VIVUS Reports First Quarter 2019 Financial Results
Company to host conference call today at
“The first quarter of 2019 represents the completion of the third quarter of our ten-quarter turnaround,” said
Mr. Amos continued, “Over the past three quarters,
Recent Business Highlights
- Launching PANCREAZE Under the VIVUS Brand
February 2019, VIVUScompleted the transition of the supply chain for PANCREAZE Delayed-Release Capsules in the United Statesfrom Janssen Pharmaceuticals, Inc.to VIVUS. Concurrent with this transition, the Company successfully re-launched PANCREAZE under the VIVUS brand.
- Announcing Marketing Approval of Avanafil in the
March 2019, the Ministry of Health of the Russian Federationapproved 50 mg, 100 mg and 200 mg tablets of avanafil for the treatment of erectile dysfunction (ED). The product will be marketed in the Russian Federationunder the brand name RAZATUS.
- Receiving Marketing Approval of Avanafil in the
United Arab Emirates
February 2019, the Ministry of Health & Prevention of the United Arab Emiratesapproved 100 mg and 200 mg tablets of avanafil. The product will be marketed in the United Arab Emiratesunder the brand name SPEDRA.
- Publishing of Data Supporting the Cardiovascular Safety of Qsymia
February 2019, results from a new retrospective study evaluating the cardiovascular safety of Qsymia® (phentermine and topiramate extended-release) capsules CIV were published in The Journal of Clinical Endocrinology & Metabolismand are currently available online. The new findings indicate that the combined risk of major adverse cardiovascular events (MACE) was not elevated in patients currently taking Qsymia, or concurrently taking both phentermine and topiramate, compared with former users of these medications. The number of MACE events (3 events during 3,245 person-years of follow-up) was too few to draw a definitive conclusion from the data.
First Quarter Financial Results
Revenue consisted of the following:
Three Months Ended
|Qsymia net product revenue||$||8,423||$||9,632|
|PANCREAZE net product revenue||5,074||—|
Total revenue for the first quarter 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
General and administrative expense was
Selling and marketing expense totaled
Research and development expense was
Total interest and other expense was
Net loss for the first quarter of 2019 was
Non-GAAP EBITDA for the first quarter of 2019 was
Conference Call Details
VIVUS will hold a conference call and an audio webcast to provide a business update and to discuss first quarter 2019 financial results today, April 30, 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 4079554. 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 or potentially reduce our outstanding balance of the convertible notes due in 2020; risks and uncertainties related to our expected future revenues, operations and expenditures; risks and uncertainties related to our ability to identify and acquire cash flow generating assets and opportunities; risks and uncertainties related to the timing, strategy, tactics and success of the marketing and sales of PANCREAZE; risks and uncertainties related to our commercialization of PANCREAZE as a new product and our recently changed management team initiating the commercialization of PANCREAZE; risks and uncertainties related to our, or our current or potential partner's, ability to successfully commercialize Qsymia; risks and uncertainties related to our ability to successfully develop or acquire a proprietary formulation of tacrolimus; 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 launches and commercialization of STENDRA/SPEDRA (avanafil) by our current or potential collaborators; 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 our ability to work with
|VIVUS, Inc.||Investor Relations: Lazar Partners|
|Mark Oki||David Carey|
|Chief Financial Officeremail@example.com|
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except par value)
|March 31,||December 31,|
|Cash and cash equivalents||$||23,021||$||30,411|
|Accounts receivable, net||24,554||25,608|
|Prepaid expenses and other current assets||6,568||7,538|
|Total current assets||157,721||167,527|
|Property and equipment, net||325||341|
|Intangible and other non-current assets||130,641||134,279|
|LIABILITIES AND STOCKHOLDERS’ DEFICIT|
|Accrued and other liabilities||33,391||33,044|
|Current portion of lease liability||705||—|
|Total current liabilities||38,966||43,200|
|Long-term debt, net of current portion||293,396||294,446|
|Deferred revenue, net of current portion||3,975||4,290|
|Lease liability, net of current portion||1,091||—|
|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 March 31, 2019 and December 31, 2018||—||—|
|Common stock; $.001 par value; 200,000 shares authorized; 10,637 and 10,636 shares issued and outstanding at March 31, 2019 and December 31, 2018, respectively||11||11|
|Additional paid-in capital||841,219||840,751|
|Accumulated other comprehensive loss||(21||)||(270||)|
|Total stockholders’ deficit||(47,245||)||(40,023||)|
|Total liabilities and stockholders’ deficit||$||290,183||$||302,147|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share data)
|Three Months Ended|
|Net product revenue||$||13,497||$||9,632|
|Cost of goods sold (excluding amortization)||4,308||2,630|
|Amortization of intangible assets||3,638||91|
|Selling, general and administrative||9,818||10,068|
|Research and development||2,469||1,403|
|Total operating expenses||20,233||14,192|
|Loss from operations||(4,087||)||(2,292||)|
|Interest expense and other expense, net||3,870||8,349|
|Loss before income taxes||(7,957||)||(10,641||)|
|(Benefit) provision for income taxes||(8||)||12|
|Basic and diluted net loss per share:||$||(0.75||)||$||(1.00||)|
|Shares used in per share computation:|
|Basic and diluted||10,637||10,601|
GAAP to NON-GAAP RECONCILIATION
NET LOSS to EBITDA
A reconciliation between net loss on a GAAP basis and non-GAAP EBITDA is as follows:
|Three Months Ended|
|Interest expense and other expense, net||3,870||8,349|
|Depreciation of fixed assets||37||66|
|Amortization of intangible assets||3,638||91|
|Share-based compensation expense||468||925|
|Provision for (benefit from) income taxes||(8||)||12|
|Non-GAAP EBITDA and Non-GAAP recurring EBITDA||$||56||$||(1,210||)|
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 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.