Q4 2024 Lexicon Pharmaceuticals Inc Earnings Call
E W. W. Dot Lex pharma dot com and through our SEC filings a webcast of this call along with a slide presentation is also available on our website.
This call we will review the information provided in the release provide a corporate update and then use the remainder of our time to answer your question.
Before we begin let me remind you that we will be making forward looking statements, including statements related to safety efficacy clinical development regulatory status and therapeutic and commercial potential of pill. It up at an Alex 90, 851, so to closing and our other drug programs as well as our business generally these.
These statements May also include characterizations and projections relating to the clinical development regulatory status and market opportunity for a drug programs and the commercial performance of Impella for heart failure.
Call May also contain forward looking statements related to our growth and future operating results.
Covering and development of our drug candidates strategic alliances and intellectual property as well as other matters that are not historical facts or information.
Various risks may cause our actual results to differ materially from those expressed or implied in such forward looking statements and we refer you to our most recent annual report on Form 10-K, and other SEC filings for detailed information describing such risks.
Mike: I would now like to turn the call over to Mike accident, Mike Hey.
Mike: Hey, great. Thanks, Lisa and good afternoon, everyone. Thanks for joining the call.
Mike: Look we've had a busy start to 2025 already including our announcement on Monday of topline results from our progress face to be studied pillow vapid in diabetic peripheral neuropathic pain or J P. M P.
Mike: But as we take a moment to look back and reflect on 2024, I'm immensely proud of the resilience and adaptability of the team and keeping our pipeline of novel medicines moving forward.
Mike: Advancing our lead to succeed strategy.
Mike: Last year, we strategically repositioned lexicon to focus the company and its resources on our clinical development programs and some key highlights from these programs included the early completion of enrollment for our progress study.
Mike: Great progress in our pivotal phase III, so not a <unk> study have started placing in hypertrophic cardiomyopathy.
Mike: C N way, we continue to enroll patients as planned.
Mike: Advancing R&D, enabling studies of Alex not at five one in obesity and related cardiovascular disorders, and lastly, we envy reinvigorated our business development efforts, including a significant licensing licensing agreement with waitress decided to players in outside of the U S and Europe.
Mike: Now I want to begin today's ive reviewed with our most recent significant development a.
Mike: On Monday, we issued a press release and held a conference call to discuss the top line results for progress if I used to be dose finding study of <unk>, our oral non opioid drug candidate a D. P. M P.
Mike: Now the two most important takeaways from our topline announcement. This week our first in all bases in the progress study, including placebo, we observed a clear separation and I D. P. S from baseline with a 10 milligram dose also showing meaningful improvement compared to placebo.
Mike: Secondly, all pill evaporated in trade to Dom showed improved tolerability when compared with our previous released APN study.
Mike: Indeed, the 10 milligram dose of <unk> and shape, particularly better tolerability as compared to relief.
Mike: For these reasons, we successfully taped out corporate objectives for progress with the 10 milligram dose.
Mike: And so these data in combination with the data from the relate study gives us greater confidence in the potential appeal of bad for them to be the first novel oral non opioid D. P M. A medication in more than two decades.
Mike: Moving forward with a 10 milligram dose.
Mike: As you can see on this slide Philip afternoon, 10 milligrams performed strongly improving I D. P. S at week eight.
Mike: Reducing it by one seven points from baseline.
Mike: Now as we continue to analyze the data they're already signals that give us even greater confidence to advance the 10 milligram dose into pivotal trials.
Mike: Cooling the two arms that utilized 10 milligrams.
Mike: The 10 milligram dose plus the 10, plus plus plus the 20 plus 10.
Mike: This podcast Hawk analysis shows an approximately 0.6 I D. P S reduction versus placebo as early as wait too.
Mike: Which is maintained throughout the treatment period.
Mike: Interestingly, while the pain reduction curve of the placebo arm appears to flatten out in the last four weeks of the trial. The 10 milligram dose continues to consistently reduced IEPS schools, suggesting that pivotal trials of 12 weeks duration further separation might be achievable.
Mike: Furthermore, as we outlined on Monday, the 10 milligram dose was well tolerated.
Mike: In progress as many patients with 10 milligram pill evaporating as with placebo completed the trial.
