Q3 2020 Intercept Pharmaceuticals Inc Earnings Call

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Thank you good morning, and thank you for joining us on today's call. This morning, we issued a press release announcing our third quarter 2020 results and financial position and also posted accompanying slides, which are available on our website at www dot intercept plasma dot com.

Before we begin our discussion I'd like to note that during the call we will be making forward looking statements, including statements regarding ARPU product and clinical development program certain regulatory matters, including the potential approval of CA for liver fibrosis, due to Nash and our strategy prospects financial guidance and future commercial and financial performance listener.

[noise] are cautioned not to place undue reliance on these forward looking statements.

Which speak only as of the date of this call and we undertake no obligation to update such statements except as required by law.

Forward looking statements are based on estimates and assumptions that although believed to be reasonable are inherently uncertain and subject to a number of risks and uncertainties, some but not all of the risk factors that could cause our actual results to differ materially from our historical results or those anticipated or predicted by our forward looking statements are discussed in this morning.

This release and our periodic public filings with the SEC.

Today's call will begin with prepared remarks from our CEO Dr. Mark Pruzanski.

Followed by those from our Chief operating Officer, Jerry There. So in our Chief financial officers Sundeep capacity I will then open the call to take your questions. Please limit yourself to one initial question in order to allow time for all questions to be addressed.

Let me now turn the call over to our CEO Dr. Mark Pruzanski.

Thanks, Lisa and good morning, everyone. Thank you for joining us on our third quarter 2020 earnings Conference call.

I'm pleased to report our core PBC business performed well during the quarter, which I'll summarize shortly but I want to focus first on providing a comprehensive regulatory update starting with Nash.

Last month, we had our tight they end of review meeting with the FDA to discuss the agency's benefit risk assessment in the CRL based on its review of the available data as well as our proposed faces for resubmitting, the NDA seeking accelerated approval, although CA for Nash fibrosis.

As you know we we prepared extensively for this meeting with the objective of re framing our efficacy and safety data supporting benefit risk associated Nash patients with advanced fibrosis based on the phase three regenerate 18 month interim analysis at a refined risk management approach for appropriate patient selection and monitor.

The end of review meeting was constructed and based on the final meeting minutes. We recently received FDA has provided us with helpful guidance regarding supplemental data. We can provide to further characterize always use efficacy and safety profile, which could in fact support resubmission based on or 18 months biopsy data together with us.

Safety update from our ongoing studies.

We are advancing accordingly, and plan to hold additional meetings with the agency with the goal of achieving sufficient alignment to proceed on this basis and potentially resubmit, our India next year.

Our work generating additional efficacy and safety data is ongoing and we remain focused on reinforcing means to identify the segment of Nash patients with advanced fibrosis score it most risk of progression to cirrhosis and could therefore, most benefit from most years that helps narcotic effects.

While achieving appropriate management of pathetic safety and other potential safety issues in treated patients as.

As we've stated we believe this can be achieved based on appropriate labeling and standard noninvasive assessments used by specialists physicians to assess and monitor the functional status of their patients.

As we've often pointed out Nash patients with advanced fibrosis, typically have comorbidities take various medications and experience in her current illnesses that taken together render them, particularly vulnerable to acute progressive chronic injury to their liver.

So we and FDA had been particularly focused on working to gain a thorough understanding of those years hepatic safety profile in this population and the identification of patients who may potentially be at greater risk.

As we previously have shared we conducted a comprehensive assessment of the public safety relatively late in the N.D.A. review and FDA did not have a chance to fully review it we.

We did have a chance to review some of the data at our end of review meeting and as a first order of business. We look forward to engaging in a more focused review of the data with the agency.

A word on some of the work we're doing on the efficacy side.

There's growing interest in digital pathology tools that are able to quantitatively score fibrosis and other histopathological features of interest in biopsy specimens and provide more accurate resolution that is supportive of pets, all interest assessments well.

While these innovative tools remain exploratory.

We believe there is interest on the part of the FDA and that such data might bring those years anti biotic benefit into even clearer focus.

In addition of course as part of any safety update from our ongoing studies, we will have the benefit of assessing the longer term durability of those she is treatment effect on a variety of noninvasive markers.

With that we very much look forward to continuing to engage with the FDA with the hoped for objective to position us for Resubmission of R. and D.A. next year, and we will of course update you on any important developments as appropriate.

A quick update now on our M&A seeking conditional approval of O'shea for Nash fibrosis in Europe.

As you May recall, we submitted the M&A at the end of 2019.

