Q1 2021 Intercept Pharmaceuticals Inc Earnings Call
Yeah.
[music].
Welcome to the Q1 on the 21 intercept pharmaceuticals.
My name's and net and I'll be your operator for today's call. At this time, all participants are and and listen only mode. Later, we will conduct a question and answer session.
First quarter 2021 earnings conference call.
We've been focused on our priorities and the first quarter of this year and have made progress across all key fronts.
Including first finalizing our Ocala of of label update and the U S, which is now nearly complete we anticipate announcing our updated label and the coming days.
Second advancing our Nash development program, where we've had multiple interactions with FDA and where and the process of generating a significant amount of additional data and support of our dialogue with the agency.
And third continuing to make progress on our pipeline.
I'm going to begin today by discussing our PVC business, including our solid performance and the first quarter. I'll, then turn it over to Gail to provide and update on our labeling discussion with FDA, Our Nash development program and our other pipeline activities Rocco will conclude with an overview of our financial performance and update to our guidance before we take your questions.
Let's start with our PVC business, where we had another quarter of.
The double digit growth worldwide O'callaghan net sales and the first quarter of 2021 were $81 $7 million representing.
Representing about 12% growth over the prior year quarter.
We had solid performance and the U S with sales of $57 3 million, representing 13% growth over the prior year quarter.
And we shared findings from a comprehensive safety assessment with the FDA earlier this year and have been working with the agency to translate the implications of the miss into updates to the yokel of of label.
These label updates focus on patients who reach the most advanced stages of PVC and not on the broader PVC population.
Patience with PVC and cirrhosis demonstrate of wide spectrum of disease severity from clinically stable compensated cirrhosis to and stage decompensate of disease.
And the development of portal hypertension, and these patients is the key pathophysiological event of longest natural disease progression and is often associated with serious consequences of advanced liver disease.
From a patient identification perspective, we believe this approach is clear and will enable prescribers to delineate those who are eligible for a calibre. The only approved second line medicine for patients with PVC.
Regarding our post approval studies cobalt and four O. One we continue to discuss potential modifications to these studies with FDA any of May.
The final Oh Khalaf of label update will play a role and the discussions about our post marketing steady requirements, but we expect that the process of defining of path forward for the studies will continue beyond the label update given the need to align with both FTA MDMA.
Now, let's turn to our Nash development program.
As we've previously stated alignment with FDA on the right data and the subsequent interpretation of that data a key dependencies prior to of potential resubmission.
We are working towards that alignment and a step by step process, including multiple recent and upcoming formal interactions with the agency each of which requires significant preparation.
As a reminder, we believe there are three key items that we need to align with FDA on prior to of potential resubmission of our NDA through the accelerated approval pathway.
First of shared understanding of <unk> safety profile and the Nash fibrosis population, which will be supported by a comprehensive safety update to refresh and increase the amount of safety data to discuss with FDA.
Second biopsy reading methodology and important topic for the field as regulators thought leaders and industry work to establish new approaches to reduce variability and improve accuracy.
And lastly, and importantly, what if any additional efficacy data will be beneficial to better support the benefit risk profile of OS.
And Nash fibrosis.
And the the 18 months interim analysis will have all reached their 48 months time point.
Importantly, the regenerate outcomes trial is and event driven study, meaning that the study complete with the pre specified number of events occur.
As such the exact timing of completion is difficult to predict as.
As we've previously stated our completion date is likely some years away and our latest estimates 0.2 of potential completion day.
Eight and 2025.
We also have our second large pivotal Nash phase three study reverse underway and patience with compensated cirrhosis due to Nash.
We believe the data from rivers will provide important learnings and the Nash compensated cirrhosis population of group of patients with very high unmet need.
We plan to take advantage of our work with FDA to rely on on biopsy methodology as we prepare for of top line read out at the end of this year.
We also continue to make progress on our pipeline our phase two O C. A plus versus hybrid trial is still currently enrolling outside the U S. And we now have an open I N D for the combination in the U S.
