UroGen Pharma Ltd 10-K for FY2022

UroGen Pharma Ltd. (URGN)

10-K 2023-03-24 For: 2022-12-31

Added on April 07, 2026

About this 10-K

UroGen Pharma Ltd filed this 10-K on March 24, 2023, covering the fiscal year ended December 31, 2022 (FY2022).

Headline figures

Fiscal year ended December 31, 2022, as reported in this filing, compared with the same period a year earlier where the filing states it.

Revenue: $64.36M; up 34.0% from $48.04M a year earlier
Net loss: $109.78M; compared with a net loss of $110.82M a year earlier

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Israel		98-1460746
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification Number)
400 Alexander Park, Princeton, NJ		08540
(Address of principal executive offices)		(Zip Code)

Title of each class	Trading Symbol	Name of exchange on which registered
Ordinary Shares, par value NIS 0.01 per share	URGN	The Nasdaq Stock Market LLC

Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated filer	☑	Smaller reporting company	☑
		Emerging growth company	☐

Document Description		10-K Part
Portions of the registrant’s definitive proxy statement to be filed with the Securities and Exchange Commission pursuant to Regulation 14A not later than May 1, 2023 are incorporated by reference into Part III of this report.		III

		Page
PART I.		1
Item 1.	Business	3
Item 1A.	Risk Factors	23
Item 1B.	Unresolved Staff Comments	58
Item 2.	Properties	58
Item 3.	Legal Proceedings	58
Item 4.	Mine Safety Disclosures	58

PART II.		59
Item 5.	Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities	59
Item 6.	[Reserved]	59
Item 7.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	60
Item 7A.	Quantitative and Qualitative Disclosures about Market Risk	70
Item 8.	Financial Statements and Supplementary Data	71
Item 9.	Changes in and Disagreements with Accountants on Accounting and Financial Disclosure	92
Item 9A.	Controls and Procedures	92
Item 9B.	Other Information	92
Item 9C.	Disclosure Regarding Foreign Jurisdictions that Prevent Inspections	92

PART III.		93
Item 10.	Directors, Executive Officers and Corporate Governance	93
Item 11.	Executive Compensation	93
Item 12.	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters	93
Item 13.	Certain Relationships and Related Transactions and Director Independence	93
Item 14.	Principal Accountant Fees and Services	93

PART IV.		94
Item 15.	Exhibits, Financial Statement Schedules	94
Item 16.	Form 10-K Summary	95

	•	We will 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.
	•	We are highly dependent on the successful commercialization of our only approved product, Jelmyto.
	•	We 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.
	•	The 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.
	•	Jelmyto 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.
	•	Jelmyto 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.
	•	In 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.
	•	Clinical 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.
	•	We have entered into collaboration and licensing agreements and in the future may enter into collaboration and licensing arrangements with other third parties for the development or commercialization of our product candidates. If our collaboration and licensing arrangements are not successful, we may not be able to capitalize on the market potential of these product candidates.
	•	We currently contract with third-party subcontractors and single-source suppliers for certain raw materials, compounds and components necessary to produce Jelmyto for commercial use, and to produce UGN-102, UGN-201 and UGN-301 for nonclinical studies and clinical trials, and expect to continue to do so to support commercial scale production of UGN-102 and UGN-201, if approved, as well as UGN-301 if approved as a monotherapy or for any approved product that includes UGN-301. There are significant risks associated with the manufacture of pharmaceutical products and contracting with contract manufacturers, including single-source suppliers. Furthermore, our existing third-party subcontractors and single-source suppliers may not be able to meet the increased need for certain raw materials, compounds and components that may result from our commercialization efforts. This increases the risk that we will not have sufficient quantities of Jelmyto, UGN-102, UGN-201 or UGN-301 or be able to obtain such quantities at an acceptable cost, which could delay, prevent or impair our development or commercialization efforts.
	•	If 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.
	•	If 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.
	•	We 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.
	•	Our indebtedness resulting from our Loan Agreement could adversely affect our financial condition or restrict our future operations.
	•	If our efforts to obtain, protect or enforce our patents and other intellectual property rights related to our product candidates and technologies are not adequate, we may not be able to compete effectively, and we otherwise may be harmed.
	•	If the FDA does not conclude that UGN-102 satisfies the requirements under 505(b)(2), or if the requirements for our product candidates are not as we expect, the approval pathway for these product candidates will likely take significantly longer, cost significantly more and entail significantly greater complications and risks than anticipated, and in either case may not be successful.
	•	We expect current and future legislation affecting the healthcare industry, including healthcare reform, to impact our business generally and to increase limitations on reimbursement, rebates and other payments, which could adversely affect third-party coverage of our products, our operations, and/or how much or under what circumstances healthcare providers will prescribe or administer our products, if approved.
	•	Jelmyto and any of our product candidates that receive regulatory approval will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expenses, limit or withdraw regulatory approval and subject us to penalties if we fail to comply with applicable regulatory requirements.
	•	It may be difficult for us to profitably sell our product candidates if coverage and reimbursement for these products is limited by government authorities and/or third-party payor policies.
	•	Our 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.

