NASDAQ:SCPH scPharmaceuticals Q2 2025 Earnings Report Profile scPharmaceuticals EPS ResultsActual EPS-$0.34Consensus EPS -$0.30Beat/MissMissed by -$0.04One Year Ago EPSN/AscPharmaceuticals Revenue ResultsActual Revenue$16.04 millionExpected Revenue$15.41 millionBeat/MissBeat by +$628.00 thousandYoY Revenue GrowthN/AscPharmaceuticals Announcement DetailsQuarterQ2 2025Date8/7/2025TimeAfter Market ClosesConference Call DateThursday, August 7, 2025Conference Call Time4:30PM ETConference Call ResourcesConference Call AudioConference Call TranscriptPress Release (8-K)Quarterly Report (10-Q)Company ProfilePowered by scPharmaceuticals Q2 2025 Earnings Call TranscriptProvided by QuartrAugust 7, 2025 ShareLink copied to clipboard.Key Takeaways Positive Sentiment: In Q2 2025, SC Pharmaceuticals generated $16 million in net revenue (up 99% YoY) and shipped approximately 20,200 Ferozix doses (up 117% YoY and 45% QoQ), driven primarily by cardiology growth. Positive Sentiment: The late-April launch of Ferozix into nephrology saw faster uptake and higher doses per prescription than cardiology, positioning nephrology as a meaningful contributor in Q3. Positive Sentiment: Favorable Medicare Part D dynamics—more patients reaching out-of-pocket maximums—have improved fill rates and supported prescription growth, a trend expected to continue through year-end. Positive Sentiment: SC Pharmaceuticals remains on track to submit the sNDA for its Ferozix auto-injector this quarter, which is projected to reduce COGS by ~75% and boost market penetration long term. Negative Sentiment: Cash and cash equivalents declined to $40.8 million as of Q2 2025 (from $75.5 million at 12/31/2024), and while $35 million in additional funding is available, net cash outflows are expected to persist through year-end. AI Generated. May Contain Errors.Conference Call Audio Live Call not available Earnings Conference CallscPharmaceuticals Q2 202500:00 / 00:00Speed:1x1.25x1.5x2xThere are 7 speakers on the call. Speaker 300:00:00Thank 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. Speaker 400:00:40Thank 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 SC Pharmaceuticals' expected future financial results, management's expectations and plans for the business, the ongoing commercialization and marketing of SC Pharmaceuticals, including the IBM distribution strategy, growth in number of prescribers, the potential SNDA filing, and other regulatory approvals of SC Pharmaceuticals, the impact of the ASM program, the anticipated GPN discount for Q3, decrease of quarterly net cash flows, cash outflows for the balance of 2025, the rise of SC Pharmaceuticals' expenses as out-of-pocket expenses decrease, and estimated reduction in COGS. Speaker 400:01:36The 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. They may involve and are subject to certain risks and uncertainties and other important factors that may affect SC Pharmaceuticals' business, financial condition, and other operating results. These include, but are not limited to, the risk factors and other qualifications contained in SC Pharmaceuticals' 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. Speaker 400:02:29Any 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. With that, I will now turn over the call to John Tucker, Chief Executive Officer of SC Pharmaceuticals. John, please go ahead. Speaker 500:02:56Thank you, William, and thank you to everyone for attending this afternoon's conference call. Today, we will begin with an overview of scPharmaceuticals' 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 scPharmaceuticals' commercial activities. Our Chief Financial Officer, Rachael Nokes, 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 FUROSCIX 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. Speaker 500:04:03In our Q1 call, we discussed several key growth drivers for the remainder of 2025, including the uptake in nephrology, the evolving Medicare 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 FUROSCIX 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 FUROSCIX. 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. Speaker 500:05:04The growing number of Medicare 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 FUROSCIX's 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 & 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. Speaker 500:06:01This 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 scPharmaceuticals. 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 scPharmaceuticals' growth trajectory with an approximate 75% reduction in COGS and an increase in our penetration rates. We remain highly optimistic about the future of scPharmaceuticals, especially with the expanded CKD indication, the favorable Part D dynamics, continual IDN growth, the launch of our autoinjector, and the proposal of the new Ambulatory Specialty Model. Speaker 500:06:58We believe scPharmaceuticals is well positioned to address the significant unmet needs in outpatient management for worsening symptoms due to fluid overload in patients with heart failure and kidney disease, and we look forward to the continued growth of scPharmaceuticals throughout the remainder of 2025. With that, I'll now pass the call to Steve Parsons for the commercial update. Steve? Speaker 100:07:21Thank you, John. From launch to