Mike: Inclusive Lee ascribing the Tolerability performance in the previous release study.
Mike: Day, one tent pole loading docks.
Mike: This gives us confidence in the Tolerability of 10 milligrams of <unk> in phase III trials.
Mike: We continue to analyze the data and look forward to presenting the full findings from the progress study.
Mike: Future medical meeting.
Mike: So now I want to talk about what <unk> can potentially mean for patients.
Mike: J P. N P is a large and growing condition that impacts approximately 9 million people in the U S.
Mike: A chronic and progressive pain disorder that severely impairs people's quality of life with the majority of patients experiencing moderate to severe pain.
Mike: When we speak with patients and physicians, it's truly devastating T. How it impacts their everyday life their ability to sleep at night and mental health and their relationships.
Speaker Change: KPN Peggy can also lead to loss of sensation lots of balance falls and fractures and a wealth of other complications.
Speaker Change: But importantly, currently available treatments simply don't provide adequate relief.
Speaker Change: It's estimated about 60% of patients who've tried multiple therapies and only a third of somewhat satisfied with their treatment.
Speaker Change: Now market research, we heard numerous HC pays in patients reporting immense need for new treatment options and in particular, a simple easy to use non opioid treatment options for D. P. M P.
Speaker Change: And finally.
Speaker Change: About a third of DPM paid patients still resorting to short term IPO I'd use for pain relief, even today, when we needed a potentially devastating effects of these treatments. This space is primed for reform.
Speaker Change: I see pes legislators and policymakers prior initiatives such as the alternative to Pine Act provide tailwind to support movement towards new non opioid options.
Speaker Change: Next I'd like to discuss Alex <unk> five one way, we are continuing to advance R&D, enabling studies.
Speaker Change: Alex <unk> five one is our first in class R. O a C. S. L. Five inhibitor for the treatment of obesity and related cardio metabolic disorders.
Speaker Change: In November we presented clinical in vivo efficacy data from two studies related to <unk> 9851 at one <unk>.
Speaker Change: The first study showed that treatment with <unk> 90, 851 resulted in significant reductions in white food intake and fat mass in diet induced obese mice and that Alex 90, 851 mitigated White re guide.
Speaker Change: Following discontinuation of the J L. P. One analog semiconductor Todd.
Speaker Change: The second study characterized the novel mechanism of action of <unk> five one and.
Speaker Change: Howard activates the ileal break to induce satiety and lower desire for additional food consumption.
Speaker Change: We remain on track for 90 submission for <unk> 905, one and 2025 as we evaluate potential partnership opportunities with this innovative mechanism.
So now I wanted to briefly touch on the current status of side of the flows in.
Speaker Change: We have a significant potential opportunity to expand that label in hypertrophic cardiomyopathy.
Speaker Change: They state with high unmet need that impacts about 1 million patients in the U S.
Speaker Change: We're currently enrolling sonata H C M. A global pivotal phase III study, including patients with both obstructive and non obstructive HCM.
Speaker Change: Upon completion of the Hydro dam study with additional evidence and data in hand, we will revisit the Tightass city have decided the flows in asset potentially in the U S.
Speaker Change: In terms of what we're doing today, though as we bridge to this future opportunity.
Speaker Change: And recall, we made the necessary decision to cease all promotion of <unk> pepper in the U S for heart failure.
Speaker Change: Due to the difficult market access environment dominated by two major <unk> two inhibitors.
Speaker Change: Currently started the plays and is available on the U S market with our continued commitment to maintain awareness and provide tools to support patients in an extremely cost effective approach.
Speaker Change: Outside of the U S and Europe were actively working with our exclusive licensee Beatrice on supporting their efforts towards registration and regional development.
Speaker Change: Our medical affairs data generation and publication activities remain ongoing.
Speaker Change: We continue to engage with the scientific community through numerous investigator initiated third party funded studies to build upon our compelling body of medical evidence and sea conditions and outcomes and support side of the pleasant as a differentiator differentiated inhibitor.
Speaker Change: S guilty, one and two.
Speaker Change: Now to that end I wanted to briefly acknowledge a notable recent publication in the lancet diabetes, and endocrinology, which highlighted the effects of side of the players and to reduce major adverse cardiovascular events or mace.
