Beyond Air (XAIR) risk factors, FY2025 10-K

Risks Related to Our Financial Position and Capital Requirements

1. 01Numerous factors, including the incurring of significant losses, are relevant to our financial success and any or all such factors could have a disproportionate impact on our bottom line
2. 02We will need to raise additional capital to meet our business requirements in the future, and such capital raising may be costly or difficult to obtain, and could dilute current stockholders’ ownership interests
3. 03Furthermore, any debt or equity financing that we may need may not be available on terms favorable to us, or at all
4. 04Our failure to comply with the covenants or other terms of the Loan Agreement, including as a result of events beyond our control, could result in a default under the Loan Agreement that could materially and adversely affect the ongoing viability of our business
5. 05The Loan Agreement contains affirmative and negative covenants customary for financings of this type that, among other things, limit the ability of the Company and its subsidiaries to incur additional debtor or pay any dividends
6. 06Our Loan Agreement contains restrictions that limit our flexibility in operating our business

Risks Related to Commercialization of Our Approved Product or Product Candidates

1. 07If the market opportunities for our approved product or product candidates are smaller than we believe they are, our revenue may be adversely affected, and our business may suffer
2. 08The insurance coverage and reimbursement status of newly-approved products is uncertain. Failure to obtain or maintain adequate coverage and reimbursement for new or current products could limit our ability to market those products and decrease our ability to generate revenue
3. 09Accordingly, the certification or approval of our product and product candidates for insurance coverage and reimbursement by governmental and private payors may impact our ability to generate revenues
4. 10The commercial success of LungFit® PH and any current or future product candidate will depend upon the degree of market acceptance by physicians, patients, third-party payors and others in the medical community
5. 11If we fail to properly manage our anticipated growth, our business could suffer
6. 12Pricing pressure from our competitors and our customers may impact our ability to sell our products at prices necessary to support our current business strategies
7. 13Cybersecurity risks and the failure to maintain the confidentiality, integrity, and availability of our computer hardware, software, and Internet applications and related tools and functions could result in harm to our business and/or subject us to costs, fines or lawsuits
8. 14Healthcare legislative or regulatory reform measures, including government restrictions on pricing and reimbursement, may have a negative impact on our business and results of operations
9. 15We are subject to additional federal and state laws and regulations relating to our business, and our failure to comply with those laws could have a material adverse effect on our results of operations and financial conditions
10. 16If we fail to comply with applicable privacy, data protection and data security laws and regulations, we could face substantial penalties, liability and adverse publicity and our business, operations and financial condition could be adversely affected
11. 17If we or our suppliers fail to comply with ongoing FDA or other foreign regulatory authority requirements, or if we experience unanticipated problems with our products, these products could be subject to restrictions or withdrawal from the market
12. 18Our approved product or product candidates may in the future be subject to product recalls that could harm our reputation, business and financial results
13. 19We may be subject to regulatory or enforcement actions if we engage in improper marketing or promotion of our approved product or product candidates
14. 20We face extensive, ongoing regulatory requirements and review, and our products may face future development and regulatory difficulties

Risks Related to the Discovery and Development of Our Product Candidates

1. 21We are heavily dependent on the success of our product candidates, which are in various stages of clinical development. We cannot give any assurance that any of our product candidates will receive certification or regulatory approval, which is necessary before they can be commercialized
2. 22The success of our business may also depend upon our ability to identify, license or discover additional product candidates
3. 23The FDA may refuse our requests for 510(k) clearance, de-novo or PMA of new products, new intended uses or modifications to existing products
4. 24Clinical development involves a lengthy and expensive process with an uncertain outcome, and results of earlier studies may not be predictive of future study results
5. 25Legislative or regulatory reforms may make it more difficult and costly for us to obtain certification, regulatory clearance or approval of any future products and to manufacture, market and distribute our products after certification, clearance or approval is obtained
6. 26We are working on bronchiolitis that usually is caused by the RSV virus and any related trials we conduct are dependent on a number of factors outside of our control, which may lead to varied trial results and possibly delays in our plans
7. 27Any of these occurrences may significantly harm our business, financial condition and prospects. In addition, many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of certification or regulatory approval of our product candidates
8. 28We may experience delays in obtaining a CE mark in the EEA for our approved product due to possible EU MDR regulatory classification that differs from the FDA’s regulatory paradigm
9. 29We may find it difficult to enroll patients in our clinical trials. Difficulty in enrolling patients could delay or prevent clinical trials of our product candidates
10. 30We may encounter substantial delays in our clinical trials, or we may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities
11. 31Our product candidates may cause undesirable side effects or have other properties that could delay or prevent their certification or regulatory approval, limit the commercial profile of an approved label or result in significant negative consequences following marketing approval, if any
12. 32NO-related side effects could affect patient recruitment, the ability of enrolled patients to complete the study or result in potential product liability claims

