Q2 2023 scPharmaceuticals Inc Earnings Call
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Good day and welcome to the SG Pharmaceuticals second quarter 2023 earnings Conference call.
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P J.
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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 Etsy pharmaceuticals expected future financial results.
Management's expectations and plans for the business in forensics.
Words anticipate believe estimate expect intend guidance confidence target project and other similar expressions typically are used typically to identify such forward looking statements. These forward looking statements are not guarantees of future performance and may involve and are subject to certain risks and uncertainties.
And other important factors that may affect S. T pharmaceuticals business financial condition and other operating results. These include but are not limited to the risk factors and other qualifications contained in S. C. Pharmaceuticals annual report on Form 10-K quarterly reports on Form 10-Q and other report.
It's followed 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 are based on current expectations as of today and that's C. Pharmaceuticals expressly disclaims any intent or obligation to update these forward looking statements.
Sept as required by law.
It is now my pleasure to turn the call over to Mr. John Tucker Chief Executive Officer of S. C Pharmaceuticals John .
Thank you P J and thanks to everyone listening to this afternoons 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 406 launch and then Rachel notes, our Chief Financial Officer for a review of our financials. We will then open the call for your questions.
The second quarter of 2023 represents our first full quarter for row, six 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 for.
<unk> 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 launch to date and.
Our two main specialty pharmacy partners have already placed orders early in Q3.
In terms of our gross to 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 G. T. M 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 O. Six is broadly accessible to heart failure patients and their treating physicians to that end, we added an additional 10 sales territory.
This 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 and.
In addition, based on the interest we have seen prefer Asics, 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 protected discussions with commercial and Medicare part D and Medicaid payers and a continuing effort to make for US it's broadly available to patients at the most favorable terms possible. This involves not only securing initial coverage for a six but also working to have it.
<unk> on formulary tier that would be affordable to most patients and not on the specialty tier.
Reflecting our continued progress recall that a top five national health plan in place for us on a preferred formulary status across all if it's a commercial plans effective June 1st.
We remain in discussions with this ban regarding part D plans with the goal of securing similarly favorable formulary placement for Medicare beneficiaries.
Additionally, we obtained national Medicaid coverage for Essex effective July one 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 for Essex under fixed gear co pays out 100 or $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 for US is significant and we believe it is worth reiterating in the U S alone 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 for US six if we assume $3300 per episode, which is four doses that for all six with the potential to access the 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 G seven countries.
At this early stage, we are seeing a wide range of doses for a six per prescription from two to 12.
As this is at the discretion of the treating physicians and some patients require more aggressive intervention 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 overtime.
Staying on the topic of market opportunity for a moment just recently, we received positive type C meetings feedback from the FDA regarding the potential expansion. The fluorosis indication to include New York Heart Association class four heart failure patients. In addition to class two and three for rich for all six is currently Indy.
Kate It is.
It is estimated that as many as 10% of all heart failure patients are considered class four and all of these we estimated that as many as 40% pay benefit from forensics. So if we are successful class four representing a meaningful expansion of our market opportunity when able for us to be prescribed to the sickest heart failure patients and based upon this feeds.
Back 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 up for us in.
This enables the possibility of dosing flexibility of subcutaneous for Us Tonight we.
We have completed initial solid believes 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 similar formulations for <unk> for the treatment of congestion in patients with heart failure and all.
Kadima in patients with chronic kidney disease and entirely new potential indication that also represents a significant market opportunity for our company.
Taken together this additional IP is foundational to our 406 lifecycle management strategy. We are also pursuing similar patent protections outside of the United States.
Before turning the call over to Steve onto find an update on our key performance indicators and our plans moving forward, we anticipate signing direct purchase agreements with several integrated health systems for OS X will be shipped directly from our three P. L. Cardinal health to these IDM facilities, bypassing our three specialty pharmacies.
As a result, those units that are shipped direct will not be captured in a prescription counts, which will no longer reflect all of the underlying demand. So we are reassessing. The kpis that we are we intend to provide going forward will have a further update when we report our third quarter results in November .
Finally, we were very pleased in June to announce that we have been added to the Russell 2000 index inclusion and it's widely followed index will help raise visibility of our company and the key unmet need that for us. It's the dresses along the heart failure care continue on and there was a reflection of the significant progress that we've made over the past 12 months, which was.
Different tireless work on behalf of the entire team.
At this point I'll turn the call over our senior Vice President commercial Steve Parsons for a deeper dive into our launch metrics Steve.
Thank you John .
As John indicated the second quarter was our first full quarter. After your Asics 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 are few houses continue to emerge as John indicated towards the end of the second quarter. We added 10 territories, bringing our total field force as of today to 54 territories is important to note that the territories we added during Q2.