Speaker Change: <unk> option and strike among patients with type two diabetes, chronic kidney disease and high cardiovascular risk.
Speaker Change: The findings show that side of the players in significantly and meaning meaningfully reduces mace versus placebo demonstrating early and broad cardiovascular protection in this population.
Speaker Change: This research also highlighted that side of the flows and is the only <unk> inhibitor to show significant reductions in both M. I N strike.
Speaker Change: Indicating the potential role of <unk> inhibition, and reducing ischemic events and important distinction from selective <unk> two inhibitors.
Speaker Change: As I shared just a moment ago. This supports our goal of demonstrating differentiation of side of the flows in and presents compelling additional support.
Speaker Change: Beatrice on regulatory submissions in key ex U S and ex European markets throughout 2025.
Speaker Change: I'll now turn it over to Scott to walk you through our financial results for the quarter and the year ended December 31 2024.
Scott: Thanks, Mike.
Scott: Lexicon ended 2024 with $238 million in cash cash equivalents and short term investments as compared to $170 million as of December 31 2023.
Scott: As noted in this afternoon's press release, we reported $26 6 million in revenue in the fourth quarter and $31 1 million in revenue for the full year 2024 <unk>.
Scott: Revenues for <unk> were $1 7 million in the fourth quarter of 2024 and $6 million for the full year 2024.
Scott: Total revenues for both the fourth quarter and full year.
Scott: Include an upfront payment of $25 million received in connection with the <unk> licensing agreement.
Scott: Research and development expenses for the fourth quarter increased.
Scott: <unk> increased to $26 7 million from $14 8 million in the fourth quarter of 2023.
Scott: Full year 2020 for research and development expenses increased to $84 5 million.
Scott: Yeah.
Scott: In the.
Scott: In 2023, primarily due to our investments in phase II and phase III clinical trials, including the sonata phase III study of surgical closing in HCM and the progress phase <unk> study of <unk> and D. P. M P.
Scott: Selling general and administrative expenses for the fourth quarter of 2024 were 30 of $32 3 million were comparable to the $32 6 million of SG&A expenses in the fourth quarter of 2023.
Scott: Full year 2020 for SG&A expenses increased to $143 1 million.
Scott: From a $114 million in 2023.
Scott: This increase in 2024 reflects higher marketing costs related to the commercialization of <unk> and increased employee salaries and benefit costs prior to the reduction of our field sales force in late 2024, as well as severance costs associated with our strategic repositioning.
Scott: Net loss for the fourth quarter of 2024 was $33 8 million or <unk> <unk> per share as compared to a net loss of $49 8 million or <unk> 20 per share in the corresponding period in 2023.
Scott: Net loss for the full year, 2024 was $204 million or <unk> 32 per share in.
Scott: In 2024 as compared to a net loss of $177 1 million or <unk> 80 per share for the same period in 2020 threats.
Scott: During 2020 for lexicon took steps to first reduce and then to eliminate all promotional efforts for <unk>.
Scott: This included a significant reduction of employees and the elimination of all promotional efforts for <unk> <unk> in heart failure in the U S.
Scott: We believe these steps will reduce operating expenses moving forward.
Scott: For 2025, we expect total operating expenses to be in the range of 135 million to $145 million.
We expect research and development expenses to be in the range of 100 million to $105 million and.
Scott: And G&A expenses to be in the range of $35 million to $40 million.
Scott: Research and development expenses include costs associated with the ongoing development of surgical closing for HCM <unk>.
Scott: Preparations for the phase III development of <unk> and preclinical costs associated with preparations for the IND filing of <unk> 90 851.
Scott: Research and development expenses for 2025 do not include the cost of pivotal phase III trials for <unk> as the size and scope of these trials will be determined as part of our end of phase II review discussions with the FDA.
Scott: I'll now turn it back to Mike for closing remarks, yes. Thanks Scott.
Mike: Look in summary, we've got a full and exciting year ahead.
Mike: The work we did in 2024 really set the foundation and we look forward to updating you all as the year progresses.
Mike: <unk>, we've got a number of important upcoming catalysts, including disclosure of the full progress dataset you end of phase II meeting with the FDA and data presentations at upcoming endocrinology and pain focused medical meetings.