Enrollment and a rare disease clinical trial does not require of high number of patients, but may take more time do the COVID-19.
We will provide and estimated timeline when trial enrollment is complete.
Recently published day, the supporting the benefit of beds of favorite and PVC are encouraging and reinforced the potential for synergistic profile and the combination approach with <unk>.
Finally, turning to our next generation FX are agonist Int 78, seven and we plan to initiate of first and human study later this year.
We will provide additional updates once this process is underway.
I will now turn the call back over to Jerry for for the remarks Jerry.
Thanks scale as we look to the remainder of the year. Our most immediate focuses on finalizing the caliber label update and the U S C.
Important to note that the significant majority of patients eligible for Ocala of it will not be impacted by the label Church.
In terms of the population that will potentially be impacted we're in the process of finalizing the label that would restrict ocala of is used and patience with day compensated cirrhosis.
Those of the priority compensation of events.
And those were the compensated cirrhosis with evidence of portal hypertension.
We estimate that roughly 20% to 25% of the current ocala of of patients could have cirrhosis of.
The portion of of of caliber patients that we expect to be impacted by the final label changes would be a subset of this overall cirrhotic group.
As you would imagine the rate of cirrhosis and PVC can vary by treatment study for example, the right tends to be higher and herpetology centers and lower and the community setting.
We're fully prepared to support and educate patients and providers through this upcoming label update and that process will be implemented as soon as the label is final.
Following the label update of significant majority of PVC patients, who could benefit from second line treatment will remain eligible pro caliber.
Our long term focus and commitment to supporting those patients will continue to be a high priority.
Turning now to Nash or continue the objective is to align with FDA on the Resubmission package for NDA that increases the probability of success. This is a multifaceted process that will require additional work and additional interactions with the agency and therefore, we can no longer reiterate of potential submission by the end of this year we.
Look forward to narrowing and refining our plans for potential resubmission and the third quarter of this year.
Now turning to the E U.
Since our last update we've been formally granted a six month clock stopped and the review of <unk> for the treatment of mashed fibrosis. This additional time allows us to focus on executing on the feedback we received from both FDA AVMA and provides us with the ability to potentially include some of the new data, we're generating as part of the review process and Europe.
Before we turn to our financial results I wanted to announce that Chris wire.
Our executive Vice President of research and development has decided to leave intercept to pursue of new opportunity I want to thank Chris for his contributions to the company and wish him well and his future endeavors.
As we've previously discussed our work towards potential Resubmission and asked fibrosis is led by a strong dedicated team of both internal experts and external advisors Mark present ski as part of his ongoing advisory role with intercept will continue to support of R&D team from of Science and strategy perspective, This will ensure business continuity and of smooth.
Transition until the new permanent ahead of R&D is named.
I wanted to say a few final words about intercept progress navigating a regulatory dialogue and both PVC of Nash.
I'm pleased that we're nearing the conclusion of our work with FDA on updates to the account of of label, which will provide important new guidance for health care providers and patients with PVC.
This clarity on the label will allow us to focus on the future and continue to support the significant majority of patients who will remain eligible for treatment.
As we continue our work with the FDA MDMA on our Nash program, we remain committed to taking the necessary actions to arrive at the right informed decisions regarding our path forward.
And parallel with our near term focus on the regulatory dialogue and PVC of Nash. We've continued to advanced key pipeline activities that position intercept for future success and build on our leadership position and the liver space, we expect to communicate more on our pipeline later this year and now that we of clarity on our label update to our foundational PVC franchise we.
Can increase our focus on identifying additional opportunities to leverage our strength and our expertise.
And now I'll turn the call over to Rocko been easier for financial updates.
Rocco.
Thank you Jerry and the.
Good morning, everyone. Please refer to our press release issued earlier today for a summary of our financial results for the first quarter and then March 31 2021.
And the first quarter, we recognized 81 $7 million and the worldwide Ocala. The net sales. This was an increase of 9 million versus prior year quarter.