Two 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 fourth quarter.
Our sales force has conducted 1129 in surfaces as of June 30th compared to 518 as of March 31st in surfaces provide healthcare providers with training and prescribing instructions Fisher Essex. It is designed to ensure office readiness demo.
It's 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 onto your Essex.
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.
The second quarter ended June 30th we had 1163 total prescriptions written.
Those 604 prescriptions were filled and an additional 279 were pending.
For the prescriptions that were still pending at the end of Q2. There is a portion that we're 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 fields category with each day.
For prescriptions that have been cancelled the reasons vary ranging from the patient being unreachable or hospitalized or deceased prior to receiving for Essex and in some other cases cases, the patient co pay was too high.
Looking ahead, we would anticipate that the difference between prescriptions written prescriptions filled will narrow as far as he says better position 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 five point to one 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 bio matrix.
From a marketing perspective, we are engaged in broad multichannel 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 appear.
Aaron says print and electronic collateral and the development of both provider and patient websites among other critical tasks overall.
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 notes for a financial update Rachel.
Thank you Steve.
We generated net product revenue of $1 $6 million during the second quarter of 2023, and the cost of revenue was $24 million, yielding a gross profit of $1 $2 million research and development expenses were $2 9 million for the second quarter of 2023.
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 in medical affairs costs pharmaceutical development costs and employee related costs.
Selling general and administrative expenses were $12 $1 million in the second quarter 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 card.
And we saw a professional service cost.
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 32023.
$102 $9 million in cash cash equivalents and short term investments compared to $118 4 million as of December 31, 2022.
As of June 32023, Etsy pharmaceutical total shares outstanding was 35 million 849482 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 we will now begin the question and answer session to ask a question you May Press Star then one on your Touchtone phone.
Using a speakerphone please pick up your handset before pressing the keys you said anytime. Your question has been interesting you would like to withdraw your question. Please press Star then two.
Our first question comes from Glen Santangelo with Jefferies. Please go ahead.
Oh, yeah. Thanks for the details will 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 <unk> sort of total scripts are written and filled numbers and.
Now reconciling that with your last communication, which I think was sort of an early June it looks like Oh.
Jus, 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 any.
To that or maybe it's maybe it's still too early to come out of the month to month volatility, but any commentary would be helpful.
Yeah sure. Thanks, Thanks glass, John Yeah, you know launches are unpredictable and lumpy.
And again, it's still early you know we had a huge run up from from May to June .
From April and May if you remember over over 55%. So we did see demand higher in June than May we saw a lot of that come in at the at the end of the 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 as 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 of a may.
The scripts just ended up getting a lot of them getting filled in July .
Yes.
Maybe as a follow up to that I mean, if you look at.
1100, 63 scripts written across 631 unique prescribers right. That's let's call. It two scripts per provider and then I know it obviously doesn't work out that way, but you're seeing a pretty broad number of unique prescribers or or could you maybe talk about where you are in your in store in services.
Initiatives are you pretty much done I thought the plan was to be relatively done by that with that about this time, but now you're almost 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.
Hey, Glenn it's Jonathan I'll turn it over to Steve Let me comment first Youre, absolutely correct, when we add new territories.
Those are those are Virgin territory. So we need to do in services just like at the beginning so youre going to continue to see in services moving forward.
We've learned you know the in services are absolutely vital to what we're doing and but the second and the second and the third caller just as important to make this part of their practice. So you know where we're still working on two things expanding the number of riders, but making sure those riders.
That have written.
Adopt it into their practice and that and that just takes time and calls I mean, a lot of times, we'll walk in Oh, yes, I use that a patient they did really really great I forgot that thanks for reminding me of MA.
And we 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 have had great results. It's just Glenn it's just getting it into their practice getting it into their their routine.
And I you know the unique prescribers is interesting because in a lot of offices, there might be five or six doctors, but one nurse practitioner that does does the writing. So so our goal is as you know as we continue to add territories continue to do in services expand the rider base, but also make sure.
Sure that we're getting back in there.
Continuously reminding on maybe re and service them again.
To make sure that they were adopting it into their practice, Steve do you want to add anything to that.
Captures it well, we will continue to demand services.
We don't count it in service.
We do a second one at the same location Glenn These are all unique locations when you see the number if.
If we have to do another one.
To reach more more providers.
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, so well always be doing and services not nearly at the clip that we were to launch, but there'll always be a part of our execution.
Okay. Thanks for the comments.
Thanks Glenn.
Our next question comes from <unk> Suisse Leerink partners. Please go ahead.
Okay.
