AQUESTIVE THERAPEUTICS, INC. Management’s Discussion and Analysis of Financial Condition and Results of Operations (Form 10-K)
The following discussion of our financial condition and results of operations should be read in conjunction with our financial statements and the notes to those financial statements appearing elsewhere in the Annual Report on Form 10-K. This discussion contains forward-looking statements that involve significant risks and uncertainties. As a result of many factors, such as those set forth under "Risk Factors" in Part 1 Item 1A of this Annual Report on Form 10-K, our actual results may differ materially from those anticipated in these forward-looking statements. All dollar amounts are stated in thousands.
Aquestive Therapeutics, Inc.is a pharmaceutical company advancing medicines to solve patients' problems with current standards of care and provide transformative products to improve their lives. We are developing orally administered products to deliver complex molecules, providing novel alternatives to invasive and inconvenient standard of care therapies. Aquestive has five commercialized products on the U.S. market, four licensed products and one stand-alone proprietary product to date, Sympazan® (clobazam) oral film for the treatment of seizures associated with Lennox-Gastaut Syndrome. Our licensees market their products in the U.S.and around the world. The Company also collaborates with pharmaceutical companies to bring new molecules to market using proprietary, best-in-class technologies, like PharmFilm®, and has proven drug development and commercialization capabilities. Aquestive is advancing a late-stage proprietary product pipeline focused on treating diseases of the central nervous system, or CNS, and an earlier stage pipeline for the treatment of severe allergic reactions, including anaphylaxis. For a summary of our product and product candidates, please refer to Item I. Business of this Form 10-K.
Business update regarding COVID-19
The current COVID-19 pandemic has continued to present substantial health and economic risks, uncertainties and challenges to our business, the
U.S.and global economies and financial markets. It is not currently possible to predict how long the pandemic will last or the time it will take for the economy to return to prior levels. The extent to which COVID-19 impacts our business, operations, clinical trials, regulatory approval process, capital, financial and monetization markets, financial results and financial condition, and those of our suppliers, distributors, customers and other third parties necessary to our business including those involved in the regulatory approval process, will depend on future developments, which are highly uncertain and cannot be predicted with certainty or clarity, including the duration and continuing severity of the outbreak, resurgence of the outbreak, continued or additional government actions to contain COVID-19, timing or efficacy of any vaccine, and new information that will emerge concerning the short-term and long-term impact of COVID-19. To date, we have been able to continue to manufacture and supply our products and currently do not anticipate any significant interruption in supply, although we continue to monitor this situation closely and there is no assurance that disruptions or delay will not occur as a result of COVID-19. We are also monitoring demand for our products, which could be negatively impacted during the COVID-19 pandemic, as well as the financial condition of our customers and licensees, one of whom delayed remittance of certain payments due to us for development services provided but ultimately made such payments. Our office-based colleagues have generally been working from home since March 2020. With additional protections and protocols, we have maintained appropriate and necessary staffing levels at both our laboratory and manufacturing sites. While we previously suspended in-person interactions by our sales and marketing personnel and engaged remotely to support our commercialization efforts, our sales and marketing practices continue to evolve in accordance with changing local rules and regulations. We believe the opportunity for in-person interactions with healthcare providers should increase as the vaccination rate continues to grow. The landscape continues to evolve as localities reestablish and or ease restrictions, as the case may be, with the rise and fall of new case rates and the pace of vaccinations.
For more information on the various uncertainties and risks caused by the COVID-19 pandemic, see Section Part I. Section IA. Risk factors included in this report.
Overview of financial operations
Our revenues to date have been earned from our manufactured products made to order for licensees, as well as revenue from our self-developed, self-commercialized proprietary product, Sympazan®. Revenues are also earned from our product development services provided under contracts with customers, and from the licensing of our intellectual property. These activities generate revenues in four primary categories: manufacture and supply revenue, co-development and research fees, license and royalty revenue, and proprietary product sales, net.
Manufacturing and Sourcing Revenue
We manufacture based on receipt of purchase orders from our licensees, and our licensees have an obligation to accept these orders once quality assurance validates the quality of the manufactured product with agreed upon technical specifications. Our licensees are responsible for all other aspects of commercialization of these products and we have no role, either direct or indirect, in our customers' commercialization activities, including those related to marketing, pricing, sales, payor access and regulatory operations. 61 -------------------------------------------------------------------------------- We expect future manufacture and supply revenue from licensed products to be based on volume demand for existing licensed products, and for manufacturing and supply rights under license and supply agreements for existing or new agreements for successful product development collaborations.