	•	the timing of, and the costs involved in, clinical development and obtaining regulatory approvals for our product candidates;

	•	changes in regulatory requirements during the development phase that can delay or force us to stop our activities related to any of our product candidates;

	•	the cost of commercialization activities for Jelmyto and any other products approved for sale, including marketing, sales and distribution costs;

	•	our degree of success in commercializing Jelmyto;

	•	the cost of third-party manufacturing of our products candidates and any approved products;

	•	the number and characteristics of any other product candidates we develop or acquire;

	•	our ability to establish and maintain strategic collaborations, licensing or other commercialization arrangements, and the terms and timing of such arrangements;

	•	the extent and rate of market acceptance of any approved products;

	•	the expenses needed to attract and retain skilled personnel;

	•	the costs associated with being a public company;

	•	the costs involved in preparing, filing, prosecuting, maintaining, defending and enforcing patent and other intellectual property claims, including potential litigation costs, and the outcome of such litigation;

	•	the timing, receipt and amount of sales of, or royalties on, future approved products, if any;

	•	the repayment of outstanding debt;

	•	any product liability or other lawsuits related to our products or business arrangements;

	•	scientific breakthroughs in the field of urothelial cancer treatment and diagnosis that could significantly diminish the demand for our product candidates or make them obsolete; and

	•	changes in reimbursement or other laws, regulations or policies that could have a negative impact on our future revenue stream.

	•	delay, limit, reduce or terminate nonclinical studies, clinical trials or other development activities for our product candidates or any of our future product candidates;

	•	delay, limit, reduce or terminate our other research and development activities; or

	•	delay, 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.

	•	if patients are physically quarantined or are unable or unwilling to visit healthcare providers;
	•	if physicians restrict access to their facilities for a material period of time;
	•	if healthcare providers prioritize treatment of acute or communicable illnesses over treatment of low-grade UTUC;
	•	if pharmacies are closed or suffering staff shortages or supply chain disruptions;
	•	if patients lose access to employer-sponsored health insurance due to periods of high unemployment; or
	•	as a result of general disruptions in the operations of payors, distributors, logistics providers and other third parties that are necessary for Jelmyto to be prescribed, reconstituted, instilled and reimbursed.

	•	the clinical indications for which the product is approved;
	•	the safety and efficacy data from the clinical trial(s) supporting the approved clinical indications;
	•	the approved labeling and packaging for our products, including the degree of product preparation and administration convenience and ease of use that is afforded to physicians by the approved labeling and product packaging;
	•	the prevalence and severity of adverse side effects and the level of benefit/risk observed in our clinical trials;
	•	sufficient patient satisfaction with the results and administration of our products and overall treatment experience, including relative convenience, ease of use and avoidance of, or reduction in, adverse side effects;
	•	the extent to which physicians recommend our products to patients;
	•	physicians’ and patients’ willingness to adopt new therapies in lieu of other products or treatments, including willingness to adopt Jelmyto, and our lead product candidate UGN-102 as locally-administered drug replacements to current surgical standards of care;
	•	the cost of treatment, safety and efficacy of our products in relation to alternative treatments, including the recurrence rate of our treatments;
	•	the extent to which the costs of our products are covered and reimbursed by third-party payors, including the availability of a physician reimbursement code for our treatments, and patients’ willingness to pay for our products;
	•	whether treatment with our products, including the treatment of low-grade UTUC with Jelmyto and the treatment of low-grade intermediate risk NMIBC with UGN-102, if approved, will be deemed to be an elective procedure by third- party payors; if so, the cost of treatment would be borne by the patient and would be less likely to be broadly adopted;
	•	proper education of physicians or nurses for the skillful administration of our approved product, Jelmyto, and UGN-102, if approved, and development of a broad experiential knowledge base of aggregated clinician feedback from which we can refine appropriate procedures for product administration, without which there could be a risk of adverse events; and
	•	the effectiveness of our sales and marketing efforts, especially the success of any targeted marketing efforts directed toward physicians and clinics and any direct-to-consumer marketing efforts we may initiate.

