e8vk
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): December 3, 2007
QUESTCOR PHARMACEUTICALS, INC.
(Exact Name of Registrant as Specified in Charter)
|
|
|
|
|
California
(State or Other Jurisdiction
of Incorporation)
|
|
001-14758
(Commission File Number)
|
|
33-0476164
(I.R.S. Employer
Identification No.) |
|
|
|
|
|
3260 Whipple Road Union City, California
(Address of Principal Executive Offices)
|
|
|
|
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):
o |
|
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|
o |
|
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
|
o |
|
Pre-commencement communications pursuant to Rule 14d-2(b) under the
Exchange Act (17 CFR 240.14d-2(b)) |
|
o |
|
Pre-commencement communications pursuant to Rule 13e-4(c) under the
Exchange Act (17 CFR 240.13e-4(c)) |
Item 7.01. Regulation FD Disclosure.
In
August 2007, Questcor Pharmaceuticals, Inc. (the Company) implemented a new strategy for its
principal product H. P. Acthar® Gel (repository corticotropin injection). In order to provide
investors with an update on the progress of the implementation of this strategy, the Company is
disclosing the actual quantity of Acthar vials shipped in the United States under its new pricing
structure during the months of October and November 2007, and intends to disclose such information for
December 2007.
The Company shipped 540 and 520 vials of Acthar to its specialty distributor during the months of
October and November 2007, respectively, for distribution to hospitals and specialty pharmacies in
the United States. Since the implementation of the new Acthar strategy, the Company estimates that
patient demand for Acthar has been 425 to 475 vials per month. The difference between the
Companys estimate of patient demand and vials shipped by the Company primarily represents
inventory maintained by hospitals and specialty pharmacies to meet future patient demand. The
Company has experienced a consistent level of ordering and insurance reimbursement for Acthar since
the inception of the new strategy. While the consistent pattern of ordering and insurance
reimbursement is continuing to date, future Acthar orders may be impacted by inventory practices at
specialty and hospital pharmacies, greater use of the safety net established for Acthar patients,
the pattern of usage by the healthcare community and reimbursement policies of insurance companies.
Accordingly, there could be volatility in the Companys shipment levels and financial results in
future periods.
The Company believes that approximately 30 percent of the estimated 425 to 475 monthly Acthar vial
demand is used by patients covered by Medicaid and other government related programs. For periods after
September 30, 2007, the amount of Medicaid rebates and government chargebacks that reduce the
Companys net sales may result in minimal, if any, net sales revenue to the Company from Acthar
used by Medicaid patients and certain government entities.
As of November 30, 2007, the Companys cash, cash equivalents and short-term investments were
approximately $20 million and its accounts receivable balance was approximately $24 million. The
Company provides 60 day payment terms to the distributor of the Companys products in the United
States.
The Company is providing this information solely to comply with the disclosure requirements of
Regulation FD and the Company makes no commitment to continue to provide such data when not
required by Regulation FD. 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.
Except for the historical information contained herein, this current report 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 strategy and business model for Acthar, 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, Questcors ability to estimate
the quantity of Acthar used by government entities and Medicaid eligible patients, 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, the sell-through by Questcors
distributors, the expenses and other cash needs for upcoming periods, the inventories
carried by Questcors distributors, 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 taxable income, 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
risk factors and other information contained in these documents should be considered in evaluating
Questcors prospects and future financial performance.
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.
|
|
|
|
|
Date: December 3, 2007 |
QUESTCOR PHARMACEUTICALS, INC.
|
|
|
By: |
/s/ George Stuart
|
|
|
|
George Stuart |
|
|
|
Senior Vice President, Finance, and
Chief Financial Officer |
|
|