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:
Risks and uncertainties related to our business:
· our ability to address our liquidity and capital resource needs, including the
remaining outstanding balance of
Notes (the "Convertible Notes") which must be addressed within the 30-day grace
period beginning
· the widespread domestic and global impact of the COVID-19 pandemic on our
business, results of operations, customers, suppliers and other counterparties,
and employees;
· our history of losses and variable quarterly results;
· our ability to continue as a going concern;
· the volatility and liquidity of the financial markets;
· our expected future revenues, operations and expenditures;
· our ability to effectively manage expenses;
· risks related to our ability to protect our intellectual property and
litigation in which we are involved or may become involved;
· uncertainties of government or third-party payor reimbursement;
· our reliance on sole-source suppliers, third parties and our collaborative
partners;
· our ability to successfully develop or acquire a proprietary formulation of
tacrolimus;
· risks related to the failure to obtain or retain federal or state-controlled
substances registrations and noncompliance with
("DEA") or state-controlled substances regulations;
· risks related to the failure to obtain FDA or foreign authority clearances or
approvals and noncompliance with FDA or foreign authority regulations;
· our ability to demonstrate through clinical testing the quality, safety, and
efficacy of our current and future investigational drug candidates or approved
products;
· the timing of initiation and completion of clinical trials and submissions to
· compliance with post-marketing regulatory standards, post-marketing obligations
or pharmacovigilance rules is not maintained;
· our ability to execute on our business strategy to enhance enterprise and
long-term stockholder value;
· our ability to identify and acquire cash flow generating assets and
opportunities;
· our ability to successfully navigate recent changes to our Board of Directors
and the senior management team;
· other factors that are described from time to time in our periodic filings with
the
this filing as "Part II. Item 1A. Risk Factors;" 23 Table of Contents
Risks and uncertainties related to Qsymia® (phentermine and topiramate extended release):
· our, or our current or potential partners', ability to successfully
commercialize Qsymia including risks and uncertainties related to expansion to
direct to patient distribution, the broadening of payor reimbursement, the
expansion of Qsymia's primary care presence, and the outcomes of our discussions with pharmaceutical companies and our strategic and franchise-specific pathways for Qsymia;
· our ability to sell through the Qsymia retail pharmacy network and the Qsymia
Advantage program;
· the impact of promotional programs for Qsymia on our net product revenue and
operating results in future periods;
· our ability to ensure that the entire supply chain for Qsymia timely,
efficiently and consistently delivers Qsymia to our customers and partners;
· our ability to accurately forecast Qsymia demand;
· our ability to maintain the relationship with the sole manufacture for Qsymia;
· our, or our current or potential partners', ability to successfully seek, gain
and maintain approval for Qsymia in territories outside the
· our dialogue with certain Concerned Member States (as defined below) in
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 on whether to grant
Marketing Authorization for Qsymia in such EU countries;
· the timing of and costs associated with the initiation and completion of the
post-approval clinical studies required as part of the approval of Qsymia by
the
· the response from FDA to any data and/or information relating to post-approval
clinical studies required for Qsymia;
· our ability to work with FDA to significantly reduce or remove the requirements
of the clinical post-approval cardiovascular outcomes trial ("CVOT");
· the impact of the indicated uses and contraindications contained in the Qsymia
label and the Risk Evaluation and Mitigation Strategy ("REMS") requirements;
· the impact of any possible future requirement to provide additional clinical
data or further analysis of previously submitted clinical trial data;
Risks and uncertainties related to PANCREAZE (pancrelipase):
· risks and uncertainties related to the timing, strategy, tactics and success of
the marketing and sales of PANCREAZE;
· our ability to successfully maintain and increase market share against current
competing products and potential competitors that may develop alternative
formulations of the drug;
· our ability to expand payor coverage for PANCREAZE;
· our ability to accurately forecast PANCREAZE demand;
· our ability to maintain the relationship with the sole manufacturer for
PANCREAZE;
· our ability to maintain a satisfactory level of PANCREAZE inventory;
· the ability of our partners to maintain regulatory approvals to manufacture and
adequately supply our products to meet demand;
Risks and uncertainties related to STENDRA® (avanafil) or SPEDRA™ (avanafil):
· our ability to manage the supply chain for STENDRA/SPEDRA for our current or
potential commercial collaborators;
· our partner's ability to find a new distribution partner or model for STENDRA
inthe United States ,Canada ,South America andIndia ; 24 Table of Contents
· risks and uncertainties related to the timing, strategy, tactics and success of
the launches and commercialization of STENDRA/SPEDRA by our current or
potential collaborators;
· our ability to successfully complete, on acceptable terms and on a timely
basis, avanafil partnering discussions for territories under our license with
collaboration partner;
·
ingredient and
tablets; and
· the ability of our partners to maintain regulatory approvals to manufacture and
adequately supply our products to meet demand or to comply with the terms of
their agreements with us.
