Beyond Air, Inc. (NASDAQ:XAIR) Q3 2023 Earnings Conference Call February 9, 2023 4:30 PM ET Company Participants Edward Barger - Head, Investor Relations Steve Lisi - Chairman and CEO Duncan Fatkin - Chief Commercial Officer Douglas Larson - Chief Financial Officer Conference Call Participants Matt Kaplan - Ladenburg Thalmann Greg Fraser - Truist Securities Yale Jen - Laidlaw & Company Suraj Kalia - Oppenheimer & Company Operator Good afternoon. And welcome everyone to the Beyond Air Financial Results Call ...

PART I FINANCIAL INFORMATION [ITEM 1. Condensed Consolidated Financial Statements (Unaudited)](index=3&type=section&id=ITEM%201.%20Condensed%20Consolidated%20Financial%20Statements%20(Unaudited)) This section presents the unaudited condensed consolidated financial statements, including balance sheets, statements of operations and comprehensive loss, changes in stockholders' equity, and cash flows, along with their accompanying notes, providing a snapshot of the company's financial position, performance, and cash movements for the periods ended December 31, 2022 [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) | Metric | Dec 31, 2022 (in thousands) | Mar 31, 2022 (in thousands) | Change (in thousands) | | :----- | :-------------------------- | :-------------------------- | :-------------------- | | Total Assets | $73,959 | $99,199 | $(25,240) | | Total Liabilities | $18,519 | $20,990 | $(2,471) | | Total Equity | $55,440 | $78,209 | $(22,769) | | Cash and cash equivalents | $25,478 | $80,242 | $(54,764) | | Marketable securities | $27,641 | $- | $27,641 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) | Metric (in thousands) | 3 Months Ended Dec 31, 2022 | 3 Months Ended Dec 31, 2021 | 9 Months Ended Dec 31, 2022 | 9 Months Ended Dec 31, 2021 | | :-------------------- | :---------------------------- | :---------------------------- | :---------------------------- | :---------------------------- | | Revenue | $- | $- | $- | $- | | Net loss | $(13,798) | $(7,962) | $(38,250) | $(23,397) | | Net loss attributable to Beyond Air, Inc. | $(12,747) | $(7,739) | $(35,649) | $(23,174) | | Net basic and diluted loss per share | $(0.43) | $(0.29) | $(1.19) | $(0.95) | | Research and development expenses | $5,000 | $2,543 | $12,679 | $8,091 | | General and administrative expenses | $8,941 | $4,943 | $25,144 | $12,188 | [Condensed Consolidated Statements of Changes in Stockholders' Equity](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders'%20Equity) | Metric (in thousands) | As of April 1, 2022 | As of Dec 31, 2022 | Change | | :-------------------- | :------------------ | :----------------- | :----- | | Total Equity | $78,209 | $55,440 | $(22,769) | | Accumulated Deficit | $(123,639) | $(159,288) | $(35,649) | | Additional Paid-in Capital | $196,269 | $210,097 | $13,828 | [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) | Metric (in thousands) | 9 Months Ended Dec 31, 2022 | 9 Months Ended Dec 31, 2021 | Change | | :-------------------- | :---------------------------- | :---------------------------- | :----- | | Net cash used in operating activities | $(24,569) | $(15,234) | $(9,335) | | Net cash used in investing activities | $(29,447) | $(1,111) | $(28,336) | | Net cash (used in) / provided by financing activities | $(713) | $73,783 | $(74,496) | | Cash, cash equivalents and restricted cash at end of period | $35,563 | $92,707 | $(57,144) | [Notes to Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) [NOTE 1 ORGANIZATION AND BUSINESS](index=11&type=section&id=NOTE%201%20ORGANIZATION%20AND%20BUSINESS) - Beyond Air, Inc. is a commercial-stage medical device and biopharmaceutical company developing the LungFit platform for nitric oxide (NO) generation and delivery[17](index=17&type=chunk) - LungFitPH received FDA premarket approval in June 2022 for the treatment of term and near-term neonates with hypoxic respiratory failure (PPHN) and commenced U.S. marketing in July 2022[17](index=17&type=chunk) - The company reorganized its oncology business into Beyond Cancer, Ltd. in November 2021, retaining **80% ownership**, to develop ultra-high concentration NO (UNO) for solid tumors[19](index=19&type=chunk) [NOTE 2 SIGNIFICANT ACCOUNTING POLICIES AND OTHER RISKS AND UNCERTAINTIES](index=12&type=section&id=NOTE%202%20SIGNIFICANT%20ACCOUNTING%20POLICIES%20AND%20OTHER%20RISKS%20AND%20UNCERTAINTIES) - The company consolidates its subsidiaries, including Beyond Cancer, Ltd., as a variable interest entity (VIE) where Beyond Air is the primary beneficiary, holding an **80% ownership**[22](index=22&type=chunk) - As of December 31, 2022, the company had **$55.7 million** in cash, cash equivalents, marketable securities, and restricted cash, estimated to be sufficient for operating requirements for at least one year[25](index=25&type=chunk) - Future capital needs depend on commercialization success, clinical trial costs, and regulatory approvals, with potential additional funding through equity/debt offerings or collaborations[26](index=26&type=chunk)[29](index=29&type=chunk) - The company faces risks related to new technological innovations, regulatory approvals, market acceptance, dependence on key personnel and third-party suppliers, and potential disruptions from the COVID-19 pandemic[30](index=30&type=chunk)[31](index=31&type=chunk)[33](index=33&type=chunk) [NOTE 3 FAIR VALUE MEASUREMENT](index=19&type=section&id=NOTE%203%20FAIR%20VALUE%20MEASUREMENT) Marketable Securities (in thousands) | Marketable Securities (in thousands) | Level 1 | Level 2 | Level 3 | | :--------------------------------- | :------ | :------ | :------ | | Corporate debt securities | $4,558 | $- | $- | | Government securities | $5,961 | $- | $- | | Mutual funds | $17,122 | $- | $- | | Total Marketable Securities | $27,641 | $- | $- | [NOTE 4 PROPERTY AND EQUIPMENT](index=19&type=section&id=NOTE%204%20PROPERTY%20AND%20EQUIPMENT) Property and Equipment Metrics (in thousands) | Metric (in thousands) | Dec 31, 2022 | Mar 31, 2022 | Change | | :-------------------- | :----------- | :----------- | :----- | | Property and equipment, net | $3,624 | $1,995 | $1,629 | | Depreciation and amortization expense (3 months) | $204 | $70 | $134 | | Depreciation and amortization expense (9 months) | $439 | $193 | $246 | [NOTE 5 STOCKHOLDERS' EQUITY](index=19&type=section&id=NOTE%205%20STOCKHOLDERS'%20EQUITY) - As of December 31, 2022, approximately **$18.1 million** remains available under the $40 million stock purchase agreement with Lincoln Park Capital Fund, LLC[60](index=60&type=chunk) - As of December 31, 2022, **$49.8 million** in funds are available under the $50 million At-The-Market Offering Sales Agreement (2022 ATM)[62](index=62&type=chunk) Stock-Based Compensation Expense (in thousands) | Stock-Based Compensation Expense (in thousands) | 3 Months Ended Dec 31, 2022 | 3 Months Ended Dec 31, 2021 | 9 Months Ended Dec 31, 2022 | 9 Months Ended Dec 31, 2021 | | :-------------------------------------------- | :---------------------------- | :---------------------------- | :---------------------------- | :---------------------------- | | Research and development | $1,290 | $416 | $3,247 | $1,160 | | General and administrative | $4,576 | $1,700 | $11,957 | $3,327 | | Total stock-based compensation expense | $5,866 | $2,116 | $15,204 | $4,487 | [NOTE 6 OTHER CURRENT ASSETS AND PREPAID EXPENSES](index=24&type=section&id=NOTE%206%20OTHER%20CURRENT%20ASSETS%20AND%20PREPAID%20EXPENSES) Other Current Assets and Prepaid Expenses (in thousands) | Category (in thousands) | Dec 31, 2022 | Mar 31, 2022 | Change | | :---------------------- | :----------- | :----------- | :----- | | Research and development | $112 | $216 | $(104) | | Insurance | $210 | $1,037 | $(827) | | Total | $1,500 | $2,044 | $(544) | [NOTE 7 ACCRUED EXPENSES](index=24&type=section&id=NOTE%207%20ACCRUED%20EXPENSES) Accrued Expenses (in thousands) | Category (in thousands) | Dec 31, 2022 | Mar 31, 2022 | Change | | :---------------------- | :----------- | :----------- | :----- | | Accrued Circassia Settlement | $3,500 | $2,500 | $1,000 | | Employee salaries and benefits | $1,058 | $409 | $649 | | Research and development | $522 | $1,006 | $(484) | | Total current accrued expenses | $9,777 | $8,374 | $1,403 | [NOTE 8 BASIC AND DILUTED NET INCOME (LOSS) PER SHARE OF COMMON STOCK](index=25&type=section&id=NOTE%208%20BASIC%20AND%20DILUTED%20NET%20INCOME%20(LOSS)%20PER%20SHARE%20OF%20COMMON%20STOCK) Potentially Dilutive Securities | Potentially Dilutive Securities | Dec 31, 2022 | Dec 31, 2021 | | :------------------------------ | :----------- | :----------- | | Common stock warrants | 460,520 | 2,219,631 | | Common stock options | 5,645,131 | 4,102,631 | | Restricted shares | 769,500 | 604,200 | | Total | 6,875,151 | 6,926,462 | [NOTE 9 LICENSE AGREEMENT](index=25&type=section&id=NOTE%209%20LICENSE%20AGREEMENT) - Beyond Air settled claims with Circassia Limited, agreeing to a total payment of **$10.5 million** in three installments[80](index=80&type=chunk) - The first payment of **$2.5 million** was made on July 28, 2022, following