Our application is under review review.

In the third quarter, we were granted an extension to respond to the day 120 questions Weve received from the gamut with our responses now do this coming January.

We requested the extension to help ensure consistency in our approach in both the U.S. and Europe.

It's useful to pull back and remind you that based on recent literature Nash is now the most rapidly increasing indication for liver transplant in the U.S. and there is an urgent unmet medical need for the treatment of advanced fibrosis due to Nash, where there are no approved therapies.

Unfortunately for patients the Nashville to seeing more than its fair share of failures in recent years.

Oh, she is the only drug to have succeeded in a phase three trial to date, having reproducibly demonstrated its ability to improve fibrosis we.

We remain committed to the Nash patient community with regenerate currently ongoing through clinical outcomes with the goal of confirming clinical benefit on a post marketing basis.

As a reminder, we are also conducting the phase III reversed study in Nash patients with compensated cirrhosis with read out of the double blind phase expected by the end of next year.

With regenerate and reverse are fully enrolled with patient retention continuing to track well despite ongoing had done that.

As a final note on our Nash program, our conviction in the potential for associated becoming the first drug approved at an important treatment for patients with advanced fibrosis is shared by many stakeholders in the liver community.

Including patient groups opinion, leading physicians and others passionate about advancing medical innovation.

So I am excited to note that money's subramanian, the former therapeutic area head of liver disease that deal yet we successfully led efforts over a decade long tenure to secure a number of drug approvals.

As agreed to join our effort to help steer associated to approval.

Pivoting now to PBC our performance during the third quarter was strong once again.

We reported worldwide Ocala to net sales of $79.5 million, reflecting impressive growth versus the prior year quarter.

We believe the growth opportunity for our PBC business remains attractive over the long term.

As a reminder for those of you not familiar with the regulatory history. Ocala was approved in May 2016 in the U.S. as a second line treatment for patients with PBC under the accelerated approval pathway based on a reduction in alkaline phosphatase as a surrogate endpoint reasonably likely to predict clinical benefit.

It also received conditional approval for PBC from the from Yemen in December 2016.

Full approval of that caliber for PBC is contingent upon among other post marketing requirements. The confirmation of clinical benefit in our ongoing phase four outcome study cobalt.

Cobalt is a placebo controlled multicenter study.

Designed to evaluate clinical outcomes in more than 400 PBC patients.

Given the challenge in successfully completing multi year post marketing placebo controlled studies in a rare disease setting do.

Do you for example to patient dropouts and placebo crossover to commercial drug over time.

Prior to initiating cobalt, we discussed with regulators potential conditions under which it might be converted to an open label study negotiate compared to a historic case matched controls from available natural history data sets.

Well, we've been enrolling cobalt globally in more than 30 countries. We've continued discussions with both FDA and EMA concerning the merits of potentially converting to an open label study design.

At both agencies advised that we revisit this possibility if warranted after a pre specified interim efficacy analysis by our data monitoring committee or DMC, which was recently completed.

The analysis included DMC review of Unblinded safety data and no safety concerns were reported resulting in no changes recommended to study conduct.

However, the DMC did conclude that it doesn't seem feasible to continue cobalt as designed.

Of course, we remain blinded to data in the ongoing study and as is typical with such DMC interactions focused on maintaining data integrity. There was minimal additional detail provided as to the relative impact of confounding factors observed by the DMC, including patient Discontinuations and placebo crossover to commercial Ocala.

We've notified both at FDA and in May of the DMC. His conclusion and further respected recommendations plan on holding a meeting with the FDA early in the new year, plus seeking formal you scientific advice.

There are examples of other confirmatory outcomes open label studies relying on historic controls for rare disease drugs approved on an accelerated basis and we of course remain committed to working with the FDA and the M&A to come to resolution on a potential modification of cobalt as soon as possible.

I also wanted to address the quote newly identified safety signal or NIS four or caliber in the PBC post marketing setting that was posted on the FDA website last month.

For background that FDA has long conducted safety evaluations in the post marketing setting and in recent years has taken steps to increase the transparency with respect to such reviews.

In our case as we previously disclosed the agency notified us that it had initiated in this regarding liver disorder that classifies as a quote potential risk the lowest level of risk.

Hertz guidance ft estimate up to a 12 month timeline for the evaluation of this kind of miss as compared to a more rapid timeline for evaluating a necessity determines is either an important potential risk or an emergency.

