NASDAQ:SCPH scPharmaceuticals Q2 2025 Earnings Report $4.63 -0.38 (-7.58%) Closing price 04:00 PM EasternExtended Trading$4.65 +0.02 (+0.45%) As of 05:50 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Polygon.io. Learn more. ProfileEarnings HistoryForecast 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)Earnings HistoryCompany 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 10 speakers on the call. Operator00:00:00Thank 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 twenty twenty five Earnings Conference Call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question and answer session. Operator00:00:32Thank you. I would now like to turn the call over to William from Investor Relations. Please go ahead. Speaker 100:00:40Thank 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 Ferosex, including the IDN distribution strategy, growth in number of prescribers, the potential sNDA filing and other regulatory approvals of Ferosex, 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 Feroxix dispenses as out of pocket expenses decrease and estimated reduction in COGS. The words anticipate, believe, estimate, expect, intend, guidance, confidence, targets, project and other similar expressions are used typically to identify such forward looking statements. These forward looking statements are not guarantees of future performance. Speaker 100:01:53It may involve and are subject to certain risks and uncertainties and other important factors that may affect Essie Pharmaceuticals' business, financial condition and other operating results. These include, but are not limited to the risk factors and other qualifications contained in SE Pharmaceuticals annual report on Form 10 ks, 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. Speaker 100:02:53John, please go ahead. Speaker 200:02:55Thank 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 twenty twenty five. Following that, I'll pass the call over to Steve Parsons, Senior Vice President of Commercial, for an update on Ferozix 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 twenty twenty five, we generated $16,000,000 in net revenue, a 99% increase over Q2 twenty twenty four. Speaker 200:03:37We filled approximately 20,200 furosex doses, an increase of 117% over Q2 twenty twenty four and more importantly a 45% increase in doses shipped over Q1 twenty twenty five. 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 position 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. Speaker 200:04:29In late April, we launched Feroxix 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 Ferozix. 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 q three and moving forward. The growing number of Part d patients reaching their out of pocket maximums had a favorable impact on our q two performance. Speaker 200:05:13We have seen this trend continue into the second half of the year, which we anticipate will further enhance Furosec'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 management of heart failure was proposed in the 2026 Physician Fee Schedule by the Centers for Medicare and Medicaid Services on 07/14/2025. Speaker 200:05:49The 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 ASN program may result in a significant tailwind to augment the already successful uptake for furosex. Lastly, we are on track for the submission of our sNDA for the auto injector in the current quarter. We continue to believe that the auto injector will be important to the long term Furosex growth trajectory with an approximate 75% reduction in COGS and an increase in our penetration rates. Speaker 200:06:41We remain highly optimistic about the future of furosex, especially with the expanded CKD indication, the favorable Part D dynamics, continued IDN growth, the launch of our auto injector, and the proposal of the new ambulatory specialty model. We believe Ferozix 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 Ferozix throughout the remainder of 02/2025. With that, I'll now pass the call to Steve Parsons for the commercial update. Steve? Speaker 300:07:20Thank 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 forty five percent increase in fluorosis doses filled, which John reported. Speaker 300:07:56We 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 twenty twenty four sales force expansion was poised to show a significant return on investment and that was evident in our Q2 results. The 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 2025 sets up nicely with a larger portion of the Medicare heart failure and chronic kidney disease population having low or no co pays. Speaker 300:08:53The 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. Targeting 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, Rachel Notes. Speaker 300:09:37Rachel? Speaker 400:09:38Thank you, Steve. Product revenues were $16,000,000 for the 2025 compared to $8,100,000 for the 2024. Cost of product revenues were $5,000,000 for the 2025 compared to $2,300,000 for the 2024. The increase in both product revenues and cost of product revenues for the quarter ended 06/30/2025 was due to an increase in demand for Furosex further into the commercial launch and related manufacturing costs. The gross to net discount for Furosex in the 2025 was approximately 27%. Speaker 400:10:24We anticipate the gross to net discount in Q3 to approach 30%. The increase in GTN throughout 2025 is primarily attributable to the implementation of the Medicare Part D redesign, including the mandatory manufacturer rebates under the Inflation Reduction Act. SC Pharmaceuticals ended the 2025 with $40,800,000 in cash and cash equivalents compared to $75,500,000 in cash and cash equivalents as of 12/31/2024. 