Beyond Air(XAIR) - 2022 Q4 - Annual Report

PART I Business Beyond Air is a commercial-stage medical device and biopharmaceutical company focused on its FDA-approved LungFit platform for nitric oxide generation and delivery, targeting various respiratory diseases and solid tumors - The company's core technology is the LungFit platform, a nitric oxide (NO) generator and delivery system that produces NO from ambient air, capable of delivering concentrations up to 400 ppm[38] - The first device, LungFit PH, received FDA Premarket Approval (PMA) in June 2022 for treating term and near-term neonates with hypoxic respiratory failure associated with pulmonary hypertension (PPHN)[38][45] Product Pipeline and Market Opportunity | Indication | Product | Development Stage | U.S. Sales Potential (Peak Year) | Global Sales Potential (Peak Year) | | :--- | :--- | :--- | :--- | :--- | | PPHN | LungFit PH | Approved (U.S.) | > $400 million | > $700 million | | Viral Pneumonia (incl. COVID-19) | LungFit PRO | Pilot Study | > $1.5 billion | > $3 billion | | Bronchiolitis (BRO) | LungFit PRO | Pivotal Ready | > $500 million | > $1.2 billion | | NTM Lung Infection | LungFit GO | Pilot Study | > $1 billion | > $2.5 billion | | Solid Tumors | UNO Therapy | Phase 1 | - | - | - The company formed a majority-owned affiliate, Beyond Cancer, Ltd., which raised $30 million in a private placement to advance the development of ultra-high concentration NO for solid tumors, with Beyond Air retaining 80% ownership[39][61] Risk Factors The company faces substantial financial losses, commercialization uncertainties for its new product, intense competition, regulatory hurdles, and reliance on third parties and intellectual property protection - The company has a history of significant losses, with an accumulated deficit of approximately $123.6 million as of March 31, 2022, and expects to incur losses for the foreseeable future[170] - Beyond Air faces intense competition from established companies like Mallinckrodt, Praxair, and VERO Biotech, which market existing NO therapies and delivery systems for PPHN and other indications[181] - The company relies on third-party contract manufacturers, such as Spartronics LLC and Medisize Ireland Limited, for the commercial manufacturing of its LungFit PH system, making it dependent on their performance and regulatory compliance[101][288][289] - The business is subject to extensive and evolving government regulation in the U.S. (FDA) and internationally (e.g., EU MDR), which impacts product approval, manufacturing, and marketing, and could lead to significant costs and delays[243][246][256] - The development and commercialization of products could be adversely affected by the COVID-19 pandemic, which has previously caused significant delays in the supply chain for the LungFit system[349] Properties The company leases its principal executive office in Garden City, NY, and maintains additional offices and an R&D facility in various U.S. and international locations - The company's principal executive office is located at 900 Stewart Avenue, Suite 310, Garden City, NY 11530, with a lease expiring in June 2031[382] - Beyond Air maintains international office leases in Dublin, Ireland (expiring Sept 2026) and Rehovot, Israel, along with a U.S. R&D facility in Madison, Wisconsin (expiring May 2026)[382] Legal Proceedings The company is involved in ongoing legal disputes with Empery Asset Master, Ltd. and Hudson Bay Master Fund concerning warrant adjustments, facing awarded damages and defending against new claims - A trial court awarded Empery approximately $5.8 million in damages related to a warrant dispute, which the company has appealed and secured with a supersedeas bond using approximately $7.4 million of cash as collateral[384] - Hudson Bay Master Fund filed a separate lawsuit alleging breach of contract related to similar warrants from the January 2017 offering, seeking damages of approximately $2.6 million, which the company is vigorously defending[385][386] PART II Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities The company's common stock trades on Nasdaq under "XAIR", with no history or current intention of paying cash dividends, prioritizing reinvestment for growth - The company's common stock trades on the Nasdaq Capital Market under the ticker symbol "XAIR"[390] - The company has never declared or paid cash dividends and intends to retain all future earnings to support operations and business