We understand that this potential low caliber risk in PBC was identified in the course of ft is routine safety monitoring activities based on a search of the fairest database and other available external sources and that FDA is further informed us that business is focused on a subset of cirrhotic or more advanced PBC patients, taking ocala and.

The broader PBC population.

As you would expect as part of our standard Pharmacovigilance activities. We've worked with the FDA to reconcile our internal safety database with the fares database and are now conducting a comprehensive assessment of all the available data.

Moving data from our completed clinical trials blinded reviews from ongoing studies, such as cobalt unblinded reviews of ongoing clinical trial data by the DMC.

Post marketing data and natural history data.

The FDA has acknowledged the limitations of post marketing data and stated that safety data from controlled clinical studies will be of most value to inform any final assessment of the potential risk.

So it is reassuring that as mentioned our DMC recently reviewed unblinded safety data from patients enrolled in cobalt, including cirrhotic patients who comprise the majority of the study population.

And stated that no acute safety concerns were observed.

We are working to complete or complete comprehensive safety assessment with respect to the newness within the coming months and intend to continue to work with the FDA to complete the review.

It's important to note that we have over 14000 patient years of post marketing exposure in PBC patients treated with Ocala, and our view of its benefit risk remains positive.

We continue to engage the physician community and are pleased to see the continued strong interest in PBC. It a cell T. This year, where multiple abstracts evaluating o'shea for the treatment of PBC will be presented.

In particular, we look forward to the presentation of OTI is durable efficacy and safety data in PBC patients treated for up to six years.

Meanwhile, we continue to be committed to fostering innovation for patients with this disease and I'm pleased to report that we have resumed enrollment in our phase two study evaluating those in combination with as a fiber it.

In addition to the strong net sales we reported in our PPC business in the third quarter.

We also took swift steps to right size, our organization in light of our receipt of the CRL industry fibrosis.

This morning, we announced that we are narrowing our 2020 financial guidance within the high end of our previously announced Ocala net sales range and within the lower end of our previously announced non-GAAP adjusted operating expense guidance range.

This will put us in a strong position as we enter 2021 to support the continued growth and advancement of our foundational rare liver disease business and the potential resubmission of our India in Nash fibrosis next year.

Now I'd like to turn the call over to Jerry who will provide an update on our global PPC business and commercial activities Jerry.

Thanks, Mark and good morning, everyone I'll.

I will start by discussing our old caliber results for the quarter and then provide you with an update on our commercial organization long with the summary of our current efforts in PVC.

In the third quarter, we reported $79.5 million in worldwide Calvin net sales, which represented growth of 29% versus the prior year quarter and is our highest quarterly sales to date.

In the U.S., we achieved net sales of $58.6 million in the third quarter.

We saw continued end market demand growth for our caliber as U.S. total prescriptions based on acuity a data increased by approximately 14% versus the prior year quarter.

In the International region, we achieved acts you asked so Calvin net sales of $20.9 million in the third quarter.

These results reflect the continued strong performance in our key international markets.

Our global caliber business continues to be resilient. Despite the challenges, resulting from the COVID-19 pandemic and we've been pleased with our ability to maintain patients on therapy.

The overall slowdown in patient visits persist in the GI segment globally, and while we saw some recovery in the third quarter trends are still below the pre pandemic levels. We continued to experience a lower level of new patient starts during the third quarter.

And although the new patient segment represents a small portion of our business. The cobot impact Weve seen in 2020 is expected to have an impact on our future quarterly growth rate versus the prior year period.

As we discussed last quarter after receiving the complete response letter for Nash, we were able to take advantage of the flexibility we had built into our commercial plan to quickly prioritize our commercial activities and turn our focus back towards PVC, while postponing our Nash launched efforts and importantly, lowering our operating expenses.

Moving forward.

Subsequently in the third quarter, we restructured our commercial and medical affairs organizations.

The resulting targeted footprint in the field has been re sized and is focused on maximizing the growth of our core PVC business.

Through this transition we have retained a strong team with deep experience in hepatology and GI segments. Our teams are fully trained and now dedicated back to PBC.

As our field teams navigate their outreach given the current pandemic, we're actively leveraging technology to increase the impact of our customer interactions.

Complementing the efforts of our field teams, we've seen a positive response to our digital educational programs. For example, we recently trained our speakers to deliver education that included the results from our poise five year open label extension study.

Overall, we have continued to experience progressive growth both in the U.S. internationally as Weve established a caliber has the first new therapy for PBC in over 20 years.

As our commercial efforts pivot back fully to PBC, we remain confident that there is an opportunity for continued expansion in this market over the long term.