	•	the FDA’s acceptance of our parameters for regulatory approval relating to UGN-102 and our other product candidates, including our proposed indications, primary and secondary endpoint assessments and measurements, safety evaluations and regulatory pathways, and proposed labeling and packaging;
	•	our ability to successfully complete the FDA requirements related to chemistry, manufacturing and controls ("CMC"), for UGN-102 and our other product candidates, and if completed, their sufficiency to support an NDA;
	•	the FDA’s timely acceptance of our INDs, for our product candidates and our inability to commence clinical trials in the United States without such IND acceptances;
	•	the FDA’s acceptance of the design, size, conduct and implementation of our clinical trials, our trial protocols and the interpretation of data from nonclinical studies or clinical trials;
	•	the FDA’s acceptance of the population studied in our clinical trials being sufficiently large, broad and representative to assess efficacy and safety in the patient population for which we seek approval;
	•	our ability to successfully complete the clinical trials of our product candidates, including timely patient enrollment and acceptable safety and efficacy data and our ability to demonstrate the safety and efficacy of the product candidates undergoing such clinical trials;
	•	our ability to demonstrate meaningful clinical or other benefits which outweigh any safety or other perceived risks, through the completion of our clinical trials for our product candidates;
	•	the FDA’s need to schedule an advisory committee meeting, and to conduct such meeting, in a timely manner to evaluate and decide on the approval of our potential future NDA for UGN-102;
	•	if applicable, the recommendation of the FDA’s advisory committee to approve our applications to market UGN-102 and our other product candidates in the United States, without limiting the approved labeling, specifications, distribution or use of the products, or imposing other restrictions;
	•	the FDA’s determination of safety and efficacy of our product candidates;
	•	the FDA’s determination that the Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act ("FDCA") regulatory pathway (“505(b)(2)”) is available for our product candidates;
	•	the prevalence and severity of adverse events associated with our product candidates, including UGN-102, as there are no drugs and related drug administration procedures approved for the primary treatment of low-grade NMIBC, that are based on RTGel technology;
	•	the timely and satisfactory performance by third-party contractors of their obligations in relation to our clinical trials;
	•	our success in educating physicians and patients about the benefits, risks, administration and use of our product candidates, if approved, particularly in light of the fact that there are no drugs that have been approved by the FDA for the primary treatment of low-grade NMIBC, and only a limited number of drugs have been approved by the FDA as adjuvant treatment for high-grade NMIBC;
	•	the availability, perceived advantages, relative cost, safety and efficacy of alternative and competing treatments for the indications addressed by our product candidates;
	•	the effectiveness of our marketing, sales and distribution strategy, and operations, as well as that of any current and future licensees;
	•	the FDA’s acceptance of the quality of our drug substance or drug product, formulation, labeling, packaging, or the specifications of our product candidates is sufficient for approval;
	•	our ability to develop, validate and maintain a commercially viable manufacturing process that is compliant with cGMP;

	•	the FDA’s acceptance of the manufacturing processes or facilities of third-party manufacturers with which we contract;
	•	our ability to secure supply of the raw materials from TAPI (Teva Active Pharmaceutical Ingredients) or other suppliers for our product candidates to support clinical trials and commercial use;
	•	our ability to manufacture or secure finished product from third-party suppliers for product candidates, including UGN-102, if approved;
	•	our ability to obtain, maintain, protect and enforce our intellectual property rights with respect to our product candidates;
	•	the extent to which the costs of our products, once approved, are covered and reimbursed by third-party payors, including the availability of a physician reimbursement code for our treatments, and patients’ willingness to pay for our products; and
	•	our ability to properly train physicians or nurses for the skillful preparation and administration of any of our product candidates that receive approval, including UGN-102, and our ability to develop a broad experiential knowledge base of aggregated clinician feedback from which we can refine appropriate procedures for product administration, without which there could be a risk of adverse events.