growth[393] Management's Discussion and Analysis of Financial Condition and Results of Operations For fiscal year 2022, the company reported a net loss of $43.2 million, driven by settlement liabilities and increased G&A expenses, ending the year with $80.2 million in cash expected to fund operations into Q4 2024 Results of Operations (in thousands) | Metric | Year Ended Mar 31, 2022 | Year Ended Mar 31, 2021 | | :--- | :--- | :--- | | License revenue | $0 | $873 | | Research and development | $(11,802) | $(12,618) | | General and administrative | $(18,408) | $(10,468) | | Liability from settlements | $(10,500) | $0 | | Loss from operations | $(40,710) | $(22,214) | | Net loss attributed to Beyond Air, Inc. | $(43,177) | $(22,875) | | Net loss per share | $(1.68) | $(1.27) | - Research and development expenses decreased by $0.8 million, primarily due to a $1.2 million reduction in investment for COVID-19 studies, partially offset by a $1.5 million increase in preclinical oncology expenses[422] - General and administrative expenses increased by $7.9 million, mainly driven by higher stock-based compensation ($3.1 million) and salaries ($2.2 million) from an increase of 16 global positions[423] - The company had $80.2 million in cash and cash equivalents as of March 31, 2022, which management believes is sufficient to fund operations into the fourth fiscal quarter of 2024[429] Quantitative and Qualitative Disclosures About Market Risk The company's primary market risk stems from foreign currency exchange rate fluctuations, particularly for expenses denominated in NIS, Euros, and AUD, with no current hedging activities - The company's main market risk is from foreign currency exchange rate fluctuations, as some operating expenses are denominated in New Israeli Shekels, Euros, and Australian Dollars[448] - Beyond Air does not currently use hedging instruments to mitigate its foreign currency exchange risk[448] Controls and Procedures As of March 31, 2022, management concluded that both disclosure controls and internal control over financial reporting were effective, supported by the implementation of new ERP and other systems - Management concluded that the company's disclosure controls and procedures were effective as of March 31, 2022[451] - Management concluded that the company's internal control over financial reporting was effective as of March 31, 2022, based on the COSO 2013 framework[453] - During fiscal 2022, the company implemented a new ERP solution, a CRM with contract management, and an expense reporting solution to enhance its control environment[455] PART III Directors, Executive Officers and Corporate Governance The company's governance structure includes an eight-member Board with independent directors and established committees, led by a combined CEO and Chairman, and guided by a Code of Business Conduct and Ethics - The company's leadership includes Steven A. Lisi as Chief Executive Officer and Chairman of the Board, and Amir Avniel as President, Chief Operating Officer, and Director[460][461][464] - The Board has three standing committees: Audit, Compensation, and Nominating, with the Audit Committee's financial expert being Erick Lucera[483][487] - The roles of Chairman and CEO are combined and held by Steven A. Lisi, which the Board believes provides appropriate leadership and oversight for the company at its current stage[498] Executive Compensation In fiscal 2022, executive compensation, primarily equity-based, totaled $9.4 million for CEO Steven A. Lisi and $4.3 million for President Amir Avniel, with employment agreements detailing salary, bonuses, and severance Summary Compensation Table (FY 2022) | Name and Principal Position | Salary ($) | Restricted Stock Awards ($) | Option Awards ($) | Total ($) | | :--- | :--- | :--- | :--- | :--- | | Steven A. Lisi (CEO and Chairman) | 450,000 | 2,000,800 | 6,942,000 | 9,392,800 | | Amir Avniel (President, COO) | 400,000 | 1,000,400 | 2,921,000 | 4,321,400 | | Douglas Larson (CFO) | 160,417 | 103,050 | 755,800 | 1,019,267 | | Douglas Beck (Previous CFO) | 291,667 | 25,975 | 0 | 317,642 | - CEO Steven Lisi's employment agreement provides for a base salary of $450,000 and a target bonus of 60% of base salary, including severance of 24 months' base salary and 1.5x the most recent bonus if terminated without cause[512][513] - During fiscal 2022, executives received substantial equity grants, including options and restricted stock units for both Beyond Air and its subsidiary, Beyond