And now I will turn the call over to our Chief Financial Officer, Sundeep capacity for a financial update.

Dave.

Thank you Jerry and good morning, everyone. Please refer to our press release issued earlier today for a full summary of our financial results for the quarter ended September Thirtyth 2020.

We reported strong Q3 results and made solid progress in our efforts to reduce operating expenses going forward.

These efforts resulted in the narrowing of our 2020 guidance.

At the higher end of our Calvin net sales guidance range at the lower end of our non-GAAP adjusted operating expense range.

Beginning with our commercial performance.

In the third quarter, we recognized 79.5 million Calvin that so our highest quarter to date upfront.

Up from $61.5 million in the third quarter of 2019.

Our third quarter Calvin net sales were comprised of U.S. that sale of 58.6 million.

Ex us net sales of 20.9 million.

This represents a growth of approximately 30% and 28% respectively versus the prior year quarter.

As a reminder, in Q3 2019, we did experience a drawdown and trade inventories in the U.S.

Our GAAP operating expenses for the third quarter were 134.7 million.

And our non-GAAP adjusted operating expenses were 118.1 million.

As a reminder, our non-GAAP adjusted operating expenses, excluding stock based compensation and depreciation.

Non-GAAP adjusted operating expenses as a non-GAAP financial measure under SEC regulations. Please.

Please refer to our press release issued earlier this morning for a full explanation and reconciliation of it.

Our cost of sales for the third quarter were 1.8 million compared to 0.5 million in the prior year quarter.

Our selling general and administrative expenses, but third quarter was 70.6 million. This.

This represents a decrease of 6.2 million versus the prior year quarter, and whats driven by our initiatives to reduce costs, including the postponement of the Nash launch.

Our research and development expenses decreased to $48.9 million in the third quarter of 2020.

From 16.2 million in the prior year quarter.

The decrease was primarily driven by lower NASS development costs, including the conclusion of enrollment activity for the regenerate and reversed study prior to the third quarter of 2020 and reduced costs related to our preparation for Nash regulatory interactions.

Restructuring expenses were $13.4 million for the three months ended September Thirtyth 2020.

These expenses include the costs related to the previously announced restructuring.

As of September Thirtyth, 2020, we were well positioned with cash cash equivalents restricted cash and investment securities available for sale of approximately 496.8.

And now turning to our updated financial guidance for the year.

As I mentioned earlier, we took the necessary steps to lower our costs.

Calvert franchise is profitable continues to grow and is expected to provide strong financial foundation for our future.

We're able to narrow our full year 2020 guidance range for both net sale and non-GAAP adjusted operating expenses.

We now expect full Calvin net sales in the range of 310 million, but 320 million up from our previous range of 300 million to 320 million.

We now expect 2020 non-GAAP adjusted operating expenses in the range of 460 to 480 million down from the previous range of 460 to 500 million.

As we close the year and look forward to 2021, we remain focused on topline growth and prioritization of our investments going forward.

Overall, I'm pleased with our strong commercial performance, which together with the initiatives, we have taken to reduce costs put us in a strong cash position.

We are well positioned to support our Nash regulatory process with the FDA.

And our ongoing clinical trial and continue to invest in the growth of our Calvin business.

So with that I'd like to turn it over to the operator for any questions.

Operator.

Ladies and gentlemen, if youd like to ask a question at this time. Please press. The Star then the number one key on your Touchtone telephone.

To withdraw your question press the pound key.

Again, that's star then one if you'd like to ask a question at this time.

Our first question comes from the line of Michael Yee with Jefferies. Your line is now open.

Hey, Thanks, good morning, and thanks for the very comprehensive update Mark.

Our two questions relate to just clarifying.

The discussions with the agency as much as you can in terms of what specifically is is.

Acquired for the safety component of things and on the efficacy to me it sounded like a detailed discussion about public safety and said that you weren't able to a point, where if you. All that you maybe is that kind of what is really the game pardon the safety side and the efficacy side. It sounded like a lot less stuff. So maybe just talk to those two sides again.

And then on Europe can you just clarify was there any discussions at all its really where they focus first on it. Thank you.

Sure. Thanks, Mike, Yes, so as I mentioned in my prepared remarks, we're happy to have the the end of review meeting.

With the agency we received the final meeting minutes and you know as we anticipated. This was the start of Reengagement with the agency with respect to potential resubmission.

The FDA and we got a lot of helpful guidance.

From the FDA with respect to elements that we.

We can address in support of ongoing discussion.

And that potential resubmission.

