UroGen Pharma Reports Fourth Quarter and Full Year 2020 Financial Results and Recent Corporate Developments

UroGen Pharma Ltd. (Nasdaq: URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat specialty cancers and urologic diseases, today announced financial results for the fourth quarter and full year ended December 31, 2020 and provided an overview of the Company’s recent developments.

“2020 was a pivotal year for UroGen with the launch of our first product marking our transition from a clinical to a commercial stage company. Reflecting on our first two full quarters of our Jelmyto launch, we observed strong interest and early uptake from physicians, both in the community and hospital setting,” said Liz Barrett, President and Chief Executive Officer of UroGen. “Beyond Jelmyto, we are pleased to have initiated the Phase 3 ATLAS trial for UGN-102 and expect to provide enrollment updates later this year. Additionally, we are looking forward to further realizing the potential of the RTGel™ platform through strategic collaborations, such as our recent immuno-oncology research agreements with leading academic centers.”

Business Highlights and Upcoming Milestones:
Jelmyto (mitomycin) for pyelocalyceal solution:

• Achieved net product revenue of $8.0 million for the fourth quarter of 2020. Since the June 1, 2020 launch of Jelmyto®, the first and only FDA approved non-surgical treatment option for adult patients with low-grade upper tract urothelial cancer (LG-UTUC), the Company reported $11.8 million in net product revenue.
• As of March 1, 2021, 250 sites have been activated, which means they have completed their internal processes and have treated or are ready to treat patients; 31 sites have treated more than one patient.
• Effective January 1, 2021, the Company received a permanent and product-specific J-code for Jelmyto from the Centers for Medicare and Medicaid Services (CMS), replacing the previously issued temporary C-code and standardizing and facilitating reimbursement in the hospital outpatient, ambulatory surgery center and physician office settings of care.
• UroGen presented final durability data from the Phase 3 OLYMPUS pivotal trial evaluating Jelmyto in LG-UTUC at the Annual Meeting of the Society of Urologic Oncology. Of the 58% (41/71) of patients who achieved a complete response (CR), 12-month durability of response was estimated at 81.8% by Kaplan-Meier analysis.

UGN-102 (mitomycin) for intravesical solution:

• Initiated ATLAS, the Phase 3 trial of UGN-102 in the fourth quarter of 2020. The ATLAS trial expects to enroll approximately 630 patients and is exploring UGN-102 as a primary non-surgical treatment compared to standard of care – transurethral resection of bladder tumor (TURBT) – in patients diagnosed with low-grade intermediate risk non-muscle invasive bladder cancer (LG-IR-NMIBC).
• Reported top-line final data from the OPTIMA II Phase 2b trial evaluating UGN-102 in patients with LG-IR-NMIBC, showing that 65% of patients receiving UGN-102 (41/63) achieved a CR three months after the start of therapy. In this subset of patients, duration of response at 12 months following treatment initiation (nine months post CR) was estimated by Kaplan-Meier analysis to be 72.5%. The Company expects to present the full data at an upcoming medical meeting and publish in a peer-reviewed journal.

UGN-302 [UGN-201 (imiquimod) TLR 7/8 + UGN-301 (zalifrelimab) CTLA-4]:

• Announced a strategic three-year collaboration agreement with The University of Texas MD Anderson Cancer Center to advance UGN-302, a combination intravesical immunotherapy, which is delivered directly into the bladder, for the treatment of high-grade non-muscle invasive bladder cancer (HG-NMIBC).
• UroGen and MD Anderson expect to progress the UGN-302 program in the first half of 2021, which includes potential non-clinical studies for UGN-301 and UGN-201, as well as potential clinical studies for UGN-201.
• UroGen continues to pursue additional collaborations and partnerships with leading academic institutions, biotech and pharma.

Strategic Funding:

• UroGen and RTW announced a transaction totaling $75 million in funding for UroGen to support the launch of Jelmyto and the development of UGN-102.
• RTW will provide UroGen with an upfront cash payment of $75 million and will receive tiered future payments based on global annual net product sales of Jelmyto and UGN-102, if approved.

Fourth Quarter and Full Year 2020 Financial Results:

Jelmyto Revenue: UroGen reported net product sales of Jelmyto for the fourth quarter ended December 31, 2020 of $8.0 million. Net product sales of Jelmyto for the year ended December 31, 2020 were $11.8 million. Jelmyto was launched on June 1, 2020.

R&D Expense: Research and development expenses for the fourth quarter ended December 31, 2020 were $12.4 million, including non-cash share-based compensation expense of $1.4 million. This compares to $20.1 million, including non-cash share-based compensation expense of $1.9 million, for the same period in 2019. Research and development expenses for the year ended December 31, 2020 were $47.3 million, including non-cash share-based compensation expense of $6.4 million. This compares to $49.3 million, including non-cash share-based compensation expense of $8.3 million, for the full year 2019.

SG&A Expense: Selling, general and administrative expenses for the fourth quarter ended December 31, 2020 were $22.2 million, including non-cash share-based compensation expense of $5.1 million. This compares to $19.7 million, including non-cash share-based compensation expense of $6.2 million, for the same period in 2019. Selling, general and administrative expenses for the year ended December 31, 2020 were $90.2 million, including non-cash share-based compensation expense of $21.6 million. This compares to $60.2 million, including non-cash share-based compensation expense of $21.7 million, for the full year 2019.

Net Loss: UroGen reported a net loss of $30.5 million, or basic and diluted net loss per ordinary share of $1.38, for the fourth quarter ended December 31, 2020. This compares to $39.0 million, or basic and diluted net loss per ordinary share of $1.86, for the same period in 2019. UroGen reported a net loss of $128.5 million, or basic and diluted net loss per ordinary share of $5.90, for the year ended December 31, 2020. This compares to $105.1 million, or basic and diluted net loss per ordinary share of $5.12, for the full year 2019.

Cash & Cash Equivalents: As of December 31, 2020, cash, cash equivalents and marketable securities totaled $103.9 million.

2021 Operating Expense Guidance: The Company anticipates operating expenses in the range of $155 to $170 million, including non-cash share-based compensation expense of $24 to $28 million, subject to market conditions.

Conference Call & Webcast Information:
Members of UroGen’s management team will host a live conference call and webcast today at 8:30 AM Eastern Time to review the Company`s financial results and provide a general business update.

The live webcast can be accessed by visiting the Investors section of the Company’s website at http://investors.urogen.com. Please connect at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast. Alternatively, please call (855) 765-5685 (U.S.) or (615) 247-5916 (International) to listen to the live conference call. The conference ID number for the live call will be 9043018. An archive of the webcast will be available for two weeks on the Company’s website.