Hi, Good afternoon, everyone. This is majestic on for Rwanda Ruiz. Thanks for taking our question maybe a quick one for John I think in your prepared remarks, you mentioned the direct purchase agreement I'm just curious what would the approximate contribution look like.
From these agreements how do you expect this to evolve over time.
Yes, you know 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.
So there's a lot there, but let me let me try it so I'll start with that and the gross to net.
It depends on the discount we offer on those on those those.
And we always thought the idea and is where the value proposition is strongest right. If you think about it they kind of own that patient and putting them on for OCD and avoiding hospitalization flows to the bottom line. So we've always thought that the idms are a key.
Part of our focus we've had doctors that are affiliated with the ideas right write scripts now, but what what we're you know we feel really confident that's going to happen. This quarter as these agreements well, we'll end up having the product directly shipped to the idea and the hospitals within the idea and the farm.
Proceeds within the Idms and we're working on on guideline structure, there, where it's really part of the treatment algorithms. So it's hard to say what the impact 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 these things are very.
Complicated to work, it's not like walking into a cardiologist office detailing and having them right. There is a number of people you got to work at <unk>, starting in cardiology to purchasing to pharmacy.
And so we've been doing that work do you think they are coming online and and we think Dell it's not in our sales now obviously, but there'll be hopefully coming online this quarter on the GCN.
I don't think we.
We have the 23% G T and we said it's going to go up we still think it well these will be part of that as these come online, but we're going to stay disciplined on our rebating strategy.
We stay 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.
So on the utilization going through these plans and their P E and that cost some money and then theyre dispensing it and theyre not getting rebates. So we will stay disciplined like that with the idea and I do think from where we are in talking to the major ones that they'll come in under.
What are what our rebate the maximum rebates, we were thinking would be so we feel it'll it'll it'll contribute and won't really impact the G. T M.
Okay. Thanks, John and then maybe quick.
Quick question on inventory I think you mentioned youre down at 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.
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.
Anytime you're in a launch it's it's just unpredictable from from day to day week to week. So they tend to keep a little more inventory early in our launch like right now.
Chile.
Probably get down to that maybe.
Maybe by the end of the year or early next year to the two to three week, but it's it's hard.
To them, 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 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.
Helpful I'll hop back in the queue. Thanks, Sean.
Okay. Thanks.
Next question comes from Stacy.
TD Cowen. Please go ahead.
Thanks, so much for taking our questions and congrats on the quarter. So we have a few first hit the clinician feedback from these heart failure specialists have been very positive and our tax. So what are you seeing in terms of adoption patterns for practices that maybe weren't in Barbara clinical trials, maybe from more community settings, So where are we.
In terms of the broader awareness of <unk>. So that's the first question.
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.
They were gonna see by year end.
And then last if youre willing to provide some others okay.
Would you be able to talk about maybe those within those adopting clinicians people you're seeing enterprise. The average number of prescriptions and any anecdotal feedback would be helpful. There. Thanks, so much.
Stacy I'll I'll cite a couple of those and then turn it over to Steve.
On the fulfillment rate.
We didn't have and we only had.
The big the big.
Commercial payer on June 1st So I think that that's continued impact of fulfillment rate and Medicaid came online July one which is not reflected in this fulfillment rate at all so we have seen the fulfillment rate tick up since 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 other things and fulfillment rates. It's also as Steve spoke to.
Doctors filling out the start form right you know if if.
We have to go back to them to it two or three times of their delayed some of those patients end up being hospitalized when we lose the patient so the fulfillment rate will will will.
We'll 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 with a patient could could end up being hospitalized and also with.
With doctors and with US we got to continue to work with 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 that will that will continue.
<unk>.
Steve do you want to talk a little bit about.
The engagement at the docks.
Our specialist.
Yes, so most of the people that we are engaging with now are part of any early utilization they weren't part of the trials as you described it.
Those those were early adopters in the March timeframe now, it's 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 has broadened.
We're in academic places where in private practices were in commodities. It is.
It really across the board.
<unk>.
And I think you asked about the average number of prescriptions per person per.
Prescriber.
Hard to hard to say that you can do simple math and look at $11 68 billion divided by unique prescribers, but.
There are some doctors have only done one so far they you know they started later than in June as the others that have done multiple multiple prescriptions. So.
I don't think you can characterize it as like everybody averages too.
It's across the board and then within <unk>.
Office.
Sometimes they all funnel to.
<unk>.
One or many prescribers so.
Not really sure how to.
Precisely answer that question.
But that's that's what we're saying.
Okay. Thank you.
Thanks Stacy.
Our next question comes from Doug Tsao with H C. Wainwright. Please go ahead.
Hi, good afternoon, Thanks for taking my questions just curious.