When we refer to "we," "our," "us," the "Company" or "VIVUS" in this document, we mean the currentDelaware corporation, orVIVUS, Inc. , and itsCalifornia predecessor, as well as all of our consolidated subsidiaries. All percentage amounts and ratios were calculated using the underlying data in thousands. Operating results for the three months endedMarch 31, 2020 are not necessarily indicative of the results that may be expected for the full fiscal year or any future period. You should read the following management's discussion and analysis of our financial condition and results of operations in conjunction with our audited consolidated financial statements and related notes thereto included as part of our Annual Report on Form 10-K for the year endedDecember 31, 2019 , as filed with theSEC onMarch 3, 2020 and other disclosures (including the disclosures under "Part II. Item 1A. Risk Factors") included in this Quarterly Report on Form 10-Q. Our unaudited condensed consolidated financial statements have been prepared in accordance withU.S. generally accepted accounting principles and are presented inU.S. dollars.
OVERVIEW
VIVUS is a specialty pharmaceutical company with three approved therapies and one product candidate in clinical development. Qsymia® (phentermine and topiramate extended release) is approved by FDA for chronic weight management. PANCREAZE®/PANCREASE® MT (pancrelipase) is indicated for the treatment of exocrine pancreatic insufficiency ("EPI") due to cystic fibrosis or other conditions. STENDRA® (avanafil) is approved by FDA for erectile dysfunction ("ED") and by the EC under the trade name SPEDRA, for the treatment of ED in the EU. VI-0106 (tacrolimus) is in clinical development and is being studied in patients with pulmonary arterial hypertension ("PAH").
Business Strategy
InApril 2018 , we addedJohn Amos as our new Chief Executive Officer and a member of the VIVUS Board of Directors. With the addition ofMr. Amos , we announced a turnaround plan of building a portfolio of cash flow generating assets to leverage our expertise in commercializing specialty pharmaceutical assets. InJune 2018 , we completed the first acquisition under this strategy as we acquired all product rights for PANCREAZE (pancrelipase) inthe United States and PANCREASE MT inCanada for$135.0 million in cash fromJanssen Pharmaceuticals . PANCREAZE/PANCREASE MT 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. We are supporting PANCREAZE in the U.S. market by leveraging our existing commercial infrastructure and 10 sales representatives in theU.S. focused on gastro-intestinal and cystic fibrosis physicians. In June of 2018, we issued$110.0 million of 10.375% 2024 Notes ("2024 Notes") with affiliates ofAthyrium Capital Management ("Athyrium"). Concurrent with the issuance of the 2024 Notes, we issued warrants to purchase 0.3 million shares of our common stock to the note holders. Additionally, concurrent with the issuance of the 2024 Notes, we repurchased Convertible Notes held by Athyrium, with a face value of$60.0 million , at a discount to par plus accrued interest. InOctober 2018 , we settled a purchase of approximately$8.6 million outstanding principal amount of our Convertible Notes for approximately$7.1 million plus accrued interest. InSeptember 2019 , we repurchased$48.6 million aggregate principal amount of our 2024 Notes plus prepayment premiums of an aggregate of$6.4 million . OnApril 3, 2020 , the Company completed a registered direct offering of 7,218,750 shares of the Company's common stock at a purchase price of$1.60 per share for net proceeds of$10.5 million , after deducting the placement agent's fees and other offering expenses payable by the Company. 25
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As ofMarch 31, 2020 , we had a total of$240.7 million of outstanding debt,$181.8 million of which was due onMay 1, 2020 . We do not currently have sufficient cash and/or credit facilities in place to pay the debt dueMay 1, 2020 . OnApril 29, 2020 , we entered into an agreement withIEH Biopharma LLC ("IEH Biopharma"), which holds a principal amount of approximately$170.2 million of our Convertible Notes with a maturity date ofMay 1, 2020 . Under the terms of the agreement, we paid IEH Biopharma$3.8 million in accrued and unpaid interest on the Convertible Notes and IEH Biopharma granted us a 30-day grace period (if not terminated sooner pursuant to the terms of the agreement), beginningMay 1 , for payment of the principal amount of the Convertible Notes during which the two parties will work exclusively to attempt to restructure the outstanding principal amount of the Convertible Notes. As part of the agreement, we paid$7.5 million to settle the remaining$11.3 million in principal and$253,000 in accrued and unpaid interest held by other holders. We are actively pursuing funding or a restructuring of our debt, which may come through public or private debt or equity financings, collaborations or other available financing sources. It is substantially uncertain whether any such funding or restructuring will be available on acceptable terms, if at all. If additional funds are raised by issuing equity securities, substantial dilution to existing stockholders may result. As a result of this uncertainly, we believe that a strategic transaction that restructures or refinances our debt may be necessary in order for us to service our existing indebtedness. We may need to seek relief under theU.S. Bankruptcy Code or otherwise complete a restructuring transaction to address our liquidity needs. If we seek bankruptcy relief, our common stockholders could receive little or no consideration for their interests. In addition, unsecured creditors would likely realize recoveries significantly