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 increased due to higher anticipated volumes and a 3.5% price increase effective 07/01/2025. Speaker 400:11:17I'll now pass the call back to John for concluding remarks. Speaker 200:11:21In the 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? Operator00:11:45We will now begin our question and answer session. First, we have Stacy Ku from T. D. Cohen. Please go ahead. Speaker 500:12:02Hey, thanks so much for taking our questions, and congratulations on the quarter. We have a few questions, as seems like we have a lot of metrics that we are hopeful you guys can go through. So just first, as we think about the growth in cardiology, can you maybe talk about those Class IV heart failure patients? RCA also highlighted these patients as ideal high flyers. So let me just talk about how the adoption rates are going and how to maximize maybe that positive clinician view there. Speaker 500:12:33Just the first question is maybe just talk some more about the class IV expansion, how that's going. Second question is obviously then as we talk about maybe early days with the CKD launch, but what are your early learnings from these initial interactions with pathologists? And then third question is maybe talk about how fulfillment is progressing and if you believe that will be kind of Speaker 400:12:58a key contributor as we Speaker 500:12:59think 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 200:13:10Hey, Stacy, it's John. Thank you for the questions. Yeah, and thanks for the so I'll handle the last one first, and then I'll turn it over to Steve and or John on the first two. So 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. There a lot of it has to do, as you mentioned, with the patient co pays. Speaker 200:13:45They'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. We get an order, we ship the order. Speaker 200:14:16We don't know how many were written. We just know what we ship. So but the fill rates have gone up in Q2 versus Q1, and we anticipate them being higher in Q3 and even higher in Q4. So I'll turn it over to Steve, maybe to hit on Class four and then or nephrology first. Speaker 600:14:38Yeah. 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. And we're not going to break out the contribution from which here. Speaker 600:15:01But 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. Some I'm not going to say all, but some will prescribe pretty quickly after one or two visits. Again, not saying all of them, but some of them and that's different than it was in cardiology. Speaker 600:15:30What'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. They're driving between offices, dialysis centers. Speaker 600:15:43So it's taken us just a little while to get their best times, their best days, the locations. But when we do speak to them, they get it right away. And then 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. Speaker 600:16:14I 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. So I guess that's the color I have on the nephrology launch so far. Speaker 600:16:31And then class IV, that continues to go well. We don't report prescriptions as class IV anymore. So I can't be specific with you. They just send in the prescription for do they have heart failure? Do they have CKD? Speaker 600:16:47Or do they have both? But we are calling on advanced heart failure clinics. They are prescribing more than they had They'll use a few more doses than on a regular patient in a general card office. Does that answer the question? Operator00:17:14Our next question comes from Christian Clark from Leerink Partners. Please go ahead. Speaker 700:17:22Good afternoon. This is Chris Clark on for Ruana Ruiz. Can you please provide more granular details on the CKD launch trajectory since late April? What percent of the roughly 20,200 doses shipped in Q2 were attributable to the CKD indication versus heart failure? And separately, with cash declining to $40,800,000 over the 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. So I'll answer the cash I'll answer both questions here. The vast majority don't forget, in nephrology, we only had two months of launch in nephrology. What we've noticed is individual nephrologists have been faster adopters than the cardiologists were. Now Steve mentioned hard to find them sometimes because they're in a dialysis center. Speaker 200:18:26They'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. And by doctor, it's faster in nephrology. And as Steve mentioned, they write bigger scripts. Speaker 200:18:45They care about drying patients out, not just relieving congestion or relieving dipsy or whatever. As far as the cash run rate, are laser focused right now on reaching profitability. We're currently evaluating impacts of tariffs and FX fluctuations and increased COGS. But we still have access to, if needed, dollars 10,000,000 from Perceptive on the royalty and another $25,000,000 on the debt. And we look at that needed as an ability to have more capital. Operator00:19:44Our next question comes from Nas Raman from Maxim Group. Please go ahead. Speaker 800:19:51Hi, 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 B payments. And I guess when is this expected to be implemented and who is