Risks Related to our Reliance on Third Parties

1. 33We rely on third parties to manufacture our NO generator and delivery system. Our business could be harmed if those third parties fail to provide us with sufficient quantities of our needed supplies, or fail to do so at acceptable quality levels or prices
2. 34We and our collaborators and contract manufacturers are subject to significant regulation with respect to manufacturing our approved product or product candidates. The manufacturing facilities on which we rely may not continue to meet regulatory requirements and have limited capacity
3. 35If we encounter issues with our contract manufacturers or suppliers, we may need to qualify alternative manufacturers or suppliers, which could impair our ability to sufficiently and timely manufacture and supply LungFit® PH
4. 36We depend on third-party manufacturers, including sole source suppliers, to manufacture LungFit® PH and our product candidates and the materials we require for our clinical trials. We may not be able to maintain these relationships and could experience supply disruptions outside of our control
5. 37Our reliance on third parties may require us to share our trade secrets, which increases the possibility that a competitor will discover them or that our trade secrets will be misappropriated or disclosed

Risks Related to Our Intellectual Property

1. 38If we are unable to obtain and maintain effective patent rights for LungFit® PH, our product candidates or any future product candidates, we may not be able to compete effectively in our markets
2. 39If we cannot obtain and maintain effective patent rights for our approved product or product candidates, we may not be able to compete effectively and our business and results of operations would be harmed
3. 40Patent terms are limited and we may not be able to effectively protect our products and business
4. 41Patent policy and rule changes could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents
5. 42If we are unable to maintain effective proprietary rights for our approved product, product candidates or any future product candidates, we may not be able to compete effectively in our markets
6. 43Third-party claims of intellectual property infringement may prevent or delay our development and commercialization efforts
7. 44We may not be successful in obtaining or maintaining necessary rights to our approved product or product candidates through acquisitions and in-licenses
8. 45If we fail to comply with our obligations in the agreements under which we license intellectual property and other rights from third parties or otherwise experience disruptions to our business relationships with our licensors, we could lose license rights that are important to our business
9. 46We may be involved in lawsuits or post-grant proceedings to protect or enforce our patents or the patents of our licensor, which could be expensive, time-consuming and unsuccessful
10. 47We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties or that our employees have wrongfully used or disclosed alleged trade secrets of their former employers
11. 48We may be subject to claims challenging the inventorship of our patents and other intellectual property
12. 49Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our products
13. 50We may not be able to protect our intellectual property rights throughout the world

Risks Related to Our Business Operations

1. 51We manage our business through a small number of employees and key consultants
2. 52We may need to expand our organization and we may experience difficulties in recruiting needed additional employees and consultants, which could disrupt our operations
3. 53International expansion of our business further exposes us to business, regulatory, political, operational, financial and economic risks associated with doing business outside of the U.S., the EEA or Israel
4. 54Conditions in Israel may materially and adversely affect the Company’s business
5. 55The use of any of our products could result in product liability or similar claims that could be expensive, damage our reputation and harm our business
6. 56Natural disasters, geopolitical unrest, war, terrorism, public health issues or other catastrophic events could disrupt the supply, delivery or demand of products, which could negatively affect our operations and performance
7. 57We are dependent on information technology and our systems and infrastructure face certain risks, including from cybersecurity breaches and data leakage

Risks Related to the Ownership of our Common Stock

1. 58Trading in our common stock has been volatile and may continue to be volatile in the future
2. 59We cannot assure you that our common stock price and volume will remain at current levels in which case investors may sustain large losses

Risks Related to Employee Matters

1. 60Our business could suffer if we lose the services of key members of our senior management, key advisors or personnel
2. 61Our employees may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements and insider trading
3. 62We are subject to applicable fraud and abuse laws, including anti-kickback and false claims, transparency, health information privacy and security and other healthcare laws. Failure to comply with such laws may result in substantial penalties
4. 63Employee litigation and unfavorable publicity could negatively affect our future business
5. 64Under applicable employment laws, such as in Israel, we may not be able to enforce covenants not to compete and therefore may be unable to prevent our competitors from benefiting from the expertise of some of our former employees
6. 65The increasing use of social media platforms presents new risks and challenges
7. 66Unfavorable U.S. or global economic conditions could adversely affect our business, financial condition, or results of operations