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spk11: Welcome to the SC Pharmaceuticals Second Quarter 2023 Earnings Conference Call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the Start key followed by 0. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press Start then 1 on a touchtone phone. To withdraw your question, please press Start then 2. Please note, this event is being recorded. I would now like to turn the conference over to P.J. Callagher of LifeSci Advisors. Please go ahead.
spk04: 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 or forward-looking statements within the meaning of the federal securities laws, including but not limited to statements regarding SC Pharmaceuticals expected future financial results, and management's expectations and plans for the business and for O6. 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. It may involve and are subject to certain risks and uncertainties and other important factors that may affect SC Pharmaceutical's business, financial condition, and other operating results. These include, but are not limited to, the risk factors and other qualifications contained in SC Pharmaceutical's annual report on Form 10-K, quarterly reports on Form 10-Q, and other reports filed by the company with the SEC to which your attention is directed. Actual outcomes and results may differ materially from what is expressed or implied by these forward-looking statements. Any forward-looking statements made in this conference call, including responses to your questions, are based on current expectations as of today. And SC Pharmaceuticals expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law. It is now my pleasure to turn the call over to Mr. John Tucker, Chief Executive Officer of SC Pharmaceuticals. John?
spk08: Thank you, PJ, and thanks to everyone listening to this afternoon's call and webcast. This afternoon, I am pleased to provide an operational update before turning the call over to Steve Parsons, our Senior Vice President of Commercial, for a more detailed update on the 406 launch, and then Rachel Noakes, our Chief Financial Officer, for a review of our financials. We'll then open the call for your questions. The second quarter of 2023 represents our first full quarter of 406 commercial availability as we launched the product in late February. And while it is still early, the key indicators underlying demand including unique prescribers, total prescriptions written, and in-services completed by our field sales force, continue to reflect a positive trend. 4.06 is being well-received in the market, and treating physicians are quickly gaining comfort prescribing it to their heart failure patients who can benefit from it, thereby avoiding hospital admissions and readmissions that are costly to the system and inconvenient to patients. For the second quarter, we reported net revenue of $1.6 million. This despite the inventory normalizing at our specialty pharmacy partners from 17 weeks at the start of Q2 to approximately five weeks at the end of Q2. In addition, July was our best sales month launched to date, and our two main specialty pharmacy partners have already placed orders early in Q3. In terms of our gross and net discount from launch through the end of Q2, it is running at approximately 23%, which is well below the 35% long-term guidance that we guided to previously. We do anticipate that GTM will continue to increase over time as contracting with payers evolves. Steve will provide a detailed commercial update shortly, but in response to these positive demand trends, we continue to evaluate our field sales force and territories To ensure that for 06 is broadly accessible to heart failure patients, and they're treating physicians to that end. We add an additional 10 sales territories towards the end of the 2nd quarter. This brings our current field sales force to 54 territories and we anticipate seeing the positive impact of these additions beginning this quarter. In addition, based on the interest we have seen for forensics, we have identified the next tranche of territories, and we are actively recruiting to fill these positions by the end of this quarter. We anticipate seeing contributions from these latest additions in Q4. Shifting now to payers, we continue to have productive discussions with commercial, Medicare Part D, and Medicaid payers in a continuing effort to make furosics broadly available to patients at the most favorable terms possible. This involves not only securing initial coverage of furosics, but also working to have it placed on a formulary tier that would be affordable to most patients and not on the specialty tier. Reflecting our continued progress, recall that a Top 5 National Health Plan placed Ferocix on a preferred formulary status across all of its commercial plans effective June 1st. We remain in discussions with this plan regarding its Part D plans with the goal of securing similarly favorable formulary placement for its Medicare beneficiaries. In addition, we obtained national Medicaid coverage of Ferocix effective July 1, 2023. As mentioned, we are engaged with many other health plans, and we hope to have several more announcements like these in the months to come. We previously indicated that approximately 60% of all heart failure patients can access Ferocix under fixed-year copays of $100 or less, and we are reiterating our goal of 75% or more over time. We are making good progress towards this goal. The market opportunity for Ferocix is significant. And we believe it is worth reiterating. In the U.S. alone, there are estimated to be 6.7 million adults suffering from heart failure, resulting in 4 million heart failure events annually. Of those, we believe 2.1 million episodes can be effectively addressed by furosics. If we assume $3,300 per episode, which is four doses of furosics, we have the potential to access a market opportunity that is nearly $7 billion. And again, this is in the U.S. alone. There are a total of 15.8 million adults suffering from heart failure if we include the other G7 countries. At this early stage, we are seeing a wide range of doses of furosix per prescription, from 2 to 12, as this is at the discretion of the treating physicians, and some patients require more aggressive interventions than others. During the second quarter, we reported just over 5.2 doses per prescription. But we continue to believe that this number will trend towards four doses per prescription over time. Staying on the topic of market opportunity for a moment, just recently we received positive type C meeting feedback