VIVUS Reports 2016 Third Quarter Financial Results
"In the third quarter of 2016, we continued our efforts to reshape
July 21, 2016, VIVUSannounced that the U.S. District Court for the District of New Jerseyhad issued a claim construction, or Markman, ruling governing patent litigation brought by VIVUSagainst Actavis Laboratories FL, Inc., Actavis Pharma, Inc., and Actavis Inc., and Teva Pharmaceuticals USA, Inc.and Teva Pharmaceutical Industries Ltd. The lawsuits were filed in response to Abbreviated New Drug Applications filed by Actavis and Teva seeking to market and sell a generic version of Qsymia prior to the expiration of certain U.S.patents. The courts adopted VIVUS'proposed constructions for all but one of the disputed claim terms and adopted a compromise construction that was acceptable to VIVUSfor the final claim term.
July 27, 2016, VIVUSfiled a lawsuit in the U.S. District Court for the District of New Jerseyagainst Hetero USA, Inc.and Hetero Labs Limited. The lawsuit was filed on the basis that Hetero's submission of their ANDA to obtain approval to manufacture, use, sell, or offer for sale generic versions of STENDRA prior to the expiration of the patents-in-suit constitutes infringement of one or more claims of those patents. In accordance with the Hatch-Waxman Act, as a result of having filed a timely lawsuit against Hetero, FDAapproval of Hetero's ANDA will be stayed until the earlier of (i) up to 30 months from the expiration of STENDRA's New Chemical Entity exclusivity period (i.e., October 27, 2019) or (ii) a District Court decision finding that the identified patents are invalid, unenforceable or not infringed.
September 30, 2016, VIVUSentered into a license and commercialization agreement and a commercial supply agreement with Metuchen Pharmaceuticals LLC. Under the terms of the license and commercialization agreement, Metuchen received a fully-paid, exclusive license to develop, commercialize and promote STENDRA in the U. S., Canada, South Americaand India, and VIVUSreceived a payment of $70 million.
Total revenue, net for the quarters ended
|Three Months Ended|
|Qsymia, net product revenue||$||12,294||$||14,011|
|STENDRA/SPEDRA supply revenue||--||10,056|
|STENDRA/SPEDRA royalty revenue||1,059||869|
Approximately 109,000 and 146,000 Qsymia prescriptions were dispensed in the quarters ended
Total cost of goods sold was
Total research and development expense remained relatively consistent at
Total selling, general and administrative expense was
NOL Rights Plan
In connection with the original adoption of the rights plan, one right was distributed for each share of
As extended and amended, the rights plan will continue in effect until
Additional information with respect to the amended and restated rights plan will be contained in the Current Report on Form 8-K that
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 (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.
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; risks and uncertainties related to the impact of promotional programs for Qsymia on our net product revenue and net income (loss) in future periods; 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, changing market dynamics shifting prescribing towards obesity specialists, and the outcomes of our discussions with pharmaceutical companies and our strategic and
franchise-specific pathways for Qsymia; risks and uncertainties related to our ability to commercialize Qsymia efficiently; 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 in the
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share data)
|Three Months Ended||Nine Months Ended|
|Net product revenue||$||12,294||$||14,011||$||37,455||$||40,652|
|License and milestone revenue||--||--||--||11,574|
|Cost of goods sold||2,065||11,765||8,416||31,531|
|Research and development||1,696||1,532||3,821||6,825|
|Selling, general and administrative||10,440||17,129||39,254||65,730|
|Inventory impairment and other non-recurring charges||--||2,539||--||32,061|
|Total operating expenses||14,201||32,965||51,491||136,147|
|Loss from operations||(848||)||(8,029||)||(9,038||)||(56,060||)|
|Interest expense and other expense, net||8,313||8,076||24,209||24,851|
|Loss before income taxes||(9,161||)||(16,105||)||(33,247||)||(80,911||)|
|Provision for income taxes||(9||)||1||14||13|
|Basic and diluted net loss per share||$||(0.09||)||$||(0.15||)||$||(0.32||)||$||(0.78||)|
|Shares used in per share computation:|
|Basic and diluted||104,484||104,014||104,228||103,950|
CONDENSED CONSOLIDATED BALANCE SHEETS
|Cash and cash equivalents||$||154,137||$||95,395|
|Accounts receivable, net||10,295||8,997|
|Prepaid expenses and other assets||5,552||9,430|
|Total current assets||310,692||273,592|
|Property and equipment, net||715||994|
|LIABILITIES AND STOCKHOLDERS' DEFICIT|
|Accrued and other liabilities||9,944||15,891|
|Current portion of long-term debt||9,015||14,356|
|Total current liabilities||114,827||59,449|
|Long-term debt, net of current portion||229,876||217,034|
|Deferred revenue, net of current portion||6,845||6,508|
|Non-current accrued and other liabilities||16||1,296|
|Commitments and contingencies|
|Common stock and additional paid-in capital||831,297||829,532|
|Accumulated other comprehensive (loss) income||207||(261||)|
|Total stockholders' deficit||(38,113||)||(7,085||)|
|Total liabilities and stockholders' deficit||$||313,151||$||277,202|
|* The Condensed Consolidated Balance Sheet at
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