Urogen Pharma Ltd. · NASDAQ:URGN
Urogen Pharma — J.P. Morgan 2021 Healthcare Conference
29 slides from Urogen Pharma's conference presentation, Jan 11, 2021
Slide 1: UroGen Pharma J.P. Morgan 2021 Healthcare Conference
UroGEN PHARMA J.P. MORGAN 2021 HEALTHCARE CONFERENCE JANUARY 11, 2021 Exhibit 99.1
Slide 2: Forward Looking Statements
Forward Looking Statements This investor presentation contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including, without limitation: the potential market opportunity of Jelmyto in LG-UTUC; commercial plans for favorable market acce
Slide 3: UroGen is at a Key Inflection Point to Deliver for Patients
Launched JELMYTO® for LG-UTUC in U.S. in June 2020 Strong momentum and early uptake with physicians and patients within first 6 months Pipeline focused on unmet need in URO-ONCOLOGY Leading novel immuno-oncology product candidate combines agonist and antagonist UGN-102 developed to potentially trans
Slide 4: RTGel Reverse-Thermal Hydrogel Technology Offers New Approach
RTGel has the potential to advance the treatment of specialty cancers and urologic diseases by: Increasing dwell time and exposure of active drugs, potentially improving the therapeutic effects of existing products Potentially increasing the viability of organ-sparing techniques and providing altern
Slide 5: Advancing Novel Uro-Oncology Programs
NONCLINICAL PHASE 1 PHASE 2 PHASE 3 REGISTRATION APPROVED UROLOGY NONCLINICAL PHASE 1 PHASE 2 PHASE 3 REGISTRATION APPROVED Advancing Novel Uro-Oncology Programs The safety and efficacy of UGN-102, UGN-201, UGN-302 for the specific conditions have not been established. 1 Worldwide license agreement
Slide 6: Unlocking the Uro-Oncology Market
Unlocking the Uro-Oncology Market-Building a Company ~$1 Billion Potential Peak Revenue Opportunity ~80,000 intermediate-risk LG NMIBC Last drug approved >15 years ago Low-grade Non-muscular Invasive Bladder Cancer (NMIBC) Low-grade Upper Tract Urothelial Carcinoma (UTUC) ~6,000 – 7,000 addressable
Slide 7: 2020 Achievements and Upcoming Milestones
2020 Achievements and Upcoming Milestones Implementation of Jelmyto permanent J-code in January Potential UGN-102 Phase 2b publication Advancement of UGN-302 program Potential collaborations and partnerships with leading academic institutions, biotech and pharma Jelmyto FDA approval Jelmyto U.S. lau
Slide 8: Jelmyto U.S. Launch
Jelmyto U.S. Launch JELMYTO (mitomycin) for pyelocalyceal solution; formerly known as UGN-101 Changing the treatment paradigm of urothelial cancers with first approved product
Slide 9: Jelmyto: First & Only FDA Approved Non-Surgical Treatment for LG-UTUC
Approved in U.S. on April 15, 2020 Strong initial launch execution Launched on June 1, 2020 NCCN guidelines updated within two weeks of approval Rapid adoption 3Q20 revenue of $3.5 million in first quarter of commercial launch Clinically meaningful data 58% Complete Response in OLYMPUS trial1 Kaplan
Slide 10: Potential to Avoid Kidney Removal in LG-UTUC
1. Upfill-Brown 2018, 2. Cutress 2012, 3. Grasso et al. (2012) BJU International, 4. Yeung et al. (2014) Pharmacoeconomics 70%-80% of LG UTUC patients ultimately receive nephroureterectomies3 Jelmyto may decrease the need for RNU, potentially sparing the kidney UC is the most costly cancer in the U.
Slide 11: Changing the LG-UTUC Landscape - U.S. Launch Update
JELMYTO Changing the LG-UTUC Landscape - U.S. Launch Update* Seamless Integration Into Physician Practice Reimbursement Patient Adoption Over 210 practices/hospitals activated Expected interest in prescribing JELMYTO over next 12 months2 High volume of completed patient enrollment forms suggest futu
Slide 12: UGN-102
UGN-102 Potential to transform the treatment paradigm in Low Grade Intermediate Risk Non-Muscle Invasive Bladder Cancer (LG-IR-NMIBC) UGN-102 (mitomycin) for intravesical solution is an investigational agent. The safety and effectiveness of UGN-102 have not been established. LG-IR-NMIBC = Low Grade
Slide 13: UGN-102 Potential to be First Primary Non-Surgical Chemoablative Therapy
UGN-102 Potential to be the First Primary Non-Surgical Chemoablative Therapy in Low-Grade Intermediate Risk Disease Defining Non-Muscle Invasive Bladder Cancer Low Grade IR Issue: chronic relapse Current treatment: Repetitive TURBT Incidence: ~20 K Recurrent: ~60 K Limited competition UGN-102 is fur
Slide 14: UGN-102 Focus on Improving Patient Outcomes in LG-IR-NMIBC
1. SEER, AUA/SUO joint guideline 2. Babjuk et al. European Urology (2019), Simon (2019), 3. Tobert et al Urology (2019), Rhijn et al Nature Urology (2016), 4. Bryan et al Ann R Coll Surg Engl (2010) *Adjuvant chemotherapy only used in 0-30% of U.S. eligible population TURBT = trans urethral resectio
Slide 15: Patients and Physicians Seek a Better Therapeutic Experience
