Q1 2022 Esperion Therapeutics Inc Earnings Call
Okay.
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. Please be advised that today's conference call may be recorded I would now like to hand, the conference over to Tiffany odd.
<unk> senior manager corporate communications at Spirit. Please go ahead.
Thank you good morning, and welcome to experience first quarter 2022 financial results and company update conference call I'm, Tiffany Aldrich and I'm part of the corporate communications team.
Garrett experience I want to remind callers that the information discussed on the call today is covered under the safe Harbor 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. 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 May three 2022, we undertake no obligation to revise or update any forward looking statement to reflect events or circumstances. After the date of this conference call and webcast as.
As a reminder, this conference call and webcast are being recorded an archive we issued a press release. This morning detailing the content of today's call a copy can be found at www dot experian 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.
Email corporate team at Experian Dot com to schedule time to speak with the team.
With us today are Sheldon kidney President and CEO , Dr. Joanne Foodie, Chief Medical Officer, Eric Warren Chief Commercial Officer, and B J Swartz Chief strategy Officer, I'll now turn the call over to Sheldon for some prepared remarks Sheldon.
Thank you Tiffany and good morning, everyone. We are excited to be here with you today to recap the first quarter of what will be a transformational year for spirit.
And reaffirm our goals for 2022 over the past few quarters Experian has outlined a strategic vision to position our company for long term growth and success and we continue to execute both commercially and in the clinic to attain our goal of becoming an innovative cardio metabolic leader.
As part of that strategy in 2020, one we streamlined our operational structure to focus our resources on driving the consistent growth of our commercial products <unk> and next with that and the advancement of our ongoing unprecedented clear outcomes trial, leading up to the planned top line readout in the first quarter of 2023.
Now during the remainder of 2022, we remain steadfast in our focus on delivering these objectives.
I'd like to begin with a brief overview of the commercial progress of next with Paul next with that.
To recap the last quarter year over year demand for our medicines grew 56, 7% in the first quarter with U S net product revenue of $13 $4 million up.
<unk>, 109% from the same period of 2021.
These robust results were the culmination of the enhanced product positioning and refined patient support program, we initiated in 2021 and continue to improve.
We have enhanced our targeting efforts, even further to identify and optimize new physician target using the contract sales organization. We began deploying this year concentrating on physicians, who will help drive more frequent utilization.
Our partners Daiichi Sankyo Europe continued to actively grow the Orlando and you send me in their European territory and have cumulatively treated at least 52000 patients through the first quarter of 2022.
Our products have demonstrated significant traction in the European market with a stronger launch trajectory than Pcs canine inhibitors, and we continue to believe that the accessibility and convenience of an oral medication and will provide a significant improvement to the quality of patient care.
I'm also pleased to report that this quarter, we have achieved year over year cost savings of 32% and our operational expenses compared to the first quarter of 2021. This represents an effective execution of our transformative plan announced in the fall.
We are approaching 95% base accumulation and our unprecedented clear outcomes trial and expect to reach 100% of mace by the end of the year with top line data in the first quarter of 2023.
As you all know this is a critical priority for spirit and our entire team is focused on the task of ensuring a high quality trial close and proper data collection.
With an estimated 41 million patients impacted by hypercholesterolemia globally, and 18 million patients in the U S alone is more crucial than average identify and treat patients who are unable to achieve their LDL cholesterol goals with existing treatment options.
Presently an estimated 70% of patients are not a guideline recommended LDL levels. Despite the numerous treatment options in the cholesterol management landscape.
Other cardiovascular drug manufacturers also see the significant value waiting to be realized in cholesterol management.
By 2026 annual worldwide revenue in the lipid market is projected to exceed $11 billion.
<unk> remains committed to its mission of providing oral accessible therapies to address cardiovascular risk.
We recently announced support for collaborative study with a large integrated and learning health care delivery system in northern California, the studying the effects of <unk> and reducing LDL cholesterol following a heart attack.
These data will add to the extensive body of evidence supporting the clinical value of <unk>.
