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scPharmaceuticals - Q1 2023

May 10, 2023

Transcript

Operator (participant)

Greetings, welcome to the scPharmaceuticals' 1st quarter 2023 earnings conference call. At this time, all participants are in listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press Star then zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, PJ Kelleher from LifeSci Advisors. Thank you. Please go ahead, sir.

PJ Kelleher (Director)

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 scPharmaceuticals' expected future financial results and management's expectations and plans for the business and FUROSCIX. The words anticipate, believe, estimate, expect, intend, guidance, confidence, target, project, and other similar expressions are 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 scPharmaceuticals' business, financial condition, and other operating results.

These include, but are not limited to, the risk factors and other qualifications contained in scPharmaceuticals' 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 scPharmaceuticals 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 scPharmaceuticals. John?

John Tucker (President and CEO)

Thank you, PJ. Thanks to everyone listening to this afternoon's call and webcast. This afternoon, I'm 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 early stages of the FUROSCIX launch, and then Rachael Nokes, our Chief Financial Officer, for a review of our financials. We will open the call up for your questions. Just two and a half months into the FUROSCIX launch on February 20th, we are pleased with our progress to date, and early feedback suggests that FUROSCIX is being well-received in the market. Notably, our commercial team continues to execute on an important leading indicator in services with healthcare providers and have completed 518 through March 31st and have completed 743 total in-services as of April 28th.

These initial in-service contacts can last up to two hours, as treating physicians often want the entire office to be educated and trained on the use of FUROSCIX. As Steve will detail momentarily, these early efforts are working as intended as both unique prescribers and total prescriptions written are growing nicely. This supports our strong belief that FUROSCIX will quickly become a core part of the heart failure treatment paradigm, either pre-hospital admission or post-discharge, as it allows patients for the very first time to receive IV equivalent furosemide based on similar systemic exposure and diuresis in the comfort of their own homes.

Not only is this beneficial to patients who would much rather be treated at home than in a hospital setting, but by avoiding hospital admissions and readmissions, significant cost savings can accrue to commercial, Medicare Part D, and Medicaid payers, as well as hospitals who face significant and worsening reimbursement pressure for their heart failure patients. As a reminder, FUROSCIX is indicated for the treatment of congestion due to fluid overload in adult patients with New York Heart Association Class II and Class III chronic heart failure. FUROSCIX is not indicated for use in emergency situations or in patients with acute pulmonary edema. The On-Body Infusor will deliver only an 80-milligram dose of FUROSCIX. Last quarter, we detailed two studies that we conducted that clearly demonstrate the potential financial benefits of FUROSCIX.

One prospective study, FREEDOM-HF, focused on select patients who presented to the emergency room with a worsening heart failure event and were treated with FUROSCIX at home, as opposed to being admitted to the hospital. The result of the study was that patients treated with FUROSCIX had heart failure-related costs that were lower by an average of $16,995 versus historically matched comparators. This result was achieved with a very high rate of statistical significance with a P value less than 0.0001. While this analysis excludes the cost of FUROSCIX, since pricing had not been established at the time of the study, the conclusion remains unchanged.

In a second study, the phase two pilot study, AT HOME-HF, compared FUROSCIX with treatment as usual approach in chronic heart failure patients presenting to a heart failure clinic with worsening congestion requiring augmented diuresis. Among the key findings, subjects randomized to FUROSCIX had a 37% reduction in the risk of a heart failure hospitalization at day 30 relative to patients randomized to treatment as usual. The outcome of both studies provide a compelling picture of the benefits of FUROSCIX and further support the efforts of our commercial team as they work to educate treating physicians and their staff. They also provide critical validation as we engage with payer pharmacy and therapeutic committees regarding reimbursement dynamics.

On the topic of the payers, we continue to have productive discussions with commercial, Medicare Part D, and Medicaid payers in a continuing effort to make FUROSCIX broadly available to patients at the most favorable terms possible. This involves not only securing initial coverage of FUROSCIX, but also working to have it placed on a formulary tier that would be affordable to most patients. We previously indicated that approximately 60% of all heart failure patients can access FUROSCIX under fixed tier copays of $100 or less, and we believe that over time, we can increase this to 75% or more. Reflecting our continued progress, we were recently notified by a top five national health plan that FUROSCIX will be placed in a preferred formulary status across all of its commercial plans effective June first.