14% UGN-102 Patients and Physicians Seek a Better Therapeutic Experience UGN-102 is designed to be primary therapy, not adjuvant therapy, providing a potential alternative to invasive surgery ~68% of recurrent patients have 2 or more recurrences1 Preliminary market research shows that physicians ide
Slide 16: Opportunity to Treat Recurring Patients with Alternative to TURBT
UGN-102 Clear Opportunity to Treat Recurring Patients with Efficacious Alternative to TURBT Discovery/ Evaluation (Cystoscopy) Pathology/ Grading TURBT Monitoring Risk Assessment Recurrence High unmet need exists with “surgical failures”: recurrence high, risk of progression low In UGN-102 Phase 2b
Slide 17: Clinical and Regulatory Success in LG-UTUC Encouraging for LG-IR-NMIBC
UGN-102 Phase 2B OPTIMA study (LG-IR-NMIBC) 72.5%* Duration of Response 65% CR UGN-102 Clinical and Regulatory Success in LG-UTUC Encouraging for LG-IR-NMIBC Opportunity Molecular profiling shows that LG-NMIBC and LG-UTUC are likely the same disease at a genetic mutational driver level Similar compl
Slide 18: Complete and Durable Responses Observed with UGN-102 in OPTIMA II
Kaplan-Meier Duration of CR of 72.5% UGN-102 Complete and Durable Responses Observed with UGN-102 in Phase 2b OPTIMA II trial *Primary endpoint of complete response based on evaluation at 3-month timepoint The majority of adverse events were reported as mild or moderate; the most commonly reported A
Slide 19: UGN-102 ATLAS Trial vs. Standard of Care Surgery
TURBT UGN-102 ATLAS Trial: Studying Differentiated Therapeutic Option vs. Standard of Care Surgery Randomization 1:1 (n=~630) -1 to -28 days Baseline 3 months Date of recurrence *Screening procedures to provide evidence of low grade NMIBC; no evidence of high-grade disease; **6 weekly doses CR = com
Slide 20: Innovating in High Grade Disease UGN-302
Innovating in High Grade Disease UGN-302 UGN-302 is a combination therapy evaluating the investigational agents UGN-201 and UGN-301. The safety and effectiveness of UGN-302 have not been established.
Slide 21: Defining Non-Muscle Invasive Bladder Cancer
Defining Non-Muscle Invasive Bladder Cancer Low Grade IR Issue: chronic relapse Current treatment: Repetitive TURBT Incidence: ~20 K Recurrent: ~60 K Limited competition UGN-102 is furthest along in clinical development as primary chemoablative therapy BCG is not used in low-grade disease High Grade
Slide 22: Significant Need for Durable Treatments to Avoid Bladder Removal in HG-NMIBC
1. Nielsen, 2014 analysis of SEER data, 2. UroGen market research, at 1L, 35% will not respond. UGN-302 Significant Need for Durable Treatments to Avoid Bladder Removal in HG-NMIBC Initial focus on BCG-refractory patients: ~15,000 addressable patients in the U.S. annually Newly Diagnosed HG NMIBC: 2
Slide 23: UGN-302 Encouraging Activity with Novel Agonist / Antagonist Combination
Patinote (2020); Falke (2013), Arends (2015), Donin (2017); Donin (2016) TLR 7/8 (UGN-201): stimulate cytokines and T & B cells Anti-CTLA4 (UGN-301): blocks ”cancer masking” action of CTLA4 UGN-201 + UGN-301 = UGN-302: Non-clinical data suggest improved survival (murine) and decreased tumor size whe
Slide 24: Looking Ahead
Looking Ahead
Slide 25: Broad IP Estate and Significant Know-How
Pending patents covering methods, systems and compositions for treating cancer locally, intravesically and using various active ingredients and combinations If issued, will expire between 2031 and 2037 Broad IP Estate and Significant Know-How To Protect Our Innovations Over 40 pending patent applica
Slide 26: Driving Further Growth with Business Development and Geographic Expansion
Driving Further Growth with Business Development and Geographic Footprint Expansion Focused on 4 key areas: Sustained, nearer-term revenue growth Innovation High unmet need Cost-effective, value-creating Specialty Oncology Specific patient population with unmet need, internal expertise Uro- oncology
Slide 27: Financial Highlights as of September 30, 2020
Financial Highlights as of September 30, 2020 $3.5 Million Jelmyto revenue in first full quarter of commercialization $125.5 Million Cash and cash equivalents* 3Q 2020 10-Q Filed with the SEC on November 9, 2020 *Cash, cash equivalents, and marketable securities as of September 30, 2020 excludes res
Slide 28: Transforming Uro-Oncology and Achieving Value Recognition in 2021
Transforming Uro-Oncology and Achieving Value Recognition in 2021 Continue Jelmyto launch momentum and efforts to establish as standard of care in LG-UTUC Execute ongoing Phase 3 ATLAS trial in LG-IR-NMIBC offering the potential to transform the treatment paradigm Develop UGN-302 as novel immuno-onc
Slide 29: Thank you
Thank you
UroGen Pharma — J.P. Morgan 2021 Healthcare Conference on 6ix