less than the principal amount of their claims and, possibly, no recovery at all. Alternatively, we will not be able to continue our operations at our current level and may be required to relinquish rights to certain of our technologies, product candidates or products that we would otherwise seek to develop on our own. We might also be required to delay, reduce the scope of or eliminate one or more of our commercialization or development programs or obtain funds through collaborations with others that are on unfavorable terms or restructure VIVUS in other ways that may not be favorable. Our independent registered public accounting firm's audit report on our consolidated financial statements as of and for the year endedDecember 31, 2019 included in our Annual Report on Form 10-K includes an explanatory paragraph stating that there is substantial doubt about our ability to continue as a going concern. If we cannot continue as a viable entity, our security holders may lose some or all of their investment in our Company. Even if adequate funds become available, we may need to raise additional funds in the near future to finance operations and pursue development and commercial opportunities. The COVID-19 pandemic may result in significant adverse impacts to our business. Although the full impact of the pandemic on our revenue, financial condition and results of operations for the remainder of the fiscal year remains uncertain and difficult to predict, the spread of the virus and public health measures being undertaken to reduce such transmission are and will likely continue to create significant disruptions with respect to consumer demand, healthcare providers and healthcare facilities and the reliability of our supply chain. The severity of the impact of the COVID-19 pandemic on our business will depend on a number of factors, including, but not limited to, the duration and severity of the pandemic and the extent and severity of the impact on the Company's customers, all of which are uncertain and cannot be predicted. Our future results of operations and liquidity could be adversely impacted by factors including, but not limited to, delays in payments of outstanding receivable amounts beyond normal payment terms, supply chain disruptions and uncertain demand.
Commercial Products
Qsymia
FDA approved Qsymia inJuly 2012 as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adult obese or overweight patients in the presence of at least one weight related comorbidity, such as hypertension, type 2 diabetes mellitus or high cholesterol, or dyslipidemia. Qsymia incorporates a proprietary formulation combining low doses of the active ingredients from two approved drugs, phentermine and topiramate. Although the exact mechanism of action is unknown, Qsymia is believed to suppress appetite and increase satiety, or the feeling of being full, the two main mechanisms that impact eating behavior. We commercialize Qsymia in theU.S. through a specialty sales force who promote Qsymia to physicians. Our sales efforts are focused on maintaining a commercial presence with high volume prescribers of anti-obesity products. Our marketing efforts have focused on rolling out unique programs to encourage targeted prescribers to 26 Table of Contents gain more experience with Qsymia with their obese or overweight patient population. In 2019, we introduced the Qsymia Advantage program to reach more of our intended patient population. The Qsymia Advantage program includes patient education resources and access to a home delivery in addition to new pricing. We continue to invest in digital media in order to amplify our messaging to information-seeking consumers. The digital messaging encourages those consumers most likely to take action to speak with their physicians about obesity treatment options. We believe our enhanced digital strategies deliver clear and compelling communications to potential patients. We utilize a patient savings plan to further drive Qsymia brand preference at the point of prescription and to encourage long-term use of the brand. InSeptember 2017 , we entered into a license and commercialization agreement (the "Alvogen License Agreement") and a commercial supply agreement (the "Alvogen Supply Agreement") withAlvogen Malta Operations (ROW) Ltd ("Alvogen"). Under the terms of the Alvogen License Agreement, Alvogen is solely responsible for obtaining and maintaining regulatory approvals for all sales and marketing activities for Qsymia inSouth Korea . We received an upfront payment of$2.5 million inSeptember 2017 , a payment of$2.5 million inSeptember 2019 upon achieving marketing authorization and$2.0 million in the first quarter of 2020 upon commercial launch. We are eligible to receive additional payments upon Alvogen reaching a sales milestone. Additionally, we receive royalties on Alvogen's Qsymia net sales inSouth Korea . Under the Alvogen Supply Agreement, we will supply product to Alvogen on an exclusive basis. InOctober 2019 , we announced that European regulatory agencies inSweden ,Denmark ,Finland ,Iceland ,Norway , andPoland (the "Concerned Member States") have accepted the Marketing Authorization Application (the "MAA") for Qsymia on a decentralized basis, withSweden acting as the lead. 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. Based on the decentralized MAA procedure timelines, we anticipate the completion of the MAA assessment in the second half of 2020. InDecember 2019 , we announced the results of a pharmacokinetic and pharmacodynamic study demonstrating that Qsymia 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 primary objective of the study was to describe the pharmacokinetic profiles of Qsymia after administration in adolescents with obesity.
