Q2 2022 Esperion Therapeutics Inc Earnings Call
And ladies and gentlemen, thank you for standing by and welcome at this time all participants are in a listen only mode. Following the presentation. There will be a question and answer session be advised that today's conference call maybe recorded.
Now like to hand, the conference over to Tiffany Aldridge Senior manager corporate communications at S. Syrian. Please go ahead Stephanie.
Thank you Carmen good morning, and welcome to a theory on second quarter 2022 financial results and company update conference call I'm took me Aldrich and I'm part of the corporate communications team here at Spirit I want to remind callers that the information discussed on the call today is covered under the safe.
Heartburn provisions of the private Securities Litigation Reform Act.
I caution listeners that management will be making forward looking statements actual results could differ materially from those stated or implied by our forward looking statements due to risks and uncertainties associated with the business piece.
These forward looking statements are qualified in their entirety by the cautionary statements contained in today's press release, and our SEC filings. The content of this conference call contains time sensitive information that is accurate only as of the date of this live broadcast August 2nd 2022, we.
Take no obligation to revise or update any forward looking statements to reflect events or circumstances. After the date of this conference call and webcast.
As a reminder, this.
This conference call and webcast are being recorded and archived we issued a press release. This morning detailing the content of today's call a copy can be found at www dot Asbury on dot com within the investors and media section.
We will begin with prepared comments and then open the call for your questions. Following today's call. The team will be available for follow up questions. Please email corporate team at Asbury on dotcom to schedule time to speak with the team.
With us today are Sheldon <unk>, President and CEO , Dr. Joanne Foodie, Chief Medical Officer, Eric Warren Chief Commercial Officer, B, J, Swartz, Chief strategy Officer, and Ben Holiday from our Finance Department.
I'll now turn the call over to Sheldon for some prepared remarks Sheldon.
Thank you Tiffany and good morning, everyone. It's incredibly exciting to speak to you today about our significant progress in the second quarter of this transformational year for spirit.
To highlight our remaining areas of focus for 2022.
We are pleased to announce that while continuing to drive consistent growth. We have achieved 100% made for accumulation and our unprecedented clear outcomes trial and are rapidly approaching the most significant inflection point for the organization today.
We remain on schedule to report top line results for clear outcomes and early first quarter 2023.
We continue to execute quality site closeout visits scrub the database and ensure accurate and complete data collection and data base lock from this large global trial encompassing 200 study sites and over 14000 patients.
We plan on releasing a brief topline statement of primary endpoint results early in the first quarter with comprehensive study results to be presented at a major medical conference in the latter part of the quarter.
The upcoming clear outcomes readout represents a significant catalyst for our business and for patients as a positive outcome study and the ensuing label has the potential to make <unk> asset the only oral LDL lowering therapy since status to be indicated for CV risk reduction.
The entire organization is working in unison to ensure flawless reporting and launch of these data and to deliver on our commitment to driving exponential growth for both <unk> and next with that.
A large 300 health care provider payer market research projects conducted in Q2 validated that positive data would unlock exponential growth through improved market access and expanded market share.
At the same time, we have assembled a diverse and prominent group of scientific experts for our scientific advisory Board and are preparing to share with you our longer term plan for our innovative pipeline at our R&D day in November .
Our partner Daiichi Sankyo reported strong the lindo and steady growth in their European territory and have cumulatively treated at least 70900 patients.
The previously launch markets include Germany, UK, Luxembourg, Austria and Belgium.
Switzerland was launched with reimbursement in second quarter of 2022, and Spain was launched during the second quarter of 2022 for private market sales.
Additionally, our partner Otsuka now has the results from its phase two dose finding trial of epigenetic assets and plans to advance the program into phase III.
I'm also pleased to report that this quarter, we continued to achieve year over year cost savings of $9 $4 million and our operational expenses compared to the second quarter of 2021 as we pull forward our transformative plan announced in the fall and continue to focus on efficiently allocating our resources.
In advance of the top line readout of the clear outcomes trial and.
