ARS Pharmaceuticals (SPRY) risk factors, FY2025 10-K

Risks Related to Our Business

1. 01We are highly dependent on the successful commercialization of neffy. To the extent neffy and EURneffy are not commercially successful, our business, financial condition and results of operations would be materially adversely affected, and the price of our common stock would likely declineNew
2. 02If we are unable to fully develop and maintain our sales, marketing and distribution capabilities on our own or through collaborations with marketing partners, we may not be successful in commercializing neffy27% rewritten
3. 03unforeseen delays, costs and expenses associated with maintaining our sales organization and receive the intended benefits to be provided by the ALK Co-Promotion Agreement28% rewritten
4. 04The market for neffy and our intranasal epinephrine technology may be smaller than we expect
5. 05If we are unable to achieve and maintain adequate levels of third-party payor coverage and reimbursement for neffy on reasonable pricing terms, its commercial success may be severely hindered24% rewritten
6. 06neffy has only been studied in a limited number of patients. neffy is now available to a much larger number of patients, and we do not know whether the results of neffy’s use in such larger number of patients will be consistent with the results from our clinical studies45% rewritten
7. 07Obtaining regulatory approval of neffy or our current or future intranasal epinephrine technology product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval in other jurisdictions
8. 08enforcing and defending intellectual property rights and claims
9. 09We may incur unexpected costs or experience delays in completing, or ultimately be unable to complete, further development and the commercialization of our current and future intranasal epinephrine technology product candidates
10. 10the potential for policies or regulations of the FDA, the EMA, the EU or any other applicable foreign regulatory authorities to significantly change in a manner rendering our clinical data insufficient for approval
11. 11The results of early-stage clinical trials and preclinical studies may not be predictive of future results. Initial data in our clinical trials may not be indicative of results obtained when these trials are completed or in later stage trials
12. 12Interim topline and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data21% rewritten
13. 13Product liability lawsuits against us or any of our current and future licensing and collaboration partners could divert our resources and attention, cause us to incur substantial liabilities and limit commercialization of neffy or our current or future intranasal epinephrine technology product candidates
14. 14the inability to successfully commercialize neffy or our current or future intranasal epinephrine technology product candidates
15. 15International trade policies, including tariffs, sanctions and trade barriers may adversely affect our business, financial condition, results of operations and prospectsNew
16. 16A pandemic, epidemic, or outbreak of an infectious disease may materially and adversely affect our business, including our nonclinical studies, clinical trials, third parties on whom we rely, our supply chain, our ability to raise capital, our ability to conduct regular business and our financial results
17. 17refusal of the FDA, the EMA or the other regulatory bodies to accept data from clinical trials in affected geographies outside the United States, the EU or other relevant local geographies
18. 18The FDA and other regulatory agencies actively enforce the laws and regulations relating to the promotion of our productsNew
19. 19The increasing use of social media platforms presents new risks and challenges

Risks Related to Our Results of Operations and Financial Position

1. 20We expect that our timing of sales and our results of operations will fluctuate for the foreseeable future, which may make it difficult to predict our future performance from period to period
2. 21We have incurred significant losses since our inception32% rewritten
3. 22acquire or in-license other product candidates and technologies
4. 23We may need additional funding, and if we are unable to raise capital when needed, we could be forced to delay, reduce or eliminate our product development activities or commercialization efforts25% rewritten
5. 24the ongoing costs of operating as a public company31% rewritten
6. 25Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidate24% rewritten
7. 26If we raise additional funds through collaborations or marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams or product candidates or grant licenses on terms that may not be favorable to usNew
8. 27Changes in tax law could adversely affect our business and financial condition43% rewritten
9. 28Our ability to use net operating loss carryforwards and certain other tax attributes may be limited

Risks Related to our Legal and Regulatory Environment

1. 29injunctions or the imposition of civil or criminal penalties100% rewritten
2. 30Recently enacted and future legislation may increase the difficulty and cost for us to commercialize neffy or our current or future intranasal epinephrine technology product candidates and affect the prices we may obtain54% rewritten
3. 31Disruptions at the FDA, including due to a reduction in the FDA’s workforce and/or inadequate funding for the FDA, could prevent the FDA from performing normal functions on which our business reliesNew
4. 32Governments outside the United States may impose strict price controls, which may adversely affect our revenues, if any23% rewritten
5. 33We will incur costs and demands upon management as a result of complying with the laws and regulations affecting public companies
6. 34If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could harm our business