it exactly implemented by? Speaker 800:20:13Is it just implemented by CMS administration or does Congress have to involve or anything? Speaker 200:20:21It's Jon Tucker. Thanks for the question. I'll let Jon Moore answer those questions. Hey, 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 in 2028 payments, and it'll happen and it'll occur for five years. Speaker 200:20:51It 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. So CMS will roll this out and apply the findings to Medicare Part B payments moving forward for the next five years. So the timing a little bit now is September 2025, so next month. The public comment period closes. November, 2025, guidance is implemented. Speaker 200:21:24And 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-twenty twenty six. Although it's up for comment, our consultants lobbyists have said they doubt there'll be any changes to this. So if you're sitting where we are, we could have wrote this bill because it just fits right into the value prop of Ferozix. So 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. Speaker 200:22:07So it is a pilot program, so we would think that all physicians would be trying to implement this. And again, this is about reducing unnecessary hospitalizations, it's about reducing signs and symptoms, and it's about patient self management of disease. That's what Ferozix does. So we are incredibly happy with this from CMS. Operator00:22:43Our next question comes from Douglas Chau from H. C. Wainwright. Please go ahead. Speaker 900:22:50Hi, good afternoon. Thanks and congrats on the progress. I guess I'm just curious, and I apologize if I might have missed it in the prepared remarks, how much of sort of patients sort of being now as Medicare part, Medicare redesign, the redesign becoming a bit of a tailwind? Because I know, at 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 we went through the year as sort of patients went through their out of pocket hit their out of pocket max. And 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 Speaker 800:23:28rest of the year? Speaker 200:23:29Yeah. Hey, Doug, it's John. So exactly, it's turned from 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 I mean, we had 45% increase in units shipped quarter over quarter. We're talking over 100% year over year, but 45% quarter over quarter. Speaker 200:24:01But it was as much driven by prescriptions, new prescriptions written, as it was really by fill rate. So we've said all along that we think when the fill rate goes up, that doctors are more confident in writing. And we think we hope that plays out really over the second half of the year. But the growth quarter over quarter was driven really by new prescriptions being written more so even than an increase in the fill rate. But we do see it as significant tailwind moving forward, both on units shipped to patients, but also on kind of the halo impact of physicians writing more. Operator00:24:54We'll have a next question from Stacy Ku from TD Cohen. Please go ahead. Speaker 500:25:01Sorry, 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. But just given that it's becoming a bigger contributor, are you able to give us a sense of the percent of sales that were IDN based in Q2? Thanks so much. Speaker 200:25:33Stacy, it's John. We haven't we're not going be breaking that out because it is so lumpy. But what we did say, grew 70% quarter over quarter. I mean, keep growing that rate. It's going to be hard. Speaker 200:25:50But it's becoming a significant part of the total sales. But we're not going to be breaking that out. Operator00:26:07That concludes our Q and A session. I will now turn the call over to Jen Tucker, President and CEO, for closing remarks. Speaker 200:26:17Thank 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. Operator00:26:30This 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. (SCPH) Q2 2025 Earnings Call TranscriptAugust 8 at 3:03 PM | seekingalpha.comscPharmaceuticals Inc. Reports Second Quarter 2025 Financial Results and Provides Business UpdateAugust 7 at 4:01 PM | globenewswire.comGreen Light for These StocksGuess Who Washington Will Partner With Next? The U.S. government just made a bold $400 million move... becoming the largest shareholder in a critical mineral company tied to national security. Former hedge fund manager Whitney Tilson believes this is just the start of a sweeping plan to unlock trillions in hidden federal assets... from oil-rich land to rare earths and energy reserves. He says this could mark the beginning of the largest wealth transfer in modern U.S. history, and has identified the surprising areas where you could benefit.August 8 at 2:00 AM | Stansberry Research (Ad)Shareholders in scPharmaceuticals (NASDAQ:SCPH) are in the red if they invested five years agoAugust 5 at 2:55 PM | uk.finance.yahoo.comscPharmaceuticals to Announce Second Quarter 2025 Financial Results After the Market Close on August 7, 2025July 31, 2025 | globenewswire.comWith 42% stake, scPharmaceuticals Inc. (NASDAQ:SCPH) seems to have captured institutional investors' interestJune 12, 2025 | finance.yahoo.