PANCREAZE/PANCREASE MT
InJune 2018 , we acquired the commercial rights to PANCREAZE and PANCREASE MT in theU.S. andCanada . Prior to the acquisition, PANCREAZE/PANCREASE MT had been commercialized by Janssen. In connection with the acquisition of PANCREAZE/PANCREASE MT, we and Janssen also entered into transition services agreements pursuant to which Janssen and a Canadian affiliate of Janssen provided certain transition services to us in theU.S. andCanada as we transitioned to full control over the PANCREAZE/PANCREASE MT supply chain, which was completed in the first quarter of 2019. In the first quarter of 2019, we relaunched PANCREAZE in theU.S. by leveraging our existing commercial infrastructure and expanding it to include 10 additional contract sales representatives in theU.S. focused on gastro-intestinal and cystic fibrosis physicians. We also introduced the PANCREAZE Advantage program, which is intended to enhance patient access and improve the patient experience with patient and physician educational materials, a patient support program, and patient and payment assistance. We transitioned to direct sales inCanada in the third quarter of 2019. We have also prioritized supply chain improvement, working capital management and moving PANCREAZE/PANCREASE MT back into the view of the medical community. InFebruary 2020 , FDA approved the supplemental New Drug Application for an improved formulation of PANCREAZE that extends the shelf life to 36 months across all PANCREAZE dosages. Approved in 2010, PANCREAZE/PANCREASE MT 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. PANCREAZE/PANCREASE MT is specifically indicated for the treatment of exocrine pancreatic insufficiency ("EPI"). EPI is a condition that results from a deficiency in the production and/or secretion of pancreatic enzymes. It is associated with cystic fibrosis, chronic pancreatitis, pancreatic cancer and other conditions, and affects approximately 85 percent of cystic fibrosis patients. There is no cure for EPI and pancreatic enzyme replacement therapy is the primary treatment for the condition. 27 Table of Contents STENDRA/SPEDRA
STENDRA is an oral phosphodiesterase type 5 ("PDE5") inhibitor that we have
licensed from
The Menarini Group , through its subsidiaryBerlin Chemie AG ("Menarini"), is our exclusive licensee for the commercialization and promotion of SPEDRA for the treatment of ED in over 40 countries, including the EU Member States. In addition, Menarini licensed rights directly from MTPC to commercialize avanafil in certain Asian territories. We receive royalties from Menarini based on SPEDRA net sales and are entitled to receive future milestone payments based on certain net sales targets. Menarini will also reimburse us for payments made to cover various obligations to MTPC during the term of the Menarini License Agreement. Menarini obtains SPEDRA exclusively from us.Metuchen Pharmaceuticals LLC ("Metuchen") is our exclusive licensee for the development, commercialization and promotion of STENDRA inthe United States ,Canada ,South America andIndia . Metuchen reimburses us for payments made to cover royalty and milestone obligations to MTPC, but otherwise owes us no future royalties. Metuchen obtains STENDRA exclusively from us. OnSeptember 30, 2019 , Metuchen provided a written notice of termination of our supply agreement with them effectiveSeptember 30, 2021 .
