1. CAMPBELL, Calif., July 07, 2020 (GLOBE NEWSWIRE) -- VIVUS, Inc. (NASDAQ:VVUS, the "Company"))), a biopharmaceutical company, today announced that it has completed the solicitation of an in-court prepackaged plan of reorganization, under which IEH Biopharma LLC ("IEH") will take 100% ownership of VIVUS (the "Prepackaged Plan"), ahead of its July 7, 2020 chapter 11 filing.  The Company solicited IEH―as the only holder of claims in classes entitled to vote on the Prepackaged Plan―and has received IEH's ballots voting in favor of the Prepackaged Plan in accordance with the amended and restated Restructuring Support Agreement executed by the Company and IEH on July 6, 2020. The Company believes that the Prepackaged Plan satisfies all requirements…

    CAMPBELL, Calif., July 07, 2020 (GLOBE NEWSWIRE) -- VIVUS, Inc. (NASDAQ:VVUS, the "Company"))), a biopharmaceutical company, today announced that it has completed the solicitation of an in-court prepackaged plan of reorganization, under which IEH Biopharma LLC ("IEH") will take 100% ownership of VIVUS (the "Prepackaged Plan"), ahead of its July 7, 2020 chapter 11 filing.  The Company solicited IEH―as the only holder of claims in classes entitled to vote on the Prepackaged Plan―and has received IEH's ballots voting in favor of the Prepackaged Plan in accordance with the amended and restated Restructuring Support Agreement executed by the Company and IEH on July 6, 2020. The Company believes that the Prepackaged Plan satisfies all requirements necessary for confirmation by the Court.  The Company will request a combined disclosure statement and confirmation hearing for August 17, 2020, subject to the Court's availability.  Upon confirmation of the Prepackaged Plan, the Company intends to consummate the restructuring transactions shortly thereafter. 

    Under the Prepackaged Plan, VIVUS stockholders of record as of July 2, 2020 will receive, subject to the satisfaction of certain conditions, a pro rata share of (a) $5 million and (b) a non-transferable contractual contingent value right to earn another $2 per share if the Company meets certain financial milestones in both 2021 and 2022.

    VIVUS will continue its ongoing clinical and commercial operations wholly owned subsidiary of IEH Biopharma LLC, including sales and marketing of Qsymia® (phentermine and topiramate extended-release) capsules CIV for weight management in adults and PANCREAZE® (pancrelipase) for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions; preclinical and clinical development of VI-1016 for the treatment of pulmonary arterial hypertension; and expansion of the VIVUS Health Platform 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. 

    "We appreciate the due diligence that the VIVUS management team undertook in exploring a variety of potential financing options, and agree with the team's conclusion that this reorganization plan is the best option available to the Company and its shareholders," said David Norton, Chairman of VIVUS' Board of Directors.

    "We appreciate the continued support of IEH Biopharma and look forward to working with them in the years to come," said John Amos, VIVUS' Chief Executive Officer. "We are also pleased that this reorganization plan will ensure continued seamless operations for our business partners and most importantly our patients and healthcare providers that utilize our pharmaceuticals and technology in their various clinical treatments."

    The Company expects that its common stock will be delisted from the Nasdaq Global Select Market because of the chapter 11 filing in connection with this transaction.

    The Company's existing NOL Rights Plan will remain in place until completion of the trading of its shares.  The NOL Rights Plan will continue to provide, subject to certain exceptions that if any person or group acquires 4.9% or more of the Company's outstanding common stock, there would be a triggering event potentially resulting in significant dilution in the voting power and economic ownership of that person or group.

    References is also made to the Company's 8-K, filed concurrently therewith, which provides as follows: 

    "In addition, the Debtors filed a motion (the "NOL Motion") seeking entry of an interim and final order establishing certain procedures (the "Procedures") with respect to direct and indirect trading and transfers of stock of the Company, and seeking related relief, in order to protect the potential value of the Company's net operating loss carryforwards and certain other tax benefits of the Company.

    If the NOL Motion is granted by the Bankruptcy Court and the Procedures approved, in certain circumstances, the Procedures would, among other things, restrict transactions on or after today's date, July 7, 2020, involving, and require notices of the holdings of and proposed transactions by, any person or group of persons that is or, as a result of such a transaction, would become, a Substantial Stockholder of the common stock issued by VIVUS (the "Common Stock"). For purposes of the Procedures, a "Substantial Stockholder" is any person or, in certain cases, group of persons that beneficially own, directly or indirectly (and/or owns options to acquire) at least 800,000 shares of Common Stock (representing approximately 4.5% of all issued and outstanding shares of Common Stock as of April 30, 2020). If the Procedures are approved, any prohibited transfer of stock of the Company on or after today's date, July 7, 2020, would be null and void ab initio and may lead to contempt, compensatory damages, punitive damages, or sanctions being imposed by the Bankruptcy Court.   A direct or indirect holder of, or prospective holder of, stock issued by the Debtors should consult the NOL Motion and Procedures proposed therein."

    About Qsymia

    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.

    About PANCREAZE

    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 VIVUS

    VIVUS is a biopharmaceutical 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.  

    Forward-Looking Statements

    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 the transactions contemplated in the Amended and Restated Restructuring Support Agreement, including the filing of the Bankruptcy Petitions and reorganization of the Company under the Chapter 11 cases, are subject to certain conditions or other factors, some of which may be outside of the Company's control, which may include: risks and uncertainties relating to the Chapter 11 cases, including but not limited to, the Company's ability to obtain Bankruptcy Court approval with respect to motions filed by the debtors in the Chapter 11 cases (including the cash collateral motion and NOL Motion), the effects of the Chapter 11 cases on the Company and on the interests of various constituents, Bankruptcy Court rulings in the Chapter 11 cases and the outcome of the Chapter 11 cases in general, the length of time the Company will operate under the Chapter 11 cases, risks associated with third-party motions in the Chapter 11 cases, the potential adverse effects of the Chapter 11 cases on the Company's liquidity or results of operations and increased legal and other professional costs necessary to execute the Company's reorganization; the Company's ability to implement and realize any anticipated benefits of Chapter 11 bankruptcy protection; the Company's ability to operate as a going concern; compliance with the applicable covenants of the Amended and Restated Restructuring Support Agreement; the timely negotiation of terms, conditions and provisions of exit financing; the ability of the Company to obtain requisite support for the Joint Prepackaged Plan of Reorganization (the "Plan"); the ability of the Company to execute any plan of reorganization, including the Plan, in the manner and on the timeline as set forth under the Plan, including the execution of the settlement with existing holders of equity; the Company's debt profile and risks related to its capital structure; the effects of disruption from any reorganization and restructuring making it more difficult to maintain business, financing and operational relationships, to obtain and maintain normal terms with customers, suppliers and service providers and to retain key executives and to maintain various licenses and approvals necessary for the Company to conduct its business; the risk of acceleration of the Company's debt obligations; trading price and volatility of VIVUS common stock and its continued listing on the Nasdaq Global Select Market; and the widespread domestic and global impact of the COVID-19 pandemic on the Company's business, results of operations, customers, suppliers and other counterparties, and employees; risks and uncertainties related to our liquidity and capital resources; risks and uncertainties related to our history of losses and variable quarterly results; risks and uncertainties related to our expected future revenues, operations and expenditures; risks and uncertainties related to the effectiveness of the VIVUS Health Platform, including its adoption by healthcare providers and its ability to improve patient outcomes and, if applicable, access to Qsymia® and PANCREAZE®; risks and uncertainties related to the timing, strategy, tactics and success of the marketing and sales of PANCREAZE, including our ability to improve patient access to PANCREAZE; risks and uncertainties related to our, or our current or potential partner's, ability to successfully commercialize Qsymia, including our ability to improve patient and physician access to Qsymia; risks and uncertainties related to our ability to sell through the Qsymia retail pharmacy network and the Qsymia Advantage Program; risks and uncertainties related to the timing of initiation and completion of the post-approval clinical studies required as part of the approval of Qsymia by the U.S. Food and Drug Administration ("FDA"), including the Phase 4 post-marketing study of Qsymia in obese adolescents; risks and uncertainties related to the response from FDA to any data and/or information relating to post-approval clinical studies required for Qsymia; risks and uncertainties related to the impact of any possible future requirement to provide further analysis of previously submitted clinical trial data; risks and uncertainties related to the design and outcome of any clinical study required by FDA to expand the Qsymia label; risks and uncertainties related to our ability to work with FDA to significantly reduce or remove the requirements of the clinical post-approval cardiovascular outcomes trial; risks and uncertainties related to the failure to obtain FDA or foreign authority clearances or approvals and noncompliance with FDA or foreign authority regulations; risks and uncertainties related to our dialog with certain concerned member states in Europe relating to the pending decentralized Marketing Authorization Application, the timing and scope of the assessment by such Concerned Member State health authorities of our Marketing Authorization Application, and ultimately the decision of such Concerned Member State health authorities whether to grant Marketing Authorization for Qsymia in such EU countries; 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 demonstrate through clinical testing the quality, safety, and efficacy of our current or future investigational drug candidates or approved products;  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; and risks and uncertainties related to the impact, if any, of changes to our Board of Directors and senior management team. 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 VIVUS' Form 10-K for the year ended December 31, 2019 as filed on March 3, 2020 and as amended on Form 10-K/A on April 29, 2020, and periodic reports filed with the Securities and Exchange Commission. VIVUS does not undertake an obligation to update or revise any forward-looking statements, unless otherwise required by law or the Bankruptcy Court.

    VIVUS, Inc.                                                   

    Mark Oki                                                         

    Chief Financial Officer                                    

                                                  

    650-934-5200                                                  

    Investor Relations: Lazar FINN Partners

    David Carey

    Senior Director



    212-867-1768

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  2. CAMPBELL, Calif., June 02, 2020 (GLOBE NEWSWIRE) -- VIVUS, Inc. (NASDAQ:VVUS, the "Company")), a biopharmaceutical company, today announced that it has updated its agreement regarding its corporate debt with Icahn Enterprises Holdings L.P. (dba IEH Biopharma LLC), which holds a principal amount of approximately $170.2 million of the Company's Convertible Senior Notes.

    Under the terms of the agreement, the Company will continue to work with IEH Biopharma on an exclusive basis in respect of any restructuring, financing or other material transaction concerning the Company or its assets, with the exception that the Company is granted a 30-day period to refinance and pay in full in cash all amounts due and owing under the Convertible Senior Notes…

    CAMPBELL, Calif., June 02, 2020 (GLOBE NEWSWIRE) -- VIVUS, Inc. (NASDAQ:VVUS, the "Company")), a biopharmaceutical company, today announced that it has updated its agreement regarding its corporate debt with Icahn Enterprises Holdings L.P. (dba IEH Biopharma LLC), which holds a principal amount of approximately $170.2 million of the Company's Convertible Senior Notes.

    Under the terms of the agreement, the Company will continue to work with IEH Biopharma on an exclusive basis in respect of any restructuring, financing or other material transaction concerning the Company or its assets, with the exception that the Company is granted a 30-day period to refinance and pay in full in cash all amounts due and owing under the Convertible Senior Notes to IEH Biopharma. If the Company is unable to refinance on or before June 30, 2020, the Company and IEH Biopharma shall exclusively pursue an in court plan of reorganization. In the event certain conditions are satisfied under the plan of reorganization, stockholders of VIVUS shall receive a pro rata share of (a) $5 million and (b) a non-transferable contractual contingent value right to earn another $2 per share if certain financial milestones are met in 2021 and 2022. Additionally, IEH Biopharma will take 100% ownership of VIVUS. The agreement is subject to, among other things, IEH Biopharma's due diligence and the Company's preservation of its tax attributes.

    "We appreciate the continued assistance and support of IEH Biopharma in allowing us an additional 30 days to refinance the Company," said John Amos, VIVUS' Chief Executive Officer.

    About VIVUS

    VIVUS is a biopharmaceutical 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 VIVUS, please visit www.vivus.com.

    Forward-Looking Statements

    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 refinance our outstanding balance of the convertible notes due in May 2020, including our ability during the agreed upon 30-day grace period to work with IEH Biopharma LLC to restructure the outstanding principal amount of the convertible notes; risk and uncertainties related to the timing, strategy, structure and implementation of any restructuring transaction with IEH Biopharma LLC; risks and uncertainties of a bankruptcy filing absent an agreement on a restructuring transaction in the short term; risks and uncertainties related to the effect of the recent coronavirus (COVID-19) outbreak on our business and the businesses of our partners; risks and uncertainties related to the effectiveness of the VIVUS Health Platform, including its adoption by healthcare providers and its ability to improve patient outcomes and, if applicable, access to Qsymia® and PANCREAZE®; risks and uncertainties related to the timing, strategy, tactics and success of the marketing and sales of PANCREAZE, including our ability to improve patient access to PANCREAZE; risks and uncertainties related to our, or our current or potential partner's, ability to successfully commercialize Qsymia, including our ability to improve patient and physician access to Qsymia; risks and uncertainties related to our ability to sell through the Qsymia retail pharmacy network and the Qsymia Advantage Program; risks and uncertainties related to the timing of initiation and completion of the post-approval clinical studies required as part of the approval of Qsymia by the U.S. Food and Drug Administration ("FDA"), including the Phase 4 post-marketing study of Qsymia in obese adolescents; risks and uncertainties related to the response from FDA to any data and/or information relating to post-approval clinical studies required for Qsymia; risks and uncertainties related to the impact of any possible future requirement to provide further analysis of previously submitted clinical trial data; risks and uncertainties related to the design and outcome of any clinical study required by FDA to expand the Qsymia label; risks and uncertainties related to our ability to work with FDA to significantly reduce or remove the requirements of the clinical post-approval cardiovascular outcomes trial; risks and uncertainties related to the failure to obtain FDA or foreign authority clearances or approvals and noncompliance with FDA or foreign authority regulations; risks and uncertainties related to our ability to demonstrate through clinical testing the quality, safety, and efficacy of our current or future investigational drug candidates or approved products; and risks and uncertainties related to the market and other conditions. 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 VIVUS' Form 10-K for the year ended December 31, 2019 as filed on March 3, 2020, and as amended by the Form 10-K/A filed on April 29, 2020, and periodic reports filed with the Securities and Exchange Commission. VIVUS does not undertake an obligation to update or revise any forward-looking statements, except as required by law.

    VIVUS, Inc. Investor Relations: Lazar FINN Partners
    Mark Oki  David Carey
    Chief Financial Officer  Senior Partner 
       
    650-934-5200 212-867-1768

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  3. Company to host conference call today at 4:30pm ET

    CAMPBELL, Calif., May 06, 2020 (GLOBE NEWSWIRE) -- VIVUS, Inc. (NASDAQ:VVUS) (the "Company"), a biopharmaceutical company, today reported financial results for the quarter ended March 31, 2020 and provided a business update.

    "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 John Amos, VIVUS' Chief Executive Officer. "Results in the quarter were minimally impacted by the pandemic as we generated quarter-over-quarter revenue growth of 13.8…

    Company to host conference call today at 4:30pm ET

    CAMPBELL, Calif., May 06, 2020 (GLOBE NEWSWIRE) -- VIVUS, Inc. (NASDAQ:VVUS) (the "Company"), a biopharmaceutical company, today reported financial results for the quarter ended March 31, 2020 and provided a business update.

    "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 John Amos, VIVUS' Chief Executive Officer. "Results in the quarter were minimally impacted by the pandemic as we generated quarter-over-quarter revenue growth of 13.8% and increased prescriptions dispensed through the Qsymia Advantage Program's Direct-to-Patient model. We continue to work closely with our debtholders to identify and execute a fair restructuring of our corporate debt that will provide a more secure capital structure on which we can continue the significant progress already made in our ten-quarter turnaround strategy."

    Recent Business Highlights

    • Announces Agreement with IEH Biopharma LLC
      In May 2020, VIVUS announced an agreement regarding its corporate debt with IEH Biopharma LLC, whereby the Company will pay IEH Biopharma $3.8 million in 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 million in principal and $253,373 in accrued interest held by other holders that was due on May 1, 2020.

    • Raises Additional Capital
      In 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
      In 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
      In 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:

      (In thousands)
    Three Months Ended
      March 31,
    2020
      December 31,
    2019
    Qsymia net product revenue $ 8,914   $ 9,750
    PANCREAZE/PANCREASE MT, net product revenue   5,783     5,849
    Milestone revenue   2,000     -
    Supply revenue   1,823     1,186
    Royalty revenue   1,111     469
      Total revenue  $ 19,631   $ 17,254

    Qsymia net product revenue was $8.9 million and $9.8 million in the first quarter of 2020 and the fourth quarter of 2019, respectively. The decrease in net revenue was due to the seasonal decrease in shipments to wholesalers in the first quarter of 2020 compared to the fourth quarter of 2019. In the first quarter of 2020 and the fourth quarter of 2019, we had approximately 83,000 scripts. The Company continues to migrate Qsymia patients from the traditional retail pharmacy model to the Qsymia Advantage Program that improves access to Qsymia through, among other things, direct-to-patient distribution and improved pricing. During the first quarter of 2020, 36% of Qsymia scripts were dispensed through the Qsymia Advantage Program's Direct-to-Patient model, up from 31% and 22% in the fourth and third quarters of 2019, respectively.

    PANCREAZE®/PANCREASE® MT net product revenue was $5.8 million in both the first quarter of 2020 and the fourth quarter of 2019. The first quarter of 2020 and the fourth quarter of 2019 results included $0.7 million and $0.9 million, respectively, of Canadian sales of PANCREASE® MT. The Company began to recognize sales revenue from Canadian sales in the third quarter of 2019. Total U.S. scripts were 5,685 and 5,735 during the first quarter of 2020 and the fourth quarter of 2019, respectively.

    Milestone revenue in the first quarter of 2020 represented the payment related to Alvogen, VIVUS' Korean marketing partner, beginning commercialization of Qsymia in South Korea.

    Supply revenue in the first quarter of 2020 consists of sales of STENDRA®/SPEDRATM to our licensees for sales in the EU and U.S. Supply revenue in the fourth quarter consists of sales of Qsymia to Alvogen to support the launch of Qsymia in South Korea in the first quarter of 2020. Supply revenue varies based on the timing of orders from our licensees and consists of minimum order requirements and such purchases do not correspond to end user demand.

    Royalty revenue was $1.1 million and $0.5 million in the first quarter of 2020 and the fourth quarter of 2019, respectively. These amounts consist of royalties earned on SPEDRA European revenues and, in 2020, also included royalties earned on Qsymia South Korean revenues.

