The following discussion and analysis of our financial condition and results of operations should be read in conjunction with "our consolidated financial statements and related notes appearing elsewhere in this Annual Report on Form 10-K. This discussion and other parts of this Annual Report contain forward-looking statements that involve risks and uncertainties, such as statements regarding our plans, objectives, expectations, intentions and projections. Our actual results could differ materially from those discussed in these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in Item 1A "Risk Factors." Introduction We are a commercial stage medical device and biopharmaceutical company developing a platform of nitric oxide ("NO") generators and delivery systems (the "LungFit® platform") capable of generating NO from ambient air. Our first device, LungFit® PH received approval for PPHN inJune 2022 . LungFit® can deliver NO either continuously or for a fixed amount of time at various flow rates and has the ability to either titrate dose on demand or maintain a constant dose. We believe that LungFit® can be used to treat patients on ventilators that require NO, as well as patients with chronic or acute severe lung infections via delivery through a breathing mask or similar apparatus. Furthermore, we believe that there is a high unmet medical need for patients suffering from certain severe lung infections that the LungFit® platform can potentially address. Our current areas of focus with LungFit® is PPHN, AVP including COVID-19, BRO NTM lung infection and those with various severe lung infections with underlying COPD. Our current product candidates will be subject to premarket reviews and certifications or regulatory approvals by the FDA, as well as comparable foreign regulatory authorities in other countries or regions. We also expect to be certified under theEU MDR in the second half of calendar year 2022. We also expect to make certain regulatory filings outside of theU.S. this year. If certifications or regulatory approvals are obtained, we anticipate a product launch in 2023 outside of theU.S. COVID-19
The development of our product candidates and the commercialization of our approved product could be further disrupted and adversely affected by a resurgence of the COVID-19 pandemic. We experienced significant delays in the supply chain for the LungFit® system due to the redundancy in parts and suppliers for ventilator manufacturing, which have since been remedied. We continually assess the impact that COVID-19 may have on our business plans and our ability to conduct the preclinical studies and clinical trials as well as on our reliance on third-party manufacturing and our supply chain. However, there can be no assurance that we will be able to avoid part or all of any impact from COVID-19 or its consequences if a resurgence occurs. Financial Operations Overview
Critical Accounting Policies and Use of Estimates
Use of Estimates The preparation of consolidated financial statements in conformity with generally accepted accounting principles inthe United States requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses for the reporting period. Actual results could differ from those estimates. On an ongoing basis, we evaluate our significant estimates and assumptions including expense recognition and accrual assumptions under consulting and clinical trial agreements, stock-based compensation, impairment assessments, accounting for licensed rights to use technologies and other long-lived assets, contingency recognition and accruals and the determination of valuation allowance requirements on deferred tax attributes. Research and Development Research and development expenses are charged to the statement of operations as incurred. Research and development expenses include salaries, benefits, stock-based compensation and costs incurred by outside laboratories, manufacturers, clinical research organizations, consultants, and accredited facilities in connection with clinical trials and preclinical studies. Research and development expenses are partially offset by the benefit of tax incentive payments for qualified research and development expenditures from the Australian tax authority ("AU Tax Rebates"). We do not record AU Tax Rebates until payment is received due to the uncertainty of receipt. As ofMarch 31, 2022 , we have not received any AU Tax Rebates. 74 Stock-Based Compensation We measure the cost of employee and non-employee services received in exchange for an award of equity instruments based on the grant date fair value of the award. Fair value for restricted stock awards is valued using the closing price of our common stock on the date of grant. The grant date fair value is recognized over the period during which an employee and non-employee is required to provide service in exchange for the award - the requisite service period. The grant date fair value of employee share options is estimated using the Black-Scholes option pricing model. The risk-free interest rate assumptions were based upon the observed interest rates appropriate for the expected term of the equity instruments. The expected dividend yield was assumed to be zero as we have not paid any dividends since our inception and do not anticipate paying dividends in the foreseeable future. Due to our limited trading history, we utilize an implied volatility based on an aggregate of guideline companies. In 2020, we began to incorporate and weight our historical volatility with our peer group in order to obtain expected volatility. The peer companies selected have similar characteristics, including industry and market capitalization. We routinely review our calculation of volatility based on our life cycle, our peer group, and other factors. We use the simplified method to estimate the expected term.