Now I'd like to turn the call over to Joanne for an overview of our ongoing clinical activities and data presentations Joanne.
Thank you Sheldon I'd like to begin by emphasizing the severe impact of cardiovascular disease on life expectancy in the U S.
Securely in recent years during the COVID-19 pandemic.
Despite the staggering losses from Covid heart disease remains the leading cause of death in the United States.
In fact heart disease, and stroke mortality rates have risen sharply since the onset of the COVID-19 pandemic.
Age adjusted death rates from heart disease increased four 1% from 2019 to 2020 contributing to a loss of life expectancy of almost two years.
Yes.
It is important to highlight that 85% of all cardiovascular disease.
Our attributable to atherosclerotic cardiovascular disease.
And in large part by high LDL cholesterol.
He's sobering statistics reaffirmed the importance of a theory on a mission to bring transformational oral therapies for patients.
<unk> reaffirmed added urgency to our ongoing clinical medical and commercial efforts tackling chronic diseases and supporting our benzoic acid franchise.
We are also leveraging our scientific data and other unique mechanisms of action to advance our pipeline of novel compounds, which we expect to be extremely competitive in the multibillion dollar lipid market projection for 2026.
We will have more to share with you on our oral PPS canine and next generation ATP citrate lyase inhibitors platform by the end of the year.
Our unprecedented clear outcomes trial continues to progress as we expected and represents the most modern outcomes data collection in today's evolving medical care environment.
As a reminder, a clear outcome is a 14000 patient randomized outcome trial.
One of the largest outcome trials of non statin therapies yet.
This study will assess them for delek assets ability to reduce incidents of adverse cardiovascular events and a unique patient population that is unable to adequately address their LDL cholesterol risks with the current standard of care.
This study was developed in partnership with experts and regulators and is headed by world renowned trial and Dr. Stephen Harrison and the team of international experts.
The trial is approaching 95% of its required major adverse cardiac events.
We are deeply committed and experienced team expect 100% accumulation of our mace for events in the second half of this year and if top line read out first quarter of 2023, which is now less than one year away.
Yes.
Positive cardiovascular outcome trial in 2023, not only has the potential to expand our current labeled indication, but also to be practice changing for physicians and paradigm shifting for millions of patients around the world advancing a theory on its mission of making cardiovascular risk reduction.
More accessible and convenient for all.
A positive outcome.
Sui label has the potential to make spend podolak asset the only oral LDL lowering therapy, so that could be indicated for CV risk reduction.
We also continue to actively presenting our data at scientific meetings.
We recently announced multiple presentations on <unk> at the American College of Cardiology, 70, <unk> annual scientific session.
Additionally, we announced multiple publications of data in peer reviewed journals, all supporting the safety and efficacy of benzoic acid in diverse patient population and highlighting patients most likely to benefit from our therapy.
As you can see a theory on has made a commitment to the science of lipid two advancing our understanding of benzoic acid is a key oral therapy to address LDL cholesterol and executing clear outcomes, while progressing our pipeline of oral compounds to address cardiovascular and cardiome.
Metabolic disease.
I'll now pass it back to Sheldon for additional commentary on our quarter when Brazil Sheldon.
Thank you Joanne earlier today, we issued a press release containing our financial results for the first quarter, which is available on our investor website.
U S product revenue for the first quarter ended March 31, 2022 was $13 $4 million up approximately 109% year over year.
Royalty revenue for the first quarter ended March 31, 2022 was $1.1 million up 83% year over year.
Combined royalty and partner revenue of $5 $5 million for the first quarter ended March 31, 2022 grew approximately 244% year over year, driven by launches in Belgium, Switzerland, and the Netherlands and continued growth in previously launched territories, we expect our partner to continue.
Rolling out the landowner and you send it to new geographies.
Finally total revenue for the first quarter ended March 31, 2022 was $18 $8 million compared to $8 million for the first quarter of 2021, an increase of approximately 135% year over year.
