VIVUS Reports First Quarter 2014 Financial Results
First Quarter 2014 Financial Results
Total net revenue was
Total research and development expense was
Selling, general and administrative expense was
Net loss was
There were approximately 121,000 Qsymia prescriptions dispensed in the first quarter of 2014, compared to 124,000 Qsymia prescriptions in the fourth quarter of 2013.
Cash, cash equivalents and available-for-sale securities (collectively cash) totaled
March 19, 2014, we announced that Shari Belafontehad teamed with the company to educate American adults about seeking medical treatment for chronic weight management when diet and physical activity alone have not been successful. (A 10% weight loss goal is recommended by the National Institutes of Healthas a benchmark to help patients reduce the risk of developing other medical conditions while making a meaningful difference in health and well-being.) Ms. Belafonte, an actress, model, photographer, writer, singer and daughter of famed musician and actor Harry Belafonte, had struggled in recent years with being overweight, had developed high cholesterol and was increasingly concerned about a family history that included cardiovascular disease and diabetes. She worked with her primary care physician and was able to achieve her weight loss goal with an available prescription medication as part of a plan including proper nutrition and physical activity. Ms. Belafonte's new photographic work features patients like herself who have successfully achieved and maintained meaningful weight loss, improving their health and well-being.
March 25, 2014, we announced that a review article had been published online in the Journal of Hypertension, the official publication of the International Society of Hypertensionand the European Society of Hypertension, summarizing the cardiovascular benefit-risk profile of Qsymia. The data suggested that Qsymia can be a safe and effective weight loss option for overweight/obese patients with cardiovascular risk factors such as hypertension or type 2 diabetes. Available data from the study did not indicate any increased cardiovascular risk associated with Qsymia.
March 2014, Menarini commenced commercialization of SPEDRA in France, Germany, Italyand the United Kingdom, for which milestone payments of EUR3.0 millionfor each country (in total EUR12.0 millionor approximately $16.6 million) were earned and recognized as license and milestone revenue in the three months ended March 31, 2014. In April 2014, Menarini commenced commercialization of SPEDRA in Spain, resulting in VIVUSreceiving its fifth and final milestone from Menarini of EUR3.0 million, or approximately $4.2 million.
April 11, 2014, we announced that a poster describing results of a clinical study examining onset of action of avanafil would be presented during the 29th Annual European Association of Urology (EAU) Congressat Stockholmsmässan in Stockholm, Sweden.
"Physicians' leading concerns with the obesity category are reimbursement/coverage, historical issues regarding safety, and the amount of time and skill required to have a successful discussion with a patient about obesity," stated
"We are pleased with the STENDRA and SPEDRA launch efforts and the results achieved to date,"
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 and are subject to risks, uncertainties and other factors, including risk and uncertainties related to the progress in educating providers, payors, and patients that the disease of obesity requires proactive treatment; risk and uncertainties related to the long-term prospects for the obesity market, as well as our continuing efforts to make Qsymia the drug of choice in this market; and risks and uncertainties related to the commercialization of STENDRA and SPEDRA by our partners in their respective territories. These risks and uncertainties could cause actual results to differ materially from those referred to in these forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. Investors should read the
risk factors set forth in
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|(In thousands, except per share data)|
Three Months Ended
|Net product revenue||$||9,138||$||4,112|
|License and milestone revenue||19,363||-|
|Cost of goods sold||9,533||390|
|Inventory impairment and commitment fee||-||5,777|
|Research and development||4,423||7,046|
|Selling, general and administrative||28,609||44,696|
|Total operating expenses||44,619||57,909|
|Loss from operations||(7,928||)||(53,797||)|
|Total interest and other expense (income)||8,058||(35||)|
|Loss from continuing operations before income taxes||(15,986||)||(53,762||)|
|Provision for (benefit from) income taxes||(436||)||6|
|Loss from continuing operations||(15,550||)||(53,768||)|
|Income from discontinued operations, net of tax||-||192|
|Basic and diluted net loss per share:|
|Net loss per share||$||(0.15||)||$||(0.53||)|
|Shares used in per share computation:|
|Basic and diluted||103,289||100,660|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|Cash and cash equivalents||$||89,659||$||103,262|
|Accounts receivable, net||31,079||12,214|
|Prepaid expenses and other assets||19,087||19,938|
|Total current assets||413,544||423,941|
|Property and equipment, net||1,758||1,954|
|Accrued and other liabilities||24,270||23,993|
|Total current liabilities||49,964||52,007|
|Deferred revenue, net of current portion||10,140||10,360|
|Non-current accrued and other liabilities||2,730||2,954|
|Commitments and contingencies|
|Common stock and additional paid-in capital||817,511||813,905|
|Accumulated other comprehensive income||109||66|
|Total stockholders' equity||141,468||153,369|
|Total liabilities and stockholders' equity||$||420,896||$||431,796|
|*The Condensed Consolidated Balance Sheet at
Corporate Development & Investor Relations
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