Licensed Right to Use Technology
Licensed right to use technology that is considered platform technology with alternative future uses is recorded as an intangible asset and is being amortized on a straight-line method over its estimated useful life, determined to be thirteen years. Income Taxes We account for income taxes using the asset and liability method. Accordingly, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between financial statement carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in the tax rate is recognized in income or expense in the period that the change is effective. Tax benefits are recognized when it is probable that the deduction will be sustained. A valuation allowance is established when it is more likely than not that all or a portion of a deferred tax asset will either expire before we are able to realize the benefit, or that future deductibility is uncertain. As ofMarch 31, 2022 andMarch 31, 2021 , we recorded a valuation allowance to the full extent of our net deferred tax assets since the likelihood of realization of the benefit does not meet the more likely than not threshold. We fileU.S. Federal, various state, and International income tax returns. Uncertain tax positions are reviewed on an ongoing basis and are adjusted in light of changing facts and circumstances. Such adjustment is reflected in the tax provision when appropriate. We will recognize interest and penalties, if any, related to unrecognized tax benefits in income taxes in the statements of operations. Tax years 2018 through 2022 remain open to examination by federal and state tax jurisdictions. We file tax returns inIsrael for which tax years 2016 through 2022 remain open. In addition, we file tax returns inIreland andAustralia and the tax years 2021 and 2022 remain open. COMMITMENTS AND CONTINGENCIES License Agreements OnOctober 22, 2013 , the Company entered into a patent license agreement (the "CareFusion Agreement") withSensorMedics Corporation , a subsidiary ofCareFusion Corp. ("CareFusion"), pursuant to which the Company agreed to pay toCareFusion a non-refundable upfront fee of$150 thousand that is credited against future royalty payments, and is obligated to pay 5% royalties of any licensed product net sales, but at least$50 thousand per annum during the term of the agreement. As ofMarch 31, 2021 , the Company has not paid any royalties toCareFusion since the Company has not received any revenues from the technology associated with the license under the CareFusion Agreement. The term of the CareFusion Agreement extends through the life of applicable patents and may be terminated by either party with 60 days' prior written notice in the event of a breach of the CareFusion Agreement, and may be terminated unilaterally byCareFusion with 30 days' prior written notice in the event that the Company does not meet certain milestones. 75 InAugust 2015 ,BA Ltd. entered into the Option Agreement with Pulmonox wherebyBA Ltd. acquired the option to purchase certain intellectual property assets and rights onSeptember 7, 2016 for$25 thousand . OnJanuary 13, 2017 , we exercised the Option and paid$500 thousand to Pulmonox. We become obligated to make certain one-time development and sales milestone payments to Pulmonox, commencing with the date on which we receive regulatory approval for the commercial sale of the first product candidate qualifying under the Option Agreement. These milestone payments are capped at a total of$87 million across three separate and distinct indications that fall under the agreement, with the majority of them, approximately$83 million , being sales-related based on cumulative sales milestones for each of the three products. OnJanuary 31, 2018 , we entered into the NitricGen Agreement to acquire a global, exclusive, transferable license and associated assets including intellectual property, know-how, trade secrets and confidential information from NitricGen related to the LungFit® We acquired the licensing right to use the technology and agreed to pay NitricGen a total of$2 million in future payments based upon achieving certain milestones, as defined in the NitricGen Agreement, and royalties on sales of the LungFit® We paid NitricGen$100 thousand upon the execution of the NitricGen Agreement,$100 thousand upon achieving the next milestone and issued to NitricGen 100,000 warrants to purchase our common stock valued at$295 thousand upon executing the NitricGen Agreement. The remaining future milestone payments are$1.8 million , of which$1.5 million are due within six months. Contingencies OnMarch 16, 2018 , Empery filed a complaint in the Trial Court against us relating to the notice of adjustment of both the exercise price of and the number of warrant shares issuable under warrants issued to Empery inJanuary 2017 . Empery alleges that, as a result of certain circumstances in connection with aFebruary 2018 financing transaction, the 166,672 warrants issued to Empery inJanuary 2017 provide for adjustments to both the exercise price of the warrants and the number of warrant shares issuable upon such exercise. OnAugust 20, 2020 , the Trial Court denied our summary judgment motion as to the first and third claims for relief, but dismissed the second claim for declaratory judgment as moot.The Appellate Division First Department