scPharmaceuticals Q2 2023 Earnings Call Transcript

Quartr
Provided by Quartr
August 10, 2023

There are 12 speakers on the call.

Operator

Good day, and welcome to the SC Pharmaceuticals Second Quarter 2023 Earnings Conference Call. All participants will be in listen only mode. After today's presentation, there will be an opportunity to ask Please note this event is being recorded. I would now like to turn the conference over to DJ Kelleher of LifeSci Advisors, please go ahead.

Speaker 1

Thank you, operator. Before turning the call over to management, I would like to make the following remarks concerning forward looking statements. All statements on this conference call other than historical facts are forward looking statements within the meaning of the federal securities laws, including, but not limited to, statements regarding SC Pharmaceuticals' expected future financial results and management's expectations and plans for the business in Ferosix. The words anticipate, believe, estimate, expect, intend, guidance, confidence, Target, project and other similar expressions are typically 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 Pharmaceuticals' business, financial condition and other operating results.

Speaker 1

These include, but are not limited to, the risk factors and other qualifications contained in SC 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. NSC 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.

Speaker 1

John Tucker, Chief Executive Officer of SC Pharmaceuticals. John?

Speaker 2

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 will then open the call for your questions. The Q2 of 2023 represents our 1st full quarter of Ferrosix 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.

Speaker 2

406 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 Q2, we reported net revenue of $1,600,000 This despite the inventory Normalizing at our specialty pharmacy partners from 17 weeks at the start of Q2 to approximately 5 weeks at the end of Q2. In addition, July was our best sales month launch to date and our 2 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 GTN will continue to increase over time as contracting with payers evolves.

Speaker 2

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 Pharosix is broadly accessible to heart failure patients and their treating physicians. To that end, we added an additional 10 sales territories towards the end of the second 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 Ferosix, we have identified the next tranche of territories and we are recruiting to fill these positions by the end of this quarter.

Speaker 2

We anticipate seeing contributions from these latest additions in Q4. Shifting now to payers. We continue to have protective discussions with commercial, Medicare Part D and Medicaid payers In a continuing effort to make Pharosix broadly available to patients at the most favorable terms possible, This involved not only securing initial coverage of Pharosix, but also working to have it placed on a formulary tier that will be affordable to most patients and not on the specialty tier. Reflecting our continued progress, recall that a top 5 national health plan placed Pharosix on preferred formulary status across all of its commercial plans effective June 1. 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.

Speaker 2

In addition, we obtained national Medicaid coverage of Pharosix 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 Pharosix under fixed care co pays 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 Pharosys is significant and we believe it is worth reiterating.

Speaker 2

In the U. S. Alone, there are estimated to be 6,700,000 adults suffering from heart failure, resulting in 4,000,000 heart failure events annually. Of those, we believe 2,100,000 can be effectively addressed by Pharosix. If we assume $3,300 per episode, which is 4 doses of Pharosix, We have the potential to access a market opportunity that is nearly $7,000,000,000 And again, this is in the U.

Speaker 2

S. Alone. There are a total of 15,800,000 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 Ferrosix per prescription from 2 to 12. As this is at During the Q2, we reported just over 5.2 doses per prescription, but we continue to believe that this number will trend towards 4 doses per prescription over time.

Speaker 2

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 The Pharosix indication to include New York Heart Association Class 4 heart failure patients in addition to Class 2 and 3 For Rich, Pharosix is currently indicated. It is estimated that as many as 10% of all heart failure patients are considered Class 4. And of these, we estimated That as many as 40% may benefit from Pharosix. So if we are successful, Class IV represent a meaningful expansion of our market opportunity We're unable for ROACE 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 IV indication without the need to conduct any additional studies.

Speaker 2

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 Key U. S.

Speaker 2

Patents cover 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 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.

Speaker 2

Taken together, this additional IP is foundational to our Pharosix lifecycle management strategy. We are also pursuing similar patent Before I turn 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. Vero six will be shipped directly from our 3PL, Cardinal Health, to these IDN facilities bypassing our 3 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.

Speaker 2

So we are reassessing the KPIs that we intend to provide going forward. We'll have a further update when we report our Q3 results in November. Finally, we were very pleased in June to announce that we've been added The Russell 2000 Index. Inclusion in its widely followed index will help raise visibility of our company and the key unmet need that Ferrosix addresses along the heart failure care continuum. It is 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.

Speaker 2

At this point, I'll turn the call over to our Senior Vice President of Commercial, Steve Parsons for a deeper dive into our launch metrics. Steve?

Speaker 3

Thank you, John. As John indicated, the 2nd quarter was our first Full quarter of SPHEROSMIC'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 Furosics 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.