Mike: In addition to the important upcoming milestones we discussed today. We're also very actively engaged in partnership discussions that would enhance our clinical and commercial capabilities and help us maximize the potential of all of our novel therapies. This will be critical focus for the company in the coming months.
Mike: With that Scott, Craig and I have time to take all of your questions. So I'll turn it back to you all correctly.
Mike: As a reminder to ask a question. Please press star one one on your telephone and wait for your name to be announced toward the draw. Your question. Please press star one one again please.
Mike: Please stand by while we compile the Q&A roster.
Speaker Change: Our first question comes from the line of Joseph Stringer from Needham and co.
Speaker Change: Hi, Thanks for taking our questions.
Speaker Change: For loss will ask on the 90, 851, oral obesity asset and kind of the clinical development plan there.
Speaker Change: Couple of questions on that is that only being considered as a combo therapy was saying with drug or is there an option for mono therapy and then.
Speaker Change: What are the potential indications <unk> trial designs that you're thinking of or an initial phase one.
Speaker Change: And then <unk>.
Speaker Change: Lastly, if if the decision is made to ultimately partner that program how much clinical data do you think you need to generate the forward makes sense too.
Speaker Change: Engage or turn it over to potential partners.
Joe: So Joe you Craig I'll answer the first two questions and probably turn it back over to Mike for the third.
Joe: We really see this molecule is being developed both as monotherapy and combination therapy monotherapy alone or mono therapy. After discontinuation of an injectable or other G. L. P. One agonist snowing.
Joe: With the data that has come in with the Injectables at least that a vast majority of patients don't remain on therapy for more than a year. In fact, the median duration of somewhere between six and 12 months.
Joe: So what we've demonstrated in the animal models is the activity of the drug is independent and additive on top of <unk>, even maximum dose <unk> and if you would draw the semi glu tight and then at the 90 851 that you've largely maintained the weight loss, whereas if you don't at the 90 851 way.
Joe: Return very quickly to baseline, which is also the situation in in patients. So we see that there is an opportunity in both.
Joe: Mono and combination therapy.
Joe: The second question on the clinical program.
Joe: Think the phase one program is going to be pretty standard what we've communicated before as we have.
Joe: A few critical goals that would be a part of the phase one clinical program first and most importantly is due patients actually lose weight similar to what we've seen in the animal models.
Joe: The second is the Tolerability.
Joe: <unk>.
Joe: The therapy, because again, you always have to wonder and these agreements. The question is will it be well tolerated, especially with the novel mechanism of action like the legal break we haven't seen anything in the animal models that suggest that would be an issue with tolerability, but that would be an important component and the third is to demonstrate that there is a clear mechanistic.
Joe: Differentiation from the G. L. P. One mechanism. So I think those would really be the three critical goals that we've certainly thought about running the phase one program and I'll turn it back over to Mike before that the last part of your yes. Thanks. Thanks for the question.
Joe: As you can imagine with a completely novel an orthogonal mechanisms.
Joe: To the GOP and one in in Cretin based mechanisms space a number of companies that have not only been interested in this particular asset.
Joe: We engaged in the data.
Joe: Over the last months, we've been talking to a number of players.
Joe: And what it would take two to move into a partnership from a data perspective.
Joe: Is really quite varied.
Joe: In a way.
Joe: If we do have the right partner with the rock conditions.
Joe: At any particular time to move into partnership because ultimately.
Joe: We believe that this program is best served with a with a partner.
Joe: To really capitalize on the on the breadth of indications again with the potential for indications beyond the basic <unk>.
Joe: As well as the.
Joe: The commercialization of this particular particular mechanism ultimately so that's where we're at with with non at 501 and potential partner partnering opportunities.
Joe: Great. Thank you so much for taking our questions.
Joe: Thank you okay.
Speaker Change: One moment for our next question.
Speaker Change: Our next question comes from the line of Yasmin Rahimi from Piper Sandler.
Speaker Change: Hi, This is Hannah on for you. Thank you for taking our questions.
Speaker Change: My first question is could you provide some color on how enrollment is progressing into your vanilla study and when you expect enrollment completion.
Speaker Change: And with that.
