VIVUS Reports Fourth Quarter and Full Year 2016 Financial Results
"Over the last six months, we have made significant strides to reshape
Business Update
- In
January 2017 ,VIVUS acquired exclusive, worldwide rights for the development and commercialization of tacrolimus and ascomycin for the treatment of Pulmonary Arterial Hypertension (PAH) and related vascular diseases fromSelten 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 withFDA to obtain an IND and identify a potential clinical pathway to approval. - In
March 2017 , we engagedAquilo Partners to assist us with our strategic process in identifying, evaluating and acquiring new product pipeline programs. - In
January 2017 ,VIVUS granted a license to Hetero to manufacture and commercialize the generic version of STENDRA described in Hetero's ANDA filing inthe United States effective no earlier thanOctober 29, 2024 . - In
January 2017 ,VIVUS promotedDeborah Larsen to the newly created position of Chief Commercial Officer. - In
December 2016 ,VIVUS relocated its corporate headquarters fromMountain View, CA to900 East Hamilton Avenue , Suite 550,Campbell, CA 95008 in our continued cost control efforts.
Financial Results
Total revenue, net for the quarter and year ended
Three Months Ended | Year Ended | ||||||||||||
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2016 | 2015 | 2016 | 2015 | ||||||||||
Qsymia, net product revenue | $ | 11,046 | $ | 13,970 | $ | 48,501 | $ | 54,622 | |||||
License and milestone revenue | 69,400 | - | 69,400 | 11,574 | |||||||||
STENDRA/SPEDRA supply revenue | 765 | 23 | 2,291 | 26,674 | |||||||||
STENDRA/SPEDRA royalty revenue | 594 | 1,350 | 4,066 | 2,560 | |||||||||
Total revenue | $ | 81,805 | $ | 15,343 | $ | 124,258 | $ | 95,430 | |||||
Approximately 100,000 and 442,000 Qsymia prescriptions were dispensed in the quarter and year ended
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,
About Qsymia
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 (MAOIs); 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.
About Avanafil
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.
About
A biopharmaceutical company developing and commercializing innovative, next-generation therapies to address unmet medical needs in human health. For more information about the company, please visit www.vivus.com.
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; risks and uncertainties related to our ability to successfully commercialize Qsymia including risks and uncertainties related to expansion to retail distribution, the broadening of payor reimbursement, the expansion of Qsymia's primary care presence, and the outcomes of our discussions with pharmaceutical companies and our strategic and franchise-specific pathways for Qsymia; risks and uncertainties related to the timing, strategy, tactics and success of the launches and commercialization of STENDRA® (avanafil) or SPEDRA™ (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
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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||||||||
(In thousands, except per share data) | ||||||||||||||||
(Unaudited) | ||||||||||||||||
Three Months Ended | Year Ended | |||||||||||||||
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2016 | 2015 | 2016 | 2015 | |||||||||||||
Revenue: | ||||||||||||||||
Net product revenue | $ | 11,046 | $ | 13,970 | $ | 48,501 | $ | 54,622 | ||||||||
License and milestone revenue | 69,400 | - | 69,400 | 11,574 | ||||||||||||
Supply revenue | 765 | 23 | 2,291 | 26,674 | ||||||||||||
Royalty revenue | 594 | 1,350 | 4,066 | 2,560 | ||||||||||||
Total revenue | 81.805 | 15,343 | 124,258 | 95,430 | ||||||||||||
Operating expenses: | ||||||||||||||||
Cost of goods sold | 2,186 | 2,626 | 10,602 | 34,157 | ||||||||||||
Selling, general and administrative | 13,125 | 13,657 | 52,379 | 79,387 | ||||||||||||
Research and development | 1,771 | 3,277 | 5,592 | 10,102 | ||||||||||||
Inventory impairment and other non-recurring charges | - | - | - | 32,061 | ||||||||||||
Total operating expenses | 17,082 | 19,560 | 68,573 | 155,707 | ||||||||||||
Income (loss) from operations | 64,723 | (4,217 | ) | 55,685 | (60,277 | ) | ||||||||||
Interest expense and other expense, net | 8,104 | 7,976 | 32,313 | 32,827 | ||||||||||||
Income (loss) before income taxes | 56,619 | (12,193 | ) | 23,372 | (93,104 | ) | ||||||||||
Provision for (benefit from) income taxes | 56 | (10 | ) | 70 | 3 | |||||||||||
Net income (loss) | $ | 56,563 | $ | (12,183 | ) | $ | 23,302 | $ | (93,107 | ) | ||||||
Basic net income (loss) per share | $ | 0.54 | $ | (0.12 | ) | $ | 0.22 | $ | (0.90 | ) | ||||||
Diluted net income (loss) per share | $ | 0.54 | $ | (0.12 | ) | $ | 0.22 | $ | (0.90 | ) | ||||||
Shares used in per share computation: | ||||||||||||||||
Basic | 104,852 | 104,046 | 104,385 | 103,926 | ||||||||||||
Diluted | 105,338 | 104,046 | 104,969 | 103,926 | ||||||||||||
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CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||||
(In thousands) | ||||||||||
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2016 | 2015* | |||||||||
ASSETS | (Unaudited) | |||||||||
Current assets: | ||||||||||
Cash and cash equivalents | $ | 84,783 | $ | 95,395 | ||||||
Available-for-sale securities | 184,736 | 146,168 | ||||||||
Accounts receivable, net | 9,478 | 8,997 | ||||||||
Inventories | 16,186 | 13,602 | ||||||||
Prepaid expenses and other assets | 8,251 | 9,430 | ||||||||
Total current assets | 303,434 | 273,592 | ||||||||
Property and equipment, net | 788 | 994 | ||||||||
Non-current assets | 1,554 | 2,616 | ||||||||
Total assets | $ | 305,776 | $ | 277,202 | ||||||
LIABILITIES AND STOCKHOLDERS' (DEFICIT) EQUITY | ||||||||||
Current liabilities: | ||||||||||
Accounts payable | $ | 4,707 | $ | 7,060 | ||||||
Accrued and other liabilities | 15,686 | 15,891 | ||||||||
Deferred revenue | 19,174 | 22,142 | ||||||||
Current portion of long-term debt | 8,708 | 14,356 | ||||||||
Total current liabilities | 48,275 | 59,449 | ||||||||
Long-term debt, net of current portion | 232,610 | 217,034 | ||||||||
Deferred revenue, net of current portion | 6,449 | 6,508 | ||||||||
Non-current accrued and other liabilities | 257 | 1,296 | ||||||||
Total liabilities | 287,591 | 284,287 | ||||||||
Commitments and contingencies | ||||||||||
Stockholders' equity: | ||||||||||
Common stock and additional paid-in capital | 831,855 | 829,532 | ||||||||
Accumulated other comprehensive (loss) income | (616 | ) | (261 | ) | ||||||
Accumulated deficit | (813,054 | ) | (836,356 | ) | ||||||
Total stockholders' equity (deficit) | 18,185 | (7,085 | ) | |||||||
Total liabilities and stockholders' equity (deficit) | $ | 305,776 | $ | 277,202 | ||||||
* The Condensed Consolidated Balance Sheets have been derived from the Company's audited financial statements at that date, as adjusted. |
Chief Financial Officer
oki@vivus.com
650-934-5200
Investor Relations:
Managing Director
bkorb@troutgroup.com
646-378-2923
Source:
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