Our worldwide Ocala. The net sales were comprised of use net sales of $57.3 million and ex U S. Net sales of $24.4 billion. This represents growth of approximately 13% and the 11% respectively versus the prior year quarter.
As Jerry mentioned earlier or solid first quarter results and the U S were driven primarily by continuing demand growth, although as anticipated we have some slower growth and new patient start as a result of the COVID-19.
During the first quarter possible scripts were generated by new prescribers.
We also experienced the typical seasonality and Q1 as patients were impacted by the resetting of insurance plans and Medicare coverage cat.
This led to a higher gross and that percentage for the quarter.
Our GAAP operating expenses and non-GAAP adjusted operating expenses for the quarter of 111.0 and $101.7 million respectively. This.
This was the decrease the $45.1 million and $41.2 million versus the prior year quarter.
As a reminder hour of non-GAAP adjusted operating expenses exclude stock based compensation and depreciation non.
Non gap adjusted operating expenses and the non-GAAP financial measure under SPC deregulation.
Please refer to our press release issued earlier this morning, or a full explanation and reconciliation of this measure.
Our cost of the sales was point $8 million and the first quarter as compared to the point $9 million and the prior year quarter.
Selling general and administrative expenses for the corridor $59.3 million.
This was the decrease of $39.3 million over the prior year quarter and was driven by our efforts to lower operating expenses and order to provide a strong financial foundation of the company going forward.
Research and development expenses for the quarter were $58 million. This was the decrease the five $9 million of a prior year quarter and was primarily driven by lower Nash and No-cal, the API developed and the call.
As of March 31, 2021, and we're well positioned with cash cash equivalents restricted cash and the investment that securities available for sale of approximately 418.6 million.
And now turning tour of financial guidance for the year.
As a reminder, last quarter, we issued a full year of 2021, well worldwide Ocala, the net sales guidance between the $325 million and $355 billion.
As a result of the latest dialogue with the FDA, which we expect the result of and the label update restrict and the use of locale of and patience with the compensate US Roses and then the subset of patients with compensate of cirrhosis, we are narrowing Ah Raquel the net sales guidance range.
We now expect a full year of 2021 worldwide o'carroll, the net sales to be between $325 million and $340 million.
What's the label finalized as we monitor posts label update market dynamics, we will plan to refine the strange throughout the year as necessary.
We are reiterating our full year of 2021, non-GAAP, but just the operating expenses to be between $380 million to $410.
In summary, I am pleased with the strong commercial performance and our ability to manage expenses and the first quarter.
Remained well positioned to continue investing and the growth of our Okello franchise supporting our national regulatory processes, with the da and and BMA and furthering of a pipeline by bowling on a strong foundation.
With that and now like to turn it over to the operator for any questions.
Operator.
Thank you we will now begin the Q&A session. If you have a <unk>.
<unk>. Please press Star then one on your Touchtone phone, if you wish to be removed from the queue press the pound sign or the hatch.
And there will be of delay before the first question is and now and if you are using a speakerphone you may need to pick up the handset first before pressing the numbers and once again if you have a question. Please press star and one on your Touchtone phone.
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[noise], Okay, and our first call and it's from and please excuse and fine and.
Uhm Mispronounce of your name I'm, sorry, <unk> from how and go ahead. Please.
Hi, guys and thanks for taking the question. This morning, so and Jerry I wanted to just fell down further on the percentage of patients P. B two patients with compensated uhm portal hypertension that we could be expecting and and we have to revise guidance, but can you.
<unk>.
Could you, let us know if like the definition of portal hypertension, whether it's like the range is at five millimeters of mercury or or that you know any any quaint within the work up for portal hypertension is different four P. B C patients and I guess the standard portal hypertension.
Yeah standard portal hypertension work up like should we be thinking about that 15 millimeters of mercury or or more.
Okay. Thanks. Thanks for the question I think what would the B b. Good I'll have Gail give you you know and and overview on what we're expecting from the label again, we're at the end of of the process. We would anticipate based on the interactions that we have of had today.