    Total cost of goods sold, excluding amortization, was $4.6 million and $4.0 million in the first quarter of 2020 and the fourth quarter of 2019, respectively. The increase was primarily due to the increase in supply revenue over the fourth quarter of 2019.

    Amortization of intangible assets was $3.6 million in both the first quarter of 2020 and the fourth quarter of 2019. The amount primarily consisted of amortization expense of costs capitalized related to the acquisition of PANCREAZE.

    Selling, general and administrative expense was $11.0 million in the first quarter of 2020 and $10.9 million in the fourth quarter of 2019, respectively, and included selling and marketing expense of $4.2 million and $4.3 million, respectively. The increase in general and administrative costs was primarily due to expenses related to our efforts to refinance our outstanding debt.

    Research and development expense was $2.4 million in both the first quarter of 2020 and the fourth quarter of 2019, respectively. In these two periods, research and development efforts primarily consisted of activities related to the Qsymia adolescent and efficacy study (OB-0403), PANCREAZE post-marketing requirements assumed from Janssen and PANCREAZE product improvement initiatives. Research and development expenses will fluctuate based on the timing of enrollment of the OB-0403 study and activities associated with the development of VI-0106.

    Total interest and other expense was $3.2 million in the first quarter of 2020 and $2.9 million in the fourth quarter of 2019, respectively.

    Net loss was $5.2 million for the first quarter of 2020 and $6.5 million for the fourth quarter of 2019. Cash, cash equivalents and available-for-sale securities were $32.9 million at March 31, 2020.

    Non-GAAP EBITDAR (Earnings Before Interest, Taxes Depreciation, Amortization and discretionary Research) was $3.2 million for the first quarter of 2020 and $1.9 million for the fourth quarter of 2019.

    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 webcast, please visit http://ir.vivus.com/, or by clicking here.

    To listen via phone, please use the dial in information provided below.

    Dial in Details:
    Toll-Free: (877) 359-2916
    International: (224) 357-2386
    Passcode: 6939389

    The webcast replay and slide presentation will be available in the Events and Presentations section on the VIVUS website for 30 days.

    About Qsymia

    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.

    About PANCREAZE

    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 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 subsidiaries to commercialize and promote SPEDRA for the treatment of erectile dysfunction in over 40 European countries plus Australia and New Zealand. 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.

    About VIVUS

    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.

    Forward-Looking Statements

    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 May 2020, including our ability during the agreed upon 30-day grace period to reach agreement with IEH Biopharma LLC to restructure the outstanding principal amount of the convertible notes and any resulting need of the Company to seek relief under the U.S. Bankruptcy Code; risk and uncertainties related to the timing, strategy, structure and implementation of any restructuring transaction with IEH Biopharma LLC; risks and uncertainties related to the effect of the recent coronavirus (COVID-19) outbreak on our business and the businesses of our partners; risks and uncertainties related to the effectiveness of the VIVUS Health Platform, including its adoption by healthcare providers and its ability to improve patient outcomes and, if applicable, access to Qsymia® and PANCREAZE®; risks and uncertainties related to the timing, strategy, tactics and success of the marketing and sales of PANCREAZE, including our ability to improve patient access to PANCREAZE; risks and uncertainties related to our, or our current or potential partner's, ability to successfully commercialize Qsymia, including our ability to improve patient and physician access to Qsymia; risks and uncertainties related to our ability to sell through the Qsymia retail pharmacy network and the Qsymia Advantage Program; risks and uncertainties related to the timing of initiation and completion of the post-approval clinical studies required as part of the approval of Qsymia by the U.S. Food and Drug Administration ("FDA"), including the Phase 4 post-marketing study of Qsymia in obese adolescents; risks and uncertainties related to the response from FDA to any data and/or information relating to post-approval clinical studies required for Qsymia; risks and uncertainties related to the impact of any possible future requirement to provide further analysis of previously submitted clinical trial data; risks and uncertainties related to the design and outcome of any clinical study required by FDA to expand the Qsymia label; risks and uncertainties related to our ability to work with FDA to significantly reduce or remove the requirements of the clinical post-approval cardiovascular outcomes trial; risks and uncertainties related to our dialog with certain concerned member states in Europe relating to the pending decentralized Marketing Authorization Application, the timing and scope of the assessment by such Concerned Member State health authorities of our Marketing Authorization Application, and ultimately the decision of such Concerned Member State health authorities whether to grant Marketing Authorization for Qsymia in such EU countries; risks and uncertainties related to the failure to obtain FDA or foreign authority clearances or approvals and noncompliance with FDA or foreign authority regulations; risks and uncertainties related to our ability to demonstrate through clinical testing the quality, safety, and efficacy of our current or future investigational drug candidates or approved products; 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; and risks and uncertainties related to the market and other conditions. 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 VIVUS' Form 10-K for the year ended December 31, 2019 as filed on March 3, 2020, and as amended by the Form 10-K/A filed on April 29, 2020, and periodic reports filed with the Securities and Exchange Commission. VIVUS does not undertake an obligation to update or revise any forward-looking statements.

    VIVUS, Inc.  Investor Relations: Lazar FINN Partners
    Mark Oki David Carey
    Chief Financial Officer  Senior Partner
    650-934-5200 212-867-1768


    VIVUS, INC.
    CONDENSED CONSOLIDATED BALANCE SHEETS
    (In thousands, except par value)

               
      March 31,    December 31, 
      2020     2019  
        Unaudited      
    ASSETS          
    Current assets:          
    Cash and cash equivalents $ 32,854     $ 32,649  
    Accounts receivable, net   24,724       22,338  
    Inventories   33,936       33,679  
    Prepaid expenses and other current assets   6,340       8,134  
    Total current assets   97,854       96,800  
    Property and equipment, net   201       233  
    Right-of-use assets   930       1,135  
    Intangible and other non-current assets   116,923       120,140  
    Total assets $ 215,908     $ 218,308  
    LIABILITIES AND STOCKHOLDERS' DEFICIT          
    Current liabilities:          
    Accounts payable $ 11,015     $ 7,726  
    Accrued and other liabilities   32,912       32,398  
    Deferred revenue   1,296       1,249  
    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  
    Total liabilities   289,864       287,532  
    Commitments and contingencies          
    Stockholders' deficit:          
    Preferred stock; $.001 par value; 5,000 shares authorized; no shares issued and outstanding at December 31, 2019 and December 31, 2018, respectively    —        —  
    Common stock; $.001 par value; 200,000 shares authorized; 10,649 and 10,649 shares issued and outstanding at March 31, 2020 and December 31, 2019, respectively   11       11  
    Additional paid-in capital   843,146       842,808  
    Accumulated other comprehensive loss   108       (35 )
    Accumulated deficit   (917,221 )     (912,008 )
    Total stockholders' deficit   (73,956 )     (69,224 )
    Total liabilities and stockholders' deficit $ 215,908     $ 218,308  


     

    VIVUS, INC.
    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
    (In thousands, except per share data)
    (Unaudited)

      Three Months Ended
      March 31,    December 31, 
      2020    2019 
    Revenue:              
    Net product revenue $ 14,697     $ 15,599  
    Milestone revenue   2,000       -  
    Supply revenue   1,823       1,186  
    Royalty revenue   1,111       469  
    Total revenue   19,631       17,254  
                   
    Operating expenses:              
    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  
    Net loss $ (5,213 )   $ (6,547 )
                   
    Basic and diluted net loss per share: $ (0.49 )   $ (0.61 )
    Shares used in per share computation:              
    Basic and diluted   10,649       10,646  

     


    VIVUS, INC.
    GAAP to NON-GAAP RECONCILIATION
    NET LOSS to EBITDAR
    (In thousands)
    (Unaudited)

    A reconciliation between net loss on a GAAP basis and non-GAAP EBITDAR is as follows:

      Three Months Ended
      March 31,    December 31,
      2020     2019  
    Net loss $  (5,213 )   $ (6,547 )
    Adjustments:          
    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  
         Non-GAAP EBITDA $ 1,969     $ 608  
               
    Research Spending   1,226       1,279  
         Non-GAAP EBITDAR $ 3,195     $ 1,887  

    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 SEC rules. We believe that the disclosure of this non-GAAP measure provides investors with additional information that reflects the basis upon which our management assesses and operates our business. This non-GAAP financial measure is not in accordance with GAAP and should not be viewed in isolation or as a substitute for GAAP net loss and is not a substitute for, or superior to, measures of financial performance performed in conformity with GAAP.

    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.

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  4. CAMPBELL, Calif., May 01, 2020 (GLOBE NEWSWIRE) -- VIVUS, Inc. (NASDAQ:VVUS) today announced that it will report financial results and provide a business update for the first quarter of 2020 after the market close on Wednesday, May 6, 2020. The Company will host a conference call beginning at 4:30 p.m. ET / 1:30 p.m. PT the same day to review results and provide a business update.

    To listen via webcast, please visit http://ir.vivus.com/, or by clicking here.

    To listen via phone, please use the dial in information provided below.

    Dial in Details:
    Toll-Free: (877) 359-2916
    International: (224) 357-2386
    Passcode: 6939389

    A webcast replay will be available on the VIVUS website for 30 days.

    About VIVUS
    VIVUS is a biopharmaceutical company committed…

    CAMPBELL, Calif., May 01, 2020 (GLOBE NEWSWIRE) -- VIVUS, Inc. (NASDAQ:VVUS) today announced that it will report financial results and provide a business update for the first quarter of 2020 after the market close on Wednesday, May 6, 2020. The Company will host a conference call beginning at 4:30 p.m. ET / 1:30 p.m. PT the same day to review results and provide a business update.

    To listen via webcast, please visit http://ir.vivus.com/, or by clicking here.

    To listen via phone, please use the dial in information provided below.

    Dial in Details:
    Toll-Free: (877) 359-2916
    International: (224) 357-2386
    Passcode: 6939389

    A webcast replay will be available on the VIVUS website for 30 days.

    About VIVUS
    VIVUS is a biopharmaceutical 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 VIVUS, please visit www.vivus.com.

    Forward-Looking Statements
    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. VIVUS does not undertake an obligation to update or revise any forward-looking statements. Investors should read the risk factors set forth in VIVUS' Form 10-K for the year ended December 31, 2019 as filed on March 3, 2020, and as amended by the Form 10-K/A filed on April 29, 2020, and periodic reports filed with the Securities and Exchange Commission. VIVUS does not undertake an obligation to update or revise any forward-looking statements.

    CONTACT:    
         
    VIVUS, Inc.   Investor Relations: Lazar FINN Partners
    Mark Oki   David Carey
    Chief Financial Officer   Senior Partner
       
    650-934-5200   212-867-1768

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  5. CAMPBELL, Calif., May 01, 2020 (GLOBE NEWSWIRE) -- VIVUS, Inc. (NASDAQ:VVUS, the "Company")), a biopharmaceutical company, today announced an agreement regarding its corporate debt with IEH Biopharma LLC, which holds a principal amount of  approximately $170.1 million of the Company's Convertible Senior Notes with a maturity date of May 1, 2020. The Company does not currently have the ability to pay the principal amount of the Convertible Senior Notes held by IEH Biopharma. Under the terms of the agreement, the Company will pay IEH Biopharma $3.8 million in 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…

    CAMPBELL, Calif., May 01, 2020 (GLOBE NEWSWIRE) -- VIVUS, Inc. (NASDAQ:VVUS, the "Company")), a biopharmaceutical company, today announced an agreement regarding its corporate debt with IEH Biopharma LLC, which holds a principal amount of  approximately $170.1 million of the Company's Convertible Senior Notes with a maturity date of May 1, 2020. The Company does not currently have the ability to pay the principal amount of the Convertible Senior Notes held by IEH Biopharma. Under the terms of the agreement, the Company will pay IEH Biopharma $3.8 million in 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 today, 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 will settle or otherwise satisfy the remaining $11.3 million in principal and $253,373 in accrued and unpaid interest held by other holders.

    About VIVUS

    VIVUS is a biopharmaceutical 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 VIVUS, please visit www.vivus.com.

    Forward-Looking Statements

    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 May 2020, including our ability during the agreed upon 30-day grace period to reach agreement with IEH Biopharma LLC to restructure the outstanding principal amount of the convertible notes and any resulting need of the Company to seek relief under the U.S. Bankruptcy Code; risk and uncertainties related to the timing, strategy, structure and implementation of any restructuring transaction with IEH Biopharma LLC; risks and uncertainties related to the effect of the recent coronavirus (COVID-19) outbreak on our business and the businesses of our partners; risks and uncertainties related to the effectiveness of the VIVUS Health Platform, including its adoption by healthcare providers and its ability to improve patient outcomes and, if applicable, access to Qsymia® and PANCREAZE®; risks and uncertainties related to the timing, strategy, tactics and success of the marketing and sales of PANCREAZE, including our ability to improve patient access to PANCREAZE; risks and uncertainties related to our, or our current or potential partner's, ability to successfully commercialize Qsymia, including our ability to improve patient and physician access to Qsymia; risks and uncertainties related to our ability to sell through the Qsymia retail pharmacy network and the Qsymia Advantage Program; risks and uncertainties related to the timing of initiation and completion of the post-approval clinical studies required as part of the approval of Qsymia by the U.S. Food and Drug Administration ("FDA"), including the Phase 4 post-marketing study of Qsymia in obese adolescents; risks and uncertainties related to the response from FDA to any data and/or information relating to post-approval clinical studies required for Qsymia; risks and uncertainties related to the impact of any possible future requirement to provide further analysis of previously submitted clinical trial data; risks and uncertainties related to the design and outcome of any clinical study required by FDA to expand the Qsymia label; risks and uncertainties related to our ability to work with FDA to significantly reduce or remove the requirements of the clinical post-approval cardiovascular outcomes trial; risks and uncertainties related to the failure to obtain FDA or foreign authority clearances or approvals and noncompliance with FDA or foreign authority regulations; risks and uncertainties related to our ability to demonstrate through clinical testing the quality, safety, and efficacy of our current or future investigational drug candidates or approved products; and risks and uncertainties related to the market and other conditions. 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 VIVUS' Form 10-K for the year ended December 31, 2019 as filed on March 3, 2020, and as amended by the Form 10-K/A filed on April 29, 2020, and periodic reports filed with the Securities and Exchange Commission, including the Form 8-K filed on May 1, 2020. VIVUS does not undertake an obligation to update or revise any forward-looking statements, except as required by law.

    VIVUS, Inc.                                                   
    Mark Oki                                                       
    Chief Financial Officer                                   
     
    650-934-5200         
      Investor Relations: Lazar FINN Partners
    David Carey
    Senior Partner

    212-867-1768


     

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  6. CAMPBELL, Calif., April 03, 2020 (GLOBE NEWSWIRE) -- VIVUS, Inc. (NASDAQ:VVUS, the "Company")), a biopharmaceutical company, today announced the completion of its previously announced registered direct offering of 7,218,750 shares of the Company's common stock at a purchase price of $1.60 per share for gross proceeds of $11.55 million, before deducting the placement agent's fees and other offering expenses payable by the Company.

    H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

    The Company intends to use the net proceeds from this offering for working capital, general corporate purposes, research and development and satisfaction of corporate debts. 

    The shares of common stock were offered by the Company pursuant…

    CAMPBELL, Calif., April 03, 2020 (GLOBE NEWSWIRE) -- VIVUS, Inc. (NASDAQ:VVUS, the "Company")), a biopharmaceutical company, today announced the completion of its previously announced registered direct offering of 7,218,750 shares of the Company's common stock at a purchase price of $1.60 per share for gross proceeds of $11.55 million, before deducting the placement agent's fees and other offering expenses payable by the Company.

    H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

    The Company intends to use the net proceeds from this offering for working capital, general corporate purposes, research and development and satisfaction of corporate debts. 

    The shares of common stock were offered by the Company pursuant to a "shelf" registration statement on Form S-3 (File No. 333-227353) previously filed with the Securities and Exchange Commission (the "SEC") on September 14, 2018 and declared effective by the SEC on September 27, 2018. A final prospectus supplement and accompanying prospectus relating to the shares of common stock has been filed with the SEC.  Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained on the SEC's website at http://www.sec.gov or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (646) 975-6996 or e-mail at .

    This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

    About VIVUS

    VIVUS is a biopharmaceutical 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 VIVUS, please visit www.vivus.com.

    Forward-Looking Statements

    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 the intended use of net proceeds from the registered direct offering as well as 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 May 2020; risk and uncertainties related to the timing, strategy, structure and success of our capital raising efforts; risks and uncertainties related to the effect of the recent coronavirus (COVID-19) outbreak on our business and the businesses of our partners; risks and uncertainties related to the effectiveness of the VIVUS Health Platform, including its adoption by healthcare providers and its ability to improve patient outcomes and, if applicable, access to Qsymia® and PANCREAZE®; risks and uncertainties related to the timing, strategy, tactics and success of the marketing and sales of PANCREAZE, including our ability to improve patient access to PANCREAZE; risks and uncertainties related to our, or our current or potential partner's, ability to successfully commercialize Qsymia, including our ability to improve patient and physician access to Qsymia; risks and uncertainties related to our ability to sell through the Qsymia retail pharmacy network and the Qsymia Advantage Program; risks and uncertainties related to the timing of initiation and completion of the post-approval clinical studies required as part of the approval of Qsymia by the U.S. Food and Drug Administration ("FDA"), including the Phase 4 post-marketing study of Qsymia in obese adolescents; risks and uncertainties related to the response from FDA to any data and/or information relating to post-approval clinical studies required for Qsymia; risks and uncertainties related to the impact of any possible future requirement to provide further analysis of previously submitted clinical trial data; risks and uncertainties related to the design and outcome of any clinical study required by FDA to expand the Qsymia label; risks and uncertainties related to our ability to work with FDA to significantly reduce or remove the requirements of the clinical post-approval cardiovascular outcomes trial; risks and uncertainties related to the failure to obtain FDA or foreign authority clearances or approvals and noncompliance with FDA or foreign authority regulations; risks and uncertainties related to our ability to demonstrate through clinical testing the quality, safety, and efficacy of our current or future investigational drug candidates or approved products and risks and uncertainties related to market and other conditions. 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 VIVUS' Form 10-K for the year ended December 31, 2019 as filed on March 3, 2020, and periodic reports filed with the Securities and Exchange Commission. VIVUS does not undertake an obligation to update or revise any forward-looking statements, except as required by law.