Speaker Change: How soon could you engage with the FDA for the end of phase two meeting for <unk> and start planning for phase III and finally, what are the rate limiting steps to complete for the IND filing for 95, one which was previously discussed.
Speaker Change: Yes.
Speaker Change: Alright, three three great questions on three different programs.
Speaker Change: Electronic have established.
Tina: Thanks Tina.
Speaker Change: I'll answer them in order on the HCM program, we've been really pleased by the feedback we've gotten we've had a number of investigator meetings, both in the U S and outside the U S.
Speaker Change: We focus first and initially on opening sites in the U S. We've communicated that we're targeting about 30 sites in the United States.
Speaker Change: Third 20 sites overall with a target enrollment of about 500 patients 250, each stratified for obstructive and non obstructive.
Speaker Change: I can say that we've made outstanding progress in getting all.
Speaker Change: All the government approvals necessary to to have those conversations in countries outside the U S and we have sites open in non U S countries right now again, we have not been forthcoming with exactly what those are but we can say that we are opening sites on plan. We have patients that are actively in screening and <unk>.
Speaker Change: Actively in treatment.
Speaker Change: Today similar to the timelines we set.
Speaker Change: The timelines I think we've talked about.
Speaker Change: Is that we're looking to have final study results towards the end of 'twenty six.
Speaker Change: Which means that we would be.
Speaker Change: Filing with the FDA, probably sometime in the first quarter of 2007 those are our current timelines. Obviously, it's early days in the trial, but those are the timelines that we've put forward and there's nothing at this point that we think theres going to be significantly changing those timelines at the moment.
Speaker Change: So if that answers your questions on HCM I'll move forward to <unk>.
Speaker Change: For <unk>, we've communicated.
Speaker Change: I'm, sorry, I didn't mean to cut you off.
Speaker Change: For <unk>, we're really as Mike mentioned and I think we mentioned in the call on Monday, we're really looking to get down to the FDA and have the end of phase II meeting sometime in the second half of this year with the possibility of starting phase III Phase III program before the end of 2025, obviously that will be dependent on.
A number of other factors, but those are the timelines that we feel comfortable that and just to reiterate what Mike said is that we are more confident than ever in that 10 milligram dose as being the right dose and that the progress study really clarified the open issues that we had.
Speaker Change: Going into the study about what is the best dose to go into phase III balancing both safety and efficacy and do you need a loading dose or not so we feel quite quite strongly.
Speaker Change: Positive now.
Speaker Change: To move to the end of Phase II published the data this year and then move into phase III.
Speaker Change: On 90 851.
Speaker Change: Mentioned and I think Mike talked about that our plan is to have all of the IND, enabling studies done this year to get down to the FDA and have that meeting and be ready to start.
Speaker Change: The first in human studies before the end of the year.
Speaker Change: The timelines that we continue to track to doing all of the IND, enabling studies right now we have to do the dose finding from the animal studies to do the final toxicology studies that are required as part of the standard IND package and were working.
Speaker Change: Actively against those targets.
Thank you so much.
Speaker Change: Thank you Tina.
Speaker Change: One moment for our next question.
Speaker Change: Our next question comes from the line of Joe Pan Janus from H C. Wainwright.
Speaker Change: Hey, everybody. Good afternoon. Thanks for taking the questions two questions. If you don't mind, so for pillow vapid and data that you just put out.
Speaker Change: Sort of looking forward question.
Speaker Change: Craig on the call earlier said.
Speaker Change: Some broad strokes as to what the phase III program might look at look like.
Speaker Change: Can you discuss anything right now with regard to what you feel might be the key opening questions. <unk> wish list that you might have going into the FDA meeting and of course, they could absolutely change tomorrow.
Joe: Yes, Joe Great Great question.
I think we mentioned, perhaps at least in passing on.
Joe: And Monday some of the critical things that we're going to look at it as we get the final data set in.
A couple of them, we've really talked about some of the key secondary endpoints that we think are most meaningful to patients as Mike talked about is particularly sleep interruption and burning pain. So those are going to be important endpoints that we.
Joe: We want to take a look at as we get the full data set in another one that we believe it's pretty important to look at is the use of the acetaminophen rescue.
Joe: Protocol as you remember from relief that correlated really nicely with response that there was much greater and earlier use of the <unk> rescue in the placebo arm than in the active arm and we feel comfortable that those three particularly are going to be important.
