UroGen Pharma (URGN) risk factors, FY2025 10-K

Risks Related to Our Financial Condition and Capital Requirements

1. 01If we are not able to generate sufficient cash flows from Jelmyto and Zusduri product sales to fund our operations, it may have an adverse impact on our working capital, total assets, stockholders’ equity and our ability to service our indebtednessNew
2. 02changes in reimbursement or other laws, regulations or policies that could have a negative impact on our future revenue stream24% rewritten
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 operations72% rewritten
4. 04All outstanding loans with Pharmakon will accrue interest at a fixed rate of 8.25% and are repayable in four equal quarterly payments commencing in the first quarter of 2030. We may prepay the loans in whole at our discretion at any time, subject to prepayment premiums, make-whole amounts, as applicable, and feesNew
5. 05delay, 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, Zusduri or any of our product candidates that obtain marketing approval
6. 06Our indebtedness resulting from our loan agreement with Pharmakon could adversely affect our financial condition or restrict our future operations85% rewritten
7. 07The obligations of the Borrower under the 2026 Loan Agreement are guaranteed on a full and unconditional basis by the Credit Parties and are secured by substantially all of the respective Credit Parties’ tangible and intangible assets and property, including intellectual property, subject to certain exceptionsNew
8. 08Covenants under our Prepaid Forward Contract with RTW restrict our ability to borrow additional capital
9. 09Raising additional capital may cause dilution to our shareholders, restrict our operations or require us to relinquish rights to our technologies or product candidates27% rewritten

Risks Related to Our Business and Strategy

1. 10We are highly dependent on the successful commercialization of our approved products, Jelmyto and Zusduri46% rewritten
2. 11Post-approval results for our approved drugs in larger numbers of patients and broader populations may not be consistent with the results from our clinical studiesNew
3. 12We 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, Zusduri and any of our product candidates that receive regulatory approval21% rewritten
4. 13If we are unable to effectively train and equip our sales force, our ability to successfully commercialize Jelmyto, Zusduri and any future product candidates will be harmed41% rewritten
5. 14The market opportunities for Jelmyto, Zusduri 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. 15Jelmyto, Zusduri 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 success25% rewritten
7. 16Jelmyto, Zusduri 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 penetration37% rewritten
8. 17Our ability to market Jelmyto, Zusduri and any of our product candidates that receive regulatory 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. 18We are dependent on the success of Jelmyto, Zusduri and our product candidates, including obtaining regulatory approval to market our product candidates in the United States40% rewritten
10. 19Interim, 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
11. 20We have limited experience in conducting clinical trials and obtaining approval for product candidates and may be unable to do so successfully
12. 21We have not yet submitted NDAs 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
13. 22If 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 candidates53% rewritten
14. 23We may not be able to advance our nonclinical product candidates into clinical development and through regulatory approval and commercialization
15. 24timely manufacture of sufficient quantities of the product candidate for use in clinical trials
16. 25Clinical 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
17. 26raise sufficient capital to fund a trial
18. 27If 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
19. 28our being sued and held liable for harm caused to patients80% rewritten
20. 29refusal of regulatory authorities to approve pending applications or supplements to applications
21. 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
22. 31If we fail to develop and successfully commercialize our 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
23. 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 candidates26% rewritten
24. 33International trade policies, including tariffs, sanctions and trade barriers may adversely affect our business, financial condition, results of operations and prospectsNew
25. 34Failure to obtain marketing approval in international jurisdictions would prevent our approved products, Jelmyto and Zusduri, and our product candidates from being marketed abroad
26. 35If 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
27. 36We will need to continue to increase the size of our organization. If we fail to manage our growth effectively, our business could be disrupted27% rewritten
28. 37continue to improve our operational, financial and management controls, reporting systems and procedures22% rewritten
29. 38If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of any of our products and product candidates, if approved
30. 39the inability to commercialize any product we develop29% rewritten
31. 40If 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 develop20% rewritten
32. 41Under applicable employment laws, we may not be able to enforce covenants not to compete27% rewritten
33. 42Our 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
34. 43Our 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
35. 44Exchange rate fluctuations between the U.S. dollar and the New Israeli Shekel may negatively affect our earnings
36. 45Our business could be adversely affected by the effects of health pandemics, epidemics or other public health emergencies
37. 46Certain 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. 47If our efforts to obtain, protect or enforce our patents and other intellectual property rights related to Jelmyto, Zusduri, and our product candidates and technologies are not adequate, we may not be able to compete effectively, and we otherwise may be harmed27% rewritten
2. 48We 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. 49We may be subject to claims that we infringe, misappropriate or otherwise violate the intellectual property rights of third parties
4. 50There can be no assurance that our patent applications 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. 51Our trade secrets may not have sufficient intellectual property protection
6. 52Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our products81% rewritten
7. 53Depending 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. 54The 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. 55We may not be able to protect our intellectual property rights throughout the world
10. 56If we are unable to protect our trademarks from infringement, our business prospects may be harmed
11. 57We 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 consuming20% rewritten
12. 58Uncertainties 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. 59We 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. 60Third-party claims alleging intellectual property infringement may adversely affect our business
15. 61We 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. 62In addition, other legislative changes have been proposed and adopted since the ACA was enacted. These changes include aggregate reductions to Medicare payments to providers of 2% per fiscal year, which began in 2013 and will remain in effect until 2032 unless additional Congressional action is takenNew
2. 63Orphan 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. 64product seizure or detention, or refusal to permit the import or export of products; and injunctions or the imposition of civil or criminal penalties
4. 65Legislative 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. 66Each 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 operations26% rewritten
6. 67If 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. 68It may be difficult for us to profitably sell our products and product candidates that receive regulatory approval if coverage and reimbursement for these products is limited by government authorities and/or third-party payor policies21% rewritten
8. 69neither experimental nor investigational

Risks Related to Ownership of Our Ordinary Shares

1. 70The 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 investment24% rewritten
2. 71general economic and market conditions and other factors, including factors unrelated to our operating performance
3. 72Future sales of our ordinary shares could reduce the market price of our ordinary shares
4. 73Future equity offerings could result in future dilution and could cause the price of our ordinary shares to decline67% rewritten
5. 74We have never paid cash dividends on our share capital, and we do not anticipate paying any cash dividends in the foreseeable future
6. 75If we are classified as a passive foreign investment company ("PFIC"), our U.S. shareholders may suffer adverse tax consequences
7. 76Changes to tax laws could have a material adverse effect on us and reduce net returns to our shareholders30% rewritten
8. 77Tax authorities may disagree with our positions and conclusions regarding certain tax positions, resulting in unanticipated costs, taxes or non-realization of expected benefits
9. 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 conditions in Israel65% rewritten
2. 80Any of these implications on Israel’s security, business, economic or financial conditions may have an adverse effect on our ability to effectively conduct our business, our results of operations and our ability to raise additional fundsNew
3. 81Israeli 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
4. 82These 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
5. 83Your 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. 84We 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. 85If 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. 86Our 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. 87Adverse developments affecting the financial services industry could adversely affect our current and projected business operations and our financial condition and results of operations
5. 88Unstable market, economic and geo-political conditions may have serious adverse consequences on our business, financial condition and share price21% rewritten
6. 89Our business could be negatively impacted by environmental, social and corporate governance matters or our reporting of such matters58% rewritten