The the process will will and shortly but perhaps guilt and give you an overview of of what we're expecting to see what we anticipate and then I can comment a little bit on on the front and of your question in terms of some of the range is.
Gail Thanks, Jerry so to give a little clarity, let me get the one step at for just a second and just again define what we said is where the uhm the label will change will apply the different patients.
First patience with the compensated cirrhosis of the most severe group of patients will be excluded from the label the.
This is of population uhm, it can be quite sick and steadying of medicine and that setting can be very very challenging, particularly when for kind of keys.
The your question focused on this population with put on hypertension. So just to clarify again for a second before we step right to your question Uhm cirrhosis on the compensated side can be divided into two subset and.
And there's those who are early on and the spectrum of seriousness and who I really am somewhat indistinguishable from patients with out to the races until they develop port of hypertension now the way port of hypertension is described P. S is clinical evidence of poured on hypertension or evidence of part of hate.
Attention. So we're not looking for and invasive procedure or something else to assess put of hypertension, but rather the clinical evidence that doctors using the practice really every day since a recognize that one stations with cirrhosis progressed of having put of hypertension the risk for adversely.
The outcomes really increases again once you have cirrhosis and progression of the portal hypertension. We then we'll have a country indication at that point.
So if we think then and the context of of the the overall Cirrhotic group. So you know we we do estimate based on a variety of of sources both from the U S and the next you asked the the proportion of.
Of Ocala of of patients overall.
That that have the evidence of cirrhosis as in that range of 20% to 25% again the day compensated group as Gail mentioned will we anticipate will be restricted.
By the new label that's in the mid single digits and then you'll have the compensated group, we're somewhere in the range of of about half of of the compensated of group of might fall into this evidence the portal hypertension.
So that's how we think about the picture at this point of.
Of court on it as the label is is is finalized will will monitor the the dynamics and the market and and and continue to update.
Got it and then the very quick follow up on the Nash side, you noted like the three topics of discussion with F. D. A safety Foxy mythology, and reset the kind of analysis on the safety side you guys highlighted liver toxicity is it fair to assume that you that the conversation on that topic.
Focus more on liver safety at this point, then any let the changes or or let the change is still the topic of discussion.
<unk>.
Sure. So uhm, it's important to recognize that F. T as really been interested and the full spectrum of the uhm account of that where the <unk> excuse me safety profile, and you know and and note that Israeli a lot of published material and the public and material and the public domain about the safety profile and way of continuing to generate more.
And as the regenerate steady continues.
Great. Thanks for taking the questions.
Thank you.
Okay and our next question.
Comes from Brian E brands from our B C. Brian go ahead.
Hi, Thanks, so much for taking my question and this is actually good with two two on for Brian.
Just making about and the mascot of them and and drove me off of <unk> of maybe could you just help us understand maybe what is the author Cheng and sort of your understanding of of the code from the directions Navy or or what needed to be alive and rethink welcome three buckets the.
Like in the Navy of clarity on a couple of online through Refiling here.
Thank you for the question David you know as as we mentioned the prepared remarks, we have had multiple interactions we have more plan.
I think we continue to to work overall on the question of risk benefit as you could imagine and then in that context. The three areas that we've outlined the comprehensive safety update the biopsy approach and and ultimately the potential for additional F.
Fricassee, So I think we've gotten.
And as the we've indicated some better clarity on some of the specifics around the day to we need to generate as we prepare for the comprehensive safety update which we anticipate the that that data will be a significant increase and the the level of exposure, which we think could be important we've been encouraged.
By the level of engagement from the agency. We we have had interactions we have more planned coming and I think you know our focus continues to be on getting clarity, sometimes that clarity create some better insight on the work we have to do as well as you know of a better idea of the sequel.
<unk> of the interactions to come and and so as we work on this thing Holistically on the overall picture of it's all of those elements that you know and the context of the step by step approach and us wanting to avoid unknowns later on that you know we continue to work on the plan moving forward and.
And do anticipate will come back and quarter three with a refinement on that.