We regard this as a significant positive reimbursement development, and we remain in discussions with this payer regarding its Part D plans with the goal of securing similarly favorable formulary placement for its Medicare beneficiaries. As mentioned, we are engaged with many other health plans, and we hope to have several more announcements like this in the months to come. We are also recently informed that we will obtain national Medicaid coverage of FUROSCIX effective July 1, 2023. The market opportunity for FUROSCIX is significant. 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 four million heart failure events annually. Of those, we believe 2.1 million episodes can be effectively addressed by FUROSCIX.

If we assume $3,300 per episode, which is four doses of FUROSCIX, we have the potential to access a market opportunity that is nearly $7 billion. 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 FUROSCIX per prescription from two to 12 as this is at the discretion of the treating physician and some patients require more aggressive interventions than others. Finally, we are well-funded with more than $116 million of cash equivalents, and short-term investments as of March 31st, providing us with ample resources to continue to execute on our commercial plan.

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

Steve Parsons (SVP of Commercial)

Thank you, John. As John indicated, while it has only been about 2.5 months since we announced the launch and commercial availability of FUROSCIX on February 20th, we are pleased with our initial progress. I'll start with an update on our commercial team. We currently have 41 field territory sales representatives with 3 additional reps expected to join by the end of May for a total of 44. They are conducting face-to-face in-services at hospitals, doctor's offices, and heart failure clinics. We stand ready to add more as demand patterns for FUROSCIX continue to emerge. Targeting approximately 150-200 healthcare providers and 12 hospitals per territory, in-services provide healthcare providers with training and prescribing instructions for FUROSCIX designed to ensure office readiness. Demo kits to train patients are provided at the completion of each in-service.

The focus on the in-service is crucial to ensuring effective use and training on FUROSCIX. As John mentioned, our sales force conducted 518 in-services as of March 31st and completed 743 total in-services as of April 28th. Many of these in-services are lasting one to two hours as physicians desire to have training done throughout the entire office or clinic. This reflects the interest in FUROSCIX by healthcare providers. This sales team is a specialized force that can target top clinics and doctor's offices efficiently and effectively. They are focused on building strong relationships with the key constituencies at these clinics through an educational and consultative approach. While it's still early, we will be ready to add more reps in the field as needed to maximize the clinic and patient access to FUROSCIX. The early results are encouraging.

Through March 31st, we had 194 total prescribers with a total of 381 prescriptions written and 161 prescriptions filled by the last day of the quarter. As of March 31st, we had 152 prescriptions still pending. The vast majority of the balance of prescriptions pending are either due to prescriptions doctors have written that are queued and ready for patients or prescriptions still in progress with payers. We continue to move pending prescriptions into the filled bucket with each day. We have a small number of prescriptions abandoned. The reason for these cancellations are varied, ranging from patient being unreachable, hospitalized, or deceased. There have also been a small number where the patient's copay was a little too high.

As we've already seen so far in April, we would anticipate that the difference between prescriptions written and filled will narrow as FUROSCIX is placed on more health plan formularies, expanding access for patients and lowering patients' out-of-pocket expense. At the moment, the average number of doses per prescription is slightly higher than four, but we continue to believe four doses per prescription to be the right number long term. In terms of distribution, as we indicated last quarter, we are 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. Cardinal has shipped initial inventory to the specialty pharmacies, which is reflected in our first quarter revenue. As a reminder, we recognize revenue when FUROSCIX moves from Cardinal to the specialty pharmacies.

FUROSCIX Direct, our reimbursement support hub, provides benefits investigations for physicians to determine insurance coverage and patient out-of-pocket costs. Our specialty pharmacy partners provide device training to patients and are available 24 hours a day to answer questions about the use of FUROSCIX. From a marketing perspective, we are engaged in a broad omni-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 KOL engagement and development, 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 our early progress and the trajectory that we are on. That concludes my update.

I would now like to turn the call over to our CFO, Rachael Nokes, for a financial update. Rachel?

