scPharmaceuticals Inc.

Thank you for standing by. This is the conference operator. Welcome to the SC Pharmaceuticals third quarter 2023 earnings conference call. As a reminder, all participants are in listen only mode and the conference is being recorded. After the presentation, there will be an opportunity to ask questions. To join the question queue, you may press star then one on your telephone keypad. Should you need assistance during the conference call, you may signal an operator by pressing star and zero. I would now like to turn the conference over to PJ Kelleher, LifeSite Advisors. Please go ahead.

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 expectations and plans for the business in Perosix. The words anticipate, believe, estimate, expect, intend, guidance, confidence, target, project, and other similar expressions are typically used 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 Etsy Pharmaceuticals 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 four 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 thank you to everyone listening to this afternoon's call and webcast. to review our third quarter 2023 results. 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 Ferocix launch, and then Rachel Nodes, our Chief Financial Officer, for a review of our financials. We will then open the call for your questions. The third quarter of 2023 represents our second full quarter of Ferocix commercial availability. as we launched the product in late February. Demand has continued to grow, reflected in our key indicators, including number of prescriptions, number of total prescribers, and doses filled per prescription. Berosix is meeting the needs of heart failure patients suffering from fluid overload, and we believe specialists are quickly gaining comfort prescribing it. The third quarter, we reported net revenue of 3.8 million, representing a sequential increase of 138% from 1.6 million for the second quarter of 2023. This was driven predominantly by units shipped to patients through our specialty pharmacy network. Also captioning our net sales for the first time are the direct sales of Ferosix to multiple integrated delivery networks. As we mentioned last quarter, as sales to IDNs increase, we will be reassessing the KPIs that we report. Inventory levels at the end of the third quarter were consistent with the inventory levels at the end of the second quarter. Our gross and net discount from launch to the end of Q3 is running at approximately 21%, down from 23% through the end of Q2. We expect this to increase over time as contracting with payers evolves. In response to positive demand trends, we added an additional 12 sales territories towards the end of the third quarter. This brings our current field sales force to 66 territories, and we anticipate seeing the positive impact of these additions beginning in the fourth quarter. Shifting now to 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. Indicative of our progress, in late October, we reached an agreement with one of the largest closed integrated delivery networks in the U.S., providing unrestricted access to Ferocix without prior authorization to over 8 million lives at a fixed copay ranging from $16 to $75 per prescription. Also, as of November 1, Ferosix has added on formulary as a preferred brand with one of the largest government retiree payer formularies, increasing the number of lives with preferred access to Ferosix by an additional 1.1 million lives. These payer decisions expand the population of heart failure patients who have access to Ferosix. and moves us towards our previously stated goal of having 75% or more heart failure patients nationally with fixed co-pays of $100 or less. We anticipate that this could positively impact Ferocik's co-pays as early as the fourth quarter. We are progressing with many other health plans, and we hope to have several more announcements like these in the months to come. Staying on the topic of payers for a moment, recall that we announced national Medicaid coverage for 06 effective July 1st. We have since added an additional specialty pharmacy to our network to maximize access to 06 in these states that require a waiver that we can address the needs of Medicaid heart failure patients as quickly and efficiently as possible. Turning now to our life cycle management initiatives. During the third quarter, we received FDA feedback on three key initiatives that we view as critical to our long-term growth strategy. In August, we announced favorable type C meeting feedback from the FDA regarding the potential expansion of the Ferosix indication to allow for use in New York Heart Association Class IV heart failure patients. Ferosix is currently indicated for the treatment of congestion due to fluid overload in adult patients with New York Heart Association Class II and Class III chronic heart failure. We estimate that as many as 10% of all heart failure patients are Class IV And a meaningful percentage of these, as many as 40%, may benefit from furosics. If we are successful, Class 4 would represent a meaningful expansion of our market opportunity and would enable furosics to be prescribed to the most severe heart failure patients. Based upon the feedback that we received from the agency, we filed for the Class 4 indication in early October. More recently, we received type C feedback from the FDA pertaining to the development of an 80 milligram by 1 ml autoinjector intended to provide an additional option to the on-body infuser for treatment of congestion due to fluid overload in eligible adult patients who do not require hospitalization. We believe that an autoinjector, if successfully developed and approved, would reduce manufacturing costs compared to the current on-body infuser and confer environmental advantages. We plan to report data from a pivotal PK study in 2024, and if successful, we are targeting the submission of a supplemental new drug application to the FDA by the end of 2024. Finally, we announced feedback from a Type D meeting with the FDA pertaining to the potential expansion of the thoracic syndication to include treatment of edema due to fluid overload in patients with chronic kidney disease, or CKD. In its feedback, the FDA confirmed that no additional clinical studies are needed to expand the indication, provided that we can demonstrate an adequate PK and pharmacodynamic bridge to the listed drug, which is furosemide injection 10 mg per ml. CKD is a progressive disease characterized by worsening renal function over time, resulting in frequent episodes of fluid overload that are treated with loop diuretic. It's estimated that 12 to 15 million Americans are aware that they have kidney disease, and 50% of patients with CKD do not have a diagnosis of heart failure. With fluid overload being one of the most common complications in CKD, which worsens with disease progression, we believe furosix to be beneficial to patients with CKD who have worsening symptoms due to fluid overload and are not responding to oral lip diuretics. plan to advance furosics as we work towards our goal of introducing a new treatment option for CKD patients with edema as efficiently as possible. At this point, I'll turn the call over to Senior Vice President of Commercials, Steve Parsons, for a deeper dive into our launch metrics. Steve?