FDA approval of LungFit PH[80](index=80&type=chunk) - Circassia will receive a **5% quarterly royalty** on LungFit PH net sales in the US, commencing in year three post-approval, capped at **$6 million**[80](index=80&type=chunk) [NOTE 10 GRANT COLLABORATON AGREEMENT](index=26&type=section&id=NOTE%2010%20GRANT%20COLLABORATON%20AGREEMENT) - Beyond Air received a grant of up to **$2.17 million** from the Cystic Fibrosis Foundation (CFF) for clinical development of high concentration NO to treat NTM pulmonary disease[82](index=82&type=chunk) - As of December 31, 2022, **$1.63 million** has been recognized as a reduction of R&D costs from this grant[82](index=82&type=chunk) [NOTE 11 COMMITMENTS AND CONTINGENCIES](index=26&type=section&id=NOTE%2011%20COMMITMENTS%20AND%20CONTINGENCIES) - The company has license agreements with CareFusion (**5% royalties**, **$50k/annum minimum**) and Pulmonox (up to **$87 million** in milestone payments across three indications)[83](index=83&type=chunk)[84](index=84&type=chunk) - A **$1.5 million** milestone payment to NitricGen related to LungFit technology was made on January 6, 2023[86](index=86&type=chunk) - Beyond Air is appealing a lawsuit with Empery, with an estimated contingent loss of **$2.6 million** as of December 31, 2022, secured by **$7.4 million** in restricted cash[91](index=91&type=chunk) - A lawsuit with Hudson Bay Master Fund regarding warrant adjustments has an estimated contingent loss of **$0.2 million** as of December 31, 2022[93](index=93&type=chunk) [NOTE 12 BEYOND CANCER AND RELATED PARTY TRANSACTIONS](index=29&type=section&id=NOTE%2012%20BEYOND%20CANCER%20AND%20RELATED%20PARTY%20TRANSACTIONS) - Beyond Cancer, Ltd., a majority-owned affiliate (**80% by Beyond Air**), raised **$30 million** in a private placement in November 2021, selling **20% equity** to investors[95](index=95&type=chunk) - The funds are intended to accelerate preclinical work, complete IND-enabling studies, conduct a Phase 1 study, and expand preclinical programs for combination studies[129](index=129&type=chunk) - Beyond Cancer will pay Beyond Air a single-digit royalty on all future revenues[95](index=95&type=chunk) [ITEM 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=23&type=section&id=ITEM%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial condition and results of operations for the three and nine months ended December 31, 2022, discussing forward-looking statements, business overview, product development progress, critical accounting estimates, and a detailed analysis of financial performance and liquidity [Note Regarding Forward-Looking Statements](index=30&type=section&id=Note%20Regarding%20Forward-Looking%20Statements) - The report contains forward-looking statements about future results, business strategy, product candidates, approvals, and costs, which are subject to known and unknown risks[99](index=99&type=chunk) - Key risks include commercialization success of LungFit PH, EU CE mark approval, future capital needs, ability to build product pipeline, clinical trial success, regulatory approvals, and intellectual property protection[105](index=105&type=chunk) [Introduction](index=30&type=section&id=Introduction) - Beyond Air is a commercial-stage medical device and biopharmaceutical company focused on the LungFit platform for nitric oxide (NO) generation and delivery[104](index=104&type=chunk) - LungFitPH received FDA approval in June 2022 for Persistent Pulmonary Hypertension of the Newborn (PPHN)[104](index=104&type=chunk) - The LungFit platform is being developed for high-concentration NO to treat viral lung infections (VCAP, bronchiolitis, NTM) and ultra-high concentration NO (UNO) for solid tumors via Beyond Cancer, Ltd[106](index=106&type=chunk)[107](index=107&type=chunk) [LungFitPH for the treatment of Persistent Pulmonary Hypertension of the Newborn (PPHN)](index=32&type=section&id=LungFitPH%20for%20the%20treatment%20of%20Persistent%20Pulmonary%20Hypertension%20of%20the%20Newborn%20(PPHN)) - LungFitPH is the first FDA-approved system using patented ionizer technology to generate on-demand nitric oxide from ambient air for PPHN, offering competitive advantages over cylinder-based systems[109](index=109&type=chunk)[110](index=110&type=chunk)[112](index=112&type=chunk) - The company expects to receive the CE Mark under the Medical Device Regulation (MDR) in the EU during the **first half of fiscal year 2024**[113](index=113&type=chunk) - Estimated U.S. sales potential for LungFitPH in PPHN is greater than **$400 million**, with