Rachael Nokes (CFO)

Thank you, Steve. We generated net product revenue of $2.1 million during the first quarter of 2023. The cost of revenue was $0.6 million, yielding a gross profit of $1.5 million. One quick note for Q1, the cost of revenue excludes inventory that was expensed prior to FDA approval in October of 2022. Research and development expenses were $2.1 million for the first quarter of 2023, compared to $4.3 million for the comparable period in 2022. The decrease was primarily due to a decrease in clinical study and medical affairs costs, employee-related costs, device and pharmaceutical development costs, and quality and regulatory costs.

Selling general and administrative expenses were $10.9 million for the first quarter of 2023, compared to $2.9 million for the first quarter of 2022. The increase in selling general and administrative expenses for the quarter ending March 31st, 2023, was primarily due to an increase in employee-related costs, commercial costs, and legal and professional service costs. We reported a net loss of $11.2 million for the first quarter of 2023, compared to a net loss of $7.7 million for the comparable period in 2022. As of March 31st, 2023, we held $116.1 million in cash equivalents, and short-term investments, compared to $118.4 million as of December 31st, 2022.

As of March 31st, 2023, scPharmaceuticals' total shares outstanding was 35,769,073 shares. That concludes the financial update. John?

John Tucker (President and CEO)

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

Operator (participant)

Thank you, sir. We will now be conducting a question and answer session. If you would like to ask a question, please press star then one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star and then two if you would like to remove your question from the queue. Again, if you would like to ask a question, please press star and then one now. The first question we have is from Glen Santangelo from Jefferies. Please go ahead.

Glen Santangelo (Managing Director and Senior Equity Research Analyst)

Yeah, good evening. Thanks for taking my question. You know, glad to see the launch is off to a great start, congrats on that. John, I don't know if this question's for you or for Steve, but I did wanna follow up on some of the KPIs you gave, particularly around, you know, the 381 scripts that were written versus the 161 that were filled. I think, Steve, I heard you say that that's due to a combination of things like the patient being unreachable or hospitalized or unfortunately deceased. Some of them I think you suggested might have been, you know, reimbursement related around copay. I was wondering if you could just flesh that out a little bit more. I think you said you expect it to sort of narrow.

Any sort of color around that you can give us would be helpful. Thanks.

John Tucker (President and CEO)

Hey, Glen, this is John. Thanks for the question. I'll let Steve answer that. Steve?

Steve Parsons (SVP of Commercial)

Yeah, it, there's multiple factors that contribute to the fill percentage, and the timing at which that happens. You know, as I alluded, it depends on the prescriber, some on the payer and the patient. It's early. We gotta get the HCPs, the healthcare providers in the habit of providing everything that the payer needs up front so that they can process the prescription quickly if they have everything that the payer needs. When they forget to include something, it might slow down the process until the hub can reach them. You know, some are sending in prescriptions for what we call pre-approval. They don't need it immediately. The patient doesn't need it immediately. It's, you know, it's in case they need FUROSCIX in the future.

There's some of that that's in the pending, as I said. In that case, there's less urgency for adjudication. There's some patients who resolve. They order FUROSCIX just in case and then, you know, using standard of care, you know, the patient resolves, which is a good thing for the patient. We do still have some plans where the copays are too high, and we're actively working to address that. We think the addition of this, you know, one top five health plan, coming online June one, could really help us help us there.

Glen Santangelo (Managing Director and Senior Equity Research Analyst)

Perfect.

Steve Parsons (SVP of Commercial)

Does that answer your question?

Glen Santangelo (Managing Director and Senior Equity Research Analyst)

Thanks for the detail. Yeah, it does. Thanks, Steve. Maybe I could just follow up on one more here. I wanted to ask about the in-services completed to date. I think you said 743 as of April 28th. You know, John, I, I thought I might have heard you quoted at a conference somewhere saying that you'd expect to have the bulk of the in-services, you know, done by the middle of the second quarter. I may be mistaken, but I don't know if that's still your goal. I'm just trying to reconcile that versus, you know, now you have 44 sales reps.

Like, when do you think you'll be through the bulk of the in-services, you know, with sort of your target audience and, you know, we can think about maybe what that's gonna mean from an expense trajectory perspective and maybe how scripts will ramp, you know, over the balance of the year once that's completed? Thanks.

