EyePoint (EYPT) risk factors, FY2024 10-K

RISKS RELATED TO OUR FINANCIAL POSITION AND OUR CAPITAL RESOURCES

1. 01We will likely need additional capital to fund our operations. If we are unable to obtain sufficient capital, we will need to curtail and reduce our operations and costs and modify our business strategy
2. 02We have incurred significant losses since our inception and anticipate that we will continue to incur losses for the foreseeable future
3. 03We may never achieve profitability from future operations
4. 04our ability to obtain coverage and adequate reimbursement from third parties, including government payors
5. 05We will need to raise additional capital in the future, which may not be available on favorable terms and may be dilutive to stockholders or impose operational restrictions
6. 06the costs of operating as a public company
7. 07Our ability to use our net operating loss carryforwards and other tax attributes may be limited

RISKS RELATED TO THE CLINICAL DEVELOPMENT AND REGULATORY APPROVAL OF OUR PRODUCT CANDIDATES

1. 08distribution and use restrictions imposed by the FDA or other regulatory authorities outside the United States
2. 09The outcomes of clinical trials are uncertain, and delays in the completion of or the termination of any clinical trial of DURAVYU™ or our other product candidates could harm our business, financial condition, and prospects
3. 10developments, clinical trial results and other factors with respect to competitive products and treatments, a process which may also create a more competitive environment for patient accrual in clinical trials
4. 11Disruptions 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 relies, which could negatively impact our business
5. 12Clinical trial results may fail to support continued clinical investigations and/or approval of DURAVYU™ or our other product candidates
6. 13Interim, top-line, initial 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 confirmation, audit and verification procedures that could result in material changes in the final data
7. 14Adverse differences between interim, top-line, initial or preliminary data and final data could significantly harm our business prospects and may cause the price of our common stock to fluctuate or decline
8. 15Phase 1 or 2 results from a clinical trial do not ensure that the trial will be successful and success in early stage clinical trials does not ensure success in later-stage clinical trials
9. 16We may find it difficult to enroll patients in our clinical trials, which could delay or prevent clinical trials of our product candidates
10. 17We may not be able to initiate or continue clinical trials if we cannot enroll a sufficient number of eligible patients to participate in the clinical trials required by regulatory agencies
11. 18If we are unable to successfully expand our product lines through internal research and new therapeutic development or keep pace with rapid technological changes in the healthcare industry, our business may be materially and adversely affected

RISKS RELATED TO THE COMMERCIALIZATION OF OUR PRODUCTS AND PRODUCT CANDIDATES

1. 19Our business strategy relies in part on our ability to successfully commercialize our product candidates, if approved; however, the products may not achieve market acceptance or be commercially successful
2. 20maintaining compliance with all applicable regulatory requirements
3. 21Our product and product candidates, if approved and commercialized, may become subject to unfavorable pricing regulations, third-party reimbursement practices, or healthcare reform initiatives which could harm our business
4. 22Even though regulatory approval DEXYCU® has been obtained in the U.S., we will still face extensive FDA regulatory requirements and may face future regulatory difficulties
5. 23refuse to allow us to enter into supply contracts, including government contracts
6. 24programs; similar to the U.S. federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation
7. 25If the market opportunities for our product candidates, including DURAVYU™, are smaller than we believe they are, our results of operations may be adversely affected and our business may suffer
8. 26If any of our products have newly discovered or developed safety problems, our business would be seriously harmed
9. 27The Affordable Care Act and any changes in healthcare laws may increase the difficulty and cost for us to commercialize our future products in the U.S. and affect the prices we may obtain
10. 28a Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research
11. 29There has been increasing legislative, regulatory, and enforcement interest in the United States with respect to drug pricing and
12. 30The Inflation Reduction Act of 2022 and other changes in healthcare law may impact the prices we are able to obtain for our products and our obligations to make payments to the government
13. 31Civil monetary penalties (CMPs) could accrue for a failure to comply with certain drug price negotiation program, inflation rebate program, or Part D manufacturer discount program requirements. In addition, excise taxes could accrue for a failure to comply with certain drug price negotiation program requirements
14. 32Patient assistance programs for pharmaceutical products have come under increasing scrutiny by governments, legislative bodies and enforcement agencies. These activities may result in actions that have the effect of harming our business or reputation, or subjecting us to fines or penalties
15. 33If the FDA or other applicable regulatory authorities approve generic products that compete with any of our product candidates, it could reduce the future sales of our product candidates
16. 34Product liability lawsuits against us could cause us to incur substantial liabilities and to limit manufacturing or commercialization of new product candidates that we may develop and commercialize, including DURAVYU™
17. 35an increase in product liability insurance premiums or an inability to maintain product liability insurance coverage