Risks Related to Our Dependence on Third Parties

1. 35We rely completely on third parties to manufacture and warehouse both our domestic and international supply of neffy and our current and future intranasal epinephrine technology product candidates
2. 36the misappropriation of our proprietary information, including our trade secrets and know-how
3. 37Our reliance on third parties requires us to share our trade secrets, know-how and other proprietary information, 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. 38Our commercial success depends on our ability to obtain and maintain sufficient intellectual property protection for neffy, our current and future intranasal epinephrine technology product candidates and other proprietary technologies24% rewritten
2. 39If the scope of any patent protection we obtain is not sufficiently broad, or if we lose any of our patent protection, our ability to prevent our competitors from commercializing similar or identical product candidates would be adversely affected
3. 40We may not be able to protect our intellectual property rights throughout the world, which could negatively impact our business29% rewritten
4. 41Patent reform legislation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents
5. 42Changes in patent law in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect neffy and our current or future intranasal epinephrine technology product candidates
6. 43Obtaining and maintaining patent protection depends on compliance with various procedural, document submissions, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements
7. 44Patent terms may be inadequate to protect our competitive position for neffy and our current or future intranasal epinephrine technology product candidates for an adequate amount of time and may adversely affect our anticipated future revenues and operating earnings
8. 45We cannot ensure that patent rights relating to inventions described and claimed in our pending patent applications will issue or that patents based on our patent applications will not be challenged and rendered invalid and/or unenforceable
9. 46whether we may experience patent office interruption or delays to our ability to timely secure patent coverage to any potential additional indications or any future product candidates
10. 47We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent which might adversely affect our ability to develop and market neffy and our current or future intranasal epinephrine technology product candidates
11. 48If we are sued for infringing on the intellectual property rights of third parties, such litigation could be costly and time consuming and could prevent or delay us from developing or commercializing neffy or our current or future intranasal epinephrine technology product candidates27% rewritten
12. 49We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time consuming and unsuccessful and could result in a court or administrative body finding our patents to be invalid or unenforceable
13. 50neffy or our current or future intranasal epinephrine technology product candidates may face competition from generic intranasal epinephrine products sooner than expected, and our patents may be challenged31% rewritten
14. 51Because of the expense and uncertainty of litigation, we may not be in a position to enforce our intellectual property rights against third parties
15. 52Intellectual property litigation may lead to unfavorable publicity that harms our reputation
16. 53We may become subject to claims challenging the inventorship or ownership of our patents and other intellectual property
17. 54If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected
18. 55Intellectual property rights do not necessarily address all potential threats to our competitive advantage
19. 56If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed
20. 57We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties
21. 58In the future, we may need to obtain additional licenses of third-party technology that may not be available to us or are available only on commercially unreasonable terms, and which may cause us to operate our business in a more costly or otherwise adverse manner that was not anticipated

Risks Related to Employee Matters and Managing Growth

1. 59Our success is highly dependent on our ability to attract and retain highly skilled executive officers and employees
2. 60Our employees, independent contractors, consultants, current and future licensing and collaboration partners and CROs may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements, which could cause significant liability for us and harm our reputation
3. 61laws that require the reporting of financial information or data accurately
4. 62We may encounter difficulties in managing our growth, which could disrupt our operations

Risks Related to the Securities Markets and Ownership of Our Common Stock

1. 63The market price of our common stock could be volatile
2. 64period-to-period fluctuations in our financial results
3. 65In the past, following periods of volatility in the market price of a company’s securities, stockholders have often instituted class action securities litigation against those companies
4. 66Delaware law and provisions in our amended and restated certificate of incorporation and amended and restated bylaws could make a merger, tender offer or proxy contest difficult, thereby depressing the trading price of our common stock
5. 67We do not anticipate paying any cash dividends in the foreseeable future
6. 68Future sales of shares by existing stockholders could cause our stock price to decline
7. 69Geo-political conditions may have serious adverse consequences on our business, financial condition and stock priceNew
8. 70If equity research analysts do not publish research or reports, or publish unfavorable research or reports, about us, our business or our market, our stock price and trading volume could decline
9. 71If we fail to maintain proper and effective internal controls, our ability to produce accurate financial statements on a timely basis could be impaired