As you mentioned on the safety side.

As weve.

Long held I mean liver related safety in patients with advanced fibrosis is really important to get a handle on.

You know, we mentioned before that both we and the agency.

I've really tried to understand across this population.

Liver health status there are a lot of confounding features in a population like this.

As mentioned that lead to progressive disease acute exacerbations of disease et cetera.

So so it's a challenge.

And we did conduct on this independent expert blinded assessment of liver safety.

Relatively late in the review cycle. So the agency you Didnt have a chance to really complete review of that.

So appetite day, we did have a chance to discuss this and I do think that you do sort of the first order of business just to follow up with the agency and really try to get a handle on.

And again part of any Resubmission would be a comprehensive safety update from from primarily regenerate and other ongoing studies.

And.

Assuming were in a position to resubmit next.

Next year.

We will essentially have the chance to.

Virtually double.

Safety database with respect to duration on study just for reference.

When when we think about the patients who comprise the month 18 interim cohort.

On average those patients are now nearing three years on study.

And those who are first enrolled in the study.

Hum are approaching five years. So so that's going to be a very rich on safety update which is invaluable in a large disease population like this.

On the efficacy side I mentioned in my remarks on a growing interest in digital pathology tools and.

I personally in the context of.

Ongoing need for a liver biopsy think that these tools are going to also proved to to have a lot of merit.

In in addressing feet, the well known variability that we see with the colleges assessment of these semi quantitative cuts categorical.

Features histopathological features.

So while they continue to be exploratory.

I think that Theres clearly growing interest in the community.

And that they can bring into clear focus.

The histologic benefit of a drug like CA. So that's just one example, and then obviously on the flip side of any such safety update is taking a look at the durability of response with respect to non invasive markers of efficacy.

Oh and then so it's only a few side on the European side, obviously, we're earlier in review.

We did get this extension to January for our day 120 responses that that allows us to align our approach.

It's both us and Europe.

And.

We're pleased to be under underway there but.

But premature to comment on what you know.

What the issues will be.

Got it thank you very much.

Thanks, Mike.

Our next question comes from Yasmeen Rahimi with Piper Sandler Your line is now open.

Hi team. Thank you for that color two quick question, maybe the first one is [noise].

Is that really an additional meeting necessary with DFT ideally it just had quite a lot of content from them on a path forward and if you could just maybe give a little bit more granular details on terms. So whether we expect any filings first half of 21 or second half and then is there a potential that you could maybe roll.

And that cirrhosis that reversed data into the filing and thank you again for taking my questions.

Thanks, Yes.

So yes, we do need to have additional interactions with the agency and frankly.

We welcome that it's in our mutual interest to try to gain as much clarity and comfort with respect to this this large and complex dataset prior.

Prior to any any resubmission.

So you know I think that.

I think that and weve anticipated that that would be the case.

Coming off the Taipei meeting and the good news is that we're constructively engaged with the review Division and have you know a lot of guidance with respect to.

Things that no date, they wish to look at.

I think with respect to your the second part of your question on timing. It is premature right now to to speculate on first half second half, we think because largely in part that we need to.

Get our ducks in a row in terms of.

Timing of generation of.

Data.

Good there the interactions with the FDA, which you know I think we can have on a timely basis, but also.

Is that a little bit at the discretion of the agency.

But they they absolutely do want to continue that discussion and meet with us.

And again as I mentioned, assuming we.

Get to adequate alignment.

I think that could position us to resubmit.

Next year based on the month 18 biopsy data with the safety update.

With respect to reverse.

Again, we anticipate it reading out by the end of next year.

It is open under separately and D.

But right now its not contemplated that we would wait for the result of reverse to to resubmit.

Thank you Mike.

Thanks, Yes.

Our next question comes from Joel Beatty with Citi. Your line is now open.

Hi, Thanks for taking the question one question. The first one is it has the next meeting with FDA already been requested.

As the next meeting been recruiting.

Well you know look again, we don't comment on any specific meetings or timing of beatings typically but.

We're right now lining up.

You know our next steps.

We just came off the meeting and just received the minutes. So we're still digesting.

Okay got it that's helpful. And then one other question is on the is there a potential the unblinded outcomes data from regenerate as well as cobalt would be submitted to the FDA as part of the Nasri filing.

Yes look I mean.

It's a good question and that was what we were wondering after receiving the complete response letter but.

But.

What's what's what we're really pleased about coming off the Taipei meeting.

Now is that there appears to be openness on the part of the agency.

Two potential resubmission based on the month 18.

