VIVUS Reports Second Quarter 2014 Financial Results
Second Quarter 2014 Financial Results
Total net revenue was
Total research and development expense was
Total selling, general and administrative expense was
There were no non-recurring charges in the current quarter, compared to the second quarter of 2013 during which we incurred
Net loss was
There were approximately 138,000 Qsymia prescriptions dispensed in the second quarter of 2014, compared to 121,000 prescriptions in the first quarter of 2014 and 81,000 in the second quarter of 2013.
Cash, cash equivalents and available-for-sale securities (collectively cash) totaled
May 15, 2014, we announced that a poster describing results of an analysis of the association between weight loss with Qsymia® (phentermine and topiramate extended-release) capsules CIV and annual concomitant medication costs would be presented at the American Association of Clinical Endocrinologists23rd Annual Scientific & Clinical Congressin Las Vegas, NV.
May 19, 2014, we announced that a poster describing results of a clinical study examining onset of action of avanafil would be presented during the American Urological AssociationAnnual Meeting in Orlando, FL.
June 12, 2014, we announced that we had filed a lawsuit in the U.S. District Court for the District of New Jerseyagainst Actavis. The lawsuit was filed in response to an Abbreviated New Drug Application, or ANDA, filed by Actavis, which seeks to market and sell generic versions of the currently approved doses of Qsymia prior to the expiration of U.S. Patents held by VIVUS. We filed the lawsuit on the basis that Actavis's proposed generic products infringe patents held by VIVUS. As a result of having filed a lawsuit within 45 days of the Paragraph IV certification notice, FDAapproval of the ANDAwill be stayed until the earlier of (i) 30 months from VIVUS'sreceipt of the notice or (ii) a District Court decision finding that the identified patents are invalid, unenforceable or not infringed.
Note to Investors
As previously announced,
Qsymia® is approved in the U.S. and is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of 30 kg/m2 or greater (obese) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related medical condition such as high blood pressure, type 2 diabetes, or high cholesterol.
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 U.S. by the
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 (
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. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate," "expect," "intend," "likely," "may," "plan," "potential," "predict," "opportunity" and "should," among others. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements.
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|(in thousands, except per share amounts)|
|Three Months Ended||Six Months Ended|
|June 30,||June 30,|
|Net product revenue||$||10,983||$||5,534||$||20,121||$||9,646|
|License and milestone revenue||4,181||-||23,544||-|
|Cost of goods sold||7,015||572||16,548||962|
|Inventory impairment and commitment fee||-||4,448||-||10,225|
|Research and development||4,086||9,232||8,509||16,278|
|Selling, general and administrative||28,266||39,509||56,875||83,499|
|Total operating expenses||39,367||56,979||83,986||114,888|
|Loss from operations||(17,486||)||(51,445||)||(25,414||)||(105,242||)|
|Total interest expense and other expense (income), net||8,341||4,183||16,399||4,148|
|Loss from continuing operations before income taxes||(25,827||)||(55,628||)||(41,813||)||(109,390||)|
|Provision for (benefit from) income taxes||(2||)||7||(438||)||13|
|Loss from continuing operations||(25,825||)||(55,635||)||(41,375||)||(109,403||)|
|Income from discontinued operations, net of tax||-||123||-||315|
|Basic and diluted net loss per share:|
|Net loss per share||$||(0.25||)||$||(0.55||)||$||(0.40||)||$||(1.08||)|
|Shares used in per share computation:|
|Basic and diluted||103,350||100,739||103,320||100,700|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|June 30,||December 31,|
|Cash and cash equivalents||$||96,262||$||103,262|
|Accounts receivable, net||13,284||12,214|
|Prepaid expenses and other assets||12,269||19,938|
|Total current assets||393,559||423,941|
|Property and equipment, net||1,725||1,954|
|Accrued and other liabilities||23,532||23,993|
|Total current liabilities||52,654||52,007|
|Long-term debt, net of current portion||216,841||213,106|
|Deferred revenue, net of current portion||9,994||10,360|
|Non-current accrued and other liabilities||2,388||2,954|
|Commitments and contingencies||-||-|
|Common stock and additional paid-in capital||820,676||813,905|
|Accumulated other comprehensive income||98||66|
|Total stockholders' equity||118,797||153,369|
|Total liabilities and stockholders' equity||$||400,674||$||431,796|
|* The Condensed Consolidated Balance Sheet at
Corporate Development & Investor Relations
Senior Vice President
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