Co-development and research costs
We work with our licensees to co-develop pharmaceutical products. In this regard, we earn fees through performance of specific tasks, activities, or completion of stages of development defined within a contractual arrangement with the relevant licensee. The nature and extent of these performance obligations, broadly referred to as milestones or deliverables, are usually dependent on the scope and structure of the project as contracted, as well as the complexity of the product and the specific regulatory approval path necessary for that product.
Revenue from licenses and royalties
We realize revenue from licenses of our intellectual property. For licenses that do not require further development or other ongoing activities by us, our licensee has acquired the right to use the licensed intellectual property for self-development of their product candidate, for manufacturing, commercialization or other specified purposes, upon the effective transfer of those rights, and related revenues are generally recorded at a point in time, subject to contingencies or constraints, if any. For licenses that may provide substantial value only in conjunction with other performance obligations to be provided by us, such as development services or the manufacture of specific products, revenues are generally recorded over the term of the license agreement. We also earn royalties based on our licensees' sales of products that use our intellectual property that are marketed and sold in the countries where we have patented technology rights. Royalty revenue related to the sale of future revenue is described further in this section under Critical Accounting Policies and Use of Estimates "Royalty Revenue and Interest Expense related to Sale of Future Revenue".
Sales of exclusive products, net
We commercialized our first proprietary CNS product, Sympazan, in
December 2018. We currently sell Sympazan through wholesalers for distribution through retail and specialty pharmacies. Revenues from sales of proprietary product are recorded net of prompt payment discounts, wholesaler service fees, returns allowances, rebates and co-pay support redemptions, each of which are described in more detail below. These reserves are based on estimates of the amounts earned or to be claimed on the related sales. These amounts are treated as variable consideration, estimated and recognized as a reduction of the transaction price at the time of the sale. We include these estimated amounts in connection with the transaction price to the extent it is probable that a significant reversal of cumulative revenue recognized for such transaction will not occur, or when the uncertainty associated with the variable consideration is resolved. The calculation of some of these items requires management to make estimates based on sales data, historical return data, contracts and other related information that may become known in the future. The adequacy of these provisions is reviewed on a quarterly basis.
Costs and expenses
Our costs and expenses are primarily the result of the following activities: generation of manufacture and supply revenues; development of our pipeline of proprietary product candidates; and selling, general and administrative expenses, including pre-launch and post-launch commercialization efforts, intellectual property procurement, protection, prosecution and litigation expenses, corporate management functions, medical and clinical affairs administration; public company costs, share-based compensation expenses and interest on our corporate borrowings. We primarily record our costs and expenses in the following categories:
Manufacturing and procurement costs and expenses
Manufacture and supply costs and expenses are primarily incurred from the manufacture of our commercialized licensed pharmaceutical products and for our self-developed, self-commercialized, approved proprietary product, including raw materials, direct labor and overhead costs principally in our
Portage, Indianafacilities. Our material costs include the costs of raw materials used in the production of our proprietary dissolving film and primary packaging materials. Direct labor costs consist of payroll costs (including taxes and benefits) of employees engaged in production activities. Overhead costs principally consist of indirect payroll, facilities rent, utilities and depreciation for leasehold improvements and production machinery and equipment. These costs can increase, or decrease, based on the costs of materials, purchased at market pricing, and the amount of direct labor required to produce a product, along with the allocation of fixed overhead, which is dependent on production volume. Our manufacture and supply costs and expenses are impacted by our customers' supply requirements. Costs of production reflect the costs of raw materials that are purchased at market prices and production efficiency (measured by the cost of a salable unit). These costs can increase or decrease based on the amount of direct labor and materials required to produce a product and the allocation of fixed overhead, which is dependent on the levels of production. We expect to continue to seek to rationalize and manage costs to prepare for a potential decline in Suboxone volumes as the generics in that market continue to take market share, modestly offset by the commercialization of our proprietary products, starting with Sympazan launched in December 2018. In addition to our proprietary products coming online, we may add licensee products which may need additional resources to manufacture. If such growth should occur for higher volume product opportunities such as Suboxone, we would incur increased costs associated with hiring additional personnel to support the increased manufacturing and supply costs arising from higher manufactured volumes from proprietary and licensed products. 62 --------------------------------------------------------------------------------
Research and development costs
Since our inception, we have focused significant resources on our research and development activities. Research and development expenses mainly include:
•personnel expenses, including compensation, benefits, stock-based compensation and travel expenses;
•external research and development expenses incurred under arrangements with third parties, such as contract research organizations, investigational sites and consultants;
•the cost of acquiring, developing and manufacturing clinical study material; and
•costs associated with preclinical and clinical activities and regulatory operations.
