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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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): January 13, 2009
QUESTCOR PHARMACEUTICALS, INC.
(Exact Name of Registrant as Specified in Charter)
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California
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001-14758
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33-0476164 |
(State or Other Jurisdiction
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(Commission File Number)
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(I.R.S. Employer |
of Incorporation)
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Identification No.) |
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3260 Whipple Road, Union City, California
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94587 |
(Address of Principal Executive Offices)
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(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 January 13, 2009, Questcor Pharmaceuticals, Inc. (the Company) announced via press
release that the Company is increasing its sales force from 15 representatives currently to 30
representatives in order to build upon continued positive growth
trends in prescriptions of its H.P.
Acthar® Gel (repository corticotropin injection) for the treatment of exacerbations associated with
multiple sclerosis (MS), an indication for which Acthar is already approved. A copy of the
Companys press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits.
(c) Exhibits.
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Exhibit No. |
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Description |
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99.1
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Questcor Pharmaceuticals, Inc. press release dated January 13, 2009. |
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: January 15, 2009 |
QUESTCOR PHARMACEUTICALS, INC.
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By: |
/s/ Gary Sawka
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Gary Sawka |
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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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Description |
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99.1
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Questcor Pharmaceuticals, Inc. press release dated January 13, 2009. |
exv99w1
Exhibit 99.1
QUESTCOR PHARMACEUTICALS TO EXPAND SALES FORCE
Continued Positive Growth in MS Market Drives Expansion Decision
Company Provides Update on Other Key Business Trends
UNION CITY, CA/January 13, 2009Questcor Pharmaceuticals, Inc. (NasdaqCM: QCOR) announced today
that it is increasing its sales force from 15 representatives currently to 30 representatives in
order to build upon continued positive growth trends in prescriptions of its H.P Acthar® Gel
(repository corticotropin injection) for the treatment of exacerbations associated with multiple
sclerosis (MS), an indication for which Acthar is already approved.
During the second quarter of 2008, we launched an effort to build prescriptions of Acthar from
doctors treating those MS patients who do not respond to, or cannot tolerate, other forms of
treatment, said Don M. Bailey, President and CEO of Questcor. As a result of our efforts,
shipped new prescriptions for this market have risen steadily each quarter. During the fourth
quarter we again saw a greater than 50% increase in new MS prescriptions over the prior quarter.
In addition, MS refill activity has been higher than expected. We estimate that, based on
preliminary information, MS sales were over 20% of net sales of Acthar in the just completed
quarter. Based on these positive trends, we are again increasing the sales team to further expand
our sales effort to physicians treating MS patients. We anticipate completing this phase of our
sales force expansion by the end of the first quarter. The final phase of our sales force expansion
to approximately 40 representatives could occur later in the year, Mr. Bailey added.
Questcor also reported today that
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A total of 1,510 Acthar vials were shipped during the fourth quarter of 2008. |
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The Company completed 2008 with approximately $55 million in cash. During 2008, Questcor
used $46 million in connection with stock repurchases. |
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The Company continues to be in regular contact with the U.S. Food & Drug Administration
regarding its supplemental New Drug Application (sNDA) seeking approval to market Acthar
for the treatment of infantile spasms. Topics of discussion with FDA to-date have included
certain aspects of the process and reformatting of specific files to better facilitate FDA
review. |
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Questcor has been notified that the first anticipated study involving the use of Acthar
to treat Nephrotic Syndrome, a serious kidney disorder treated by nephrologists, has
received IRB approval and is expected to begin enrolling patients in the first quarter of
2009. |
About Questcor
Questcor Pharmaceuticals, Inc. is a pharmaceutical company that markets two commercial products,
H.P. Acthar(r) Gel (Acthar) and Doral(r). Acthar (repository corticotropin injection) is an
injectable drug that is approved for the treatment of certain disorders with an inflammatory
component, including the treatment of exacerbations associated with multiple sclerosis (MS) and
to induce a diuresis or a remission of proteinuria in the nephrotic syndrome without uremia of the
idiopathic type or that due to lupus erythamatosus. In addition, Acthar is not indicated for,
but is used in treating patients with infantile spasms (IS), a rare form of refractory childhood
epilepsy, and opsoclonus myoclonus syndrome, a rare autoimmune-related childhood neurological
disorder. Doral 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 within the meaning of the Private Securities Litigation Reform Act of
1995. Such statements involve risks and uncertainties and 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:
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Questcors ability to continue to successfully implement its
Acthar-centric business strategy; |
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the introduction of competitive products, |
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regulatory changes including possible outcomes relating to a July
2008 Congressional hearing regarding orphan drug pricing; |
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Questcors ability to accurately forecast the demand for its products; |
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the gross margin achieved from the sale of its products; |
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Questcors ability to estimate the quantity of Acthar used by
government entities and Medicaid-eligible patients; |
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that the actual amount of rebates and discounts related to the use
of Acthar by government entities and Medicaid-eligible patients may
differ materially from Questcors estimates; |
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the expenses and other cash needs for upcoming periods; |
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the inventories carried by Questcors distributors, specialty
pharmacies and hospitals, |
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volatility in Questcors monthly and quarterly Acthar shipments
and end-user demand; |
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Questcors ability to obtain finished goods from its sole source
contract manufacturers on a timely basis if at all; |
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Questcors ability to attract and retain key management personnel; |
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Questcors ability to utilize its net operating loss carry
forwards to reduce income taxes on taxable income; |
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research and development risks, including risks associated with
Questcors sNDA for IS and its preliminary work in the area of
nephrotic syndrome; |
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uncertainties regarding Questcors intellectual property; |
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the uncertainty of receiving required regulatory approvals in a
timely way, or at all; |
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uncertainties in the credit and capital markets and the impact a
further deterioration of these markets could have on Questcors
investment portfolio; |
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as well as the risks discussed in Questcors annual report on Form |
10-K for the year ended December 31, 2007 and other documents filed
with the Securities and Exchange Commission. The 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.
Contacts:
Questcor Pharmaceuticals, Inc.
Don Bailey
510-400-0776
dbailey@Questcor.com
EVC Group, Inc.
Investors
Doug Sherk
415-896-6820
Media
Christopher Gale
646-201-5431