Daughter to help one and a quick follow up on on the T. V. C thought of on the Uhm, just just thinking more about the I guess, the ex zero five and and stronghold.
Stronghold on on could you make a digging by the both of your Christmas Darken off of the digital education and activity.
Could you.
How 'bout the better understand the dynamics on the eve, but I know for the record and egg a little bit more navy volatile on the outside but.
And you're thinking about the rest of the year on him.
The Navy continue the digital education activities and and I I.
I, just want to come and stay on it and how.
How much of a room day here, we might see and how much the contributes maybe at the Guy though.
So I can start on that and perhaps rocker would would the would want to add on you know we do continue to.
And when you give that updated and the third quarter or are you just gonna come out and and sort of say that you have the alignment now you're gonna give more color around that and and secondly can you just sort of set expectations for the phase III data.
You should be getting around the ear and of the ear.
Thank you.
Thanks, sorry.
I'll I'll I'll start so I think.
The as we've outlined on on Nash the interactions.
We have had multiple formal interactions and I think importantly of good view forward for some some steps to come.
Think that within the context of the quarter three update we anticipate the have feedback from some of these key discussion.
On some of the key topics again.
Coming back to progress on the clarity.
Clarity on what the state the updates could look like.
Some of the details that will have to work through yet with the with the agency for example on the analysis plan on on safety biopsy, we will anticipate making some some progress so the update that I referred to in quarter. Three we should think about that both update on our work and our planning as well as.
And update on some of the key elements coming from.
Coming from the regulatory dialogue.
I think your second question was about reverse.
So we are.
Continuing to view reverse is an important data set and and important population as a reminder of this as a group of Nash patients with compensated.
Cirrhosis, that's our second major.
Phase three that we're working towards the top line readout of by the end of the year, where we're going to learn.
More about the role of OS da and a different Inc.
And the incremental patient population.
So we're working towards that.
Thanks.
Thank you all right.
Okay and the next question is from F. T F from Cantor Fitzgerald out the go ahead.
Hi, This is Emily on currently.
Just a quick question can you spell expect beverage on the right childhood resolved to be and also re file an advocacy for Nash and kind of sounded like you may need additional data. Besides the study and I'm just wondering what the base case and stolen and it says on on the other day.
And.
Thanks, Emily Uhm, our approach has been focused on defining of path forward and alignment on the potential resubmission package that would support accelerated review, we did reference and the prepared remarks.
That there is this the additional group of of patients.
That were not part of the interim cohort.
That we do have an opportunity on the 18 month biopsies to.
The include that the efficacy element in any potential resubmission and as I indicated we're also.
Interested in what if any additional efficacy items might be relevant to the the agencies thinking and that topic will be one of the the the topics discussed in the future interactions that I described.
Thinking thanks.
Thanks.
Mhm Okay.
And the next question is from Steve with Raymond James.
Good morning, and this is Ryan Dishner on for Steve's details can you elaborate a little more on the difference between the additional data sets to assess efficacy and the actual 48 months efficacy on the interim patient population coming and mid 2021.
So I'll I'll start and then I'll ask scale to comment so what I did indicate is that that we're.
We're open to the discussion on potential additional efficacy beyond the the interim.
Data that we've already generated and and we did reference the additional 500 of biopsies as another day to item that we would anticipate the could be part.
Gail maybe you Wanna, you want and give some some additional color on on.
And the efficacy and I'm happy to do so so like by the middle of the year of the studies on going and that means and that way of just progressing through the protocol and by the middle of the year. The original patients who are part of the interim analysis, whereas all reached the 48 months time point is the point also where there's an additional seminal biopsy and it also means.
Our exposure Israeli greatly increased so both on the safety and the efficacy sigh, we really have a large and robust database and just continues to get to get bigger and we are looking to those FTA interactions to define exactly how we can provide the most compelling data.
Okay. Thank you and then and then also the additional datasets to assist the efficacy well that until of reread of biopsies and of pooled manor and then of rid of all post treatment biopsies sort of scrambled together.