    VIVUS, Inc. Investor Relations: Lazar FINN Partners
    Mark Oki David Carey
    Chief Financial Officer Senior Partner
    650-934-5200 212-867-1768

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  7. PLANO, Texas, April 3, 2020 /PRNewswire/ -- VitalTech, a rapidly growing market leader in Virtual Care, announced today its partnership with VIVUS, Inc, a publicly held biopharmaceutical company (NASDAQ:VVUS). Leveraging VitalTech's industry-leading virtual care platform and comprehensive medical device product line, VIVUS plans to rapidly accelerate the launch of its telemedicine, virtual care and remote patient monitoring capabilities.

    PLANO, Texas, April 3, 2020 /PRNewswire/ -- VitalTech, a rapidly growing market leader in Virtual Care, announced today its partnership with VIVUS, Inc, a publicly held biopharmaceutical company (NASDAQ:VVUS). Leveraging VitalTech's industry-leading virtual care platform and comprehensive medical device product line, VIVUS plans to rapidly accelerate the launch of its telemedicine, virtual care and remote patient monitoring capabilities.


    or visit our website at www.vitaltech.com. (PRNewsfoto/VitalTech)" alt="VitalTech's mission is to enhance the quality of life for seniors through connected care services and smart wearable devices that improve health outcomes, increase safety and lower the cost of care. Our digital health platform simplifies provider workflows and supports connected care through real-time remote patient monitoring and telemedicine capabilities. For more information or a free consultation, please email or visit our website at www.vitaltech.com. (PRNewsfoto/VitalTech)">

    Providing digital health solutions that transform connected care, VitalTech is at the forefront of rapidly advancing healthcare technologies. VitalTech's virtual care platform enables health systems, physicians and clinicians to streamline workflows while improving health-related outcomes, thereby increasing patient safety and lowering the cost of care. Additionally, VitalTech's innovative medical grade monitoring devices integrate seamlessly with any mobile or smart devices increasing patient engagement and compliance. 

    "We are pleased to be partnering with VIVUS supporting their continued commitment to their patients and their network.  The launch of the VIVUS Health platform allows thousands of patients to access their care provider without putting either at risk in the current COVID-19 crisis," says James Hamilton, chief executive officer of VitalTech. "In the current environment, telehealth is a vital tool for physicians to support patients who may become ill, as well as those who have chronic conditions. By adopting telehealth, virtual care and remote patient monitoring, VIVUS's highest risk patients can stay home and stay safe."

    With the addition of VitalTech's virtual care and remote patient monitoring technologies, VIVUS will rapidly accelerate its ability to conduct virtual office visits and monitor patients remotely. The telemedicine and remote monitoring modules are designed to allow the patient-physician interaction to take place virtually through the new VIVUS Health Platform, powered by VitalTech.

    "We are excited to partner with VitalTech to power our VIVUS Health Platform. This collaboration allows us to expand our platform's capabilities to better serve our patient populations," says VIVUS chief executive officer, John Amos. "It is important that we provide robust, integrated telehealth and remote monitoring modules to allow our healthcare providers to continue their clinical practices and ensure patients are receiving the best treatment from home, now more than ever during this unprecedented pandemic."

    VitalTech's remote patient monitoring will be integrated into the VIVUS Health Platform and include Bluetooth-enabled blood pressure cuffs, weight scales, pulse oximeters, and spirometers. Data from these devices will be transmitted directly to the VIVUS Health Platform, and dynamically updated to the patient's physician. Physicians can then actively monitor a patient's physiological data, and implement or adapt treatment in real time to achieve patient care goals.

    About VitalTech
    VitalTech is a rapidly growing provider of fully integrated digital health solutions and smart biomedical wearables that provide real-time remote patient monitoring. Our proprietary VitalCare platform enables health systems, skilled nursing facilities, home health providers, physicians and senior living facilities to streamline workflows while improving health outcomes, increasing patient safety and lowering the cost of care. The company's innovative medical grade biosensors integrate seamlessly into our suite of easy-to-use devices and software, which increase patient engagement and compliance. For more information or a free consultation, please email  or visit our website at www.vitaltech.com.

    About VIVUS
    VIVUS is a biopharmaceutical 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 VIVUS, please visit www.vivus.com.

    VitalTech Media Contacts
    Kelly Miller

    941-713-0082

    Zoe Wood 
     
    (972) 544-7077 ext. 116

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  8. CAMPBELL, Calif., April 01, 2020 (GLOBE NEWSWIRE) -- VIVUS, Inc. (NASDAQ:VVUS, the "Company")), a biopharmaceutical company, today announced that it has entered into definitive agreements with several institutional and accredited investors for the purchase and sale of 7,218,750 shares of the Company's common stock, at a purchase price of $1.60 per share, in a registered direct offering priced at-the-market under Nasdaq rules. The closing of the offering is expected to occur on or about April 3, 2020, subject to the satisfaction of customary closing conditions.

    H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

    The gross proceeds to the Company from this offering are expected to be $11.55 million, before deducting…

    CAMPBELL, Calif., April 01, 2020 (GLOBE NEWSWIRE) -- VIVUS, Inc. (NASDAQ:VVUS, the "Company")), a biopharmaceutical company, today announced that it has entered into definitive agreements with several institutional and accredited investors for the purchase and sale of 7,218,750 shares of the Company's common stock, at a purchase price of $1.60 per share, in a registered direct offering priced at-the-market under Nasdaq rules. The closing of the offering is expected to occur on or about April 3, 2020, subject to the satisfaction of customary closing conditions.

    H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

    The gross proceeds to the Company from this offering are expected to be $11.55 million, before deducting the placement agent's fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from this offering for working capital, general corporate purposes, research and development and satisfaction of corporate debts. 

    The shares of common stock are being offered by the Company pursuant to a "shelf" registration statement on Form S-3 (File No. 333-227353) previously filed with the Securities and Exchange Commission (the "SEC") on September 14, 2018 and declared effective by the SEC on September 27, 2018. The offering of the securities will be made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the securities being offered will be filed with the SEC.  Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC's website at http://www.sec.gov or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (646) 975-6996 or e-mail at .

    This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

    About VIVUS

    VIVUS is a biopharmaceutical 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 VIVUS, please visit www.vivus.com.

    Forward-Looking Statements

    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 the completion of the registered direct offering, the satisfaction of customary closing conditions related to the registered direct offering and the intended use of net proceeds from the registered direct offering as well as 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 May 2020; risk and uncertainties related to the timing, strategy, structure and success of our capital raising efforts; risks and uncertainties related to the effect of the recent coronavirus (COVID-19) outbreak on our business and the businesses of our partners; risks and uncertainties related to the effectiveness of the VIVUS Health Platform, including its adoption by healthcare providers and its ability to improve patient outcomes and, if applicable, access to Qsymia® and PANCREAZE®; risks and uncertainties related to the timing, strategy, tactics and success of the marketing and sales of PANCREAZE, including our ability to improve patient access to PANCREAZE; risks and uncertainties related to our, or our current or potential partner's, ability to successfully commercialize Qsymia, including our ability to improve patient and physician access to Qsymia; risks and uncertainties related to our ability to sell through the Qsymia retail pharmacy network and the Qsymia Advantage Program; risks and uncertainties related to the timing of initiation and completion of the post-approval clinical studies required as part of the approval of Qsymia by the U.S. Food and Drug Administration ("FDA"), including the Phase 4 post-marketing study of Qsymia in obese adolescents; risks and uncertainties related to the response from FDA to any data and/or information relating to post-approval clinical studies required for Qsymia; risks and uncertainties related to the impact of any possible future requirement to provide further analysis of previously submitted clinical trial data; risks and uncertainties related to the design and outcome of any clinical study required by FDA to expand the Qsymia label; risks and uncertainties related to our ability to work with FDA to significantly reduce or remove the requirements of the clinical post-approval cardiovascular outcomes trial; risks and uncertainties related to the failure to obtain FDA or foreign authority clearances or approvals and noncompliance with FDA or foreign authority regulations; risks and uncertainties related to our ability to demonstrate through clinical testing the quality, safety, and efficacy of our current or future investigational drug candidates or approved products and risks and uncertainties related to market and other conditions. 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 VIVUS' Form 10-K for the year ended December 31, 2019 as filed on March 3, 2020, and periodic reports filed with the Securities and Exchange Commission. VIVUS does not undertake an obligation to update or revise any forward-looking statements, except as required by law.

    VIVUS, Inc. Investor Relations: Lazar FINN Partners
    Mark Oki David Carey
    Chief Financial Officer Senior Partner
    650-934-5200 212-867-1768

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  9. Virtual office visits and smart health devices available through the VIVUS Health Platform give physicians new tools for optimizing patient care and protecting the health of those at increased risk for COVID-19

    CAMPBELL, Calif., March 31, 2020 (GLOBE NEWSWIRE) -- VIVUS, Inc. (NASDAQ:VVUS, the "Company")), a biopharmaceutical company, today 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 or not the patient is prescribed a VIVUS product.  The Company expects to enroll 150-200 physicians into the new modules each week.

    "Effective communication around health…

    Virtual office visits and smart health devices available through the VIVUS Health Platform give physicians new tools for optimizing patient care and protecting the health of those at increased risk for COVID-19

    CAMPBELL, Calif., March 31, 2020 (GLOBE NEWSWIRE) -- VIVUS, Inc. (NASDAQ:VVUS, the "Company")), a biopharmaceutical company, today 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 or not the patient is prescribed a VIVUS product.  The Company expects to enroll 150-200 physicians into the new modules each week.

    "Effective communication around health conditions, such as obesity, can be difficult under the best of circumstances, and are even more challenging in the current environment in which patients, physicians, and care facilities are adhering to social distancing guidelines to prevent the spread of COVID-19.  These guidelines also make it difficult for cystic fibrosis patients, who are at increased risk of COVID-19 due to their compromised lung function, to consult with their healthcare providers," said John Amos, Chief Executive Officer at VIVUS.  "We have rapidly accelerated the launch of our telemedicine and remote monitoring modules to facilitate communication during this unprecedented pandemic and ensure that patients can receive optimum care without leaving their homes."

    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.  It includes the VIVUS Advantage Programs, which offer Patient Assistance Programs to facilitate access to medication for uninsured or underinsured patients with obesity or exocrine pancreatic insufficiency, and also allows patients prescribed VIVUS medications to have their prescriptions filled online and sent directly to their homes.

    The telemedicine and remote monitoring modules are designed to leverage normal clinical practices without disrupting routine clinical operations.  While the patient-physician interaction takes place virtually through the VIVUS Health Platform, powered by Vital Tech, all other activities, such as scheduling, patient administration, billing, etc., take place utilizing existing clinic processes and resources.  The telemedicine module is configured for easy and rapid activation, allowing physician offices and clinics to implement the platform with minimal effort.

    Remote patient monitoring is integrated into the VIVUS Health Platform through the Apple Health Kit, Apple Watch, and a wide variety of blue tooth-enabled health devices that will include weight scales, pulse oximeters, spirometers to measure lung function, and blood pressure cuffs.  Data from these devices and the Apple Health Kit are transmitted and collated directly into the VIVUS Health Platform, which can be accessed by the patient's physician.  Physicians can utilize these data to monitor a patient's vital functions, and can implement or adapt treatment to achieve or maintain target goals for important health metrics.

    There are no upfront or monthly fees, and physicians pay a fee only for each telemedicine visit and/or for remote patient monitoring.  The VIVUS Health Platform is also not limited by a patient's health insurance plan.

    "Obesity is an epidemic in its own right, and in this time of social distancing, patients may find it more difficult to adhere to a healthy diet and activity goals.  Patients with cystic fibrosis are challenged day-to-day with the need to avoid respiratory infections, a challenge that is even more critical during the COVID-19 pandemic. This pandemic underscores the critical importance of helping patients manage health conditions that increase their susceptibility to other diseases," added Santosh T. Varghese, MD, Senior Vice President, Chief Medical Officer at VIVUS.  "VIVUS is committed to addressing these challenges by increasing access to care through telemedicine, online fulfillment of prescriptions, and data collection from smart health devices that allow patients and healthcare providers to monitor health progress in real-time.  Additionally, we are expanding this platform into the clinical trial space as we address the challenges of conducting studies in this new environment."

    Physicians interested in enrolling in the VIVUS Health Platform may contact .

    About VIVUS

    VIVUS is a biopharmaceutical 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 VIVUS, please visit www.vivus.com.

    Forward-Looking Statements

    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 May 2020; risk and uncertainties related to the timing, strategy, structure and success of our capital raising efforts; risks and uncertainties related to the effect of the recent coronavirus (COVID-19) outbreak on our business and the businesses of our partners; risks and uncertainties related to the effectiveness of the VIVUS Health Platform, including its adoption by healthcare providers and its ability to improve patient outcomes and, if applicable, access to Qsymia® and PANCREAZE®; risks and uncertainties related to the timing, strategy, tactics and success of the marketing and sales of PANCREAZE, including our ability to improve patient access to PANCREAZE; risks and uncertainties related to our, or our current or potential partner's, ability to successfully commercialize Qsymia, including our ability to improve patient and physician access to Qsymia; risks and uncertainties related to our ability to sell through the Qsymia retail pharmacy network and the Qsymia Advantage Program; risks and uncertainties related to the timing of initiation and completion of the post-approval clinical studies required as part of the approval of Qsymia by the U.S. Food and Drug Administration ("FDA"), including the Phase 4 post-marketing study of Qsymia in obese adolescents; risks and uncertainties related to the response from FDA to any data and/or information relating to post-approval clinical studies required for Qsymia; risks and uncertainties related to the impact of any possible future requirement to provide further analysis of previously submitted clinical trial data; risks and uncertainties related to the design and outcome of any clinical study required by FDA to expand the Qsymia label; risks and uncertainties related to our ability to work with FDA to significantly reduce or remove the requirements of the clinical post-approval cardiovascular outcomes trial; risks and uncertainties related to the failure to obtain FDA or foreign authority clearances or approvals and noncompliance with FDA or foreign authority regulations; and risks and uncertainties related to our ability to demonstrate through clinical testing the quality, safety, and efficacy of our current or future investigational drug candidates or approved products. 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 VIVUS' Form 10-K for the year ended December 31, 2019 as filed on March 3, 2020, and periodic reports filed with the Securities and Exchange Commission. VIVUS does not undertake an obligation to update or revise any forward-looking statements.

    VIVUS, Inc. Investor Relations: Lazar FINN Partners
    Mark Oki David Carey
    Chief Financial Officer Senior Partner
    
    650-934-5200  212-867-1768

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  10. - Company to host conference call today at 4:30pm ET -

    CAMPBELL, Calif., March 03, 2020 (GLOBE NEWSWIRE) -- VIVUS, Inc. (NASDAQ:VVUS) (the "Company"), a biopharmaceutical company, today reported financial results for the quarter and fiscal year ended December 31, 2019 and provided a business update.

    "Fiscal year 2019 represents our first full year of operating results as a fully integrated business and clinical team," said John Amos, VIVUS' Chief Executive Officer.  "In 2019, our team delivered nearly $70 million of revenue, a 7% increase compared to 2018, increased adjusted EBITDA 7% compared to 2018 and reduced our net loss by $5.5 million, a 15% decrease.  VIVUS is now six quarters through a 10-quarter turnaround, and we are pleased with…

    - Company to host conference call today at 4:30pm ET -

    CAMPBELL, Calif., March 03, 2020 (GLOBE NEWSWIRE) -- VIVUS, Inc. (NASDAQ:VVUS) (the "Company"), a biopharmaceutical company, today reported financial results for the quarter and fiscal year ended December 31, 2019 and provided a business update.

    "Fiscal year 2019 represents our first full year of operating results as a fully integrated business and clinical team," said John Amos, VIVUS' Chief Executive Officer.  "In 2019, our team delivered nearly $70 million of revenue, a 7% increase compared to 2018, increased adjusted EBITDA 7% compared to 2018 and reduced our net loss by $5.5 million, a 15% decrease.  VIVUS is now six quarters through a 10-quarter turnaround, and we are pleased with our progress towards achieving our goals."

    Recent Business Highlights

    • Completes Enrollment of Phase 4 Safety and Efficacy Study of Qsymia® in Adolescents
      In 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.

    • Qsymia Launches in South Korea
      In February 2020, VIVUS announced that its Korean marketing partner, Alvogen Malta Operations (ROW) Ltd., has launched Qsymia in the Republic of Korea. VIVUS will receive a $2 million payment tied to the commercial launch of Qsymia.

    • Results of "Toolbox Trial" Demonstrating Qsymia's Effectiveness Are Published
      In January 2020, The University of Colorado announced the publication of new results from its Toolbox Trial, a real-world clinical trial conducted in urban safety-net primary care clinics offering patients a "toolbox" of cost-effective weight management tools. The study, published in the Journal of General Internal Medicine, found that a higher proportion of subjects who initially selected Qsymia from the toolbox or added it to their weight management plans during the study period achieved at least a 5% weight loss compared with subjects who never used Qsymia.

    • New Clinical Data Released Demonstrating that Qsymia is Effective at Reducing Binge Eating in Patients with Binge-Eating Disorder or Bulimia Nervosa
      In November 2019, the results of a clinical study were published demonstrating that patients with binge-eating disorder or bulimia nervosa receiving Qsymia had a significant reduction in binge day frequency compared with placebo over four weeks and was well tolerated in these patient populations. The study results appear online in the International Journal of Eating Disorders.

    • FDA Approves Improved PANCREAZE Formulation
      In February 2020, the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for an improved formulation of PANCREAZE® (pancrelipase) Delayed Release Capsules that extends the shelf life to 36 months across all PANCREAZE dosages.

    Fourth Quarter 2019 vs Third Quarter 2019 Financial Results

    Revenue consisted of the following:

        (In thousands)
    Three Months Ended
     
        December 31,
    2019
      September 30,
    2019
     
    Qsymia net product revenue   $ 9,750   $ 9,583  
    PANCREAZE/PANCREASE MT, net product revenue     5,849     5,266  
    Milestone revenue         2,500  
    Supply revenue     1,186     64  
    Royalty revenue     469     557  
      Total revenue    $ 17,254   $ 17,970  

    Qsymia net product revenue was $9.8 million and $9.6 million in the fourth and third quarters of 2019, respectively. The Company continues to migrate Qsymia patients from the traditional retail pharmacy model to the Qsymia Advantage Program that improves access to Qsymia through, among other things, direct-to-patient distribution and improved pricing. During the fourth quarter of 2019, 31% of Qsymia scripts were dispensed through the Qsymia Advantage Program's Direct-to-Patient model, up from 22% and 8% in the third and second quarters of 2019, respectively. In the fourth quarter of 2019, the Company experienced a seasonal drop in scripts to 83,116 compared to 85,899 in the third quarter of 2019, a decrease of 3%. This compares to a 7% decrease between the same periods in 2018.

