VIVUS Posts Investor Presentation

        Print
| Source: VIVUS, Inc.

Urges Stockholders Not to be Misled by FMC's Distracting Proxy Campaign

Vote the GOLD Proxy Card Today and Support VIVUS's Highly Qualified Directors

MOUNTAIN VIEW, Calif., June 19, 2013 (GLOBE NEWSWIRE) -- VIVUS, Inc. (Nasdaq:VVUS) (the "Company"), a pharmaceutical company commercializing and developing innovative, next-generation therapies to address unmet needs in obesity and sexual health, today announced that it has posted an investor presentation to the Company's website. The Board of Directors and management team are using the presentation during meetings with investors beginning today. The presentation is available on the Company's website at www.vivus.com/investors/stockholder-materials.

Highlights of the presentation include:

  • VIVUS's Board and Management Team Have Positioned the Company for Success.
  • The Board and management team have successfully developed four products through FDA approval, most recently Qsymia® (phentermine and topiramate extended-release) capsules CIV and STENDRA™ (avanafil).
  • Throughout 2013, the VIVUS Board and management team have worked diligently to establish a strong foundation for Qsymia.
  • Your Board and management team are actively pursuing strategies to expand the Company's primary care physician (PCP) reach, activate consumers through direct-to-consumer (DTC) advertising and grow prescriptions.
  • VIVUS is at a critical juncture in the commercialization of Qsymia.
  • VIVUS Has a Clear Plan to Build a Successful Qsymia Brand.
  • VIVUS has achieved important milestones that have established a strong foundation to drive future sales and increase stockholder value. 
  • During 2013, the Company has:
     
  • Helped to establish the medical obesity market;
  • Broadened payor reimbursement;
  • Increased patient access to retail pharmacies;
  • Initiated discussions with large pharmaceutical companies to expand PCP reach;
  • Created a DTC strategy to activate consumers in Fall 2013; and
  • Secured $360 million of capital to fund future growth.
  • VIVUS's Board Has the Right Experience for VIVUS at the Right Time.
  • The VIVUS Board, which includes seven independent directors, is committed to maximizing value for ALL stockholders and considering a broad range of opportunities to achieve this objective.
  • The Board is comprised of proven business leaders who possess a broad range of commercial, management, financial, clinical and operational experience, as well as expertise in the biopharmaceutical industry and other areas important to VIVUS.  
  • VIVUS directors have extensive experience launching drugs and structuring relationships with large pharmaceutical companies, which is critical to the commercialization of Qsymia.
  • VIVUS directors have numerous industry relationships that are critical to the Company's ongoing discussions with large pharmaceutical companies.
  • Supporting First Manhattan Co. (FMC) Would Remove a Board and Management Team with the Institutional Knowledge Necessary to Make Qsymia a Successful Brand and Would Jeopardize the Progress Made To Date.
  • FMC has failed to articulate a plan as to what its nominees would do differently if they were to take control of VIVUS.
  • FMC's nominees have minimal relevant experience to drive long-term stockholder value.
  • We believe FMC would create unnecessary risk for VIVUS and its stockholders and electing its nominees would throw VIVUS into turmoil at a critical juncture.
  • VIVUS Stockholders Have a Clear Choice.
  • Support the VIVUS Board, which:
     
  • Has a clear strategic and tactical plan.
  • Is comprised of directors with relevant operational experience.
  • Has achieved significant milestones for Qsymia to drive future sales.
  • Is in ongoing discussions with large pharmaceutical companies.
  • Is acting in the best interests of ALL VIVUS stockholders.
     
  • Don't support FMC, which:
     
  • Has no detailed strategic or tactical plan.
  • Is a minority stockholder seeking to have its nominees control 100% of the VIVUS Board although, if elected, its nominees will have fiduciary obligations to VIVUS's stockholders.
  • Is proposing nine nominees, seven who have no executive experience in pharmaceutical commercialization. 
  • Has not outlined what its nominees would do differently than the current Board and management team.

