UroGen Pharma (URGN) risk factors, FY2024 10-K

Risks Related to Our Limited Operating History, Financial Condition and Capital Requirements

1. 01We have a limited operating history and have incurred significant losses and negative cash flows since our inception, and we anticipate that we will continue to incur significant losses and negative cash flows for the foreseeable future, which makes it difficult to assess our future viability
2. 02changes in reimbursement or other laws, regulations or policies that could have a negative impact on our future revenue stream
3. 03We may require additional financing to fund our operations and achieve our goals, and a failure to obtain this capital when needed and on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our product development, commercialization efforts or other operations
4. 04delay, limit, reduce or terminate our establishment or expansion of manufacturing, sales and marketing or distribution capabilities or other activities that may be necessary to commercialize Jelmyto or any of our product candidates that obtain marketing approval
5. 05Our indebtedness resulting from our loan agreement with Pharmakon could adversely affect our financial condition or restrict our future operations
6. 06Covenants under our Prepaid Forward Contract with RTW restrict our ability to borrow additional capital
7. 07Raising additional capital may cause dilution to our shareholders, restrict our operations or require us to relinquish rights to our technologies or product candidates

Risks Related to Our Business and Strategy

1. 08We are highly dependent on the successful commercialization of our only approved product, Jelmyto
2. 09If Jelmyto sales do not meet expectations, our share price could decline significantly and the long-term success of the product and our company could be harmed
3. 10We have limited experience as an organization in marketing and distributing products and are therefore subject to certain risks in relation to the commercialization of Jelmyto and any of our product candidates that receive regulatory approval
4. 11If we are unable to effectively train and equip our sales force, our ability to successfully commercialize Jelmyto and any future product candidates will be harmed
5. 12The market opportunities for Jelmyto and our product candidates may be smaller than we anticipate or limited to those patients who are ineligible for established therapies or for whom prior therapies have failed and may be small
6. 13Jelmyto and any of our product candidates that receive regulatory approval may fail to achieve the broad degree of physician adoption and use and market acceptance necessary for commercial success
7. 14Jelmyto and our product candidates, if approved, will face significant competition with competing technologies and our failure to compete effectively may prevent us from achieving significant market penetration
8. 15Our ability to market Jelmyto and any of our product candidates that receive marketing approval is and will be limited to certain indications. If we want to expand the indications for which we may market our products, we will need to obtain additional regulatory approvals, which may not be granted
9. 16In addition to Jelmyto, we are dependent on the success of our lead product candidate, UGN-102, and our other product candidates, including obtaining regulatory approval to market our product candidates in the United States
10. 17The data from our pivotal Phase 3 ENVISION trial and supporting ATLAS and OPTIMA II trials may be insufficient to support regulatory approval of UGN-102
11. 18Interim, 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 data
12. 19We have limited experience in conducting clinical trials and obtaining approval for product candidates and may be unable to do so successfully
13. 20We have not yet completed submission of our NDA for certain product candidates in our pipeline, and we may be delayed in obtaining or fail to obtain such regulatory approvals and to commercialize our product candidates
14. 21If any of these outcomes occur, we may not receive regulatory approval for the corresponding product candidates, and our business would not be able to generate revenue from the sale of any such product candidates
15. 22We may not be able to advance our nonclinical product candidates into clinical development and through regulatory approval and commercialization
16. 23timely manufacture of sufficient quantities of the product candidate for use in clinical trials
17. 24Clinical drug development involves a lengthy and expensive process with an uncertain outcome, results of earlier studies and trials may not be predictive of future trial results, and our clinical trials may fail to adequately demonstrate the safety and efficacy of our product candidates
18. 25raise sufficient capital to fund a trial
19. 26If we experience delays in carrying out or completing any clinical trial of our product candidates, the commercial prospects of our product candidates may be harmed, and our ability to generate product revenues from any of these product candidates will be delayed
20. 27our being sued and held liable for harm caused to patients
21. 28We may face future developmental and regulatory difficulties related to Jelmyto and any of our product candidates that receive marketing approval. In addition, we are subject to government regulations and we may experience delays in obtaining required regulatory approvals to market our proposed product candidates
22. 29refusal of regulatory authorities to approve pending applications or supplements to applications
23. 30If we are not successful in developing, receiving regulatory approval for and commercializing our nonclinical and clinical product candidates, our ability to expand our business and achieve our strategic objectives could be impaired
24. 31If we fail to develop and successfully commercialize other product candidates, our business and future prospects may be harmed, and our business will be more vulnerable to any problems that we encounter in developing and commercializing our product candidates
25. 32collaborations may be terminated for the convenience of the collaborator and, if terminated, we may need to raise additional capital to pursue further development or commercialization of the applicable product candidates
26. 33Failure to obtain marketing approval in international jurisdictions would prevent our approved product, Jelmyto, and our product candidates from being marketed abroad
27. 34If in the future we acquire or in-license technologies or product candidates, we may incur various costs, may have integration difficulties and may experience other risks that could harm our business and results of operations
28. 35We will need to continue to increase the size of our organization. If we fail to manage our growth effectively, our business could be disrupted
29. 36continue to improve our operational, financial and management controls, reporting systems and procedures
30. 37If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of any of our other products we develop
31. 38the inability to commercialize any product we develop
32. 39If we fail to attract and keep senior management and key personnel, we may be unable to successfully develop our product candidates, conduct our clinical trials and commercialize any of the products we develop
33. 40Under applicable employment laws, we may not be able to enforce covenants not to compete
34. 41Our employees, independent contractors, clinical investigators, CROs, consultants and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements and insider trading
35. 42Our business involves the use of hazardous materials and we and our third-party manufacturers and suppliers must comply with environmental laws and regulations, which can be expensive and restrict how we do business
36. 43Exchange rate fluctuations between the U.S. Dollar and the New Israeli Shekel may negatively affect our earnings
37. 44Our business could be adversely affected by the effects of health pandemics, epidemics or other public health emergencies
38. 45Certain of our clinical trials and other significant operations (including our Israeli corporate offices and contract manufacturers) are located outside of the United States and, therefore, our results may be adversely affected by geopolitical, economic and military instability

