scPharmaceuticals Inc.

Greetings, and welcome to the SC Pharmaceuticals First Quarter 2023 Earnings Conference Call. At this time, all participants are in listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star then zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host. TJ Kelleher from LifeSci Advisors. Thank you. Please go ahead, sir.

Thank you, operator. Before turning the call over to management, I would like to make the following remarks concerning 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 and management's expectations and plans. for the business in Ferocix. 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 and 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 expressly disclaims any intent or obligation to update these forward-looking statements except as required by law. It is now my pleasure to turn the call over to Mr. John Tucker, Chief Executive Officer of SC Pharmaceuticals. John?

Thank you, PJ, and thanks to everyone listening to this afternoon's call and webcast. This afternoon, I am pleased to provide an operational update before turning the call over to Steve Parsons, our Senior Vice President of Commercial, for a more detailed update on the early stages of the Ferosix launch, and then Rachel Noakes, our Chief Financial Officer, for a review of our financials. We will then open the call up for your questions. Just two and a half months into the Ferosix launch on February 20th, We are pleased with our progress to date, and early feedback suggests that Ferosix is being well-received in the market. Notably, our commercial team continues to execute on an important leading indicator in services with healthcare providers and have completed 518 through March 31st and have completed 743 total in-services as of April 28th. These initial in-service contacts can last up to two hours, as treating physicians often want the entire office to be educated and trained on the use of Ferosix. As Steve will detail momentarily, these early efforts are working as intended, as both unique prescribers and total prescriptions written are growing nicely. This supports a strong belief that Ferosix will quickly become a core part of the heart failure treatment paradigm. Either pre-hospital admission or post-discharge, as it allows patients for the very first time to receive IV equivalent furosemide based on similar systemic exposure and diuresis in the comfort of their own homes. Not only is this beneficial to patients who would much rather be treated at home than in a hospital setting, but by avoiding hospital admissions and readmissions, significant cost savings can accrue to commercial, Medicare Part D, and Medicaid payers, as well as hospitals who face significant and worsening reimbursement pressure for their heart failure patients. As a reminder, furosix is indicated for the treatment of congestion due to fluid overload in adult patients with New York Heart Association Class 2 and Class 3 chronic heart failure. Furosix is not indicated for use in emergency situations or in patients with acute pulmonary edema. The on-body infuser will deliver only an 80-milligram dose of furosix. Last quarter, we detailed two studies that we conducted that clearly demonstrate the potential financial benefits of furosics. One prospective study, FreedomHF, focused on select patients who presented to the emergency room with a worsening heart failure event and were treated with furosics at home, as opposed to being admitted to the hospital. The result of the study was that patients treated with furosics had heart failure-related costs that were lower by an average of $16,995 versus historically matched comparators. And this result was achieved with a very high rate of statistical significance, with a p-value less than 0.0001. While this analysis excludes the cost of furosics, since pricing had not been established at the time of the study, the conclusion remains unchanged. And the second study, the phase two pilot study at home HF, compared furosics with treatment as usual approach in chronic heart failure presenting to a heart failure clinic with worsening congestion requiring augmented diuresis. Among the key findings, subjects randomized to cirrhosis had a 37% reduction in the risk of a heart failure hospitalization at day 30 relative to patients randomized to treatment as usual. The outcome of both studies provide a compelling picture of the benefits of furosics and further support the efforts of our commercial team as they work to educate treating physicians and their staff. They also provide critical validation as we engage with payer pharmacy and therapeutic committees regarding reimbursement dynamics. On the topic of the payers, we continue to have productive discussions with commercial, Medicare Part D, and Medicaid payers in a continuing effort to make Ferocix broadly available to patients at the most favorable terms possible. This involves not only securing initial coverage of Ferocix, but also working to have it placed on a formulary tier that would be affordable to most patients. We previously indicated that approximately 60% of all heart failure patients can access Ferosix under fixed-tier co-pays of $100 or less, and we believe that over time we can increase this to 75% or more. Reflecting our continued progress, we were recently notified by a top-five national health plan that Ferosix will be placed in a preferred formulary status across all of its commercial plans effective June 1st. We regard this as a significant positive reimbursement development, and we remain in discussions with this payer regarding its Part D plans with the goal of securing similarly favorable formula replacement for its Medicare beneficiaries. As mentioned, we are engaged with many other health plans, and we hope to have several more announcements like this in the months to come. In addition, we are also recently informed that we will obtain national Medicaid coverage of Ferocik's effect of July 1, 2023. The market opportunity for 406 is significant. We believe it is worth reiterating. In the U.S. alone, there are estimated to be 6.7 million adults suffering from heart failure, resulting in 4 million heart failure events annually. Of those, we believe 2.1 million episodes can be effectively addressed by 406. If we assume $3,300 per episode, which is four doses of Ferosix, we have the potential to access a market opportunity that is nearly $7 billion. And again, this is in the U.S. alone. There are a total of 15.8 million adults suffering from heart failure if we include the other G7 countries. At this early stage, we are seeing a wide range of doses of Ferosix per prescription from 2 to 12. as this is at the discretion of the treating physician, and some patients require more aggressive interventions than others. Finally, we are well-funded with more than $116 million of cash, cash equivalents, and short-term investments as of March 31st, providing us with ample resources to continue to execute on our commercial plan. At this point, I'll turn the call over to our Senior Vice President of Commercial, Steve Parsons, for a deeper dive into our early launch metrics. Steve?