denied our appeal of theAugust 20 Decision onSeptember 30, 2021 . Following a three-day bench trial, the Trial Court issued a decision onOctober 14, 2021 , finding in favor of Empery on the two remaining claims, granting reformation of the Warrant Agreement, and awarding Empery damages in the aggregate amount of approximately$5.8 million . OnNovember 12, 2021 , we filed a notice of appeal. Pending appeal, we are required to use approximately$7.4 million of cash as collateral to secure a supersedeas bond for the full amount of damages and interest in case we are unsuccessful in our appeal. OnSeptember 30, 2021 , we recorded an estimate for a contingent loss of$2.4 million related to the Empery litigation. In consultation with outside legal counsel, we believe that we have several meritorious defenses against the claims, and the decision of the Trial Court including, but not limited to, the quantification of damages. OnDecember 28, 2021 Hudson filed a lawsuit against us related to the notice of adjustment of the exercise price of and the number of warrant shares issuable under warrants issued to Hudson inJanuary 2017 . Hudson received 83,334 warrants in connection with theJanuary 2017 offering. Hudson's complaint alleges breach of contract and that Hudson is entitled to damages estimated at approximately$2.6 million as a result of certain adjustments to the exercise price and number of warrant shares issuable following theFebruary 2018 financing transaction. The fact pattern of these claims differs from the claims associated with the initial Empery judgment and in consultation with outside legal counsel, we believe that we have several meritorious defenses against Hudson's claims. We believe that Hudson's claims have no merit and we will vigorously defend such lawsuit. 76 OnMay 25, 2021 , we andCircassia Limited entered into a Settlement Agreement resolving all claims by and between both parties and mutually terminating the Circassia agreement disclosed in Note 10 of the consolidated financial statements included in this Annual Report. Pursuant to the terms of the Settlement Agreement, we agreed to pay Circassia$10.5 million in three installments, the first being a payment of$2.5 million on the Initial Payment Due Date. Thereafter, we shall pay$3.5 million to Circassia on the first anniversary of the Initial Payment Due Date and$4.5 million on the second anniversary of the Initial Payment Due Date. Additionally, beginning in year three post-approval, Circassia will receive a quarterly royalty payment equal to 5% of LungFit® PH net sales in theU.S. This royalty will terminate once the aggregate payment reaches$6 million .
Results of Operations and Other Comprehensive Income (Loss)
(in thousands, except number of shares and loss per Year Ended
Year Ended share) March 31, 2022 March 31, 2021 License revenue $ - $ 873 Operating expenses Research and development (11,802 ) (12,618 ) General and administrative (18,408 ) (10,468 ) Liability from settlements contingent on FDA approval (10,500 ) - Loss from operations (40,710 ) (22,214 ) Other income (expense)
Estimated liability for contingent loss (2,435 ) - Dividend and interest income 4 17 Interest expense and financing expense (775 ) (642 ) Foreign exchange loss (gain) (144 ) (37 ) Total other loss (3,350 ) (661 ) Net loss before income taxes (44,060 )
(22,875 ) Benefit for income taxes - - Net loss$ (44,060 ) $ (22,875 ) Less : Net loss attributable to non-controlling interests (882 ) - Net loss attributed to Beyond Air, Inc.$ (43,177 )
Other Comprehensive Income: Foreign currency translation gain 96 - Comprehensive loss attributable to Beyond Air, Inc. (43,081 )
(22,875 )
Net loss per share - basic and diluted $ (1.68 )
$ (1.27 )
Weighted average number of shares of common stock outstanding - basic and diluted 25,668,230
18,005,226 77
Comparison of the year ended
License Revenue OnJanuary 23, 2019 , we entered into the Circassia Agreement for PPHN and future related indications at concentrations of < 80 ppm in the hospital setting inthe United States andChina . OnDecember 18, 2019 , we terminated the Circassia Agreement. OnMay 25, 2021 , we entered into a settlement with Circassia whereby we retain all rights to LungFit®. As ofMarch 31, 2022 , we met our performance obligation under the Circassia Agreement and revenue therefrom has been previously recognized. License revenue of$0 and$873 thousand associated with the Company's second performance obligation has been recognized for the year endedMarch 31, 2022 andMarch 31, 2021 , respectively. No further revenue will be recognized from the former performance obligations due to the settlement entered into inMay 2021 . See
Note 10.
Revenue from the commercialization of LungFit® PH is expected to commence in the second half of fiscal 2023.
Research and Development Research and development expenses for the year endedMarch 31, 2022 were$11.8 million , as compared to$12.6 million for the year endedMarch 31, 2021 . The decrease of$0.8 million was attributed primarily to a decrease in investment in Covid studies ($1.2 million ), a reduction in stock-based compensation and salaries ($0.6 million ) and a reduction in the development costs for PH (for$0.5 million ) partially offset by an increased pre-clinical expense in Oncology (including Beyond Cancer) of$1.5 million .