We are currently in discussions with potential collaboration partners to
develop, market and sell STENDRA/SPEDRA for territories in which we do not
currently have a commercial collaboration, including
Product Development Pipeline and Life Cycle Management
VI-0106 - Pulmonary Arterial Hypertension
PAH is a chronic, life-threatening disease characterized by elevated blood pressure in the pulmonary arteries, which are the arteries between the heart and lungs, due to pathologic proliferation of endothelial and vascular smooth muscle cells in the lining of these blood vessels and excess vasoconstriction. Pulmonary blood pressure is normally between 8 and 20 mmHg at rest as measured by right heart catheterization. In patients with PAH, the pressure in the pulmonary artery is greater than 25 mmHg at rest or 30 mmHg during physical activity. These high pressures make it difficult for the heart to pump blood through the lungs to be oxygenated. The current medical therapies for PAH involve endothelin receptor antagonists, PDE5 inhibitors, prostacyclin analogues, selective prostaglandin I2 receptor agonists, and soluble guanylate cyclase stimulators, all of which have been shown to effectively dilate arterioles in the pulmonary circulation, to reduce symptoms and improve quality of life. While currently approved products treat the symptoms of PAH, they do little to address the pathologic cell proliferation that is the underlying cause of the disease. We believe that tacrolimus can be used to enhance bone morphogenetic protein receptor type 2 ("BMPR2") signaling. BMPR2 signaling has been shown to be reduced in PAH patients, and this reduction in signaling is an important factor leading to cell proliferation within the pulmonary arteries. By restoring BMPR2 signaling, tacrolimus may therefore address a fundamental cause of PAH. The prevalence of PAH varies among specific populations, but it is estimated at between 15 and 50 cases per million adults. PAH usually develops between the ages of 20 and 60 but can occur at any age, with a mean age of diagnosis around 45 years. Idiopathic PAH is the most common type, constituting approximately 40% of the total diagnosed PAH cases, and occurs two to four times more frequently in females. OnJanuary 6, 2017 , we acquired the exclusive, worldwide rights for the development and commercialization of BMPR2 activators for the treatment of PAH and related vascular diseases fromSelten Pharma, Inc. ("Selten").Selten assigned to us its license to a group of patents owned by theBoard of Trustees of theLeland Stanford Junior University ("Stanford") which cover uses of tacrolimus and ascomycin to treat PAH. We paidSelten an upfront payment of$1.0 million , and we will pay additional milestone payments based on global development status and future sales milestones, as well as tiered royalty payments on future sales of these compounds. The total potential milestone payments are$39.0 million toSelten . We have assumed full responsibility for the development and commercialization of the licensed compounds for the treatment of PAH and related vascular diseases. InOctober 2017 , we held a pre-IND meeting with FDA for VI-0106, our proprietary formulation of tacrolimus for the treatment of PAH. FDA addressed our questions related to preclinical, nonclinical and clinical 28
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data and the planned design of clinical trials of tacrolimus in class 3 and 4 PAH patients, and clarified the requirements needed to file an IND to initiate a clinical trial in this indication. As discussed with FDA, we currently intend to design and conduct clinical trials that could qualify for Fast Track and/or Breakthrough Therapy designation. Tacrolimus for the treatment of PAH has received Orphan Drug Designation from FDA in theU.S. and the EU on the basis of a scientific opinion adopted by the Committee for Orphan Medicinal Products of theEuropean Medicines Agency in the EU. We are focusing on the development of a proprietary oral formulation of tacrolimus to be used in a clinical development program and, if approved, for commercial use. If we are successful in our development efforts, we anticipate filing an IND with FDA and completing the development of our proprietary formulation of tacrolimus in the second half of 2020. We are currently seeking alternatives for financing the development of tacrolimus.
Qsymia for Additional Indications
We are currently considering further development of Qsymia for the treatment of various diseases, including obstructive sleep apnea and nonalcoholic steatohepatitis ("NASH").
