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spk06: Good afternoon, ladies and gentlemen, and welcome to the SC Pharmaceuticals first quarter 2024 earnings conference call. At this time, all participants are in a listen-only mode. Following the presentation, we will conduct a question and answer session. And if at any time during this call you require immediate assistance, please press star zero for an operator. Also note that the call is being recorded Tuesday, May 14, 2024. And I would like to turn the conference over to PJ Keller, Investor Relations. Please go ahead.
spk03: Thank you, operator. Before turning the call over to management, I would like to make the following remarks concerning forward-looking statements. All statements on this conference call, other than historical facts, are forward-looking statements within the meaning of the federal securities laws, including but not limited to statements regarding SD Pharmaceuticals' expected future financial results, management's expectations and plans for the business, the ongoing commercialization and marketing of furosics, and the potential label expansion and other regulatory approval of furosics. The words anticipate, believe, estimate, expect, intend, guidance, confidence, target, project, and other similar expressions are used typically to identify such forward-looking statements. These forward-looking statements are not guarantees of future performance and may involve and are subject to certain risks and uncertainties and other important factors that may affect SC Pharmaceutical's business, financial condition, and other operating results. These include, but are not limited to, the risk factors and other qualifications contained in SC Pharmaceutical's annual report on Form 10-K, quarterly reports on Form 10-Q, and other reports filed by the company with the SEC to which your attention is directed. Actual outcomes and results may differ materially from what is expressed or implied by these four looking statements. Any forward-looking statements made in this conference call, including responses to your questions, are based on current expectations as of today. And SC Pharmaceuticals expressly disclaims any intent or obligation to update these forward-looking statements except as required by law. It is now my pleasure to turn the call over to Mr. John Tucker, Chief Executive Officer of SC Pharmaceuticals. John?
spk08: Thank you, PJ, and thanks to everyone listening to this afternoon's call and webcast. to review our first quarter 2024 results. This has been our practice. I will begin with an operational update before turning the call over to Steve Parsons, our Senior Vice President of Commercial, for a more detailed commercial update on Ferocix, and then Rachel Knowles, our Chief Financial Officer, for review of our financials. We will then open the call for your questions. During the first quarter, we saw a continuation of the positive trends that we believe reflect growing awareness and utilization as a new and innovative part of a heart failure care continuum. As Steve will detail shortly, our leading indicators, including doses written, unique prescribers, and in-services completed, suggest that providers are increasingly more comfortable prescribing cirrhosis to their heart failure patients during critical intervention windows, which are pre-hospital admission or post-discharge. We reported net revenue of $6.1 million despite experiencing approximately 10% negative impact on doses filled during the quarter due to the widely reported and previously disclosed change healthcare cyber attack. We also experienced some seasonal impact during the first quarter as patient deductibles reset with the new year. We continue to take steps to increase and improve our prescription fill rate. In March, we transitioned our patient service provider, or as we call it, the hub, which we think will result in an improved patient and physician experience. We are very pleased to have tuned in another solid quarter, notwithstanding these temporary headwinds. Our gross net discount during the first quarter was 19%, up slightly from 2023. We continue to expect the GPM discount to increase over time as contracting with payers and the marketplace evolve. and we expect that the GTN discount will approach 30% to 35% on a quarterly basis by the end of this year, consistent with our prior long-term guidance for GTN. Inventory levels at the end of the first quarter at our specialty pharmacy partners were generally consistent with the inventory levels at the end of 2023. Shifting now to payers, we continue to have productive discussions with commercial, Medicare Part D, and Medicaid payers in an ongoing effort to make furosics broadly available to patients at the most favorable terms possible. With favorable market dynamics in Medicare, we have expanded the population of heart failure patients who have access to furosics with fixed-tier co-pays of $100 or less to 70%, moving us closer to our previously stated goal of 75% or more over time. We are progressing with many other health plans, and we hope to have updates in the months to come. At this point, I would like to provide an update on several long-term growth initiatives that we previewed last quarter that we view as critical to our long-term growth strategy. As we discussed previously, last year we received positive feedback from the FDA regarding the potential expansion of the Ferrosix indication to allow for use in New York Heart Association class IV heart failure patients. Recall that Ferrosix is currently indicated for the treatment of congesting due to fluid overload in adult patients in New York Heart Association Class 2 and Class 3 chronic heart failure. We estimate that as many as 10% of all heart failure patients are Class 4, and a meaningful percent of these, as many as 40%, may benefit from cirrhosis. Based upon the feedback that we received from the agency, we filed for the Class 4 indication in early October of last year, and we have been assigned a PDUPA date for this August, although the possibility does still exist that the PDUPA date could occur sooner. If we are