Turning to expenses gross margin decreased as a percent of revenue largely driven by an increase in the purchase of inventory from our international partners, which has a lower margin in our U S. Sales. We expect this to improve over the year as shipments reached steady state compared to the first half of 2022.
R&D expense for the first quarter was $24 $3 million, a decrease of 13% year over year, primarily related to a reduction in alternative supply manufacturing and compensation costs.
SG&A expense was $34 million for the first quarter, a decrease of 50% year over year or 36% year over year when adjusting for one time legal expenses of $13 $3 million in Q1 2021.
These decreases reflect savings from the transformation for long term success plan implemented in Q4 of 2021.
As of March 31, 2022, cash cash equivalents restricted cash and investment securities available for sale totaled $268 $5 million compared with $309 3 million on December 31 2021.
We are well capitalized and anticipate that our cash runway extends through the anticipated completion and readout of declare outcomes trial and continues to fund continuing operations for the foreseeable future following those results.
Our operating expense guidance for the full year 2022 remains 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 estimate.
Are inclusive of approximately $25 million of noncash stock based compensation expense expected to be incurred during this year.
We recently filed a $400 million shelf registration statement after our previous registration statement expired in February upon the filing of our annual report.
This new filing preserves our financial flexibility for the future, but does not change our belief that we are financed through the readout of the clear outcomes trial and for the foreseeable future beyond that.
That said, we view our stock price is extremely depressed at current levels and continue to work diligently to maximize shareholder value.
In closing I am proud of what our team has accomplished in positioning our organization for the future and alignment with our ever important mission of reducing cardiovascular risk today and in the future.
Cardiovascular disease continues to be the number one killer across the world and it is critical for patients to be able to manage their cholesterol levels effectively.
We believe <unk> has significant potential to help patients reduce their risk of heart attack and stroke and we look forward to the topline results from our clear outcomes trial to provide further insight into the benefits our medicines can provide and key underrepresented patient groups within today's medical care environment.
We have a solid strategy in place to execute on our planned activities and we look forward to providing additional updates on what will be an exciting and productive year for us.
Thank you all for joining today and for your continued support and interest in the spring on operator, we are now ready for Q&A.
Thank you to ask a question you will need to press star one on your telephone to withdraw your question press the pound key again Thats star one on your touched on telephone to ask a question. Please standby, while we compile the Q&A roster.
Our first question comes from the line of Michael <unk> of Jefferies. Your question. Please.
Hi, Good morning, this discharge and wait on the line for Mike <unk>.
Thanks for taking my question and congrats on the strong quarter.
Two for me first of all could you comment on the U S sales trajectory appreciating there's a reasonable increase in price and can you comment on the bottom as well do you see the bottom.
Accelerating into the second quarter, as well and maybe beyond or do you see any impact from the pandemic.
I guess the second one is could you clarify how good your C V O T data needs to be to get the milestone payment from Daiichi.
Specifically is there a bar for efficacy and if you could talk about what are the scenarios for the data to drive what kind of payments and how confident are you in each of the scenarios that would be very helpful. Thank you.
Great Great well first of all good morning, Let me start with your second question and I'll turn it over to Eric Warren for your first question.
As it relates to sales et cetera. So again, thank you for your message as rates of milestone payments for Daiichi Sankyo.
We have the ability to receive up to $300 million from Daiichi sankyo. Upon the conclusion of the clear outcome study and then that data being included into the European label.
I just want to reiterate again the timing the timing of the topline. This is again the top line will be.
In the first quarter of 2023, then the data will be reported at a major meeting but of course, we will also be filing the data with regulatory committees, but that is the milestone and that's how it works with with Daiichi Sankyo, Eric Yeah, absolutely. Good morning, and thank you for the question with.
To growth from a volume perspective, we saw about a six 5% volume increase so that's consistent with the mantra that we've provided of delivering consistent growth throughout the year.
So that will be the mission for the team. We're on track to do so and then of course with clear outcomes, we unlock the exponential growth.
Okay.
Great. Thank you.
Thank you.
Thank you. Our next question comes from Serge Belanger of Needham Your line is open.
Hey, good morning.