Yeah. So I think that we're looking at the way of the reading the biopsies and discussing with the FDA really mm mm.
And right right now and and the in the in the short term, it's important to recognize that and FTA has publicly said that they believe of consensus approach to reading biopsies is and important next step and that's something that we will be discussing with SDA to assure that we have and approach that will.
Have the objective of really decreasing variability and improving accuracy. So we get the best readings FTA has not asked us and present to go back and reread earlier biopsies, but we're.
Looking forward to having those discussions and of lining on and approach and and the new.
Future.
Okay. Thank you very much.
Alright, our next question comes from Jasmine with Piper Sandler.
[noise], how can I assist is jesse on for your <expletive>.
I was wondering.
And was there a reason why that and <unk> and what's not file for that and let's see and tens of five eight and the last one of the study began.
I'm sorry, Jessie can you repeat the question of was a little low on the scent.
Yeah on the on no problem I was wondering why and I and <unk> was not filed for O C and and the high rate and the last one of the study began and.
As opposed to the wide and he's being filed right now.
Great and scale and so we do have an opening in the right now is that just filed but it's open and ready to start of steady later this year we.
And we took advantage of the approval of desert vibrate and Europe to get things going earlier ex U S and our phase two uhm Fcap's Pleasant does of February trial, and is currently enrolling and progressing outside of the U S. And believe this provided a way to move my development program along expeditiously.
Great. Thank you and then one more maybe I missed it but is that and I F F.
That clear or eventually and expect the decision on it.
I'm sorry Jessie.
Can you just repeat.
Oh, yes, sorry is that and I S S and the nurse four O C. A is that cleared I might've missed it earlier and the discussion and if it's not cleared when can we expect the decision.
Yeah, I can take that one so the the and this process as we've said, it's a relatively new process. So there's very few drugs and I've gone through the totality of the process and.
But based on the communications, we've had with FDA. The new label change is really the outfit and the actions of Fda's taken based on their assessment in the and I S. S. S. S. So uhm I think you can look at that as the totality of the process and again from.
R and based on the the most recent interactions we do anticipate the.
That we're we're nearing the very end of the process and we would anticipate that the new label happens the shortly.
Alright, Thank you too.
Thank you.
Alright, and our next question is from Brian and what's our from R. W. Bird.
Hi, there. This is the news on for Brian for PVC could you provide some color and where [noise].
New dialogue is on Subpart H post approval of studies and requirements to maintain labeling sort of in the midst of labeling updates day and place do you see about the converting so the full approval of at this point.
So important.
The important topic Yale can you can you give the update on the post marketing conversations with both agencies sure. So as we mentioned and the prepared remarks, we are continuing to discuss potential modifications two of posted proof of requirements. The cobalt studying and the four O. One study with both FDA and EMEA since they are commitments in both of <unk>.
And both parts of the world.
The final o'kelly of of label update that we anticipate is Cherry said, just and the next short period of time, we'll play and important role and the discussions about I post marketing steady commitments, but we do expect that the process and the fighting of path forward for the studies will continue beyond the label update given the need for that alignment.
Great. Thank you.
Okay. Next question excuse me is N. R. C. Please go ahead.
Alright. Good morning, everyone. This this Thomas of your best kind of a couple of questions for.
So so first question, perhaps on the financial sorry, you guys motion.
About 225% of PVC of patients have cirrhosis can you can you tell us the financial impact of the propose or update of P. B C of label. This past that the the 45th and to the <unk> Mary and her revised so patterns for.
Four year 20 of 21.
Yeah, maybe I'll start and and and Rocco can can come and just to clarify so the estimate of of the 20th of 25% is we're we're.
The estimating the overall rate of cirrhosis.
The impact.
The impact of the label is with the subset of that population.
And we've tried to factor that dynamic into the into the sales guidance as we look at the rest of this year.
Rocco.
And some additional color and might be helpful. For Thomas's question, Yes sure absolutely.
And as we had indicated we have narrowed our sales guidance for the year two to 325 to 340 million obviously this contemplate.