She data with the safety update of course and.

And so you know that would not necessarily include any kind of interim.

Outcomes data from the ongoing regenerate study remember we remain blinded.

Two two outcomes studies ongoing as I mentioned.

But but.

As of right now we anticipate you will take.

You know.

Another three years or so until we get to a target number of outcomes to get to the end of the study.

Got it thank you.

Our next question comes from Brian Abrahams with RBC capital markets. Your line is now open.

Hey, guys. Thank you so much for taking my questions and thank you for the comprehensive update.

You mentioned some of the I guess on the efficacy side, you talked about the potential.

For a filing with greater clarification on the existing 18 months biopsy data set from a January just wonder if you could talk a little bit more about that have you mentioned this some digital assessments of histologies that those analyses that you guys have already done and if not how long it might those take to do and then secondarily I'm wondering.

How much of the discussion with the agency is centered around a potential narrowing of the population maybe closer to this.

At risk advanced population that you guys have always talked about as you're.

Framing from a commercial standpoint versus the broader regenerate population. Thanks.

Yes.

Brian We may have.

Mark just stand by while we got them back.

We have marked back on the line now.

Oh geez.

My line dropped.

Fine can you repeat your question.

Yes sure Mike My first question was just on the digital assessment of Histology data that you guys have talked about.

As the weather you've done some of those analyses that yet and if not how long those might take to conduct and then secondly, just wondering the degree to which your discussions with the agency or centering around potential narrowing of the label maybe closer to this at risk population of advanced fibrosis patient that that patient that you guys have always talked about when framing.

Potential commercial.

Our effort versus the broader regenerate population. Thanks.

Thanks, Brian.

Sorry to drop there.

So with respect to digital pathology that work is ongoing.

But I don't think it will be represent critical that with respect to.

Yes, getting to a potential resubmission next year.

And by the way I would point out that there are number of abstracts at this year's a SLB starting towards the end of next week.

To look out for just just to if you're interested to look at the power of the technology.

With respect to second part of your question on narrowing label I mean, it's it's premature to speculate on on labeling but.

Yeah, I mean, we've been very consistent.

With respect to our intend to focus and that is on patients with advanced fibrosis score at most risk and you know that clearly represents a narrower segment than the population we studied overall.

Got it thanks.

Our next question comes from a lead their young with Cantor Fitzgerald. Your line is now open.

Hey, guys. Thanks for taking my question.

The first one on can you just talk a little bit about like.

How you think about that like macro environment dancing around that I mean is it like a question of you know sort of education that you're having to provide that your first are you talking to more Gary and I guess you guys are like there have been some failure in the state and the second question is that you know.

When you when you think about like PB, saying that that's Crazy question. Now you know how do you think about potentially being more aggressive there and taking share in light you know, what's going on with passion and you know the fact that like that and perhaps like hopefully not in the group I think also now Pvp of I think that clear marketing focus, but the thing is tied mostly to play there. Thanks.

Yeah, I look at least here with respect to the first question.

No I mean, obviously there was a tremendous unmet need in Nash. It is too large population as I mentioned on my remarks, it's now become.

Become the fastest growing region for for liver transplant with no approved therapies, you know that said.

No I think it's appropriate for for F.D.A. too you know really scrutinize every drug that comes through I mean at the end of the day you know we all acknowledge that.

Well that the these endpoints as high as the bar is.

Or surrogate endpoints reasonably likely to predict clinical benefit and so you know you need to really rigorously assess both both sides of benefit risk I do think that on that that F.D.A.. Andy you may continue to be committed.

Two on two Nash too high to the potential for surrogate endpoints to support accelerated and conditional approvals respectively.

But clearly the buys the bar is high and you know where she is the only drug as you know to have succeeded in phase three on certainly the only drug to reproducibly shown and antibiotic benefit.

But the leading care wells compare you know too.

Kind of anti fibrotic effect that you see with parametric surgery, and Nash, which is the only reference standard. So you know we're confident in in in the drug, but clearly more work needs to be done in updating our safety and efficacy data and reviewing it with the FDA to put us.

So hopefully back in position for Resubmission.

On the second part of your question on the PBC side, you know look like you know we we clearly are very pleased with growth that we've seen in the BDC business globally I.

I mentioned that you know we're now past.

Asked 14000 years of exposure, we've got long term safety durability safety and efficacy.

Data in the population we continue to innovate.

And be committed to the population maybe you know Jerry could ask or answer more specific question about your penetration.

Yeah, Hi, Lisa it's Jerry I.