worldwide potential exceeding **$700 million**[113](index=113&type=chunk) [LungFitPRO for the treatment of viral lung infections in hospitalized patients](index=32&type=section&id=LungFitPRO%20for%20the%20treatment%20of%20viral%20lung%20infections%20in%20hospitalized%20patients) [Viral Community-Acquired Pneumonia (including COVID-19)](index=32&type=section&id=Viral%20Community-Acquired%20Pneumonia%20(including%20COVID-19)) - The U.S. market potential for VCAP is estimated to be greater than **$1.5 billion**, with worldwide potential exceeding **$3 billion**[114](index=114&type=chunk) - A pilot study for LungFit PRO (150 ppm NO) in VCAP patients (including COVID-19) demonstrated that inhaled NO was well-tolerated, significantly shortened the duration of oxygen support (**p=0.0339**), and showed a trend towards shorter hospital length of stay[116](index=116&type=chunk)[117](index=117&type=chunk) - The company anticipates commencing a pivotal study for VCAP in **calendar year 2023**[117](index=117&type=chunk) [Bronchiolitis](index=33&type=section&id=Bronchiolitis) - Bronchiolitis is a leading cause of infant hospitalization with no approved treatment, with estimated U.S. market potential over **$500 million** and worldwide over **$1.2 billion**[118](index=118&type=chunk) - Three pilot studies (n=198 infants) for 150-160 ppm NO in bronchiolitis showed the treatment was safe, well-tolerated, and effective in shortening hospital length of stay and accelerating time to stable oxygen saturation[119](index=119&type=chunk) - Long-term safety data for high concentration inhaled NO in bronchiolitis showed a favorable re-hospitalization rate for the inhaled NO group compared to control[120](index=120&type=chunk) [LungFitGO for the treatment of Nontuberculous mycobacteria (NTM)](index=34&type=section&id=LungFitGO%20for%20the%20treatment%20of%20Nontuberculous%20mycobacteria%20(NTM)) - NTM lung infection, particularly M. abscessus, has no specific approved treatments, with an estimated U.S. market potential over **$1 billion** and worldwide over **$2.5 billion**[122](index=122&type=chunk)[123](index=123&type=chunk) - A 12-week pilot study for LungFit GO (150-250 ppm NO) in NTM patients demonstrated safety and tolerability in both hospital and home settings, high treatment compliance (**>90%**), and improvements in quality of life[126](index=126&type=chunk)[127](index=127&type=chunk) - The study observed trends in the reduction of microbial load, with one subject achieving culture conversion, and a pivotal study is anticipated in the **second half of fiscal year 2025**[127](index=127&type=chunk) [Ultra-High Concentration NO (UNO) in solid tumors through majority-owned affiliate Beyond Cancer, Ltd.](index=35&type=section&id=Ultra-High%20Concentration%20NO%20(UNO)%20in%20solid%20tumors%20through%20majority-owned%20affiliate%20Beyond%20Cancer,%20Ltd.) - Beyond Cancer is developing Ultra-High Concentration NO (UNO) for solid tumors, with preclinical data showing anticancer properties by eliciting an immune response and causing dose-dependent cytotoxic responses[131](index=131&type=chunk) - Preclinical studies demonstrated UNO (20,000-200,000 ppm) increased recruitment of T cells, B cells, macrophages, and dendrocytes to tumors, and significantly higher tumor regression rates in combination with anti-PD-1 treatment[131](index=131&type=chunk)[132](index=132&type=chunk) - The first patient in a Phase 1 study for UNO therapy was treated in August 2022, with top-line results expected in **calendar year 2023**[107](index=107&type=chunk)[132](index=132&type=chunk)[134](index=134&type=chunk) [COVID-19](index=36&type=section&id=COVID-19) - The COVID-19 pandemic caused significant supply chain delays for the LungFit system, which have been remedied[33](index=33&type=chunk)[135](index=135&type=chunk) - The company continuously assesses the potential impact of COVID-19 resurgences on its business plans, preclinical/clinical trials, and reliance on third-party manufacturing and supply chains[135](index=135&type=chunk) [Critical Accounting Estimates and Policies](index=36&type=section&id=Critical%20Accounting%20Estimates%20and%20Policies) - The preparation of consolidated financial statements involves subjective and complex estimates[137](index=137&type=chunk) - Critical accounting policies include contingent loss judgments, R&D expense recognition, licensed right-to-use technology, stock-based compensation valuation, and income taxes[137](index=137&type=chunk)[138](index=138&type=chunk) [Results of Operations