ANAHEIM, Calif., Sept. 28, 2011 /PRNewswire/ -- Questcor Pharmaceuticals, Inc. (NASDAQ: QCOR) today announced preliminary operating metrics for its third quarter ending September 30, 2011. The Company announced the estimated metrics in conjunction with the Jeffries Global Healthcare Conference in London, where Don M. Bailey, President and Chief Executive Officer of Questcor, presented on Wednesday, September 28, 2011, at 8:00 a.m. BT, 3:00 a.m. ET. To listen to the audio web cast of the presentation, please visit www.questcor.com. The replay will be available for 90 days after the event.
For the quarter ending September 30, 2011, the Company provided the following preliminary estimated operating metrics:
- Based on internal Company data through September 26, 2011:
- New, paid prescriptions of the Company's principal drug, H.P. Acthar® Gel (Acthar), for the treatment of exacerbations of multiple sclerosis (MS) during the full third quarter are expected to exceed 850, up over 160% from the year ago period.
- New, paid prescriptions for nephrotic syndrome (NS) are expected to exceed 55.
- New, paid prescriptions for infantile spasms (IS) are expected to exceed 105.
- Vials of Acthar, shipped during the quarter are expected to exceed 2,750, up over 45% from the year ago period.
During the third quarter, the Company has not repurchased any of its common stock. Prior repurchases have used over $78 million since this effort began in 2008. As of September 26, 2011, Questcor had 62.7 million shares of common stock outstanding, with 4.3 million shares remaining under its common stock repurchase program.
As of September 26, 2011, Questcor's cash, cash equivalents and short-term investments totaled $174 million.
Questcor currently expects to release its financial results for the third quarter on October 25, 2011.
"Increases in new, paid MS prescriptions are the result of increased productivity from our Specialty Sales Force which consists of 77 Acthar sales representatives," said Don M. Bailey, President and CEO of Questcor Pharmaceuticals. "In addition, despite disruption in our nephrology selling effort as we expanded the Nephrology Sales Force from 5 to 28 sales representatives, new, paid NS prescriptions have increased from the second quarter of 2011. The new Nephrology Sales Force has been hired and training will be completed this week. Some of the new nephrology sales representatives and the Specialty Sales Force contributed to the increased script count in the quarter."
The Company's quarterly vial shipments continue to be subject to significant variation due to the size and timing of individual orders from its distributor, and the timing of these orders can significantly affect net sales and net income in any particular quarter. For this reason, as well as other factors causing quarter-to-quarter variability in Questcor's operating results, the Company believes that investors should consider the Company's results over several quarters when analyzing the Company's financial performance. All of the financial and prescription information above is based on preliminary estimates and analysis and are subject to change as the Company continues to close the quarter and conduct its normal financial reviews.
Prescription Information for MS, IS and NS
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, Questcor is able to monitor therapeutic use for new Acthar prescriptions based on data it receives from its reimbursement support center. Questcor estimates that over 90% of new Acthar prescriptions are processed by this support center.
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 www.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 including systemic lupus erythematosus;
- Research and development risks, including risks associated with Questcor's work in the area of NS and potential work in the area of systemic lupus erythematosus, 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 in connection with U.S. health care reform or efforts to reduce federal and state government deficits;
- 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 prescriptions 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, including the expansion of our NS selling effort, 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 December 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.
SOURCE Questcor Pharmaceuticals, Inc.