    PANCREAZE® net product revenue was $5.8 million and $5.3 million in the fourth and third quarters of 2019, respectively. The results in the fourth and third quarters of 2019 included $0.9 million and $0.1 million of Canadian sales of PANCREASE® MT, respectively. The Company began to recognize sales revenue from Canadian sales in the third quarter of 2019. Total U.S. scripts were 5,735 and 5,777 during the fourth and third quarters of 2019, respectively. In the U.S., the Company has a dedicated 10-person sales force, sampling program, full patient support program, a plan for investigator-sponsored trials in oncology, and a digital marketing campaign strategy, along with several other enhancements.

    Milestone revenue in the third quarter of 2019 represented the payment received related to Alvogen, VIVUS' Korean marketing partner, obtaining marketing approval for Qsymia from the South Korea Ministry of Food and Drug Safety.

    Supply revenue in the fourth quarter of 2019 consisted of sales of Qsymia to Alvogen to support the recent launch of Qsymia in South Korea. Prior to the fourth quarter, supply revenue consisted of sales of STENDRA®/SPEDRATM to the Company's licensees for sales in the EU and U.S. Supply revenue varies based on the timing of orders from the Company's licensees and consists of minimum order requirements and such purchases do not correspond to end user demand.

    Royalty revenue was $0.5 million and $0.6 million in the fourth and third quarters of 2019, respectively. These amounts consisted of royalties earned on SPEDRA European revenues.

    Total cost of goods sold, excluding amortization, was $4.0 million and $3.0 million in the fourth and third quarters of 2019, respectively. The increase was primarily due to the increase in Qsymia and PANCREAZE product sales as well as the increase in supply revenue over the third quarter.

    Amortization of intangible assets was $3.6 million in both the fourth and third quarters of 2019. The amount primarily consisted of amortization expense of costs capitalized related to the acquisition of PANCREAZE.

    Selling, general and administrative expense was $10.9 million and $9.2 million in the fourth and third quarters of 2019, respectively, and included selling and marketing expense of $4.3 million and $4.5 million, respectively. The increase in general and administrative costs was primarily due to the Company incurring $1.9 million of severance costs associated with the elimination of two officers.

    Research and development expense was $2.4 million and $3.3 million in the fourth and third quarters of 2019, respectively. In 2019, research and development efforts primarily consisted of activities related to the Qsymia adolescent and efficacy study (OB-0403), PANCREAZE post-marketing requirements assumed from Janssen and PANCREAZE product improvement initiatives.

    Total interest and other expense was $2.9 million and $9.9 million in the fourth and third quarters of 2019, respectively.  The decrease in interest expense in the fourth quarter was primarily a result of prepayment premiums related to the reduction in debt balances incurred in the third quarter.

    Net loss for the fourth and third quarters of 2019 was $6.5 million and $11.1 million, respectively. Cash and cash equivalents were $32.6 million at December 31, 2019.

    Non-GAAP EBITDA for the fourth and third quarters of 2019 was $0.6 million and $3.0 million, respectively. Recurring non-GAAP EBITDA was $2.3 million and $1.2 million for the fourth and third quarters of 2019, respectively. In the fourth quarter, non-GAAP EBITDA was adjusted to remove the severance expense related to the elimination of two officers during the quarter and the third quarter was adjusted to exclude the Qsymia milestone revenue and certain professional fees related to the Company's debt buyback.

    Conference Call Details

    VIVUS will hold a conference call and an audio webcast to provide a business update and to discuss fourth quarter 2019 financial results today, March 3, 2020, beginning at 4:30 PM Eastern Time.

    To listen via webcast, please visit http://ir.vivus.com/, or by clicking here.

    To listen via phone, please use the dial in information provided below.

    Dial in Details:
    Toll-Free: (877) 359-2916
    International: (224) 357-2386
    Passcode: 6791889

    The webcast replay and slide presentation will be available in the Events and Presentations section on the VIVUS website for 30 days.

    About Qsymia

    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.

    About PANCREAZE

    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 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 subsidiaries to commercialize and promote SPEDRA for the treatment of erectile dysfunction in over 40 European countries plus Australia and New Zealand.

    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.

    About VIVUS

    VIVUS is a biopharmaceutical 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.

    Forward-Looking Statements

    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 May 2020; risk and uncertainties related to the timing, strategy, structure and success of our capital raising efforts; 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, including our ability to improve patient access to PANCREAZE; risks and uncertainties related to our commercialization of PANCREAZE as a new product and our 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, including our ability to improve patient and physician access to Qsymia; risks and uncertainties related to the impact of promotional programs for Qsymia on our net product revenue and net income (loss) in future periods; risks and uncertainties related to our ability to sell through the Qsymia retail pharmacy network and the Qsymia Advantage Program; risks and uncertainties related to the timing of initiation and completion of the post-approval clinical studies required as part of the approval of Qsymia by the U.S. Food and Drug Administration ("FDA"), including the Phase 4 post-marketing study of Qsymia in obese adolescents; risks and uncertainties related to the response from FDA to any data and/or information relating to post-approval clinical studies required for Qsymia; risks and uncertainties related to the impact of any possible future requirement to provide further analysis of previously submitted clinical trial data; risks and uncertainties related to the design and outcome of any clinical study required by FDA to expand the Qsymia label; 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 demonstrate through clinical testing the quality, safety, and efficacy of our current or future investigational drug candidates or approved products; 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 FDA to significantly reduce or remove the requirements of the clinical post-approval cardiovascular outcomes trial ("CVOT"); risks and uncertainties related to our dialog with certain concerned member states in Europe relating to the pending decentralized Marketing Authorization Application, the timing and scope of the assessment by such Concerned Member State health authorities of our Marketing Authorization Application, and ultimately the decision of such Concerned Member State health authorities whether to grant Marketing Authorization for Qsymia in such EU countries; risks and uncertainties related to the failure to obtain FDA or foreign authority clearances or approvals and noncompliance with FDA or foreign authority regulations; and risks and uncertainties related to the impact, if any, of changes to our Board of Directors and senior management team. 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 VIVUS' Form 10-K for the year ended December 31, 2019 as filed on March 3, 2020, and periodic reports filed with the Securities and Exchange Commission. VIVUS does not undertake an obligation to update or revise any forward-looking statements.

    VIVUS, Inc.
    Mark Oki
    Chief Financial Officer

    650-934-5200

    Investor Relations: Lazar FINN Partners
    David Carey
    Senior Partner

    212-867-1768

               
    VIVUS, INC.
    CONDENSED CONSOLIDATED BALANCE SHEETS
    (In thousands, except par value)
               
      December 31,    December 31, 
      2019
      2018
               
    ASSETS          
    Current assets:          
    Cash and cash equivalents $ 32,649     $ 30,411  
    Available-for-sale securities         80,838  
    Accounts receivable, net   22,338       25,608  
    Inventories   33,679       23,132  
    Prepaid expenses and other current assets   8,134       7,538  
    Total current assets   96,800       167,527  
    Property and equipment, net   233       341  
    Right-of-use assets   1,135        
    Intangible and other non-current assets   120,140       134,279  
    Total assets $ 218,308     $ 302,147  
    LIABILITIES AND STOCKHOLDERS' DEFICIT          
    Current liabilities:          
    Accounts payable $ 7,726     $ 8,921  
    Accrued and other liabilities   32,398       33,044  
    Deferred revenue   1,249       1,235  
    Current portion of lease liability   767        
    Current portion of long-term debt   183,006        
    Total current liabilities   225,146       43,200  
    Long-term debt, net of current portion   58,721       294,446  
    Deferred revenue, net of current portion   3,063       4,290  
    Lease liability, net of current portion   602        
    Non-current accrued and other liabilities         234  
    Total liabilities   287,532       342,170  
    Commitments and contingencies          
    Stockholders' deficit:          
    Preferred stock; $.001 par value; 5,000 shares authorized; no shares issued and outstanding at December 31, 2019 and December 31, 2018, respectively          
    Common stock; $.001 par value; 200,000 shares authorized; 10,643 and 10,636 shares issued and outstanding at December 31, 2019 and 2018, respectively   11       11  
    Additional paid-in capital   842,808       840,751  
    Accumulated other comprehensive loss   (35 )     (270 )
    Accumulated deficit   (912,008 )     (880,515 )
    Total stockholders' deficit   (69,224 )     (40,023 )
    Total liabilities and stockholders' deficit $ 218,308     $ 302,147  


     
    VIVUS, INC.
    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
    (In thousands, except per share data)
    (Unaudited)
               
      Three Months Ended
      December 31,
    2019
      September 30,
    2019
    Revenue:          
    Net product revenue $ 15,599     $ 14,849  
    Milestone revenue         2,500  
    Supply revenue   1,186       64  
    Royalty revenue   469       557  
    Total revenue   17,254       17,970  
               
    Operating expenses:          
    Cost of goods sold (excluding amortization)   3,970       3,016  
    Amortization of intangible assets   3,638       3,638  
    Selling, general and administrative   10,944       9,207  
    Research and development   2,380       3,266  
    Total operating expenses   20,932       19,127  
               
    Loss from operations   (3,678 )     (1,157 )
               
    Interest expense and other expense, net   2,852       9,911  
    Loss before income taxes   (6,530 )     (11,068 )
    Provision for income taxes   17       4  
    Net loss $ (6,547 )   $ (11,072 )
               
    Basic and diluted net loss per share: $ (0.61 )   $ (1.04 )
    Shares used in per share computation:          
    Basic and diluted   10,646       10,643  


     
    VIVUS, INC.
    GAAP to NON-GAAP RECONCILIATION
    NET LOSS to EBITDA and RECURRING EBITDA
    (In thousands)
    (Unaudited)
     
    A reconciliation between net loss on a GAAP basis, non-GAAP EBITDA and non-GAAP recurring EBITDA for the fourth and third quarters of 2019 is as follows:
     
      Three Months Ended
      December 31,   September 30,
    2019
    2019
    Net loss $ (6,547 )   $ (11,072 )
    Adjustments:          
    Interest expense and other expense, net   2,852       9,911  
    Depreciation of fixed assets   40       36  
    Amortization of intangible assets   3,638       3,638  
    Share-based compensation expense   608       483  
    Provision for income taxes   17       4  
    Non-GAAP EBITDA $ 608     $ 3,000  
    Milestone revenue         (2,500 )
    Fees from debt buy down         656  
    Severance expense   1,645        
    Non-GAAP recurring EBITDA $ 2,253     $ 1,156  


     
    VIVUS, INC.
    GAAP to NON-GAAP RECONCILIATION
    NET LOSS to ADJUSTED EBITDA
    (In thousands)
    (Unaudited)
     
    A reconciliation between net loss on a GAAP basis and adjusted non-GAAP EBITDA for the years ended December 31, 2019 and 2019 is as follows:
     
      Year Ended December 31,
      2019   2018
    Net loss $   (31,503 )   $   (36,950 )
    Adjustments:          
    Interest expense and other expense, net   20,513       33,419  
    Gain on extinguishment of debt         1,427  
    Depreciation of fixed assets   150       235  
    Amortization of intangible assets   14,552       8,640  
    Share-based compensation expense   2,026       3,285  
    Provision for income taxes   21       52  
    Non-GAAP EBITDA $   5,759     $ 10,108  
               
    Non-recurring and discretionary spending          
    Milestone revenue   (2,500 )      
    One-time expenses   2,301       2,034  
    Gain on extinguishment of debt         (1,427 )
    Incremental sales and marketing   3,998        
    Research and development   5,680       3,563  
    Adjusted Non-GAAP EBITDA $   15,238     $   14,278  
                   

    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 SEC rules. We believe that the disclosure of this non-GAAP measure provides investors with additional information that reflects the basis upon which our management assesses and operates our business. This non-GAAP financial measure is not in accordance with GAAP and should not be viewed in isolation or as a substitute for GAAP net loss and is not a substitute for, or superior to, measures of financial performance performed in conformity with GAAP.

    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. We define Adjusted non-GAAP 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 and discretionary incremental sales and marketing expenses and discretionary research and development expenses.

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  11. -Post-marketing study designed to evaluate Qsymia as an approach to weight management in a growing patient population with significant unmet medical need-

    CAMPBELL, Calif., March 02, 2020 (GLOBE NEWSWIRE) -- VIVUS, Inc. (NASDAQ:VVUS, the "Company")), a biopharmaceutical company, today announced the completion of patient enrollment in a Phase 4 clinical study designed to evaluate the safety and efficacy of Qsymia® (phentermine and topiramate extended-release) capsules CIV in adolescents between the ages of 12 and 17 years who are obese (NCT# 03922945). 

    "Completing enrollment in this study is an important milestone in our ongoing efforts to expand the clinical use of Qsymia based on robust safety and efficacy data," said Santosh T. Varghese…

    -Post-marketing study designed to evaluate Qsymia as an approach to weight management in a growing patient population with significant unmet medical need-

    CAMPBELL, Calif., March 02, 2020 (GLOBE NEWSWIRE) -- VIVUS, Inc. (NASDAQ:VVUS, the "Company")), a biopharmaceutical company, today announced the completion of patient enrollment in a Phase 4 clinical study designed to evaluate the safety and efficacy of Qsymia® (phentermine and topiramate extended-release) capsules CIV in adolescents between the ages of 12 and 17 years who are obese (NCT# 03922945). 

    "Completing enrollment in this study is an important milestone in our ongoing efforts to expand the clinical use of Qsymia based on robust safety and efficacy data," said Santosh T. Varghese, MD, Senior Vice President, Chief Medical Officer at VIVUS.  "The enthusiasm among clinicians, adolescent patients and their parents for participating in this study reflects the unmet need for new medical treatments that safely and effectively address the challenges of obesity in this patient population."

    The Centers for Disease Control and Prevention estimates that nearly 21 percent of adolescents ages 12 to 19 years in the United States are obese.1  A study conducted by the World Health Organization found 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 2022.2

    "We believe that Qsymia has significant clinical and commercial potential, and we are committed to capturing a larger share of the global market for anti-obesity medications," said John Amos, Chief Executive Officer at VIVUS.  "Expanding the body of clinical evidence supporting the safety and efficacy of Qsymia in diverse patient populations and clinical settings is an essential component of our strategy to demonstrate the clinical value of Qsymia and to make this product the leading global anti-obesity medication."

    In December 2019, VIVUS reported that data from a pharmacokinetic (PK) and pharmacodynamic (PD) study (NCT# 02714062) conducted in order to establish dosing levels for the ongoing Phase 4 post-marketing study demonstrated that Qsymia has favorable PK, efficacy, and safety/tolerability profiles when used for eight weeks to treat adolescents with obesity.

    About the Phase 4 Post-Marketing Study

    The Phase 4 post-marketing study, which the U.S. Food and Drug Administration (FDA) required as part of the approval of Qsymia in 2012, enrolled approximately 200 patients at 26 clinical sites in the United States.  The primary endpoint of the randomized, double blind, placebo-controlled, parallel-design study is the mean percentage change in body-mass index (BMI) in patients randomized 1:2:1 to daily mid- or top-dose Qsymia compared with placebo over 56 weeks of treatment.  Participants will also be instructed to follow a reduced-calorie diet and to implement a family-based lifestyle modification program that includes physical activity, behavioral change and family support. Safety and tolerability of Qsymia will also be assessed.

    About Qsymia

    Qsymia is approved in the United States and South Korea 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; 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.

    About VIVUS

    VIVUS is a biopharmaceutical 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 VIVUS, please visit www.vivus.com.

    Forward-Looking Statements

    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 May 2020; risk and uncertainties related to the timing, strategy, structure and success of our capital raising efforts; risks and uncertainties related to our expected future revenues, operations and expenditures; risks and uncertainties related to the impact of the indicated uses and contraindications contained in the Qsymia label and the Risk Evaluation and Mitigation Strategy requirements; risks and uncertainties related to the timing of initiation and completion of the post-approval clinical studies required as part of the approval of Qsymia by the U.S. Food and Drug Administration ("FDA"), including the Phase 4 post-marketing study of Qsymia in obese adolescents; risks and uncertainties related to the response from FDA to any data and/or information relating to post-approval clinical studies required for Qsymia; risks and uncertainties related to the impact of any possible future requirement to provide further analysis of previously submitted clinical trial data; risks and uncertainties related to the design and outcome of any clinical study required by FDA to expand the Qsymia label; risks and uncertainties related to our, or our current or potential partners', ability to successfully commercialize Qsymia in their respective territories, including our partner in South Korea; and risks and uncertainties related to our ability to sell through the Qsymia retail pharmacy network and the Qsymia Advantage Program.  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 VIVUS' Form 10-K for the year ended December 31, 2018 as filed on February 26, 2019, and periodic reports filed with the Securities and Exchange Commission.  VIVUS does not undertake an obligation to update or revise any forward-looking statements.

    VIVUS, Inc.
    Mark Oki
    Chief Financial Officer

    650-934-5200
                                Investor Relations: Lazar FINN Partners
    David Carey
    Senior Partner

    212-867-1768
         

    _______________
    1 Centers for Disease Control and Prevention. Childhood Obesity Facts. Prevalence of Childhood Obesity in the United States. Available at: https://www.cdc.gov/obesity/data/childhood.html
    2 NCD Risk Factor Collaboration (NCD-RisC). Worldwide trends in body-mass index, underweight, overweight, and obesity from 1975 to 2016: a pooled analysis of 2416 population-based measurement studies in 128.9 million children, adolescents, and adults. Lancet 2017;390:2627-42.

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  12. - VIVUS to Receive Milestone Payment from Alvogen; Significant Worldwide Growth Potential for Qsymia -

    CAMPBELL, Calif., Feb. 19, 2020 (GLOBE NEWSWIRE) -- VIVUS, Inc. (NASDAQ:VVUS) (the "Company"), a biopharmaceutical company, announced today that its Korean marketing partner, Alvogen, has launched Qsymia (phentermine and topiramate extended-release) in the Republic of Korea.  