and Comprehensive Loss](index=38&type=section&id=Results%20of%20Operations%20and%20Comprehensive%20Loss) [Comparison of Three and Nine Months Ended December 31, 2022 with the Three and Nine Months Ended December 31, 2021](index=38&type=section&id=Comparison%20of%20Three%20and%20Nine%20Months%20Ended%20December%2031,%202022%20with%20the%20Three%20and%20Nine%20Months%20Ended%20December%2031,%202021) [Revenue](index=38&type=section&id=Revenue) - No revenue was recognized for the three or nine months ended December 31, 2022, or the comparable periods in 2021[141](index=141&type=chunk) - Revenue generation is expected to begin in **fiscal year 2023** following FDA approval of LungFit PH in June 2022[141](index=141&type=chunk) [Cost of Revenue](index=39&type=section&id=Cost%20of%20Revenue) Cost of Revenue (in thousands) | Metric (in thousands) | 3 Months Ended Dec 31, 2022 | 9 Months Ended Dec 31, 2022 | | :-------------------- | :---------------------------- | :---------------------------- | | Cost of revenue | $68 | $247 | - Cost of revenue in 2022 was primarily related to establishing warehouse locations to optimize future deliveries[142](index=142&type=chunk) [Research and Development Expenses](index=39&type=section&id=Research%20and%20Development%20Expenses) Research and Development Expenses (in thousands) | Metric (in thousands) | 3 Months Ended Dec 31, 2022 | 3 Months Ended Dec 31, 2021 | 9 Months Ended Dec 31, 2022 | 9 Months Ended Dec 31, 2021 | | :-------------------- | :---------------------------- | :---------------------------- | :---------------------------- | :---------------------------- | | Research and development | $5,000 | $2,543 | $12,679 | $8,091 | | Increase (YoY) | $2,457 | - | $4,588 | - | - The increase in R&D expenses was primarily due to scaling up spending on UNO (**$1.3 million** for 3 months), increased R&D infrastructure and preclinical work in UNO (**$1.7 million** for 9 months), and a **$2.1 million** increase in stock-based compensation for the nine months[143](index=143&type=chunk)[144](index=144&type=chunk) [General and Administrative Expenses](index=39&type=section&id=General%20and%20Administrative%20Expenses) General and Administrative Expenses (in thousands) | Metric (in thousands) | 3 Months Ended Dec 31, 2022 | 3 Months Ended Dec 31, 2021 | 9 Months Ended Dec 31, 2022 | 9 Months Ended Dec 31, 2021 | | :-------------------- | :---------------------------- | :---------------------------- | :---------------------------- | :---------------------------- | | General and administrative | $8,941 | $4,943 | $25,144 | $12,188 | | Increase (YoY) | $3,998 | - | $12,956 | - | - The increase in G&A expenses was primarily attributed to the creation of the Beyond Cancer entity (**$3.0 million** for 3 months, **$8.2 million** for 9 months, including **$2.9 million** and **$6.6 million** in stock-based compensation, respectively)[145](index=145&type=chunk)[146](index=146&type=chunk) - Beyond Air also saw increases in salaries, benefits, travel, and legal fees[145](index=145&type=chunk)[146](index=146&type=chunk) [Other Income (Loss)](index=40&type=section&id=Other%20Income%20(Loss)) Total Other Expense (in thousands) | Metric (in thousands) | 3 Months Ended Dec 31, 2022 | 3 Months Ended Dec 31, 2021 | 9 Months Ended Dec 31, 2022 | 9 Months Ended Dec 31, 2021 | | :-------------------- | :---------------------------- | :---------------------------- | :---------------------------- | :---------------------------- | | Total other expense | $211 (gain) | $(476) (loss) | $(180) (loss) | $(3,118) (loss) | - The reduction in other loss was mainly due to gains from investments in marketable securities (**$0.4 million** for 9 months) and foreign exchange gains (**$0.4 million** for 3 months), and a lower contingent liability recording compared to 2021[148](index=148&type=chunk)[149](index=149&type=chunk) [Net Loss Attributable to Non-controlling Interests](index=40&type=section&id=Net%20Loss%20Attributable%20to%20Non-controlling%20Interests) Net Loss Attributable to Non-controlling Interests (in thousands) | Metric (in thousands) | 3 Months Ended Dec 31, 2022 | 3 Months Ended Dec 31, 2021 | 9 Months Ended Dec 31, 2022 | 9 Months Ended Dec 31, 2021 | | :-------------------- | :---------------------------- | :---------------------------- | :---------------------------- | :---------------------------- | | Net loss attributable to non-controlling interests | $(1,051) | $(223) | $(2,601) | $(223) | - The increase is due to the **20% share of net loss** from the Beyond