In the first half of 2022, we have spent $47 million less in operating cash compared to the first half of 2021.
Earlier today, we issued a press release containing our financial results for the second quarter, which is available on our investor website.
U S product revenue for the second quarter ended June 32022 was $13 6 million up 28% year over year and $26 9 million for the six months ended June 32022 up 59% year over year.
Royalty revenue for the second quarter ended June 32022 was $1 5 million up 50% year over year and $2 $6 million for the six months ended June <unk> 2022 up 63% year over year, driven by new country launches and continued growth in <unk>.
Obviously launched territories.
We expect our partner to continue watching the lando and extending to new geographies.
Combined royalty and partner revenue was $5 $3 million for the second quarter ended June 30th 2022, a decrease of 82% year over year and $10 $7 million for six months ended June 32022, a decrease of 66% year over year attributed to a large mine.
Stone payment of $28 $1 million that was booked to revenue in second quarter 2021.
When adjusting for this onetime payment total partner revenue grew 170% in the second quarter ended June 32022.
Finally total revenue for the second quarter ended June 32022 was $18 8 million compared to $47 million for the second quarter of 2021, an increase of approximately 50% year over year after adjusting for the one time upfront payment.
Turning to expenses gross margin decreased as a percentage of revenue largely driven by an increase in the purchase of inventory from our international partners, which has a lower margin than our U S sales.
We expect this margin to improve over the year as shipments reached a steady state compared to the FERC of 2022.
R&D expenses for the second quarter ended June 32022 were $32 $4 million, an increase of 29% year over year and $56 $8 million for the six months ended June 32022, an increase of 7% year over year. The increases were primarily driven.
Even by the acceleration of expenses related to the rapid closeout of a clear outcome study earlier in the curve.
SG&A expenses were $29 6 million for the second quarter ended June 32022, a decrease of 36% year over year and $60 million for the six months ended June 32022, a decrease of 44% year over year. These decreases reflect saved.
Gains from the channel transformation for long term success plan implemented Q4 of 2021.
As of June 32022, cash cash equivalents restricted cash and investment securities available for sale totaled $235 $8 million compared with $309 $3 million at December 31, 2021.
We are well capitalized even without our $50 million of restricted cash and anticipate that our cash runway extends through the anticipated completion and readout of the clear outcomes trial and continues to fund continuing operations for the foreseeable future following those results.
Our operating expense guidance for the full year 2022 remained unchanged.
We continue to anticipate full year 2022, R&D expenses to be between $100 million to $110 million and SG&A expenses to be between $120 million to $130 million.
These estimates are inclusive of approximately $25 million of noncash stock based compensation expense expected to be incurred during this year.
To close I want to highlight that we are approaching a significant catalyst in our <unk> story with a potential to harvest over $1 billion in partner milestones and significantly higher revenues until patent expiry in mid 2031 with a positive readout of our clear outcomes trial.
We believe we are part of a paradigm shift in the management of lipids as LDL cholesterol as a foundation of cardiovascular risk reduction.
Early upfront combination therapy as an approach for most chronic diseases, including hypertension and diabetes, our products have the potential opportunity to address LDL cholesterol with early combination therapy in much the same way.
Therefore, we are poised to begin an entirely new chapter for our company with opportunities to help even more patients reach their goals.
We look forward to updating you on our progress as we near a crucial milestone in our journey to help patients address the leading cause of death worldwide.
Thank you all for joining today and for your continued support and interest in the spirit.
Operator, we are now ready for Q&A.
Thank you and as a reminder to ask a question simply press Star one one on your telephone one moment, while we compile the Q&A roster.
Yes.
Yes.
Our first question comes from Michael Yee with Jefferies. Please go ahead.
Okay.
Yes.
Yes.
Michael Your line is open.
Okay.
Okay.
Please check your mute button Mr <unk>.
Okay.
We're ready Mike, we just need to hear you.
Sure.
Can I continue with the next question maybe Harold.
Yes, as long as we can come back to Mike that would be great.
No problem and one moment our next question.