    "We believe that Qsymia has significant unrealized clinical and commercial value, and the South Korean launch of this important tool for helping patients achieve and maintain a healthy body-mass index will advance our strategy for unlocking this potential," said John Amos, CEO of VIVUS.  "Alvogen is an established leader in the South Korean anti-obesity market, and…

    - VIVUS to Receive Milestone Payment from Alvogen; Significant Worldwide Growth Potential for Qsymia -

    CAMPBELL, Calif., Feb. 19, 2020 (GLOBE NEWSWIRE) -- VIVUS, Inc. (NASDAQ:VVUS) (the "Company"), a biopharmaceutical company, announced today that its Korean marketing partner, Alvogen, has launched Qsymia (phentermine and topiramate extended-release) in the Republic of Korea.  

    "We believe that Qsymia has significant unrealized clinical and commercial value, and the South Korean launch of this important tool for helping patients achieve and maintain a healthy body-mass index will advance our strategy for unlocking this potential," said John Amos, CEO of VIVUS.  "Alvogen is an established leader in the South Korean anti-obesity market, and we believe that our agreement with Alvogen exemplifies our strategy for maximizing the value of our commercial-stage assets in an efficient and cost-effective manner. We are confident in Alvogen's ability to make Qsymia a significant product in the South Korean market."

    Under an agreement executed in September 2017, Alvogen, a leader in the South Korean anti-obesity market, is solely responsible for obtaining and maintaining regulatory approvals and for all sales and marketing activities in Korea.  In addition to the upfront payment that VIVUS received at the time the agreement was executed and the milestone payment received upon approval of Qsymia by the South Korea Ministry of Food and Drug Safety (MFDS) in August 2019, VIVUS will receive a $2 million payment tied to the  commercial launch of Qsymia.  Under the agreement, VIVUS is also eligible to receive royalties on Alvogen's net sales of Qsymia and future milestone payments contingent upon achievement of net sales goals within the covered territory. 

    About Qsymia

    Qsymia is approved in the United States and South Korea 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; 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.

    About VIVUS

    VIVUS is a biopharmaceutical 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 VIVUS, please visit www.vivus.com.

    Forward-Looking Statements

    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 May 2020; risk and uncertainties related to the timing, strategy, structure and success of our capital raising efforts; risks and uncertainties related to our expected future revenues, operations and expenditures; risks and uncertainties related to the impact of the indicated uses and contraindications contained in the Qsymia label and the Risk Evaluation and Mitigation Strategy requirements; risks and uncertainties related to the timing of initiation and completion of the post-approval clinical studies required as part of the approval of Qsymia by the U.S. Food and Drug Administration ("FDA"), including the Phase 4 post-marketing study of Qsymia in obese adolescents; risks and uncertainties related to the response from FDA to any data and/or information relating to post-approval clinical studies required for Qsymia; risks and uncertainties related to the impact of any possible future requirement to provide further analysis of previously submitted clinical trial data; risks and uncertainties related to the design and outcome of any clinical study required by FDA to expand the Qsymia label; risks and uncertainties related to our, or our current or potential partners', ability to successfully commercialize Qsymia in their respective territories, including our partner in South Korea; and risks and uncertainties related to our ability to sell through the Qsymia retail pharmacy network and the Qsymia Advantage Program.  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 VIVUS' Form 10-K for the year ended December 31, 2018 as filed on February 26, 2019, and periodic reports filed with the Securities and Exchange Commission.  VIVUS does not undertake an obligation to update or revise any forward-looking statements.           

    VIVUS, Inc. Investor Relations: Lazar FINN Partners
    Mark Oki David Carey
    Chief Financial Officer Senior Partner
    650-934-5200 212-867-1768

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  13. CAMPBELL, Calif., Feb. 18, 2020 (GLOBE NEWSWIRE) -- VIVUS, Inc. (NASDAQ:VVUS) today announced that it will report financial results and provide a business update for the fourth quarter of 2019 after the market close on Tuesday, March 3, 2020. The company will host a conference call with accompanying presentation slides beginning at 4:30 p.m. ET / 1:30 p.m. PT the same day to review results and provide a business update.

    To listen via webcast, please visit http://ir.vivus.com/, or by clicking here.

    To listen via phone, please use the dial in information provided below.

    Dial in Details:
    Toll-Free: (877) 359-2916
    International: (224) 357-2386
    Passcode: 6791889

    The webcast replay and slide presentation will be available in the Events and Presentations…

    CAMPBELL, Calif., Feb. 18, 2020 (GLOBE NEWSWIRE) -- VIVUS, Inc. (NASDAQ:VVUS) today announced that it will report financial results and provide a business update for the fourth quarter of 2019 after the market close on Tuesday, March 3, 2020. The company will host a conference call with accompanying presentation slides beginning at 4:30 p.m. ET / 1:30 p.m. PT the same day to review results and provide a business update.

    To listen via webcast, please visit http://ir.vivus.com/, or by clicking here.

    To listen via phone, please use the dial in information provided below.

    Dial in Details:
    Toll-Free: (877) 359-2916
    International: (224) 357-2386
    Passcode: 6791889

    The webcast replay and slide presentation will be available in the Events and Presentations section on the VIVUS website for 30 days.

    About VIVUS
    VIVUS is a biopharmaceutical 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 VIVUS, please visit www.vivus.com.

    Forward-Looking Statements
    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. VIVUS does not undertake an obligation to update or revise any forward-looking statements. Investors should read the risk factors set forth in VIVUS' Form 10-K for the year ended December 31, 2018 as filed on February 26, 2019, and periodic reports filed with the Securities and Exchange Commission. VIVUS does not undertake an obligation to update or revise any forward-looking statements.

    CONTACT:

    VIVUS, Inc. Investor Relations: Lazar FINN Partners
    Mark Oki David Carey
    Chief Financial Officer Senior Partner
    650-934-5200 212-867-1768

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  14. CAMPBELL, Calif., Feb. 05, 2020 (GLOBE NEWSWIRE) -- VIVUS, Inc. (NASDAQ:VVUS) ("VIVUS"), a biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for an improved formulation of PANCREAZE® (pancrelipase) Delayed Release Capsules that extends the shelf life to 36 months across all PANCREAZE dosages. VIVUS worked closely with Nordmark Arzneimittel GmbH & Co. KG, its manufacturing partner for PANCREAZE, on the FDA approval pursuant to the terms of the  amended contract manufacturing agreement announced in June 2019. PANCREAZE is indicated for the treatment of exocrine pancreatic insufficiency (EPI) due to cystic fibrosis or other conditions.

    "The approval…

    CAMPBELL, Calif., Feb. 05, 2020 (GLOBE NEWSWIRE) -- VIVUS, Inc. (NASDAQ:VVUS) ("VIVUS"), a biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for an improved formulation of PANCREAZE® (pancrelipase) Delayed Release Capsules that extends the shelf life to 36 months across all PANCREAZE dosages. VIVUS worked closely with Nordmark Arzneimittel GmbH & Co. KG, its manufacturing partner for PANCREAZE, on the FDA approval pursuant to the terms of the  amended contract manufacturing agreement announced in June 2019. PANCREAZE is indicated for the treatment of exocrine pancreatic insufficiency (EPI) due to cystic fibrosis or other conditions.

    "The approval of this sNDA is an important milestone for VIVUS and for the patients with EPI we seek to treat," said John Amos, Chief Executive Officer at VIVUS. "It highlights our ability to derive additional value from our marketed products and allows patients to store PANCREAZE for longer periods of time, which may help to reduce their out-of-pocket expenses. We also expect that the 36-month shelf life will limit the amount of returned product and, over time, will lower our overall supply chain costs.  We look forward to working with Nordmark and our supply chain and commercial partners on the transition to the improved formulation."

    Approved in 2010, PANCREAZE is a pancreatic enzyme preparation consisting of pancrelipase, an extract derived from porcine pancreatic glands, as well as other enzyme classes, including porcine-derived lipases, proteases and amylases. The pancreatic enzymes in PANCREAZE act like digestive enzymes physiologically secreted by the pancreas. 

    About PANCREAZE

    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 VIVUS

    VIVUS is a biopharmaceutical 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 VIVUS, please visit www.vivus.com.

    Forward-Looking Statements

    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 expected future revenues, operations and expenditures; risks and uncertainties related to our ability to maintain the relationship with the sole manufacturer for PANCREAZE; risks and uncertainties related to our ability to accurately forecast PANCREAZE demand; risks and uncertainties related to our ability to maintain a satisfactory level of PANCREAZE inventory; risks and uncertainties related to the timing, strategy, tactics and success of the marketing and sales of PANCREAZE; risks and uncertainties related to our ability to transition to the improved formulation of PANCREAZE; risks and uncertainties related to our ability to successfully maintain and increase market share against current competing products and potential competitors that may develop alternative formulations of the drug; and risks and uncertainties related to the ability of our partners to maintain regulatory approvals to manufacture and adequately supply our products to meet demand. 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 VIVUS' Form 10-K for the year ended December 31, 2018 as filed on February 26, 2019, and periodic reports filed with the Securities and Exchange Commission. VIVUS does not undertake an obligation to update or revise any forward-looking statements.

    VIVUS, Inc. Investor Relations: Lazar FINN Partners
    Mark Oki David Carey
    Chief Financial Officer Senior Partner
    650-934-5200 212-867-1768

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  15. -Data published in Journal of General Internal Medicine show that patients using Qsymia and other weight loss tools, lost at least 5% of body weight loss compared with those not using Qsymia-

    CAMPBELL, Calif., Jan. 07, 2020 (GLOBE NEWSWIRE) -- VIVUS, Inc. (NASDAQ:VVUS), a biopharmaceutical company, today announced the publication of a new study from the Toolbox Trial (NCT01922934), a real-world clinical trial conducted in urban safety-net primary care clinics offering patients a "toolbox" of cost-effective weight management tools. The study, published in the Journal of General Internal Medicine1 (JGIM), found that a higher proportion of subjects who initially selected Qsymia from the toolbox or added it to their weight management plans during…

    -Data published in Journal of General Internal Medicine show that patients using Qsymia and other weight loss tools, lost at least 5% of body weight loss compared with those not using Qsymia-

    CAMPBELL, Calif., Jan. 07, 2020 (GLOBE NEWSWIRE) -- VIVUS, Inc. (NASDAQ:VVUS), a biopharmaceutical company, today announced the publication of a new study from the Toolbox Trial (NCT01922934), a real-world clinical trial conducted in urban safety-net primary care clinics offering patients a "toolbox" of cost-effective weight management tools. The study, published in the Journal of General Internal Medicine1 (JGIM), found that a higher proportion of subjects who initially selected Qsymia from the toolbox or added it to their weight management plans during the study period achieved at least a 5% weight loss compared with subjects who never used Qsymia.

    "Despite the known health benefits of maintaining a healthy weight, many patients do not receive ongoing counsel and access to cost-effective weight management tools," said Daniel Bessesen, MD, Professor of Medicine, Division of Endocrinology, Metabolism and Diabetes, University of Colorado, School of Medicine and the principle investigator and senior author on the study. "The Toolbox Trial was designed to provide insight into treatment choices and outcomes when patients are offered a variety of low out-of-pocket cost weight management options. The finding that more patients who included a weight loss medication in their weight management plans (almost all of whom chose Qsymia as their medication option compared with phentermine) achieved at least 5% weight loss provides additional support for the use of pharmacotherapy in helping patients achieve and maintain a healthy weight in real-world settings."

    About the Toolbox Trial
    The Toolbox Trial was a 12-month real-world, open-label, single institution intervention study with a registry-based comparator group that offered patients with obesity a toolbox of weight management services for $5 or $10 per month. The services included partial meal replacement, recreation center membership, phentermine, Qsymia, Weight Watchers vouchers and group behavioral weight loss program. At the start of the trial, each patient selected one tool. At each monthly visit, patients had the option of continuing with the initial tool selected or switching to a different tool. After six months, patients could pay an additional $5 per month to add recreation center vouchers or a behavioral weight loss program. The trial was conducted in primary care clinics at Denver Health, an urban safety-net healthcare organization serving a low-income, ethnically diverse population. The primary outcome was at least 5% weight loss at 12 months. There were 305 intervention-eligible participants, of which 119 selected and paid for a tool.

    Key findings from the study include:

    • Significantly more intervention-eligible patients than comparators achieved the primary endpoint (23.3% vs. 15.7%, p<0.001).
    • Of the 113 patients who were on treatment, 34.5% achieved the primary endpoint.
    • Of the 119 patients who selected and paid for a tool, initial selections were meal replacements (35.3%), weight loss medication (28.6%, including 33 subjects, or 27.7%, who chose Qsymia), recreation center membership (21.8%), Weight Watchers vouchers (6.7%), group behavioral weight loss program (5.9%) and ongoing contact (1.7%).
    • More than half (56.3%) of patients switched tools at least once and 29.4% added a second tool at six months.
    • The proportion of patients selecting Qsymia increased over time, while the proportion of patients using meal replacements or recreation center passes declined.
    • A higher proportion of patients who added a second tool or ever used Qsymia during the study achieved the primary endpoint compared with those who never used Qsymia.
    • The proportion of intervention-eligible and on-treatment patients who achieved the primary endpoint was higher than the comparator group who received usual care.

    These findings build on an earlier study from the Toolbox Trial published in 2018 in Obesity Journal2, which found that education about the relative effectiveness of the weight-loss tools within the primary care setting as well as direct experience with patients using these medications, resulted in physicians giving higher effectiveness ratings to weight loss medications. In this study, PCPs from the four intervention clinics (PCP-I) as well as PCPs from the five control clinics (PCP-C) who were part of the Toolbox Trial completed pre- and post-trial surveys on weight-loss counseling, comfort discussing obesity treatments and perceived effectiveness of weight loss interventions. PCP-I received updates on their patients who were participating in the trial and education about weight loss medication, while PCP-C did not receive this information. The key finding from this study was that providers initially overvalued exercise and undervalued weight-loss medications in the treatment of obesity, and that providers who were exposed to education and patient experience gave higher comfort and effectiveness ratings to weight loss medications.

    "These two studies highlight the significant market opportunity for Qsymia and provide important insight into the types of physician education and patient outreach initiatives required to educate stakeholders about Qsymia's role in helping individuals who are overweight or obese achieve and maintain a healthy weight," said John Amos, Chief Executive Officer at VIVUS. "We are evaluating how to incorporate these insights into the VIVUS Health Platform and the Qsymia Advantage Program. Our goal is to provide individuals who are overweight or obese with an integrated weight management strategy that integrates nutrition science, pharmaceutical science and technology and is optimized for long-term success in achieving and maintaining a healthy weight."

    References

    1 Saxon DR, Chaussee EL, Juarez-Colunga E, Tsai AG, Iwamoto SJ, Speer RB, et al. A toolbox approach to obesity treatment in urban safety-net primary care clinics: a pragmatic clinical trial. J Gen Intern Med. 2019;34(11):2405-2413.

    2 Iwamoto S, Saxon D, Tsai A, Leister E, Speer R, Heyn H, et al. Effects of education and experience on primary care providers' perspectives of obesity treatments during a pragmatic trial. Obesity Journal. 2019;26(10):1532-1538.

    About Qsymia

    Qsymia is approved in the United States 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; 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.

    About VIVUS

    VIVUS is a biopharmaceutical 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 VIVUS, please visit www.vivus.com.

    Forward-Looking Statements

    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 May 2020; risk and uncertainties related to the timing, strategy, structure and success of our capital raising efforts; risks and uncertainties related to our expected future revenues, operations and expenditures; risks and uncertainties related to the impact of the indicated uses and contraindications contained in the Qsymia label and the Risk Evaluation and Mitigation Strategy requirements; risks and uncertainties related to the timing of initiation and completion of the post-approval clinical studies required as part of the approval of Qsymia by the U.S. Food and Drug Administration ("FDA"), including the Phase 4 post-marketing study of Qsymia in obese adolescents; risks and uncertainties related to the response from FDA to any data and/or information relating to post-approval clinical studies required for Qsymia; risks and uncertainties related to the impact of any possible future requirement to provide further analysis of previously submitted clinical trial data; risks and uncertainties related to the design and outcome of any clinical study required by FDA to expand the Qsymia label; risks and uncertainties related to our, or our current or potential partners', ability to successfully commercialize Qsymia; and risks and uncertainties related to our ability to sell through the Qsymia retail pharmacy network and the Qsymia Advantage Program. 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 VIVUS' Form 10-K for the year ended December 31, 2018 as filed on February 26, 2019, and periodic reports filed with the Securities and Exchange Commission. VIVUS does not undertake an obligation to update or revise any forward-looking statements.

    VIVUS, Inc. Investor Relations: Lazar FINN Partners
    Mark Oki David Carey
    Chief Financial Officer Senior Partner
    650-934-5200 212-867-1768

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  16. CAMPBELL, Calif., Jan. 02, 2020 (GLOBE NEWSWIRE) -- VIVUS, Inc. (NASDAQ:VVUS) (the "Company"), a biopharmaceutical company, today announced that John Amos, Chief Executive Officer, will present at the Biotech Showcase™ 2020 on Monday, January 13, 2020 at 3:30 pm PT/6:30pm ET. The conference will be held at the Hilton San Francisco Union Square.

    An audio webcast of the presentation will be available in the events and presentations section of the Company's investor relations website, or by clicking here.

    Biotech Showcase, produced by Demy-Colton and EBD Group, is an investor conference focused on driving advances in therapeutic development by providing a sophisticated networking platform for executives and investors that fosters investment and…

    CAMPBELL, Calif., Jan. 02, 2020 (GLOBE NEWSWIRE) -- VIVUS, Inc. (NASDAQ:VVUS) (the "Company"), a biopharmaceutical company, today announced that John Amos, Chief Executive Officer, will present at the Biotech Showcase™ 2020 on Monday, January 13, 2020 at 3:30 pm PT/6:30pm ET. The conference will be held at the Hilton San Francisco Union Square.

    An audio webcast of the presentation will be available in the events and presentations section of the Company's investor relations website, or by clicking here.

    Biotech Showcase, produced by Demy-Colton and EBD Group, is an investor conference focused on driving advances in therapeutic development by providing a sophisticated networking platform for executives and investors that fosters investment and partnership opportunities. The conference takes place each year during the course of one of the industry's largest gatherings and busiest weeks.

    About VIVUS

    VIVUS is a biopharmaceutical 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.

    Forward-Looking Statements

    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. VIVUS does not undertake an obligation to update or revise any forward-looking statements. Investors should read the risk factors set forth in VIVUS' Form 10-K for the year ended December 31, 2018 as filed on February 26, 2019, and periodic reports filed with the Securities and Exchange Commission. VIVUS does not undertake an obligation to update or revise any forward-looking statements.