successful, we believe Class IV would represent a meaningful expansion of our market opportunity as providers would be able to prescribe cirrhosis to the most severe heart failure patients. Turning now to the 80 mg over 1 ml low-volume autoinjector that we are developing as an additional option to the on-body infuser. Just a few weeks ago, we announced that we initiated a pivotal PK study, and we plan to report results later this year that if successful, will allow us to submit a supplemental new drug application to the FDA by the end of this year. As we stated previously, we believe an auto-injector, if improved, would reduce manufacturing costs compared to the current on-body infuser and confer environmental advantages as well, in addition to giving treating providers and their patients more treatment flexibility. Finally, we previously discussed feedback that we received from the FDA pertaining to the potential expansion of the ferrosis indication to include treatment of edema due to fluid overload in patients with chronic kidney disease, or CKD. Recalled in its feedback, the FDA confirmed that no additional clinical studies are needed to expand the indication of CKD, provided that we can demonstrate an adequate PK and pharmacodynamic bridge to the listed drug, which is furosemide injection 10 mg over mL. CKD is a progressive disease characterized by worsening renal function over time, resulting in frequent episodes of fluid overload that are treated with loop diuretics. It is estimated that 12 to 15 million Americans are aware that they have kidney disease, and 50% of patients with CKD do not have a diagnosis of heart failure. With fluid overload being one of the most common complications with CKD, which worsens with disease progression, we believe cirrhosis could be beneficial to patients with CKD who have worsening symptoms due to fluid overload and are not responding to oral loop diuretics. To that end, earlier this month, we submitted a supplemental new drug application with the FDA for the CKD indication. At this point, I'll turn the call of our Senior Vice President of Commercial, Steve Parsons, for a deeper dive into our launch metrics. Steve?
spk10: Thank you. As John indicated, we continue to be pleased with our progress since launch. From launch in February 2023 through March 31st, 2024, we've had 2,184 unique prescribers, up 29% from the 1,696 unique prescribers we had from launch through December 31st. We are encouraged by the prescriber growth in this quarter as we believe it reflects our strategy of establishing a broader prescriber base. Importantly, more than half of these prescribers have written multiple prescriptions. During the first quarter, we had 17,736 doses written, and 8,074 doses have been filled. As John indicated earlier, our doses filled during the first quarter were negatively impacted by the widely reported change healthcare cyber attack. We also faced normal calendar seasonality as patient deductibles reset at the start of the year. Despite those headwinds, we are pleased with the trajectory that we are currently on, and we continue to explore steps to increase our fill rate going forward. One of those steps is a change in our patient services hub that we completed in March. An increasing number of our providers are writing prescriptions for patients in anticipation of future need. These prescriptions may not be filled in the month or quarter in which they are written. They make up a significant portion of the spread between doses written and doses filled that we report on. Pre-approved prescriptions are reported in the doses written statistics and we report on them as doses filled when they actually ship to patients as the prescriber directs. It's a portion of doses that do get canceled by prescribers or patients for a variety of reasons. Some patients are very difficult to reach or have been hospitalized or are deceased. Other reasons for cancellation are a high copay or because the patient resolved with standard of care before filling 406. The changed healthcare situation did lead to an increase in cancellations during the quarter as some prescriptions could not be processed when needed. Cancellation was 19% in quarter one of 2024. Over time, we anticipate that the cancellation rates will normalize. Better position on prescription formularies, quicker coverage decisions by payers, and lower patient out-of-pocket costs will improve fill rates and stabilize the percent that get canceled. During the first quarter, the average number of doses per prescription filled was 6.1, which remains higher than our long-term expectations, and up slightly, sequentially, from 5.9 in the fourth quarter of 2023. Our service force has conducted 2,938 in-services from launch through March 31st, up from 2,331 in-services completed as of December 31st of last year. Inservices provide important training to offices on the prescribing process of furosics, and this ensures office readiness. As we open more new accounts, the execution of inservices remains fundamental to furosic success, and we regard the number of inservices conducted each quarter as an important leading indicator. Regarding our sales force, We've said previously that we stand ready to add additional territories as demand warrants. We plan on adding additional territories in advance of potential Class 4 and CKD long-term growth initiatives. From a marketing perspective, we are engaged in a broad, multi-channel marketing campaign to drive brand awareness, adoption, and commitment. This program encompasses many different activities, but some of the key ongoing activities include engagement and development of key opinion leaders, conference presence, print and electronic collateral, and the development of both provider and patient websites, among other critical tasks. We continue to reach out to heart failure patients and their caregivers with patient education materials for furosem. Overall, we are pleased with our continued progress. and the path that we are on. That concludes my update. I would like now to turn the call over to our CFO, Rachel Noakes, for a review of our financials. Rachel?