John what's the average <unk>.
<unk> time, right now that you're.
Currently experiencing from when a script is written to when it's being shipped.
Yes. This is Steve I'll take that I'm closer to our.
Day to day reports.
And I'm not evading, it's a very difficult thing I think <unk> heard.
Some doctors want it right right away they stay Mark off expedite a 24 hour of you on the farm they submit and we get those out pretty quickly and then theres other doctors who.
Submit in advance they wanted to answer they want to know is that it is going to be covered the copay going to be and you know.
It gets appropriately put it in the Q, it's all 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 is it to have I guess, an average would really do you justice because of all the.
A variety a variability in how how the officers want to use the product. That's I think if you looked at a median Doug is probably better than amine on this because you said like we said retail scripts from March.
Last week right.
Were queued up and patient got in trouble and the dog said send it right, but if you. If you look at kind of a median you're probably looking at and it depends on Friday, obviously, it's kind of it's not going to shed, probably Monday or Tuesday, but it's probably about two days two and a half days on median.
But but again there is there's a lot of them that either the payer is requiring information from the dock for the or it's cute and it.
And it it could go.
A month later so it's it's it's.
We're looking at it we only have.
Scripts say, Steve said go out at the same day, and we have a specialty pharmacy that does carrier service and big Msas and those scripts get written in the morning get cleared and go that afternoon.
As you know.
Again, it has to be within MSA and the plan is to improve 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 cute or not and how we read it so.
So I wish we had a more precise answer, but that's where we are.
And I'm curious what proportion of 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, and then ultimately.
Given the nature of the product will you be able to sort of provide seven day a week coverage.
Okay.
Yes, so I mean, we have a program if the doctor really really needs to patients have it over the weekend, we have what's called a quick start program. So we shipped something on Saturday morning, whether the payer has processed it quickly enough or not we'll shift from product to get them through the weekend.
We do that one time for a patient because after that there's usually a prior off thats been approved and things can go quickly. The second time they need it it's really only the first time, you're using it but theres any potential delay.
And any Dr 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 get some yes.
And the docs that samples as well for those patients. So between the quick start and the sample for an expedited docket, we cover that cover that gap.
Okay.
Great. Thank you so much thanks.
Thanks, Doug.
Our next question comes from NASA.
Maxim Group. Please go ahead.
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 process only applicable in about 40% of those patients instead of let's say a larger percentage of those clos for patients.
And finally in those cost per patient how many doses of <unk> do you think those patients will need compared to what you currently things like for for the class two and three.
So I'm going to ask John to answer some of that question, but I think that on the 40%. That's just kind of our estimate on our market share not really what we how many of them are qualified for it.
Some of them, we know are going to be.
And acute pulmonary edema and have to go to the hospital, but we think a large majority of them will will will need treatment and for us. It 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 by managed care if they put <unk>.
Limits on let's say quality limits, let's say, it's a script for four but they will have to get another script for for the next week or two weeks later, but we do think thats probably.
Those are probably higher utilization patients than per month than the twos or threes, John do you want to get a little bit of light on the meeting with the FDA.
Yes sure.
The Big difference between New York Heart Association classifications, all the way the one through four really is based upon the amount of exercise in which a patient can tolerate and as you go to class for the amount of exercise with certain degrees of exertion.
Becomes less less tolerated.
With New York Heart Association classification, it's great preclinical trials. When you really have when you have a specific way of which to measure that but as you get into clinical practice that becomes so subjective about how this is done and this was really the basis of the of the discussion back and forth with the FDA about why despite that we included mainly class II.
Three patients in our clinical trials that they agreed that we would be able to expand in the class four as the pharmacokinetics between IV and subcutaneous is not expected to be different amongst that population and that was the the data and the argument that which we've made to the to the agency but to answer your question directly. It's all based upon how much exercise a person could kantar.
All right.
Got it thanks, and I guess one last question on this is.
In regards to the filing is this on the F&B. Finally is this something you would expect a 600 routes.
Cycle four or are you sticking with the one year review for this.
So we would not expect a one year review I think there's a couple of 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.
Some of the device the device documentation I'm not trivializing, how long that takes to do but but it's it's a pretty straightforward review. So we wouldn't think it's like a full 10 month review or anything like that.
Got it thanks for taking my questions.
Thanks Nancy.
There are no further questions at this time. So this concludes our question and answer session.
I'd like to turn the conference back over to John Tucker for any closing remarks.
Thank you.
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 <unk>, which we believe will translate into a nice trajectory for both prescriptions and revenue we look forward to providing more.
More information during our third quarter update in November Thank you and have a great evening.
The conference has now concluded. Thank you for attending today's presentation you may now disconnect.
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