We have a question from Joseph <unk> with Cowen. Please go ahead.
Hey, there good morning, and thank you for taking my question.
Maybe just as you're thinking about a potential sales inflection I know you mentioned doing some work in the second quarter is there a level of CV risk reduction that you think physicians are looking for in order to.
Use the therapy, a little bit more in their patients.
Or just kind of seeing a stat sig benefit in the outcomes trial going to be sufficient and I'd be looking for anything more or are they giving you any kind of numbers guidelines yes.
Hey, Joe first of all good morning, and thank you for the question. So I think it's a little bit of both I think it's it is the outcomes and awaiting for outcomes.
And also they are looking for a certain result, something obviously.
That is positive I think theres always also two levels there is an academic level.
And then there is the if you will for lack of better words common prescriber from an academic perspective, when the study reads out. This study is powered for a 15% residual risk reduction.
And.
I do think that from an academic perspective, and discussion physicians will be talking about that will be speaking to different metrics to statistical significance, maybe even looking at subgroups etcetera, Payors and physicians are looking for outcomes.
But with that in mind, we also did as I mentioned in my previous remarks, we just conducted a very large quantitative market research to examine this I'll have our chief commercial officer add some color to that sure. Thanks Sheldon. Thanks for your question Joseph Yes, so the level of reduction and we looked at multiple flavors in this 300 <unk>.
And payer Quant study and we found that that 15% level of reduction which is the base, which is what this study is powered for <unk>.
Experience at significant inflection we also looked at different flavors.
Potential outcome so.
So I'm really encouraged by the results we saw from that study and again at the base level of impact if you will to 15% at the study is powered for we see that significant value.
Perfect and then maybe just some work again.
Obviously, that's going to be the key inflection driver here.
Before then though when you're discussing with your positions in the sales teams are out there is there anything you can do in the.
The interim or the physicians really just saying we need outcome, then obviously the payer structure to change a little bit or are they able to get the therapy is there anything else that you can kind of try and unlock to.
Gross scripts and there are more near term and even beyond I guess can you do that.
Yes, so Joseph it's Eric again, so as you know in October of 'twenty. One we made the conscious decision to scale back some of our commercial footprint and investment in anticipation of the future clear outcomes and the fact that really thats going to create the most bang for our Buck.
I will say, though that in our current infrastructure and footprint, we've been able to consistently deliver this growth and 6% volume growth. This quarter. Prior authorizations are continued to be a bit of a challenge for hcp's, we've implemented a program.
<unk>.
Kind of the middle of last year to help solve that we've really amped up our resources associated with that program.
Deployed actually individuals from Labcorp, just recently to help hcp's navigate the prior authorization environment, a little bit closer and clear outcomes really is the catalyst for.
Breaking the prior authorization barrier, if you will the burden of prior authorizations is real now, but with the clear outcomes data.
I expect a very significant reduction in that difficult to hear that barrier associated with PFS.
Perfect very helpful. Thank you very much.
Welcome operator can we try can we try and Mike again.
He is able to ask a question.
Mr. <unk>, if you can press star one one on your telephone keypad.
Okay.
Okay, having some type of technical issue.
Yes, I do.
Do not see him Sir okay.
Next caller.
One moment for our next question please.
Our next question comes from Mr. Jeff Hung with Morgan Stanley . Please go ahead hi.
Hi, This is Mike on for Jeff hung.
Can you provide us any updates on engagement process with HCP are you hearing more patients returning to the physician offices or has that stabilized at all.
Eric do you want to yes.
Yes, good morning, and thanks for your questions.
The environment is at returning to quote unquote more.
<unk>.
Still challenging from a cardiovascular perspective.
There is a lot of unmeet unmet need but there is also apathy that needs to be addressed in the marketplace. So page.
Patients are returning to the office or Hcp's are able to interact with our sales representatives more and more but there still is apathy in the market that does need to be addressed.
Perfect and maybe just a quick follow up if I could.
Or the program that you had mentioned I think it's like the next step programs on increasing adherence would you see as the main drivers for this program to actually be able to increase adherence and what are you looking for out of this.