We expect our research and development expenses to continue to be significant over the next several years as we continue to develop existing product candidates such as AQST-109, AQST-108, AQST-305 and others, and we identify and develop or acquire additional product candidates and technologies. We may hire or engage additional skilled colleagues or third parties to perform these activities, conduct clinical trials and ultimately seek regulatory approvals for any product candidate that successfully completes those clinical trials.
Selling, general and administrative expenses
Selling, general and administrative expenses consist primarily of salaries, benefits, share-based compensation, commercialization and marketing costs and other related costs for executive, finance, selling and operational personnel. Other costs include facility and related costs not otherwise included in research and development expenses such as: professional fees for patent-related and other legal expenses, consulting, tax and accounting services; insurance; selling; market research; advisory board and key opinion leaders; depreciation; and general corporate expenses, inclusive of IT systems related costs. A significant portion of selling, general and administrative expenses relates to the sale and marketing of our proprietary product, Sympazan. Sympazan is the precursor and complement to the launch of Libervant, assuming that Libervant is approved and granted U.S. market access by the FDA. We believe there is a very high degree of overlap and correlation between prescribers of Sympazan and the likely prescribers of an approved Libervant. While Sympazan continues to grow, we will continue to rationalize its contribution to move towards profitability while continuing to introduce epilepsy prescribers and patients to Aquestive and PharmFilm® technology in advance of the anticipated launch of Libervant, assuming FDA approval for U.S. market access, which cannot be assured. The current commercial organization would begin the launch of Libervant, subject to approval of Libervant for U.S. market access by the FDA, shortly after its approval. Until a Libervant launch is certain, we do not plan to increase the costs of our commercial organization and expect to continue to improve the efficiency of the Sympazan commercial investments. Our general and administrative costs include costs related to accounting, audit, legal regulatory, and tax-related services required to maintain compliance with exchange listing and
SECregulations, director and officer insurance costs, and investor and public relations costs. We continue to incur significant costs in seeking to protect our intellectual property rights, including significant litigation costs in connection with seeking to enforce our rights concerning third parties' at-risk launch of generic products. We will continue to manage business costs to prepare for a potential future decline in Suboxone revenue, the marketing and sales costs related to Sympazan and other external factors affecting our business,, as we continue to focus on our core business:
•seek approval and subsequent launch of Libervant, subject to FDA approval for US market access, which cannot be assured;
•Continue development of AQST-109 and AQST-108 along the 505(b)(2) pathway; and
• Increase Sympazan’s revenue contribution as a first step in positioning Aquestive in the epilepsy community.
Interest expense consists of interest costs on our 12.5% Notes at a fixed rate of 12.5%, payable quarterly, as well as amortization of loan costs and the debt discount. The 12.5% Notes are discussed in Note 12, 12.5% Senior Secured Notes due 2025, to our consolidated financial statements. See Liquidity and Capital Resources below for further detail on our 12.5% Notes.
Royalty income and interest expense related to the sale of future income
November 3, 2020, we entered into a Purchase and Sale Agreement (the "Monetization Agreement") with MAM Pangolin Royalty, LLC, an affiliate of Marathon Asset Management ("Marathon"). Under the terms of the Monetization Agreement, we sold all of our contractual rights to receive royalties and milestone payments due under the Sunovion License Agreement related to Sunovion's apomorphine product, KYNMOBI. KYNMOBI, an apomorphine film therapy for the treatment of off episodes in Parkinson's disease patients, received approval from the U.S. Food and Drug Administration(FDA) on May 21, 2020. In exchange for the sale of these rights, we received an 63 --------------------------------------------------------------------------------
initial payment of
Under the Monetization Agreement, additional aggregate contingent payments of up to
$75,000may be due to us upon the achievement of worldwide royalty and other commercial targets within a specified timeframe, which could result in total potential proceeds of $125,000. Based on the current forecast of estimated KYNMOBI sales as of December 31, 2021, the Company may not receive any of the additional aggregate contingent payments under the Monetization agreement. During the second quarter of 2020, under the Sunovion License Agreement, we recognized $8,000of royalty revenue and corresponding royalty receivable, related to the $1,000annual minimum guaranteed royalty that is due in each of the next eight years. In connection with the Monetization Agreement, we performed an assessment under ASC 860, Transfer and Servicing to determine whether the existing receivable was transferred to Marathon and concluded that the receivable was not transferred. See Note 14, Sale of Future Revenue, to our consolidated financial statements for further detail.
Interest income and other income (expenses), net
Interest income and other income (expense), net consists of earnings derived from an interest-bearing account and other miscellaneous income and expense items. The interest-bearing account has no minimum amount to be maintained in the account nor any fixed length of period for which interest is earned.