RISKS RELATED TO OUR INTELLECTUAL PROPERTY

1. 36If we are unable to protect our intellectual property rights or if our intellectual property rights are inadequate to protect our product candidates, our competitors could develop and commercialize technology and products similar to ours, and our competitive position could be harmed
2. 37We may become involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time consuming and unsuccessful
3. 38We may not be able to protect our intellectual property rights throughout the world
4. 39Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, 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
5. 40Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which could be uncertain and could harm our business
6. 41pending patent applications owned by third parties exist in the fields in which we are developing our product candidates. Third parties may assert infringement claims against us based on existing patents or patents that may be granted in the future
7. 42Our competitors may be able to circumvent our patents by developing similar or alternative technologies or products in a non-infringing manner
8. 43Changes in either U.S. or foreign patent law or interpretation of such laws could diminish the value of patents in general, thereby impairing our ability to protect our products or product candidates
9. 44We may be subject to claims asserting that our employees, consultants, independent contractors and advisors have wrongfully used or disclosed confidential information and/or alleged trade secrets of their current or former employers or claims asserting ownership of what we regard as our own intellectual property
10. 45The degree of future protection afforded by our intellectual property rights is uncertain because intellectual property rights have limitations, and intellectual property rights may not adequately protect our business or permit us to maintain our competitive advantage
11. 46If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed
12. 47may not be able to obtain adequate remedies for such breaches. In addition, our trade secrets may otherwise become known, including through a potential cybersecurity incident, or may be independently developed by competitors
13. 48If our trademarks 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

RISKS RELATED TO OUR RELIANCE ON THIRD PARTIES

1. 49responsibilities or if their performance is inadequate, the development, and commercialization of our product candidates could be delayed
2. 50Moreover, if a foreign regulatory authority curtails operations at such foreign facilities of our CMOs or CDMOs, or if trade laws are adopted limiting our ability to use such CMO or CDMO facilities, we may need to find alternative facilities, which could negatively impact our clinical development timelines
3. 51We use our own facility for the manufacturing of YUTIQ® and rely on third party suppliers for key components, and any disruptions to our or our suppliers’ operations could adversely affect YUTIQ®’s commercial viability and our ability to supply YUTIQ® to ANI and Ocumension
4. 52other things, recordkeeping, production processes, and controls, personnel, and quality control. To ensure that we continue to meet these requirements, we have and will continue to expend significant time, money, and effort
5. 53Our manufacturing operations currently depend on our Watertown, MA and Northbridge, MA facilities. If either location is destroyed or out of operation, our business may be adversely impacted
6. 54Our employees, collaborators, service providers, independent contractors, principal investigators, consultants, co-promotion partners, vendors and CROs may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements
7. 55laws that require the true, complete, and accurate reporting of financial information or data
8. 56Changes in U.S. and international trade policies may adversely impact our business and operating results

RISKS RELATED TO OWNERSHIP OF OUR COMMON STOCK

1. 57The trading price of the shares of our common stock has been highly volatile, and purchasers of our common stock could incur substantial losses
2. 58A small concentration of approximately ten stockholders beneficially own 67% of our total outstanding common stock, which gives certain stockholders significant control over matters subject to stockholder approval, which would prevent new investors from influencing significant corporate decisions
3. 59Sales of a substantial number of shares of our common stock, or the perception by the market that those sales could occur, could cause the market price of our common stock to decline or could make it more difficult for us to raise funds through the sale of equity in the future
4. 60We do not currently intend to pay dividends on our common stock, and any return to investors is expected to come, if at all, only from potential increases in the price of our common stock
5. 61Provisions in our charter documents could prevent or delay stockholders’ attempts to takeover our company
6. 62Provisions in our bylaws provide for indemnification of officers and directors, which could require us to direct funds away from our business and the development of our product candidates
7. 63We will need to grow the size of our organization, and we may experience difficulties in managing this growth
8. 64managing our internal development efforts effectively while complying with our contractual obligations to licensors, licensees, contractors and other third parties; and improving our managerial, development, operational and financial systems, and procedures
9. 65Our business and operations would suffer in the event of computer system failures, cyberattacks or a deficiency in our cybersecurity
10. 66If we fail to comply with data protection laws and regulations, we could be subject to government enforcement actions, which could include civil or criminal penalties, as well as private litigation and/or adverse publicity, any of which could negatively affect our operating results and business
11. 67compliance within a certain timeframe). Further, the UK Government may amend/update UK data protection law, which may result in changes to our business operations and potentially incur commercial cost