    Contact:

    VIVUS, Inc. Lazar FINN Partners
    Mark Oki David Carey
    Chief Financial Officer Senior Partner
    650-934-5200 212-687-1768

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  17. CAMPBELL, Calif., Dec. 31, 2019 (GLOBE NEWSWIRE) -- VIVUS, Inc. (NASDAQ:VVUS) (the "Company"), a biopharmaceutical company, today announced that on December 30, 2019 its board of directors adopted a new stockholder rights plan to replace the Company's stockholder rights plan that expired in accordance with its terms on November 9, 2019.

    Under the new rights plan, the terms of which are substantially similar to the terms of the Company's prior rights plan, VIVUS will issue a dividend of one right for each share of its common stock held by stockholders of record as of the close of business on January 13, 2020.

    The new rights plan is designed to protect stockholder value by mitigating the likelihood of an "ownership change" that would result…

    CAMPBELL, Calif., Dec. 31, 2019 (GLOBE NEWSWIRE) -- VIVUS, Inc. (NASDAQ:VVUS) (the "Company"), a biopharmaceutical company, today announced that on December 30, 2019 its board of directors adopted a new stockholder rights plan to replace the Company's stockholder rights plan that expired in accordance with its terms on November 9, 2019.

    Under the new rights plan, the terms of which are substantially similar to the terms of the Company's prior rights plan, VIVUS will issue a dividend of one right for each share of its common stock held by stockholders of record as of the close of business on January 13, 2020.

    The new rights plan is designed to protect stockholder value by mitigating the likelihood of an "ownership change" that would result in significant limitations on the Company's ability to use its net operating losses or other tax attributes to offset future income. The new rights plan is similar to rights plans adopted by other public companies with significant net operating loss carryforwards. The new rights plan provides, subject to certain exceptions that if any person or group acquires 4.9% or more of the Company's outstanding common stock, there would be a triggering event potentially resulting in significant dilution in the voting power and economic ownership of that person or group. Existing stockholders who hold 4.9% or more of the Company's outstanding common stock as of the date of the new rights plan will trigger a dilutive event only if they acquire an additional 1% of the outstanding shares of VIVUS common stock.   

    "The stockholder rights plan protects the interests of all stockholders from the possibility of losing potential substantial value through limitations on the Company's ability to utilize its net operating loss carryforwards under Section 382 of the Internal Revenue Code of 1986, as amended," said VIVUS Chief Executive Officer, John Amos. "The rights plan is not intended for defensive or antitakeover purposes, but to preserve stockholder value, and our Board of Directors believes it is in the best interests of VIVUS' stockholders."

    The new rights plan will continue in effect until December 30, 2022, unless earlier terminated or the rights are earlier exchanged or redeemed by the Board of Directors. The Company expects to submit the new rights plan to a vote at the Company's 2020 annual meeting of stockholders. If stockholders do not approve the plan at the 2020 annual meeting, it will expire at the close of business on the following day.

    Additional information with respect to the new stockholder rights plan will be contained in the Current Report on Form 8-K that the Company is filing with the Securities and Exchange Commission. A copy of the Form 8-K can be obtained at the SEC's Internet website at www.sec.gov.

    About VIVUS

    VIVUS is a biopharmaceutical 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 VIVUS, please visit www.vivus.com.

    Forward-Looking Statements

    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 May 2020; risk and uncertainties related to the timing, strategy, structure and success of our capital raising efforts; risks and uncertainties related to our expected future revenues, operations and expenditures; risks and uncertainties related to the impact of the indicated uses and contraindications contained in the Qsymia label and the Risk Evaluation and Mitigation Strategy requirements; risks and uncertainties related to the design and outcome of any clinical study required by the U.S. Food and Drug Administration to expand the Qsymia label for a binge eating indication; risks and uncertainties related to our, or our current or potential partners', ability to successfully commercialize Qsymia; risks and uncertainties related to our ability to sell through the Qsymia retail pharmacy network and the Qsymia Advantage Program; risks associated with the preservation of our net operating losses; risks associated with the difficulty of determining all of the facts relevant to Section 382 of the Internal Revenue Code of 1986, as amended (the "Code"); risks associated with soliciting and obtaining stockholder approval of the rights plan at the Company's 2020 annual meeting of stockholders; risks associated with the unreported buying and selling activity with respect to our common stock; risks associated with unanticipated interpretations of the Code and related regulations; the risk that the approval of the rights plan does not prevent one or more stockholders of the Company from, notwithstanding the dilution to such stockholder's interests under the plan, engaging in buying and selling activity that may have an adverse impact on the Company's tax attributes; risks associated with the ability of the rights plan to preserve the value of our net operating losses; risks associated with the enforceability of the rights plan under Delaware law or other applicable law; the risk that the rights plan may discourage third-party offers to acquire the Company, or an interest therein; and the risk that the rights plan may have an adverse effect on the value of our common stock. 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 VIVUS' Form 10-K for the year ended December 31, 2018 as filed on February 26, 2019, and periodic reports filed with the Securities and Exchange Commission. VIVUS does not undertake an obligation to update or revise any forward-looking statements.

    Contact:
    VIVUS, Inc.              
    Mark Oki                   
    Chief Financial Officer
              
    650-934-5200

    Lazar FINN Partners
    David Carey
    Senior Partner

    212-687-1768 

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  18. -Data published in Diabetes, Obesity and Metabolism demonstrate that Qsymia provides statistically significant weight loss compared with placebo over an 8 week period, provide basis for ongoing 56 week phase 4 study in obese adolescents-

    CAMPBELL, Calif., Dec. 18, 2019 (GLOBE NEWSWIRE) -- VIVUS, Inc. (NASDAQ:VVUS) (the "Company"), a biopharmaceutical company, today announced the results of a pharmacokinetic (PK) and pharmacodynamic (PD) study (NCT02714062) demonstrating that Qsymia® (phentermine and topiramate extended-release) capsules CIV has favorable pharmacokinetic, efficacy, and safety/tolerability profiles when used for eight weeks to treat adolescents with obesity.  The study was conducted in order to establish dosing levels for the…

    -Data published in Diabetes, Obesity and Metabolism demonstrate that Qsymia provides statistically significant weight loss compared with placebo over an 8 week period, provide basis for ongoing 56 week phase 4 study in obese adolescents-

    CAMPBELL, Calif., Dec. 18, 2019 (GLOBE NEWSWIRE) -- VIVUS, Inc. (NASDAQ:VVUS) (the "Company"), a biopharmaceutical company, today announced the results of a pharmacokinetic (PK) and pharmacodynamic (PD) study (NCT02714062) demonstrating that Qsymia® (phentermine and topiramate extended-release) capsules CIV has favorable pharmacokinetic, efficacy, and safety/tolerability profiles when used for eight weeks to treat adolescents with obesity.  The study was conducted in order to establish dosing levels for the ongoing Phase 4 post-marketing study of Qsymia in obese adolescents.  The results have been published online in Diabetes, Obesity and Metabolism.1

    "Over the past 30 years, childhood obesity has become an epidemic and continues to be a major public health concern, with obesity rates currently over 18% for those between the ages of 12 and 19 years based on U.S. government data2," said Daniel Hsia, MD, an adult/pediatric endocrinologist, Associate Professor at Pennington Biomedical Research Center and lead author on the publication. "Lifestyle-based interventions alone often show only a modest effect on long-term weight loss, and overweight and obese children have more comorbidities compared with children with normal weight.  Importantly, they are also five times more likely to become overweight or obese adults and have a higher risk of developing diabetes, hypertension, dyslipidemia, and coronary heart disease later in adulthood.  More effective treatment modalities are urgently needed to address childhood obesity."

    This randomized, double blind, placebo-controlled, study was conducted at four U.S. sites and enrolled 42 participants ages 12-17 years with a body-mass index (BMI) greater than or equal to the 95th percentile for age and sex.  The study consisted of a 14-day (maximum) screening period followed by a 56-day treatment period.  Eligible participants were randomly assigned in a 1:1:1 ratio to placebo, mid-dose Qsymia or top-dose Qsymia.  Within each active treatment arm, doses were titrated at two-week intervals starting with low dose Qsymia and increasing until the randomized dose was achieved. Participants assigned to placebo underwent a sham titration to ensure that both participants and site personnel remained blinded to treatment assignment. The primary objective of the study was to describe the PK profiles of Qsymia after administration in adolescents with obesity. 

    Key findings from the study include:

    • The study authors conclude that both the mid- and top-doses of Qsymia evaluated in this study are appropriate for longer-term safety and efficacy study in adolescents.
    • PK analyses were conducted in 26 patients in the Qsymia groups (14 mid-dose and 12 top-dose), and results show that exposure to the mid- and top-dose Qsymia groups was comparable to that observed in prior studies of Qsymia in overweight and obese adults.
    • Significant differences from baseline to Day 56 were observed with respect to mean percentage change in weight for both Qsymia groups compared with placebo (-3.72%, -4.96% and +1.06% for the mid- and top-dose Qsymia groups and placebo group, respectively); and for mean change in waist circumference and hunger scores for the top-dose Qsymia group compared with placebo (-2.8 cm, -4.9 cm, and +0.3 cm for the mid- and top-dose Qsymia groups and placebo group, respectively).
    • Treatment emergent adverse events were reported in 54.8% of the 42 patients who entered the trial; specific events reported by two or more subjects included headache, paresthesia, hypoesthesia, dry mouth, decreased appetite, and insomnia.  All of these have been observed in previous studies with Qsymia.
    • Of the 42 patients enrolled, 37 (88.1%) completed the study, indicating tolerability of Qsymia.  

    "These findings add to the growing body of data supporting the safety and clinical benefit of Qsymia in diverse patient populations," said John Amos, Chief Executive Officer at VIVUS.  "Currently, there is only one approved weight loss drug for patients age 12 years and older and, while it effectively lowers BMI, its side effect profile of gastrointestinal distress has limited its clinical use. The data reported today suggest that Qsymia could be an important treatment option in this patient population, and our ongoing Phase 4 trial of Qsymia, if successful, could support label expansion to include adolescents who are overweight or obese." 

    In May 2019, VIVUS initiated a Phase 4 post-marketing study, which the U.S. Food and Drug Administration (FDA) required as part of the approval of Qsymia in 2012. The study is expected to enroll 200 participants at approximately 20 clinical sites in the United States.  The primary endpoint of the randomized, double blind, placebo-controlled, parallel-design study is the mean percentage change in body-mass index (BMI) in patients randomized 1:1:2 to daily mid- or top-dose Qsymia compared with placebo over 56 weeks of treatment.  Participants will also be instructed to follow a reduced-calorie diet and to implement a family-based lifestyle modification program that includes physical activity, behavioral change and family support. Safety and tolerability of Qsymia will also be assessed.  To date, 98 patients have been enrolled and randomized.

    References

    1 Hsia DS, Gosselin N, Williams J, Farhat N, Marier JF, Shih W, et al. A randomized, double-blind, placebo-controlled, pharmacokinetic and pharmacodynamic study of a fixed-dose combination of phentermine/topiramate in adolescents with obesity. Diabetes, Obesity and Metabolism. doi: 10.1111/dom.13910.

    2 Hales CM, Fryar CD, Carroll MD, Freedman DS and Ogden CL. Trends in obesity and severe obesity prevalence in US youth and adults by sex and age, 2007-2008 to 2015-2016. JAMA. 2018;319(16):1723-1725.

    About Qsymia

    Qsymia is approved in the United States 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; 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.

    About VIVUS

    VIVUS is a biopharmaceutical 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 VIVUS, please visit www.vivus.com.

    Forward-Looking Statements

    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 May 2020; risk and uncertainties related to the timing, strategy, structure and success of our capital raising efforts; risks and uncertainties related to our expected future revenues, operations and expenditures; risks and uncertainties related to the impact of the indicated uses and contraindications contained in the Qsymia label and the Risk Evaluation and Mitigation Strategy requirements; risks and uncertainties related to the timing of initiation and completion of the post-approval clinical studies required as part of the approval of Qsymia by the U.S. Food and Drug Administration ("FDA"), including Phase 4 post-marketing study of Qsymia in obese adolescents; risks and uncertainties related to the response from FDA to any data and/or information relating to post-approval clinical studies required for Qsymia; risks and uncertainties related to the impact of any possible future requirement to provide further analysis of previously submitted clinical trial data; risks and uncertainties related to the design and outcome of any clinical study required by FDA to expand the Qsymia label; risks and uncertainties related to our, or our current or potential partners', ability to successfully commercialize Qsymia; and risks and uncertainties related to our ability to sell through the Qsymia retail pharmacy network and the Qsymia Advantage Program. 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 VIVUS' Form 10-K for the year ended December 31, 2018 as filed on February 26, 2019, and periodic reports filed with the Securities and Exchange Commission. VIVUS does not undertake an obligation to update or revise any forward-looking statements.

    VIVUS, Inc.
    Mark Oki
    Chief Financial Officer
     
    650-934-5200
    Investor Relations: Lazar FINN Partners
    David Carey
    Senior Partner
     
    212-867-1768

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  19. CAMPBELL, Calif., Nov. 25, 2019 (GLOBE NEWSWIRE) -- VIVUS, Inc. (NASDAQ:VVUS) (the "Company"), a biopharmaceutical company, today announced that John Amos, Chief Executive Officer at VIVUS, will present at the Piper Jaffray 31st Annual Healthcare Conference at 1:10 P.M. ET on Tuesday, December 3, 2019 in New York.

    An audio webcast of the presentation will be available in the events and presentations section of the Company's investor relations website, or by clicking here.

    About VIVUS

    VIVUS is a biopharmaceutical 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

    CAMPBELL, Calif., Nov. 25, 2019 (GLOBE NEWSWIRE) -- VIVUS, Inc. (NASDAQ:VVUS) (the "Company"), a biopharmaceutical company, today announced that John Amos, Chief Executive Officer at VIVUS, will present at the Piper Jaffray 31st Annual Healthcare Conference at 1:10 P.M. ET on Tuesday, December 3, 2019 in New York.

    An audio webcast of the presentation will be available in the events and presentations section of the Company's investor relations website, or by clicking here.

    About VIVUS

    VIVUS is a biopharmaceutical 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.

    Forward-Looking Statements

    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. VIVUS does not undertake an obligation to update or revise any forward-looking statements. Investors should read the risk factors set forth in VIVUS' Form 10-K for the year ended December 31, 2018 as filed on February 26, 2019, and periodic reports filed with the Securities and Exchange Commission. VIVUS does not undertake an obligation to update or revise any forward-looking statements.

    Contact:

    VIVUS, Inc. Lazar FINN Partners
    Mark Oki David Carey
    Chief Financial Officer Senior Partner
    650-934-5200 212-687-1768

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  20. -Data published in International Journal of Eating Disorders show patients in the Qsymia group had 75% decrease in binge day frequency compared with 19% for placebo-

    CAMPBELL, Calif., Nov. 20, 2019 (GLOBE NEWSWIRE) -- VIVUS, Inc. (NASDAQ:VVUS) (the "Company"), a biopharmaceutical company, today announced the results of a clinical study (NCT02553824) demonstrating that patients with binge-eating disorder (BED) or bulimia nervosa (BN) receiving Qsymia (phentermine and topiramate extended-release (ER)) capsules CIV had a significant reduction in binge day frequency compared with placebo over four weeks.  Additionally, Qsymia was well tolerated in these patient populations. The study results appear online in the International Journal of Eating

    -Data published in International Journal of Eating Disorders show patients in the Qsymia group had 75% decrease in binge day frequency compared with 19% for placebo-

    CAMPBELL, Calif., Nov. 20, 2019 (GLOBE NEWSWIRE) -- VIVUS, Inc. (NASDAQ:VVUS) (the "Company"), a biopharmaceutical company, today announced the results of a clinical study (NCT02553824) demonstrating that patients with binge-eating disorder (BED) or bulimia nervosa (BN) receiving Qsymia (phentermine and topiramate extended-release (ER)) capsules CIV had a significant reduction in binge day frequency compared with placebo over four weeks.  Additionally, Qsymia was well tolerated in these patient populations. The study results appear online in the International Journal of Eating Disorders.

    "Dropout rates for the two pharmacologic therapies approved for BED and BN range from 20 to 30 percent and many patients using these medications remain symptomatic, underscoring the need for alternative therapeutic approaches," said Santosh T. Varghese, MD, Chief Medical Officer at VIVUS.  "The promising results announced today, along with previously reported data from another study evaluating Qsymia in BED, suggest that Qsymia could address an unmet treatment need in BED and BN and support further investigation of Qsymia as a treatment option for these serious medical conditions."

    The randomized, double blind, placebo-controlled, crossover study enrolled 22 patients (BED=18 and BN=4) who were randomized to Qsymia (n=12, 3.75/23 mg phentermine [PHEN]/topiramate [TPM]-ER – 15 mg PHEN/92 mg TPM-ER) or placebo (n=10) for 12 weeks.  The mean baseline body mass index for the 22 was 31.1 kg/m2.  Following a two-week washout, patients crossed over to the other arm for 12 weeks. The primary outcome was the number of objective binge-eating (OBE) days over four weeks; secondary outcomes included binge abstinence. Demographics, vital signs, eating disorder behaviors, mood and side effect data were also collected.

    Key findings from the study include:

    • Mean OBE days over four weeks was 16.2 at baseline and decreased to 4.2 days and 13.2 days following Qsymia treatment and placebo, respectively (p < .0001).
    • Abstinence rates were 63.6% with Qsymia and 9.1% with placebo (p < .0001).
    • Qsymia was associated with a mean decrease in weight of 5.8 kg, compared with a mean gain of 0.4 kg on placebo.
    • There was a significant improvement in secondary measures assessing eating disordered related pathologies and comorbid mood symptoms and marked improvements in depressive symptoms were also observed in patients receiving Qsymia compared to placebo.
    • No serious adverse events were reported. Patient-reported adverse events while on Qsymia were dry mouth (52.4% of patients), insomnia (28.6%), paresthesia (28.6%), dysgeusia (23.8%), anxiety (14.3%), nausea, cold intolerance, decreased appetite, dizziness, fatigue, hair loss and difficulty finding words (9.5% each).
    • Dropout rates were the same between the Qsymia and placebo groups (9%).
    • Blood pressure and heart rate changes with Qsymia were minimal and similar to placebo.
    • Responses were not significantly different for BED versus BN.
    • Binge eating returned and abstinence rates decreased during the eight-week post-treatment follow-up period, suggesting that additional approaches to improved maintenance are needed.