spk12: Thank you, Steve. As of March 31st, 2024, we held $58.4 million in cash and cash equivalents compared to $76 million in cash, cash equivalents, and investments as of December 31st, 2023. Now I will cover a few income statement items. We reported a net loss of $14.1 million for the first quarter of 2024, compared to a net loss of $11.2 million for the first quarter of 2023. Product revenues were $6.1 million for the first quarter of 2024, compared to $2.1 million for the first quarter of 2023. Cost of product revenues were $1.8 million for the first quarter of 2024 compared to $0.6 million for the first quarter of 2023. The increase in both product revenues and cost of product revenues for the quarter ended March 31, 2024, with due to a full quarter of sales in the first quarter of 2024 and an increase in demand at Bureau 6 further into the commercial launch and related manufacturing costs. Research and development expenses were $2.7 million for the first quarter of 2024 compared to $2.1 million for the comparable period in 2023. The increase in research and development expenses for the quarter ended March 31, 2024 was primarily due to an increase in device development costs, employee-related costs, and clinical study costs. Selling general and administrative expenses are $17.4 million for the first quarter of 2024, compared to $10.9 million for the comparable period in 2023. The increase in selling general and administrative expenses for the quarter ended March 31, 2024, was primarily due to an increase in employee-related costs, commercial costs, and patient support. As of March 31, 2024, We have 36,054,409 total shares outstanding. That concludes the financial update. John? Thanks, Rachel.
spk08: This concludes our prepared remarks. At this point, we will open the call for questions.
spk06: Thank you. Ladies and gentlemen, if you would like to ask a question, please press star followed by one on your touchtone phone. You will then hear a prompt that your hand has been raised. And if you would like to withdraw from the question queue, Simply press star followed by two. And out of consideration to other callers today, we ask that you please limit yourself to one question and one follow-up. Please go ahead and press star one now if you do have any questions. And your first question will be from Glenn Sanangelo at Jefferies. Please go ahead.
spk05: Yeah, thanks for taking my question. Hey, John or Rachel, I'm not sure who wants to answer, but I guess my first question is on revenues. Just sort of looking at the 6.1 million is sort of flat sequentially from where you were in 4Q. And I'm just trying to reconcile that versus the fact that the doses filled was up 15% sequentially. So, I just want to make sure I understand how the math and all that revenue recognition works.
spk08: Yeah, sure, Glenn. This is John. So, in the 6.1 was similar to the last quarter again. We had the impact of the changed healthcare, which knocked that down. You know, you always have the headwinds in Q1 of patients out of pockets resetting. But the difference in the higher amount of doses filled versus last quarter and why the revenue stayed the same was just in Q4. We had, as we've talked about on the Q4 call, a very large order from Kaiser Direct that doesn't go into our filled doses but is in our net revenues. So that's why there's a difference between what you would think the difference and the net revenue would be from doses filled.