The the various scenarios that we've discussed and we will continue to refine the sales forecast as we work through that process and implement the new label.
The other thanks, thanks for the consultation perhaps one more question regarding the.
With the six months club stopped with the yeah. The is it safe to assume the any dialogue and that market will come after your current with the half of the area. Perhaps some time later this year or corner of fourth quarter of this year.
Yeah, so as as we did the.
Announced we received the six months the clock stoppage and.
It allows us to.
Execute and and work and parallel on the on the work with the F D a and.
And potentially include some of the additional data on.
On the the responses and the process and you're up the later this year.
Okay got it. Thank you so much for several questions and we look forward to the updates of this year. Thank you times.
HM.
Mmk next question.
Comes from maiden Jacob with you B S.
Hi, everyone, Sean one on for Nosy and Jacob This morning, I'll keep it the one question and I'll keep the broad, but if possible could you give us a overview of the status of your conversations what's the may for Okay of cross P. B C and Nash understood.
And at the last call we were talking about today 120 responses any updates from there.
Yeah, So maybe Gail can start on the PVC.
The view with with Europe, and then we can come back to the nurse.
Sure. So on the PVC side, our focus of our discussions has been on the.
Post marketing commitment studies, cobalt and four O one and assuring we find a path forward to to meet commitments, particularly those around our conditional approval.
We also uhm given the label update and the U S will plan to file of type two variation and I would say that.
<unk> has had a a somewhat different approach to thinking about things as they are want to do for example, after our periodic benefit risk annual update this past year.
Crack the M. A regulatory authority that looks at safety did a note that the benefit risk was unchanged given the current label Nonetheless.
<unk>, we will be doing the tech to variation on the PVC side.
And to reiterate on the on the Nash side. So uhm, we did talk last quarter about the submitting our responses to the day 120.
Questions.
And then after the the response from the agency and we did receive the the six months Clark stoppage and and so that's where the process is currently again it gives us an opportunity to.
Work and parallel to potentially use some of the additional data as we <unk>.
Work on on the approach with Europe importantly, working towards the definition of responses the highlight the risk benefit and the right population and that and that contact so more to come later later this year.
That's very helpful. Thank you very much.
Thanks.
Okay. Next question is from Matthew with B M B M O.
Hey, this is Jan on for the Matthew Uhm, Yeah. Thanks for taking our questions and two for me.
So you guys to be true diet and for that'd be submission timing where is the good and set for that'd be filing are you guys displayed and for the 48 months day that sort of a chore or is there anything else that you guys are waiting on and I have a follow up after that.
The thanks for the question as we work on the overall.
The risk benefit the dialogue with the agency I think we're again, we're looking at this combination of the feedback that we will continue to get as we get clarity on some of these items.
The the the operational the impact of of some of those requirements and it's really the full picture that we have in mind.
So as we come back and and clarify that the at this point the weird.
Unable to reiterate the guidance of of potential resubmission by by the end of this year. So it's a holistic view on the dialogue I think importantly, we have coming.
Planned interactions with them, where will continue to advance the conversation on some of these key topics get further clarity and be in a position at each step to define what's the what's the right path ahead, and and as I said before look forward to coming back and quarter three.
As we've continued our work as we continue the dialogue and and provide refinements to the plan.
Got it and then and it looks like the new guidance doesn't of a slight the label updates is it fair too and the addressable patients for P. B C may come down to say like 80, like 80% of the initial market and uhm.
What are your potential like what are your expectations for the potential outcomes of the F. T discussion on the Kovach's post Mark getting trial.
So maybe it will start with the with cobalt, which as Gale indicated as an ongoing day.
Discussion, which will be where we will be able to which will be impacted by the finalization of the label Galeote, maybe you want to start on that and and we can come back to the first question.
Sure. So on the cobalt side and it's important to recognize this is a commitment we have of subpart age of approval, we will find the past the head. It's the question of working through the process with both F D. A and M. A M and the time it takes to align on that path forward.