Cancer subsidiary, established in November 2021[150](index=150&type=chunk) [Net Loss Attributed to Common Stockholders](index=40&type=section&id=Net%20Loss%20Attributed%20to%20Common%20Stockholders) Net Loss Attributable to Beyond Air, Inc. (in thousands) | Metric | 3 Months Ended Dec 31, 2022 | 3 Months Ended Dec 31, 2021 | 9 Months Ended Dec 31, 2022 | 9 Months Ended Dec 31, 2021 | | :------------------------------------------ | :---------------------------- | :---------------------------- | :---------------------------- | :---------------------------- | | Net loss attributable to Beyond Air, Inc. (in thousands) | $(12,747) | $(7,739) | $(35,649) | $(23,174) | | Net basic and diluted loss per share | $(0.43) | $(0.29) | $(1.19) | $(0.95) | [Liquidity and Capital Resources](index=40&type=section&id=Liquidity%20and%20Capital%20Resources) [Cash Flows](index=40&type=section&id=Cash%20Flows) Cash Flow Summary (in thousands) | Metric (in thousands) | 9 Months Ended Dec 31, 2022 | 9 Months Ended Dec 31, 2021 | Change | | :-------------------- | :---------------------------- | :---------------------------- | :----- | | Net cash used in operating activities | $(24,569) | $(15,234) | $(9,335) | | Net cash used in investing activities | $(29,447) | $(1,111) | $(28,336) | | Net cash (used in) / provided by financing activities | $(713) | $73,783 | $(74,496) | [Operating Activities](index=41&type=section&id=Operating%20Activities) - Net cash used in operating activities was **$24.6 million** for the nine months ended December 31, 2022[154](index=154&type=chunk) - This was primarily due to a net loss of **$38.3 million**, partially offset by **$15.2 million** in stock-based compensation and **$1.0 million** in depreciation and amortization[154](index=154&type=chunk) [Investing Activities](index=41&type=section&id=Investing%20Activities) - Net cash used in investing activities was **($29.4) million** for the nine months ended December 31, 2022[156](index=156&type=chunk) - This included a net investment of **$27.6 million** in marketable securities and **$1.9 million** for property and equipment, including LungFit PH devices[156](index=156&type=chunk) [Financing Activities](index=41&type=section&id=Financing%20Activities) - Net cash used in financing activities was **$0.7 million** for the nine months ended December 31, 2022, mainly from loan payments, partially offset by ATM offerings[157](index=157&type=chunk) - In contrast, the prior year (2021) saw **$73.7 million** provided by financing activities, including **$11.1 million** from LPC, **$36.5 million** from ATM offerings, and **$30.0 million** from the sale of Beyond Cancer common stock[157](index=157&type=chunk) [Contractual Obligations](index=41&type=section&id=Contractual%20Obligations) - No material changes to contractual obligations since March 31, 2022[158](index=158&type=chunk) [Overview](index=42&type=section&id=Overview) - The company expects to begin generating revenue in **fiscal year 2023** following LungFit PH regulatory approval[160](index=160&type=chunk) - As of December 31, 2022, the company had an accumulated loss of **$159.3 million** and **$63.2 million** in total cash, cash equivalents, marketable securities, and restricted cash[160](index=160&type=chunk) - The company has **$49.8 million** available under the 2022 ATM and **$18.1 million** under the New Stock Purchase Agreement with LPC for future financing[162](index=162&type=chunk)[163](index=163&type=chunk) [ITEM 3. Quantitative and Qualitative Disclosures About Market Risk](index=34&type=section&id=ITEM%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section outlines the company's exposure to market risks, primarily focusing on foreign currency exchange rates - The company's primary market risk exposure is foreign currency exchange rates[167](index=167&type=chunk) [ITEM 4. Controls and Procedures](index=34&type=section&id=ITEM%204.%20Controls%20and%20Procedures) This section details the evaluation of the company's disclosure controls and procedures and reports on any changes in internal control over financial reporting [Evaluation of Disclosure Controls and Procedures](index=43&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) - Disclosure controls and procedures were evaluated and deemed effective at a reasonable assurance level as of December 31, 2022[168](index=168&type=chunk) [Changes in Internal Control Over Financial Reporting](index=43&type=section&id=Changes%20in%20Internal%20Control%20Over%20Financial%20Reporting) - No material changes to internal controls over financial reporting occurred during the three months ended December 31, 2022[169](index=169&type=chunk) PART II OTHER INFORMATION [ITEM 1. Legal Proceedings](index=35&type=section&id=ITEM%201.