spk05: All right, I'll go back and take a look at that. And then, John, maybe just one quick follow-up. Obviously, a lot of people are focused on the compelling value proposition for the managed care companies, but maybe either you or Steve can just sort of give us some sense of how the conversations are going with the feedback from the doctors and And are you getting any pushback at all at this point in terms of, you know, wanting to prescribe more, what the barriers are to prescribing more? Thank you.
spk11: Sure. Steve, you want to handle that?
spk10: Yeah. We're not getting pushback from the doctors. You can see our demand is going up month over month, continuing our conversations with payers. Most of our prescriptions are getting covered, and they're getting covered at affordable copays. As you heard John say, 70% of our copays are $100 or less. We're engaging with them. They're all calculating what they're going to do in 2025. So we're meeting with them regularly, and it's been pretty positive for us. And the docs aren't having an issue really at all getting the product.
spk11: that they want. Okay, thank you. Thanks, bye.
spk07: Next question will be from Stacy Ku at TD Cowan. Please go ahead.
spk00: Hey, thanks so much for taking our questions. Congratulations on the progress, especially navigating the change healthcare cyber attack. So we just had a few questions. Sounds like we're seeing good prescriber and patient demand. So can you just comment on expectations regarding seasonality this year? And if so, if you think there is going to be seasonality, what do you plan that could allow you to capture patient share during crucial high-demand quarters? Is it just trying to get a lot of infrastructure in place ahead of the summer, for instance, where you might have a higher need for furosics, unfortunately? And then the second question is going to be around formulary additions. So when you talk about the hospital systems and it comes to kind of the phorosis opportunity, how are you thinking about it long term? And how long do you expect that process will take with kind of IDNs and kind of formulary access? So where are you in that progress as we think about account targets? Thank you so much.
spk08: Thanks, Kate. This is John. Seasonality, you know, it's interesting. So there's seasonality. You know, you get an impact in Q1. mainly because out-of-pockets reset patients' deductibles and their out-of-pockets reset. So there's always a little headwind in Q1. If you look at Q2, Q3, we don't see that same seasonality. Into the end of Q4, you know, second half of Q4, you have something Steve calls holiday heart, where patients are, you know, doctors are worried they're going to grab too much salt. So you tend to see doctors writing, a lot more scripts kind of for the patients just in case. And a lot of the patients end up using them. So, I do think there's some seasonality based on the holidays in Q4. We don't see it quite as much like around July 4th or something as opposed to Christmas and Thanksgiving. So, and the question on the IDNs. So, you know, IDNs come in all shapes and sizes. Obviously, the biggest one is the VA. Our goal this year is to get on national formulary. The VA, we're selling to VAs, you know, every month to separate VAs. But again, we want to go up a national formulary. The second biggest VA is Kaiser. We've talked about the formulary there and did ship a big, almost thousand unit order there at the end of Q4. And they put it in their protocols. So they're using it now. on patients so we anticipate them continue to order that's your second biggest idn and then you have a number of idns again idns all look different that are sometimes this hospital system maybe steve you can talk about some of the ones we're working with now yeah for example the university of california system that's uc davis you see san francisco uc la san diego irvine we're working with them to
spk10: for them to direct purchase Furosix, put it into all of their sites, load it into their EMR so they're fully integrated. It's really fast, really easy, you know, having that integration, having the patient information and being able to see who got what when across the whole system. So that's one that's, you know, a Q2, we think. There's other ones all over the country like that. Think of big IDNs that are academic or university systems. they have the same interest in bringing Ferozix in directly and giving their patients access through them.
spk11: Okay. Okay. Very helpful.
spk00: Thank you so much.
spk07: Thank you. Next question will be from Rana Ruiz at Learing Partners.
spk06: Please go ahead.
spk02: Great. Afternoon, everyone. So I noticed you mentioned you completed Afternoon. I noticed you mentioned you completed a transition to a new patient services provider and specialty pharmacy network. I was curious, does that impact inventory or stocking at all? And could it help streamline or even boost the process of getting 406 to patients?
spk08: So it doesn't really impact our inventory at all. But yes, we're really looking to improve the patient and physician experience, streamline getting product to patients, as fast as we can and actually get better data as well. So that was the reason we made the change, but it didn't have any impact on inventory.