Joe: Elements that will be consistent or hopefully consistent with the primary endpoint data that we shared and we're certainly consistent in their elite study I think the other area that we have an interest and I know.
Joe: Number of people that have asked have interest is what was the response.
Joe: Regardless of the underlying single D. Pnp medication use and as a reminder, in relief we demonstrated activity independent from the underlying <unk> medication and on top of the <unk> medication. So I think that is going to be another important question, because I think going into phase III.
Joe: If we can demonstrate we have activity, both with or without underlying <unk> medication here. So I think that will be very important for patients healthcare providers.
Joe: And payers to know.
Joe: We will also continue to look at some of the additional safety parameters.
Joe: In reference to <unk> looking at that in some of the demographic factors as I think we mentioned there were some notable differences in the demographics, particularly the representation of.
Black Americans in the trial was nearly double so we will continue to look at some of those factors as well I hope that wasn't too long a list Joe no no thats fantastic I appreciate that color and then just quickly I guess.
Joe: Financial logistical question, if you will.
Joe: Just wanted to make sure have the in Perth.
Joe: One time charges worked through the system already or should we expect any for the first quarter.
Scott: Hey, Joe It's Scott.
Joe: No I would say that it's safe assumption that all the costs were a crew.
Crude certainly accrued as of the end of the year.
Speaker Change: Perfect. Thanks for all the color guys.
Joe: Yeah.
Joe: Thanks Chuck.
Joe: Thank you one moment for our next question.
Speaker Change: Our next question comes from the line of Andrew Tsai from Jefferies.
Andrew Tsai: Hey, Thanks, Good afternoon I appreciate all the updates.
Andrew Tsai: Two questions on pain on my side for.
Andrew Tsai: For the upcoming FDA end of phase II meeting could it make sense to ask them. If this phase <unk>.
Andrew Tsai: Counts as a supporting pivotal.
Andrew Tsai: And by extension do you have a base case or upside case internally and then secondly at this juncture do you think you would be powering the phase III.
Andrew Tsai: To what you saw in the phase II or the phase two b for the 10 nicked us. Thank you.
Andrew Tsai: Yeah, Andrew Thanks for the question.
Andrew Tsai: Certainly that would be an upside in our current scenario planning of having this trial be counted as a pivotal we would see it counting strong as a supportive trial, but our base assumption would not be that this was a pivotal trial in <unk>.
Andrew Tsai: As we've previously shared our current thinking, which obviously will be impacted by FDA is that we'd be looking at two pivotal trials going into the phase III program. Each one of which would have a roughly 3% to 400 patients in size and to your question, we would probably power it.
Andrew Tsai: Similarly, we powered.
Andrew Tsai: Both of these.
Andrew Tsai: Current trials for the statistics of a 0.6 drop on a placebo adjusted basis.
Speaker Change: I wanted to reaffirm one of the points that Mike made.
Andrew Tsai: In passing.
Andrew Tsai: That.
Andrew Tsai: We demonstrated in the progress study that at the 10 milligram dose the pain scores continue to decline at a linear rate that was really consistent from week three arms that you saw a sharp drop in the first couple of weeks and then the slope of the curve changed but remained pretty consistent.
Andrew Tsai: From week, three or so do we gate, we don't see any reason why that would particularly mitigate between week eight and week 12, and a few quarters.
Andrew Tsai: Rate line that out we think that that pain score is going to continue to significantly drop.
If you look at the placebo in what has traditionally been seen in pain studies with placebo.
Andrew Tsai: That tends to plateau at somewhere between four and eight weeks and you can already see hints of that in this trial and in the relief trial, that's a plateau.
Andrew Tsai: Placebo is beginning a plateau, so we feel quite confident or comfortable that that wedge that growing wedge of difference from the placebo in pain score to the drug will continue to grow between week eight and week 12, and net debt zero point fixed drop is something that we think as we can.
Andrew Tsai: Comfortably achieved.
Andrew Tsai: Thanks I appreciate it.
Thanks, Andrew.
Andrew Tsai: Thank you one moment for our next question.
Speaker Change: Our next question comes from the line of Rowenta Reece from Leerink partners.
