scPharmaceuticals Inc.

Thank you for standing by. My name is Danielle, and I will be your conference operator today. At this time, I would like to welcome everyone to the SC Pharmaceuticals second quarter 2025 earnings conference call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session, and if you would like to ask a question during this time, simply press star followed by the number one on your telephone keypad. If you would like to withdraw your question, press star one again. Thank you. I would now like to turn the call over to William from Investor Relations. 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 made on this conference call, other than historical facts, are forward-looking statements within the meaning of federal securities laws, including but not limited to statements regarding SE Pharmaceuticals' expected future financial results, management's expectations and plans for the business, the ongoing commercialization and marketing of Ferosix, including the IDM distribution strategy, growth in number of prescribers, the potential S&DA filing, and other regulatory approvals of Ferosix, the impact of the ASM program, the anticipated GCN discount for Q3, decrease of quarterly net cash flows, cash outflows for the balance of 2025, the rise of ferocity, expenses as out-of-pocket expenses decrease, and estimated reduction in COGS. 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 SE Pharmaceuticals' business, financial condition, and other operating results. These include, but are not limited to, the risk factors and other qualifications contained in SE 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 disclaim any intent or obligation to update these forward-looking statements, except as required by law. With that, I will now turn over the call to John Tucker, Chief Executive Officer of SC Pharmaceuticals. John, please go ahead.

Thank you, William, and thank you to everyone for attending this afternoon's conference call. Today, we will begin with an overview of SC Pharmaceuticals' core business and key operational highlights for Q2 2025. Following that, I'll pass the call over to Steve Parsons, Senior Vice President of Commercial, for an update on Ferosix commercial activities. Our Chief Financial Officer, Rachel Noakes, will then share the financial results for Q2, after which we will open the line for questions. In Q2 2025, we generated $16 million in net revenue, a 99% increase over Q2 2024. We filled approximately 20,200 ferocity doses, an increase of 117% over Q2 2024, and more importantly, a 45% increase in doses shipped over Q1 2025. It's important to note that the vast majority of the increase in doses shipped came from cardiology, as nephrology had just started to contribute. In our Q1 call, we discussed several key growth drivers for the remainder of 2025, including the uptake in nephrology, the evolving Part D dynamics, and advancements within the IDN business. These factors positioned us well in Q2 and have continued to drive momentum to date in Q3. we remain confident in their continued contributions to our long-term growth strategy. In late April, we launched Ferosix into nephrology. Given that nephrologists are the primary diuretic managers for CKD patients and play an important role in fluid management with heart failure patients, we are seeing strong enthusiasm for Ferosix. In comparing the first eight weeks of the nephrology launch to the first eight weeks of the cardiology launch, we have seen a faster uptake by individual nephrologists than we did with individual cardiologists. We anticipate nephrology will have a meaningful contribution in Q3 and moving forward. The growing number of Part D patients reaching their out-of-pocket maximums had a favorable impact on our Q2 performance. We have seen this trend continue into the second half of the year, which we anticipate will further enhance for us its market penetration and prescription growth. We are very pleased with the growth we have seen in our IDN business. Steve will speak more about this. We anticipate this segment of our business will continue to grow. We are encouraged that an ambulatory specialty model aimed at improving the upstream management of heart failure was proposed in the 2026 Physician Fee Schedule by the Centers for Medicare and Medicaid Services on July 14, 2025. The ASM would test whether adjusting Medicare Part B payments for specialists based on their performance on targeted quality measures results in enhanced quality of care and reduced costs. This places accountability onto the clinical specialist for unplanned heart failure hospitalizations with a specific reference to early intervention for worsening symptoms. We believe that this new ASM program may result in a significant tailwind to augment the already successful uptake for furosics. Lastly, we are on track for the submission of our SNDA for the autoinjector in the current quarter. We continue to believe that the autoinjector will be important to the long-term furosics growth trajectory with an approximate 75% reduction in cause and an increase in our penetration rates. We remain highly optimistic about the future of furosics, especially with the expanded CKD indication the favorable Part D dynamics, continue IDN growth, the launch of our auto-injector, and the proposal of the new ambulatory specialty model. We believe Ferosix is well-positioned to address the significant unmet needs and help patient management for worsening symptoms due to fluid overload in patients with heart failure and kidney disease and will afford to the continued growth of Ferosix throughout the remainder of 2025. With that, I'll pass the call to Steve Parsons for the commercial update. Steve?