Questcor Provides Updated New Paid Prescription Trends
ANAHEIM, Calif., Sept. 10, 2011 /PRNewswire via COMTEX/ -- Commencing on
September 12, 2011, Questcor Pharmaceuticals, Inc. (QCOR) will utilize an updated
presentation for meetings with investors. This presentation was filed under Form
8-K with the SEC on Friday, September 9 at 3 p.m. PST and will be posted on the
SEC's website prior to market open on Monday, September 12. The presentation
includes an update regarding prescription trends for the Company's primary
product, H.P. Acthar Gel (repository corticotropin injection) through the end of
August 2011 as follows:
For acute exacerbations of multiple sclerosis (MS), the run-rate of new, paid
prescriptions for the quarter ending September 30, 2011, based on the first two
months of the quarter, is approximately 10% higher than the number of new, paid
prescriptions in the quarter ended June 30, 2011.
For each of nephrotic syndrome (NS) and infantile spasms (IS), the run-rate of
new, paid prescriptions for the quarter ending September 30, 2011, based on the
first two months for the quarter is approximately equal to the number of new,
paid prescriptions in the quarter ended June 30, 2011.
The Company has calculated "run-rate" for the quarter ending September 30, 2011
by taking its preliminary results for the first two months of the quarter and
multiplying that amount by 1.5.
The Company is also disclosing the following unaudited balance sheet information
as of September 6, 2011:
Cash, cash equivalents and short-term investments: $170 million.
Accounts receivable: $19 million.
Questcor expects to post the updated presentation on its website prior to Monday,
September 12.
Important Information Regarding Prescriptions and Net Sales
Net sales of Acthar are derived from our 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
sales and inventory practices. End-user demand for Acthar results from physicians
writing prescriptions to patients for the treatment of MS exacerbations, NS, IS
and various other conditions. 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 re-fill
prescription orders, there is typically a delay between changes in prescription
levels and changes in the levels of orders we receive from CuraScript SD.
Additionally, treatment regimens and patient compliance with physician
recommended treatment regimens, may vary over time.
Additionally, our ability to accurately determine the number of prescriptions is
subject to the following important notes:
(1) Because Acthar prescriptions are filled at specialty pharmacies, we do 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, we are able to monitor trends in payer mix and areas of
therapeutic use for new (non-refill) Acthar prescriptions based on data we
receive from our reimbursement support center. We estimate that over 90% of new
Acthar prescriptions are processed by this support center, but believe that very
few refill prescriptions are processed there.
(2) 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 which is the
focus of the table. For example, a prescription for "Demyelinating disease of the
central nervous system" would be included as an MS related condition for purpose
of this table. About 5% of the prescriptions referenced for a specific indication
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. We use business rules to determine
whether a prescription should be classified as new for counting purposes. From
time to time, we may modify these rules.
About Questcor
Questcor Pharmaceuticals, Inc. is a biopharmaceutical company whose primary
product helps patients with serious, difficult-to-treat medical conditions.
Questcor's primary product is H.P. Acthar? Gel (repository corticotropin
injection), an injectable drug that is approved by the FDA for the treatment of
19 indications. Of these 19 indications, Questcor currently generates
substantially all of its net sales from three indications: the treatment of acute
exacerbations of multiple sclerosis in adults, the treatment of nephrotic
syndrome, and the treatment of infantile spasms in children under two years of
age. With respect to nephrotic syndrome, the FDA has approved Acthar to "induce a
diuresis or a remission of proteinuria in the nephrotic syndrome without uremia
of the idiopathic type or that due to lupus erythematosus." Questcor is also
exploring the use of Acthar to treat systemic lupus erythematosus, for which
Acthar is approved as both a maintenance therapy and to treat exacerbations.
Questcor is also exploring the possibility of developing markets for other
on-label indications and the possibility of pursuing FDA approval of additional
indications not currently on the Acthar label where there is high unmet medical
need. For more information, please visit questcor.com.
Note: Except for the historical information contained herein, this press release
contains forward-looking statements that have been made pursuant to the Private
Securities Litigation Reform Act of 1995. These statements relate to future
events or our future financial performance. In some cases, you can identify
forward-looking statements by terminology such as "believes," "continue,"
"could," "estimates," "expects," "growth," "may," "plans," "potential," "should,"
"substantial" or "will" or the negative of such terms and other comparable
terminology. These statements are only predictions. Actual events or results may
differ materially. Factors that could cause or contribute to such differences
include, but are not limited to, the following:
Our reliance on Acthar for substantially all of our net sales and profits;
Reductions in vials used per prescription resulting from changes in treatment
regimens by physicians or patient compliance with physician recommendations;
The complex nature of our manufacturing process and the potential for supply
disruptions or other business disruptions;
The lack of patent protection for Acthar; and the possible FDA approval and
market introduction of competitive products;
Our ability to generate revenue from sales of Acthar to treat on-label
indications associated with NS, and our ability to develop other therapeutic uses
for Acthar;
Research and development risks, including risks associated with Questcor's
preliminary work in the area of nephrotic syndrome and our reliance on
third-parties to conduct research and development and the ability of research and
development to generate successful results;
Regulatory changes or other policy actions by governmental authorities and other
third parties as recently adopted U.S. health care reform legislation is
implemented;
Our ability to receive high reimbursement levels from third party payers;
An increase in the proportion of our Acthar unit sales comprised of
Medicaid-eligible patients and government entities;
Our ability to estimate reserves required for Acthar used by government entities
and Medicaid-eligible patients and the impact that unforeseen invoicing of
historical Medicaid sales may have upon our results;
Our ability to operate within an industry that is highly regulated at both the
Federal and state level;
Our ability to effectively manage our growth and our reliance on key personnel;
The impact to our business caused by economic conditions;
Our ability to protect our proprietary rights;
Our ability to maintain effective controls over financial reporting;
The risk of product liability lawsuits;
Unforeseen business interruptions;
Volatility in Questcor's monthly and quarterly Acthar shipments and end-user
demand, as well as volatility in our stock price; and
Other risks discussed in Questcor's annual report on Form 10-K for the year ended
March 31, 2010, 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 Questcor's 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 of this release.
For more information, please visit questcor.com or
acthar.com. |