I'll take that question P J.
As far as the next steps Navigator program, what we see is physicians still even though we have a 90% commercial coverage and significant Medicare coverage. The prior authorization burden has been not.
Not allowing patients to get the product in the short period of time. So the biggest driver is really assisting with the prior authorizations to ensure patients do get their products and their physician puts tended to pad in the shortest period of time, we had just as Eric mentioned partnered with Labcorp, where a program to have field reimbursement support in the field.
That group will work hand in glove with the offices and payers to stay on those prescriptions until the patient gets the prescription in hand, and so we are super excited about that program just kicked off July one.
Awesome. Thank you so much and congrats again on reaching a 100% of accumulation.
Thank you. Thank you.
Thank you one moment for our next question. Please.
Alright, we have the line of Mr. Michael Yee with Jefferies Open. Please go ahead.
Hey, guys. Good morning can you hear me, yes, great Hey, Mike.
Sorry about that.
I like going back to the gyms.
Hi.
Two questions one on the commercial and then one on the thinking.
Thinking about the outcome study on the commercial I know it grew five 9%.
Just wondering if there were any changes to gross to net or inventory in the quarter.
The reported number was that just a little bit lower than than that amount. So just trying to figure out quarter to quarter, what what's going on there or are there any changes and then on that.
Thinking about when the outcome study reads out in early first quarter. I know you have historically said that it will take some time to get the label and traction to valid market all of that so that will take some time.
That there are different.
Avenues of capital to seek can you just remind us I think one is the.
Warrant coverage that's out there remind me that's one but just talk to us about how you would foresee the different scenarios for capital.
Push the push the outcomes. Thanks sure.
So first of all I'm glad we could get your line on mute there, Mike and again apologize trained technical difficulties.
Regarding your question as it relates to gross to net.
Two things that occurred in the quarter.
One was we actually initiated a contract of Medicare coverage. It was a win at Cigna and we started to see the volume come through with that contract. We also had Medicare coverage gap that we also had to pay during the quarter. The signal when we view as a win for us.
Not only for the quarter, but in the future.
Today, when we announced the fact that we have the 100% made for accumulation. That's one big step forward again to what we've been consistently describing as the clear outcome study being a inflection point for silver.
One step closer to that I bring that up because that's going to allow for us to have more volume of prescribing once the clear study actually reach out.
And Thats whats really going to help stabilize our GTS.
And I would move forward to say that volume increases also will significantly reduce our distribution fees as well.
So we're well poised as it relates to moving forward, having the clear outcome study and again that will be our inflection point for volume and allow us to.
Stabilize our gross to net but these events that occurred merit Medicare coverage gap and also the win at Sigma at Cigna sorry.
It's really like any other pharmaceutical business and this is the cost of doing business.
And.
We are happy to see that consistent growth in volume as you mentioned, a five 9% and we've been consistent in saying that that we would demonstrate continuous growth.
Through the year as it relates to capital strategy and the warrant coverage et cetera. So we did do the raised of last December and that did come with warrants.
At a strike price of $9. If you look at the total value of those warrants there roughly $305 million they have a two year expiry on them.
And our.
Our capital strategy, although we're not giving explicit details once we have the clear outcome study in hand, we believe that we have a lot of different pathways that we can go as it relates to getting the capital that we need in order to move forward.
As I mentioned in our prepared remarks, we are well capitalized to the end of a clear outcome study and some runway post the study.
We will be looking at what leverage do we want to use.
As it relates to bringing in capital once we have our positive clear outcome study.
Okay. Thanks, guys.
Thank you one moment for our next question. Please.
Okay.
Our next question comes from Jessica Fye with Jpmorgan. Please go ahead.
Hey, guys. Good morning, Thanks for taking my questions first one yes.
Following up on the comments about your market research what does your market research suggests about the potential change in utilization of back to the toll in Mexico is that once the outcomes data are available.
Can you walk us through how you think about the magnitude of the reduction in clear outcomes based on the LDL baseline of the patients enrolled and the expected LDL reduction.