John Tucker (President and CEO)

Yes. Go ahead, John. With the 743 complete, you know, we still have a number booked moving forward, both in new territories and some existing territories. It's important to note that, you know, in some places, one in-service isn't enough. They might have, you know, all kinds of satellite locations. They might want us to come back to see a different part of their staff. I think we'll have the bulk of them done here, you know, in the next month or so. We wanna be doing in-services. Now, we don't wanna be doing just in-services forever because it slows down your call average a little bit. We think we'll still be doing them, you know, at least through the end of this quarter, probably into third.

I think the bulk of them will be done, you know. The big bulk can be done by the end of this quarter.

Glen Santangelo (Managing Director and Senior Equity Research Analyst)

Okay, thanks for the comments.

John Tucker (President and CEO)

Thanks, Glenn.

Operator (participant)

The next question we have is from Roanna Ruiz from SVB Securities. Please go aheaHey. Afternoon, everyone. Congrats on the progress so far. A few from me. I wanted to ask about the range of doses seen for FUROSCIX. I think you mentioned two to 12. I was curious what's driving the high end of that range, what are physicians saying basically to justify those more doses for which patients, basically?

John Tucker (President and CEO)

Yeah. Steve, do you wanna?

Steve Parsons (SVP of Commercial)

Yeah. Well, you'll hear this a lot. It's really early on, you know, drawing any conclusions on, you know, what those doses will moderate to. You know, we still think our guidance of around four will be where we end up. It's a little higher than that right now, we admit. The 12 versus the two. The two is really someone just, you know, putting their toe in the pool. They're not quite sure how it's gonna work yet, so they just wanna see, they wanna try it, and then they'll order a couple more. The 12 is, it's your more severe patients, people who have an awful lot of fluid. They wanna, you know, really. Sometimes they'll use two a day, you know, to try to address that fluid.

These are people who, you know, are pretty close to going to the ER or the hospital. They don't need to, but they're close if they don't get an intervention. Those are the extremes. I think we just wanted to give you color on how big or small they get, but we think it'll moderate around four.

John Tucker (President and CEO)

Mm-hmm.

Roanna Ruiz (Senior Biotech Analyst)

Okay, great. Thinking about the total FUROSCIX prescriptions written, I was curious if you could give us some detail around if any of them are pre-admission versus post-discharge and just trying to understand the dynamics there. I know it's pretty early, but if you're seeing any themes, that would be super interesting.

John Tucker (President and CEO)

Steve, I'll probably add a comment, but why don't you go ahead.

Steve Parsons (SVP of Commercial)

Yeah. We don't capture that information in our RxSTART forms or anywhere in our hub data. Anecdotally, we feel like more Rx's are happening pre-admission than post-discharge at this early stage. There's a lot more patients who are in the pre-admission setting with fluid issues than there are post-discharge, which is really just a 30-day period. That makes sense. Again, it's early in the launch. We don't know the split, but I would say anecdotally it's more on the front end before they get hospitalized.

John Tucker (President and CEO)

I think, Roanna. This is John. By the way, thanks for joining the call. I also think that anecdotally what we're hearing on these pre-admissions might be part of the reason why we're seeing a little higher average number of units per script. 'Cause I think if you think about it, a patient that's being discharged, was discharged and is coming back in, you know, five days after the discharge has been diuresed actively, IV diuresed for four or five days. You would think they would need less. I think the higher script count or the higher doses per script might also kind of here follow what we're hearing anecdotally, that it's more pre-admission right now.

Roanna Ruiz (Senior Biotech Analyst)

Interesting. Super helpful. Last one for me. I was curious, what are you seeing in the regional trends, any sort of like fast-growing areas, that you're noticing so far?

John Tucker (President and CEO)

Steve, do you wanna?

Steve Parsons (SVP of Commercial)

I don't think it's regional. I could say it's that way. We have territories that are doing better and, you know, the rep... it's really rep-driven where people are ahead of others, ahead of the average, ahead of the norm, but it's not regional. You know, we have territories in every region of the country. Even with just 40 reps, we cover the nation except for the, you know, the big, you know, centers. I don't have regional observations, just individual rep performances.