CRITICAL ACCOUNTING POLICIES AND ESTIMATES
The discussion and analysis of our financial condition and results of operations are based upon our unaudited condensed consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in theU.S. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues, expenses and related disclosures. On an ongoing basis, we evaluate our estimates, including those related to available-for-sale securities, research and development expenses, income taxes, inventories, revenues, including revenues from multiple-element arrangements, contingencies and litigation and share-based compensation. We base our estimates on historical experience, information received from third parties and on various market specific and other relevant assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ significantly from these estimates under different assumptions or conditions. Our significant accounting policies are more fully described in Note 1 to our audited consolidated financial statements and in "Management's Discussion and Analysis of Financial Condition and Results of Operations - Critical Accounting Policies and Estimates" contained in our Annual Report on Form 10-K for the year endedDecember 31, 2019 as filed with theSEC onMarch 3, 2020 . There have been no changes to our significant accounting policies since our Annual Report on Form 10-K for the year endedDecember 31, 2019 . RESULTS OF OPERATIONS Revenues Three Months Ended March 31, Increase/ (in thousands, except for percentages) 2020 2019 (Decrease) Qsymia-Net product revenue $ 8,914 $ 8,423 6 % PANCREAZE/PANCREASE MT - Net product revenue 5,783 5,074 14 % License and milestone revenue 2,000 - N/A Supply revenue 1,823 1,604 14 % Qsymia royalty revenue 564 - N/A STENDRA/SPEDRA royalty revenue 547 475 15 % PANCREASE MT royalty revenue - 570 (100) % Total revenue$ 19,631 $ 16,146 22 % 29 Table of Contents Net product revenue Shipments and prescriptions for net product revenue consisted of the following: Three Months Ended March 31, Increase/ (in thousands, except for percentages) 2020 2019
(Decrease)
Qsymia units shipped 79 77 3 % Qsymia prescriptions dispensed 83 82 1 % PANCREAZE/PANCREASE MT units shipped 33 26
27 %
Units shipped represent our direct shipments into the sales channel or to end customers through a direct-to-patient specialty pharmacy. We are uncertain about the impacts that COVID-19 will have on our future product revenue, including its general impact on the economy and on the ability of patients to access pharmacies, retail outlets and healthcare providers.
License and milestone revenue
License and milestone revenue for the three months endedMarch 31, 2020 related to contractual payments due to us upon Alvogen commencing commercialization of Qsymia inSouth Korea . License and milestone revenues are dependent on the timing of entering into new collaborations and the timing of our collaborators meeting or being reasonably certain of meeting certain milestone events. As a result, we anticipate that our license and milestone revenue will fluctuate materially between periods.
Supply revenue
We supply Qsymia and STENDRA/SPEDRA to our collaboration partners on a cost-plus basis. The variations in supply revenue are a result of the timing of orders placed by our partners and may or may not reflect end user demand. The timing of purchases by our commercialization partners will be affected by, among other items, their minimum purchase commitments, end user demand, and distributor inventory levels. As a result, supply revenue has and will continue to fluctuate materially between reporting periods.
Royalty revenue
We record royalty revenue related to sales of STENDRA/SPEDRA, Qsymia inSouth Korea and, in 2019, Canadian sales of PANCREASE MT based on reports provided by our partners. Upon taking over operations for Canadian sales for PANCREASE MT, including ownership of the Canadian inventory in the third quarter of 2019, net sales of PANCREASE MT began to be recorded as net product revenue with costs recorded as cost of goods sold. We expect STENDRA/SPEDRA royalty revenue for the next quarters to remain relatively consistent with current levels. We expect Qsymia royalty revenue to vary on a quarterly basis due to the recent launch. We are uncertain about the impacts that COVID-19 will have on our future STENDRA/SPEDRA and Qsymia royalty revenue, including its general impact on the economy and on the ability of patients to access pharmacies, retail outlets and healthcare providers. Cost of goods sold Three Months Ended March 31, 2020 2019 (In thousands, except percentages) Qsymia PANCREAZE STENDRA/ SPEDRA Total Qsymia PANCREAZE STENDRA/ SPEDRA Total Net product revenue$ 8,914 $ 5,783 $ -$ 14,697 $ 8,423 $ 5,074 $ -$ 13,497 Supply revenue - - 1,823 1,823 - - 1,604 1,604 Total product and supply revenue 8,914 100%$ 5,783 100%$ 1,823 100%$ 16,520 100%$ 8,423 100%$ 5,074 100%$ 1,604 100%$ 15,101 100% Cost of goods sold (excluding amortization) 1,340 15%$ 1,602 28% $
1,685 92%
- 0% 3,638 22% 91 1% 3,547 70% - 0%$ 3,638 24% Total cost of goods sold 1,431 16%$ 5,149 89%$ 1,685 92%$ 8,265 50%$ 1,473 17%$ 5,008 99%$ 1,465 91%$ 7,946 53%$ 7,483 84%$ 634 11%$ 138 8%$ 8,255 50%$ 6,950 83%$ 66 1%$ 139 9%$ 7,155 47% Cost of goods sold for Qsymia includes the inventory costs of API, third party contract manufacturing and packaging and distribution costs, royalties, cargo insurance, freight, shipping, handling and storage costs, and 30
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overhead costs of the employees involved with production. Cost of goods sold for PANCREAZE includes third party contract manufacturing costs, amortization of the PANCREAZE license, service fees, royalties, insurance, and overhead costs. Cost of goods sold for STENDRA/SPEDRA shipped to our commercialization partners includes the inventory costs of API and tableting. Fluctuations in the cost of goods sold as a percentage of net product and supply revenue over the periods was primarily due to the sales mix among Qsymia, STENDRA/SPEDRA and PANCREAZE.
