VIVUS Reports Third Quarter 2017 Financial Results
"We achieved several key objectives for our marketed products and our lead pipeline program in the third quarter. We expanded the market opportunity for Qsymia® to
Recent Business Highlights
VIVUS Resolves Qsymia IP Challenges
In July and
August 2017, VIVUSannounced settlement agreements with Actavis Laboratories FL(Actavis) and Dr. Reddy's Laboratories, S.A.and Dr. Reddy's Laboratories, Inc.(Dr. Reddy's). The settlement agreements permit Actavis and Dr. Reddy's to begin selling a generic version of Qsymia on December 1, 2024and June 1, 2025, respectively, or earlier under certain circumstances. In the event of a launch earlier than these dates, VIVUSwill receive a royalty on net sales of the generic version of Qsymia.
VIVUS Expands Qsymia Beyond the
September 2017, VIVUSannounced an agreement under which Alvogen Malta Operations (ROW) Ltd(Alvogen) will market Qsymia® in the Republic of Koreafor the treatment of chronic weight management or weight-related conditions. Alvogen will be solely responsible for obtaining and maintaining regulatory approvals and for all sales and marketing activities in South Korea. VIVUSreceived an upfront payment and is eligible to receive additional future milestone payments. In addition, VIVUSwill receive royalties on Alvogen's net sales of Qsymia.
Tacrolimus Hits Key Milestones and Releases Clinical Data
September 2017, VIVUSannounced that the European Medicines Agency(EMA) has granted Orphan Designation to its lead clinical candidate tacrolimus, for the treatment of PAH.
October 2017, VIVUSannounced that it held a pre-IND meeting with the FDAin October for its proprietary formulation of tacrolimus for the treatment of PAH. The FDAaddressed VIVUS'questions related to preclinical, nonclinical and clinical data and planned design of clinical trials of tacrolimus in class III and IV PAH patients, and clarified the requirements needed to file an IND to initiate a clinical trial in this indication. VIVUSis on track to file this IND in the first half of 2018. As discussed with the FDA, VIVUScurrently intends to design and conduct clinical trials that could qualify for Fast Track and/or Breakthrough Therapy designation.
September 2017, results of a clinical study of tacrolimus, VIVUS'lead product development candidate, in patients with PAH were published in the European Respiratory Journal. Study results demonstrate the safety of tacrolimus in patients with PAH, a chronic life-threatening disease characterized by elevated blood pressure in the pulmonary arteries (arteries between the heart and lungs) due to severe constriction of these blood vessels.
Net loss for the third quarter of 2017 was
Total revenue, net for the third quarters of 2017 and 2016, was
|Three Months Ended|
|Qsymia, net product revenue||$||9,911||$||12,294|
|License and milestone revenue||2,500||-|
|STENDRA/SPEDRA supply revenue||2,133||-|
|STENDRA/SPEDRA royalty revenue||649||1,059|
Beginning in the first quarter of 2017, with 48 months of returns experience,
Approximately 97,000 and 109,000 Qsymia prescriptions were dispensed in the third quarters of 2017 and 2016, respectively. In the third quarter of 2017,
Total cost of goods sold was
Research and development expense was
General and administrative expense was
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, or our partner's, 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 our ability to develop a proprietary formulation and to demonstrate through clinical
testing the quality, safety, and efficacy of our current or future investigational drug 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; risks and uncertainties related to the failure to obtain
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|(In thousands, except per share data)|
|Three Months Ended||Nine Months Ended|
|Net product revenue||$||9,911||$||12,294||$||36,049||$||37,455|
|License and milestone revenue||2,500||-||7,500||-|
|Cost of goods sold||3,514||2,065||13,251||8,416|
|Research and development||865||1,696||4,059||3,821|
|Selling, general and administrative||8,388||10,440||31,449||39,254|
|Total operating expenses||12,767||14,201||48,759||51,491|
|Income (loss) from operations||2,426||(848)||4,673||(9,038)|
|Interest expense and other expense, net||8,412||8,313||25,112||24,209|
|Loss before income taxes||(5,986)||(9,161)||(20,439)||(33,247)|
|Provision (benefit) for income taxes||8||(9)||(3)||14|
|Basic and diluted net loss per share||$||(0.06)||$||(0.09)||$||(0.19)||$||(0.32)|
|Shares used in per share computation:|
|Basic and diluted||105,826||104,484||105,674||104,228|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|Cash and cash equivalents||$||73,151||$||84,783|
|Accounts receivable, net||11,806||9,478|
|Prepaid expenses and other assets||3,754||8,251|
|Total current assets||265,025||303,434|
|Property and equipment, net||606||788|
|LIABILITIES AND STOCKHOLDERS' (DEFICIT) EQUITY|
|Accrued and other liabilities||19,806||15,686|
|Current portion of long-term debt||9,357||8,708|
|Total current liabilities||35,477||48,275|
|Long-term debt, net of current portion||225,354||232,610|
|Deferred revenue, net of current portion||5,205||6,449|
|Non-current accrued and other liabilities||348||257|
|Commitments and contingencies|
|Stockholders' (deficit) equity:|
|Common stock and additional paid-in capital||834,102||831,855|
|Accumulated other comprehensive loss||(257)||(616)|
|Total stockholders' (deficit) equity||355||18,185|
|Total liabilities and stockholders' (deficit) equity||$||266,739||$||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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