the end of Q2, we were up to approximately 4,700 unique cardiology and nephrology prescribers. This number continues to increase as we add more cardiology practices and penetrate into nephrology. We've been intentional about continuing to grow and support the cardiology market as we expand into nephrology. Cardiology accounts for the vast majority of the 45% increase in SC Pharmaceuticals doses filled which John reported. We expect our number of unique prescribers to increase steadily as we grow further in cardiology and expand deeper into the nephrology market. I've mentioned previously that our Q4 2024 sales force expansion was poised to show a significant return on investment, and that was evident in our Q2 results. Speaker 100:08:18The cumulative impact of the larger team, smaller territory size, and thousands of additional interactions with healthcare providers allowed for greater reach and frequency to both targeted and non-targeted prescribers. The extra sales force horsepower has started to hit its stride, and we expect that will continue to pay dividends over the balance of 2025. The second half of 2025 sets up nicely with a larger portion of the Medicare heart failure and chronic kidney disease population having low or no co-pays. The additional reach and frequency will benefit cardiology accounts who are still in the early portion of their adoption curve. As John stated, we are very positive about the progress of our IDN distribution strategy. Performance in this segment continues to beat our internal expectations and will accelerate as we open more new accounts every month and see reorders from some of the top systems in the country. Speaker 100:09:24Targeting IDN-managed providers has been a great complement to our office-based specialty targeting. I will now hand the call over to our Chief Financial Officer, Rachael Nokes. Rachael? Speaker 300:09:39Thank you, Steve. Product revenues were $16 million for the second quarter of 2025, compared to $8.1 million for the second quarter of 2024. Cost of product revenues were $5 million for the second quarter of 2025, compared to $2.3 million for the second quarter of 2024. The increase in both product revenues and cost of product revenues for the quarter ended June 30, 2025, was due to an increase in demand for SC Pharmaceuticals further into the commercial launch and related manufacturing costs. The gross to net discount for SC Pharmaceuticals in the second quarter of 2025 was approximately 27%. We anticipate the gross to net discount in Q3 to approach 30%. The increase in GPN throughout 2025 is primarily attributable to the implementation of the Medicare Part D redesign, including the mandatory manufacturer rebates under the Inflation Reduction Act. Speaker 300:10:41SC Pharmaceuticals ended the second quarter of 2025 with $40.8 million in cash and cash equivalents, compared to $75.5 million in cash and cash equivalents as of December 31, 2024. Net cash outflows in the second quarter were lower than in the first quarter, despite an increase in accounts receivable from our customers. We continue to expect quarterly net cash flows to decrease for the balance of 2025 as revenues increase due to higher anticipated volumes and a 3.5% price increase effective July 1, 2025. I'll now pass the call back to John for concluding remarks. Speaker 500:11:22In the second quarter of 2025, SC Pharmaceuticals delivered solid progress across our commercial, operational, and financial fronts. We remain confident in our ability to scale effectively and deliver value for patients and shareholders alike. We will now open the call for questions. Operator? Speaker 300:11:45this time, I would like to remind everyone that in order to ask questions, press star and the number one on your telephone keypad. We will now begin our question and answer session. First, we have Stacy Ku from TD Cowen. Please go ahead. Operator00:12:03Hey, thanks so much for taking our questions and congratulations on the quarter. We have a few questions as it seems like we have a lot of metrics that we are hopeful you guys can go through. Just first, as we think about the growth in cardiology, can you maybe talk about those class four heart failure patients? Rachael Nokes also highlighted these patients as ideal high flyers. Let me just talk about how the adoption rates are going and how to maximize maybe that positive clinician view there. The first question is maybe just talk some more about the class four expansion, how that's going. Second question is obviously as we talk about maybe early days with the CKD launch, what are your early learnings from these initial interactions with nephrologists? Operator00:12:50Third question is maybe talk about how fulfillment is progressing and if you believe that will be kind of a key contributor as we think into the second half, especially as we talk about kind of these low or no co-pays that we're trying to start to approach. Thanks so much. Speaker 200:13:10Right. Hey, Stacy, it's John. Thank you for the questions. Yeah, and thanks for the call. I'll handle the last one first and then I'll turn it over to Steve and/or John on the first two. Fill rates in the second quarter obviously went up from the first quarter and we anticipate them continuing to increase in Q3 and in Q4, kind of similar to what we saw last