In this population.
And third following up on <unk> question do you expect.
Meaningful changes in the net price once your outcomes data is available.
Beyond just maybe economies of scale on distribution.
On the one hand, it seems like it's sort of hard to move that net price higher in your respective of new data.
But any indication from a payers there or is it less about improving net price and more about volume. Thanks.
Absolutely Eric I'll start great. Yes, good morning, Jess So with regards to the market Research study and we saw and I'll just categorize them as exponential increases in penetration from the Hcp's that we interviewed and that ultimately participated in quant and.
For the other question that came in earlier this exponential increases in penetration came at that base level of benefit or that 15% at which the study is powered for we also saw improvements significant improvements from a payer perspective and both to <unk>.
<unk> of coverage as well as improvements in the utilization management criteria that will make it much easier for HCP to prescribe the product.
Jeff This is joanne. Thank you so much for your question I think we are absolutely thrilled that we've hit 100% lease for accumulation for the cbot and are really looking forward to our top line results in Q1 of 2023 to your question regarding IL I'll say reasons to believe.
And confidence in the study the study as you know with powered for a 15% reduction in cardiovascular events.
Based on all that we know.
Bamboo delek asset I think though as we think about this understand that the population is very unique it has the highest LDL cholesterol of any recent non statin trial that being 139 milligrams per deciliter and not only is the LDL high but it's a very unique population with 80% of patients not <unk>.
To take a statin.
No that in patients like these as well as given the high rates of diabetes pre diabetes and obesity in the cardiovascular outcome trial that these patients tend to be hyper responders to our drug.
If we look further at smart analysis conducted by Cos Ray and now published we see a potential cardiovascular risk reduction closer to 20%. So we are highly confident in this study again emphasizing that it is powered at 15% and as Eric previously mentioned.
That is enough to move the needle in the clinical community and we look forward to having hopefully positive result, and having been podolak asset would be the first non statin oral therapy with cardiovascular risk reduction.
Comes in a potential label as we move forward.
Great. Thanks, Joanne and then just for your question regarding net price and how we can demonstrate meaningful improvement beyond just the economies of scale at BJ answer that he is actively working on that P. J.
Thank you, Jeff as Charlie mentioned, the wholesaler DSA fees is that volume.
It's unlocked those fees will be reduced but also as the volumes increase with our payer contracts that are in place and we hit a breakeven from a profitability standpoint, and then hit the trajectory of growth. That's another significant factor in reducing the GTS. We recently had a payer advisory board in person.
And actually conducted a mock PNT and at that Mark PMT the payers all.
Agreed that significant volume will be unlocked with the with the readout of clear and so we're very excited about that again in the interim as mentioned we partner with lab for the field reimbursement support team that will work hand in glove now and also payers are starting to re look at their U N criteria, even prior to the clear outcomes readout.
Based on the demand that we start to see a patient with payors.
I would just add we've also just have recently seen in the past week or so we've talked about this before but we have aspen, which is somewhat of a mini hub for us that actually helps physicians facilitate prior authorization fulfillment.
Physicians offices and <unk>.
And for patients so they can get the drug and we've seen the highest increase ever in this program.
We had actually over 300 patients in one week alone. So this is again something very promising and we're starting to really see this as we as we move forward and also awareness grows.
Thank you.
Thank you one moment for our next question. Please.
Okay.
Our next question comes from Judah Frommer with credit Suisse. Please proceed.
Thanks for taking the question guys.
Right.
Could you just remind us of the timing around potential guideline changes and then potential label change and then you did call out in the release that the Ut southwestern real World data that you collected it.
It does seem like there's going to be another lift in terms of you know insuring.
Ensuring it's too new guidelines, so how do you plan on talking about.
Joanne so judah. Thank you so much too so as we mentioned right we will.
Anticipate.
Our data from the cbot to be available publicly Q1 of 2023.
With those data we anticipate then the potential for guidelines to be updated whether it be from the American College of Cardiology, The American Heart Association or the European Society of Cardiology within 2023.