General and Administrative Expenses
General and administrative expense for the year endedMarch 31, 2022 andMarch 31, 2021 were$18.4 million and$10.5 million , respectively. The increase of$7.9 million was attributed primarily to an increase in stock-based compensation ($3.1 million ) and salaries ($2.2 million ) mainly driven by an increase of 16 positions globally, legal and professional fees ($1.0 million ), leases and related office costs ($0.5 million ), IT costs ($0.5 million ) and increased insurance costs ($0.4 million ). Other Operating Expenses
Other operating expenses for the year ended
Other Income and Expense
Net other expense for the year endedMarch 31, 2022 andMarch 31, 2021 were($3.4) million and($0.7) million , respectively. The increase of$2.7 million was attributed primarily to an estimated liability for a contingent loss on a lawsuit ($2.4 million ) and accretion of debt discount costs ($0.4 million ).
Net Loss Attributable to Non-controlling Interests
Net loss attributed to non-controlling interests for the year endedMarch 31, 2022 , was$0.9 million , compared to$0 for the year endedMarch 31, 2021 . Non-controlling interests represent 20% of the net loss of our Beyond Cancer subsidiary which was established inNovember 2021 .
Net Loss Attributed to Common Stockholders
Net loss attributed to common stockholders for the year endedMarch 31, 2022 , was($43.2) million or a loss of ($1.68 ) per share, basic and diluted. As a result of the foregoing, our net loss attributed to common stockholders for the year endedMarch 31, 2021 , was($22.9) million or a loss of ($1.27 ) per share, basic and diluted. 78
Liquidity and Capital Resources
We have not generated any revenue from the sale of products, but now that we have obtained regulatory approval LungFit® PH, we expect to begin generating revenue in fiscal 2023. We had an operating cash flow decrease of$23.1 million for the year endedMarch 31, 2022 and we have experienced an accumulated loss of$123.6 million since inception throughMarch 31, 2022 . As ofMarch 31, 2022 , we had cash and cash equivalents of$80.2 million and$10.0 million restricted cash. We believe that our cash and cash equivalents as ofMarch 31, 2022 will enable us to fund our operating expenses and capital expenditure requirements into the fourth fiscal quarter of 2024. Our future capital needs and the adequacy of its available funds beyond one year from the date of filing these financial statements will depend on many factors, including, but not necessarily limited to, the cost and time necessary for the development, clinical studies and certification or regulatory approval of our other medical devices, indications as well as the commercial success of our approved product and any product candidates that receive marketing approval by the FDA. We may be required to raise additional funds through sale of equity or debt securities or through strategic collaborations and/or licensing agreements in order to fund operations until we are able to generate enough product or royalty revenues, if any. Financing may not be available on acceptable terms, or at all, and our failure to raise capital when needed could have a material adverse effect on our strategic objectives, results of operations and financial condition. OnMarch 17, 2020 , we entered into a facility agreement with certain lenders for up to$25.0 million in five tranches of$5.0 million per tranche (the "Facility Agreement"). We received proceeds from the first tranche in fiscal year 2020. DuringOctober 2021 , we amended the Facility agreement to offer the lenders the ability to accept redemption of all amounts outstanding from the first tranche of$5.0 million and to terminate the Facility Agreement without penalty. The Facility Agreement was terminated onNovember 10, 2021 . In connection with the termination of the Facility Agreement, onNovember 8, 2021 , the Company entered into a modification of the Facility Agreement for one lender to allow for repayment of$0.2 million on unchanged payment terms. The loan is unsecured with interest at 10% per year which is to be paid quarterly. The loan shall be repaid in installments commencing onJune 15, 2023 with all outstanding amounts due onMarch 17, 2025 . OnApril 2, 2020 , we entered an At-The-Market Equity Offering Sales Agreement withSunTrust Robinson Humphrey, Inc. andOppenheimer & Co. (the "2020 ATM"). Under the 2020 ATM, we may sell shares of our common stock having aggregate sales proceeds of up to$50 million , from time to time and at various prices. If shares of our common stock are sold, there is a 3% fee paid to the sales agent. As ofMarch 31, 2022 , there were no remaining funds available under the 2020 ATM. OnFebruary 4, 2022 , we entered into a new At-The-Market Equity Offering Sales Agreement withTruist Securities, Inc. andOppenheimer & Co, Inc. (the "2022 ATM"). Under the 2022 ATM, we may sell shares of our common stock having aggregate sales proceeds of up to$50 million , from time to time and at various prices. If shares of our common stock are sold, there is a 3% fee paid to the sales agent. As ofMarch 31, 2022 , there was a balance of$50 million available under the 2022 ATM. OnMay 14, 2020 , we entered into a$40 million stock purchase agreement (the "New Stock Purchase Agreement") withLincoln Park Capital Fund, LLC ("LPC"), which replaced the former$20 million purchase agreement with LPC, datedAugust 10, 2018 . The New Stock Purchase Agreement provides for the issuance of up to$40 million of our common stock, which we may sell from time to time in our sole discretion, to LPC over a period of 36 months, subject to the conditions and limitations in the New Stock Purchase Agreement. As ofMarch 31, 2022 , there was a balance of approximately$18.1 million available under the New Stock Purchase Agreement.