Speaker 3

It's 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, doctors' 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 Q4. Our sales force has conducted 119 in services as of June 30 compared to 518 As of March 31, in services provide healthcare providers with training and prescribing instructions for cirrhosis that is designed to ensure office readiness. Demo kits to train patients are provided at the completion of each in service.

Speaker 3

Our focus on the in service is crucial to ensuring effective use and training on PRIOROSIX. The results continue to be encouraging. From launch through June 30, we've had 631 unique prescribers, which is up from 194 through March 31. For the 2nd quarter ended June 30, we at 11.63 total prescriptions written. Of those, 604 prescriptions were filled an additional 279 were pending.

Speaker 3

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 or hospitalized or deceased prior to receiving cirrhosis. And in some other cases, the patient co pay was too high. Looking ahead, we would anticipate that the difference between prescriptions written And prescriptions filled will narrow as furosics is better positioned on more health plan formularies, providing quicker access for the patients and lower patient out of pocket expense.

Speaker 3

During the Q2, the average number of doses per prescriptions was 5.21, which is running higher than our expectation. We continue to believe 4 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 3rd party logistics provider. Cardinal is working well with our 3 specialty pharmacy partners, including our main specialty pharmacy, Biometrics. From a marketing perspective, we are engaged in broad multichannel Market awareness campaign to drive brand awareness, adoption and commitment.

Speaker 3

This program encompasses many different activities, 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?

Speaker 4

Thank you, Steve. We generated net product revenue of $1,600,000 during the Q2 of 2023 And the cost of revenue was $400,000 yielding a gross profit of $1,200,000 Research and development expenses were $2,900,000 for the Q2 of 2023 compared to $5,100,000 for the comparable period in 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 $12,100,000 for the Q2 2023 compared to $4,300,000 for the Q2 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 $14,200,000 for the Q2 of 2023 compared to a net loss of $9,700,000 for the comparable period in 2022.

Speaker 4

As of June 30, 2023, We held $102,900,000 in cash, cash equivalents and short term investments compared to 100 and $14,000,000 as of December 31, 2022. As of June 30, 2023, SC Pharmaceuticals total shares outstanding was 35,849,482. That concludes the financial update. John?

Speaker 2

Thanks, Rachel. This concludes our prepared remarks. At this point, we will open the call for questions.

Operator

Thank you. We'll now begin the question and answer session. Our first question comes from Glenn Santangelo with Jefferies. Please go ahead.

Speaker 5

Yes. Thanks for the details for taking my question. Hey, John, I just wanted 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 reconciling that with your last Communication, which I think was sort of in early June. It looks like June maybe took a modest step down from I'm sorry, yes, 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.

Speaker 5

Yes,

Speaker 2

sure. Thanks, Glass. John. Yes. Launches are unpredictable, lumpy.

Speaker 2

And again, it's still early. We had a Huge run up from May to June, from April to May, if you remember, over 55%. 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 July.

Speaker 2

And so as I said in my remarks, July is we're off to a good start in Q3 and July has been our was our best month, but a lot of scripts in June came in last week of June were cued, 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.

Speaker 5

Yes. And maybe as a follow-up to that, I mean, if you look at 11 63 scripts written across 631 unique prescribers, right? That's call it 2 scripts per provider. I mean, I know it Obviously, it 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?

Speaker 5

I thought the plan was to be relatively Done by that 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 Q3?

Speaker 2

Hey, Glenn. This is John again. I'll turn it over to Steve. And Matt, let me comment You're absolutely correct. When we add new territories, those are virgin territories.

Speaker 2

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. And But the second and the second and the third call are just as important to make this part of their practice. So We're still working on 2 things, expanding the number of writers, but making sure those writers that have written adopted into their And that just takes time and calls.

Speaker 2

I mean, a lot of times we'll walk in, oh, yes, I use that patient. They did really, really great. I forgot. Thanks for reminding me. And we got to keep doing that.

Speaker 2

As we said last month or 2 months ago, the product is doing great. I mean, the docs have used it, have had great results. The patients have had great results. It's just going to 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 5 or 6 doctors, but 1 nurse practitioner that does the writing.

Speaker 2

So our goal is, As we continue to add territories, continue to do in services, expand the rider base, but also make sure that we're getting back in there Continuously reminding them, maybe re in service them again, to make sure that they're adopting it into their practice. Steve, do you want to add anything to that?

Speaker 3

No, that captures it well. We'll continue to do in services. We don't count it in service 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 more providers, then we won't count that. But if they asked 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.

Speaker 3

So we'll always be doing in services Not nearly at the clip that we were to launch, but they'll always be a part of our execution.