And then we would anticipate label being filed and submitted as quickly as possible thereafter with an anticipated label in first half of 2024.
Understand though that many of the patients within the cardiovascular outcome trial are on label for US currently in the U S and we imagine that that will cause an increased utilization of the product and bolstered by guidelines, which then will also improve.
Or reduce prior authorizations potentially as we move forward. So we see this as really a critical.
Inflection for the organization for providers and for patients as we get the therapy out to them.
Okay.
I guess another way of asking the question is updating the guidelines you know enough to reduce prior authorization burden and do you think that's enough.
<unk> utilization or do you do.
Have you seen the sales force go out in an alert providers to guidelines as well.
So due to first I think that having the study in public domain is enough.
Irrespective of the guideline.
<unk>.
Change payer conversations and BJ can speak more to that.
Our strategy to engage payers prior to the guideline.
Certainly.
Did that.
Readout is going to be helpful, but with the guideline.
Payers always look to other resources in the meantime, they often look to validate.
With large societies and.
So again I think from our recent Payor Advisory Board that we just had and Mark PMT that was one area that advisers told us as well as soon as they saw the guidelines that that would be tremendous in validating the utilization and validating changing their prior authorizations and <unk> criteria.
Great. Thank you.
One moment for our next question please.
Yeah.
Okay.
Yes.
Our next question comes from Serge Belanger with Needham <unk> Company. Your line is open.
Hi, Serge.
Hi, Good morning, just a couple of questions on the ongoing European launch.
Looks like the product will be available in all the major markets plenty of time. The outcome study reads out just curious if you expect the same kind of inflection in improved access in <unk>.
Expanding market share.
With a positive outcome study in Europe as you do in the U S.
Sure. So you are correct that most of the major markets either have launched or will be launched again in Europe . Daiichi Sankyo has been very successful as a matter of fact in the U S. We actually look at their launches almost a marker for us when we have our outcome study and the reason why I say that.
It's because when you do a comparison of the EU label to the U S label, one of the biggest headwinds for us in the U S is the fact that patients have to be on the maximum tolerated dose of a statin and they also have to be identified as having <unk>, which is in Europe . They do not have that hurdle upon the.
Clear label here in the U S. Those elements maximum tolerated dose of a statin having.
Having to actually identify a patient that has a CBD those will go away and those will reduce the hurdles of patient.
<unk>.
As it relates to getting the drug here in the United States now in Europe to gain back to your question.
We actually think that again based upon the success that they already have having the outcome study and having residual risk reduction and looking at other cardiovascular products that have launched that have outcomes in Europe , you always see an inflection post outcomes as it relates to more uptake, especially if you can share reduction.
<unk> of.
Of risk so.
And as Joanne mentioned in a previous question. This is a very unique study as you know Serge.
It's not only the fact that we're looking at LDL level of 139 milligrams per deciliter, but there's also areas that we're looking at from our perspective Hs CRP glucose and a median follow up time of close to four years, which is dramatically different than other lipid lowering products have demonstrated.
Outcomes, whether that be in Europe , or the U S. So this will definitely help our partners Daiichi sankyo continue to fuel their success.
Does that answer your question Serge.
Thank you.
One moment for our next question.
Our next question comes from Jason Butler with JMP Securities. Please proceed.
Hi, Thanks for taking the question.
Just when you establish the scientific Advisory Board.
The potential for lifecycle management, obviously understand that you are fully focused on clear outcomes right now, but can you just talk to the longer opportunities.
Be able to evaluate with lifecycle management of the franchise.
Yes, we can sorry, Jason.
Maybe our phone here, but.
First of all we're really excited about the fact that we have the scientific advisory board and the people that are in our scientific.
Advisory Board, we will be having an R&D day, that's going to take place. We mentioned in November we havent given the specific date yet.
But.
<unk>, we do have a very interesting pipeline, we have never really talked about it before we have a second generation.
