Add
QCOR to Portfolio
Set Alert
Email to a
Friend
| |||
|
|
Quotes & Info
|
| QCOR > SEC Filings for QCOR > Form 8-K on 7-Sep-2012 | All Recent SEC Filings |
7-Sep-2012
Regulation FD Disclosure
Questcor Pharmaceuticals, Inc. (the "Company") is providing the following update regarding key operating metrics and its share repurchase program. The operating metrics discussed below relate to the Company's 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:
Acthar Prescriptions
The table below includes both paid and fully rebated prescriptions. On September 4, 2012, the Company announced that it is in the process of taking the necessary steps to change the Medicaid rebate for Acthar. The Company estimates that it will take 3 to 6 months to effect this change and that the new rebate will only relate to prescriptions filled after the effective date of this change.
Paid Prescriptions Fully Rebated Paid Prescriptions Fully Rebated
July 2012 July 2012 August 2012* August 2012*
Nephrotic Syndrome (NS) 108 3 117-122 3-6
Multiple Sclerosis (MS) 376 15 505-515 17-20
Infantile Spasms (IS) 39 24 35-40 30-35
Dermatomyositis/Polymyositis (DM/PM) 1 0 13-15 1-3
|
* Preliminary; subject to adjustment.
Earlier this quarter, the Company completed the expansion of its Nephrology Sales Force from 28 to 58 representatives and its Neurology Sales Force from 77 to 107 representatives. Furthermore, it completed the hiring of its 12 person pilot Rheumatology Sales Force which is now calling on rheumatologists to build awareness of the availability of Acthar for the treatment of DM/PM. The Company believes these expansions will enable it to further broaden physician awareness of Acthar and its appropriate role in the treatment of Nephrotic Syndrome, MS relapses and the rheumatology-related autoimmune disorders Dermatomyositis and Polymyositis. Based on the increased number of prescriptions paid and shipped in August for MS, NS and DM/PM, as well as the number of prescriptions received by the Company's reimbursement support center during August 2012, the Company believes that its strategy to further increase physician awareness of Acthar through sales force expansion is generating positive results.
Insurance coverage continued to remain favorable for Acthar during August 2012.
The Company's monthly and quarterly vial shipments continue to be subject to significant variation due to the size and timing of individual orders received from Questcor's distributor. The number of business days in a period can also have an impact on the number of paid prescriptions, shipped vials and other metrics. For example, there were 23 business days in the month of August 2012, as compared to 21 in July 2012, and there are 19 business days in September 2012. The timing of when these orders are received and filled can significantly affect net sales and net income in any particular quarter. The Company believes that investors should consider the Company's results over several quarters when analyzing the Company's performance.
Shipped Acthar Vials
Net sales of Acthar are derived from the Company's sales of vials to CuraScript Specialty Distributor ("CuraScript SD"). During August 2012, Questcor shipped a total of 2,190 vials of Acthar to CuraScript SD. This figure includes vials for which the Company
• changes in the Company's reserve percentage for Medicaid and other government programs. The Company's total sales reserve percentage is primarily driven by its Medicaid reserve percentage, which exhibits significant quarterly volatility.
• changes in distribution channel inventory levels from period to period. The Company believes that while distribution channel inventory increased during August, the number of Acthar vials in its distribution channel remained within its normal historic range as of August 31, 2012. The Company's monthly and quarterly vial shipments continue to be subject to significant variation due to the size and timing of individual orders received from Questcor's distributor. The timing of when these orders are received and filled can significantly affect net sales and net income in any particular quarter. The Company believes that investors should consider the Company's results over several quarters when analyzing the Company's performance.
• changes in the number of vials per script for each indication, the number of vials shipped in the most recent period in connection with prescriptions written in previous periods, and the number of vials that could be shipped in future periods in connection with prescriptions written in the most recent period.
Share Repurchase Program and Balance Sheet Information
The Company has not repurchased any shares since the filing of the Company's Form 8-K on August 9, 2012.
• During the third quarter of 2012, through September 6, 2012, the Company used $58.1 million in cash to repurchase 1,484,300 shares of its common stock in open market transactions, at an average price of $39.15 per share.
• Year to date through September 6, 2012, the Company used $243.2 million in cash to repurchase 6,012,654 shares of its common stock in open market transactions, at an average price of $40.45 per share, representing approximately 10% of total outstanding common stock.
• Since the repurchase program began in 2008, the Company has returned $321.7 million in cash to shareholders though the repurchase of its common and preferred stock, representing approximately 94% of the Company's operating cash flow during that period.