And then Rocco maybe on the second yeah sure so just to clarify.
The narrowing of our guidance does include all of the scenarios.
Which we've contemplated with the label what day. So I just wanted to make sure that that was clear because I think your question was did it or did it not.
Okay, Yeah that's helpful.
Mmk next question is from Cherry of Oppenheimer.
Okay, It's true Olson from Oppenheimer, Thanks for taking the questions.
Uhm I was curious can you talk about what percent of your operating expenses are <unk> dedicated to Nash versus PVC and what would the financial profile of of the company. You look like you intercept chose to become a P. B C. On the company and have you contemplated that scenario.
Of you internally and when and if so when might the company be willing to to make a decision like that thank you.
Sure. So thank you for the question with respect to our R&D costs. As a reminder, we have two large phase III trials that are ongoing uhm. So specifically two thirds of I would say are R&D costs are.
Our Nash specific and.
And.
Yeah, So as Rocco indicated the.
The the cost structure around Nash at the same time, if you can.
<unk>.
Intensely engaged on the process that we've outlined the on Nash and and ensuring that the we're working towards the linemen and making sure at each step along the way, we're advancing and making the right decision on the path ahead.
I <unk>.
Think the that work will will continue to get more insight from some of the important the interactions which are the common which are are planned we have talked about in the past. The if you viewed the standalone PVC franchise the.
It would be a profitable franchise, which.
Plays on some of our core capabilities.
And our strengths and and I think as we move forward now and and implement the label changed that's an important short term focus that also gives us the.
You know a better ability to be able to.
Work on on some of the future opportunity that still exists and the PVC Margaret.
Great. Thanks for taking the question.
Thanks Jay.
Mmm. Okay. Our next question is from Chaff with Bank of America. Just go ahead.
Hey, guys. It's asthma suggest thanks for taking the questions Uhm just to kind of quick ones first of all maybe you can walk us through how are you thinking about the and this update on your expectations for the label as of specifically pertains to your development pathway for Oh, and see if there's a five day combo.
I guess the are there any specific learning the apply there in terms of the development for the design of some of the studies.
And then secondly, maybe we can talk through and what the contingency plans are of any for reverse you know trying to incorporate the the feedback on the update workshop of a few weeks or I guess the month of sogo. Thank you.
And so it.
The guide to the <unk> as of February program like week, you always learn over the course of of the development program. One of the objectives of the Phase. Two study is of course to find the right dose and in a combination product, it's uhm that extra step of finding the right synergistic dose ideally.
Between two different medicines are.
Our hope is that that can be a relatively low dose for both so that we can really look for opportunities to have the sort of and optimize benefit Ms profile.
That said.
There's we use of component of looking at a new medicine and learning as you go but we have been very encouraged by the date of that exists the really wide array of data that exists on basis, thyroid and P. B C C, a and PVC or of Calif, and P. B C and even some day to that and independently exists and has been <unk>.
Published way of both medicines are on the market on the two together.
And I guess just on the question on on reverse so you know the the importance of the the reverse data is something that we continue.
The distress again, it's an incremental data set and incremental of population we have had the.
Historical conversations with the F D a on the potential.
<unk> forward based on a successful reverse the.
For all the approach and and really stressing alignment at the stage I think we we look forward to regrouping with the agency.
With a positive data set in and if for.
And the scenario and discussing the about that.
Got it okay. Thank.
Thank you.
Okay and that concludes our two and a session now let me turn the call on over to Jerry day, or so for clothing remarks.
So thanks, everyone for joining us today, we were able to bring four of another quarter of double.
Digit revenue growth, while working the finalize are updated ocala of a prescribing information.
The FDA and advance our Nash regulatory process and our pipeline, we remain as committed as ever to serving patients with progressive non viral liver disease as well as the health care providers, who care for them and we definitely look forward to update and you on our progress on the future calls thanks for the time today.
Thank you ladies and gentlemen. This concludes today's conference. Thank you for participating you may now disconnect.
Okay.
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