year in Q4. A lot of it has to do, as you mentioned, with the patient co-pays. They're continuing to go down. We see more low or $0 co-pays in Q2 than we saw in Q1 and we anticipate continuing to see that accelerate into Q3 and Q4. We're not actually reporting on the fill rate. The IDNs, as it continues to be a bigger part of the business, we don't have visibility on fill rates there. Speaker 200:14:14We get an order, we ship the order, we don't know how many were written, we just know what we shipped. The fill rates have gone up in Q2 versus Q1 and we anticipate them being higher in Q3 and even higher in Q4. I'll turn it over to Steve, maybe to hit on class four and then or nephrology first. Speaker 100:14:38Yeah, I guess I'll start with nephrology and how that launch is going. I think it's important that we reiterate that the majority of the prescriptions in Q2 were for heart failure, and given that the CKD launch was only about eight weeks. We're not going to break out the contribution from which here, but we do anticipate a meaningful impact from nephrology starting in Q3. The launch is progressing well. The speed of adoption and the trial by individual nephrologists is faster than it was in cardiology. I'm not going to say all, but some will prescribe pretty quickly after one or two visits. Not saying all of them, but some of them, and that's different than it was in cardiology. What's a key learning? Nephrologists are highly mobile. They move around a lot. It's just been a little harder to track them down because they have multiple locations. Speaker 100:15:41They're driving between offices, dialysis centers. It's taken us just a little while to get their best times, their best days, the locations. When we do speak to them, they get it right away. We just have to follow up to establish those habits. Not going to talk about doses per Rx overall, but I will speak to it for nephrology because it's different. The doses per Rx are higher than with cardiology. I think the difference is they want their patients to be dry. They don't want extra fluid. They want them euvolemic, they say. Cardiologists are just looking to reduce symptoms. I guess that's the color I have on the nephrology launch so far. Class four, that continues to go well. We don't report prescriptions as class four anymore, so I can't be specific with you. Speaker 100:16:43They just send in the prescription for, do they have heart failure, do they have CKD, or do they have both? We are calling on advanced heart failure clinics. They are prescribing more than they had been. They'll use a few more doses than on a regular patient in a general card office. Does that answer the question? Speaker 300:17:15Our next question comes from Christian Clark from Leerink Partners. Please go ahead. Speaker 600:17:23Good afternoon. This is Chris Clark on for Roanna Ruiz. Can you please provide more granular details on the CKD launch trajectory since late April? What % of the roughly 20,200 doses shipped in Q2 were attributable to the CKD indication versus heart failure? Separately, with cash declining to $40.8 million over the first half of 2025, can you provide updated clarity on your cash runway and the optionality you have to bolster your balance sheet in the near term if needed? Speaker 200:17:55Sure, great. I'll answer the cash. I'll answer both questions here. The vast majority, now don't forget in nephrology, we didn't launch, we only had two months of launch in nephrology. What we've noticed is individual nephrologists have been faster adopters than the cardiologists were. Steve mentioned or defined them sometimes because they're in a dialysis center, they're in two different satellite offices, but the reception has been faster there. We looked at the first eight weeks of cardiology launch versus the first eight weeks of nephrology launch. By doctor, it's faster in nephrology. As Steve mentioned, they write bigger scripts. They care about drying patients out, not just relieving congestion or relieving dyspnea or whatever. As far as the cash runway, you know, we are laser focused right now on reaching profitability. We're currently evaluating impacts of tariffs and FX fluctuations and increased COGS. Speaker 200:19:10You know, we still have access to, if needed, $10 million from Perceptive on the royalty and another $25 million on the debt. We look at that needed as an ability to have more capital. Speaker 300:19:44Our next question comes from Naz Rahman from Maxim Group. Please go ahead. Speaker 600:19:51Hi, everyone. Congrats on the quarter and thanks for taking my questions. I have a few questions on the ASM. Could you provide some color on exactly what the timelines are that physicians are, I guess, evaluated for determining payments and performance penalties under the Part D payments? I guess, when is this expected to be implemented and who is it exactly implemented by? Is it just implemented by CMS administration or does Congress have to be involved or anything? Speaker 200:20:21Naz, this is John Tucker. Thanks for the question. I'll let John Mohr answer those questions. Speaker 600:20:27Hey, Naz. Right now, the rule is under review for comment. The anticipated timeline for rollout is in January 2027, where data will be collected and that information will be applied to 2028 payments. It'll