VIVUS Reports Second Quarter 2019 Financial Results
“We recently initiated a variety of programs designed to improve patient access to Qsymia and PANCREAZE. The initial response to the Qsymia Advantage Program, while early, has been positive, accounting for 8% of second quarter prescriptions after just 4 months of this platform’s launch,” said
Recent Business Highlights
- Announced Approval of Qsymia® in the
Republic of Korea
August 2019, VIVUSannounced that its Korean marketing partner, Alvogen Malta Operations (ROW) Ltd, has obtained marketing approval for Qsymia (phentermine and topiramate extended-release) from the South Korea Ministry of Food and Drug Safety(MFDS). VIVUSwill receive a milestone payment associated with the approval and remain eligible for future commercial milestones and royalties on net revenues.
- Launch of Online Platform to Improve Patient Access to Qsymia
June 2019, VIVUSlaunched an e-medicine platform that enables patients with a prescription for Qsymia to purchase the medication online and have their orders delivered directly to their homes. The online ordering platform is another component of the Qsymia Advantage Program, which is designed to improve patient access to Qsymia.
- Initiated Phase Four Safety and Efficacy Study of Qsymia in Obese Adolescents
May 2019, the first patient was enrolled in VIVUS’ Phase four clinical study designed to evaluate the safety and efficacy of Qsymia® (phentermine and topiramate extended-release) capsules CIV in obese adolescents between the ages of 12 and 17 years. The Centers for Disease Control and Preventionestimates that nearly 21 percent of adolescents ages 12 to 19 years are obese. A study conducted by the World Health Organizationfound that obesity in children ages five to 19 years has risen ten-fold in the past four decades and estimates that more children globally will be overweight rather than underweight by 2022.
- Amended its Contract Manufacturing Agreement to Supply Current and Future Demand for PANCREAZE
June 2019, VIVUSamended its manufacturing and supply agreement with Nordmark Arzneimittel GmbH & Co. KGfor PANCREAZE. The amended agreement covers a ten-year initial term and may be renewed for additional five-year periods, the first at VIVUS’ option and by mutual agreement thereafter.
- Launched the PANCREAZE® Patient Assistance Program
May 2019, VIVUSannounced a partnership to facilitate access to PANCREAZE (pancrelipase) Delayed Release Capsules for uninsured or underinsured patients with exocrine pancreatic insufficiency (EPI) that meet applicable eligibility criteria. PANCREAZE is available to eligible patients through the VIVUS Health Platform and the PANCREAZE Advantage Program integrated with HarborPath Direct’s SuccorRx™ Patient Assistance Program (PAP) platform.
2019 Second Quarter vs 2019 First Quarter Financial Results
Revenue consisted of the following:
Three Months Ended
|Qsymia net product revenue||$||9,994||$||8,423|
|PANCREAZE net product revenue||5,110||5,074|
Total revenue for the second and first quarters of 2019 was
Qsymia net product revenue was
PANCREAZE net product revenue was
Total cost of goods sold excluding amortization was
Amortization of intangible assets was
Selling, general and administrative expense was
Research and development expense was
Total interest and other expense was
Net loss for the second and first quarters of 2019 was
Recurring non-GAAP EBITDA for the second and first quarters of 2019 was
Conference Call Details
VIVUS will hold a conference call and an audio webcast to provide a business update and to discuss second quarter 2019 financial results today, August 6, 2019, beginning at 4:30 PM Eastern Time. Investors may listen to this call by dialing toll-free 1-877-359-2916 in the U.S. and 1-224-357-2386 from outside the U.S. The audience passcode is 5386769. A webcast replay will be available for 30 days and may be accessed at http://ir.vivus.com/events-and-presentations.
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.
For more information about Qsymia, please visit www.Qsymia.com.
Important Safety Information for Qsymia
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.
PANCREAZE is a prescription medicine used to treat people who cannot digest food normally because their pancreas does not make enough enzymes due to cystic fibrosis or other conditions. PANCREAZE may help your body use fats, proteins, and sugars from food. PANCREAZE contains a mixture of digestive enzymes including lipases, proteases, and amylases from pig pancreas. PANCREAZE is safe and effective in children when taken as prescribed by your doctor.
Important Safety Information for PANCREAZE
What is the most important information I should know about PANCREAZE?
- PANCREAZE may increase your chance of having a serious, rare bowel disorder called fibrosing colonopathy that may require surgery.
- The risk of having this condition may be reduced by following the dosing instructions that your healthcare provider gave you.
Call your doctor right away if you have any unusual or severe stomach area (abdominal) pain, bloating, trouble passing stool (having bowel movements), nausea, vomiting, or diarrhea.
Take PANCREAZE exactly as prescribed by your doctor. Do not take more or less PANCREAZE than directed by your doctor.
What are the possible side effects of PANCREAZE?
PANCREAZE may cause serious side effects, including:
- A rare bowel disorder called fibrosing colonopathy.
- Irritation of the inside of your mouth. This can happen if PANCREAZE is not swallowed completely.
- Increase in blood uric acid levels. This may cause worsening of swollen, painful joints (gout) caused by an increase in your blood uric acid levels.
- Allergic reactions including trouble with breathing, skin rashes, or swollen lips.
Call your doctor right away if you have any of these symptoms.
The most common side effects include pain in your stomach (abdominal pain) and gas.
Other possible side effects: PANCREAZE and other pancreatic enzyme products are made from the pancreas of pigs, the same pigs people eat as pork. These pigs may carry viruses. Although it has never been reported, it may be possible for a person to get a viral infection from taking pancreatic enzyme products that come from pigs.