	•	generating adequate and sufficient nonclinical safety and efficacy data in a timely fashion to support the initiation of clinical trials;

	•	obtaining regulatory approval to commence clinical trials in any jurisdiction, including the submission and acceptance of INDs;

	•	contracting with the necessary parties to conduct a clinical trial;

	•	enrolling sufficient numbers of patients in clinical trials in timely fashion, if at all; and

	•	timely manufacture of sufficient quantities of the product candidate for use in clinical trials.

	•	generate sufficient nonclinical, toxicology, or other in vivo or in vitro data to support the initiation or continuation of clinical trials;

	•	obtain regulatory approval or feedback on trial design, in order to commence a trial;

	•	identify, recruit and train suitable clinical investigators;

	•	reach agreement on acceptable terms with prospective contract research organizations ("CROs") and clinical trial sites, and have such CROs and sites effect the proper and timely conduct of our clinical trials;

	•	obtain and maintain institutional review board ("IRB") approval at each clinical trial site;

	•	identify, recruit, enroll and retain suitable patients to participate in a trial;

	•	have a sufficient number of patients enrolled, complete a trial or return for post-treatment follow-up;

	•	ensure clinical investigators and clinical trial sites observe trial protocol or continue to participate in a trial;

	•	address any patient safety concerns that arise during the course of a trial;

	•	address any conflicts with new or existing laws or regulations;

	•	add a sufficient number of clinical trial sites;

	•	manufacture sufficient quantities at the required quality of product candidate for use in clinical trials; or

	•	raise sufficient capital to fund a trial.

	•	our inability to submit an NDA or similar application for our product candidates because of insufficient risk-reward, or the denial of such application by the FDA or foreign regulatory authorities;

	•	the FDA or foreign regulatory authorities suspending or terminating our clinical trials or suspending or withdrawing their approval of the product;

	•	the FDA or foreign regulatory authorities requiring the addition of labeling statements, such as boxed or other warnings or contraindications or distribution and use restrictions;

	•	the FDA or foreign regulatory authorities requiring us to issue specific communications to healthcare professionals, such as letters alerting them to new safety information about our product, changes in dosage or other important information;

	•	the FDA or foreign regulatory authorities issuing negative publicity regarding the affected product, including safety communications;

	•	our being limited with respect to the safety-related claims that we can make in our marketing or promotional materials;

	•	our being required to change the way the product is administered, conduct additional nonclinical studies or clinical trials or restrict or cease the distribution or use of the product; and

	•	our being sued and held liable for harm caused to patients.

	•	suspension or imposition of restrictions on operations, including costly new manufacturing requirements;

	•	regulatory agency refusal to approve pending applications or supplements to applications;

	•	suspension of any ongoing clinical trials;

	•	suspension or withdrawal of marketing approval;

	•	an injunction or imposition of civil or criminal penalties or monetary fines;

	•	seizure or detention of products;

	•	bans or restrictions on imports and exports;

	•	issuance of warning letters or untitled letters;

	•	suspension or imposition of restrictions on operations, including costly new manufacturing requirements; or

	•	refusal of regulatory authorities to approve pending applications or supplements to applications.

	•	the research methodology used may not be successful in identifying potential product candidates;

	•	competitors may develop alternatives that render our product candidates obsolete or less attractive;

	•	a product candidate may in a subsequent trial be shown to have harmful side effects or other characteristics that indicate it is unlikely to be effective or otherwise does not meet applicable regulatory criteria;

	•	a product candidate may not be capable of being produced in commercial quantities at an acceptable cost, or at all;

	•	a product candidate may not be accepted as safe and effective by patients, the medical community or third-party payors, if applicable; and

	•	intellectual property or other proprietary rights of third parties for product candidates we develop may potentially block our entry into certain markets or make such entry economically impracticable.