Risks Related to Our Intellectual Property

1. 46If our efforts to obtain, protect or enforce our patents and other intellectual property rights related to Jelmyto, our product candidates and technologies are not adequate, we may not be able to compete effectively, and we otherwise may be harmed
2. 47We will not necessarily seek to protect our intellectual property rights in all jurisdictions throughout the world and we may not be able to adequately enforce our intellectual property rights even in the jurisdictions where we seek protection
3. 48We may be subject to claims that we infringe, misappropriate or otherwise violate the intellectual property rights of third parties
4. 49There can be no assurance that any pending patent application will be granted. The term of individual patents depends upon the legal term of the patents in the countries in which they are obtained
5. 50Our trade secrets may not have sufficient intellectual property protection
6. 51Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our products
7. 52Depending on decisions by the U.S. Congress, the federal courts, and the USPTO, the laws and regulations governing patents could change in unpredictable ways that would weaken our ability to obtain new patents or to enforce our existing patents and patents that we might obtain in the future
8. 53The USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other similar provisions during the patent prosecution process
9. 54We may not be able to protect our intellectual property rights throughout the world
10. 55If we are unable to protect our trademarks from infringement, our business prospects may be harmed
11. 56We may become involved in lawsuits to protect or enforce our patents or other intellectual property rights or the patents of our licensors, which could be expensive and time consuming
12. 57Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could impair our ability to compete in the marketplace. The occurrence of any of the foregoing could harm our business, financial condition or results of operations
13. 58We may become subject to claims for remuneration or royalties for assigned service invention rights by our employees, which could result in litigation and adversely affect our business
14. 59Third-party claims alleging intellectual property infringement may adversely affect our business
15. 60We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties

Risks Related to Government Regulation

1. 61Orphan Drug Designation may not ensure that we will enjoy market exclusivity in a particular market, and if we fail to obtain or maintain orphan drug exclusivity for our product candidates, we may be subject to earlier competition and our potential revenue will be reduced
2. 62Orphan Drug Designation entitles a party to financial incentives, such as opportunities for grant funding towards clinical trial costs, tax advantages, user-fee waivers and market exclusivity for certain periods of time
3. 63product seizure or detention, or refusal to permit the import or export of products; and injunctions or the imposition of civil or criminal penalties
4. 64Legislative or regulatory healthcare reforms in the United States or abroad may make it more difficult and costly for us to obtain regulatory clearance or approval of our product candidates or any future product candidates and to produce, market, and distribute our products after clearance or approval is obtained
5. 65Each of these would likely entail substantial time and cost and could harm our business and our financial results. In addition, delays in receipt of or failure to receive regulatory clearances or approvals for any future products would harm our business, financial condition, and results of operations
6. 66If 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 negatively impact our business
7. 67It may be difficult for us to profitably sell our product and any product candidates that receive regulatory approval if coverage and reimbursement for these products is limited by government authorities and/or third-party payor policies
8. 68neither experimental nor investigational

Risks Related to Ownership of Our Ordinary Shares

1. 69The market price of our ordinary shares has been and may continue to be subject to fluctuation and you could lose all or part of your investment
2. 70general economic and market conditions and other factors, including factors unrelated to our operating performance
3. 71Future sales of our ordinary shares could reduce the market price of our ordinary shares
4. 72Future equity offerings could result in future dilution and could cause the price of our ordinary shares to decline
5. 73We have never paid cash dividends on our share capital, and we do not anticipate paying any cash dividends in the foreseeable future
6. 74If we are classified as a passive foreign investment company ("PFIC"), our U.S. shareholders may suffer adverse tax consequences
7. 75Changes to tax laws could have a material adverse effect on us and reduce net returns to our shareholders
8. 76Tax authorities may disagree with our positions and conclusions regarding certain tax positions, resulting in unanticipated costs, taxes or non-realization of expected benefits
9. 77If a United States person is treated as owning at least 10% of our ordinary shares, such holder may be subject to adverse U.S. federal income tax consequences
10. 78Our ability to use our U.S. net operating loss carryforwards and certain other tax attributes to offset future taxable income and taxes may be limited

Risks Related to our Operations in Israel

1. 79Our research and development and other significant operations are located in Israel and, therefore, our results may be adversely affected by political, economic and military instability in Israel
2. 80Israeli corporate law regulates mergers, requires tender offers for acquisitions of shares above specified thresholds, requires special approvals for transactions involving directors, officers or significant shareholders and regulates other matters that may be relevant to such types of transactions
3. 81These provisions could delay, prevent or impede an acquisition of us or our merger with another company, even if such an acquisition or merger would be considered to be beneficial by some of our shareholders and may limit the price that investors may be willing to pay in the future for our ordinary shares
4. 82Your rights and responsibilities as a shareholder will be governed by Israeli law, which differs in some material respects from the rights and responsibilities of shareholders of U.S. companies

Risks Related to Our Management and Employees

1. 83We depend on our executive officers and key clinical, technical and commercial personnel to operate our business effectively, and we must attract and retain highly skilled employees in order to succeed
2. 84If equity research analysts do not publish research or reports about us or our business or if they issue unfavorable commentary or downgrade our ordinary shares, the price of our ordinary shares could decline
3. 85Our business could be negatively affected as a result of actions of activist shareholders, and such activism could impact the trading value of our securities
4. 86Adverse developments affecting the financial services industry could adversely affect our current and projected business operations and our financial condition and results of operations
5. 87Unstable market, economic and geo-political conditions may have serious adverse consequences on our business, financial condition and share price
6. 88Our business could be negatively impacted by environmental, social and corporate governance matters or our reporting of such matters