happen and occur for five years. It doesn't have to be voted on by Congress. This is something that CMS has the authority, just like they do for the hospital readmission reduction program. CMS will roll this out and apply the findings to Medicare Part D payments moving forward for the next five years. Speaker 200:21:11Yeah. The timing a little bit now is September 2025. Next month, the public comment period closes. November of this year, 2025, guidance is implemented. Then somewhere unclear, but somewhere in 2026, the doctors will be notified, the doctors that will be measured will be notified in somewhere, we're thinking mid-2026. Although it's up for comment, our consultants, lobbyists have said they doubt there'll be any changes to this. If you're sitting where we are, you know, we could have, you know, we could have wrote this bill because it just fits right into the value prop of SC Pharmaceuticals. You can imagine that we will, as soon as that target list is named public, that those will be our priority targets for these physicians. It is a pilot program. We would think that all physicians would be trying to implement this. This is about reducing unnecessary hospitalizations. Speaker 200:22:22It's about reducing signs and symptoms, and it's about patient self-management of disease. That's what SC Pharmaceuticals does. We are incredibly happy with this from CMS. Speaker 300:22:43Our next question comes from Douglas Tsao from H.C. Wainwright. Please go ahead. Speaker 600:22:50Hi, good afternoon. Thanks. Congrats on the progress. I guess I'm just curious, and I apologize if I might have missed it in the prepared remarks, is, you know, how much of sort of patients sort of being, you know, now as the Medicare Part D redesign, becoming a bit of a tailwind? Because I know, you know, in the beginning of the year, there was a little bit of a headwind and you expected that it would really start to pick up steam as it went through the year, as sort of patients went through their out-of-pocket, hit their out-of-pocket max. I'm just curious if you got a sense of where that was and how much of a tailwind do you expect to see for the rest of the year? Speaker 200:23:29Yeah, hey Doug, it's John. Exactly, it's turned from a headwind last year and really in the first quarter of this year to a mixed breeze, I guess, in the beginning of Q2, now turning into a tailwind. I do think it's important to note that it wasn't just the growth in fill rate that, you know, I mean, we had a 45% increase in units shipped quarter over quarter. We're talking over 100% year over year, but 45% quarter over quarter. It was as much driven by prescriptions, new prescriptions written, as it was really by fill rate. We've said all along that we think when the fill rate goes up, doctors are more confident in writing. We think, we hope that plays out really over the second half of the year. Speaker 200:24:25The growth quarter over quarter was driven really by new prescriptions being written more so even than an increase in the fill rate. We do see it as a significant tailwind moving forward, both on units shipped to patients, but also on kind of the halo impact of physicians writing more. Speaker 300:24:54We have a next question from Stacy Ku from TD Cowen. Please go ahead. Operator00:25:01Sorry, just a quick follow-up. You guys talked about fulfillment and the dynamics around IDN. To which extent, I understand you all do not want to set a precedent in terms of IDNs because in the past you have talked about how bumpy it can be quarter by quarter. Just given that it's becoming a bigger contributor, are you able to give us a sense of the % of sales that were IDN-based in Q2? Thanks so much. Speaker 200:25:33Stacy, it's John. Yeah, we haven't, we're not going to be breaking that out because it is so lumpy. What we did say, it grew 70% quarter over quarter. I mean, keep growing that rate, it's going to be hard. It's becoming a significant part of the total sales. We're not going to be breaking that out. Speaker 300:26:07That concludes our Q&A session. I will now turn the call over to John Tucker, Chief Executive Officer, for closing remarks. Speaker 500:26:17Thank you again for your time today. We remain confident in our momentum and look forward to sharing continued progress as we advance through 2025. Thank you. Speaker 300:26:30This concludes today's conference call. You may now disconnect.Read morePowered by Earnings DocumentsPress Release(8-K)Quarterly report(10-Q) scPharmaceuticals Earnings HeadlinesscPharmaceuticals Inc. Common Stock (SCPH)April 17, 2026 | nasdaq.comMannKind initiated with a Buy at TruistNovember 24, 2025 | msn.comYou’re Being LIED To About The Iran WarThe mainstream explanation for the Iran airstrikes may not be the full story. Addison Wiggin, Founder of Grey Swan Investment Fraternity, says there's a deeper motive behind the bombing campaign that most coverage is ignoring. If you're making investment decisions based on what you're hearing in the news, Wiggin argues you could be working with an incomplete picture.May 5 at 1:00 AM | Banyan Hill Publishing (Ad)MannKind (MNKD): Evaluating Valuation After Strong Q3 Revenue Beat and Pipeline ExpansionNovember 8, 2025 | finance.yahoo.comMannKind Stock Soared 8% Today: Why A Surge In Afrezza Inhaled Insulin Sales MattersNovember 