	•	collaborators have significant discretion in determining the amount and timing of efforts and resources that they will apply to these collaborations;

	•	collaborators may not perform their obligations as expected;

	•	product candidates developed by collaborators may not perform sufficiently in clinical trials to be determined to be safe and effective, thereby delaying or terminating the drug approval process and reducing or eliminating milestone payments to which we would otherwise be entitled if the product candidates had successfully met their endpoints and/or received FDA approval;

	•	clinical trials conducted by collaborators could give rise to new safety concerns;

	•	collaborators may not pursue development and commercialization of our product candidates that receive marketing approval or may elect not to continue or renew development or commercialization programs based on clinical trial results, changes in the collaborators’ strategic focus or available funding, or external factors, such as an acquisition, that divert resources or create competing priorities;

	•	collaborators may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon a product candidate, repeat or conduct new clinical trials or require a new formulation of a product candidate for clinical testing;

	•	collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our products or product candidates if the collaborators believe that competitive products are more likely to be successfully developed or can be commercialized under terms that are more economically attractive than ours;

	•	product candidates discovered in collaboration with us may be viewed by our collaborators as competitive with their own product candidates or products, which may cause collaborators to cease to devote resources to the commercialization of our product candidates;

	•	a collaborator with marketing and distribution rights to one or more of our product candidates that achieve regulatory approval may not commit sufficient resources to the marketing and distribution of such product or products;

	•	disagreements with collaborators, including disagreements over proprietary rights, contract interpretation or the preferred course of development, might cause delays or termination of the research, development or commercialization of product candidates, might lead to additional responsibilities for us with respect to product candidates, or might result in litigation or arbitration, any of which would divert management attention and resources, be time-consuming and expensive;

	•	collaborators may not properly maintain or defend our intellectual property rights or may use our proprietary information in such a way as to invite litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to potential litigation;

	•	collaborators may infringe the intellectual property rights of third parties, which may expose us to litigation and potential liability; and

	•	collaborations may be terminated for the convenience of the collaborator and, if terminated, we could be required to raise additional capital to pursue further development or commercialization of the applicable product candidates.

	•	manage our clinical trials effectively;

	•	identify, recruit, retain, incentivize and integrate additional employees;

	•	manage our internal development efforts effectively while carrying out our contractual obligations to third parties; and

	•	continue to improve our operational, financial and management controls, reporting systems and procedures.

	•	decreased demand for Jelmyto and our investigational product candidates we develop;

	•	injury to our reputation and significant negative media attention;

	•	withdrawal of clinical trial participants or cancellation of clinical trials;

	•	costs to defend the related litigation, which may be only partially recoverable even in the event of successful defenses;

	•	a diversion of management’s time and our resources;

	•	substantial monetary awards to trial participants or patients;

	•	regulatory investigations, product recalls, withdrawals or labeling, marketing or promotional restrictions;

	•	loss of revenues;

	•	exhaustion of any available insurance and our capital resources; and

	•	the inability to commercialize any product we develop.

	•	restrictions on the marketing or manufacturing of the product, withdrawal of the product from the market, or voluntary or mandatory product recalls;

	•	fines, warning letters or holds on clinical trials;

	•	refusal by the FDA to approve pending applications or supplements to approved applications submitted by us, or suspension or revocation of product license approvals; and

	•	product seizure or detention, or refusal to permit the import or export of products; and injunctions or the imposition of civil or criminal penalties.

	•	changes to manufacturing methods;

	•	recall, replacement, or discontinuance of one or more of our products; and

	•	additional recordkeeping.

	•	a covered benefit under its health plan;

	•	safe, effective and medically necessary;

	•	appropriate for the specific patient;

	•	cost-effective; and

	•	neither experimental nor investigational.