These are not all the side effects of PANCREAZE. Talk to your doctor about any side effect that bothers you or does not go away.
You may report side effects to
What should I tell my doctor before taking PANCREAZE?
Tell your doctor if you:
- are allergic to pork (pig) products.
- have a history of blockage of your intestines, or scarring or thickening of your bowel wall (fibrosing colonopathy).
- have gout, kidney disease, or high blood uric acid (hyperuricemia).
- have trouble swallowing capsules.
- have any other medical condition.
- are pregnant or plan to become pregnant.
- are breast-feeding or plan to breast-feed.
Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.
The Product Information and Medication Guide for PANCREAZE is available at www.pancreaze.com.
About STENDRA/SPEDRA (Avanafil)
STENDRA® (avanafil) is approved in the U.S. by the FDA for the treatment of erectile dysfunction. Metuchen Pharmaceuticals LLC has exclusive marketing rights to STENDRA in the U.S., Canada, South America and India.
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. VIVUS has granted an exclusive license to the Menarini Group through its subsidiary Berlin-Chemie AG to commercialize and promote SPEDRA for the treatment of erectile dysfunction in over 40 European countries plus Australia and
Avanafil is licensed from Mitsubishi Tanabe Pharma Corporation (MTPC). VIVUS owns worldwide development and commercial rights to avanafil for the treatment of sexual dysfunction, with the exception of certain Asian-Pacific Rim countries. VIVUS is in discussions with other parties for the commercialization rights to its remaining territories.
For more information about STENDRA, please visit www.STENDRA.com.
Important Safety Information for STENDRA
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.
VIVUS is a specialty pharmaceutical company committed to the development and commercialization of innovative therapies that focus on advancing treatments for patients with serious unmet medical needs. 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 our ability to execute on our business strategy to enhance long-term stockholder value; risks and uncertainties related to our ability to address our outstanding balance of the convertible notes due in
|VIVUS, Inc.||Investor Relations: Lazar Partners|
|Mark Oki||David Carey|
|Chief Financial Officerfirstname.lastname@example.org|
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except par value)
|June 30,||December 31,|
|Cash and cash equivalents||$||25,022||$||30,411|
|Accounts receivable, net||24,568||25,608|
|Prepaid expenses and other current assets||6,970||7,538|
|Total current assets||156,015||167,527|
|Property and equipment, net||306||341|
|Intangible and other non-current assets||127,003||134,279|
|LIABILITIES AND STOCKHOLDERS’ DEFICIT|
|Accrued and other liabilities||34,384||33,044|
|Current portion of lease liability||710||—|
|Current portion of long-term debt||185,384||—|
|Total current liabilities||225,483||43,200|
|Long-term debt, net of current portion||107,007||294,446|
|Deferred revenue, net of current portion||3,738||4,290|
|Lease liability, net of current portion||894||—|
|Non-current accrued and other liabilities||—||234|
|Commitments and contingencies|
|Preferred stock; $.001 par value; 5,000 shares authorized; no shares issued and outstanding at June 30, 2019 and December 31, 2018||—||—|
|Common stock; $.001 par value; 200,000 shares authorized; 10,643 and 10,636 shares issued and outstanding at June 30, 2019 and December 31, 2018, respectively||11||11|
|Additional paid-in capital||841,702||840,751|
|Accumulated other comprehensive loss||201||(270||)|
|Total stockholders’ deficit||(52,475||)||(40,023||)|
|Total liabilities and stockholders’ deficit||$||284,647||$||302,147|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share data)
|Three Months Ended|
|June 30,||March 31,|
|Net product revenue||$||15,104||$||13,497|
|Cost of goods sold (excluding amortization)||4,377||4,308|
|Amortization of intangible assets||3,638||3,638|
|Selling, general and administrative||10,070||9,818|
|Research and development||2,352||2,469|
|Total operating expenses||20,437||20,233|
|Loss from operations||(2,047||)||(4,087||)|
|Interest expense and other expense, net||3,880||3,870|
|Loss before income taxes||(5,927||)||(7,957||)|
|Provision for income taxes||8||(8||)|
|Basic and diluted net loss per share:||$||(0.56||)||$||(0.75||)|
|Shares used in per share computation:|
|Basic and diluted||10,640||10,637|
GAAP to NON-GAAP RECONCILIATION
NET LOSS to EBITDA
A reconciliation between net loss on a GAAP basis and non-GAAP EBITDA is as follows:
|Three Months Ended|
| March 31,
|Interest expense and other expense, net||3,880||3,870|
|Depreciation of fixed assets||37||37|
|Amortization of intangible assets||3,638||3,638|
|Share-based compensation expense||467||468|
|Provision for income taxes||8||(8||)|
|Non-GAAP EBITDA and Non-GAAP recurring EBITDA||$||2,095||$||56|
Use of Non-GAAP Financial Measures
We supplement our condensed consolidated financial statements presented on a GAAP basis by providing an additional measure which is considered non-GAAP under applicable
We define non-GAAP EBITDA as net loss before interest expense and other expense, depreciation of fixed assets, amortization of intangible assets, share-based compensation expense and provision for or benefit from income taxes. We define non-GAAP Recurring EBITDA as non-GAAP EBITDA adjusted for certain non-recurring revenues and expenses, such as non-recurring milestone revenues, non-recurring restructuring and transaction costs and the one-time impact of changes in accounting estimates or the impact of new accounting standards. Management believes that non-GAAP EBITDA is a meaningful indicator of our performance and provides useful information to investors regarding our results of operations and financial condition.
Source: VIVUS, Inc.