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) Inc., a pharmaceutical company, engages in the development and commercialization of various pharmaceutical products. Its lead product candidate is FUROSCIX that consists of formulation of furosemide, which is delivered through an on-body infusor for treatment of congestion due to fluid overload in adults with chronic heart failure and kidney disease, as well as consists of subcutaneous loop diuretic that delivers IV equivalent diuresis at home; and FUROSCIX On-Body Infusor, a drug-device combination product consisting of FUROSCIX. The company's product pipeline also includes SCP-111 (furosemide injection), an investigational pH neutral aqueous furosemide formulation that is being developed for subcutaneous administration outside of the hospital setting, including patient self-administration in the home; and SCP-111 Autoinjector, an investigational single-entity, drug-device combination product candidate consisting of a prefilled syringe containing SCP-111, preloaded into a commercially available, fixed single dose, disposable, two step mechanical autoinjector. It has a collaboration agreement with West Pharmaceutical Services, Inc. The company was incorporated in 2013 and is headquartered in Burlington, Massachusetts.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 Earnings By Country U.S. Earnings Reports Canadian Earnings Reports U.K. Earnings Reports Latest Articles Airbnb Beats Earnings, But the Growth Story Is Losing AltitudeDutch Bros Just Flipped the Script With a Massive Earnings BeatIs Eli Lilly’s 14% Post-Earnings Slide a Buy-the-Dip Opportunity?Constellation Energy’s Earnings Beat Signals a New EraRealty Income Rallies Post-Earnings Miss—Here’s What Drove ItDon't Mix the Signal for Noise in Super Micro Computer's EarningsWhy Monolithic Power's Earnings and Guidance Ignited a Rally Upcoming Earnings SEA (8/12/2025)Cisco Systems (8/13/2025)Alibaba Group (8/13/2025)Applied Materials (8/14/2025)NetEase (8/14/2025)Deere & Company (8/14/2025)NU (8/14/2025)Petroleo Brasileiro S.A.- Petrobras (8/14/2025)Palo Alto Networks (8/18/2025)Home Depot (8/19/2025) Get 30 Days of MarketBeat All Access for Free Sign up for MarketBeat All Access to gain access to MarketBeat's full suite of research tools. 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There are 10 speakers on the call. Operator00:00:00Thank 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 twenty twenty five Earnings Conference Call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question and answer session. Operator00:00:32Thank you. I would now like to turn the call over to William from Investor Relations. Please go ahead. Speaker 100:00:40Thank 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 Ferosex, including the IDN distribution strategy, growth in number of prescribers, the potential sNDA filing and other regulatory approvals of Ferosex, 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 Feroxix dispenses as out of pocket expenses decrease and estimated reduction in COGS. The words anticipate, believe, estimate, expect, intend, guidance, confidence, targets, project and other similar expressions are used typically to identify such forward looking statements. These forward looking statements are not guarantees of future performance. Speaker 100:01:53It may involve and are subject to certain risks and uncertainties and other important factors that may affect Essie Pharmaceuticals' business, financial condition and other operating results. These include, but are not limited to the risk factors and other qualifications contained in SE Pharmaceuticals annual report on Form 10 ks, 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. Speaker 100:02:53John, please go ahead. Speaker 200:02:55Thank 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 twenty twenty five. Following that, I'll pass the call over to Steve Parsons, Senior Vice President of Commercial, for an update on Ferozix 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 twenty twenty five, we generated $16,000,000 in net revenue, a 99% increase over Q2 twenty twenty four. Speaker 200:03:37We filled approximately 20,200 furosex doses, an increase of 117% over Q2 twenty twenty four and more importantly a 45% increase in doses shipped over Q1 twenty twenty five. 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 position 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. Speaker 200:04:29In late April, we launched Feroxix 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 Ferozix. 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 q three and moving forward. The growing number of Part d patients reaching their out of pocket maximums had a favorable impact on our q two performance. Speaker 200:05:13We have seen this trend continue into the second half of the year, which we anticipate will further enhance Furosec'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 management of heart failure was proposed in the 2026 Physician Fee Schedule by the Centers for Medicare and Medicaid Services on 07/14/2025. Speaker 200:05:49The 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 ASN program may result in a significant tailwind to augment the already successful uptake for furosex. Lastly, we are on track for the submission of our sNDA for the auto injector in the current quarter. We continue to believe that the auto injector will be important to the long term Furosex growth trajectory with an approximate 75% reduction in COGS and an increase in our penetration rates. Speaker 200:06:41We remain highly optimistic about the future of furosex, especially with the expanded CKD indication, the favorable Part D dynamics, continued IDN growth, the launch of our auto injector, and the proposal of the new ambulatory specialty model. We believe Ferozix 