	•	the success of our launch and commercialization of Jelmyto;

	•	actual or anticipated variations in our and our competitors’ results of operations and financial condition;

	•	physician and market acceptance of Jelmyto or any other approved product;

	•	the mix of products that we sell;

	•	any voluntary or mandatory recall of Jelmyto or any other approved product, or the imposition of any additional labeling, marketing or promotional restrictions;

	•	our success or failure to obtain approval for and commercialize our product candidates;

	•	changes in the structure of healthcare payment systems;

	•	changes in earnings estimates or recommendations by securities analysts, if our ordinary shares are covered by analysts;

	•	development of technological innovations or new competitive products by others;

	•	announcements of technological innovations or new products by us;

	•	publication of the results of nonclinical or clinical trials for Jelmyto, UGN-102 or our other product candidates;

	•	failure by us to achieve a publicly announced milestone;

	•	delays between our expenditures to develop and market new or enhanced product candidates and the generation of sales from those products;

	•	developments concerning intellectual property rights;

	•	the announcement of, or developments in, any litigation matters, including any product liability claims related to Jelmyto or any of our product candidates;

	•	regulatory developments and the decisions of regulatory authorities as to the approval or rejection of new or modified products;

	•	changes in the amounts that we spend to develop, acquire or license new products, technologies or businesses;

	•	changes in our expenditures to promote our products;

	•	our sale or proposed sale, or the sale by our significant shareholders, of our ordinary shares or other securities in the future;

	•	changes in key personnel;

	•	success or failure of our research and development projects or those of our competitors;

	•	the trading volume of our ordinary shares; and

	•	general economic and market conditions and other factors, such as the COVID-19 pandemic, including factors unrelated to our operating performance.

	Year Ended December 31,
	2022			2021			Change
	(in thousands)
Revenue	$	64,357		$	48,042		$	16,315
Cost of revenue		7,654			5,157			2,497
Gross profit		56,703			42,885			13,818
Operating expenses:
Research and development		52,906			47,642			5,264
Selling and marketing		51,920			47,592			4,328
General and administrative		30,918			39,943			(9,025	)
Total operating expenses		135,744			135,177			567
Operating loss		(79,041	)		(92,292	)		13,251
Financing on prepaid forward obligation		(21,559	)		(17,291	)		(4,268	)
Interest expense on long-term debt		(8,438	)		—			(8,438	)
Interest and other income, net		1,010			212			798
Loss before income taxes		(108,028	)		(109,371	)		1,343
Income tax expense		(1,755	)		(1,449	)		(306	)
Net loss	$	(109,783	)	$	(110,820	)	$	1,037

	•	revenues we may derive either directly or in the form of royalty payments from future sales of Jelmyto, UGN-102, UGN-301, RTGel reverse thermal hydrogel technology and any other product candidates; and

	•	the repayment of outstanding debt.

	Pages
Report of Independent Registered Public Accounting Firm (PCAOB ID 238)	72
Consolidated Balance Sheets	73
Consolidated Statements of Operations and Comprehensive Loss	74
Consolidated Statements of Shareholders’ Equity (Deficit)	75
Consolidated Statements of Cash Flows	76
Notes to Consolidated Financial Statements	77

	*December 31,*
	*2022*			*2021*
Assets
Current assets:
Cash and cash equivalents	$	55,408		$	44,360
Marketable securities		44,556			44,779
Restricted cash		813			1,226
Accounts receivable		12,704			11,717
Inventories		4,325			4,832
Prepaid expenses and other current assets		11,101			7,476
Total current assets		128,907			114,390
Non-current assets:
Property and equipment, net		1,297			1,967
Restricted deposit		223			223
Right of use assets		2,452			1,180
Marketable securities		—			675
Other non-current assets		2,740			1,311
Total Assets	$	135,619		$	119,746
Liabilities and Shareholders' Equity (Deficit)
Current liabilities:
Accounts payable and accrued expenses	$	12,383		$	12,102
Employee related accrued expenses		8,257			6,948
Other current liabilities		3,276			3,330
Total current liabilities:		23,916			22,380
Non-current liabilities:
Prepaid forward obligation		98,923			85,713
Long-term debt		97,537			—
Long-term lease liabilities		1,586			398
Uncertain tax positions liability		3,018			2,842
Total Liabilities		224,980			111,333
Commitments and Contingencies (Note 19)
Shareholders' Equity (Deficit):
Ordinary shares, NIS 0.01 par value; 100,000,000 shares authorized at December 31, 2022 and 2021; 23,129,953 and 22,462,995 shares issued and outstanding as of December 31, 2022 and 2021, respectively		63			61
Additional paid-in capital		487,787			475,698
Accumulated deficit		(577,104	)		(467,321	)
Accumulated other comprehensive loss		(107	)		(25	)
Total Shareholders' (Deficit) Equity		(89,361	)		8,413
Total Liabilities and Shareholders' (Deficit) Equity	$	135,619		$	119,746