Our ability to continue to operate beyond the fourth fiscal quarter of 2024 will be largely dependent upon the successful commercial launch of LungFit® PH, as well as obtaining partners in other parts of the world, and raising additional funds to finance our activities until we are generating cash flow from operations. Further, there are no assurances that we will be successful in obtaining an adequate level of financing for the development and commercialization of our other product candidates. 79
There are numerous risks and uncertainties associated with the development of our NO delivery system and we are unable to estimate the amounts of increased capital outlays and operating expenses associated with completing the research and development of our product candidates.
Our future capital requirements will depend on many factors, including:
? the effects of the COVID-19 pandemic on our business, the medical community
and the global economy;
? the progress and costs of our preclinical studies, clinical trials and other
research and development activities;
? the costs of commercializing the LungFit® system;
? the scope, prioritization and number of our clinical trials and other research
and development programs;
? the costs and timing of obtaining certification or regulatory approval for our
product candidates;
? the costs of filing, prosecuting, enforcing and defending patent claims and
other intellectual property rights;
? the costs of, and timing for, strengthening our manufacturing agreements for
production of sufficient clinical quantities of our product candidate;
? the potential costs of contracting with third parties to provide marketing and
distribution services for us or for building such capacities internally;
? the costs of acquiring or undertaking the development and commercialization
efforts for additional, future therapeutic applications of our product
candidate;
? the magnitude of our general and administrative expenses; and
? any cost that we may incur under current and future in-and out-licensing
arrangements relating to our product candidate. Cash Flows Below is a summary of the statements of cash flows for the years endedMarch 31, 2022 andMarch 31, 2021 . For The Year Ended For The Year Ended (in thousands)March 31, 2022
Net cash provided by (used in): Operating activities $ (23,134 ) $ (19,639 ) Investing activities $ (1,450 ) $ (890 ) Financing activities $ 79,450 $ 30,332
Effect of exchange rate changes $ 96 $ - Net increase in cash, cash equivalents and restricted cash $ 54,962 $ 9,803
Comparison between
For the year endedMarch 31, 2022 , net cash used by operating activities was$23.1 million which was primarily due to our net loss of$44.1 million , which included non-cash stock based compensation of$7.8 million and an increase in liabilities for the recognition of contingent liabilities of$10.5 million and a contingent liability for a lawsuit of$2.5 million . For the year endedMarch 31, 2021 , net cash used by operating activities was$19.6 million which was primarily due to our net loss of$22.9 million , an increase in grant receivable of$0.4 million , a net decrease in deferred revenue of$0.9 million , partially offset by non-cash stock based compensation of$4.9 million . 80 Investing Activities For the year endedMarch 31, 2022 , cash used in investing activities was$1.4 million which was from purchase of property and equipment. For the year endedMarch 31, 2021 , cash used in investing activities was$0.9 million which was from the purchase of property and equipment. Financing Activities For the year endedMarch 31, 2022 , net cash provided by financing activities was$79.5 million which was primarily from the issuance of common stock in connection with our New Stock Purchase Agreement and 2020 ATM ($11.1 million and$36.5 million , respectively), issuance of common stock in connection with the exercise of warrants and stock options ($6.0 million and$0.3 million , respectively), and proceeds from the sale of common stock of Beyond Cancer for$30.0 million less($4.8) million from lenders in our retired loan facility. For the year endedMarch 31, 2021 , net cash provided by financing activities of$30.3 million which was primarily from the net proceeds from New Stock Purchase Agreement ($11.6 million ), net proceeds from the 2020 ATM ($11.9 million ) and from the exercise from the issuance of common stock for warrants ($6.7 million ).
The effect of exchange rates changes on entities using a functional currency
other than US dollars was
Contractual Obligations
The following tables sets forth our contractual obligations for the next five
fiscal years and thereafter for the year ended
(in thousands) 2023 2024 2025 2026 2027
Thereafter Total Circassia settlement$ 2,500 $ 3,500 $ 4,500 $ - $ -
$ -$ 10,500 NitricGen payments 1,500 - - - - - 1,500 Rent 462 443 434 441 325 1,081 3,186 Long-term loan - - 80 120 - - 200 Loan 927 - - - - - 927 Total$ 5,389 $ 3,943 $ 5,014 $ 561 $ 325 $ 1,081 $ 16,313
© Edgar Online, source