VIVUS recommends that stockholders vote "FOR" the Company's nine highly qualified nominees today by Internet, by telephone or by returning any GOLD proxy card received. Please do not return or otherwise vote any proxy card sent by FMC. If you have already voted a white proxy card sent to you by FMC, you have every right to change that vote by simply voting a later-dated GOLD proxy card. Please review VIVUS's proxy materials and other stockholder communications at www.vivus.com/investors/stockholder-materials.

If stockholders have any questions or would like assistance
in voting the GOLD proxy card, please contact:

MORROW & CO., LLC
Call Toll Free: (800) 607-0088
Call Collect: (203) 658-9400
E-mail: vivusinfo@morrowco.com

About Qsymia

Qsymia® (phentermine and topiramate extended-release) capsules CIV is approved in the U.S. and is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of 30 kg/m2 or greater (obese) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related medical condition such as high blood pressure, type 2 diabetes, or high cholesterol.

The effect of Qsymia on cardiovascular morbidity and mortality has not been established. The safety and effectiveness of Qsymia in combination with other products intended for weight loss, including prescription and over-the-counter drugs and herbal preparations, have not been established.

Important Safety Information

Qsymia (phentermine and topiramate extended-release) capsules CIV is contraindicated in pregnancy; in patients with glaucoma; in hyperthyroidism; in patients receiving treatment or within 14 days following treatment with monoamine oxidase inhibitors (MAOIs); or in patients with hypersensitivity to sympathomimetic amines, topiramate, or any of the inactive ingredients in Qsymia.

Qsymia can cause fetal harm. Females of reproductive potential should have a negative pregnancy test before treatment and monthly thereafter and use effective contraception consistently during Qsymia therapy. If a patient becomes pregnant while taking Qsymia, treatment should be discontinued immediately, and the patient should be informed of the potential hazard to the fetus.

The most commonly observed side effects in controlled clinical studies, 5% or greater and at least 1.5 times placebo, include paraesthesia, dizziness, dysgeusia, insomnia, constipation, and dry mouth.

About Avanafil

STENDRA (avanafil) is approved by the FDA for the treatment of erectile dysfunction in the U.S. VIVUS, through collaboration arrangements with third parties, intends to market and sell STENDRA in the U.S. and under the trade name SPEDRA in the EU and other territories outside the U.S. Avanafil was 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 and Pacific Rim countries.

VIVUS is currently in discussions with potential partners to commercialize STENDRA in the United States and other territories throughout the world.

Currently, it is recommended that STENDRA should be taken approximately 30 minutes before sexual activity. STENDRA should not be taken more than once per day. For more information about STENDRA, please visit www.stendra.com.

Important Safety Information

STENDRA™ (avanafil) is indicated for the treatment of erectile dysfunction.

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 itraconozole (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. The recommended starting dose is 100 mg.

About VIVUS

VIVUS is a biopharmaceutical company commercializing and developing innovative, next-generation therapies to address unmet needs in obesity, sleep apnea, diabetes and sexual health. For more information about the company, please visit www.vivus.com.

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995 and are subject to risks, uncertainties and other factors, including risks and uncertainties related to the implementation of our REMS amendment and expansion to retail distribution, the broadening payor reimbursement, the expansion of Qsymia's primary care presence, the outcomes of our discussions with pharmaceutical companies and our strategic and franchise-specific pathways for Qsymia. 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's Form 10-K for the year ending December 31, 2012 (as amended by the Form 10-K/A filed on April 30, 2013 and the Form 10-K/A filed on June 12, 2013) and periodic reports filed with the Securities and Exchange Commission. VIVUS does not undertake an obligation to update or revise any forward-looking statements.

Important Additional Information

On June 3, 2013, VIVUS filed a definitive proxy statement and GOLD proxy card with the SEC in connection with the solicitation of proxies for its 2013 Annual Meeting of Stockholders. Stockholders are strongly advised to read VIVUS's 2013 proxy statement because it contains important information. Stockholders may obtain a free copy of the 2013 proxy statement and other documents that the Company files with the SEC from the SEC's website at www.sec.gov or VIVUS's website at www.vivus.com.

VIVUS, Inc.
Timothy E. Morris
Chief Financial Officer

        
Investor Relations:
The Trout Group
Brian Korb

646-378-2923

Proxy Solicitor:
Morrow & Co., LLC
Joseph J. Mills

203-658-9423