	*Year Ended December 31,*
	*2022*			*2021*
Revenue	$	64,357		$	48,042
Cost of revenue		7,654			5,157
Gross profit		56,703			42,885
Operating expenses:
Research and development expenses		52,906			47,642
Selling, general and administrative expenses		82,838			87,535
Operating loss		(79,041	)		(92,292	)
Financing on prepaid forward obligation		(21,559	)		(17,291	)
Interest expense on long-term debt		(8,438	)		—
Interest and other income, net		1,010			212
Loss before income taxes		(108,028	)		(109,371	)
Income tax expense		(1,755	)		(1,449	)
Net Loss	$	(109,783	)	$	(110,820	)

Statements of Comprehensive Loss
Net loss	$	(109,783	)	$	(110,820	)
Other comprehensive (loss)
Unrealized (loss) on investments		(82	)		(296	)
Comprehensive Loss	$	(109,865	)	$	(111,116	)
Net loss per ordinary share - basic and diluted	$	(4.81	)	$	(4.96	)
Weighted average number of shares outstanding used in computation of basic and diluted loss per ordinary share		22,806,812			22,347,481

	*Ordinary Shares*				*Additional Paid-in Capital*		*Accumulated Deficit*			*Other Comprehensive Loss*			*Total*
	*Number of Shares*		*Amount*		*Amounts*
Balance as of January 1, 2021		22,167,791	$	60	$	452,525	$	(356,501	)	$	271		$	96,355
Changes During 2021
Exercise of options into ordinary shares		295,204		1		60								61
Share-based compensation						23,113								23,113
Other comprehensive loss											(296	)		(296	)
Net loss								(110,820	)					(110,820	)
Balance as of January 1, 2022		22,462,995	$	61	$	475,698	$	(467,321	)	$	(25	)	$	8,413
Changes during 2022
Exercise of options into ordinary shares		666,958		2		1,509								1,511
Share-based compensation						10,580								10,580
Other comprehensive loss											(82	)		(82	)
Net loss								(109,783	)					(109,783	)
Balance as of December 31, 2022		23,129,953	$	63	$	487,787	$	(577,104	)	$	(107	)	$	(89,361	)

	*Useful Lives*
Computers and software		3
Laboratory equipment		3 - 6.5
Furniture		5 - 16.5
Manufacturing equipment		2 - 10

	*December 31, 2022*		*December 31, 2021*
Accounts payable	$	5,527	$	5,786
Accrued sales reserves		618		497
Accrued clinical expenses		2,853		1,377
Accrued research and development expenses		1,285		1,748
Accrued selling, general and administrative expenses		1,609		1,965
Accrued other expenses		491		729
Total accounts payable and accrued expenses	$	12,383	$	12,102

	*December 31, 2022*		*December 31, 2021*
Raw materials ⁽¹⁾	$	4,676	$	3,894
Finished goods		2,019		1,958
Total inventories	$	6,695	$	5,852

			*Fair Value Measurements Using*
			*Quoted Prices*		*Significant*
			*in Active*		*Other*
	*Balance as of*		*Markets for*		*Observable*
	*December 31,*		*Identical Assets*		*Inputs*
	*2022*		*(Level 1)*		*(Level 2)*
Marketable securities
US government	$	28,693	$	28,693	$	—
Corporate bonds		2,387		—		2,387
Commercial paper		9,392		—		9,392
Certificates of deposit		4,084		—		4,084
Total marketable securities	$	44,556	$	28,693	$	15,863

	*Amortized Cost Basis*		*Unrealized Gains*		*Unrealized Losses*			*Fair Value*
Marketable securities
US government	$	28,742	$	—	$	(49	)	$	28,693
Corporate bonds		2,392		—		(5	)		2,387
Commercial paper		9,417		—		(25	)		9,392
Certificates of deposit		4,112		—		(28	)		4,084
Total marketable securities	$	44,663	$	—	$	(107	)	$	44,556