from the FDA regarding the potential expansion of the Ferosex syndication to include New York Heart Association Class IV heart failure patients in addition to Class II and III for which Ferosex is currently indicated. It is estimated that as many as 10% of all heart failure patients are considered class for, and of these, we estimated that as many as 40% may benefit from for us. So, if we are successful class for representing meaningful expansion of our market opportunity, when able to be prescribed to the sickest heart failure patients. And based upon the feedback that we received from the agency, we believe we can file for the class for indication without the need to conduct any additional studies. We plan to do so by the end of the year. Turning now to IP, I want to cover a key development with respect to our intellectual property estate. We recently announced the issuance of key U.S. patents covering the development of more concentrated formulations of furosemide. This enables the possibility of dosing flexibility of subcutaneous furosemide. We have completed initial solubility and stability studies on multiple formulations described in the patent properties. We've identified potential product candidates, and we have initiated IND-enabling studies. We also have patent applications pending that cover similar formulations for verosimide for the treatment of congestions in patients with heart failure and also edema in patients with chronic kidney disease. an entirely new potential indication that also represents a significant market opportunity for our company. Taken together, this additional IP is foundational to our Ferosix lifecycle management strategy. We are also pursuing similar patent protections outside of the United States. Before turning the call over to Steve, I want to provide an update on our key performance indicators and our plans moving forward. We anticipate signing direct purchase agreements with several integrated health systems Berosix will be shipped directly from our 3PL, Cardinal Health, to these IDN facilities, bypassing our three specialty pharmacies. As a result, those units that are shipped direct will not be captured in our prescription counts, which will no longer reflect all of the underlying demand. So we are reassessing the KPIs that we intend to provide going forward. We'll have a further update when we report our third quarter results in November. Finally, we were very pleased in June to announce that we've been added to the Russell 2000 index. Inclusion in its widely followed index will help raise visibility of our company and the key unmet need that Ferosix addresses along the heart failure care continuum. It was a reflection of the significant progress that we've made over the past 12 months, which resulted from tireless work on behalf of the entire team. At this point, I'll turn the call over our Senior Vice President of Commercials, Steve Parsons, for a deeper dive into our launch metrics. Steve?
spk02: Thank you, John. As John indicated, the second quarter was our first full quarter of Furosic's commercial availability, and we continue to be pleased with our progress. I will start with an update on our commercial team. We have said previously that we stand ready to add additional territories as demand patterns for Furosic's continue to emerge, As John indicated, toward the end of the second quarter, we added 10 territories, bringing our total field force as of today to 54 territories. It is important to note that the territories we added during Q2 were added towards the end of the quarter and, as such, will not contribute meaningfully until Q3, when the additional sales reps have been fully trained and are conducting face-to-face in-services at hospitals, doctor's offices, and heart failure clinics. As John mentioned earlier, we have identified additional territories. We are in the process of recruiting for those positions. We anticipate contributions from these additional territories beginning in the fourth quarter. Our sales force has conducted 1,129 in-services as of June 30th compared to 518 as of March 31st. In-services provide healthcare providers with training and prescribing instructions for furosics that is designed to ensure office readiness. Demo kits to train patients are provided at the completion of each in-service. Our focus on the in-service is crucial to ensuring effective use and training on furosics. The results continue to be encouraging. From launch through June 30th, we've had 631 unique prescribers, which is up from 194 through March 31st. For the second quarter ended June 30th, we had 1,163 total prescriptions written. Of those, 604 prescriptions were filled and an additional 279 were pending. For the prescriptions that were still pending at the end of Q2, there's a portion that were still in process with the payers and another portion that were approved and queued waiting for direction from the prescriber on when to contact the patient. We continue to move pending prescriptions into the filled category with each day. For prescriptions that have been canceled, the reasons vary, ranging from the patient being unreachable, hospitalized or deceased prior to receiving furosix and in some other cases cases the patient copay was too high looking ahead we would anticipate that the difference between prescriptions written and prescriptions filled will narrow as furosix is better positioned on more health plan formularies providing quicker access for the patients and lower patient out-of-pocket expense During the second quarter, the average number of doses per prescriptions was 5.21, which is running higher than our expectation. We continue to believe four doses per prescription to be the right number long term. In terms of distribution, we continue to be pleased with the functioning of our distribution process thus far through our strategic partnership with Cardinal Health as our third-party logistics provider. Cardinal is working well with our three specialty pharmacy partners, including our main specialty pharmacy, Biomatrix. From a marketing perspective, we are engaged in broad multi-channel market awareness 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 appearances, print, and electronic collateral, and the development of both provider and patient websites, among other critical tasks. Overall, although we still have a lot of work to do, we are pleased with the continued progress and the trajectory that we are on. That concludes my update. I would now like to turn the call over to our Chief Financial Officer, Rachel Noakes, for a financial update. Rachel?