Selling, general and administrative expense
Three Months Ended March 31, Increase/ (In thousands, except percentages) 2020 2019 (Decrease) Selling and marketing $ 4,233 $ 4,534 (7) % General and administrative 6,727 5,284 27 % Total selling, general and administrative expenses $ 10,960 $
9,818 12 %
The decrease in selling and marketing expenses in the three months endedMarch 31, 2020 compared to the same period in 2019 was primarily due to the stabilization of our sales force and recurring promotional activities for Qsymia and PANCREAZE/PANREASE MT. Selling and marketing expenses are expected generally to remain stable in future quarters, exclusive of any currently-uncertain changes in order to address changing market conditions due to COVID-19. The increase in general and administrative expenses in the three months endedMarch 31, 2020 compared to the same period in 2019 was primarily due to professional fees related to our refinancing efforts. We expect general and administrative expenses to be higher in the second quarter of 2020 due to fees associated with our refinancing and restructuring efforts and to fluctuate significantly on a quarterly basis in future quarters.
Research and development expense
Three Months Ended March 31, Increase/ Drug Indication/Description 2020 2019 (Decrease) (In thousands, except percentages) Qsymia $ 1,061 $ 692 53 % STENDRA/SPEDRA 65 41 59 % PANCREAZE/PANCREASE MT 426 642 (34) % VI-0106 67 25 168 % Share-based compensation 33 55 (40) % Overhead costs* 793
1,014 (22) % Total research and development expenses $ 2,445 $ 2,469 (1) %
--------------------------------------------------------------------------------
*Overhead costs include compensation and related expenses, consulting, legal and other professional services fees relating to research and development activities, which we do not allocate to specific projects.
The decrease in total research and development expenses in the three months endedMarch 31, 2020 as compared to the same period in 2019 was primarily due to completion of enrollment for Qsymia adolescent safety and efficacy study and the completion of the PANCREAZE longer shelf life formulation. We expect research and development expenses to remain stable over the remaining months of 2020 for OB-403 as we monitor patient activity as well as work on the remaining PANCREAZE post-marketing requirements.
Interest expense and other expense, net
Interest expense and other expense, net for the three months endedMarch 31, 2020 and 2019 was$3.2 million and$3.9 million , respectively. The decrease is due to the decrease in the principal amounts due to repurchases of our 2024 Notes in 2019. We anticipate that interest expense in future quarters could fluctuate significantly depending on possible refinancing or restructuring activities in the second quarter of 2020.
Benefit from income taxes
The benefit from income taxes for the three months endedMarch 31, 2020 and 2019 was$45,000 and$8,000 , respectively. Income taxes for both of the periods are primarily comprised of state taxes during the period. 31
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We periodically evaluate the realizability of our net deferred tax assets based on all available evidence, both positive and negative. The realization of net deferred tax assets is dependent on our ability to generate sufficient future taxable income during periods prior to the expiration of tax attributes to fully utilize these assets. We weighed both positive and negative evidence and determined that there is a continued need for a full valuation allowance on our deferred tax assets in theU.S. as ofMarch 31, 2020 . Should there be a change in our ability to recover our deferred tax assets, we would recognize a benefit to our tax provision in the period in which we determine that it is more likely than not that we will recover its deferred tax assets.