5, 2025 | msn.comMannKind outlines FUROSCIX market expansion and Afrezza pediatric launch strategy following record $82M Q3 revenueNovember 5, 2025 | msn.comSee More scPharmaceuticals Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like scPharmaceuticals? Sign up for Earnings360's daily newsletter to receive timely earnings updates on scPharmaceuticals and other key companies, straight to your email. Email Address About scPharmaceuticalsscPharmaceuticals (NASDAQ:SCPH) is a clinical‐stage biopharmaceutical company focused on developing innovative therapies for sickle cell disease. The company’s lead product candidate, SC411, is an investigational intravenous formulation of a hemoglobin polymerization inhibitor designed to rapidly increase hemoglobin oxygen affinity and potentially reduce the severity and duration of vaso‐occlusive crises. By delivering a water‐soluble prodrug directly into the bloodstream, scPharmaceuticals aims to address an acute unmet need in emergency and inpatient settings where swift intervention can improve patient outcomes. In addition to SC411, scPharmaceuticals is advancing a pipeline of small‐molecule candidates that target different aspects of red blood cell pathology in sickle cell disease. The company’s research and development efforts leverage proprietary prodrug technology to enhance delivery and bioavailability, with the goal of providing both acute crisis interventions and chronic disease management options. scPharmaceuticals collaborates with academic institutions and clinical research organizations to conduct Phase 1 studies and plans to initiate later‐stage trials upon successful completion of early safety and pharmacokinetic assessments. Headquartered in Cambridge, Massachusetts, scPharmaceuticals was founded to translate cutting‐edge science into practical treatments for patients suffering from sickle cell disease. The company’s leadership team comprises industry veterans with experience in hematology, drug development and regulatory affairs. While initially focused on the U.S. market, scPharmaceuticals has stated its intention to expand clinical programs internationally as it progresses toward potential product approvals.View scPharmaceuticals ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Latest Articles Palantir Drops After a Blowout Q1—What Investors Should KnowShopify’s Valuation Crisis Creates Opportunity in 2026onsemi Stock Dips After Earnings: Why the Dip Is BuyableTSLA: 3 Reasons the Stock Could Hit $400 in MayNebius Breaks Out to All-Time Highs—Here's What's Driving It.3 Reasons Analysts Love DexComMonolithic Power Systems: AI Stock Beat, Raised and Upgraded Post-Earnings Upcoming Earnings AppLovin (5/6/2026)ARM (5/6/2026)DoorDash (5/6/2026)Fortinet (5/6/2026)Marriott International (5/6/2026)Warner Bros. 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There are 7 speakers on the call. Speaker 300:00:00Thank 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. Speaker 400:00:40Thank 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 SC Pharmaceuticals' expected future financial results, management's expectations and plans for the business, the ongoing commercialization and marketing of SC Pharmaceuticals, including the IBM distribution strategy, growth in number of prescribers, the potential SNDA filing, and other regulatory approvals of SC Pharmaceuticals, the impact of the ASM program, the anticipated GPN discount for Q3, decrease of quarterly net cash flows, cash outflows for the balance of 2025, the rise of SC Pharmaceuticals' expenses as out-of-pocket expenses decrease, and estimated reduction in COGS. Speaker 400:01:36The 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. They may involve and are subject to certain risks and uncertainties and other important factors that may affect SC Pharmaceuticals' business, financial condition, and other operating results. These include, but are not limited to, the risk factors and other qualifications contained in SC Pharmaceuticals' 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. Speaker 400:02:29Any 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. With that, I will now turn over the call to John Tucker, Chief Executive Officer of SC Pharmaceuticals. John, please go ahead. Speaker 500:02:56Thank you, William, and thank you to everyone for attending this afternoon's conference call. Today, we will begin with an overview of scPharmaceuticals' 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 scPharmaceuticals' commercial activities. Our Chief Financial Officer, Rachael Nokes, 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 FUROSCIX 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. Speaker 500:04:03In our Q1 call, we discussed several key growth drivers for the remainder of 2025, including the uptake in nephrology, the evolving Medicare 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 FUROSCIX 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 FUROSCIX. 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. Speaker 500:05:04The growing number of Medicare 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 FUROSCIX's 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 & 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. Speaker 500:06:01This 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 scPharmaceuticals. 