A couple of questions for me the first one on the contract.
Salesforce effort. Thank you.
You mentioned, you've been able to target some some new physicians so maybe just.
Describe the effort and whether it can be scaled up as you see success with it and then secondly regarding the collaborative studies with health care.
Delivery system in Northern California.
To that end up in a label expansion or it's more of a.
Move to four guideline positioning down the road. Thank you.
Eric.
Morning, Serge, yes, so the CSO team as you know.
In pilot form we're leveraging the CSO to do three things for US cover the white space cover vacancies as they may arise and to create overlapping coverage for some.
Some targeted hcp's, where we feel like it's essential to have dual coverage. So far so good and we're seeing the CSO able to get in April to have meaningful discussions.
We deployed the team late in January .
Still early but encouraging so far and you're absolutely right. We've got the ability to scale depending upon the returns that we see also depending upon the environment that we operate in so so far so good but still in pilot in early phase.
Sure. This is Joanne. Thank you for your second question regarding the system in Northern California.
Sure.
Is actually a pragmatic study that really is looking at the ability of next door that.
To improve the LDL levels in patients post heart attack.
To your point it would be unlikely that this would indicate a label expansion, but importantly, this is a significant for practicing clinicians and particularly for our system level approach to allow the utilization of Nexus at time of discharge from an acute coronary syndrome or heart attack. So we believe that that will have an important practice.
It's changing implications, but not illegal changing one.
And continues to add to the wealth of information already out there as it relates to <unk>. So.
<unk> about that.
Thanks, Joanne Thank you Serge.
Thank you.
Yeah.
Thank you. Our next question comes from Jason Butler of JMP Securities. Your line is open.
Thanks, Thanks for taking the questions.
A couple for me can you.
I guess I'm a clear outcome study can you just give us an update on the progress you're making with adjudicating events.
And just preparing for database lock and you know in the patients where you already have the events accumulated.
And then a commercial question can you just speak to the dynamics of growth between adding new physicians versus new physicians, writing more prescriptions in the quarter. Thanks.
Okay. Jason. Thank you for your question on the C. V O T. We are continuing to adjudicated events essentially in real time.
Really staying up to speed with that are nearly 95% of events for our mates for.
As well as well over now 100% of the maze three events, we will continue to do that.
Importantly, we are beginning to start end of study visit for the entire global study, which includes bringing in.
Over 28000 end of study visit two periods of 2000 14000 patients and these are progressing if anything ahead of schedule. So we're continuing to look towards top line results Q1 of 2023 and stay.
Stay tuned for less than a year away and then Jason with regards to your commercial question. It's Eric So we're symbol so new HCP are coming in to the to the mix and this is driven by some of the digital activity as you're aware, we've got a three pronged approach, we're leveraging digital world.
Leveraging our personal promotion and we're leveraging peer to peer but we're also seeing increased depth that depth comes as a result of the personal promotion and our representatives are encouraging hcp's two prescribed deeper levels of the products. So we've seen some meaning.
<unk> gains in both of those dynamics.
Great. Thanks for taking my questions.
Thank you.
Okay.
Our next question comes from Jessica Fye of Jpmorgan. Please go ahead.
Hey, guys. Good morning, Thanks for taking my questions.
Following up on one of the prior questions with the Macy's accumulation in clear outcomes nearing 95% is it reasonable to assume the trial could reach 100% of accumulation by early in the third quarter.
Second question is just.
Hoping for a little more color on where Youre seeing next upon next those that use today is it more so in statin intolerant patients or more so in those taking statin, who need some additional LDL lowering and then last question gross to nets looks like they improved this quarter is.
This quarter's Christian that a good run rate for the rest of the year or could we think about continued improvement there.
No just thank you so much for your question with respect to the T V O T.
Certainly we could consider having that 100% in earlier are in.
In the second half of the year.
However, you know that'll depend on the events. The the key though is that there still is a significant amount of time required to close out the study, but we are confident that this study will be closed out including all those end of study visit by the end of the year with topline results Q1.
