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VVUSQ Vivus

VIVUS, Inc. engages in the development and commercialization of novel therapeutic products. The firm’s products are indicated for the treatment of obese and overweight patients, exocrine pancreatic insufficiency, and erectile dysfunction. Its products include PANCREAZE, Qsymia, and STENDRA/SPEDRA. The company was founded by Virgil A. Place in April 16, 1991 and is headquartered in Campbell, CA.

Company profile

Ticker
VVUSQ, VVUSQ
Exchange
Website
CEO
John P. Amos
Employees
Incorporated
Location
Fiscal year end
SEC CIK
IRS number
943136179

VVUSQ stock data

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Calendar

17 Aug 20
17 Apr 21
31 Dec 21
Date Owner Security Transaction Code Indirect 10b5-1 $Price #Shares $Value #Remaining
20 Feb 20 Rosenman Herm NQSO Common Stock Grant Aquire A No No 2.41 15,000 36.15K 15,000
20 Feb 20 Jorge MD Plutzky NQSO Common Stock Grant Aquire A No No 2.41 15,000 36.15K 15,000
20 Feb 20 Norton David Y NQSO Common Stock Grant Aquire A No No 2.41 15,000 36.15K 15,000
20 Feb 20 King Thomas Braxton NQSO Common Stock Grant Aquire A No No 2.41 15,000 36.15K 15,000
20 Feb 20 Kangas Edward A NQSO Common Stock Grant Aquire A No No 2.41 15,000 36.15K 15,000

Data for the last complete 13F reporting period. To see the most recent changes to ownership, click the ownership history button above.

13F holders
Current Prev Q Change
Total holders 0 0
Opened positions 0 0
Closed positions 0 3 EXIT
Increased positions 0 0
Reduced positions 0 0
13F shares
Current Prev Q Change
Total value 0 0
Total shares 0 0
Total puts 0 0
Total calls 0 0
Total put/call ratio
Largest owners
Shares Value Change
Largest transactions
Shares Bought/sold Change
Sabby Management 0 0

