scPharmaceuticals (SCPH) Status Update summary

Market opportunity and product positioning

• FUROSCIX targets heart failure and chronic kidney disease (CKD) patients with fluid overload, offering a $9.4B U.S. heart failure and $3B CKD market opportunity.

• The product delivers subcutaneous furosemide with nearly 100% bioavailability, matching IV efficacy and enabling at-home treatment.

• Expansion into CKD is anticipated, with a PDUFA date set for March and launch readiness activities underway.

• Sales force has expanded to 90 reps, targeting both centers of excellence and community nephrology practices.

• The company is preparing for further growth with an auto-injector submission and strong IP protection through 2040.

Clinical insights and treatment paradigm

• Fluid overload is a key driver of hospitalizations in both heart failure and CKD, with diuretic resistance common in advanced CKD.

• Oral diuretics lose effectiveness in hypervolemic states due to poor GI absorption, making parenteral options like FUROSCIX valuable.

• FUROSCIX is positioned as a rescue therapy to prevent hospitalizations and manage post-discharge patients, especially those with diuretic resistance.

• Protocols are being developed to proactively identify at-risk patients and ensure timely access to FUROSCIX.

• Uptake is expected to be rapid among nephrologists if coverage is adequate, with education and protocol integration as key drivers.

Financial and operational update

• Revenues increased 33% quarter-over-quarter, with Q3 results pending.

• Cash position is strong, with $38.5M at June end and an additional $75M raised in August.

• Co-pays for Medicare patients are decreasing, with further improvements expected as out-of-pocket caps are implemented in 2024.

• The company is focused on payer engagement to ensure broad access and minimize prior authorization barriers.