Speaker 5

Okay. Thanks for the comments.

Speaker 3

Thanks, Glenn.

Operator

Our next question comes from Roan Ruiz with Leerink Partners. Please go ahead.

Speaker 6

Hi, good afternoon, everyone. This is Nick Gasek on for Ruan or Ruiz. Thanks for taking our questions. Maybe a quick one for John. I think in your prepared remarks, you mentioned direct purchase agreements.

Speaker 6

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 what sort of demand Are you seeing from this channel right now? And what sort of impact could this have on your overall gross to net going forward?

Speaker 2

There's a lot there, Nick. But let me try it. So I'll start with the end. The gross to net, it depends on The discount we offer on those IDNs. We always thought the IDN is where the value proposition is the strongest, right?

Speaker 2

If you think about it, they kind of own that patient And putting them on for 06 and avoiding the hospitalization flows to the bottom line. So we've 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 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.

Speaker 2

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 office detailing and having them right.

Speaker 2

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 hopefully come online this quarter. On the GTN, I don't think we have the 23% GTN. We've said It's going to go up.

Speaker 2

We still think it will. These will be part of that as these come online. But we're going to stay Disciplined on our rebating strategy. We've stayed disciplined. Sometimes it's a little painful when you're seeing high co pays 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 cost them money and then they're dispensing it and they're not getting rebates.

Speaker 2

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 will contribute And it won't really impact the GTN.

Speaker 6

Helpful. Thanks, John. And then maybe, quick question on Inventory, I think you mentioned you're down to 5 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?

Speaker 2

Yes. So thanks, Nick. Yes. So, as I said, we kind of normalized it down to 5 weeks. We think we're going Around here, anytime you're in a launch, it's just unpredictable from day to day, week to week.

Speaker 2

So they tend to keep A little more inventory early in a launch like right now. Eventually, they'll probably get down to the Maybe by the end of the year or early next year to the 2 to 3 week, but it's hard. It's up to them. We obviously stay Contact with them, but we've got a number of different locations and with minimum order requirements, they can be sitting at any time with a lot or a little Inventory, but we do think that that 5 week kind of normalizes, maybe works down another week or 2 through the end of the year. But I think that's probably where it stays.

Speaker 6

Helpful. I'll hop back in the queue. Thanks, John.

Speaker 7

Great. Thanks.

Operator

Next question comes from Stacy Ku with TD Cowen. Please go ahead.

Speaker 8

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 or maybe from more community settings. So where are we In terms of the broader awareness of Pharosix.

Speaker 8

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 Are you willing to provide any expectation or guidance for the expected fulfillment rate that we're going to

Speaker 4

see by year

Speaker 8

end? And then last, if you're willing to provide some other concern there, would you be able to talk about maybe within those adopting clinicians, What you're seeing in terms of the average number of prescriptions, any anecdotal feedback would be helpful there? Thanks so much.

Speaker 2

Okay, I'll cite a couple of those and then turn it over to Steve. So on the fulfillment rate, we didn't have we only had The big commercial payer on June 1. 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 30, we think we'll continue to do so, as we move forward as payers come online.

Speaker 2

And it's a couple of things in fulfillment rates. It's also, as Steve spoke to, doctors filling out the start form, right? If we have to go back to them 2 or 3 times or they're delayed, some of those patients end up being hospitalized and we lose the patients. So the fulfillment rate 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.

Speaker 2

And also with doctors And with us, we 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 will continue. Steve, do you want to talk a little bit about the engagement at the docs, the hepato specialist?

Speaker 3

Yes. 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.

Speaker 3

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. We're in academic places. We're in private practices. We're in communities.

Speaker 3

It's really across the board. And I think you asked about the average number of prescriptions per prescriber. Hard to say that. You can do simple math and look at 1163 and divide it by unique prescribers. But There are some doctors who've only done one so far.

Speaker 3

They started later in June. There's others that have done multiple, multiple prescriptions. I don't think you can characterize it as like everybody averages 2. It's across the board. And then within an office, Sometimes they all funnel to 1 or many prescribers.

Speaker 3

So Not really sure how to precisely answer that question, but that's what we're seeing.

Speaker 8

Okay. Thank you.

Speaker 2

Thanks, Stacy.

Operator

Our next question comes from Doug Zhao with HEC Wainwright. Please go ahead.

Speaker 9

Hi, good afternoon. Thanks for taking my questions. Just I'm curious, John, what's the average fulfillment time right now that you're currently experiencing from when a script is written to when it's being shipped?

Speaker 3

Yes. This is Steve. I'll take that. I'm closer to the day to day reports. And I'm not evading, it's a very difficult thing.