spk01: Thank you, Steve. We generated net product revenue of $1.6 million during the second quarter of 2023, and the cost of revenue was $0.4 million, yielding a gross profit of $1.2 million. Research and development expenses were $2.9 million for the second quarter of 2023 compared to $5.1 million for the comparable period in 2022. Decrease in research and development expenses for the quarter was primarily due to a decrease in clinical study and medical affairs costs, pharmaceutical development costs, and employee-related costs. Selling general and administrative expenses were $12.1 million for the second quarter of 2023, compared to $4.3 million for the second quarter of 2022. The increase in selling general and administrative expenses for the quarter was primarily due to an increase in employee-related costs commercial costs, and legal and professional service costs. We reported a net loss of $14.2 million for the second quarter of 2023, compared to a net loss of $9.7 million for the comparable period in 2022. As of June 30, 2023, we held $102.9 million in cash, cash equivalents, and short-term investments, compared to $118.4 million as of December 31, 2022. As of June 30, 2023, SE Pharmaceutical's total shares outstanding was $35,849,482. That concludes the financial update. John? Thanks, Rachel. This concludes our prepared remarks. At this point, we will open the call for questions. Thank you.
spk11: We'll now begin the question and answer session. To ask a question, you may press star then one on your touchtone phone. If you're using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star then two. Our first question comes from Glenn Santangelo with Jefferies. Please go ahead.
spk05: Thanks for the details and taking my question. Hey, John, I just want to follow up on something you said in your prepared remarks around July, because if we're sort of looking at the 2Q sort of total script written and filled numbers and, you know, reconciling that with your last communication, which I think was sort of in early June, it looks like, you know, June maybe took a modest step down from, I'm sorry, yeah, June took a modest step down from sort of where we were in May, but In your prepared remarks, you said July was the best month yet. And so I'm just kind of curious if you can give us a little bit more color about how things sort of trended from month to month and if we should really be reading anything into that or maybe it's still too early to matter, the month-to-month volatility. But any comments there would be helpful.
spk08: Sure. Thanks, Glass, John. Yeah, you know, launches are unpredictable, lumpy, and again, it's still early. You know, we had a huge run-up from May to June, from April to May, if you remember, over 55 percent. So, we did see demand higher in June than May. We saw a lot of that come in at the end of the month, at the end of the quarter. A lot of those scripts were then filled in in July. And so, as I said, in my remarks, July is, you know, we're off to a good start in Q3 and in July has been our what was our best month. But a lot of scripts in June came in last week of June were queued. But June demand was actually up quite a bit over May. The scripts just ended up getting a lot of them getting filled in July.
spk05: Yeah, and maybe as a follow-up to that, I mean, if you look at, you know, 1,163 scripts written across 631 unique prescribers, right, that's, you know, call it two scripts per provider. I mean, I know it obviously doesn't work out that way, but you're seeing a pretty broad number of unique prescribers. Or could you maybe talk about where you are in your in-servicing initiatives? Are you pretty much done? I thought the plan was to be relatively short. done with that about this time, but now you're adding sort of more territories. Like, how should we think about the physician education piece, where we are in that process, and what we should be expecting in the third quarter?