Comparison of completed exercises
The following discussion of our operating results explains the significant factors in these operating results.
The following table shows our revenue data for the periods indicated.
Change 2021 2020 $ % (In thousands, except %) Manufacture and supply revenue
$ 35,312 $ 24,881 $ 10,43142 % License and royalty revenue 5,380 14,055 (8,675) (62 %) Co-development and research fees 1,635 1,264 371 29 % Proprietary product sales, net 8,505 5,649 2,856 51 % Revenues $ 50,832 $ 45,849 $ 4,98311 % Revenues increased 11% or $4,983in 2021 compared to the same period in 2020. The increase was primarily due to higher Sympazan revenue and manufacture and supply revenue, offset by lower license and royalty revenue. Manufacture and supply revenue increased approximately 42% or $10,431for the year ended December 31, 2021compared to the same period in 2020. This increase was due to higher Suboxone manufacturing volume. License and royalty revenue decreased 62% or $8,675for the year ended December 31, 2021compared to the same period in 2020. This decrease was due to a milestone earned of $4,000as well as royalty revenue of $8,000recognized upon the FDA approval of Sunovion's KYNMOBI ™ product during the second quarter of 2020 that did not reoccur in 2021. This was partly offset by an increase in milestones earned from KemPharm, Inc. of $1,500and the recognition of remaining deferred revenue of over $2,000associated with the license and supply agreement for Zuplenz with Fortovia Therapeutics Inc.which was terminated in the first quarter of 2021.
Co-development and research costs increased by 29% or
Proprietary product sales, net increased 51% or
$2,856for the year ended December 31, 2021compared to the same period in 2020. The increase was due to a steady rise in acceptance with the medical and patient communities over time which has led to increased prescriptions and improved payor approval rates for Sympazan. Expenses:
The following table shows our spending data for the periods indicated:
Change 2021 2020 $ % (In thousands, except %) Manufacture and supply
$ 14,989 $ 12,964 $ 2,02516 % Research and development 17,047 19,886 (2,839) (14 %) Selling, general and administrative 53,475 55,892 (2,417) (4 %) Interest expense 10,049 11,064 (1,015) (9 %) Interest expense related to the sale of future revenue 12,412 1,958 10,454 534 % Interest income and other income, net (423) (132) (291) 220 % Loss on extinguishment of debt 13,822 - 13,822 100 % Manufacture and supply costs and expenses increased 16% or $2,025for the year ended December 31, 2021compared to the same period in 2020. The increase in manufacture and supply costs was due to volume growth of Suboxone. Research and development expenses decreased 14% or $2,839for the year ended December 31, 2021compared to the same period in 2020. Research and development expenses are driven by the delayed timing of clinical trial as well as other product development activities associated with the Company's pipeline. Below are research and development expenses by type of cost for each period presented: Year Ended December 31, (In thousands) 2021 2020 Clinical Trials $ 3,189 $ 6,435Labor - R&D staff 4,915 4,857 Development and manufacturing 1,538 2,034 Preclinical 599 667 All Other R&D 6,806 5,893 Total $ 17,047 $ 19,886Selling, general and administrative expenses decreased 4% or $2,417for the year ended December 31, 2021as compared to the same period in 2020. The decrease was due to lower sales and marketing costs and patent costs, partially offset by an increase in litigation expense that arose through the course of business.
Interest expense decreased by 9% or
compared to the same period in 2020. The decrease is due to lower outstanding debt in 2021 due to the partial redemption of the 12.5% notes in
Interest expense related to the sale of future revenue was
$12,412for the year ended December 31, 2021. This amount is due to the accounting associated with the sale of future revenue related to KYNMOBI royalties sold to Marathon on November 3, 2020and does not represent or imply a monetary obligation or cash output at any time during the life of the transaction. See Note 14 to our Consolidated Financial Statements for details. Interest income and other income, net increased 220% or $291for the year ended December 31, 2021compared to the same period in 2020. This increase was due to the fair value adjustment of the put option related to the 12.5% Notes. See Note 12 to our Consolidated Financial Statements for details. Loss on the extinguishment of debt was $13,822for the year ended December 31, 2021. During 2021, we recognized loss on extinguishment of debt for fees and expenses related to the Fourth Supplemental Indenture that was executed in October 2021. The loss on extinguishment of debt was a one-time charge that did not occur in 2020.