And then with regards the justice Eric to the types of patients so maximally tolerated statin and DVD.
D V D still require additional ldlc reduction as the primary population that aligns with the label that aligns with the prior authorization criteria and of course, we remained very encouraged by clear outcomes and the potential to expand that population.
And then just regarding your question on G can even going back to this time last year. The one thing that we've been consistent with is the fact that we will look for ways to improve our gross to net so that's something that is continuous we're always continually.
Look for ways to improve RG can I think I've mentioned this before we have weekly meeting to concentrate on this and we'll continue to update you as we go through the quarters on our on our progress, but it's obviously a focus and a priority and we have shown a notable improvement since last year and we will continue to do so.
Great Hey, Eric can I just follow up on that question recognizing that a statin intolerant patient is on their maximum tolerated dose statin, even if it might be no statin.
I was hoping you could kind of within the label.
Break out maybe we can trade that is you know which patients are on moderate to high intensity statin versus low or no statin.
Their Max tolerated statin.
Yeah, I'll, just say the bulk of the focus of our promotion has been on those patients that have tried that and they're not able to get to go and they have that underlying a S. D V. D. Theres some interest from an HCP level and those are those physicians.
From this position.
Are able to push the statin dose at higher levels, but thats not the area where that were encouraging that just creates challenges from a prior authorization perspective, Julian yeah, and just if I could just provide some context I think that you know in general in the U S population, even in a S. C V D patients.
That the majority of statin use its still in that lower intensity.
Lipitor 10 is still the most commonly prescribed.
We're seeing that I think if we switch our label in the U S.
Does not allow technically for statin intolerance right, although to your point you could say that maximally tolerated with Europe . However in Europe in part of the reason for their success is that they don't have maximally tolerated in their label and in their population they do target to your point.
More consistently statin intolerant group of patients and then lastly, we see the P. D O T as really being that opportunity to remove the maximally tolerated from our label and gives us a much broader expansive opportunity irrespective of Skagit.
Yeah.
Great. Thank you.
Thank you. Our next question comes from Jeff Hung of Morgan Stanley . Please go ahead.
For taking my questions you talked about the goal of driving consistent growth up to the cbot results can you talk about any additional levers that you have you may have to further drive growth ahead of the outcomes data.
And then for the next Gen ACO inhibitor.
The broad therapeutic application, how do you think about prioritizing the different indications you'll pursue thanks.
Thanks, Jeff Yeah, so with regards to consistent growth obviously.
Environment that we play in has a it has a factor it was with the Covid environment, we're seeing greater access that's a it's a good sign for us and our ability to drive growth there.
There is a increased level of awareness that we're starting to see as the world opens up we're starting to see for example live Congress engagement and we just recently completed our ACC Congress.
That there is somewhere in the neighborhood of eight to 9000 lives attendees. Obviously the team had a full suite of activities. So as the world continues to open up that creates more momentum for US obviously, we're doing our three pronged approach from a digital perspective, where we are.
Spending more and more time.
So I expect that to continue to bear fruit as well also from a managed care perspective, maybe ill be Jay comment on some momentum that we've got with regards to managed care.
From a payer perspective, we have favorable coverage from a commercial standpoint, and we've done our segmentation analysis down to each geography level showing the opportunity for pull through in addition to that we're also working with very specific ideas on demonstration project from an AUR perspective as well as.
Really embarking into the long term care market, as well, which should provide incremental growth as well and I would just add I think that speaks the partnership we've talked about our partnership with the Northern California institution as well you've seen a number of publications that have also been rolling out over the past few weeks and months and these are always to continue.
To gain more awareness as we continue to March towards the completion of clear and Joanne you want to speak too absolutely. So Jeff. Thank you. So much for the question on our next generation ATP citrate lyase platform.
As Youre aware, we believe the mechanism is one that has opportunity across multiple disease states beyond cardiovascular and moving into cardio metabolic and even oncology.
As you've stated we are continuing to refine potential opportunities in disease states with consideration of diseases, such as Nash kidney disease, as well as cardio metabolic and even oncology with diseases like pattern cellular carcinoma.
