VIVUS Reports First Quarter 2020 Financial Results
Company to host conference call today at
“Our ability to respond quickly to the COVID-19 pandemic by successfully accelerating the launch of our telemedicine and remote monitoring modules through the VIVUS Health Platform reflects our commitment to providing patients and physicians with real-world solutions that can improve health outcomes,” said
Recent Business Highlights
- Announces Agreement with
IEH Biopharma LLC
May 2020, VIVUS announced an agreement regarding its corporate debt with IEH Biopharma LLC, whereby the Company will pay IEH Biopharma $3.8 millionin accrued and unpaid interest on the Convertible Senior Notes and IEH Biopharma will grant the Company a 30-day grace period (if not terminated sooner pursuant to the terms of the agreement), beginning on May 1, 2020, for payment of the principal amount of the Convertible Senior Notes, during which the two parties will work exclusively to attempt to restructure the outstanding principal amount of the Convertible Senior Notes. As part of the agreement, VIVUS retired the remaining $11.3 millionin principal and $253,373in accrued interest held by other holders that was due on May 1, 2020. Raises Additional Capital
April 2020, VIVUS completed a registered direct offering of 7,218,750 shares of its common stock at a purchase price of $1.60 per share for proceeds of $10.5 million, net of placement agent’s fees and other offering expenses.
- Accelerates Launch of Telemedicine and Remote Monitoring Modules
March 2020, VIVUS announced the accelerated launch of the telemedicine and remote monitoring modules of the VIVUS Health Platform. Participating physicians will be able to use the VIVUS Health Platform to conduct virtual office visits, regardless of whether the patient is prescribed a VIVUS product. The VIVUS Health Platform is designed to integrate pharmaceutical solutions, technology and clinical stakeholders to improve patient outcomes through increased information capture, resulting in enhanced patient access, increased adoption, and treatment durability.
- Completes Enrollment of Phase 4 Safety and Efficacy Study of Qsymia® in Adolescents
March 2020, completed patient enrollment in VIVUS’ Phase 4 clinical study designed to evaluate the safety and efficacy of Qsymia (phentermine and topiramate extended-release) capsules CIV in obese adolescents between the ages of 12 and 17 years.
2020 First Quarter vs 2019 Fourth Quarter Financial Results
Revenue consisted of the following:
Three Months Ended
|Qsymia net product revenue||$||8,914||$||9,750|
|PANCREAZE/PANCREASE MT, net product revenue||5,783||5,849|
Qsymia net product revenue was
PANCREAZE®/PANCREASE® MT net product revenue was
Milestone revenue in the first quarter of 2020 represented the payment related to Alvogen, VIVUS’ Korean marketing partner, beginning commercialization of Qsymia in
Supply revenue in the first quarter of 2020 consists of sales of STENDRA®/SPEDRATM to our licensees for sales in the EU and
Royalty 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 was
Non-GAAP EBITDAR (Earnings Before Interest, Taxes Depreciation, Amortization and discretionary Research) was
Conference Call Details
VIVUS will hold a conference call and an audio webcast to provide a business update and to discuss first quarter 2020 financial results today, May 6, 2020, beginning at 4:30 PM Eastern Time.
To listen via phone, please use the dial in information provided below.
Dial in Details:
Toll-Free: (877) 359-2916
International: (224) 357-2386
The webcast replay and slide presentation will be available in the Events and Presentations section on the VIVUS website for 30 days.
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.
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 FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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
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 subsidiaries to commercialize and promote SPEDRA for the treatment of erectile dysfunction in over 40 European countries plus Australia and
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:
|Chief Financial Officer||Senior Partner|
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except par value)
|Cash and cash equivalents||$||32,854||$||32,649|
|Accounts receivable, net||24,724||22,338|
|Prepaid expenses and other current assets||6,340||8,134|
|Total current assets||97,854||96,800|
|Property and equipment, net||201||233|
|Intangible and other non-current assets||116,923||120,140|
|LIABILITIES AND STOCKHOLDERS’ DEFICIT|
|Accrued and other liabilities||32,912||32,398|
|Current portion of lease liability||741||767|
|Current portion of long-term debt||181,822||183,006|
|Total current liabilities||227,786||225,146|
|Long-term debt, net of current portion||58,910||58,721|
|Deferred revenue, net of current portion||2,769||3,063|
|Lease liability, net of current portion||399||602|
|Commitments and contingencies|
|Additional paid-in capital||843,146||842,808|
|Accumulated other comprehensive loss||108||(35||)|
|Total stockholders’ deficit||(73,956||)||(69,224||)|
|Total liabilities and stockholders’ deficit||$||215,908||$||218,308|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share data)
|Three Months Ended|
|Net product revenue||$||14,697||$||15,599|
|Cost of goods sold (excluding amortization)||4,627||3,970|
|Amortization of intangible assets||3,638||3,638|
|Selling, general and administrative||10,960||10,944|
|Research and development||2,445||2,380|
|Total operating expenses||21,670||20,932|
|Loss from operations||(2,039||)||(3,678||)|
|Interest expense and other expense, net||3,219||2,852|
|Loss before income taxes||(5,258||)||(6,530||)|
|Provision for income taxes||(45||)||17|
|Basic and diluted net loss per share:||$||(0.49||)||$||(0.61||)|
|Shares used in per share computation:|
|Basic and diluted||10,649||10,646|
GAAP to NON-GAAP RECONCILIATION
NET LOSS to EBITDAR
A reconciliation between net loss on a GAAP basis and non-GAAP EBITDAR is as follows:
|Three Months Ended|
|Interest expense and other expense, net (excluding amortization)||3,219||2,852|
|Depreciation of fixed assets||32||40|
|Amortization of intangible assets||3,638||3,638|
|Share-based compensation expense||338||608|
|Provision for (benefit from) income taxes||(45||)||17|
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 EBITDAR as net loss before interest expense and other expense, depreciation of fixed assets, amortization of intangible assets, share-based compensation expense, provision for or benefit from income taxes and discretionary research expenses. Management believes that non-GAAP EBITDAR is a meaningful indicator of the performance of our commercial business, providing useful information to investors.
Source: VIVUS, Inc.