- UroGen's Jelmyto, approved April 2020 for LG-UTUC, has a J code effective 1/1/2021 allowing for dramatically more convenient coding & reimbursement. Revenues should be about $115,000/patient as labelled (6 doses).
- Jelmyto's clinical, quality of life & healthcare economic value propositions versus current SOC should keep gross to nets low and allow faster ramp to peak annual sales.
- At ~$120MM FY2020 annual OPEX (with full Jelmyto commercial infrastructure excluding stock compensation) & a ~90% gross margin, URGN breaks even at ~1,150 patients/year (market = 5,000-7,000 patients/year/US).
- UGN-102's Phase 2 data produced 60%+ CRR (Phase 3 imminent). If eventually approved UGN-102 would be indicated for ~80,000 patients/year (US only) and, our analysis concludes, a potential "Blockbuster."
- UGN-202 (Phase 1), a CTLA-4 compound (like BMY's Yervoy), is administered via Jelmyto's drug delivery system. Since both are (or will soon be) approved, the clinical/regulatory pathways should be straightforward.
For further details see:
URGN Is Worth $50/Share Should It Trade At Revenue Multiples Consistent With Its Peers