John Tucker (President and CEO)

It's a little early. John, I think you had one observation, though.

John Moore (SVP, Commercial)

I think, Roanna, you had asked about the number of doses, and I think that we had doctors that participated in both the FREEDOM and the AT HOME study as well, that have, that are that have had experience. They have them with a little bit more experience, have a little bit more comfort and are the ones that are probably using some of the higher doses. That has had an impact on that as well.

Steve Parsons (SVP of Commercial)

I think the other thing we've seen, which I think is encouraging, is that the doctors that did participate in FREEDOM and AT HOME have been early writers of the product. Which, you know, hopefully they've had experience and they did well on the study and can embrace it, you know, as it gets into the market. It's really early, but we have seen some of those doctors writing early.

Roanna Ruiz (Senior Biotech Analyst)

Got it. Great. Super helpful. Thanks.

John Tucker (President and CEO)

Thanks, Roanna.

Operator (participant)

Ladies and gentlemen, just a reminder, if you would like to ask a question, please press star and then one now. The next question we have is from Stacy Ku from TD Cowen. Please go ahead.

Stacy Ku (Director, Healthcare – Biotechnology Research Analyst)

Thanks so much for taking our questions, and congratulations on the progress. First, as we think about the different centers and where you're seeing patients, it seems to be a lot of pre-admission. Are you able to get a sense of which heart failure centers might not have easy access to IV diuretics? Maybe some more low-hanging fruit. Are you getting any feedback for as you're kind of onboarding? That's the first question. The second is just about the clinicians. Would they need to be more comfortable kind of using it post-admission? What do they wanna see to be able to use FUROSCIX to shorten hospital stays? What practices would need to be adjusted from their end? Any feedback that they're providing would also be really helpful.

Last, can you just clarify, is this a single copay for this range of doses? Thank you.

John Tucker (President and CEO)

I think those are all yours, Steve.

Steve Parsons (SVP of Commercial)

Yeah. Yes.

John Tucker (President and CEO)

Steve show today.

Steve Parsons (SVP of Commercial)

I think the first one is around any differentiation between places that have access to IV diuretics versus places that don't. Does that affect the adoption rate?

Stacy Ku (Director, Healthcare – Biotechnology Research Analyst)

Yep.

Steve Parsons (SVP of Commercial)

I think it does. I think it does. Did I get that question right?

Stacy Ku (Director, Healthcare – Biotechnology Research Analyst)

Yeah. Absolutely. Yes. Are you seeing any-

Steve Parsons (SVP of Commercial)

Okay. Yeah.

Stacy Ku (Director, Healthcare – Biotechnology Research Analyst)

Kind of-

Steve Parsons (SVP of Commercial)

We are.

Stacy Ku (Director, Healthcare – Biotechnology Research Analyst)

Centers that don't have-

Steve Parsons (SVP of Commercial)

I think we are.

Stacy Ku (Director, Healthcare – Biotechnology Research Analyst)

... IV diuretics, and maybe that's why that you're seeing kind of this really high-

Steve Parsons (SVP of Commercial)

I-

Stacy Ku (Director, Healthcare – Biotechnology Research Analyst)

range of doses.

Steve Parsons (SVP of Commercial)

Yes. Well, they're certainly quicker adopters if they don't have IV access, for sure. There's a much greater unmet need for them than some other places. I think it's probably true. You know, if they do have access to IV, you know, they might treat them, diuresis them in the office and then finish the job with FUROSCIX at home, and maybe they don't need as many doses if they've done a day in the office. You know, if they normally four days or five days and it'd be one less, right? I think that's rational. You asked about comfort in the discharge setting. I don't think that's an issue. I think people are comfortable using it there. We don't wanna say that there's none happening there.

I think people ask me to characterize, you know, what the, what the mix is, and it is, it is a little higher in the pre-admission. There's just not as many patients who are fluid overloaded after they've been discharged from the hospital. There's about 20%-25% who get in trouble in the next 30 days. I think those will be our patients. You just look at the raw numbers, there's more patients who are, quote-unquote, "pre-admission.