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 scPharmaceuticals' growth trajectory with an approximate 75% reduction in COGS and an increase in our penetration rates. We remain highly optimistic about the future of scPharmaceuticals, especially with the expanded CKD indication, the favorable Part D dynamics, continual IDN growth, the launch of our autoinjector, and the proposal of the new Ambulatory Specialty Model. Speaker 500:06:58We believe scPharmaceuticals is well positioned to address the significant unmet needs in outpatient management for worsening symptoms due to fluid overload in patients with heart failure and kidney disease, and we look forward to the continued growth of scPharmaceuticals throughout the remainder of 2025. With that, I'll now pass the call to Steve Parsons for the commercial update. Steve? Speaker 100:07:21Thank you, John. From launch to the end of Q2, we were up to approximately 4,700 unique cardiology and nephrology prescribers. This number continues to increase as we add more cardiology practices and penetrate into nephrology. We've been intentional about continuing to grow and support the cardiology market as we expand into nephrology. Cardiology accounts for the vast majority of the 45% increase in SC Pharmaceuticals doses filled which John reported. We expect our number of unique prescribers to increase steadily as we grow further in cardiology and expand deeper into the nephrology market. I've mentioned previously that our Q4 2024 sales force expansion was poised to show a significant return on investment, and that was evident in our Q2 results. Speaker 100:08:18The cumulative impact of the larger team, smaller territory size, and thousands of additional interactions with healthcare providers allowed for greater reach and frequency to both targeted and non-targeted prescribers. The extra sales force horsepower has started to hit its stride, and we expect that will continue to pay dividends over the balance of 2025. The second half of 2025 sets up nicely with a larger portion of the Medicare heart failure and chronic kidney disease population having low or no co-pays. The additional reach and frequency will benefit cardiology accounts who are still in the early portion of their adoption curve. As John stated, we are very positive about the progress of our IDN distribution strategy. Performance in this segment continues to beat our internal expectations and will accelerate as we open more new accounts every month and see reorders from some of the top systems in the country. Speaker 100:09:24Targeting IDN-managed providers has been a great complement to our office-based specialty targeting. I will now hand the call over to our Chief Financial Officer, Rachael Nokes. Rachael? Speaker 300:09:39Thank you, Steve. Product revenues were $16 million for the second quarter of 2025, compared to $8.1 million for the second quarter of 2024. Cost of product revenues were $5 million for the second quarter of 2025, compared to $2.3 million for the second quarter of 2024. The increase in both product revenues and cost of product revenues for the quarter ended June 30, 2025, was due to an increase in demand for SC Pharmaceuticals further into the commercial launch and related manufacturing costs. The gross to net discount for SC Pharmaceuticals in the second quarter of 2025 was approximately 27%. We anticipate the gross to net discount in Q3 to approach 30%. The increase in GPN throughout 2025 is primarily attributable to the implementation of the Medicare Part D redesign, including the mandatory manufacturer rebates under the Inflation Reduction Act. Speaker 300:10:41SC Pharmaceuticals ended the second quarter of 2025 with $40.8 million in cash and cash equivalents, compared to $75.5 million in cash and cash equivalents as of December 31, 2024. Net cash outflows in the second quarter were lower than in the first quarter, despite an increase in accounts receivable from our customers. We continue to expect quarterly net cash flows to decrease for the balance of 2025 as revenues increase due to higher anticipated volumes and a 3.5% price increase effective July 1, 2025. I'll now pass the call back to John for concluding remarks. Speaker 500:11:22In the second quarter of 2025, SC Pharmaceuticals delivered solid progress across our commercial, operational, and financial fronts. We remain confident in our ability to scale effectively and deliver value for patients and shareholders alike. We will now open the call for questions. Operator? Speaker 300:11:45this time, I would like to remind everyone that in order to ask questions, press star and the number one on your telephone keypad. We will now begin our question and answer session. First, we have Stacy Ku from TD Cowen. Please go ahead. Operator00:12:03Hey, thanks so much for taking our questions and congratulations on the quarter. We have a few questions as it seems like we have a lot of metrics that we are hopeful you guys can go through. Just first, as we think about the growth in cardiology, can you maybe talk about those class four heart failure patients? Rachael Nokes also highlighted these patients as ideal high flyers. Let me just talk about how the adoption rates are going and how to maximize maybe that positive clinician view there. The first question is maybe