On this page of StockholderLetter.com we present the latest annual shareholder letter from UroGen Pharma Ltd. — ticker symbol URGN. Reading current and past URGN letters to shareholders can bring important insights into the investment thesis.

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URGN Shareholder/Stockholder Letter Transcript:

UroGen Pharma Ltd.
ANNUAL REPORT
2023

Dear Shareholders,
As we re   ect on this past year, I continue to be amazed by the persistence and resilience of our UroGen team. Following many
years of developing medicines to treat patients with urothelial cancers, we are on the precipice of what has the potential to be
the most exciting time for our company.
A major milestone was reached in our UGN-102 clinical development program when we announced the 12-month durability
data from the Phase 3 ENVISION study in June. The results showed an unprecedented 12-month duration of response of 82.3%
by Kaplan-Meier estimate in patients who had achieved a complete response with UGN-102 at three months after the    rst
instillation. UGN-102 has demonstrated a strong clinical pro   le across multiple trials, with these latest results reinforcing its
potential to be the    rst U.S. Food and Drug Administration (FDA)-approved medicine for the treatment of low-grade intermediate
risk non-muscle invasive bladder cancer, a disease impacting nearly 82,000 patients in the U.S. each year.
We initiated the submission of a rolling New Drug Application (NDA) to the FDA for UGN-102 in January and we plan to complete
the    ling of our NDA in the third quarter of 2024. We believe we have a compelling package for a high unmet need and may
qualify for priority review, which if granted, could allow for a commercial launch in the    rst quarter of 2025, if approved.
The compelling data demonstrating signi   cant complete response rates, with the vast majority of patients maintaining their
complete response at 12 months, gives us con   dence in UGN-102   s rapid adoption if approved. We plan on leveraging our existing
commercial organization with an incremental increase in resources to execute on the potential launch of UGN-102. We recently
made an important addition to our management team with the appointment of David Lin as Chief Commercial Of   cer. David
has a proven track record of success within the pharmaceutical industry including multiple launches, and we are con   dent in
his ability to support our commercial efforts.
We continue to grow the body of real-world evidence supporting usage of Jelmyto  , highlighted by three abstracts presented at
the American Urological Association meeting in May. These included independent long-term real-world analyses that explored
the use of the product in broad patient and tumor types and with different methods of administration. The results showed that
Jelmyto treatment demonstrated favorable recurrence-free survival rates for patients who responded to initial induction. There
was no discernible difference in disease recurrence based on tumor characteristics or timing of administration, including primary
chemoablation or post-endoscopic ablation. These    ndings provide additional evidence reinforcing Jelmyto's position as a
valuable non-surgical therapeutic option for patients with low-grade upper tract urothelial carcinoma.
We are also working on next generation formulations of UGN-102 and Jelmyto. In April we announced FDA acceptance of the
Investigational New Drug application for UGN-103, a key step in our life cycle management strategy. UGN-103, a next-generation
formulation of UGN-102, combines our proprietary RTGel technology with medac GmbH   s proprietary formulation of mitomycin.
Importantly, this program may extend our urothelial cancer franchise patents with protection to 2035 and the potential for
additional protection up to 2041. We are preparing to initiate clinical endpoint studies to support NDAs for UGN-103 and UGN-104,
the latter being our next-generation formulation of Jelmyto. We anticipate dosing patients in the planned Phase 3 trial of UGN-103
by the end of this year and UGN-104 shortly thereafter.
Our balance sheet remains strong, reinforced by recent additional capital secured this year. This funding will support
the potential launch of UGN-102, as well as provide additional resources to invest in business development and life cycle
management initiatives.
At UroGen, we have pioneered an innovative approach to treating urothelial cancers, offering a breakthrough non-surgical
treatment option with the potential to reduce recurrence risk and prolong disease-free intervals. We believe UGN-102 addresses
a signi   cant recognized unmet need amongst both urologists and patients. Importantly, our research indicates a strong patient
preference for non-surgical options that can reduce their overall treatment burden. Looking ahead, we remain focused on driving
for results that will have a meaningful impact on the people that use and receive our therapies. We believe this is a pivotal period
in UroGen   s evolution as we strive to establish leadership in uro-oncology and build a long-term sustainable growth enterprise.
To our shareholders, we appreciate your con   dence in our medicines and in our team to generate value for you as we deliver
paradigm-shifting treatments for patients that deserve better. We sincerely appreciate the steadfast support of our shareholders
and the invaluable contributions of our dedicated employees, patients, and the urology community.
Warm regards,
Liz Barrett
President and Chief Executive Of   cer

UNITED STATES 
SECURITIES AND EXCHANGE COMMISSION 
Washington, D.C. 20549 
Form 10  K 
(Mark One) 
     ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 
For the fiscal year ended December 31, 2023  
OR  
     TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 
For the transition period from_____________ to ________________ 
Commission file number: 001  38079 
UROGEN PHARMA LTD. 
(Exact name of registrant as specified in its charter) 
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) 
Registrant   s telephone number, including area code: 
(646) 768  9780 
Securities registered pursuant to Section 12(b) of the Act: 
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 
Securities registered pursuant to Section 12(g) of the Act: None 
Indicate by check mark if the registrant is a well  known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes   No    

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes    No    

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 
during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing 
requirements for the past 90 days. Yes    No    

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of 
Regulation S  T (   232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such 
files). Yes    No    

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non  accelerated filer, a smaller reporting company, or an 
emerging growth company. See the definitions of    large accelerated filer,       accelerated filer,       smaller reporting company    and    emerging growth 
company    in Rule 12b  2 of the Exchange Act. 

Large accelerated filer 


Accelerated filer 

Non  accelerated filer 


Smaller reporting company 




Emerging growth company 


If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any 
new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.    

Indicate by check mark whether the registrant has filed a report on and attestation to its management   s assessment of the effectiveness of its internal 
control over financial reporting under Section 404(b) of the Sarbanes  Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that 
prepared or issued its audit report.    

If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the 
filing reflect the correction of an error to previously issued financial statements.    

Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive  based compensation 
received by any of the registrant   s executive officers during the relevant recovery period pursuant to   240.10D  1(b).    

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b  2 of the Act). Yes    No    

The aggregate market value of the ordinary shares held by non  affiliates of the registrant as of June 30, 2023 totaled approximately $190.4 million based 
on the closing price for the registrant   s ordinary shares on that day as reported by the Nasdaq Stock Market LLC. Such value excludes ordinary shares 
held by executive officers, directors and certain entities affiliated with directors as of June 30, 2023. 

As of March 7, 2024, there were 34,122,087 of the registrant   s ordinary shares outstanding. 



Table of Contents 

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

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

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

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

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 7/9/2024 Letter Continued (Full PDF)