VIVUS Reports 2017 First Quarter Financial Results
"We continue our efforts to reshape
March 2017, VIVUSreacquired the commercial rights for STENDRA in Africa, the Middle East, Turkeyand the Commonwealth of Independent States, including Russia, from Sanofi.
March 2017, VIVUSengaged Aquilo Partnersto assist us with our strategic process in identifying, evaluating and acquiring new product pipeline programs.
January 2017, VIVUSacquired exclusive, worldwide rights for the development and commercialization of tacrolimus and ascomycin for the treatment of Pulmonary Arterial Hypertension (PAH) and related vascular diseases from Selten Pharma, Inc.For 2017, our goals for this program will be to develop or in-license a proprietary formulation for tacrolimus and have a pre-IND meeting with FDAto obtain an IND and identify a potential clinical pathway to approval.
January 2017, VIVUSgranted a license to Hetero to manufacture and commercialize the generic version of STENDRA described in Hetero's ANDA filing in the United Stateseffective no earlier than October 29, 2024.
January 2017, VIVUSpromoted Deborah Larsento the newly created position of Chief Commercial Officer.
Total revenue, net for the first quarters of 2017 and 2016, was
|Three Months Ended|
|Qsymia, net product revenue||$||17,620||$||12,412|
|License and milestone revenue||5,000||-|
|STENDRA/SPEDRA supply revenue||3,812||1,526|
|STENDRA/SPEDRA royalty revenue||580||1,386|
In the first quarter of 2017, we changed our revenue recognition methodology for Qsymia sales from a "sell-through" method to a "sell-in" method. This change resulted in the Company recognizing
Approximately 102,000 and 116,000 Qsymia prescriptions were dispensed in the first quarters of 2017 and 2016, respectively. Due to our switch to a "sell-in" model, revenue will be based on units shipped to the wholesaler rather than prescriptions dispensed in a given period. In the first quarter of 2017, we shipped approximately 89,000 units of Qsymia to the wholesalers. The "sell-in" model could result in higher volatility of Qsymia sales compared to those historically reported.
In the first quarter of 2017, we also recognized revenue related to a one-time
Total cost of goods sold, excluding inventory impairment, was
General and administrative expense was
Selling and marketing expense for the commercialization of Qsymia totaled
Research and development expense was
Note to Investors
As previously announced,
Qsymia is approved in the
The effect of Qsymia on cardiovascular morbidity and mortality has not been established. The safety and effectiveness of Qsymia in combination with other products intended for weight loss, including prescription and over-the-counter drugs, and herbal preparations, have not been established.
Important Safety Information
Qsymia® (phentermine and topiramate extended-release) capsules CIV is contraindicated in pregnancy; in patients with glaucoma; in hyperthyroidism; in patients receiving treatment or within 14 days following treatment with monoamine oxidase inhibitors; or in patients with hypersensitivity to sympathomimetic amines, topiramate, or any of the inactive ingredients in Qsymia.
Qsymia can cause fetal harm. Females of reproductive potential should have a negative pregnancy test before treatment and monthly thereafter and use effective contraception consistently during Qsymia therapy. If a patient becomes pregnant while taking Qsymia, treatment should be discontinued immediately, and the patient should be informed of the potential hazard to the fetus.
The most commonly observed side effects in controlled clinical studies, 5% or greater and at least 1.5 times placebo, include paraesthesia, dizziness, dysgeusia, insomnia, constipation, and dry mouth.
STENDRA® (avanafil) is approved in the
STENDRA is available through retail and mail order pharmacies.
SPEDRA™, the trade name for avanafil in the EU, is approved by the EMA for the treatment of erectile dysfunction in the EU.
Avanafil is licensed from Mitsubishi Tanabe Pharma Corporation (MTPC).
For more information about STENDRA, please visit www.STENDRA.com.
Important Safety Information
STENDRA® (avanafil) is prescribed to treat erectile dysfunction (ED).
Do not take STENDRA if you take nitrates, often prescribed for chest pain, as this may cause a sudden, unsafe drop in blood pressure.
Discuss your general health status with your healthcare provider to ensure that you are healthy enough to engage in sexual activity. If you experience chest pain, nausea, or any other discomforts during sex, seek immediate medical help.