spk08: John, again, I'll turn it over to Steve, and Matt, let me comment first. You're absolutely correct. When we add new territories, those are virgin territories, so we need to do in-services just like at the beginning. So you're going to continue to see in-services moving forward. We've learned the in-services are absolutely vital to what we're doing, but the second and the third call are just as important to make this part of their practice. So we're still working on two things, expanding the number of writers, but making sure those writers that have written you know, adopted into their practice. And that just takes time and calls. I mean, a lot of times we'll walk in, oh, yeah, I use that in a patient. They did really, really great. I forgot. Thanks for reminding me. I'm going to, you know, and we've got to keep doing that. As we said, you know, last month or two months ago, the product's doing great. I mean, the docs that have used it have had great results. The patients have had great results. It's just getting it into their practice, getting it into their routine. And the unique prescribers is interesting because in a lot of offices, there might be five or six doctors, but one nurse practitioner that does the writing. So our goal is, as we continue to add territories, continue to do in-services, expand the writer base, but also make sure that we're getting back in there continuously, reminding them, maybe re-inservice them again to make sure that they're adopting it into their practice. Steve, do you want to add anything to that?
spk02: No, that captures it well. We'll continue to do inservices. You know, we don't count an inservice if we do a second one at the same location, Glenn. These are all unique locations when you see the number. If we have to do another one, to reach, you know, more providers, then, you know, we won't count that. But if they ask us to go to a satellite location or if we open new accounts, even in our existing territories, we're going to go back to the basics, the fundamentals, and do it the proper way. So we'll always be doing inservices, you know, not nearly at the clip that we were to launch, but they'll always be a part of our execution.
spk05: Okay. Thanks for the comments.
spk02: Thanks, Glenn.
spk11: Our next question comes from Rowana Ruiz with Learing Partners. Please go ahead.
spk06: Hi, good afternoon, everyone. This is Nick Jasik on for Rowana Ruiz. Thanks for taking our question. Maybe a quick one for John. I think in your prepared remarks, you mentioned direct purchase agreements. I'm just curious, what would the approximate contribution look like from these agreements? How do you expect this to evolve over time? And I guess, you know, what sort of demand are you seeing from this channel right now? And, you know, what sort of impact could this have on your overall gross to net going forward?
spk08: There's a lot there, Nick, but let me try it. So I'll start with the end. The gross to net, you know, it depends on the discount we offer on those IDNs.
spk00: You know, we've
spk08: always thought the IDN is where the value proposition is the strongest, right? If you think about it, they kind of own that patient and putting them on furosics and avoiding the hospitalization flows to the bottom line. So we've all always thought that the IDNs are a key part of our focus. We've had doctors that are affiliated with the IDNs write scripts now, but what we're, you know, we feel really confident it's going to happen this quarter is these agreements will end up having the product directly shipped to the IDNs the hospitals within the IDNs, the pharmacies within the IDNs, and we're working on guideline structure there where it's really part of the treatment algorithm. So it's hard to say what the impact, and we've always thought that we'd have this business, so I don't think it's extra business on top of what we forecast internally. But it's coming in line maybe a little longer. These things are very complicated to work. It's not like walking into a cardiologist's office, detailing them and having them write. There's a number of people you got to work at IDN, starting at cardiology to purchasing to pharmacy. And so we've been doing that work. We think they're coming online and we think they'll... It's not in our sales now, obviously, but they'll be, you know, hopefully coming online this quarter. On the GTN, I don't think, you know, we have the 23% GTN. We've said it's going to go up. We still think it will. These will be part of that as these come online. But we're going to stay disciplined online. on our rebating strategy. We've stayed disciplined. Sometimes it's a little painful when you're seeing high copays because we're not giving those gigantic rebates. But we think the plan long-term works where we're showing the value of the product, We're showing the utilization going through these plans and they're PA in it and that costs them money and then they're dispensing it and they're not getting rebates. So we will stay disciplined like that with the IDN. I do think from where we are in talking to the major ones that they'll come in under what our rebate, the maximum rebates we were thinking would be. So we feel it'll contribute and won't really impact the GTN.
spk06: Helpful. Thanks, John. And then maybe a quick question on inventory. I think you mentioned you're down to five weeks by the end of the quarter. I'm just wondering how you expect those inventory dynamics to play out towards the end of the year, 2024.
spk08: Yeah. So, thanks, Nick. Yeah. So, as I said, we kind of normalized it down to five weeks. We think we're going to stay around here. You know, anytime you're in a launch, it's just unpredictable from day to day, week to week. So, they tend to keep a little bit more inventory early in a launch like right now. Eventually, you know, they'll probably get down to the maybe by the end of the year or early next year to the two to three week. But it's hard. You know, it's up to them. You know, we obviously stay in contact with them. But we've got a number of different locations. And with minimum order requirements, they can be sitting, you know, at any time with a lot or a little inventory. But we do think that that five-week kind of normalizes, maybe works down another week or two through the end of the year. But I think that's probably where it stays.