Cancer[524][525][526] Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters As of March 31, 2022, Charles Mosseri Marlio was the sole 5% beneficial owner at 7.7%, while all executive officers and directors collectively owned 11.6% of common stock, with 1,168,761 shares remaining available under the 2013 BA Plan Beneficial Ownership (as of March 31, 2022) | Name of Beneficial Owner | Number of Shares | Percentage of Outstanding Shares | | :--- | :--- | :--- | | Charles Mosseri Marlio (5% Owner) | 2,312,627 | 7.7% | | Steven A. Lisi (CEO & Chairman) | 1,825,945 | 6.0% | | All Executive Officers and Directors as a Group | 3,688,717 | 11.6% | - The company's 2013 Beyond Air Equity Incentive Plan has 7,600,000 shares authorized, with 1,168,761 shares remaining available for future issuance as of March 31, 2022[543][545] Certain Relationships and Related Transactions, and Director Independence The company reported no significant related-party transactions since April 2020, with five directors determined to be independent under Nasdaq and SEC regulations - Since April 1, 2020, there have been no related-party transactions exceeding the lesser of $120,000 or 1% of average total assets, aside from described compensation arrangements[548] - The Board has determined that directors Ron Bentsur, Erick Lucera, Yoori Lee, William Forbes, and Robert F. Carey are independent[549] Principal Accountant Fees and Services For fiscal year 2022, Friedman LLP billed $215,800 for audit services, an increase from $150,600 in fiscal 2021, with all services pre-approved by the audit committee Accountant Fees (in thousands) | Fee Category | FY 2022 | FY 2021 | | :--- | :--- | :--- | | Audit Fees | $215,800 | $150,600 | | Audit Related Fees | $0 | $0 | | Tax Fees | $0 | $0 | | All Other Fees | $0 | $0 | | Total | $215,800 | $150,600 | PART IV Exhibits and Financial Statement Schedules This section provides a comprehensive list of exhibits filed with the Form 10-K, encompassing corporate governance documents, material contracts, and executive certifications - This section contains a comprehensive list of all exhibits filed with the annual report, including foundational corporate documents, material contracts, and required certifications by executive officers[556][557] Financial Statements Consolidated Financial Statements For fiscal year 2022, total assets increased to $99.2 million, driven by cash, while total liabilities rose to $21.0 million, resulting in a net loss of $44.1 million and an accumulated deficit of $123.6 million Consolidated Balance Sheet Data (in thousands) | Account | March 31, 2022 | March 31, 2021 | | :--- | :--- | :--- | | Cash and cash equivalents | $80,242 | $34,631 | | Total current assets | $92,945 | $37,223 | | Total Assets | $99,199 | $40,525 | | Total current liabilities | $10,712 | $3,800 | | Total Liabilities | $20,990 | $10,061 | | Accumulated deficit | $(123,639) | $(80,462) | | Total Equity | $78,209 | $30,464 | Consolidated Cash Flow Data (in thousands) | Activity | Year Ended Mar 31, 2022 | Year Ended Mar 31, 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | $(23,134) | $(19,639) | | Net cash used in investing activities | $(1,450) | $(890) | | Net cash provided by financing activities | $79,450 | $30,332 | Notes to Consolidated Financial Statements The notes detail accounting policies, financial position, and operational activities, including the consolidation of Beyond Cancer, liquidity from $80.2 million cash, significant milestone and settlement obligations, and $61.9 million in U.S. federal net operating loss carryforwards - The company's financial statements are fully consolidated with its subsidiary Beyond Cancer, in which it holds an 80% ownership stake, with the 20% external ownership reported as a non-controlling interest[591][594] - The company has a $10.5 million settlement obligation to Circassia, payable in three installments following FDA approval, and a remaining $1.8 million in potential milestone payments to NitricGen, of which $1.5 million was accrued as of March 31, 2022[664][685] - As of March 31, 2022, the company has U.S. federal net operating loss (NOL) carryforwards of approximately $61.9 million, which can be used to offset future taxable income, subject to Section 382 limitations[676] - The company established its Beyond Cancer subsidiary in November 2021, which secured $30 million in a private placement for a 20% equity stake, focusing on developing UNO for solid tumors[693]