%20Legal%20Proceedings) This section refers to the detailed discussion of legal proceedings in Note 11 of the unaudited condensed consolidated financial statements - Legal proceedings are detailed in Note 11 of the unaudited condensed consolidated financial statements[171](index=171&type=chunk) [ITEM 1A. Risk Factors](index=35&type=section&id=ITEM%201A.%20Risk%20Factors) This section states that there have been no material changes to the risk factors previously disclosed in the company's most recent Annual Report on Form 10-K - No material changes to risk factors since the 2022 Annual Report on Form 10-K[172](index=172&type=chunk) [ITEM 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=35&type=section&id=ITEM%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section reports that there were no unregistered sales of equity securities or use of proceeds during the reporting period - No unregistered sales of equity securities or use of proceeds to report[173](index=173&type=chunk) [ITEM 3. Defaults Upon Senior Securities](index=35&type=section&id=ITEM%203.%20Defaults%20Upon%20Senior%20Securities) This section indicates that there were no defaults upon senior securities during the reporting period - No defaults upon senior securities to report[174](index=174&type=chunk) [ITEM 4. Mine Safety Disclosures](index=35&type=section&id=ITEM%204.%20Mine%20Safety%20Disclosures) This section states that the disclosure requirements for mine safety are not applicable to the company - Mine Safety Disclosures are not applicable[175](index=175&type=chunk) [ITEM 5. Other Information](index=35&type=section&id=ITEM%205.%20Other%20Information) This section reports that there is no other information to disclose under this item - No other information to report[176](index=176&type=chunk) [ITEM 6. Exhibits](index=36&type=section&id=ITEM%206.%20Exhibits) This section provides a comprehensive list of all exhibits filed as part of this Form 10-Q, including corporate governance documents, warrant forms, and certifications - The section lists all exhibits filed with the Form 10-Q, including organizational documents, warrant forms, and certifications[178](index=178&type=chunk) [SIGNATURES](index=37&type=section&id=SIGNATURES) This section contains the required signatures of the company's principal executive and financial officers, certifying the accuracy of the report - The report was signed by Steven Lisi (President and CEO) and Douglas Larson (CFO) on February 9, 2023[183](index=183&type=chunk)

Beyond Air, Inc. (NASDAQ:XAIR) Q2 2023 Results Earnings Conference Call November 8, 2022 4:30 PM ET Company Participants Edward Barger - Head of Investor Relations Steve Lisi - Chairman and Chief Executive Officer Duncan Fatkin - Chief Commercial Officer Douglas Larson - Chief Financial Officer Conference Call Participants Suraj Kalia - Oppenheimer & Co. Inc. Matthew Kaplan - Ladenburg Thalmann Greg Fraser - Truist Securities Operator Good afternoon. And welcome, everyone, to the Beyond Air Second Quarter 2 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________to _________ Commission File Number: 001-38892 BEYOND AIR, INC. (Exact name of registrant as specified in its charter) Delaware 47-3812456 (State or other j ...

Corporate Presentation September 2022 Forward Looking Statements This presentation is for informational purposes only and shall not constitute an offer to sell or the solicitation of an offer to sell or the solicitation of an offer to buy any securities of Beyond Air, Inc. (the "Company") nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction. The C ...

Beyond Air, Inc. (NASDAQ:XAIR) Q1 2023 Results Earnings Conference Call August 11, 2022 4:30 PM ET Company Participants Corey Davis - Investor Relations, LifeSci Advisors Steve Lisi - Chairman and Chief Executive Officer Duncan Fatkin - Chief Commercial Officer Douglas Larson - Chief Financial Officer Conference Call Participants Greg Fraser - Truist Securities Scott Henry - ROTH Capital Partners, LLC Matt Kaplan - Ladenburg Thalmann Yale Jen - Laidlaw & Company Kalia - Oppenheimer Operator Good afternoon. ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________to _________ Commission File Number: 001-38892 BEYOND AIR, INC. (Exact name of registrant as specified in its charter) Delaware 47-3812456 (State or other jurisd ...