just talk some more about the class four expansion, how that's going. Second question is obviously as we talk about maybe early days with the CKD launch, what are your early learnings from these initial interactions with nephrologists? Operator00:12:50Third question is maybe talk about how fulfillment is progressing and if you believe that will be kind of a key contributor as we think into the second half, especially as we talk about kind of these low or no co-pays that we're trying to start to approach. Thanks so much. Speaker 200:13:10Right. Hey, Stacy, it's John. Thank you for the questions. Yeah, and thanks for the call. I'll handle the last one first and then I'll turn it over to Steve and/or John on the first two. Fill rates in the second quarter obviously went up from the first quarter and we anticipate them continuing to increase in Q3 and in Q4, kind of similar to what we saw last year in Q4. A lot of it has to do, as you mentioned, with the patient co-pays. They're continuing to go down. We see more low or $0 co-pays in Q2 than we saw in Q1 and we anticipate continuing to see that accelerate into Q3 and Q4. We're not actually reporting on the fill rate. The IDNs, as it continues to be a bigger part of the business, we don't have visibility on fill rates there. Speaker 200:14:14We get an order, we ship the order, we don't know how many were written, we just know what we shipped. The fill rates have gone up in Q2 versus Q1 and we anticipate them being higher in Q3 and even higher in Q4. I'll turn it over to Steve, maybe to hit on class four and then or nephrology first. Speaker 100:14:38Yeah, I guess I'll start with nephrology and how that launch is going. I think it's important that we reiterate that the majority of the prescriptions in Q2 were for heart failure, and given that the CKD launch was only about eight weeks. We're not going to break out the contribution from which here, but we do anticipate a meaningful impact from nephrology starting in Q3. The launch is progressing well. The speed of adoption and the trial by individual nephrologists is faster than it was in cardiology. I'm not going to say all, but some will prescribe pretty quickly after one or two visits. Not saying all of them, but some of them, and that's different than it was in cardiology. What's a key learning? Nephrologists are highly mobile. They move around a lot. It's just been a little harder to track them down because they have multiple locations. Speaker 100:15:41They're driving between offices, dialysis centers. It's taken us just a little while to get their best times, their best days, the locations. When we do speak to them, they get it right away. We just have to follow up to establish those habits. Not going to talk about doses per Rx overall, but I will speak to it for nephrology because it's different. The doses per Rx are higher than with cardiology. I think the difference is they want their patients to be dry. They don't want extra fluid. They want them euvolemic, they say. Cardiologists are just looking to reduce symptoms. I guess that's the color I have on the nephrology launch so far. Class four, that continues to go well. We don't report prescriptions as class four anymore, so I can't be specific with you. Speaker 100:16:43They just send in the prescription for, do they have heart failure, do they have CKD, or do they have both? We are calling on advanced heart failure clinics. They are prescribing more than they had been. They'll use a few more doses than on a regular patient in a general card office. Does that answer the question? Speaker 300:17:15Our next question comes from Christian Clark from Leerink Partners. Please go ahead. Speaker 600:17:23Good afternoon. This is Chris Clark on for Roanna Ruiz. Can you please provide more granular details on the CKD launch trajectory since late April? What % of the roughly 20,200 doses shipped in Q2 were attributable to the CKD indication versus heart failure? Separately, with cash declining to $40.8 million over the first half of 2025, can you provide updated clarity on your cash runway and the optionality you have to bolster your balance sheet in the near term if needed? Speaker 200:17:55Sure, great. I'll answer the cash. I'll answer both questions here. The vast majority, now don't forget in nephrology, we didn't launch, we only had two months of launch in nephrology. What we've noticed is individual nephrologists have been faster adopters than the cardiologists were. Steve mentioned or defined them sometimes because they're in a dialysis center, they're in two different satellite offices, but the reception has been faster there. We looked at the first eight weeks of cardiology launch versus the first eight weeks of nephrology launch. By doctor, it's faster in nephrology. As Steve mentioned, they write bigger scripts. They care about drying patients out, not just relieving congestion or relieving dyspnea or whatever. As far as the cash runway, you know, we are laser focused right now on reaching profitability. We're currently evaluating impacts of tariffs and FX fluctuations and increased COGS. Speaker 200:19:10You know, we still have access to, if needed, $10 million from Perceptive on the royalty and another $25 million on the debt. We look at that needed as an ability to have more capital. Speaker 