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 Ferozix throughout the remainder of 02/2025. With that, I'll now pass the call to Steve Parsons for the commercial update. Steve? Speaker 300:07:20Thank 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 forty five percent increase in fluorosis doses filled, which John reported. Speaker 300:07:56We 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 twenty twenty four sales force expansion was poised to show a significant return on investment and that was evident in our Q2 results. The 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 2025 sets up nicely with a larger portion of the Medicare heart failure and chronic kidney disease population having low or no co pays. Speaker 300:08:53The 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. Targeting 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, Rachel Notes. Speaker 300:09:37Rachel? Speaker 400:09:38Thank you, Steve. Product revenues were $16,000,000 for the 2025 compared to $8,100,000 for the 2024. Cost of product revenues were $5,000,000 for the 2025 compared to $2,300,000 for the 2024. The increase in both product revenues and cost of product revenues for the quarter ended 06/30/2025 was due to an increase in demand for Furosex further into the commercial launch and related manufacturing costs. The gross to net discount for Furosex in the 2025 was approximately 27%. Speaker 400:10:24We anticipate the gross to net discount in Q3 to approach 30%. The increase in GTN throughout 2025 is primarily attributable to the implementation of the Medicare Part D redesign, including the mandatory manufacturer rebates under the Inflation Reduction Act. SC Pharmaceuticals ended the 2025 with $40,800,000 in cash and cash equivalents compared to $75,500,000 in cash and cash equivalents as of 12/31/2024. 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 increased due to higher anticipated volumes and a 3.5% price increase effective 07/01/2025. Speaker 400:11:17I'll now pass the call back to John for concluding remarks. Speaker 200:11:21In the 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? Operator00:11:45We will now begin our question and answer session. First, we have Stacy Ku from T. D. Cohen. Please go ahead. Speaker 500:12:02Hey, thanks so much for taking our questions, and congratulations on the quarter. We have a few questions, as seems like we have a lot of metrics that we are hopeful you guys can go through. So just first, as we think about the growth in cardiology, can you maybe talk about those Class IV heart failure patients? RCA also highlighted these patients as ideal high flyers. So let me just talk about how the adoption rates are going and how to maximize maybe that positive clinician view there. Speaker 500:12:33Just the first question is maybe just talk some more about the class IV expansion, how that's going. Second question is obviously then as we talk about maybe early days with the CKD launch, but what are your early learnings from these initial interactions with pathologists? And then third question is maybe talk about how fulfillment is progressing and if you believe that will be kind of Speaker 400:12:58a key contributor as we Speaker 500:12:59think 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 200:13:10Hey, Stacy, it's John. Thank you for the questions. Yeah, and thanks for the so I'll handle the last one first, and then I'll turn it over to Steve and or John on the first two. So 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. There a lot of it has to do, as you mentioned, with the patient co pays. Speaker 200:13:45They'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. We get an order, we ship the order. Speaker 200:14:16We don't know how many were written. We just know what we ship. So but the fill rates have gone up in Q2 versus Q1, and we anticipate them being higher in Q3 and even higher in Q4. So I'll turn it over to Steve, maybe to hit on Class four and then or nephrology first. Speaker 600:14:38Yeah. 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. And we're not going to break out the contribution from which here. Speaker 600:15:01But 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. Some I'm not going to say all, but some will prescribe pretty quickly after one or two visits. Again, not saying all of them, but some of them and that's different than it was in cardiology. Speaker 600:15:30What'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. They're driving between offices, dialysis centers. Speaker 600:15:43So it's taken us just a little while to get their best times, their best days, the locations. But when we do speak to them, they get it right away. And then 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. Speaker 600:16:14I 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. So I guess that's the color I have on the nephrology launch so far. Speaker 600:16:31And then class IV, that continues to go well. We don't report prescriptions as class IV anymore. So I can't be specific with you. They just send in the prescription for do they have heart failure? Do they have CKD? Speaker 600:16:47Or do they have both? But we are calling on advanced heart failure clinics. They are prescribing more than they had They'll use a few more doses than on a regular patient in a general card office. Does that answer the question? Operator00:17:14Our next question comes from Christian Clark from Leerink Partners. Please go ahead. Speaker 700:17:22Good