John Tucker (President and CEO)

Stacy, it's John. I think, you know, we think about the different use cases, pre-admission, post-discharge, even reduction of length of stay. It's the same patient, it's the same treating doc. It's kinda where they are in their in the journey. We do think once physicians get more and more comfortable using it, and I think one thing, you know, we're hearing anecdotally is that patients are doing well on FUROSCIX. It's working as advertised, which kind of is a key thing here.

Once doctors are more and more comfortable using it, even if they start with just their pre-admission patients, we think then they'd, you know, they'd expand that usage, if appropriate for, you know, potential or early discharge and then, you know, for that, to keep that patient from bouncing back in the hospital. We think, you know, that's why the in-services are important, that's why positive use is important. I think the other question. I think, John, did you have something to add?

John Moore (SVP, Commercial)

I think around, Stacy, John Moore, on the IV clinics. I think it's important to just to point out that it makes sense that these things should be very, very common because they make sense to have the ability to give IV diuretics. It's just not commonly used, and we've sort of estimated that about 20% of institutions have the availability to administer IV diuretics in the outpatient setting because it's logistically challenging to be able to do that. On the flip side, those that do do it have demonstrated comfort with the ability to give IV diuretics in that setting and have. And it kinda makes sense for them to be some of the early adopters on the FUROSCIX side.

John Tucker (President and CEO)

Your third question, Stacy, on the copays, what we've seen, is that it doesn't matter if the dose is two or 12, it's a single copay for the patient.

Roanna Ruiz (Senior Biotech Analyst)

That's incredibly helpful. Thank you for all the details.

John Tucker (President and CEO)

Thanks, Stacy.

Operator (participant)

The next question we have is from Douglas Tsao from H.C. Wainwright. Please go ahead.

Douglas Tsao (Managing Director and Senior Healthcare Analyst)

Hi. Thanks for taking the questions. Maybe to start, John, in terms of how quick is it taking from a physician to participating in an in-service to actually starting to write, or are they needing sort of a follow-up call from a sales rep? Just in terms of the physicians that participated in the FREEDOM and AT HOME studies, are they using the product in a different way than other people who are writing for FUROSCIX? Thank you.

John Tucker (President and CEO)

Hey, Doug, it's John. Thanks for the question. I'll probably have Steve and John chime in. I think it depends on the in-service. I think we did see early on, I think we talked about on the last call, kind of a queue of patients that some doctors did have. Not all doctors clearly, but some. They already had a patient in their mind or. We in-service them. They ask for the in-service. They outreach to us either at a conference or over the phone. They were very quick to activate after an in-service. Other physicians, it does take the in-service and then a call and then maybe another call. You know, it's the same thing.

It, you know, it's the difference between getting the one script, which is maybe right after an in-service. What you wanna do is change long-term behavior, and that's gonna take a number of calls. It just depends on it. Again, the docs that had a patient in the queue, as soon as we activated them, they were writing scripts. Some of them, you know, it's taken a little bit longer to get a patient. The other question, John?

John Moore (SVP, Commercial)

Are the, Doug, John Moore. Are the individuals that participate in the study using FUROSCIX differently than other clinicians? I don't think that that's true. I think that the criteria used for the study on inclusion criteria and exclusion criteria were very, very clinically oriented. It's the way that they're evaluated in the clinic today. It was that when they were controlled, they were very pragmatic and real world. I would say that they're probably using it the same way as others. I think the comment was is that even in some of those studies, they were using a little bit more doses because of the types of patients that they were enrolling in the study. That.

it was just the total number of doses that I think would be different. The way in which they're using it, I say is very, very, very similar.

John Tucker (President and CEO)

They have confidence. Some of them are speakers for us, right? We're, you know, doing peer-to-peer speaker programs, and, you know, it's very helpful for them to talk to, you know, their peer physicians, their peer, you know, nurse practitioners and PAs. 'Cause they have questions about, "Well, what about higher BMI patients? What about lower BMI patients? What about elderly patients, you know, 80-year-olds?" They're able to speak to, "I've used it in all of these patients, and there's no restrictions in my mind on who you can use it with." That takes a, you know, a potential reservation, a reluctance, because it's unknown to the, to the new prescriber, off the table when they hear about the broad use.

We'll continue to do speaker programs, peer to peer, you know, virtual, and we're starting to ramp up face-to-face.