Financial report summary

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Risks
  • As of March 31, 2020, we had a total of $240.7 million of outstanding debt, $181.4 million of which was due on May 1, 2020. We did not and do not have sufficient financial resources or cash flows from our business to pay our substantial debt, including the full amounts that were due on May 1, 2020 and thus are actively pursuing strategies to address this indebtedness, including transactions with our existing debtholders that restructure or refinance our debt. We may need to seek relief under the U.S. Bankruptcy Code (the “Bankruptcy Code”) or otherwise complete a restructuring transaction to address our upcoming debt maturity.
  • The Company has been managing its liquidity position and, while we continue to evaluate our alternatives, including to restructure or refinance our debt, if we cannot reach agreements with our existing noteholders it likely will be necessary for us to commence reorganization proceedings under Chapter 11 (“Chapter 11”) of Title 11 of the Bankruptcy Code.
  • In the event we pursue an in-court restructuring and file for relief under Chapter 11, we will be subject to the risks and uncertainties associated with Chapter 11 proceedings.
  • We may not be able to obtain sufficient stakeholder support for a financial restructuring of the Company.
  • The pursuit of the restructuring of our capital structure has consumed, and compliance with the terms thereof will consume, a substantial portion of the time and attention of our management, which may have a material adverse effect on our business and results of operations.
  • Our inability to effectuate a satisfactory financial restructuring transaction could have a material adverse effect on us.
  • Even if a restructuring or refinancing is consummated, we may not be able to achieve our stated goals and continue as a going concern.
  • In the event that we commence proceedings under Chapter 11, trading in our Common Stock will be highly speculative and pose substantial risks.
  • If we fail to maintain compliance with the continued listing standards of the Nasdaq Global Select Market (“Nasdaq”), it may result in the delisting of our common stock from Nasdaq and have other negative implications under our material agreements with lenders and counterparties.
  • The execution of clinical studies may be materially adversely impacted by COVID-19.
  • Our ability to raise capital may be materially adversely impacted by the COVID-19 pandemic.
  • The value of our long-lived intangible assets may be materially impaired as a result of COVID-19.
  • Our worldwide operations and sales and the markets in which we operate are subject to public health risks, including due to COVID-19, which could have a material adverse effect on us.
  • Our success will depend on our ability and that of our current or future collaborators to effectively and profitably commercialize Qsymia®, PANCREAZE and STENDRA/SPEDRA.
  • We have had changes to our Board of Directors and to our management team which may cause disruption in our business, which disruption could have a materially adverse effect on our results of operations.
  • We may not be able to successfully develop, launch and commercialize VI-0106 or any other potential future development programs.
  • Changes to our strategic business plan, including in connection with our consideration of alternatives for the Company, including to restructure or refinance our debt, may cause uncertainty regarding the future of our business, and may adversely impact employee hiring and retention, our stock price, and our revenue, operating results, and financial condition.
  • We depend on our collaboration partners to gain or maintain approval, market, and sell Qsymia and STENDRA/SPEDRA in their respective licensed territories.
  • There have been substantial changes to the Internal Revenue Code, some of which could have an adverse effect on our business.
  • We currently rely on reports from our commercialization partners in determining our royalty revenues, and these reports may be subject to adjustment or restatement, which may materially affect our financial results.
  • If we are unable to enter into agreements with collaborators for the territories that are not covered by our existing commercialization agreements, our ability to commercialize Qsymia and STENDRA/SPEDRA in these territories may be impaired.
  • Failure to obtain regulatory approval in foreign jurisdictions will prevent us from marketing our products abroad.
  • We, together with Alvogen, Menarini, Metuchen and any potential future collaborators in certain territories, intend to market Qsymia and STENDRA/SPEDRA outside the U.S., which will subject us to risks related to conducting business internationally.
  • We have significant inventories on hand, and, in 2015, we recorded inventory impairment and commitment fees totaling $29.5 million, primarily to write off excess inventory related to Qsymia.
  • Our failure to manage and maintain our distribution network for Qsymia or compliance with certain requirements, including requirements of the Qsymia REMS program, could compromise the commercialization of this product.
  • If we are unable to maintain or enter into agreements with suppliers or our suppliers fail to supply us with the API for our products, bulk products or finished products or if we rely on single-source suppliers, we may experience delays in commercializing our products.
  • We have in-licensed all or a portion of the rights to Qsymia, PANCREAZE and STENDRA from third parties. If we default on any of our material obligations under those licenses, we could lose rights to these drugs.
  • Our ability to gain and increase market acceptance and generate revenues will be subject to a variety of risks, many of which are out of our control.
  • We are required to complete post-approval studies and trials mandated by FDA for Qsymia, and such studies and trials are expected to be costly and time consuming. If the results of these studies and trials reveal unacceptable safety risks, Qsymia may be subject to additional REMS restrictions or required to be withdrawn from the market.
  • We depend upon consultants and outside contractors extensively in important roles within our company.
  • Qsymia is a combination of two active ingredient drug products approved individually by FDA that are commercially available and marketed by other companies, although the specific dose strengths differ. As a result, Qsymia may be subject to substitution by prescribing physicians, or by pharmacists, with individual drugs contained in the Qsymia formulation, which would adversely affect our business.
  • If we become subject to product liability claims, we may be required to pay damages that exceed our insurance coverage.
  • The markets in which we operate are highly competitive and we may be unable to compete successfully against new entrants or established companies.
  • We may participate in new partnerships and other strategic transactions that could impact our liquidity, increase our expenses, and present significant distractions to our management.
  • Our failure to successfully identify, acquire, develop and market additional investigational drug candidates or approved drugs would impair our ability to grow.