Cash and capital resources
Sources of liquidity
We have experienced a history of net losses. Our accumulated deficits totaled
$256,796as of December 31, 2021. The net losses and accumulated deficits were partially offset by gross margins from sales of commercialized licensed and proprietary products, license fees, milestone and royalty payments from commercial licensees and co-development parties. Our funding requirements are met by our cash and 65 -------------------------------------------------------------------------------- cash equivalents, as well as our existing equity and debt offerings, including the Senior Secured Notes due 2025 (the "12.5% Notes"). We had $28,024in cash and cash equivalents as of December 31, 2021. On November 3, 2020, we entered into a Purchase and Sale Agreement (the "Monetization Agreement") with MAM Pangolin Royalty, LLC, an affiliate of Marathon Asset Management ("Marathon"). Under the terms of the Monetization Agreement, we sold all of our contractual rights to receive royalties and milestone payments due under the Sunovion License Agreement related to Sunovion's apomorphine product, KYNMOBI. KYNMOBI, an apomorphine film therapy for the treatment of off episodes in Parkinson's disease patients, received approval from the U.S. Food and Drug Administration(FDA) on May 21, 2020. We have received an aggregate amount of $50,000through December 31, 2021under the Monetization Agreement. Under the Monetization Agreement, additional aggregate contingent payments of up to $75,000may be due to us upon the achievement of worldwide royalty and other commercial targets within a specified timeframe, which could result in total potential proceeds of $125,000. Based on the current forecast of estimated KYNMOBI sales as of December 31, 2021, the Company may not receive any of the additional aggregate contingent payments under the Monetization agreement. With the upfront proceeds of the monetization, we repaid $22,500of the 12.5% Notes, and issued $4,000of new 12.5% Notes in lieu of paying a prepayment premium on the early repayment of the 12.5% Notes, reducing the aggregate principal balance of 12.5% Notes outstanding to $51,500. In addition, the holders of the 12.5% Notes agreed to extend to December 31, 2021our ability to access, at our option, and additional $30,000of 12.5% Notes re-openers under the Indenture. The first $10,000senior notes re-opener represents a commitment of such amount by current holders of 12.5% Notes, at our option, contingent upon FDA approval of our product candidate Libervant. A second $20,000senior notes re-opener represents a right, at our option, to market to current holders of our 12.5% Notes, and/or other lenders, additional senior notes up to such amount, contingent upon FDA approval of Libervant for U.S. market access. If and to the extent that we access these re-openers, we will grant warrants to purchase up to 714,000 shares of common stock, with the strike price calculated based on the 30-day volume weighted average closing price of our common stock at the warrant grant date. In addition, as of the closing of this transaction, we issued to the holders of the 12.5% Notes warrants to purchase 143,000 shares of our common stock. On August 6, 2021, pursuant to the Third Supplemental Indenture, the holders of the 12.5% Notes extended to June 30, 2022from December 31, 2021, our ability to access, at our option, $30,000of 12.5% Notes re-openers under the Indenture. The first $10,000of 12.5% Notes represents a commitment of such amount by current holders of 12.5% Notes, at the option of the Company, contingent upon FDA approval of the Company's product candidate Libervant (diazepam) Buccal Film for the management of seizure clusters. A second $20,00012.5% Notes re-opener represents a right, at the Company's option, to market to current holders of the Company's 12.5% Notes, and or other lenders, additional 12.5% Notes up to such amount, contingent upon FDA approval of Libervant for U.S. market access. If and to the extent that the Company accesses these re-openers, it will grant warrants to purchase up to 714,000 shares of common stock, with the strike price calculated based on the 30-day volume weighted average closing price of the Company's common stock at the warrant grant date. On September 30, 2021, the Company entered into a waiver agreement (the "Waiver") with the holders of the 12.5% Notes pursuant to which the principal payment due under the 12.5% Notes on September 30, 2021was deferred in order to provide sufficient time for the execution of the Fourth Supplemental Indenture (the "Fourth Supplemental Indenture"). On October 7, 2021, the Company entered into the Fourth Supplemental Indenture, by and among the Company and the Trustee and collateral agent thereunder, to the Indenture in connection with the 12.5% Notes. Pursuant to the Fourth Supplemental Indenture, the amortization schedule for the 12.5% Notes was amended to provide for the date of the first amortization payment to be extended to March 30, 2023. The Fourth Supplemental Indenture did not change the maturity date of the Notes or the interest payment obligation due under the Notes. In connection with the Fourth Supplemental Indenture, the Company entered into a Consent Fee Letterwith the holders of the 12.5% Notes, pursuant to which the Company agreed to pay the holders of the 12.5% Notes an additional cash payment of $2,700in the aggregate, payable in four quarterly payments beginning May 15, 2022. See Note 12 to our Consolidated Financial Statements for discussion. In 2019, we established an "at-the-market" (ATM) facility pursuant to which we may offer up to $25,000of shares of common stock. We began utilizing the ATM facility in November 2020. For the year ended December 31, 2020, we sold 930,993 shares which provided net proceeds of approximately $6,055after deducting commissions and other transaction costs of $473. On March 26, 2021, we filed a prospectus supplement to offer up to an additional $50,000of shares of common stock under the ATM facility. For the year ended December 31, 2021, the Company sold 6,550,486 shares which provided net proceeds of approximately $29,778after deducting commissions and other transaction costs of $1,291. This ATM facility has approximately $37,408available at December 31, 2021. Cash Flows
The following table provides information on our cash flows for the years ended
66 -------------------------------------------------------------------------------- (In thousands) 2021
Net cash used for operating activities
Net cash used for investing activities (913)
Net cash provided by financing activities 30,109
(Decrease) net increase in cash and cash equivalents
Net cash used for operating activities for the year ended
December 31, 2021decreased by $12,480compared to the same period in 2020. The decrease was related to higher non-cash operating expenses of $24,553, changes in operating assets and liabilities of $2,683, partially offset by a higher net loss of $14,756. The higher non-cash operating expenses were primarily due to a loss on the extinguishment of debt ( $13,822) and an increase in interest expense related to sale of future revenue ( $10,315). The change in operating assets and liabilities was primarily due to timing of payments related to prepaid expenses and other assets, accounts payable, accrued expenses and other liabilities, offset by higher trade and other receivables due to increased revenue.