We're doing this in a very refined way leveraging data science analytics big data to really help us understand where the opportunities might lie not only from a medical clinical perspective, but also from a commercial one and we will be amassing a group of international experts to advise us in this.
So that we can really ensure that we're making the right decisions with respect to the platform with respect to the reason with respect to the investment in those areas, but really very excited for that platform and the opportunity to expand to a much broader patient population with ATP citrate lyase inhibitors stay tuned.
We will have more information for you at the end of this year.
As we plan, our research and development day.
Thank you. Thank you.
Thank you. Our next question comes from Joseph Thome of Cowen Your line is open.
Good morning, and thank you for taking my question I guess as you look across 'twenty 'twenty three we'll have the data then you'll have the incorporation into treatment guidelines and then also hopefully the updated label I guess when you talk to your physicians, what do they watch and respond to the most I guess, which one of these events could potentially cause the largest.
Increase in scripts and then second.
I guess when you talk to physicians do they say we want to prescribe.
But we want to wait and see how can these data.
How does that conversation go.
And any idea on reorder rates would be helpful. Thank you.
What does.
You're fading at the end.
We got the part of what the folks want to see for outcomes.
We got your second question, but that the last part kind of faded out yes.
Yeah, just on reordering rates.
Once a patient commodity are they staying on therapy.
Yeah, Yeah yeah.
So again, thank you for the question so exactly as you laid out right. We we anticipate that.
'twenty 'twenty three we will have our topline result, ultimately we would anticipate a presentation and publication of the results are early within the year and then label inclusion 'twenty 'twenty four over that time, what we would likely see and what we anticipate is that there will be those who.
Who are have been awaiting outcomes and if you will voting with their feet and waiting for that we anticipate that those individuals will start to prescribe well before we have data in the label and importantly, we anticipate the guidelines would be updated mid year based on our best understanding of the.
Process within the U S and what we anticipate for prevention guideline.
Understand that Pampa delek acid is already in a very significant number of guidelines at present, but we do have that asterisk that says we don't have outcomes, but we anticipate those would be removed them clearly than the label is one that starts to give us greatest value of course with payers. However.
We'll be talking with payers are well before and have a strategy to discuss the data with them before and would anticipate some wins well before the label.
And Eric did you want to speak to the prescription.
Yes, yes. Thanks, so much for the question so with regards to the to the growth comes from from a few sources. So penetration, yes, obviously, a greater depth of penetration. It also comes from access to Joanne point.
Eliminating the maximally tolerated statin and eliminating the dependence upon secondary prevention or is the focus on a S. CBD patients. We recently did some significant quantitative research and we confirmed that both of those components of those leavers are unlocked with clear outcomes.
<unk> significant opportunity with clear outcomes on those two thresholds.
Yeah.
Great and then and then just on the reorder rates are patients staying on therapy once they once they come on.
Yeah from a.
From an adherence perspective now our adherence is very consistent with chronic oral therapies. So we're focused on driving new patients, but we're also focused on maintaining our existing existing patients on therapy at the team coming up with a program called next step which will provide us.
Of resources to further improve that rate of adherence, but very consistent with current chronic oral therapies.
Great. Thank you very much.
Thank you. Our next question comes from Tom Shrader of <unk>. Your line is open.
Hey, good morning. This is <unk>, calling in for Tom. So just one question for me.
Given the recent publications showing the long term durability of empathetic asset I was just wondering if you guys have any plans to.
Perform additional studies as a combination therapy with either <unk> or improved or in the development.
To see how much additional LDL lowering you guys can achieve thank you.
Yeah.
So good morning. Thank you for the question this is Joanne.
So as you mentioned, we just recently published our open label extension studies, demonstrating that consistent benefit I think right now we are waiting for a clear outcome.
And that will really then tell us the opportunity of whether or not we pursue additional studies with respect to combination therapy or the like importantly in our discovery phase as you know we already have an oral P. C. S canine inhibitor as well as the next generation of <unk>.