Speaker Change: Hi, all this is amazing on for marijuana.
Speaker Change: We just had to commercialization questions kind of around <unk> and HCM. So for one what are your thoughts around partnership and commercial commercialization.
Speaker Change: For that asset and it's kind of a two parter and the second part B.
Speaker Change: How does that differ across different regions, where CMI use may be.
Speaker Change: Impacted countries of.
Speaker Change: In Africa, and Asia, I think that we are seeing that uses a lot less and so just kind of wanted your insights around that please thanks.
Speaker Change: No great great questions. So firstly.
Speaker Change: HCM ex U S and ex Europe.
Speaker Change: That is entirely license to <unk> flows and partner. So if you like rest of world.
Speaker Change: <unk>, where we're closely connected with them to help them in the registration process et cetera.
Speaker Change: For HCM as well as the other indications.
Speaker Change: The U S and for Europe.
Speaker Change: I think we've mentioned before we don't have any any intention and expanding our presence and certainly not our commercial presence outside of the U S. So we would be seeking a partner for Europe, where there is pretty substantial CMI uses eni.
Speaker Change: And then it comes to the U S and really we feel we've got the expertise and capabilities to commercialize HCM outside of the flows and for HCM and as we've mentioned before it's going to be a very different payer situation for HCM as the first and only <unk>.
Speaker Change: T inhibitor approved for HCM to what we see for and Pepper in heart failure, and so that will provide us with a much different potential commercialization trajectory now one interesting.
Speaker Change: And final aspect to that commercialization approach is unlike the semis and I think this will continue.
Speaker Change: With currently approved and future approved <unk> there will be used.
Speaker Change: Pretty focused way incentives of excellence that treat <unk> cm patients journey.
Speaker Change: Cardiology.
Speaker Change: C <unk> patients and are able to diagnose.
Speaker Change: And the <unk> as a class is very well known by general cardiologists, and so really there is an opportunity.
Speaker Change: Although we certainly see ourselves playing a significant role commercially in the U S. There may be other partnering opportunities as we move forward, but we will hold a very significant if not so.
Speaker Change: To commercializing that in the U S.
Oh, great. Okay. Thanks for the added color actually develop on that then.
As we think about the baseline characteristics percent order.
Speaker Change: Are there any targets for the amount of patients that could be on background beta blocker CMI therapy.
Speaker Change: Great Great question, Nathan Thats, we have not put limitations on any baseline or background therapy. We took a very similar approach to what we did with the scored and soloist trials, where we included all patients with heart failure in those trials, regardless of where they were half rep or have passed.
Speaker Change: In this trial were taking all patients that remained symptomatic as defined by baseline <unk> score.
Speaker Change: So they can be on any underlying medications, including our CMI in that regard.
Speaker Change: And what we really care most about is that they have.
Speaker Change: A adequate we low cases EQ score at baseline that's really the major criteria as a reminder, also.
Speaker Change: Ejection fraction that we allow as and es down to 50%.
Speaker Change: So I think the opportunity to include both obstructive non obstructive.
Speaker Change: Background therapies that exist, including <unk>, and then <unk> down to 50%.
Speaker Change: As well as having the primary endpoint as Casey CQ. The secondary endpoint is New York Heart and no requirement for all of the echoes that the CMI require that has all of the other physiologic testing the peak Rio two and others that really make it very difficult.
Speaker Change: To enroll those trials and limit the number of centers in those trials, we believe that our trial offers a number of different upsides in that regard.
Speaker Change: Very helpful.
Speaker Change: Thank you all for the added color.
Speaker Change: Yes, Thanks, Brian.
Speaker Change: Thank you.
Mike: At this time I would now like to turn the conference back over to Mike <unk> for closing remarks.
Speaker Change: Well, thanks, everyone for joining us this afternoon that was great.
Mike: Great to have you all here and give you a complete update across the three pretty significant programs that we have.
Mike: Good players and fulfill <unk> 501.
Mike: We've got a busy quarter ahead of us.
Mike: And really look forward to updating you as we progress throughout the quarter and indeed throughout the year. So thank.
Mike: Thank you very much operator, and say everyone later.
Mike: This concludes today's conference call. Thank you for participating you may now disconnect.
Mike: Okay.
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