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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): April 1, 2008
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.
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 additional update on the progress of the implementation of this strategy, the
Company is disclosing the actual quantity of Acthar vials shipped by the Company and received by
its U.S. distributor under its new pricing structure during the Companys first calendar quarter
ended March 31, 2008 and the total quantity of Acthar vials shipped during each month within the
quarter. The Company recognizes Acthar gross revenue when product has been received by its U.S.
distributor. The Company has now disclosed the actual quantity of Acthar vials shipped for each
month during the seven month period ended March 31, 2008. Effective with the second quarter ending
June 30, 2008, the Company will report the quarterly quantity of Acthar vial shipments in
connection with the public release of the Companys financial results.
The Company shipped and its U.S. distributor received 1,260 vials of Acthar during the first
calendar quarter ended March 31, 2008 for distribution to U.S. hospitals and specialty pharmacies.
This total included 460, 350, and 450 vials shipped by the Company and received by its U.S.
distributor in January, February, and March 2008, respectively. In the months since the Companys
August 27, 2007 price increase, Acthar vial shipments to the Companys U.S. distributor have ranged
from 310 vials in September 2007 to 540 vials in October 2007. As discussed in the Companys March
3, 2008 press release announcing its fourth quarter and 2007 year end results, this variation in
shipments follows a distinct historical pattern of significant month-to-month variability and
apparent seasonality in Acthar end user demand.
Month-to-month variability drives quarterly variability. The Company evaluated the historical
patterns of quarterly Acthar usage within child neurology, as measured by Wolters-Kluwer, a leading
provider of prescription data for the pharmaceutical industry. The Company tabulated the average
retail demand for each quarter, from July 2002 to June 2007, as a percentage of the overall average
quarterly retail demand. According to this data, while annual retail demand in child neurology,
where Acthar is now primarily used, stayed constant during the five-year period July 2002 to June
2007, variation from the mean was frequently observed for individual quarters. For example, the
third calendar quarter has historically been the strongest quarter at 113% of the quarterly
average, with a range of as low as 94% to as high as 130% of the average quarter. The first
calendar quarter, historically the weakest quarter at 85% of average, has ranged from as low as 74%
to as high as 93% of the average quarter. The Company believes that this historical variability is
due to quarter-to-quarter variations in diagnosis and treatment of the very small IS patient
population, coupled with some seasonal influences. These factors make predictions about Acthar vial
demand for any specific short time period difficult and future variability in quarterly Acthar
orders and demand should be expected.
As required by federal regulations, the Company provides a rebate related to product dispensed to
Medicaid eligible patients and certain government entities are permitted to purchase our products
for a nominal amount from the Companys customers who charge back the significant discount to the
Company. These Medicaid rebates and government chargebacks are estimated by the Company each
quarter and reduce the Companys gross sales in the determination of its net sales. Effective
January 1, 2008, the Company estimates that Acthar gross sales resulting from its reported
shipments will be reduced by approximately 30% related to Medicaid rebates and government
chargebacks.
As of
March 31, 2008, the Companys cash, cash equivalents and short-term investments were
approximately $32 million and its accounts receivable balance
was approximately $18 million. The
Company provides 60 day payment terms to the Companys U.S. distributor. The cash balance as of
March 31, 2008 is net of approximately $16.5 million of cash used by the Company to repurchase all
of the outstanding 2,155,715 Series A preferred shares in February 2008 and the repurchase of
1,527,700 of the Companys common shares in March 2008 under the Companys stock repurchase plan.
The Companys stock repurchase plan provides for the Companys repurchase of up to a total of 7
million of its common shares in either open market or private transactions, which may occur from
time to time and in such amounts as management deems appropriate.
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
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achieved from the sale of its products, competitors developing and marketing similar 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, 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.
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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: April 1, 2008 |
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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