300:19:44Our next question comes from Naz Rahman from Maxim Group. Please go ahead. Speaker 600:19:51Hi, everyone. Congrats on the quarter and thanks for taking my questions. I have a few questions on the ASM. Could you provide some color on exactly what the timelines are that physicians are, I guess, evaluated for determining payments and performance penalties under the Part D payments? I guess, when is this expected to be implemented and who is it exactly implemented by? Is it just implemented by CMS administration or does Congress have to be involved or anything? Speaker 200:20:21Naz, this is John Tucker. Thanks for the question. I'll let John Mohr answer those questions. Speaker 600:20:27Hey, Naz. Right now, the rule is under review for comment. The anticipated timeline for rollout is in January 2027, where data will be collected and that information will be applied to 2028 payments. It'll happen and occur for five years. It doesn't have to be voted on by Congress. This is something that CMS has the authority, just like they do for the hospital readmission reduction program. CMS will roll this out and apply the findings to Medicare Part D payments moving forward for the next five years. Speaker 200:21:11Yeah. The timing a little bit now is September 2025. Next month, the public comment period closes. November of this year, 2025, guidance is implemented. Then somewhere unclear, but somewhere in 2026, the doctors will be notified, the doctors that will be measured will be notified in somewhere, we're thinking mid-2026. Although it's up for comment, our consultants, lobbyists have said they doubt there'll be any changes to this. If you're sitting where we are, you know, we could have, you know, we could have wrote this bill because it just fits right into the value prop of SC Pharmaceuticals. You can imagine that we will, as soon as that target list is named public, that those will be our priority targets for these physicians. It is a pilot program. We would think that all physicians would be trying to implement this. This is about reducing unnecessary hospitalizations. Speaker 200:22:22It's about reducing signs and symptoms, and it's about patient self-management of disease. That's what SC Pharmaceuticals does. We are incredibly happy with this from CMS. Speaker 300:22:43Our next question comes from Douglas Tsao from H.C. Wainwright. Please go ahead. Speaker 600:22:50Hi, good afternoon. Thanks. Congrats on the progress. I guess I'm just curious, and I apologize if I might have missed it in the prepared remarks, is, you know, how much of sort of patients sort of being, you know, now as the Medicare Part D redesign, becoming a bit of a tailwind? Because I know, you know, in the beginning of the year, there was a little bit of a headwind and you expected that it would really start to pick up steam as it went through the year, as sort of patients went through their out-of-pocket, hit their out-of-pocket max. I'm just curious if you got a sense of where that was and how much of a tailwind do you expect to see for the rest of the year? Speaker 200:23:29Yeah, hey Doug, it's John. Exactly, it's turned from a headwind last year and really in the first quarter of this year to a mixed breeze, I guess, in the beginning of Q2, now turning into a tailwind. I do think it's important to note that it wasn't just the growth in fill rate that, you know, I mean, we had a 45% increase in units shipped quarter over quarter. We're talking over 100% year over year, but 45% quarter over quarter. It was as much driven by prescriptions, new prescriptions written, as it was really by fill rate. We've said all along that we think when the fill rate goes up, doctors are more confident in writing. We think, we hope that plays out really over the second half of the year. Speaker 200:24:25The growth quarter over quarter was driven really by new prescriptions being written more so even than an increase in the fill rate. We do see it as a significant tailwind moving forward, both on units shipped to patients, but also on kind of the halo impact of physicians writing more. Speaker 300:24:54We have a next question from Stacy Ku from TD Cowen. Please go ahead. Operator00:25:01Sorry, just a quick follow-up. You guys talked about fulfillment and the dynamics around IDN. To which extent, I understand you all do not want to set a precedent in terms of IDNs because in the past you have talked about how bumpy it can be quarter by quarter. Just given that it's becoming a bigger contributor, are you able to give us a sense of the % of sales that were IDN-based in Q2? Thanks so much. Speaker 200:25:33Stacy, it's John. Yeah, we haven't, we're not going to be breaking that out because it is so lumpy. What we did say, it grew 70% quarter over quarter. I mean, keep growing that rate, it's going to be hard. It's becoming a significant part of the total sales. We're not going to be breaking that out. Speaker 300:26:07That concludes our Q&A session. I will now turn the call over to John Tucker, Chief Executive Officer, for closing remarks. Speaker 500:26:17Thank you again for your time today. We remain confident in our momentum and look forward to sharing continued progress as we advance through 2025. Thank you. Speaker 300:26:30This concludes today's conference call. You may now disconnect.Read morePowered by