Mineralys Therapeutics (MLYS) investor relations material

Strategic focus and product development

• Lorundrostat targets aldosterone for hypertension and related comorbidities, with an NDA filed and a PDUFA date set for December 22 this year.

• The company has built out commercial functions, including market access, medical affairs, and a national accounts team, to prepare for launch.

• Ongoing clinical development continues to explore further indications and optimize organizational efficiency.

• The sales strategy targets approximately 50,000 prescribers, using both direct sales and digital omnichannel approaches.

• Market segmentation focuses on third- and fourth-line hypertension, with initial uptake expected in fourth-line patients.

Market access, pricing, and payer dynamics

• Parity access is prioritized over preferred positioning, aiming to provide physicians with accessible choice between ASIs.

• Early payer feedback indicates step edits rather than prior authorization through older generics, with pre-existing patient histories facilitating access.

• Medicare access is expected to follow a similar path as baxdrostat, with medical exceptions supporting early utilization.

• Pricing will be clarified at launch, but current benchmarks include baxdrostat at $900/month.

• Net price and rebate strategies will be disclosed closer to launch, with a focus on broad access and value.

Clinical data and label expectations

• Three pivotal studies (LAUNCH-HTN, ADVANCE-HTN, EXPLORE-CKD) support the NDA, with data expected to be reflected in the label.

• LAUNCH-HTN showed a placebo-adjusted reduction of 11.7 mmHg and low hyperkalemia rates.

• ADVANCE-HTN demonstrated efficacy in patients on high-dose background therapy, relevant for specialists.

• EXPLORE-CKD and post-hoc LAUNCH-HTN analyses showed benefits in CKD populations, including significant reductions in proteinuria and mild hyperkalemia risk.

• Both 25 mg and 50 mg doses are included in the NDA, with 50 mg as the likely starting dose and 25 mg for renal-compromised patients.