LIQUIDITY AND CAPITAL RESOURCES
Cash. Cash, cash equivalents and available for sale securities totaled$32.9 million atMarch 31, 2020 , as compared to$32.6 million atDecember 31, 2019 . The increase was primarily due to positive cash flows from operations. Our investment policy has the primary investment objectives of preservation of principal; however, there may be times when certain of the securities in our portfolio will fall below the credit ratings required in the policy. If those securities are downgraded or impaired, we would experience realized or unrealized losses in the value of our portfolio, which would have an adverse effect on our results of operations, liquidity and financial condition. From time to time, the Company may also invest its cash to retire or purchase its outstanding debt, make asset acquisitions, conduct research and development or expand the Company. Investment securities are exposed to various risks, such as interest rate, market and credit. Due to the level of risk associated with certain investment securities and the level of uncertainty related to changes in the value of investment securities, it is possible that changes in these risk factors in the near term could have an adverse material impact on our results of operations or stockholders' deficit. Our cash and cash equivalents as ofMarch 31, 2020 andDecember 31, 2019 consisted of cash deposits and money market funds. Accounts Receivable. We extend credit to our customers for product sales resulting in accounts receivable. Customer accounts are monitored for past due amounts. Past due accounts receivable, determined to be uncollectible, are written off against the allowance for doubtful accounts. Allowances for doubtful accounts are estimated based upon past due amounts, historical losses and existing economic factors, and are adjusted periodically. Historically, we have had no significant uncollectable accounts receivable. We offer cash discounts to our customers, generally 2% of the sales price as an incentive for prompt payment. Accounts receivable (net of allowance for cash discounts) atMarch 31, 2020 , was$24.7 million , compared to$22.3 million atDecember 31, 2019 . Summary Cash Flows Three Months Ended March 31, 2020 2019 Cash provided by (used for): (in thousands) Operating activities$ 114 $ (6,940) Investing activities - (450) Financing activities (52) - Operating Activities. For the three months ended March 31, 2020, cash provided by operating activities resulted from our net loss as adjusted for non-cash items, in addition to increases in accounts payable and accrued and other liabilities, partially offset by increases in accounts receivable and inventories. For the three months endedMarch 31, 2019 , cash used for operating activities resulted from our net loss as adjusted for non-cash items, including the decrease in deferred revenue, partially offset by decreases in accounts receivable and inventories and a decrease in accounts payable. Investing Activities. Cash used for investing activities for the three months endedMarch 31, 2019 resulted primarily from the net purchases from sales and maturities of our investment securities.
Financing Activities. Cash used by financing activities for the three months
ended
We do not currently have sufficient cash and/or credit facilities in place to pay the debt dueMay 1, 2020 . OnApril 29, 2020 , we entered into an agreement withIEH Biopharma LLC , which holds a principal amount of approximately$170.2 million of our Convertible Notes with a maturity date ofMay 1, 2020 . Under the terms of the agreement, we paid IEH Biopharma$3.8 million in accrued and unpaid interest on the Convertible Notes and IEH 32
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Biopharma granted us a 30-day grace period (if not terminated sooner pursuant to the terms of the agreement), beginningMay 1 , for payment of the principal amount of the Convertible Notes during which the two parties will work exclusively to attempt to restructure the outstanding principal amount of the Convertible Notes. As part of the agreement, we paid$7.5 million to settle the remaining$11.3 million in principal and$253,000 in accrued and unpaid interest held by other holders. We are actively pursuing funding or a restructuring of our debt, which may come through public or private debt or equity financings, collaborations or other available financing sources. Such funding may not be available on acceptable terms, or at all. If additional funds are raised by issuing equity securities, substantial dilution to existing stockholders may result. If adequate funds are not available, we will not be able to continue our operations at our current level and may be required to relinquish rights to certain of our technologies, product candidates or products that we would otherwise seek to develop on our own. We might also be required to delay, reduce the scope of or eliminate one or more of our commercialization or development programs or obtain funds through collaborations with others that are on unfavorable terms or restructure VIVUS in other ways that may not be favorable. Even if adequate funds become available, we may need to raise additional funds in the near future to finance operations and pursue development and commercial opportunities. Our unaudited condensed consolidated financial statements have been prepared assuming that we will continue as a going concern. Our coming debt maturities as well as our negative cash flow from operations and accumulated deficit raise substantial doubt about our ability to continue as a going concern. Our unaudited condensed consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Off-Balance Sheet Arrangements
We have not entered into any off-balance sheet financing arrangements and have not established any special purpose entities. We have not guaranteed any debt or commitments of other entities or entered into any options on non-financial assets.
Commitments and Contingencies
We indemnify our officers and directors for certain events or occurrences pursuant to indemnification agreements, subject to certain limits. We may be subject to contingencies that may arise from matters such as product liability claims, legal proceedings, stockholder suits and tax matters and as such, we are unable to estimate the potential exposure related to these indemnification agreements. We have not recognized any liabilities relating to these agreements as ofMarch 31, 2020 . Contractual Obligations During the three months endedMarch 31, 2020 , there were no material changes to our contractual obligations described under Management's Discussion and Analysis of Financial Condition and Results of Operations contained in Part II, Item 7 of our Annual Report on Form 10-K for our fiscal year endedDecember 31, 2019 , filed with theSEC onMarch 3, 2020 , other than the fulfillment of existing obligations in the ordinary course of business.
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