  • If we fail to retain our key personnel and hire, train and retain qualified employees, we may not be able to compete effectively, which could result in reduced revenues or delays in the development of our investigational drug candidates or commercialization of our approved drugs.
  • We rely on third parties and collaborative partners to manufacture sufficient quantities of compounds within product specifications as required by regulatory agencies for use in our pre-clinical and clinical trials and commercial operations and an interruption to this service may harm our business.
  • We rely on third parties to maintain appropriate levels of confidentiality of the data compiled during clinical, pre-clinical and retrospective observational studies and trials.
  • If we fail to comply with applicable healthcare and privacy and data security laws and regulations, we could face substantial penalties, liability and adverse publicity and our business, operations and financial condition could be adversely affected.
  • Significant disruptions of information technology systems or security breaches could adversely affect our business.
  • Marketing activities for our approved drugs are subject to continued governmental regulation.
  • We are subject to ongoing regulatory obligations and restrictions, which may result in significant expense or limit our ability to commercialize our drugs.
  • We and our contract manufacturers are subject to significant regulation with respect to manufacturing of our products.
  • If we fail to comply with our reporting and payment obligations under the Medicaid Drug Rebate program or other governmental pricing programs, we could be subject to additional reimbursement requirements, penalties, sanctions and fines, which could have a material adverse effect on our business, financial condition, results of operations and growth prospects.
  • Changes in reimbursement procedures by government and other third-party payors, including changes in healthcare law and implementing regulations, may limit our ability to market and sell our approved drugs, or any future drugs, if approved, may limit our product revenues and delay profitability, and may impact our business in ways that we cannot currently predict. These changes could have a material adverse effect on our business and financial condition.
  • Setbacks and consolidation in the pharmaceutical and biotechnology industries, and our, or our collaborators’, inability to obtain third-party coverage and adequate reimbursement, could make partnering more difficult and diminish our revenues.
  • Our business and operations would suffer in the event of system failures.
  • Natural disasters or resource shortages could disrupt our investigational drug candidate development and approved drug commercialization efforts and adversely affect results.
  • Brexit may harm our ability to market our products, to do business, increase our costs and negatively affect our stock price.
  • Obtaining intellectual property rights is a complex process, and we may be unable to adequately protect our proprietary technologies.
  • We may receive additional notices of ANDA filings submitted by generic drug companies asserting that generic forms of our approved therapies would not infringe on our issued patents. As a result of these potential filings, we may commence additional litigation to defend our patent rights, which would result in additional litigation costs and, depending on the outcome of the litigation, might result in competition from lower cost generic or follow-on products earlier than anticipated.
  • We may be sued for infringing the intellectual property rights of others, which could be costly and result in delays or termination of our future research, development, manufacturing and sales activities.
  • We may face additional competition outside of the U.S. as a result of a lack of patent coverage in some territories and differences in patent prosecution and enforcement laws in foreign countries.
  • We require additional capital for our debt servicing requirements and future operating plans, and we may not be able to secure the requisite additional funding on acceptable terms, or at all, which would not allow us to continue our operations at current levels or continue as a going concern and may force us to delay, reduce or eliminate commercialization or development efforts.
  • Raising additional funds by issuing securities will cause dilution to existing stockholders and raising funds through lending and licensing arrangements may restrict our operations or require us to relinquish proprietary rights.
  • The investment of our cash balance and our available-for-sale securities are subject to risks that may cause losses and affect the liquidity of these investments.
  • Our involvement in securities-related class action and shareholder litigation could divert our resources and management’s attention and harm our business.
  • We have an accumulated deficit of $917.2 million as of March 31, 2020, and we may continue to incur substantial operating losses for the future.
  • Our ability to utilize our net operating loss carryforwards and other tax attributes to offset future taxable income may be limited.
  • We may have exposure to additional tax liabilities that could negatively impact our income tax provision, net income, and cash flow.
  • Our stock price has been and may continue to be volatile.
  • Our operating results are unpredictable and may fluctuate. If our operating results are below the expectations of securities analysts or investors, the trading price of our stock could decline.
  • Future sales of our common stock may depress our stock price.
  • Our charter documents and Delaware law could make an acquisition of our company difficult, even if an acquisition may benefit our stockholders.
Management Discussion
  • ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
  • This Management’s Discussion and Analysis of Financial Condition and Results of Operations and other parts of this Quarterly Report on Form 10-Q contain “forward looking” statements that involve risks and uncertainties. These statements typically may be identified by the use of forward-looking words or phrases such as “may,” “believe,” “expect,” “forecast,” “intend,” “anticipate,” “predict,” “should,” “plan,” “likely,” “opportunity,” “estimated,” and “potential,” the negative use of these words or other similar words. All forward-looking statements included in this document are based on our current expectations, and we assume no obligation to update any such forward-looking statements. The Private Securities Litigation Reform Act of 1995 provides a “safe harbor” for such forward-looking statements. In order to comply with the terms of the safe harbor, we note that a variety of factors could cause actual results and experiences to differ materially from the anticipated results or other expectations expressed in such forward-looking statements. The risks and uncertainties that may affect the operations, performance, development, and results of our business include but are not limited to:
  • When we refer to “we,” “our,” “us,” the “Company” or “VIVUS” in this document, we mean the current Delaware corporation, or VIVUS, Inc., and its California predecessor, as well as all of our consolidated subsidiaries.
Content analysis
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H.S. sophomore Avg
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