Douglas Tsao (Managing Director and Senior Healthcare Analyst)

Great. Thank you.

John Tucker (President and CEO)

Thanks, Doug.

Operator (participant)

Ladies and gentlemen, just a reminder, if you would like to ask a question, please press star and then 1 now. The next question we have is from Naz Rahman from Maxim Group. Please go ahead.

Naz Rahman (Analyst)

Hi, everyone. Thanks for taking my questions. Congrats on the initial launch metrics. Just a few. The first question I have is, in regards to prior auths, could you provide us some color on, I guess, like, the rate of prior auth that are approved, like, on the first pass? My second question is on the formal decision by the top five national health plan. Could you give some color on how many covered lives that plan covers, how many covered lives that adds? My third question is, I guess based on the initial feedback and perception that hospitals and physician groups and practices have gotten from FUROSCIX, have you seen any requests to potentially purchase bulk orders of FUROSCIX by said practices?

John Tucker (President and CEO)

Let me try to take the last two and then maybe turn it over to Steve for the first one. You know, is it the bulk purchases by offices probably doesn't make sense. It's not a Part B. There's not buy and bill. I would think in the future that there will be direct purchases from systems that have. You know, they might have infusion clinics, they might have pharmacies, they might have an outpatient pharmacy in the hospital just to make sure patients have pretty quick access. That's, you know, I think that's what we see. What was the second question? I tried to write it down.

Steve Parsons (SVP of Commercial)

How many lives in this top five plan?

John Tucker (President and CEO)

We... The problem with that, and we'd love to tell you who it is.

Steve Parsons (SVP of Commercial)

June first we can tell you.

John Tucker (President and CEO)

June 1st we can tell you. You'll know the name well. Maybe I leave it there. We're, you know, really happy. It's the commercial plan. We've had negotiations now. You know, negotiations on their Part D with them at now as well. We're really not allowed to use their name.

Steve Parsons (SVP of Commercial)

You know, 25.

John Tucker (President and CEO)

... 25 million lives covered on the commercial side of the business, so it's one of the big, big guys.

Steve Parsons (SVP of Commercial)

The last one I think was the PA.

John Tucker (President and CEO)

Yeah.

Steve Parsons (SVP of Commercial)

timing. How long that takes.

John Tucker (President and CEO)

What's required.

Steve Parsons (SVP of Commercial)

You know. What's that?

John Tucker (President and CEO)

What's required in the PA?

Steve Parsons (SVP of Commercial)

Oh, what's required in the PA?

Naz Rahman (Analyst)

Like, what % of those PAs go through like the first pass?

Steve Parsons (SVP of Commercial)

Oh, good question. I actually don't know that data precisely. It's more than not. First pass, you know, I mean, if the doc sends in the information that's required, and they're getting better at that, should be around 80%. 75%-80%.

John Tucker (President and CEO)

Keep in mind though, just, you know, that 75%, 80%, the prior auth could be approved, they still could have a very high copay. A PA getting approved obviously is huge, but if the patient still has, you know, a percent co-insurance, then that's an obstacle.

Steve Parsons (SVP of Commercial)

Yeah. I think we've said, you know, the patient has to be Class II or Class 3, you know. There's some Class 4s that have come through, that, you know, not indicated for at the moment. You know, there's a little bit of that that you factor in. but if they provide the right information, you know, they go through. Medicare is, you know, got rules about how quickly they have to be done. So.

Naz Rahman (Analyst)

Got it. Thanks for taking the answer my questions and, congrats on the initial launch.

John Tucker (President and CEO)

Thanks. Thank you, Naz.

Operator (participant)

There are no further questions at this time. I would like to turn the floor back over to John Tucker for closing comments. Please go ahead, sir.

John Tucker (President and CEO)

Okay. That concludes our call this afternoon. We hope you take away from this call that we are 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 with affordable access to FUROSCIX, which we believe will translate into a nice trajectory for both prescriptions and revenue. We look forward to providing more information during our second quarter update in August. Thank you again, and have a good evening.

Operator (participant)

Thank you, sir. Ladies and gentlemen, that then concludes today's conference. Thank you for joining us. You may now disconnect your line.