VIVUS (VVUS) March Qsymia Shipments Rose 29%
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VIVUS, Inc. (Nasdaq: VVUS) is reporting in this Form 8-K operating metrics related to the Company’s product, Qsymia® (phentermine and topiramate extended-release), which are based on data available to the Company as of March 31, 2013. The Company previously has reported the number of prescriptions of Qsymia shipped to patients based on four-week rolling periods. The Company has changed the basis for reporting this data to calendar months and intends to report the number of prescriptions shipped to patients on this basis in the future. Accordingly, the table below presents the number of prescriptions shipped to patients for the calendar-month periods ended January 31, 2013, February 28, 2013 and March 31, 2013.
Qsymia prescriptions shipped(1):
(1)Represents Qsymia prescriptions shipped to patients. This data is derived from data made available to the Company from third parties; due to this and other factors, the data reported above may be subject to adjustment should the Company receive adjusted information from these third parties.
As the Company has disclosed in its previous filings with the Securities and Exchange Commission, its ability to effectively and profitably commercialize Qsymia will depend in part on its ability to create market demand for Qsymia through education, marketing and sales activities; to achieve market acceptance of Qsymia and generate product revenue; to receive adequate levels of reimbursement from third-party payers, such as private insurance programs and pharmacy benefit managers; and to comply with the post-marketing requirements established by the U.S. Food and Drug Administration, or FDA, including the Risk Evaluation and Mitigation Strategy, or REMS, and any other requirements established by the FDA in the future.
Important Information Regarding Prescriptions Shipped and Net Product Revenue
The relationship between the number of prescriptions shipped and net product revenue may vary based on a number of factors. In particular, product revenue is recognized net of deductions which may vary from period to period. These deductions include cash consideration paid to the certified pharmacies for services rendered by the pharmacies in accordance with certified pharmacy services network agreements, and include a fixed rate per prescription shipped and monthly program management and data fees. Other deductions include certain prompt pay cash discounts, discounts offered to patients under the Qsymia Save Now! Program, and rebates.
Calculating certain of these items involves estimates and judgments based on revenue or invoice data and historical experience. Amounts accrued for revenue deductions are adjusted when trends, significant events, or actual results indicate that adjustment is appropriate. Revisions of estimates for revenue deductions are recorded as a reduction of revenue in the period in which the information that gives rise to the revision becomes known.
In addition, the prescriptions shipped at no charge from participating certified pharmacies under the Qsymia Get Started! Free Trial Offer Program will result in no revenue, and the prescriptions shipped at a discount from participating certified pharmacies under the Qsymia Save Now! Program will result in reduced revenue.
The Company launched Qsymia to the market on September 17, 2012. Accordingly, there is a limited amount of information regarding the number of prescriptions shipped and net product revenue related to Qsymia. The Company believes that investors should view the data provided in this Current Report on Form 8-K with caution, as data for a single period or limited period, as in this case, may not be representative of a trend or otherwise predictive of future results. The Company believes that investors should consider Company results over several quarters or longer when analyzing Company performance.
Qsymia prescriptions shipped(1):
- Month ended Jan. 31, 2013 - 16,733;
- Month ended Feb. 28, 2013 - 18,417; and
- Month ended March 31, 2013 - 23,812.
(1)Represents Qsymia prescriptions shipped to patients. This data is derived from data made available to the Company from third parties; due to this and other factors, the data reported above may be subject to adjustment should the Company receive adjusted information from these third parties.
As the Company has disclosed in its previous filings with the Securities and Exchange Commission, its ability to effectively and profitably commercialize Qsymia will depend in part on its ability to create market demand for Qsymia through education, marketing and sales activities; to achieve market acceptance of Qsymia and generate product revenue; to receive adequate levels of reimbursement from third-party payers, such as private insurance programs and pharmacy benefit managers; and to comply with the post-marketing requirements established by the U.S. Food and Drug Administration, or FDA, including the Risk Evaluation and Mitigation Strategy, or REMS, and any other requirements established by the FDA in the future.
Important Information Regarding Prescriptions Shipped and Net Product Revenue
The relationship between the number of prescriptions shipped and net product revenue may vary based on a number of factors. In particular, product revenue is recognized net of deductions which may vary from period to period. These deductions include cash consideration paid to the certified pharmacies for services rendered by the pharmacies in accordance with certified pharmacy services network agreements, and include a fixed rate per prescription shipped and monthly program management and data fees. Other deductions include certain prompt pay cash discounts, discounts offered to patients under the Qsymia Save Now! Program, and rebates.
Calculating certain of these items involves estimates and judgments based on revenue or invoice data and historical experience. Amounts accrued for revenue deductions are adjusted when trends, significant events, or actual results indicate that adjustment is appropriate. Revisions of estimates for revenue deductions are recorded as a reduction of revenue in the period in which the information that gives rise to the revision becomes known.
In addition, the prescriptions shipped at no charge from participating certified pharmacies under the Qsymia Get Started! Free Trial Offer Program will result in no revenue, and the prescriptions shipped at a discount from participating certified pharmacies under the Qsymia Save Now! Program will result in reduced revenue.
The Company launched Qsymia to the market on September 17, 2012. Accordingly, there is a limited amount of information regarding the number of prescriptions shipped and net product revenue related to Qsymia. The Company believes that investors should view the data provided in this Current Report on Form 8-K with caution, as data for a single period or limited period, as in this case, may not be representative of a trend or otherwise predictive of future results. The Company believes that investors should consider Company results over several quarters or longer when analyzing Company performance.
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