    "These data further validate the clinical utility of Qsymia in helping patients with a variety of weight-related health conditions to achieve healthier eating behaviors," said John Amos, Chief Executive Officer at VIVUS.  "A growing body of data demonstrates that Qsymia has an excellent safety profile in diverse patient populations and that it may offer clinical benefit across a wide spectrum of weight- and eating-related health conditions." 

    About Qsymia

    Qsymia is approved in the United States 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; 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.

    About VIVUS

    VIVUS is a biopharmaceutical 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 VIVUS, please visit www.vivus.com.

    Forward-Looking Statements

    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 May 2020; risk and uncertainties related to the timing, strategy, structure and success of our capital raising efforts; risks and uncertainties related to our expected future revenues, operations and expenditures; risks and uncertainties related to the impact of the indicated uses and contraindications contained in the Qsymia label and the Risk Evaluation and Mitigation Strategy requirements; risks and uncertainties related to the design and outcome of any clinical study required by the U.S. Food and Drug Administration to expand the Qsymia label for a binge eating indication; risks and uncertainties related to our, or our current or potential partners', ability to successfully commercialize Qsymia; and risks and uncertainties related to our ability to sell through the Qsymia retail pharmacy network and the Qsymia Advantage Program. 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 VIVUS' Form 10-K for the year ended December 31, 2018 as filed on February 26, 2019, and periodic reports filed with the Securities and Exchange Commission. VIVUS does not undertake an obligation to update or revise any forward-looking statements.

    VIVUS, Inc. Investor Relations: Lazar FINN Partners
    Mark Oki David Carey
    Chief Financial Officer Senior Partner
    650-934-5200 212-867-1768

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  21. CAMPBELL, Calif., Nov. 05, 2019 (GLOBE NEWSWIRE) -- VIVUS, Inc. (NASDAQ:VVUS) (the "Company"), a specialty pharmaceutical company committed to the development and commercialization of innovative therapies focusing on treatments for patients with serious unmet medical needs, today reported financial results for the quarter ended September 30, 2019 and provided a business update.

    "The strategies that we have implemented over the past several quarters continue to gain traction, as evidenced by growing patient adoption rates from our Qsymia Advantage Program, which increased 170% in prescriptions in the third quarter compared with the second quarter," said John Amos, VIVUS' Chief Executive Officer. "As we implement our plan to expand the U.S…

    CAMPBELL, Calif., Nov. 05, 2019 (GLOBE NEWSWIRE) -- VIVUS, Inc. (NASDAQ:VVUS) (the "Company"), a specialty pharmaceutical company committed to the development and commercialization of innovative therapies focusing on treatments for patients with serious unmet medical needs, today reported financial results for the quarter ended September 30, 2019 and provided a business update.

    "The strategies that we have implemented over the past several quarters continue to gain traction, as evidenced by growing patient adoption rates from our Qsymia Advantage Program, which increased 170% in prescriptions in the third quarter compared with the second quarter," said John Amos, VIVUS' Chief Executive Officer. "As we implement our plan to expand the U.S. market for Qsymia, we are also making significant strides toward unlocking its full global potential, having recently obtained marketing approval in the Republic of Korea and having our Marketing Authorization Application for Qsymia accepted on a decentralized basis in Europe. The initiation of our strategy for reducing our corporate debt is helping to improve our capital structure, while providing us with financial flexibility to advance the growth opportunities for both Qsymia and PANCREAZE."

    Recent Business Highlights

    • Qsymia® Marketing Authorization Application (MAA) Accepted on a Decentralized Basis
      In September 2019, the European regulatory agencies in Sweden, Denmark, Finland, Iceland, Norway, and Poland (the "Concerned Member States") accepted the MAA for Qsymia (phentermine and topiramate extended-release) on a decentralized basis, with Sweden acting as the lead Concerned Member State, also known as the Reference Member State, for purposes of assessing the MAA.
    • Qsymia Approved in the Republic of Korea
      In August 2019, VIVUS announced that its Korean marketing partner, Alvogen Malta Operations (ROW) Ltd, obtained marketing approval for Qsymia from the South Korea Ministry of Food and Drug Safety (MFDS).
    • Released Results of a Pilot Study with Qsymia and Laparoscopic Sleeve Surgery
      In August 2019, VIVUS announced the results of a pilot clinical study demonstrating that patients receiving Qsymia before and after laparoscopic sleeve gastrectomy surgery lost more weight and had a greater probability of achieving a body mass index of less than 40 compared with patients undergoing surgery alone without anti-obesity medication. The study was conducted at the Wake Forest School of Medicine and the results appear in the current issue of Surgery for Obesity and Related Diseases.
    • Reduced Debt and Interest Expense
      In September 2019, VIVUS paid down $48.6 million of its Senior Secured Notes due 2024 resulting in savings of $10.5 million due to a reduction in interest payments over the remaining term of the loan. 

    2019 Third Quarter vs 2019 Second Quarter Financial Results

    Revenue consisted of the following:

        (In thousands)
    Three Months Ended
     
        September 30,
    2019
      June 30,
    2019
     
    Qsymia net product revenue   $ 9,583   $ 9,994  
    Milestone revenue     2,500     -  
    PANCREAZE/PANCREASE MT, net product revenue     5,266     5,110  
    Supply revenue     64     1,780  
    Royalty revenue     557     1,506  
      Total revenue    $ 17,970   $ 18,390  

    Qsymia net product revenue was $9.6 million and $10.0 million in the third and second quarters of 2019, respectively. In both the third and second quarters of 2019, approximately 86,000 prescriptions were dispensed. The Company continues to migrate Qsymia patients from a traditional retail pharmacy model to the Qsymia Advantage Program that is expected to improve access to Qsymia through, among other things, direct-to-patient distribution and improved pricing. During the third quarter, 22% of Qsymia scripts were dispensed through the Qsymia Advantage Program's Direct-to-Patient model, up from 8% and less than 2% in the second and first quarters of 2019, respectively.

    Milestone revenue represents the payment received related to Alvogen, VIVUS' Korean marketing partner, obtaining marketing approval for Qsymia from the South Korea MFDS.

    PANCREAZE® net product revenue was $5.3 million and $5.1 million in the third and second quarters of 2019, respectively. In the third quarter, this amount includes $0.1 million related to Canadian sales of PANCREASE® MT. Prior to the third quarter, the Company received a royalty on Canadian sales. The Company currently has a dedicated 10-person sales force, sampling program, full patient support program, a plan for investigator-sponsored trials in oncology, a digital marketing campaign strategy, along with a number of other enhancements.

    Supply revenue consists of sales of STENDRA®/SPEDRA to our licensees for sales in the EU and U.S. Supply revenue varies based on the timing of orders from our licensees and consists of minimum order requirements and such purchases do not correspond to end user demand.

    Royalty revenue was $0.6 million and $1.5 million in the third and second quarters of 2019, respectively. Third quarter 2019 royalty revenue consisted of royalties earned on SPEDRA European revenues. Second quarter 2019 royalty revenue consisted of $1.0 million of royalties on PANCREASE MT Canadian revenue and $0.5 million of royalties on SPEDRA European revenues. In the third quarter, the Company assumed commercial responsibility for PANCREASE MT and began recording sales of PANCREASE MT as net product revenue.

    Total cost of goods sold excluding amortization was $3.0 million and $4.4 million in the third and second quarters of 2019, respectively. The decrease was primarily due to no STENDRA supply revenue in the third quarter. Supply revenue varies based on the timing of orders by our commercial partners.

    Amortization of intangible assets was $3.6 million in both the third and second quarters of 2019. The amount primarily consisted of amortization expense of costs capitalized related to the acquisition of PANCREAZE.

    Selling, general and administrative expense was $9.2 million and $10.1 million for the third and second quarters of 2019, respectively, and included selling and marketing expense of $4.5 million and $4.6 million, respectively. VIVUS expects selling, general and administrative expenses to fluctuate with business development activities.

    Research and development expense was $3.3 million and $2.4 million in the third and second quarters of 2019, respectively. In 2019, research and development efforts primarily consisted of activities related to the Qsymia adolescent and efficacy study (OB-0403), PANCREAZE post-marketing requirements assumed from Janssen and ongoing PANCREAZE product improvement initiatives.

    Total interest and other expense was $9.9 million and $3.9 million in the third and second quarters of 2019, respectively. The increase in interest expense in the third quarter was due to prepayment premiums related to the reduction in debt balances.

    Net loss for the third and second quarters of 2019 was $11.1 million and $5.9 million, respectively. Cash, cash equivalents and available-for-sale securities were $40.1 million at September 30, 2019.

    Non-GAAP EBITDA for the third and second quarters of 2019 was $3.0 million and $2.1 million, respectively. Excluding the Qsymia milestone revenue and certain professional fees related to our debt buyback, recurring non-GAAP EBITDA was $1.2 million for the third quarter of 2019.

    Conference Call Details

    VIVUS will hold a conference call and an audio webcast to provide a business update and to discuss third quarter 2019 financial results today, November 5, 2019, beginning at 4:30 PM Eastern Time. Investors may listen to this call by dialing toll-free (877) 359-2916 in the U.S. and (224) 357-2386 from outside the U.S. The audience passcode is 2467905. A webcast replay will be available for 30 days and may be accessed at http://ir.vivus.com/events-and-presentations.

    About Qsymia

    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.

    About PANCREAZE

    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 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 subsidiaries to commercialize and promote SPEDRA for the treatment of erectile dysfunction in over 40 European countries plus Australia and New Zealand.

    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.

    About VIVUS

    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.

    Forward-Looking Statements

    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 May 2020; risk and uncertainties related to the timing, strategy, structure and success of our capital raising efforts; 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, including our ability to improve patient access to PANCREAZE; risks and uncertainties related to our commercialization of PANCREAZE as a new product and our 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, including our ability to improve patient and physician access to Qsymia; risks and uncertainties related to the impact of promotional programs for Qsymia on our net product revenue and net income (loss) in future periods; risks and uncertainties related to our ability to sell through the Qsymia retail pharmacy network and the Qsymia Advantage Program; 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 demonstrate through clinical testing the quality, safety, and efficacy of our current or future investigational drug candidates or approved products; 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 FDA to significantly reduce or remove the requirements of the clinical post-approval cardiovascular outcomes trial ("CVOT"); risks and uncertainties related to our dialog with certain concerned member states in Europe relating to the pending decentralized Marketing Authorization Application, the timing and scope of the assessment by such Concerned Member State health authorities of our Marketing Authorization Application, and ultimately the decision of such Concerned Member State health authorities whether to grant Marketing Authorization for Qsymia in such EU countries; risks and uncertainties related to the failure to obtain FDA or foreign authority clearances or approvals and noncompliance with FDA or foreign authority regulations; and risks and uncertainties related to the impact, if any, of changes to our Board of Directors and senior management team. 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 VIVUS' Form 10-K for the year ended December 31, 2018 as filed on February 26, 2019, and periodic reports filed with the Securities and Exchange Commission. VIVUS does not undertake an obligation to update or revise any forward-looking statements.

    VIVUS, Inc. Investor Relations: Lazar FINN Partners
    Mark Oki  David Carey
    Chief Financial Officer Senior Partner
     
    650-934-5200  212-867-1768

     

                                                       

    VIVUS, INC.
    CONDENSED CONSOLIDATED BALANCE SHEETS
    (In thousands, except par value)

               
      September 30,    December 31, 
      2019     2018  
        Unaudited      
    ASSETS          
    Current assets:          
    Cash and cash equivalents $ 40,113     $  30,411  
    Available-for-sale securities    —        80,838  
    Accounts receivable, net   24,065        25,608  
    Inventories   30,008        23,132  
    Prepaid expenses and other current assets   6,979        7,538  
    Total current assets   101,165        167,527  
    Property and equipment, net   273        341  
    Right-of-use assets   1,299        —  
    Intangible and other non-current assets   123,366        134,279  
    Total assets $ 226,103     $  302,147  
    LIABILITIES AND STOCKHOLDERS' DEFICIT          
    Current liabilities:          
    Accounts payable $ 6,159     $  8,921  
    Accrued and other liabilities   34,304        33,044  
    Deferred revenue   1,251        1,235  
    Current portion of lease liability   768        —  
    Current portion of long-term debt   184,190        —  
    Total current liabilities   226,672        43,200  
    Long-term debt, net of current portion   58,538        294,446  
    Deferred revenue, net of current portion   3,376        4,290  
    Lease liability, net of current portion   788        —  
    Non-current accrued and other liabilities    —        234  
    Total liabilities   289,374        342,170  
    Commitments and contingencies          
    Stockholders' deficit:          
    Preferred stock; $.001 par value; 5,000 shares authorized; no shares issued and outstanding at September 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 September 30, 2019 and December 31, 2018, respectively   11        11  
    Additional paid-in capital   842,185        840,751  
    Accumulated other comprehensive loss   (6 )      (270 )
    Accumulated deficit   (905,461 )      (880,515 )
    Total stockholders' deficit   (63,271 )      (40,023 )
    Total liabilities and stockholders' deficit $ 226,103     $  302,147  


    VIVUS, INC.
    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
    (In thousands, except per share data)
    (Unaudited)

               
      Three Months Ended
      September 30,
    2019
      June 30,
    2019
    Revenue:          
    Net product revenue $ 14,849   $ 15,104
    Milestone revenue   2,500      —
    Supply revenue   64     1,780
    Royalty revenue   557     1,506
    Total revenue   17,970     18,390
               
    Operating expenses:          
    Cost of goods sold (excluding amortization)   3,016     4,377
    Amortization of intangible assets   3,638     3,638
    Selling, general and administrative   9,207     10,070
    Research and development   3,266     2,352
    Total operating expenses   19,127     20,437
               
    Loss from operations   (1,157)     (2,047)
               
    Interest expense and other expense, net   9,911     3,880
    Loss before income taxes   (11,068)     (5,927)
    Provision for income taxes   4     8
    Net loss $ (11,072)   $ (5,935)
               
    Basic and diluted net loss per share: $ (1.04)   $ (0.56)
    Shares used in per share computation:          
    Basic and diluted   10,643     10,640


    VIVUS, INC.
    GAAP to NON-GAAP RECONCILIATION
    NET LOSS to EBITDA
    (In thousands)
    (Unaudited)

    A reconciliation between net loss on a GAAP basis and non-GAAP EBITDA is as follows:

      Three Months Ended  
      September 30,
    2019
      June 30,
    2019
     
    Net loss $ (11,072)   $ (5,935)  
    Adjustments:            
    Interest expense and other expense, net   9,911      3,880   
    Depreciation of fixed assets   36      37   
    Amortization of intangible assets   3,638      3,638   
    Share-based compensation expense   483      467   
    Provision for income taxes        
    Non-GAAP EBITDA $ 3,000    $ 2,095   
    Milestone revenue   (2,500)     —   
    Fees from debt buy down   656      —   
    Non-GAAP recurring EBITDA $ 1,156    $ 2,095   

    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 SEC rules. We believe that the disclosure of this non-GAAP measure provides investors with additional information that reflects the basis upon which our management assesses and operates our business. This non-GAAP financial measure is not in accordance with GAAP and should not be viewed in isolation or as a substitute for GAAP net loss and is not a substitute for, or superior to, measures of financial performance performed in conformity with GAAP.

    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.

     

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  22. CAMPBELL, Calif., Oct. 28, 2019 (GLOBE NEWSWIRE) -- VIVUS, Inc. (NASDAQ:VVUS) (the "Company"), a biopharmaceutical company, announced today that Eric W. Roberts and Allan L. Shaw have resigned from its Board of Directors and all of its committees in order to increase their focus on other personal business interests. Mr. Roberts and Mr. Shaw joined the Board of Directors in September 2015. The Company does not intend to replace either of them at this time, resulting in a total of seven directors, including six independent members. 

    "Serving as a director on the Board of a publicly traded company, especially one that is significantly transforming its business model and continually evaluating its complex capital structure, is a substantial time…

    CAMPBELL, Calif., Oct. 28, 2019 (GLOBE NEWSWIRE) -- VIVUS, Inc. (NASDAQ:VVUS) (the "Company"), a biopharmaceutical company, announced today that Eric W. Roberts and Allan L. Shaw have resigned from its Board of Directors and all of its committees in order to increase their focus on other personal business interests. Mr. Roberts and Mr. Shaw joined the Board of Directors in September 2015. The Company does not intend to replace either of them at this time, resulting in a total of seven directors, including six independent members. 

    "Serving as a director on the Board of a publicly traded company, especially one that is significantly transforming its business model and continually evaluating its complex capital structure, is a substantial time commitment, and we appreciate the substantive contributions that Eric and Allan have made to VIVUS over the past four years," said David Y. Norton, Chairman of VIVUS' Board of Directors. "I thank them for their service on behalf of the directors and the Company's management team, and wish them well in their personal endeavors."

    Forward-Looking Statements

    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 expected future revenues, operations and expenditures; risks and uncertainties related to our, or our current or potential partners', ability to successfully commercialize Qsymia; risks and uncertainties related to our ability to sell through the Qsymia retail pharmacy network and the Qsymia Advantage Program; risks and uncertainties related to the timing, strategy, tactics and success of the marketing and sales of PANCREAZE; risk and uncertainties related to the timing, strategy, structure and success of our capital raising efforts; and risks and uncertainties related to the impact, if any, of changes to our Board of Directors and senior management team. 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 VIVUS' Form 10-K for the year ended December 31, 2018 as filed on February 26, 2019, and periodic reports filed with the Securities and Exchange Commission. VIVUS does not undertake an obligation to update or revise any forward-looking statements.

    VIVUS, Inc. 
    Mark Oki 
    Chief Financial Officer

    650-934-5200
    Investor Relations: Lazar FINN Partners
    David Carey
    Senior Partner

    212-867-1768

        
                                                      

     

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  23. CAMPBELL, Calif., Oct. 22, 2019 (GLOBE NEWSWIRE) -- VIVUS, Inc. (NASDAQ:VVUS) today announced that it will report financial results and provide a business update for the third quarter of 2019 after the market close on Tuesday, November 5, 2019. The company will host a conference call beginning at 4:30 p.m. ET / 1:30 p.m. PT the same day to review results and provide a business update.

    To listen via webcast, please visit http://ir.vivus.com/, or by clicking here.

    To listen via phone, please use the dial in information provided below.

