intermediate
term from progress in drug developments. Given the strong balance sheet, significant cash
reserves, growing revenue stream and impressive management talent and track record, QCS
shares represent a strong buy opportunity for aggressive long-term investors who can
withstand the risks associated with a micro-cap company and the volatile nature of the
biotech sector. We believe the post valuation of the combined company is very attractive.
Alan Stone, Managing Director
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Disclaimers:
The information presented in this
report is not to be construed as an offer to sell, nor a solicitation of an offer to
purchase, any securities referred to herein or otherwise. The information contained in
this report is considered reliable, although it has been obtained from the company
featured herein, and other sources, in each case without independent verification. Such
information includes certain forward-looking statements issued by the company, which is
not an indicator of actual performance. The reader is advised to review all SEC filings
for a more complete description of the business, including financial statements and all
risk factors. By accepting and reading this report, the reader hereby acknowledges that
neither WallStreet Research, nor any other affiliate thereof (including without
limitation, Alan Stone & Company LLC, which is retained by the company featured herein
as an investor relations counsel for a monthly fee of $5,500) makes any representation,
either express or implied, as to the accuracy, completeness, fitness for a particular
purpose or future results, of any statement contained herein. Neither WallStreet Research,
nor any of its officers, agents or affiliates, accepts any liability whatsoever for any
statements made herein, including without limitation any liability for direct,
consequential or special damages of any kind or nature.
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