I think clearly we believe that there is considerable potential left for us to access in PBC I would not at all consider that we're at the late stage of.

The lifecycle at this point, we should be able to continue to access more of the patients that are eligible for Ocala and havent been started yet I think when we look at the market research that we continue to do on a regular basis.

Significant opportunities for growth remain I think if you look at every quarter even in the period like we're in now where where cobalt has some some disruption in the market, we're seeing new prescribers come on board.

For the first time, which is not always the case when you're several years into the launch I think it just speaks to the need for us to continue to educate the market and as you said importantly, now.

Our commercial and medical field teams are now refocused and dedicated and frankly, I think and I've been really pleased with the level of engagement on our teams as we've made the pivot over the last several months from a a lot of the preparatory education for Nash back fully focused commercially to all Calvin PBC, So well continue.

To.

You know to ensure the right focus to drive the growth, but again the key message for me is a considerable opportunity remains.

In PBC.

Thanks.

Hi, guys.

Our next question comes from Steve <unk> with Raymond James Your line is now open.

Yes, Hi, this is actually more of a lot of on for Steve see in house and we have a couple of questions. So in terms of NIS. When do you expect to provide data analysis results to the FDA and then could you remind us what portion of your PBC patients are cirrhotic. Thank you.

Sure. So second part of your question there what proportion are our cirrhotic <unk>. The vast majority of patients are not cirrhotic, we estimate up to 85%. So we're talking about a pretty narrow segment of the population with respect to the work that's ongoing I mean this comprehensive safety so.

Smith.

Cross post marketing and clinical data as I mentioned in my prepared remarks.

We're working as expeditiously as we can to complete that work.

Which we expect to happen over the next few months and Ah you.

And that will then facilitate discussion with with F.D.A.

With respect to.

Any any resulting recommendations.

Okay. Thank you for that and then on on Cobalt could you clarify what was the main reason cobalt cannot consignors a blinded study. Thank you.

Yeah, so you're referring to the DMC is conclusion coming off the interim efficacy analysis.

And as I mentioned I mean, you know we've long been aware as I was have the.

FDA and EMA the challenge of conducting these multi year placebo controlled out.

Outcome studies in a rare disease setting and into post marketing on a post marketing basis.

You know weve clearly doing our utmost to enroll cobalt over the last few years as I mentioned, you know in over 30 countries.

Countries and also its important context to know that it's not only that we're studying a rare disease population, but this.

This is primarily a more advanced.

Segment, the population right. So a majority of the patients and cobalt are already cirrhotic when they entered the study so it's an exceedingly.

Tough I study to enroll and takes many many years.

And the concern of course going in is that overall over the years of course, you're going to get just continue patient discontinuations and you're going to get patients crossing over to commercially available drugs.

So.

This is a concern not not unique to cobalt of course I think it's it it's a more generalizable challenge for anyone who follows us in PBC and frankly another.

Chronic rare diseases, so or it is something we've had an ongoing dialogue with Ftn you may on and as I mentioned, you know we will in the in the new year.

Following up with stuff with Sta, getting scientific advice in Europe, but to see what we can do but we remain committed of course to confirming a benefit.

But.

You know again, you need to see where the where the regulators would like to go with respect to modifications to the study.

Okay. Thank you very much Marc.

Thanks.

Our next question comes from re Tubaro with Cowen. Your line is now open.

Hey, guys. Thanks for taking the question I wanted to ask you about what you were thinking as far as your strategy for your 2023 Cooper.

Is that going to be wholly dependent on.

Your conversations with X y or can you sort of have a a standalone strategy regardless.

On how to deal with those and then my follow up is on your beaten Fibrate study.

You mentioned, one can you talk about the data timing and and potentially regulatory path.

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Beyond the current study and if you could as well could you just walk us exactly to the rationale for the comparator arm because it's just a little confusing on Clin trials. There. So there's a bunch of them if.

Maybe kind of the same but not really.

Sure Richard So Sundeep could you take the first part on convert.

Sure Hey, Rick. Thanks. Thanks for the question I think we took a lot of the initial steps obviously to reduce our operating expenses I'm very pleased with the progress we've made so far.

First maturity on the convert is not until 2023 and so we're always.

Evaluating options you know, we're always thinking proactively and strategically ways to manage our future capital capital needs. I think we will certainly as we understand better the timelines for Resubmission you know.

And and in the coming months you know, we can continue to sort of evaluate and provide provide you an update there.

HM Yeah, Richard with respect to the combo best if I read so just a reminder to everybody that.