Net cash used in investing activities for the year ended
Net cash provided by financing activities
Net cash provided by financing activities for the year ended
December 31, 2021increased by $1,652compared to the same period in 2020. The increase was primarily related to net proceeds from the sale of shares under the ATM facility in 2021, partially offset by several non-recurring events in 2020. In 2020, we received $50,000of proceeds under the Monetization Agreement. With the proceeds of the monetization, we repaid $22,500of the 12.5% Notes, and issued $4,000of new 12.5% Notes in lieu of paying a prepayment premium on the early repayment of the 12.5% Notes. In connection with the early repayment and issuance of new 12.5% Notes, we paid $2,909in financing costs and $2,250of premium related to the early repayment. Funding Requirements Based on our current operating plan, we believe that our existing cash and cash equivalents, revenue from our on-going business, continued business development activities, expense management actions, and our ability to access funds under our existing ATM facility and, assuming Libervant approval, our debt offering will enable us to fund our expected cash requirements for the next 12 months. We can provide no assurance that any of these sources of funding, either individually or in combination, will be available on reasonable terms, if at all. In addition, we may be required to utilize available financial resources sooner than expected. We have based our expectation on assumptions that could change or prove to be inaccurate, either due to the impact of COVID-19 or to unrelated factors including factors arising in the capital markets, asset monetization markets, regulatory approval process, including the approval of Libervant by the FDA, and regulatory oversight and other factors. Key factors and assumptions inherent in our planned continued operations and anticipated growth include, without limitation, those related to the following: •the effects of the COVID-19 pandemic on our operations, operations of our key suppliers and third-party clinical and other service providers, our colleagues and contractors and debt equity and other capital markets;
• our customers’ continued ability to pay, on a timely basis, for currently contracted and expected future orders for our manufactured products, Suboxone, Sympazan and Exservan, including the effects of generics and other competitive pressures as currently contemplated;
•the continued ability of our customers to pay, in a timely manner, currently contracted and anticipated future orders for co-development and feasibility services provided, as well as regulatory support services for recently licensed products, such as Exservan;
• access to the debt or equity markets if and when required for any future financing required;
•FDA approval of our new key drug candidate, Libervant, for access to the US market;
•our ability to issue up to
•ongoing review and appropriate adjustment of our cost structure in accordance with our expected revenues and funding;
67 -------------------------------------------------------------------------------- •continued growth and market penetration of Sympazan within expected commercialization cost levels for this product, including anticipated patient and physician acceptance and our ability to obtain adequate price and payment support from government agencies and other private medical insurers;
•the effective commercialization within the cost levels and the expected ramp-up times of our product candidate Libervant, if it is approved for US market access by the FDA;
• infrastructure and administrative costs at the levels expected to support operations as an FDA and a highly regulated public company;
•a manageable level of costs for ongoing efforts to protect our intellectual property rights, including litigation costs related to attempting to enforce our rights regarding the “at risk” launch of generic products by third parties;
•continued compliance with all covenants under our 12.5% Notes; and
•absence of significant unforeseen cash requirements.