spk10: I'll hop back in the queue. Thanks, John. Great. Thanks.
spk11: Next question comes from Stacy with . Please go ahead.
spk00: Thanks so much for taking our questions and congrats on the quarter. So, we have a few. First, the clinician feedback from these heart failure specialists have been very positive in our checks. So, what are you seeing in terms of adoption patterns for practices that maybe weren't involved in the clinical trials? maybe from more community settings. So where are we in terms of the broader awareness of Ferozex? So that's the first question. And then just some follow up on some of the metrics you provided. Thanks so much for the details. Given your improvements in payer coverage, are you willing to provide any expectation or guidance for the expected kind of fulfillment rate that we're going to see by year end? And then last, if you're willing to provide some other, would you be able to talk about maybe Those within those adopting clinicians, maybe what you're seeing in terms of the average number of prescriptions, any anecdotal feedback would be helpful there. Thanks so much.
spk08: I'll try a couple of those mentor over Steve. So, on the fulfillment rate, we didn't have, we only had the. you know, the big commercial payer on June 1st. So I think that's continued to impact the fulfillment rate. And Medicaid came online July 1, which is not reflective in this fulfillment rate at all. So we have seen the fulfillment rate tick up since June 30th. We think it will continue to do so as we move forward as payers come online. And it's a couple of things in fulfillment rates. It's also, as Steve spoke to, doctors filling out the start form, right? You know, if we have to go back to them two or three times or they're delayed, you know, some of those patients end up being hospitalized and we lose the patient. So the fulfillment rate will increase. will really be dictated by how things go with the payers, both in getting co-pays down, we've talked a lot about that, as well as improving fill time so we don't have that lag where the patient could end up being hospitalized. and also with doctors and with us. We've got to continue to work with our doctors' offices to make sure that they know exactly what the plan is going to need for them to fill the script. But we have seen the fulfillment rate start ticking up, and we think as payers come online and education continues, that that will continue. Steve, do you want to talk a little bit about the engagement at the docs, the operator specialists?
spk02: Yeah, so most of the people that we are engaging with now weren't part of any early utilization. They weren't part of the trials as you described it. Those were early adopters in the March timeframe. Now it's regular docs. It's people who are dealing with this problem of patients with too much fluid and feeling badly and asking for some extra help. And so The adoption is broadened. You know, we're in academic places. We're in private practices. We're in communities. It's really across the board. And I think you asked about the average number of prescriptions per prescriber. Hard to say that. You know, you can do simple math and look at 1163 and divide it by unique prescribers. You know, there are some doctors who've only done one so far. You know, they started later in June. There's others that have done multiple, multiple prescriptions. So, you know, I don't think you can characterize it as, like, everybody averages two. It's across the board. And then within an office, you know, sometimes they all funnel to, you know, one or many prescribers. So, yeah. Not really sure how to precisely answer that question, but that's what we're seeing.
spk01: Okay, thank you.
spk10: Thanks, Stacy.
spk11: Our next question comes from Doug Tsao with HEC Wainwright. Please go ahead.
spk03: Hi, good afternoon. Thanks for taking the questions. I'm curious, John, what's the average rate uh fulfillment time right now that you're um currently experiencing from when a script is written to when it's being shipped yeah this is steve i'll take that i'm closer to uh you know the day-to-day reports um
spk02: And, you know, I'm not evading. It's a very difficult thing. I think you've heard, you know, some doctors, you know, want it right away. They mark off expedited 24-hour review on the form they submit, and we get those out pretty quickly. Then there's other doctors who, you know, submit in advance. They want an answer. You know, they want to know, is this going to be covered? What's the copay going to be? And, you know, it gets approved, and we put it in a queue. It's really all over the place. We do have prescriptions that are very old that eventually get filled. And then we have prescriptions that come in and go back out the same day. So to have like an average wouldn't really do you justice because of all the, you know, the variability in how the offices want to use the product.
spk08: I think if you look at a median, Doug, it's probably better than a mean on this because as Steve said, like, we filled scripts from March last week, right? Just were queued up and the patient got in trouble and the doc said, send it, right? But if you look at kind of a median, you're probably looking at, and it depends, you know, on Friday, obviously, it's not going to ship probably until Monday or Tuesday. But it's probably about two days, two and a half days on median. You know, but again, there's a lot of them that either the payer is requiring information from the doc or or it's queued, and it could go a month later. So we're looking at it. We have scripts that Steve said go out the same day. We have a specialty pharmacy that does courier service and big MSAs, and those scripts get written in the morning, get cleared, and go that afternoon. That's you know, again, it has to be within an MSA and the plan has to approve it quickly, but that happens as well. So it's kind of all over the board. It's really hard to look at that other than, you know, looking at what's it, because when we really can't see if it's cued or not in how we read it. So I wish we had a more precise answer, but that's where we are.
