Mineralys Therapeutics (MLYS) investor relations material

Strategic updates and financial transactions

• NDA for lorundrostat was submitted late last year, with a PDUFA date set for December 6; preparations for launch are ongoing, including building out market access and medical affairs teams.

• Acquired full IP and royalty rights to lorundrostat from Tanabe for $200M upfront and $100M in future milestones, expected to be offset by royalty savings.

• Raised $150M in equity and secured a $500M debt facility, with $100M drawn upfront and additional tranches tied to FDA approval and commercial milestones.

• The royalty buyback was opportunistic, driven by Bain Capital's acquisition of Tanabe and their desire to monetize non-core assets.

• Leadership emphasized alignment of the royalty buyback with long-term value creation and business development strategy.

Clinical data and market positioning

• LAUNCH-HTN post-hoc analysis showed lorundrostat reduced blood pressure effectively in both CKD and non-CKD patients, with a 55% reduction in albuminuria for those with baseline albuminuria.

• Safety profile was favorable, with low incidence of hyperkalemia, and results were consistent with prior Explore-CKD data.

• Data supports potential renal protection and de-risks future CKD development, with significant overlap between hypertension and CKD populations.

• Physicians value blood pressure reduction, safety, and proteinuria benefit; lorundrostat addresses all three.

Market access, payer dynamics, and launch strategy

• Initial market entry targeted at fourth-line hypertension, with anticipated rapid expansion to third-line based on demand and payer feedback.

• Step edits for access will require evidence of prior use of three antihypertensive drugs, but not necessarily an MRA; process expected to be straightforward for most patients.

• PBM reforms have shifted incentives, but clinical value and service-based fees remain important; parity access is the goal rather than exclusive contracts.

• Sales force buildout is underway, with leadership and MSL teams in place; full sales force expected to be ready 90 days before PDUFA.

• Baxfendy’s $500/month price aligns with payer research and is not expected to restrict access for the target population.