We expect to continue to manage business costs to appropriately reflect the anticipated general decline in Suboxone revenue, the marketing and sales costs related to Sympazan, the proceeds from the KYNMOBI Monetization Agreement, and other external resources or factors affecting our business including, if available, any future potential issuances of additional 12.5% Notes under the Indenture, net proceeds or future equity financing, other future access to the capital markets or other potential available sources of liquidity, as well as the uncertainties associated with the coronavirus pandemic. In doing so, we plan to continue to focus on the core drivers of value for our stockholders, including, more importantly, continued investments in our ongoing product development and planned commercialization activities in support of Libervant, AQST-109 and AQST-108. Until sufficient profitability is achieved, if at all, additional capital and/or other financing or funding will be required, which could be material, to further advance the development and commercialization of Libervant, AQST-109 and AQST-108, if approved by the FDA for U.S. market access, and to meet our other cash requirements, including debt service. We plan to conservatively manage our pre-launch spending as to both timing and level relating to Libervant, including cost rationalization associated with marketing and selling Sympazan. In this regard, absent spending on launch activities for Libervant, we expect to continue to spend less on commercialization in 2021 compared to 2020. Even as such, we expect to incur losses and negative cash flows for the foreseeable future and, therefore, we expect to be dependent upon external financing and funding to achieve our operating plan. The sufficiency of our short-term and longer-term liquidity is directly impacted by our level of operating revenues and our ability to achieve our operating plan for revenues, regulatory approval in the time period planned for our late-stage proprietary products and our ability to monetize other royalty streams or other licensed rights within planned timeframes. Although we may also be entitled to further potential milestones, royalty and other payments under our Indivior Supplemental Agreement, which are suspended and may only be reinstated if Indivior successfully adjudicates or settles the related patent infringement litigation, and under the KYNMOBI Monetization Agreement, there can be no assurance when, or if, any such payments may be realized. Our operating revenues have fluctuated in the past and can be expected to fluctuate in the future. We expect to incur significant operating losses and negative operating cash flows for the foreseeable future, and we have a significant level of debt on which we have substantial ongoing debt repayment and debt service obligations and have principal repayments related to our 12.5% Notes due through the debt maturity date, which is further discussed in Note 12 to our Consolidated Financial Statements. A substantial portion of our current and past revenues has been dependent upon our licensing, manufacturing and sales with one customer, Indivior, which is expected to continue while we commercialize our own proprietary products and it could take significantly longer than planned to achieve anticipated levels of cash flows to help fund our operations and cash needs from sales of our proprietary products. To the extent that we raise additional funds by issuance of equity securities, our stockholders would experience further dilution and the terms of these securities could include liquidation or other preferences (if and to the extent permitted under the Indenture) that would adversely affect our stockholders' rights. Our ability to secure additional equity financing could be significantly impacted by numerous factors including our operating performance and prospects, positive or negative developments in the regulatory approval process for our proprietary products, timely achievement of regulatory approval of our late-stage proprietary products, our existing level of debt which is secured by substantially all of our assets, restriction under the Indenture, and general market conditions, and there can be no assurance that we will continue to be successful in raising capital or that any such needed financing will be available, available on favorable or acceptable terms or at the times, or in the amounts needed, if at all. Additionally, while the potential economic impact brought on by and the duration of the coronavirus pandemic is difficult to assess or predict, the significant impact of the coronavirus pandemic on the global financial markets, and on our own stock trading price, may reduce our ability to access additional capital, which would negatively impact our short-term and longer-term liquidity. 68 -------------------------------------------------------------------------------- If adequate funds are not available for our short-term or longer-term liquidity needs and cash requirements as and when needed, we would be required to engage in expense management activities such as reducing staff, delaying, significantly scaling back, or even discontinuing some or all of our current or planned research and development programs and clinical and other product development activities, or reducing our planned commercialization efforts and otherwise significantly reducing our other spending and adjusting our operating plan, and we would need to seek to take other steps intended to improve our liquidity. We also may be required to evaluate additional licensing opportunities, if any become available, of our proprietary product candidate programs that we currently plan to self-commercialize or explore other potential liquidity opportunities or other alternatives or options or strategic alternatives, although we cannot assure that any of these actions would be available or available on reasonable terms.
See also Part I, Item II, Risk Factors regarding significant risks and uncertainties regarding the Company’s business, operations, financial results and capital resources associated with the impact of the global coronavirus pandemic.
Contractual obligations and commitments
We have entered into various contractual agreements under which we have long term obligations. For more information regarding our commitments, see Part II, Item 8. Financial Statements and Supplementary Data, Note 20. Contingencies. For more information regarding our future lease payments, see "Part II, Item 8. Financial Statements and Supplementary Data, Note 9. Right of Use Assets and Lease Liabilities" for our minimum lease payments schedule. The expected timing of our leases may be different if future years, depending on our decision to extend lease terms and/or enter into leases in preceding years.