Take a look at it and I think all of these programs will be informed.
Based on clear outcomes.
As well as the opportunity that presents for combination therapy I think in the field. There is a growing importance of early combination oral therapies to address cardiovascular risk and I think that we are well positioned with our existing therapy next lutalo next was that and have the opportunity as you say to potentially combine.
With other oral therapy to bring those to patients.
Great. Thank you.
Thank you. Our next question comes from Paul Choi of Goldman Sachs. Please go ahead.
Thank you good morning team and thanks for taking our questions questions. Congratulations on the progress.
Sheldon I was wondering if you could maybe just elaborate on your earlier comments regarding the commercial environment and could you maybe just give us a little more color on how you are seeing in your sales force is seeing return to office in terms of patient visits and how much in person or in based on your contract sales force is able to gain versus let's say.
The last couple of quarters in terms of direct interaction in person interactions with prescribers.
Thanks, Paul.
Start and then I'll then also turn it over to Eric.
I think what we've been seeing and I know you've been personally from having been to a doctor's office. The past couple of weeks I think patients are.
Definitely coming back to the office we're hearing.
I was just speaking to one of our business managers, who Eric had a meeting with all of them last week in Philadelphia, there, even see large areas for large practices open up again and welcome patients in so I still think there's a bit of a balance where people are doing telehealth et cetera, but for the most part you know patients are star.
Going to return back to the office.
Our representatives are actually able to gain access where these physicians are open and I know in the news. There is more talk about variance et cetera, but I think also everyone I'm not an expert in this is getting used to the ability to deal with this and get their house health care are addressed so.
I don't see the environment been like what it was a year ago or even a year before that.
So that would just be my overall comments and Eric can talk about some specific examples yeah. So.
Paul.
To hear your voice.
DSO team as a virtual team again, a small team and their focus is on engaging virtually which is got it gives us flexibility for times when the.
The environment may not be as friendly or personal promotion.
<unk> team I would say, it's about 95% in person.
5% virtual engagement.
And rather than being a kind of an or it's an and I really want the team to leverage both virtual and in person to extend their reach to also improve their frequency.
Let's see from an environmental perspective, as I mentioned earlier in the call Congresses that are starting to open up I was encouraged by ACC. Obviously it wasn't ACC of 2019 from an attendance perspective, but it was a step in the right direction. We're also saw.
A lot more live in person peer to peer.
Speaker programs, such as larger programs or smaller pure discussion groups that we conduct so I remain encouraged by the work that the team is doing but I do think that we have the right model and not being completely dependent upon any pillar, but having a balanced promotional pillar.
Going to be really important for us going forward to flex as the environment changes.
Okay, great. Thanks for that Eric and maybe just one for Joanne which is just.
You will debut a little bit more on your oral piece, yes can I and program could you maybe sort of comment on how you think about potential development here relative to the <unk>.
M. K O 616 program, which had some data last year at J, I believe theyre, showing like 60% to 70% type of LDL reduction in patients.
You think about developed.
Development, there and potential areas of focus for differentiation. Thank you.
Yeah. So Paul Thank you so much. So we're excited as you mentioned, we do have this world P. T S canine and we're well aware of the Merck data, which was very impressive.
Given that however, we believe that the scaffold that we have and the approach which is the allosteric inhibition allows us for a smaller molecule with better Cogs and I think as we think about development there really the key with an oral P. C. S. Canine is obviously efficacy, which we believe will optimize with them with our development programs, but.
If anything and almost more importantly, it is allowing and accessible.
Well, it's relatively less expensive option.
And we believe that our Cogs will be critical in that and the approach. We have is critical so stay tuned we're hoping to have more information for the investor community. The scientific community later in the year.
Thank you.
Thank you. Our next question comes from Manuela branch Eddie of H C. Wainwright. Your line is open.
Good morning, everyone and thank you for taking my question and so a question regarding the launch of both drugs in Europe , and perhaps if you could could you provide more color on the stop yourself a dead launch in Europe have T could have any in the regions that were recently I did want to say that any specific update.