Beyond Air, Inc. (NASDAQ:XAIR) Q4 2022 Earnings Conference Call June 28, 2022 4:30 PM ET Company Participants Corey Davis - Investor Relations Steve Lisi - Chairman and Chief Executive Officer Duncan Fatkin - Chief Commercial Officer Douglas Larson - Chief Financial Officer Conference Call Participants Matt Kaplan - Ladenburg Thalmann Suraj Kalia - Oppenheimer Greg Fraser - Truist Securities Yale Jen - Laidlaw & Company Operator Good afternoon and welcome to the Beyond Air Fiscal Year 2022 Financial Results ...

PART I [Business](index=9&type=section&id=Item%201.%20Business) 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](index=38&type=chunk) - 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](index=38&type=chunk)[45](index=45&type=chunk) 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](index=39&type=chunk)[61](index=61&type=chunk) [Risk Factors](index=35&type=section&id=Item%201A.%20Risk%20Factors) 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](index=170&type=chunk) - 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](index=181&type=chunk) - 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](index=101&type=chunk)[288](index=288&type=chunk)[289](index=289&type=chunk) - 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](index=243&type=chunk)[246](index=246&type=chunk)[256](index=256&type=chunk) - 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](index=349&type=chunk) [Properties](index=78&type=section&id=Item%202.%20Properties) 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](index=382&type=chunk) - 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](index=382&type=chunk) [Legal Proceedings](index=78&type=section&id=Item%203.%20Legal%20Proceedings) 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](index=384&type=chunk) - 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](index=385&type=chunk)[386](index=386&type=chunk) PART II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=79&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) 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](index=390&type=chunk) - The company has never declared or paid cash dividends and intends to retain all future earnings to support operations and business growth[393](index=393&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=80&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) 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](index=422&type=chunk) - 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](index=423&type=chunk) - 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](index=429&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=87&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) 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](index=448&type=chunk) - Beyond Air does not currently use hedging instruments to mitigate its foreign currency exchange risk[448](index=448&type=chunk) [Controls and Procedures](index=88&type=section&id=Item%209A.%20Controls%20and%20Procedures) 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](index=451&type=chunk) - 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](index=453&type=chunk) - 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](index=455&type=chunk) PART III [Directors, Executive Officers and Corporate Governance](index=89&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) 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](index=460&type=chunk)[461](index=461&type=chunk)[464](index=464&type=chunk) - The Board has three standing committees: **Audit**, **Compensation**, and **Nominating**, with the Audit Committee's financial expert being **Erick Lucera**[483](index=483&type=chunk)[487](index=487&type=chunk) - 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](index=498&type=chunk) [Executive Compensation](index=96&type=section&id=Item%2011.%20Executive%20Compensation) 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](index=512&type=chunk)[513](index=513&type=chunk) - During fiscal 2022, executives received substantial equity grants, including options and restricted stock units for both Beyond Air and its subsidiary, Beyond Cancer[524](index=524&type=chunk)[525](index=525&type=chunk)[526](index=526&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=102&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) 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](index=543&type=chunk)[545](index=545&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=104&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) 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](index=548&type=chunk) - The Board has determined that directors Ron Bentsur, Erick Lucera, Yoori Lee, William Forbes, and Robert F. Carey are **independent**[549](index=549&type=chunk) [Principal Accountant Fees and Services](index=105&type=section&id=Item%2014.%20Principal%20Accountant%20Fees%20and%20Services) 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](index=106&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) 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](index=556&type=chunk)[557](index=557&type=chunk) Financial Statements [Consolidated Financial Statements](index=115&type=section&id=Consolidated%20Financial%20Statements) 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](index=120&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) 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](index=591&type=chunk)[594](index=594&type=chunk) - 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](index=664&type=chunk)[685](index=685&type=chunk) - 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](index=676&type=chunk) - 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](index=693&type=chunk)

Beyond Air, Inc. (NASDAQ:XAIR) Q3 2022 Earnings Conference Call February 10, 2022 4:30 PM ET Company Participants Maria Yonkoski - Head of Investor Relations Steve Lisi - Chairman and Chief Executive Officer Douglas Larson - Chief Financial Officer Duncan Fatkin - Chief Commercial Officer Conference Call Participants Gregory Fraser - Truist Securities Suraj Kalia - Oppenheimer Matt Kaplan - Ladenburg Thalmann Yale Jen - Laidlaw & Company Scott Henry - ROTH Capital Disclaimer*: This transcript is designed to ...