spk02: Got it. Okay. And as a follow-up, I was curious, knowing that the PDUFA date is coming up in August for Class 4 heart failure, Do you plan to do anything different with the field force strategy, educating physicians at that time, et cetera, to help boost 406 education and awareness ahead of the label expansion?
spk08: Yeah, as soon as, you know, you can't pre-promote that, but as soon as we have the approval, we'll be doing mailings and notification to all, you know, providers. And obviously the sales force would have been trained in advance of that. Keep in mind, it's really the same physicians that we're calling on. So we'll be educating them through direct and non-direct routes that, hey, these patients are now eligible for Ferocix use. So it'll be, again, direct and non-direct promotion awareness to the physicians that we now have class four indication. But it's the same docs in the same offices.
spk11: Got it. Thanks.
spk07: Thank you. Next question will be from Chase Knickerbocker at Craig Hallam Capital.
spk06: Please go ahead.
spk04: Good afternoon. Thanks for taking my questions as well. Maybe just to start, might have missed this, but just to confirm, you've seen kind of that script fill rate normalized thus far in April where it's kind of back to your usual expectations and along those same lines. Any reason to believe that, you know, doses written could have potentially been, you know, partially impacted as well as physicians maybe were a little less confident around potential script approval in March when we were in the heat of the change situation? Thanks.
spk08: You know, Chase, we don't think so. We were looking at the prescription trends coming in as we were going through the cyber attack. There might have been a little lull, but it wasn't anywhere near what we were seeing on the fill side. And, you know, doctors knew what was going on. Don't forget the doctors weren't getting paid because their claims weren't getting paid at all. So there might have been a little slowdown, nothing we could really see. I was worried it would cut some momentum out from underneath us, but we don't think so because we saw Scripps really growing through the end of the quarter into this quarter especially. So any impact, we really think it was, It was contained in Q1 and really was the impact on doses shipped.
spk04: Got it. And that dose is shipped as certainly normalized to normal expectations and so far on Q2 just to, yeah.
spk08: Yeah, correct. Back to the similar level where we were before change.
spk04: Great. And is it time for us to kind of adjust our thinking on average doses per script? And then how does that also kind of That same question, does that become a little bit more relevant as well when we contract with some of the larger Medicare Advantage plans? Are they going to kind of force a cap of four doses per script on the Medicare Advantage size when that's contracted? Maybe just kind of help us with our long-term expectations around doses per script.
spk08: So it's still higher than we anticipated. I do think change might have had a little impact on it because if they were going to get a script through, they were going to make sure, you know, it was a six or a seven. We do think with plans that plans will bring that back down. Our contract with United on their commercial formula is a script of four. We think as more and more plans adopt it, that that will help moderate it. But it's important to note, we're still seeing about 75% of our business be the pre-acute, the pre-admission patient. And we just know those doses are gonna be fives and sixes. So I think that combination of things But I do think it will come back down. Is it going to come all the way back down to four? We don't think so anymore. I think we're thinking it moderates in the five area.
spk04: Got it. And you kind of mentioned on Kaiser's protocols around how they're using furosics. Can you kind of give us a look into there on how an IDN like Kaiser could be utilizing your product? Is it largely on the front end, pre-acute? Is it post-acute after? you know, just to prevent readmissions, like where are they really leaning into furosics and kind of talk about their experience thus far that you've heard?
spk11: So this is Steve.
spk10: Their experience, what they're doing is a little different than what we've seen in the preventing admission. Their hospitalists, their home care staff, they're prescribing furosics post-discharge. pretty regularly to prevent that readmission. That's their first use case of it. We know that will expand to pre-admission to save on an unnecessary hospitalization, but they are a little different than what we see. They're their own animal, and they always They always think a little differently than everybody else. So that is a nuanced difference, but we expect it to be used in both cases over the long haul.
spk11: Got it. Thanks for taking the questions, guys. Thanks, Chase.
spk06: Ladies and gentlemen, a reminder to please press star 1 if you have any questions. Next will be Naz Rahman at Maxine Kapp Group. Please go ahead.
spk09: Hi, everyone. Congrats on the progress. Just a couple. On the upcoming class 4 and also CKD potential launches, could you comment on what you think the number of doses might be for those indications?