STENDRA may affect the way other medicines work. Tell your healthcare provider if you take any of the following; medicines called HIV protease inhibitors, such as ritonavir (Norvir®), indinavir (Crixivan®), saquinavir (Fortavase® or Invirase®) or atazanavir (Reyataz®); some types of oral antifungal medicines, such as ketoconazole (Nizoral®), and itraconazole (Sporanox®); or some types of antibiotics, such as clarithromycin (Biaxin®), telithromycin (Ketek®), or erythromycin.
In the rare event of an erection lasting more than 4 hours, seek immediate medical help to avoid long-term injury.
In rare instances, men taking PDE5 inhibitors (oral erectile dysfunction medicines, including STENDRA) reported a sudden decrease or loss of vision. It is not possible to determine whether these events are related directly to these medicines or to other factors. If you experience sudden decrease or loss of vision, stop taking PDE5 inhibitors, including STENDRA, and call a doctor right away.
Sudden decrease or loss of hearing has been rarely reported in people taking PDE5 inhibitors, including STENDRA. It is not possible to determine whether these events are related directly to the PDE5 inhibitors or to other factors. If you experience sudden decrease or loss of hearing, stop taking STENDRA and contact a doctor right away. If you have prostate problems or high blood pressure for which you take medicines called alpha blockers or other anti-hypertensives, your doctor may start you on a lower dose of STENDRA.
Drinking too much alcohol when taking STENDRA may lead to headache, dizziness, and lower blood pressure.
STENDRA in combination with other treatments for ED is not recommended.
STENDRA does not protect against sexually transmitted diseases, including HIV.
The most common side effects of STENDRA are headache, flushing, runny nose and congestion.
Please see full patient prescribing information for STENDRA (50 mg, 100 mg, 200 mg) tablets.
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995 and are subject to risks, uncertainties and other factors, including risks and uncertainties related to potential change in our business strategy to enhance long-term stockholder value, including the evaluation of development opportunities; risks and uncertainties related to our ability to successfully commercialize Qsymia; risks and uncertainties related to our ability to successfully develop or acquire a proprietary formulation of tacrolimus as a precursor to the clinical development process; risks and uncertainties related to our ability to identify, acquire and develop new product pipeline candidates; risks and uncertainties related to the timing, strategy, tactics and success of the commercialization of STENDRA (avanafil) by our
sublicensees; risks and uncertainties related to our ability to successfully complete on acceptable terms, and on a timely basis, avanafil partnering discussions for territories under our license with MTPC in which we do not have a commercial collaboration, including the former Sanofi territories; risks and uncertainties related to
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|(In thousands, except per share data)|
|Three Months Ended|
|Net product revenue||$||17,620||$||12,412|
|License and milestone revenue||5,000||-|
|Cost of goods sold||6,167||3,704|
|Selling, general and administrative||11,431||15,122|
|Research and development||2,180||1,029|
|Total operating expenses||19,778||19,855|
|Income (loss) from operations||7,234||(4,531)|
|Interest expense and other expense, net||8,302||8,161|
|Loss before income taxes||(1,068)||(12,692)|
|(Benefit from) provision for income taxes||(12)||16|
|Basic and diluted net loss per share||$||(0.01)||$||(0.12)|
|Shares used in per share computation:|
|Basic and diluted||105,479||104,071|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|Cash and cash equivalents||$||67,753||$||84,783|
|Accounts receivable, net||11,443||9,478|
|Prepaid expenses and other assets||4,505||8,251|
|Total current assets||293,368||303,434|
|Property and equipment, net||738||788|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Accrued and other liabilities||20,313||15,686|
|Current portion of long-term debt||9,311||8,708|
|Total current liabilities||36,036||48,275|
|Long-term debt, net of current portion||234,866||232,610|
|Deferred revenue, net of current portion||6,232||6,449|
|Non-current accrued and other liabilities||370||257|
|Commitments and contingencies|
|Common stock and additional paid-in capital||832,582||831,855|
|Accumulated other comprehensive (loss) income||(491)||(616)|
|Total stockholders' equity||17,981||18,185|
|Total liabilities and stockholders' equity||$||295,485||$||305,776|
|* The Condensed Consolidated Balance Sheets have been derived from the Company's audited financial statements at that date, as adjusted.|
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