Our strategy for a launch in additional geographies.
Sure Yeah sure happy to so first of all good morning Emmanuel.
So Europe is actually as we mentioned in our prepared remarks is doing very well.
Our leading market there is Germany, that's their largest market. There are also launched in the U K they've launched in Belgium, they've launched in Switzerland and.
And as soon as I believe they will also be in Spain.
As we mentioned the launch has been received very well now again, they have a different label than what we have.
They have a label that allows for patients do not have to be on the maximum tolerate dose of a statin.
And they've done a very good job in being able.
We're able to get out there a gain awareness and use that message the number of patients that are.
Currently on a whether it be the lando or do you study actually exceeds.
The number of patients who are actually on Tcf's canines and keep in mind pieces canines had been out in Europe for about seven years. So we've been very happy with their performance and we work very well together, we have weekly meetings with them and it's a very good collaboration.
Great. Thank you for that and if that's the question regarding D create atheists sagging.
Could you give a sense of what he is the past and tissue for patients that currently achieve as Dr. Siegal is supposed Acs event only with the current stand out of Canada, and I guess, how important is the quicker you can see that.
They can go fast Acs eventful or that patient prognosis I'm trying to understand what would be considered a positive outcome in our advantaged study, Florida fourth position.
Yeah, Hi, Manuel and thank you. So much we're really excited about clear Acs for many reasons, but one is that despite the existing therapy and we know that still to this day that post the Acs patients at a year.
70% are not at their goal and we appreciate that and post Acs patients see the LDL recommendation is less than 55. So you recognize that that's a very high bar to achieve with respect to LDL cholesterol, we believe that Denver, delek asset, but particularly the combination with at that.
Next Liz that.
<unk> has a significant opportunity to achieve the LDL goals in these patients and that's exactly the study design of clear Acs right can we add our therapy to existing standard of care in this northern California system.
To improve the proportionate of individuals' post Acs who achieved their LDL goal short term, but even long term and it's a very pragmatic study, but I think we'll provide clinicians a tremendous amount of information in how to better achieve LDL goals in this very high risk group of patients. So hopefully that helps.
It does thank you.
Thank you once again to ask a question. Please press star one on your Touchtone telephone again star one on your Touchtone telephone.
Our next question comes from Judah Frommer of Credit Suisse. Your line is open.
Yeah, Hi, Thanks for taking the question I was just hoping you could remind us of the patient support process you have in place right now as you've moved away from the copay cards. During the pandemic what can patients expect with their first prescription and how is the prior authorization support process for physicians offices changed any.
And what is feedback as of now.
Sure. So what we have found with our office is about 50% of the offices.
Do prior authorizations, exquisitely, well and they have their own support process in place that theres about 50% of our offices.
It really do need assistance with prior authorization, we had put together the next steps navigator program too.
To assist with this endeavor and we have over 5000 patients now enrolled in that program, we're seeing rebuilds from a persistency standpoint, and we have a host of other materials and tactics to use and Austin offices pull through.
And really get patients on product and staying on products. So the prior authorizations continue but what we found is with the right patient. The prior authorizations are to our label exact and when.
When physicians are writing for the right patient and their doctor many.
Where the prior authorizations and those prescriptions do go through so it's been an education, but pleased to say, it's going much better and also to service. We have the next best navigator is the conduit.
It almost comes their services with the offices the patients and then often we'll go back and forth with the payer on behalf of the physician office.
Okay. Thank you.
Thank you at this time I'd like to turn the call back over to Shannon for closing remarks, Sir.
Great. Thank you Rajeev. So I just wanted to first of all again, thank everybody and remind everyone that we are actively educating physicians about the benefits of benzoic acid different patient populations ahead as a clear outcome study.
And and the conference presentations that will come in the future with over $268 million on the balance sheet, our spirit is well capitalized and positioned to execute on our strategy in these current market conditions and beyond and again wanted to thank everyone for their interest in this purion and have a great day.
This concludes today's conference call. Thank you for participating you may now disconnect.
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