afternoon. This is Chris Clark on for Ruana Ruiz. Can you please provide more granular details on the CKD launch trajectory since late April? What percent of the roughly 20,200 doses shipped in Q2 were attributable to the CKD indication versus heart failure? And separately, with cash declining to $40,800,000 over the 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. So I'll answer the cash I'll answer both questions here. The vast majority don't forget, in nephrology, we only had two months of launch in nephrology. What we've noticed is individual nephrologists have been faster adopters than the cardiologists were. Now Steve mentioned hard to find them sometimes because they're in a dialysis center. Speaker 200:18:26They'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. And by doctor, it's faster in nephrology. And as Steve mentioned, they write bigger scripts. Speaker 200:18:45They care about drying patients out, not just relieving congestion or relieving dipsy or whatever. As far as the cash run rate, are laser focused right now on reaching profitability. We're currently evaluating impacts of tariffs and FX fluctuations and increased COGS. But we still have access to, if needed, dollars 10,000,000 from Perceptive on the royalty and another $25,000,000 on the debt. And we look at that needed as an ability to have more capital. Operator00:19:44Our next question comes from Nas Raman from Maxim Group. Please go ahead. Speaker 800:19:51Hi, 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 B payments. And I guess when is this expected to be implemented and who is it exactly implemented by? Speaker 800:20:13Is it just implemented by CMS administration or does Congress have to involve or anything? Speaker 200:20:21It's Jon Tucker. Thanks for the question. I'll let Jon Moore answer those questions. Hey, 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 in 2028 payments, and it'll happen and it'll occur for five years. Speaker 200:20:51It 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. So CMS will roll this out and apply the findings to Medicare Part B payments moving forward for the next five years. So the timing a little bit now is September 2025, so next month. The public comment period closes. November, 2025, guidance is implemented. Speaker 200:21:24And 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-twenty twenty six. Although it's up for comment, our consultants lobbyists have said they doubt there'll be any changes to this. So if you're sitting where we are, we could have wrote this bill because it just fits right into the value prop of Ferozix. So 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. Speaker 200:22:07So it is a pilot program, so we would think that all physicians would be trying to implement this. And again, this is about reducing unnecessary hospitalizations, it's about reducing signs and symptoms, and it's about patient self management of disease. That's what Ferozix does. So we are incredibly happy with this from CMS. Operator00:22:43Our next question comes from Douglas Chau from H. C. Wainwright. Please go ahead. Speaker 900:22:50Hi, good afternoon. Thanks and congrats on the progress. I guess I'm just curious, and I apologize if I might have missed it in the prepared remarks, how much of sort of patients sort of being now as Medicare part, Medicare redesign, the redesign becoming a bit of a tailwind? Because I know, at 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 we went through the year as sort of patients went through their out of pocket hit their out of pocket max. And 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 Speaker 800:23:28rest of the year? Speaker 200:23:29Yeah. Hey, Doug, it's John. So exactly, it's turned from 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 I mean, we had 45% increase in units shipped quarter over quarter. We're talking over 100% year over year, but 45% quarter over quarter. Speaker 200:24:01But it was as much driven by prescriptions, new prescriptions written, as it was really by fill rate. So we've said all along that we think when the fill rate goes up, that doctors are more confident in writing. And we think we hope that plays out really over the second half of the year. But the growth quarter over quarter was driven really by new prescriptions being written more so even than an increase in the fill rate. But we do see it as significant tailwind moving forward, both on units shipped to patients, but also on kind of the halo impact of physicians writing more. Operator00:24:54We'll have a next question from Stacy Ku from TD Cohen. Please go ahead. Speaker 500:25:01Sorry, 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. But just given that it's becoming a bigger contributor, are you able to give us a sense of the percent of sales that were IDN based in Q2? Thanks so much. Speaker 200:25:33Stacy, it's John. We haven't we're not going be breaking that out because it is so lumpy. But what we did say, grew 70% quarter over quarter. I mean, keep growing that rate. It's going to be hard. Speaker 200:25:50But it's becoming a significant part of the total sales. But we're not going to be breaking that out. Operator00:26:07That concludes our Q and A session. I will now turn the call over to Jen Tucker, President and CEO, for closing remarks. Speaker 200:26:17Thank 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. Operator00:26:30This concludes today's conference call. You may now disconnect.Read morePowered by