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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): September 26, 2007
QUESTCOR PHARMACEUTICALS, INC.
(Exact Name of Registrant as Specified in Charter)
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California
(State or Other Jurisdiction
of Incorporation)
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001-14758
(Commission File Number)
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33-0476164
(I.R.S. Employer
Identification No.) |
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3260 Whipple Road Union City, California
(Address of Principal Executive Offices)
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94587
(Zip Code) |
Registrants telephone number, including area code:
(510) 400-0700
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the
filing obligation of the registrant under any of the following provisions (see General Instruction
A.2. below):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
TABLE OF CONTENTS
Item 7.01. Regulation FD Disclosure.
On September 26, 2007, Questcor Pharmaceuticals, Inc. (the Company) issued a press release
providing a progress report on the Companys new pricing strategy for H.P. Acthar Gel ®, a natural
form of adrenocorticotropic hormone. A copy of the press release is attached hereto as Exhibit
99.1 and is incorporated herein by this reference.
The foregoing information is furnished pursuant to Item 7.01 and shall not be deemed filed
for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise
subject to the liability of that section, nor shall it be deemed incorporated by reference in any
filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by
specific reference in such a filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
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Exhibit No. |
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Exhibit Description |
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99.1
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Questcor Pharmaceuticals, Inc. Press Release, dated September 26, 2007. |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly
caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Date: September 26, 2007 |
QUESTCOR PHARMACEUTICALS, INC.
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By: |
/s/ George Stuart
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George Stuart |
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Senior Vice President, Finance, and
Chief Financial Officer |
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EXHIBIT INDEX
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Exhibit No. |
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Exhibit Description |
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99.1
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Press release issued by Questcor Pharmaceuticals, Inc., dated as of September 26, 2007. |
exv99w1
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Exhibit 99.1 |
NEWS RELEASE
QUESTCOR PROVIDES PROGRESS REPORT ON NEW H.P. ACTHAR GEL
STRATEGY
UNION CITY, Calif.September 26, 2007 Questcor Pharmaceuticals, Inc. (AMEX:QSC) provided today a
progress report on the companys new pricing strategy for H.P. Acthar Gel(R), a natural
form of adrenocorticotropic hormone (ACTH). Since August 27, 2007, when the new strategy was
announced, results have met Questcors expectations. Specifically, while overall units shipped
have decreased, the company has seen an expansion of revenues, reflecting a positive pattern of
ordering and insurance reimbursement at the new pricing level. In conjunction with the new
strategy, Questcor has significantly expanded its sponsorship of Acthar patient assistance and
co-pay assistance programs, which provide an important safety net for uninsured and under-insured
patients using Acthar.
These initial trends may not reflect orders in the steady state due to a number of transition
factors. These factors include inventory practices at specialty and hospital pharmacies, greater
use of the safety net established for Acthar patients, the pattern of usage of Acthar by the health
care community and reimbursement policies of insurance companies.
Don Bailey, Interim President, commented, The overriding goal of this new strategy is to ensure
the continued long-term availability of Acthar for those patients who need it most. Although it is
early in the implementation of the strategy, the initial results are positive. We are encouraged
by both the continuing pace of orders for Acthar and the initial pattern of insurance coverage. We
are also pleased to see expanded utilization of the Acthar patient assistance and co-pay assistance
programs, which are sponsored by Questcor and independently operated by the National Organization
for Rare Disorders (NORD).
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Mr. Bailey continued, If these early trends continue, Questcor will have positive cash-flow in the
near future. In addition, this trend would make it likely that Questcor could become consistently
profitable, thereby assuring the continued availability of Acthar.
Questcor believes that this financial stability may allow the company to fund important research
and development activities, including efforts to better understand Acthars utility in the
treatment of neurological disorders.