spk10: Steve, you want to? I would say for class 4, they are a little bit sicker. They are more severe. They tend to have excess fluid. more often and more times a year where they lose control a little bit. So I don't think the script says we'll moderate down for the class four patients specifically. It could be in that six range or maybe they'll get refills more often than a standard patient. For CKD, our market research tells us it's about the same as heart failure. It'll be in that four to five range unless they're thicker with chronic kidney disease and have more fluid. And then it might be similar to a class four in heart failure.
spk09: Got it. Thanks. That was helpful. And my last question is on, you mentioned that an increasing number of providers are writing scripts in anticipation of future needs. Do you have an idea of what percentage of the scripts providers are writing that are for potential future needs?
spk11: It's sometimes hard to tell.
spk08: You can look at the expedited ones because those are definitely needed. But I think it's 20% or so that they kind of put on layaway.
spk11: Got it. Thanks. Thank you for my question. Thanks.
spk07: Next is Douglas Sal at HCC Wainwright. Please go ahead.
spk01: Hi, good afternoon. Thanks for taking the questions. John, maybe as a follow-up, I guess, in terms of the physicians who are prescribing in advance, can you maybe just help us understand how far in advance that is? And maybe what's the sort of process between them or sort of the value of writing the script? I mean, I guess, is it just pre-adjudicated and then it sort of ships when they tell you to ship it?
spk08: Hey, Doug, it's John. Yes, we filled one from January, September I saw last week that was put on layaway. The doctor checked to make sure, you know, that everything cleared and understood what the copay was. And as soon as the patient ran into trouble, the doc was ready to send it to the patient. Steve, do you want to talk?
spk10: Yeah, I think that's certainly an example. These prescriptions aren't gone. They're not lost. They're not canceled. Every week we see prescriptions getting filled from months ago. But the most common utilization is the doctor sees a patient. They have some excess fluid. They have symptoms. Maybe it's early. They order fluorosics because they think they might need it. The patient progresses. They do the normal standard of care a little bit. If that doesn't work, they immediately call down Thorosic. So sometimes these layaway scripts are only a matter of days. Other times, you know what? I know we have a group of frequent flyers. Let's just send in a few prescriptions, get those approved. Let's get the known copay. Let's get it all ready to go. And when we see them, if they're in trouble, we'll just call it down. So it's good housekeeping for them in some cases in terms of fluid management. Other cases, they just want to see if the patient resolves under standard of care, and then in some cases it is filled, you know, more remotely from when it was prescribed.
spk11: Okay, great. All over, I should say.
spk01: Highly variable. And then a follow-up. I mean, it sounds like you sort of navigated the change healthcare disruption well. I'm just curious if you have a sense of, you know, how many scripts you ultimately lost, or was it just a matter that most of them ultimately just fell out of the first quarter and maybe were filled in Q2?
spk08: No, I think, I don't think they were filled in Q2. I think we, you know, we said about 10% of units, if you look at units, that if you looked at what we were filling and it was about 10, we think it's about 10%. When we looked at what was coming in, That should have been going out that wasn't going out. It was higher than that. We recovered and some of them did ship later in March. So we recovered some of them. It was, I was worried it was going to be closer to 20 or 25% because it was just shut down. I think we recovered most of it. So we think we lost about six or $700,000 in there.
spk11: Okay, great. Thank you so much.
spk07: Thank you.
spk06: At this time, I would like to turn the call back over to Mr. John Tucker.
spk08: Thank you. Okay, that concludes our call this afternoon. We are very pleased with our first quarter results, which we generated nonwithstanding the headwinds of the change healthcare cyber attack and the annual resetting of out-of-pocket patient deductibles. We expect this momentum to continue as more treating physicians gain comfort prescribing furosix to their heart failure patients and as we make incremental progress with payer formulas. At the same time, we are excited about our lifecycle initiatives, having had productive discussions with the FDA and look forward to providing more updates as we progress through 2024. I look forward to a successful year and requiring our next quarterly update in August. Thank you again and have a good evening.
spk06: Thank you, sir. Ladies and gentlemen, this does indeed conclude the conference call for today. Once again, thank you for attending. And at this time, we do ask that you please disconnect your lines.
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