scPharmaceuticals Inc.

Good afternoon, and welcome to SD Pharmaceuticals' fourth quarter and four-year 2024 earnings conference call. At this time, all participants are in listen-only mode. Following management's prepared remarks, we will hold a question-and-answer session. To ask the question at that time, please press star followed by 11 on your touchtone phone. As a reminder, today's conference is being recorded. I would now like to turn the conference call over to Nick Colangelo, Investor Relations, to cover forward-looking statements. Nick, please go ahead.

Thank you, operator. Before beginning this afternoon's earnings call, we would like to highlight the following forward-looking statements. All statements on this conference call, other than historical facts, are forward-looking statements within the meaning of the federal securities laws, including but not limited to statements regarding SC Pharmaceuticals' expected future financial results, management's expectations and plans for the business, the ongoing commercialization and marketing of FURO6, and the potential label expansion and other regulatory approvals of FURO6. The words anticipate, believe, estimate, expect, intend, guidance, confidence, target, project, and other similar expressions are used typically to identify such forward-looking statements. These forward-looking statements are not guarantees of future performance. It may involve and are subject to certain risks and uncertainties and other important factors that may affect SC Pharmaceutical's business, financial condition, and other operating results. These include but are not limited to the risk factors and other qualifications contained in SC Pharmaceutical's annual report on Form 10-K, quarterly reports on Form 10-Q, and other reports filed by the company with the SEC to which your attention is directed. Actual outcomes and results may differ materially from what is expressed or implied by these forward-looking statements. Any forward-looking statements made in this conference call, including responses to your questions, are based on current expectations as of today, and SC Pharmaceuticals expressively disclaims any intent or obligation to update these forward-looking statements, except as required by law. With that, I will turn the call over to John Tucker, Chief Executive Officer of SC Pharmaceuticals. John, please go ahead.

Thank you, Nick, and thank you all for joining this afternoon's conference call. Today, we'll provide an overview of the company's core business and operational highlights for the fourth quarter of 2024, a commercial update from Steve Parsons, our Senior Vice President of Commercial, as well as an overview of our fourth quarter and full year 2024 financial results from our Chief Financial Officer, Rachel Mokes. We will then open the line for questions. Overall, although we're satisfied with the 406 commercial growth over the course of 2024, we were especially encouraged by what we saw in Q4, accumulating a net revenue of $12.2 million at the midpoint of the $12 to $12.3 million range that was previously announced in January. For the full year 2024, SC Pharmaceuticals generated $36.3 million in net 406 revenue, representing an approximately 167% increase in net revenue year over year, driven primarily by the increased awareness of furosics, further expansion into the class IV heart failure patient population, and increased reach and market penetration in Q4 due to our larger commercial sales force. The gross and net discount for furosics in the fourth quarter of 2024 was approximately 19% at the high end of the range we provided in January. The increase in GTN is primarily due to the continued payment of coverage gap rebates in Q4 and the impact of the Medicare redesign on inventory in the channel. We expect a long-run GTN discount for Ferosix to be in the range of 30% to 35% for 2025. As we have stated previously, while we do take a hit on our GTN with the Medicare redesign, we believe 406 is uniquely positioned to benefit from the $2,000 out-of-pocket maximum for Part D beneficiaries or for these patients enrolling in the smoothing option over the balance of the year. As we approach the end of the first quarter, we have seen evidence of more patients this month hitting their out-of-pocket caps or enrolling in smoothing than we did in either January or February. As a reminder and reflected in today's financial results, the ferocity demand and fill rate significantly increases when patients' out-of-pocket costs are lower. With the Medicare redesign fully implemented in 2025, patients will progress into catastrophic coverage faster, which should lower out-of-pocket co-pays, or they will enroll in the CMS smoothing program. With approximately 70% to 75% of our prescriptions filled by Part D beneficiaries, we believe the Medicare redesign will serve as a tailwind enhancing our commercial strategy, and supporting organic growth of furosix. As previously announced, on March 6, 2025, the FDA approved a supplemental new drug application for furosix to expand its indication to include the treatment of edema in patients with chronic kidney disease. Fluid overload, which occurs in over 700,000 cases annually, is one of the most prevalent symptoms of CKD and requires intervention. Given the opportunities to intervene pre-hospitalization or post-discharge, furosix has the potential to play a significant role in managing edema in patients living with CKD. This resonates strongly with nephrologists we have engaged with to date. Steve will provide an overview of our pre-commercial activities and expectations for the CKD launch in greater detail, though I do want to highlight that we expect to fully launch the CKD indication in April and already have seen prescriptions from nephrologists. Based on the awareness level we saw in our initial awareness trial and usage market research among nephrologists, as well as preliminary call points, we remain confident that the Ferosix expansion into CKD patients will prove to be a meaningful growth driver for the Ferosix franchise. Turning to the autoinjector, we are pleased to provide a positive update following additional shelf life testing. We have seen encouraging data with the enhanced silicone syringe in the testing conducted thus far. We are targeting a mid-year submission of the autoinjector SNDA pending the results of remaining testing. Though delaying the filing was disappointing, we remain confident this will be a critical advancement in our product pipeline. We are very pleased with the feedback we've received on the performance of Ferrosix in the market and believe that with the expanded sales force, the CKD indication, and the Medicare redesign, we are well positioned for 2025. With that, I will pass the line to Steve Parsons, SC Pharmaceuticals Senior Vice President of Commercial. Steve?