One of our interests going forward is to invest in research to develop a better understanding of
Acthars actions on the central nervous system. Acthar is a complex biologic product consisting of
the 39-amino-acid peptide ACTH and multiple peptide fragments. We would like to better understand
what makes Acthar effective in the treatment of certain rare neurological diseases, such as
infantile spasms and opsoclonus-myoclonus, stated Steve Cartt, Questcors Executive Vice
President. Such exploration has the potential to not only optimize how Acthar is used but may
also result in a better understanding of the diseases themselves. In addition, we also look
forward to continuing our efforts to optimize key Acthar manufacturing processes, and to conducting
additional clinical research if required by the FDA in pursuit of an indication for infantile
spasms.
Acthar is currently approved in the U.S. for the treatment of MS exacerbations and other
conditions. No drug is approved in the U.S. for the treatment of infantile spasms (IS), a very
rare and potentially life-threatening form of epilepsy that typically begins in the first year of
life. However, pursuant to guidelines published by the American Academy of Neurology and the Child
Neurology Society, many child neurologists use Acthar to treat infants afflicted with this
condition. In June 2006, Questcor submitted a Supplemental New Drug Application for IS to the
Food and Drug Administration (FDA). Questcor has a meeting scheduled with the Agency to discuss
its application.
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Questcor currently plans to report its third quarter financial results during the week of November
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About H.P. Acthar Gel
H.P. Acthar Gel(R) is a natural adrenocorticotropic hormone (ACTH) designed to provide a
prolonged release after intramuscular or subcutaneous injection. Acthar is currently indicated for
the treatment of a wide range of conditions with an inflammatory component, like acute
exacerbations of multiple sclerosis, various types of arthritis and ulcerative colitis. For full
prescribing information and safety information on Acthar, please visit http://www.acthar.com.
About Questcor
Questcor Pharmaceuticals, Inc â(AMEX:QSC) is a specialty pharmaceutical company
that develops and sells therapeutics for the treatment of neurological disorders. Questcors
products include H.P. Actharâ Gel (repository corticotropin injection) and Doralâ
(quazepam), which is indicated for the treatment of insomnia characterized by difficulty in falling
asleep, frequent nocturnal awakenings, and/or early morning awakenings. For more information,
please visit www.questcor.com.
Note: Except for the historical information contained herein, this press release contains
forward-looking statements that involve risks and uncertainties. Such statements are subject to
certain factors, which may cause Questcors results to differ from those reported herein. Factors
that may cause such differences include, but are not limited to, Questcors ability to continue to
successfully implement the new pricing strategy for Acthar, Questcors ability to identify and hire
a permanent Chief Executive Officer, Questcors ability to accurately forecast the demand for its
products, the gross margin achieved from the sale of its products, Questcors ability to enforce
its product returns policy, the accuracy of the prescription data purchased from independent third
parties by Questcor, the sell-through by Questcors distributors, the inventories carried by
Questcors distributors, and the expenses and other cash needs for upcoming periods, Questcors
ability to obtain finished goods from its sole source contract manufacturers on a timely basis if
at all, Questcors potential future need for additional funding, Questcors ability to utilize its
net operating loss carry forwards to reduce income taxes on the sale of its non-core products,
research and development risks, uncertainties regarding Questcors intellectual property and the
uncertainty of receiving required regulatory approvals in a timely way, or at all, other research,
development, and regulatory risks, and the ability of Questcor to acquire products and, if
acquired, to market them successfully and find marketing partners where appropriate, as well as the
risks discussed in Questcors annual report on Form 10-K for the year ended December 31, 2006 and
other documents filed with the Securities and Exchange Commission. The
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risk factors and other information contained in these documents should be considered in evaluating
Questcors prospects and future financial performance.
Questcor undertakes no obligation to publicly release the result of any revisions to these
forward-looking statements, which may be made to reflect events or circumstances after the date
hereof or to reflect the occurrence of unanticipated events.
CONTACT: Questcor Pharmaceuticals, Inc.
Don Bailey or Steve Cartt, 510-400-0700
IR2@Questcor.com
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