For more information on our repayments of our 12.5% Notes, see Part II, Item 8. Financial Statements and Supplementary Data, Note 12. 12.5% Senior Secured Notes.
Significant Accounting Policies and Use of Estimates
We have based our Management's Discussion and Analysis of our financial condition and results of operations on our Consolidated Financial Statements, which have been prepared in accordance with generally accepted accounting principles, or GAAP, in the
U.S.The preparation of the Consolidated Financial Statements requires us to make estimates and judgments that affect the reported amounts of assets and liabilities at the date of the financial statements as well as the revenues and expenses during the reporting periods. On an ongoing basis, we evaluate our estimates and judgments. We base our estimates on historical experience when available and on various other assumptions that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. While significant accounting policies are more fully described in Note 3, Summary of Significant Accounting Policies, of the Notes to our Consolidated Financial Statements included in this filing, we believe that the following accounting policies are those that are most critical to the significant judgements and estimates used in the preparation of our Consolidated Financial Statements. Revenue Recognition Proprietary product sales, net - this net revenue is recognized when product is shipped and title passes to the customer, typically at time of delivery. At the time of sale, estimates for various revenue allowances are recorded based on historical trends and judgmental estimates. For sales of Sympazan, returns allowances and prompt pay discounts are estimated based on contract terms and historical return rates, if available, and these estimates are recorded as a reduction of receivables. Similarly determined estimates are recorded relating to wholesaler service fees, co-pay support redemptions, Medicare, Medicaid and other rebates, and these estimates are reflected as a component of accrued liabilities. Once all related variable considerations are resolved and uncertainties as to collectable amounts are eliminated, estimates are adjusted to actual allowance amounts. Provisions for these estimated amounts are reviewed and adjusted on no less than a quarterly basis. License and Royalty Revenue - license revenues are determined based on an assessment of whether the license is distinct from any other performance obligations that may be included in the underlying licensing arrangement. If the customer is able to benefit from the license without provision of any other performance obligations by the Company and the license is thereby viewed as a distinct or functional license, the Company then determines whether the customer has acquired a right to use the license or a right to access the license. For functional licenses that do not require further development or other ongoing activities by the Company, the customer is viewed as acquiring the right to use the license as, and when, transferred and revenues are generally recorded at a point in time, subject to contingencies or constraints. For symbolic licenses providing substantial value only in conjunction with other performance obligations to be provided by the Company, revenues are generally recorded over the term of the license agreement. Such other obligations provided by the Company generally include manufactured products, additional development services or other deliverables that are contracted to be provided during the license term. Payments received in excess of amounts ratably or otherwise earned are deferred and recognized over the term of the license or as contingencies or other performance obligations are met. 69 -------------------------------------------------------------------------------- Revenue recognition arising from milestone payments is dependent upon the facts and circumstances surrounding the milestone payments. Milestone payments based on a non-sales metric such as a development-based milestone (e.g., an NDA filing or obtaining regulatory approval) represent variable consideration and are included in the transaction price subject to any constraints. If the milestone payments relate to future development, the timing of recognition depends upon historical experience and the significance a third party has on the outcome. For milestone payments to be received upon the achievement of a sales threshold, the revenue from the milestone payments is recognized at the later of when the actual sales are incurred or the performance obligation to which the sales relate to has been satisfied.
Liability related to the sale of future revenue, royalty revenue and interest expense
The Company treated the sale of future revenue related to KYNMOBI® as debt financing in accordance with ASC 470 Debt, amortized under the effective interest rate method over the estimated life of the related expected royalty stream. The liability related to the sale of future revenue has been initially recorded at its proceeds, net of deferred cost. The liability related to the sale of future revenue and the related interest expense are based on our current estimates of future royalties expected to be paid over the life of the arrangement. The Company will periodically assess the expected royalty payments using a combination of internal projections and forecasts from external resources. To the extent our future estimates of royalty payments are greater or less than previous estimates or the interest timing of such payments is materially different than its previous estimates, the Company will prospectively recognize related interest expense. Royalty revenue related to the sale of future revenue is reflected in license fees and royalties, and amortization of debt is reflected as interest expense related to the sale of future revenue in the Consolidated Statement of Operations and Comprehensive Loss. For further discussion of the sale of the future revenue, refer to Part II Item 8. Financial Statements and Supplementary Data, Note 14, Sale of Future Revenue.
Recent accounting pronouncements
Refer to Part II Item 8. Financial Statements and Supplementary Data, Note 3 "Summary of Significant Accounting Policies" in the accompanying Notes to our Consolidated Financial Statements for a discussion of recent accounting pronouncements. 70
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