We also have an oral PCF canine, but I'll have Joanne maybe just highlight some of the things that we'll be thinking of as we move forward with the <unk>. Yeah. Thank you. So much. We again are thrilled to have a scientific advisory board that has a deep and experienced expertise with really internationally renowned.
Researchers.
Including Dr. Peter Libby as our co chair of the scientific Advisory Board. We felt it was critical to set this up to really ensure that we had the best direction for our assets in our pipeline the first being the platform for our ATP citrate lyase inhibitor. If you will the next generation of <unk>.
Delek asset and leveraging all of their scientific expertise.
To bring in the best technologies approaches to ensure the maximal.
Value being brought to that pipeline set of assets and just to be clear. The next generation has opportunities not only in cardiovascular but in broad cardio metabolic features such as Nash kidney disease, and even broad reaching implications in oncology and our advisors reflect.
That with a broad and diverse range. We also have our oral PCF canine inhibitor again moving forward in preclinical phases. So again stay tuned for research and development day in November where we will have an opportunity focus focus on that as well as once we have the.
Topline information from clear outcome, the opportunity to think more deeply about lifecycle management as we move forward with vantage Delek asset.
Great. Thanks for taking the question.
Thanks, Jason.
Thank you one moment for our next question.
And our next question is from Paul Choi with Goldman Sachs. Please proceed.
Hi, good morning, and congratulations on <unk>.
Keeping the 100% of the Euro makes for events in your study a few questions from us. Please.
Have you.
Scheduled any.
Payer discussions just for early 'twenty three post your topline data just.
Sure.
Four four improving access.
Working on the prior authorization barriers that you referenced earlier are these meetings already scheduled or are you still will you have to schedule them after the topline data.
Paul It's P. J. Thank you for your question.
Absolutely.
Having those meetings are scheduling now, but we are in constant engagement with our payers just improving the UN criteria prior to that as well. So we have our payer value proposition deck ready to go and we're super excited and as are the payers for the readout. So they will be taking place and part of what the payer team can do couple.
With medical is we can actually engage in some of the succession way before the label teams or anything there in thinking.
Discussions we're getting excited for it as are the payers as well as evidenced by Cigna, just adding it.
Adding up to formulary.
<unk> certainly seen the demand and so we're excited for the future.
Great Thanks for that.
Then.
I know youll, probably detailed this a little bit more at your upcoming R&D day, but with the operating.
Expense I guess around clear outcomes, starting to wind down here in the back half of this year.
Can you maybe just speak to how youre thinking about the cadence of potential <unk> for those assets that you were describing earlier Joanne like the oral piece, you're asking and your next generation.
ACL compound as a follow up to that but delek asset should we expect <unk> to start.
Start trickling out in 'twenty, three or are you assuming sort of a longer timelines there.
So Paul Thank you so much I think as we think about it trickle out is the right word.
Probably the very earliest we would think would be the end of 2023, depending on the approach a lot of that is hinged to on where we stand after the outcome study with respect to benefit delek asset and potential opportunities there.
But as well with the next generation platform and oral P. C S canine more likely the rollout as.
As we look at prioritizing indications across the platform for ACI.
Would be more likely.
Bulk of those in 2020 for.
Oral PCF canine again similarly, it would anticipate probably 2024 as we think about that.
Okay, great. Thanks for taking our questions.
Great. Thanks, Paul.
Thank you and as a reminder, ladies and gentlemen, if you have a question simply press Star then one one on your telephone keypad.
And I'm not showing any further questions in the queue Sir.
Great.
I just wanted to first of all for those on the line again. Thank you for your interest in <unk> and we really appreciate your questions. The organization is extremely excited about what we've announced today of getting one step closer.
Two realizing declare outcomes trial with the fact that we've accumulated 100% of the mace for accumulation. So thank you all again and speak to everyone. Soon have a great day.
And thank you ladies and gentlemen. This concludes today's conference call. Thank you for participating and you may now disconnect.
Okay.
The conference will begin shortly to raise your hand during Q&A you can dial one one.
[music].
Okay.
Okay.
Okay.
[music].
Okay.
Okay.
[music].
So.
Yes.