Speaker 3

I think you've heard some doctors want it right away. They mark off expedited 24 hour review On the form that you submit and we get those out pretty quickly. Then there's other doctors who submit in advance. They want an Sir, they want to know is going to be covered, what's the co pay going to be and it gets approved, we put it in a queue. It's really all over the place.

Speaker 3

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 would really do you justice because of all the variability in How the offices want to use the product?

Speaker 2

I think if you look at a mean, Doug, it's probably better than a mean on this Because as Steve said, like we filled scripts from March last week, right? Just we're queued up And the patient got in trouble and the dog said send it, right. But if you look at kind of a median, You're probably looking at and it depends on Friday, obviously, it's going to it's not going to ship probably till Monday or Tuesday, but it's probably about 2 days, 2.5 days on median. But again, there's a lot of them that Either the payer is requiring information from the dock or it's queued And it could go a month later. So it's we're looking at it.

Speaker 2

We have scripts that Steve said go out the same day. We have a specialty pharmacy that does courier service in big MSAs and those scripts get written in the morning, get cleared and go that afternoon. That's again, it has to be within 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 looking at what's it because when we really can't see if it's skewed or not and how We read it. So, I wish we had a more precise answer, but that's where we are.

Speaker 9

And I'm curious, John, what A portion of the scripts that are being written are 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 can't probably is not going to go out until Monday or Tuesday. I mean, ultimately, Given the nature of the product, will you be able to sort of provide 7 day a week coverage?

Speaker 2

Steve, do you want to?

Speaker 3

Yes. So I mean, we have a program if the doctor really needs the patient to have it over the weekend, we have what's The Quick Start program, so we ship something on Saturday morning. 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 auth that's been approved and things can go quickly the second time they need it. It's really only that first You're using it, if there's any potential delay.

Speaker 3

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

Speaker 2

and the docs have samples as well for those patients. So between the quick start And the sample for an expedited doctor, we cover that gap.

Speaker 1

Okay, Great. Thank you so much.

Speaker 2

Thanks, Doug.

Operator

Our next question comes from naz Rahman with Maxim Group. Please go ahead.

Speaker 7

Hi, everyone. Congrats on the progress so far. I just had 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 III and Class IV patients? And also why do you think for us it's only applicable in about 40% of those patients that have let's say a larger percentage of this class for patients?

Speaker 7

And finally, in those class 4 patients, how many doses of PROSIX do you think those patients will need compared to what you currently think is like 4 for the class 2 and 3?

Speaker 2

So I'm going to have John answer some of that question. But I think on the 40%, that's just kind of our estimate on a market share, not really Well, we how many of them are qualified for it. Some of them we know are going to be In acute pulmonary edema and have to go to the hospital, but we think a large majority of them will need treatment and ferrosix 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, they put quality limits on, let's say, quantity limits, let's say, it's a script for 4, but They'll get to get another script for 4 the next week or 2 weeks later.

Speaker 2

But we do think that's probably Those are probably higher utilization patients than per month than the 2s or 3s. John, do you want to get a little bit light on

Speaker 10

the meeting with the FDA? Yes, sure. So the big difference between New York Heart Association classifications all the way to 1 through 4 really is based upon

Speaker 11

the All the way to 1 through 4 really is based upon the amount of exercise in which a patient can tolerate. And as you go to Class 4, The amount of exercise with certain degrees of exertion becomes less tolerated. So the problem with New York Heart Association classification, great for clinical trials when you really have 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? This was really the basis of the discussion back and forth with the FDA about why Despite that we included mainly Class II and III patients in our clinical trials that they agreed that we would be able to expand in the Class IV As the pharmacokinetics between IV and subcutaneous is not expected to be different amongst that population.

Speaker 11

That was The data and the argument that we which we made to the agency. But to answer your question directly, it's all based upon how much exercise a person can tolerate

Speaker 2

Got it.

Speaker 7

Thanks. And I guess one last question on this is, in regards to the filing, Is this some the S and A filing, is this something you would expect a 6 month review cycle for or are you expecting like a 1 year review for this?

Speaker 2

So we would not expect a 1 year review. I think there's a couple of different avenues here. Probably 6 months, we think there might A way to shorten that, again, we're not putting in any clinical data at all. It's really just 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.

Speaker 7

Got it. Thanks for taking my questions.

Speaker 2

Thanks, Nez.

Operator

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.

Speaker 2

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 On our commercial plan, we anticipate continued growth in the percentage of heart failure patients who have affordable access to porosix, which we believe will translate into a nice trajectory for both prescriptions and revenue. We look forward to providing more information during our Q3 update in November.

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