• As of September 6, 2012, Questcor had approximately 58.4 million shares of common stock outstanding, approximately 61.3 million shares of common stock outstanding on a diluted basis using the treasury method, and had repurchased a total of 21.4 million shares of common and preferred stock, at an average price of $15.02 per share, with 3.2 million shares remaining under its common stock repurchase program.
The Company is also providing the following unaudited balance sheet information as of September 6, 2012:
• Cash, cash equivalents and short-term investments: $132.8 million.
• Accounts receivable: $53.2 million.
Important Information Regarding Prescriptions and Net Sales
End-user demand for Acthar results from physicians writing prescriptions to patients, currently primarily for the treatment of NS, MS, IS and DM/PM. The number of paid prescriptions for Acthar in each therapeutic area is volatile and the Company believes that investors should consider the Company's 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 derived from the Company's 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.
(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," "Dermatomyositis/Polymyositis" 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
Paid Prescriptions Paid Prescriptions
Quarterly
Multiple Year over Nephrotic Infantile Dermatomyositis/
Sclerosis Year Growth Syndrome Spasms Polymyositis
(MS) MS Paid Rx (NS) (IS) (DM/PM)*
Q1-10 231 196 % 11 89
Q2-10 304 145 % 4 95
Q3-10 323 129 % 8 92
Q4-10 354 66 % 7 91
Q1-11 508 120 % 18 89
Q2-11 751 147 % 45 106
Q3-11 886 174 % 60 112
Q4-11 945 167 % 146 120
Q1-12 1,000 97 % 238 112 1
Q2-12 1,110 48 % 314 96 6
|
* Paid prescription data for DM/PM provided beginning in Q1-12.
Monthly Paid Prescriptions by Therapeutic Area
Paid Prescriptions
Multiple Nephrotic Infantile Dermatomyositis/
Sclerosis Syndrome Spasms Polymyositis
(MS) (NS) (IS) (DM/PM)**
Jan-10 67 6 26
Feb-10 72 4 30
Mar-10 92 1 33
Apr-10 107 0 34
May-10 90 2 28
Jun-10 107 2 33
Jul-10 101 3 27
Aug-10 119 2 31
Sep-10 103 3 34
Oct-10 107 0 23
Nov-10 119 4 25
Dec-10 128 3 43
Jan-11 114 4 31
Feb-11 157 6 28
Mar-11 237 8 30
Apr-11 245 9 34
May-11 239 15 32
Jun-11 267 21 40
Jul-11 241 12 31
Aug-11 303 19 37
Sep-11 342 29 44
Oct-11 297 39 33
Nov-11 326 46 56
Dec-11 322 61 31
Jan-12 338 72 48 0
Feb-12 316 73 39 1
Mar-12 346 93 25 0
Apr-12 339 94 31 0
May-12 365 103 32 3
Jun-12 406 117 33 3
Jul-12 376 108 39 1
Aug-12* 505 - 515 117 - 122 35 - 40 13 - 15
|
* Preliminary; subject to adjustment.
** Paid prescription data for DM/PM provided beginning in Jan-12.
Quarterly Shipped Vials***
Quarterly
Shipped Vials Year over Year Growth
Q1-10 1,446 1 %
Q2-10 1,680 7 %
Q3-10 1,890 40 %
Q4-10 1,680 3 %
Q1-11 2,010 39 %
Q2-11 2,430 45 %
Q3-11 2,910 54 %
Q4-11 3,360 100 %
Q1-12 4,111 105 %
Q2-12 4,710 94 %
|
Monthly Shipped Vials***
Shipped Vials
Jan-10 424
Feb-10 392
Mar-10 630
Apr-10 510
May-10 660
Jun-10 510
Jul-10 690
Aug-10 600
Sep-10 600
Oct-10 600
Nov-10 450
Dec-10 630
Jan-11 480
Feb-11 870
Mar-11 660
Apr-11 810
May-11 660
Jun-11 960
Jul-11 960
Aug-11 840
Sep-11 1,110
Oct-11 900
Nov-11 1,170
Dec-11 1,290
Jan-12 1,440
Feb-12 1,140
Mar-12 1,530
Apr-12 1,350
May-12 1,560
Jun-12 1,800
Jul-12 1,650
Aug-12 2,190
|
*** The Company's monthly and quarterly vial shipments continue to be subject to significant variation due to the size and timing of individual orders received from Questcor's distributor, as well as the number of business days. The timing of when these orders are received and filled can significantly affect net sales and net income in any particular quarter. The Company believes that investors should consider the Company's results over several quarters when analyzing the Company's performance.
In accordance with General Instruction B.2. of Form 8-K, the information in Items 2.02 and 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.
|
|