QUESTCOR PHARMACEUTICALS 8-K 2012
Documents found in this filing:
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): June 6, 2012
QUESTCOR PHARMACEUTICALS, INC.
(Exact Name of Registrant as Specified in Charter)
Registrants telephone number, including area code: (714) 786-4200
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:
Commencing on June 6, 2012, Questcor Pharmaceuticals, Inc. (the Company) will utilize an updated presentation for investor relations purposes. A copy of the updated presentation is attached hereto as Exhibit 99.1 and incorporated herein by reference.
The Company is providing the following update regarding key operating metrics and its share repurchase program. The operating metrics discussed below relate to the Companys primary product, H.P. Acthar® Gel (repository corticotropin injection) (Acthar), and are based on the most recent data available to the Company at the time of this filing:
Paid Acthar Prescriptions
The Company has completed the expansion of its Nephrology Sales Force from 28 to 58 representatives, with all of the new representatives trained and in the field as of May 29, 2012. Additionally, Questcor has begun the process of expanding its Neurology Sales Force from 77 to 109 representatives, with hiring and training expected to be completed in August 2012. The Company believes these expansions will enable it to further broaden physician awareness of Acthar and its appropriate role in the treatment of both Nephrotic Syndrome and MS relapses. Furthermore, the Companys efforts to initiate a pilot commercial effort in rheumatology by the end of 2012 are running ahead of schedule.
Insurance coverage continued to remain favorable for Acthar during May 2012.
Shipped Acthar Vials
Net sales of Acthar are predominately derived from the Companys sales of vials to CuraScript Specialty Distributor (CuraScript SD). During May 2012, Questcor shipped a total of 1,560 vials of Acthar to CuraScript SD, for a combined total of 2,910 vials for the period April and May 2012. This figure includes vials for which the Company established reserves for future Medicaid and other government program rebates and chargebacks, but does not include vials related to the Companys patient assistance program. The relationship between vials shipped, net sales and prescriptions can change from period to period due to several factors including:
Share Repurchase Program and Balance Sheet Information
The Company is also providing the following unaudited balance sheet information as of June 4, 2012:
Important Information Regarding Prescriptions and Net Sales
End-user demand for Acthar results from physicians writing prescriptions to patients, primarily for the treatment of NS, MS and IS. The number of paid prescriptions for Acthar in each therapeutic area is volatile and the Company believes that investors should consider the Companys results over several quarters when analyzing its performance. Physicians do not purchase Acthar for resale to patients. Instead, patients purchase Acthar directly from specialty pharmacies after receiving a prescription and, typically, arranging for third party reimbursement (government or commercial insurance) often after satisfying a prior authorization requirement imposed by their insurance carrier.
Net sales of Acthar are predominately derived from the Companys sales of vials to CuraScript SD, which in turn sells Acthar primarily to specialty pharmacies. These specialty pharmacies place orders to CuraScript SD based on their respective levels of prescription filling activity related to Acthar and their respective inventory practices.
Recommended treatment regimens among physicians prescribing Acthar vary within each therapeutic area. Due to various factors, including inventory levels at both the specialty pharmacies and at CuraScript SD, the duration of treatment regimens and the timing of the placement of refill prescription orders, there is typically a delay between changes in prescription levels and changes in the levels of orders the Company receives from CuraScript SD. Additionally, physician-recommended treatment regimens, and patient compliance with treatment regimens, may vary over time.
The Companys ability to accurately determine the number of prescriptions is subject to the following important notes:
(1) Because Acthar prescriptions are filled at specialty pharmacies, the Company does not receive complete information regarding either the number of prescriptions or the number of vials by therapeutic area for all of the patients being treated with Acthar. However, the Company is able to monitor trends in payer mix and areas of therapeutic use for new (non-refill) Acthar prescriptions based on data the Company receives from its reimbursement support center. The Company estimates that over 90% of new Acthar prescriptions are processed by this support center, but believes that very few refill prescriptions are processed there.
(2) In this Form 8-K, the terms Nephrotic Syndrome, Multiple Sclerosis, Infantile Spasms, and Rheumatology, and their abbreviations, refer to the on-label indications for Acthar associated with such conditions. Investors should refer to the FDA approved Acthar label, which can be found at http://www.acthar.com/files/Acthar-PI.pdf. Prescription figures include related conditions for each therapeutic area. Related conditions are diagnoses that are either alternative descriptions of the medical condition or are closely related to the medical condition referenced above. For example, a prescription for Demyelinating disease of the central nervous system would be included as an MS-related condition for purpose of the prescription information provided above. About 5% of the prescriptions referenced are for related conditions.
(3) A new prescription may or may not represent a new patient or a new therapy for the patient receiving the prescription. The Company uses business rules to determine whether a prescription should be classified as new for counting purposes. From time to time, the Company may modify these rules.
Quarterly Paid Prescriptions by Therapeutic Area
Monthly Paid Prescriptions by Therapeutic Area
Quarterly Shipped Vials**
Monthly Shipped Vials**
In accordance with General Instruction B.2. of Form 8-K, the information in Item 7.01 of this Current Report on Form 8-K, shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the Exchange Act), 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, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Pursuant to the requirements of the Exchange Act, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.