    Dial in Details:
    Toll-Free: (877) 359-2916
    International: (224) 357-2386
    Passcode: 2467905

    A webcast replay will be available on the VIVUS website for 30 days.

    About VIVUS
    VIVUS is a biopharmaceutical company committed…

    CAMPBELL, Calif., Oct. 22, 2019 (GLOBE NEWSWIRE) -- VIVUS, Inc. (NASDAQ:VVUS) today announced that it will report financial results and provide a business update for the third quarter of 2019 after the market close on Tuesday, November 5, 2019. The company will host a conference call beginning at 4:30 p.m. ET / 1:30 p.m. PT the same day to review results and provide a business update.

    To listen via webcast, please visit http://ir.vivus.com/, or by clicking here.

    To listen via phone, please use the dial in information provided below.

    Dial in Details:
    Toll-Free: (877) 359-2916
    International: (224) 357-2386
    Passcode: 2467905

    A webcast replay will be available on the VIVUS website for 30 days.

    About VIVUS
    VIVUS is a biopharmaceutical 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 VIVUS, please visit www.vivus.com.

    Forward-Looking Statements

    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. VIVUS does not undertake an obligation to update or revise any forward-looking statements. Investors should read the risk factors set forth in VIVUS' Form 10-K for the year ended December 31, 2018 as filed on February 26, 2019, and periodic reports filed with the Securities and Exchange Commission. VIVUS does not undertake an obligation to update or revise any forward-looking statements.

    CONTACT:

    VIVUS, Inc.               
    Mark Oki                    
    Chief Financial Officer
              
    650-934-5200

    Investor Relations: Lazar FINN Partners
    David Carey
    Senior Partner
    finnpartners.com
    212-687-1768

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  24. CAMPBELL, Calif., Oct. 21, 2019 (GLOBE NEWSWIRE) -- VIVUS, Inc. (NASDAQ:VVUS) (the "Company"), a biopharmaceutical company, announced today that John Amos, Chief Executive Officer, will participate in a panel discussion at the Cleveland Clinic 2019 Medical Innovation Summit, which is taking place October 21 – 23 in Cleveland. The panel discussion, titled "Beneath the Epidemic. Treating Obesity." will be held on Tuesday, October 22 at 2:35 PM ET at Upper Concourse, Room 4.

    "The rapidly growing obesity epidemic is becoming a greater threat to the long term health of the global population, resulting in lower quality of life, greater medical challenges and higher out-of-pocket insurance costs," said John Amos, Chief Executive Officer of VIVUS…

    CAMPBELL, Calif., Oct. 21, 2019 (GLOBE NEWSWIRE) -- VIVUS, Inc. (NASDAQ:VVUS) (the "Company"), a biopharmaceutical company, announced today that John Amos, Chief Executive Officer, will participate in a panel discussion at the Cleveland Clinic 2019 Medical Innovation Summit, which is taking place October 21 – 23 in Cleveland. The panel discussion, titled "Beneath the Epidemic. Treating Obesity." will be held on Tuesday, October 22 at 2:35 PM ET at Upper Concourse, Room 4.

    "The rapidly growing obesity epidemic is becoming a greater threat to the long term health of the global population, resulting in lower quality of life, greater medical challenges and higher out-of-pocket insurance costs," said John Amos, Chief Executive Officer of VIVUS. "We believe that VIVUS is uniquely positioned to play a critical role in providing integrated solutions that utilize both BMI therapeutics as well as information solutions. Qsymia is clinically proven to help patients achieve and maintain a healthy body mass index, and our innovative VIVUS Health Platform is enabling more patients to access and adhere to effective treatment. VIVUS is honored and humbled to have the opportunity to showcase our unique and innovative approach to addressing the obesity epidemic at a world renowned healthcare center such as the Cleveland Clinic."

    About Qsymia

    Qsymia is approved in the United States 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; 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.

    About VIVUS

    VIVUS is a biopharmaceutical 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, please visit www.vivus.com.

    Forward-Looking Statements

    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 expected future revenues, operations and expenditures; risks and uncertainties related to our, or our current or potential partners', ability to successfully seek and gain approval for Qsymia in territories outside the U.S.; risks and uncertainties related to our, or our current or potential partners', ability to successfully commercialize Qsymia; risks and uncertainties related to our dialog with certain concerned member states in Europe relating to the pending decentralized Marketing Authorization Application, the timing and scope of the assessment by such Concerned Member State health authorities of our Marketing Authorization Application, and ultimately the decision of such Concerned Member State health authorities whether to grant Marketing Authorization for Qsymia in such EU countries; our ability to work with the U.S. Food and Drug Administration to significantly reduce or remove the requirements of the clinical post-approval cardiovascular outcomes trial; and risks and uncertainties related to our ability to sell through the Qsymia retail pharmacy network and the Qsymia Advantage Program. 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 VIVUS' Form 10-K for the year ended December 31, 2018 as filed on February 26, 2019, and periodic reports filed with the Securities and Exchange Commission. VIVUS does not undertake an obligation to update or revise any forward-looking statements.

    VIVUS, Inc. Investor Relations: Lazar FINN Partners
    Mark Oki David Carey
    Chief Financial Officer  Senior Partner
    650-934-5200 212-867-1768

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  25. CAMPBELL, Calif., Oct. 07, 2019 (GLOBE NEWSWIRE) -- VIVUS, Inc. (NASDAQ:VVUS) (the "Company"), a biopharmaceutical company, announced today that European regulatory agencies in Sweden, Denmark, Finland, Iceland, Norway, and Poland (the "Concerned Member States") have accepted the Marketing Authorization Application (the "MAA") for Qsymia (phentermine and topiramate extended-release) on a decentralized basis, with Sweden acting as the lead Concerned Member State, also known as the Reference Member State, for purposes of assessing the MAA. Under the decentralized MAA procedure, the regulatory authorities in each of the Concerned Member States may simultaneously provide Marketing Authorization for use of a product within those specific countries…

    CAMPBELL, Calif., Oct. 07, 2019 (GLOBE NEWSWIRE) -- VIVUS, Inc. (NASDAQ:VVUS) (the "Company"), a biopharmaceutical company, announced today that European regulatory agencies in Sweden, Denmark, Finland, Iceland, Norway, and Poland (the "Concerned Member States") have accepted the Marketing Authorization Application (the "MAA") for Qsymia (phentermine and topiramate extended-release) on a decentralized basis, with Sweden acting as the lead Concerned Member State, also known as the Reference Member State, for purposes of assessing the MAA. Under the decentralized MAA procedure, the regulatory authorities in each of the Concerned Member States may simultaneously provide Marketing Authorization for use of a product within those specific countries.

    "With the growing body of real world evidence supporting the safety and efficacy of Qsymia and its recent approval in the Republic of Korea, we believe that there is growing recognition of the benefit that this therapy can provide to patients seeking to achieve and maintain a healthy body mass index," said John Amos, Chief Executive Officer of VIVUS. "As we gain traction in capturing a growing share of the market for weight management therapies in the United States, we continue to work with international regulators and current or potential commercial partners to expand Qsymia into additional countries. We believe that Qsymia has an important role to play in addressing the growing challenge of obesity in the United States, Europe, and other markets."

    Based on the decentralized MAA procedure timelines, the Company anticipates the completion of the MAA assessment and, if approved, Marketing Authorizations to begin in the second half of 2020.

    About Qsymia

    Qsymia is approved in the United States 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; 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.

    About VIVUS

    VIVUS is a biopharmaceutical 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, please visit www.vivus.com.

    Forward-Looking Statements

    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 expected future revenues, operations and expenditures; risks and uncertainties related to our dialog with certain concerned member states in Europe relating to the pending decentralized Marketing Authorization Application, the timing and scope of the assessment by such Concerned Member State health authorities of our Marketing Authorization Application, and ultimately the decision of such Concerned Member State health authorities whether to grant Marketing Authorization for Qsymia in such EU countries; risks and uncertainties related to our, or our current or potential partners', ability to successfully seek and gain approval for Qsymia in territories outside the U.S.; risks and uncertainties related to our, or our current or potential partners', ability to successfully commercialize Qsymia; and risks and uncertainties related to our ability to sell through the Qsymia retail pharmacy network and the Qsymia Advantage Program. 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 VIVUS' Form 10-K for the year ended December 31, 2018 as filed on February 26, 2019, and periodic reports filed with the Securities and Exchange Commission. VIVUS does not undertake an obligation to update or revise any forward-looking statements.


     VIVUS, Inc.
    Mark Oki   
    Chief Financial Officer
       
    650-934-5200
       Investor Relations: Lazar FINN Partners
    David Carey
    Senior Partner
     
    212-867-1768
     

                  

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  26. -Reduction of $48.6 million of Secured Debt will result in total interest savings of $10.5 million-
    -Organizational change streamlines commercial operations-

    CAMPBELL, Calif., Oct. 03, 2019 (GLOBE NEWSWIRE) -- VIVUS, Inc. (NASDAQ:VVUS) (the "Company"), a biopharmaceutical company, announced today that it has paid down $48.6 million of its Senior Secured Notes due 2024.  This debt reduction will result in savings of $10.5 million due to a reduction in interest payments over the remaining term of the loan.  

    "As we are executing the ten-quarter turnaround plan of VIVUS, an essential component of such plan is to address our total debt," said John Amos, Chief Executive Officer at VIVUS.  "Accordingly, we intend to actively manage our capital structure…

    -Reduction of $48.6 million of Secured Debt will result in total interest savings of $10.5 million-
    -Organizational change streamlines commercial operations-

    CAMPBELL, Calif., Oct. 03, 2019 (GLOBE NEWSWIRE) -- VIVUS, Inc. (NASDAQ:VVUS) (the "Company"), a biopharmaceutical company, announced today that it has paid down $48.6 million of its Senior Secured Notes due 2024.  This debt reduction will result in savings of $10.5 million due to a reduction in interest payments over the remaining term of the loan.  

    "As we are executing the ten-quarter turnaround plan of VIVUS, an essential component of such plan is to address our total debt," said John Amos, Chief Executive Officer at VIVUS.  "Accordingly, we intend to actively manage our capital structure, including retiring our outstanding debt to appropriate levels in a series of steps consistent with our ten-quarter turnaround plan.  The $48.6 million repayment announced today is the first of these steps and will result in a net savings of interest of $10.5 million over the remaining term of the loan.  This action is consistent with our longstanding goal of lowering our cost of capital and cash usage related to the interest on our debt.  Based on the improvement of our operations and the underlying collateral, the expense of this debt is no longer warranted.  We are pleased to have taken this important step toward improving our long-term financial health, and we intend to address our remaining debt obligations in ordinary course."

    The Company also announced the departure of Ken Suh, President, and Scott Oehrlein, Chief Operations Officer, effective October 31, 2019.

    "I would like to thank both Ken and Scott for the important contributions they have made to VIVUS, each having improved the Company through the acquisition and transition of Pancreaze. We wish them well in their future endeavors," said Mr. Amos.  As of this time, the Company does not intend on hiring replacements for the positions of President and Chief Operations Officer.

    About VIVUS

    VIVUS is a biopharmaceutical 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.

    Forward-Looking Statements

    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 May 2020; risks and uncertainties related to our expected future revenues, operations and expenditures; risks and uncertainties related to our liquidity and capital resources; and risks and uncertainties related to the impact, if any, of changes to our Board of Directors and senior management team. The reader is cautioned not to rely on these forward-looking statements. Investors should read the risk factors set forth in VIVUS' Form 10-K for the year ended December 31, 2018 as filed on February 26, 2019, and periodic reports filed with the Securities and Exchange Commission. VIVUS does not undertake an obligation to update or revise any forward-looking statements.

    VIVUS, Inc.  Investor Relations: Lazar FINN Partners
    Mark Oki David Carey
    Chief Financial Officer Senior Partner
    650-934-5200 212-867-1768

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  27. CAMPBELL, Calif., Aug. 28, 2019 (GLOBE NEWSWIRE) -- VIVUS, Inc. (NASDAQ:VVUS) (the "Company"), a biopharmaceutical company, today announced that John Amos, Chief Executive Officer at VIVUS, will present at the following conferences:

    • RHK Capital 4th Annual Disruptive Growth Conference hosted by ReedSmith at 10:20 A.M. ET on Thursday, September 5, 2019 in New York.
       
    • 21st Annual H.C. Wainwright Global Investment Conference at 1:45 P.M. ET on Monday, September 9, 2019 in New York.

    An audio webcast of both presentations will be available in the events and presentations section of the Company's investor relations website, or by clicking here.

    About VIVUS

    VIVUS is a biopharmaceutical company committed to the development and commercialization of innovative…

    CAMPBELL, Calif., Aug. 28, 2019 (GLOBE NEWSWIRE) -- VIVUS, Inc. (NASDAQ:VVUS) (the "Company"), a biopharmaceutical company, today announced that John Amos, Chief Executive Officer at VIVUS, will present at the following conferences:

    • RHK Capital 4th Annual Disruptive Growth Conference hosted by ReedSmith at 10:20 A.M. ET on Thursday, September 5, 2019 in New York.
       
    • 21st Annual H.C. Wainwright Global Investment Conference at 1:45 P.M. ET on Monday, September 9, 2019 in New York.

    An audio webcast of both presentations will be available in the events and presentations section of the Company's investor relations website, or by clicking here.

    About VIVUS

    VIVUS is a biopharmaceutical 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.

    Forward-Looking Statements

    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. VIVUS does not undertake an obligation to update or revise any forward-looking statements. Investors should read the risk factors set forth in VIVUS' Form 10-K for the year ended December 31, 2018 as filed on February 26, 2019, and periodic reports filed with the Securities and Exchange Commission. VIVUS does not undertake an obligation to update or revise any forward-looking statements.

    Contact:

    VIVUS, Inc.
    Mark Oki
    Chief Financial Officer

    650-934-5200

    Lazar Partners
    David Carey

    212-687-1768

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  28. -Conference in Seoul provides opportunity to introduce an international audience to the clinical safety and benefits of Qsymia following its approval in the Republic of Korea-

    CAMPBELL, Calif., Aug. 27, 2019 (GLOBE NEWSWIRE) -- VIVUS, Inc. (NASDAQ:VVUS, the "Company")) today announced that Santosh T. Varghese, MD, Chief Medical Officer at VIVUS, will present at the 2019 International Congress on Obesity and MEtabolic Syndrome (ICOMES) & Asia-Oceania Conference on Obesity (AOCO), in Seoul, Korea, which is taking place August 29-31, 2019.  Dr. Varghese will give two presentations summarizing previously reported safety and efficacy data for Qsymia (phentermine and topiramate extended-release) capsules CIV.

    "The joint ICOMES and AOCO conference…

    -Conference in Seoul provides opportunity to introduce an international audience to the clinical safety and benefits of Qsymia following its approval in the Republic of Korea-

    CAMPBELL, Calif., Aug. 27, 2019 (GLOBE NEWSWIRE) -- VIVUS, Inc. (NASDAQ:VVUS, the "Company")) today announced that Santosh T. Varghese, MD, Chief Medical Officer at VIVUS, will present at the 2019 International Congress on Obesity and MEtabolic Syndrome (ICOMES) & Asia-Oceania Conference on Obesity (AOCO), in Seoul, Korea, which is taking place August 29-31, 2019.  Dr. Varghese will give two presentations summarizing previously reported safety and efficacy data for Qsymia (phentermine and topiramate extended-release) capsules CIV.

    "The joint ICOMES and AOCO conference is an excellent venue in which to introduce Qsymia to the international community of physicians and researchers focused on advancing treatments and improving outcomes for patients who are overweight or obese," said Dr. Varghese.  "Qsymia is relevant to the theme of this year's meeting, ‘Sea of Obesity: Navigating the Future,' as we believe it has an important role in helping patients achieve and maintain their healthy body mass index goals.  With Alvogen's recent receipt of approval of Qsymia by the South Korea Ministry of Food and Drug Safety, this an opportune time for us to educate physicians in Korea and other global regions about the robust body of data supporting the safety and efficacy of Qsymia."

    Dr. Varghese will make the following presentations:

    • Optimizing clinical outcomes in obese and overweight patients with combination phentermine plus topiramate extended release. Thursday, August 29, 6:00 p.m. – 6:30 p.m. Korea Standard Time (KST), Room 3.
    • Addressing common challenges in obesity treatment and optimizing long-term patient outcomes with combination phentermine plus topiramate extended release. Saturday, August 31, 7:30 a.m. – 8:30 a.m. KST, Room 6.

    "Our participation in ICOMES and AOCO is an important step in our strategy for making Qsymia a global brand, and we look forward to leveraging Dr. Varghese's presence at the event to build productive relationships with physicians in Korea and other countries," said John Amos, Chief Executive Officer at VIVUS.  "Other ongoing initiatives designed to expand the Qsymia market include our planned re-filing of a new Qsymia Marketing Authorization Application on a decentralized basis in Europe, the launch of our U.S. telemedicine program and an improved payor strategy. VIVUS is committed to realizing the full clinical and commercial potential of Qsymia in the U.S. and in our international markets." 

    About Qsymia

    Qsymia is approved in the United States 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; 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.

    About VIVUS

    VIVUS is a biopharmaceutical 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.

    Forward-Looking Statements

    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 expected future revenues, operations and expenditures; risks and uncertainties related to our, or our current or potential partners', ability to successfully commercialize Qsymia; risks and uncertainties related to our ability to sell through the Qsymia retail pharmacy network and the Qsymia Advantage Program; risks and uncertainties related to our, or our current or potential partners', ability to successfully seek and gain approval for Qsymia in territories outside the U.S.; risks and uncertainties related to the impact of the indicated uses and contraindications contained in the Qsymia label and the Risk Evaluation and Mitigation Strategy requirements; and risks and uncertainties related to our dialog with the European Medicines Agency ("EMA") or certain member states on a decentralized basis relating to the resubmission of an application for the grant of a marketing authorization, the timing and scope of such resubmission, the assessment by European health authorities of the application for marketing authorization, and ultimately the decision of such European health authorities whether to grant marketing authorization for Qsymia in the EU. 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 VIVUS' Form 10-K for the year ended December 31, 2018 as filed on February 26, 2019, and periodic reports filed with the Securities and Exchange Commission. VIVUS does not undertake an obligation to update or revise any forward-looking statements.

    VIVUS, Inc.
    Mark Oki
    Chief Financial Officer

    650-934-5200

    Investor Relations: Lazar Partners
    David Carey
    Managing Director

    212-867-1768

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