spk03: And I'm curious, John, what proportion of the scripts that are being written are you know, sort of being requested to be sort of on an expedited basis. And I think you said, like, if a script is written on a Friday, it probably is not going to go out until, you know, Monday or Tuesday. I mean, ultimately, given the nature of the product, will you be able to sort of provide seven-day-a-week coverage? Yeah. Steve, you want to?
spk02: Yeah, so, I mean, we have a program if the doctor really, really needs the patient to have it over the weekend. We have what's called a quick start program. So we ship something on Saturday morning. You know, whether the payer has processed it quickly enough or not, we'll ship them product to get them through the weekend. We do that one time for a patient because after that, there's usually a prior off that's been approved and things can go quickly the second time they need it. It's really only that first time you're using it that there's any, you know, potential delay. And any doctor, really, who needs it the next day, we have a quick start program. It's one dose, but it gets them through that day and gets them, you know.
spk08: And the docs have samples as well for those patients. So between the quick start and the sample for an expedited doctor, we've covered that gap.
spk10: Okay. Great. Thank you so much. Thanks, Doug.
spk11: Our next question comes from Naz Rahman with Maxine Group. Please go ahead.
spk09: Hi, everyone. Congrats on the progress so far. I just have a few questions regarding your positive type C meeting. First of all, could you kind of give us more color on what's the difference between the class three and class four patients? And also, why do you think cirrhosis is only applicable in about 40% of those patients instead of, let's say, a larger percentage of those class four patients? And finally, in those class four patients, how many doses of Ferrosix do you think those patients will need compared to what you currently think is like four for the class two and three?
spk08: So I'm going to have John answer some of that question. But I think that on the 40%, that's just kind of our estimate on a market share, not really how many of them are qualified for it. You know, some of them we know are going to be, you know, in acute pulmonary edema and have to go to the hospital. But we think a large majority of them will need treatment and cirrhosis is appropriate for them. As far as dosing, you're right. We would think that they would probably need more doses, but that will be governed a bit by managed care. If they put quality limits on, let's say quantity limits, let's say it's a script for four, but they'll have to get another script for four the next week or two weeks later. But we do think that's probably – those are probably higher utilization patients per month than the twos or threes. John, do you want to get a little bit of light on the meeting with the FDA?
spk07: Yeah, sure. So the big difference between New York Heart Association classifications all the way to one through four really is based upon the amount of exercise in which a patient can tolerate. And as you go to class four, the amount of exercise with certain degrees of exertion becomes less, less tolerated. So the problem with New York Heart Association classification, it's great for clinical trials when you have a specific way in which to measure that. But as you get into clinical practice, it becomes so subjective about how this is done. And this was really the basis of the discussion back and forth with the FDA about why, despite that we included mainly class two and three patients in our clinical trials, that they agreed that we would be able to expand into class four as the pharmacokinetics between IV and subcutaneous is not expected to be different amongst that population. That was the data and the argument which we made to the agency. But to answer your question directly, it's all based upon how much exercise a person can tolerate. Got it. Thanks.
spk09: And I guess one last question on this is, in regards to the filing, the S&DA filing, is this something you would expect a six-month review cycle for, or are you expecting a one-year review for this?
spk08: So we would not expect a one-year review. You know, I think there's a couple different avenues here. Probably six months, we think there might be a way to shorten that. Again, we're not putting in any clinical data at all. It's really just, you know, some of the device documentation. I'm not trivializing how long that takes to do, but it's a pretty straightforward review. So we wouldn't think it's like a full 10-month review or anything like that.
spk10: Got it.
spk09: Thanks for taking my questions.
spk11: There are no further questions at this time, so this concludes our question and answer session. I would like to turn the conference back over to John Tucker for any closing remarks.
spk08: Thank you. That concludes our call this afternoon. We hope you take away from this call that we are very pleased with our progress to date. And as we continue to execute on our commercial plan, we anticipate continued growth in the percentage of heart failure patients who have affordable access to Ferocix, which we believe will translate into a nice trajectory for both prescriptions and revenue. We look forward to providing more information during our third quarter update in November. Thank you and have a great evening.
spk11: The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.
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