scPharmaceuticals Inc.

Good afternoon and welcome to SC Pharmaceutical's third quarter 2024 earnings conference call. At this time, all participants are in a listen-only mode. Following management's prepared remarks, we will hold the question and answer session. To ask a question at that time, please press star followed by one on your touchtone phone. If anyone has difficulty hearing the conference call, please press star zero for operator assistance. As a reminder, today's conference call is being recorded. I would now like to turn the conference call over to Nick Colangelo of Vesta Relations to cover forward-looking statements. Nick, please go ahead.

Thank you, Operator. Before beginning today'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, expectations, and plans for the business, the ongoing commercialization and marketing of Bureau 6, and other regulatory approvals of Bureau 6. 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 the future performance. It may involve and are subject to certain risks and uncertainties, and other crucial 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 now turn the call over to John Tucker, Chief Executive Officer of SC Pharmaceuticals. John, please go ahead.

Thank you, Nick, and thank you to everyone who has dialed in to this afternoon's call. I will begin today's call by discussing the company's operational and business highlights for the third quarter of 2024 before handing the call to Steve Parsons, our Senior Vice President of Commercial, to provide a more thorough for O6 commercial update. We will then provide a detailed review of our financials from Rachel Noakes, SC Pharmaceutical's Chief Financial Officer, before closing the call out with a question and answer session. In the third quarter of 2024, we generated net revenue of $10 million. This represents an approximately 24% increase in net revenue from the second quarter of 2024. While we were disappointed with where the third quarter ended, given the strong demand at the beginning of the quarter, we are pleased with the growth we have seen so far in the fourth quarter. We see this growth being driven by the Salesforce expansion the indication expansion to include Class IV patients, and continued growth in the IDN business. I will give a more comprehensive update on our longer-term growth initiatives momentarily. Ferocix FerociMet discount was approximately 15.7%, just over the high end of the range of 10 to 15% that we guided to during our second quarter results. The increase in our GTN is largely due to lagging CMS reporting on coverage gap rebates and to a lesser degree on thoracic sales, integrated delivery networks and hospital system pharmacies. For the balance of 2024, we anticipate the GTN to stay in the 10 to 15% range. And in 2025, we anticipate the GTN discount to increase up to 35% by the end of the year, driven by the Medicare Part D redesign. Please keep in mind, we feel the impact on the GTN to be more than offset by the lower patient co-pays due to the Medicare Part D redesign. We feel we are uniquely positioned to take advantage of the redesign and the lower patient out-of-pocket costs in 2025. Looking towards our future growth opportunities for Ferocix, one of our long-term initiatives has been the Ferocix Indication Expansion to cover all heart failure patients, including Class IV patients that present more severe symptoms more frequently and have the greatest limitation on physical activity. Despite consisting of roughly 10% of the overall chronic heart failure market, Class IV patients are responsible for over 30% of the hospitalizations for heart failure, and Class IV patients are more likely to benefit from cirrhosis to manage their increased fluid events outside of the inpatient setting. Ultimately, we are focused on getting patients back to their maintenance therapies without the costly hospitalization and delay in patients having symptom resolution. This is a message that resonates strongly with both physicians and their patients. We are already filming prescriptions for Class 4 patients and are seeing an uptick in the size of our prescriptions, reflecting larger script sizes in Class 4 patients. Another key objective we accomplished this quarter that relates to the ongoing franchise expansion in Ferosix with the acceptance of our SNCA filing by the FDA to expand the indication to include the treatment of edema to the fluid overload in patients with chronic kidney disease, or CKD. We believe Ferrosix, if approved, has the potential to play an important role in the CKD market, again, being utilized by the patients who are comfortable with an at-home treatment option for their fluid buildup until their everyday oral loop diuretic treatment regime begins to work again. While these oral loop diuretics are the current standard of care in fluid overload for CKD patients, they do have limitations, particularly around acute spikes in fluid levels given that these oral loop diuretics have less predictable bioavailability. It is crucial that CKD patients' fluid levels are well controlled as fluid overload in CKD is associated with both significantly increased mortality as well as a faster decline in renal function and dialysis initiation. we've undertaken several steps to prepare for a potential launch of Perosix and CKD. These initiatives include establishing a cross-functional team that has been field testing, positioning, conducting exploratory market research, identifying key opinion leaders, and calling on high-impact nephrologists who are already treating heart failure patients that also have CKD. While we await our Purdue update of March 6, 2025, we're undertaking every pre-launch activity to enable rapid commercial uptake should Ferocix receive approval for CKD. The final growth initiative we were focused on executing over the course of the third quarter is our low-volume autoinjector, which we announced positive top-line results from a PK-PD bridging study in August. Importantly, the autoinjector demonstrated bioavailability 107.3%, and participants receiving the autoinjector had similar urine output and urinary sodium and potassium excretion compared to IV furosemide. The autoinjector, if approved, has the potential to meaningfully reduce manufacturing costs compared to Furosix's current on-body infuser and offers a compelling treatment option for HCPs in patients. We are continuing to work through our SNDA package and currently anticipate submitting to the FDA in January of 2025. Before I hand the call to Steve Parsons for a more comprehensive overview of Furosix's launch metrics, I wanted to quickly highlight the transformative financing that we completed in early August that resulted in the net addition of roughly $75 million to SC Pharmaceuticals' balance sheet and bolsters our projected cash runway through expected profitability. In addition to the $75 million that was immediately available, SC Pharmaceuticals had the ability to pull down an additional $50 million via both a debt and royalty stream facility that we put in place with perceptive advisors. In summary, we are pleased to have the validation and continued support from a great roster of both our new and existing equity investors. I will now turn the call over to Steve Parsons, SC Pharmaceuticals Senior Vice President of Commercial. Steve?