That's a fibrate is a pan PBR agonist on Thats been on the market in a number of countries ex U.S. for for many many years and there's been a lot of interest in bed.

In PBC, specifically around the world in fact among many.

Datasets at the at the recent European liver meeting useful.

The first abstract in the general session was on tenure outcomes data from Japan.

In PBC showing.

Outcomes benefit with with best a fibrate.

Treatment as compared to Urso alone. The first line treatment. There are there have also been.

Several combination datasets clinical data sets out of Europe, there's been presented at various meetings I'm looking at kind of a combination of Oh CA with that's a fibrate, which again look look quite promising and support the potential for the combination.

As a follow on.

Treatment for Fourq.

For PBC. So the phase two study that is currently enrolling.

I think retool its premature I mean, it was on hold during the fan you know a lot lot of the pandemic I'm happy that you know we're now.

We initiated enrollment, but but it's a bit premature to try to project on the timing of agreed out terms of where you know what the regulatory path would look like.

You know that there is guidance of course for combination product development.

Typically you have to characterize component a versus component b versus component versus a plus b hopefully, we'll be able to do a lot of that characterization in phase two.

But ultimately phase three design will be you know a function of our discussions but at the end you may at the time [noise].

The other development of the fixed dose combination is going well from a product development standpoint.

And we currently don't see any major insurmountable challenges there.

So I'll stop there.

And so the the current study doesn't answer then factorial question that play.

Well lot about.

That will come afterwards.

Well you know to be typically in in in phase two you do Ah you know.

The guidance you do do the factorial you do do the a versus b per se, let's be but but again there are exceptions to that.

I think we'll just have to see and you know again I think we will want to leverage as much as possible the available data.

You know that's why I mentioned to you know.

Almost all of the data sets that currently out there on published et cetera.

Got it thanks for taking the questions. Thanks Richard.

Our next question comes from Jay Olson with Oppenheimer. Your line is now open.

Oh, Hey, thanks for taking the questions I had two of them starting with the Nash CRL I think at the time you received the CRL you suggested a timeline of about six months to resubmit your and dealing with a six month review and a potential Nash approval mid two.

Only 21.

And I was wondering it just seems like today's language sounds like could potentially longer timeline. So now that you've met with the FDA what changed why does the timeline seen longer now and was there something incrementally more time consuming that you got from your at the meeting.

And then I had to PTC question, I'm kind of surprised to intercept would want to convert cobalt to an unblinded design since Ocala has repeatedly been a victimless unwarranted safety concerns which were all based on uncontrolled safety records. So why would you want to deliberately give up an ideal.

Source of controlled safety data.

Which you could use to potentially ensures a clean safety profile of locales.

Sure So with respect to the first question on timeline, you know right on the heels of the CR letter.

You know I put out you know speculatively, what a best case could look like in response to the CRL that are obviously that was created in the first instance by on timing of the first interaction that type a end of review meeting, which which we just had.

Had.

Last month so.

I think that you know we've adjusted our thinking about potential timeline. Accordingly. In addition, you know as as we contemplated at the time, we knew that this was the Taipei meeting was an opportunity to reengage with the agency and whats helpful. Here is that there was a mutual desire on.

On our part nephews part to get together again and have substantive interactions on to try to gain further clarity and comfort.

With respect to first and foremost safety data, including ultimately safety update that I've mentioned in my remarks.

And and of course additional efficacy data, but but you know what what we're pleased about is that number one we're constructively engaged with reviewed edition number two.

That they've expressed an openness to potential resubmission based on the month 18 biopsy data with safety update.

And that in fact was was was our AR was and remains our hope for objective here on the PBC side.

Look you know as I mentioned, you know, we've been 100% committed to conducting cobalt globally.

On on an ongoing basis is a placebo controlled study and Andy you know as I mentioned also with respect to addressing.

The.

The newest that's currently caught currently being looked at we believe that the safety data from that controlled study and again, just just to punctuate point right. The majority of the patients in that study our cirrhotic patients.

That will be the by far the most valuable source of safety data that we will tap and we have.

Pretty extensive safety data at this point given how long. This study has been ongoing.

So it with respect to you on a forward looking basis than the idea.

Converting it took the label it's not necessarily that that was our our intent kits that we we have long been aware as have ftn DNA of the challenge of successfully completing a placebo controlled confirmatory.

Outcome study in this kind of rare disease setting taking many years in the post marketing setting. So we now have a DMC conclusion based.

Based on a pre specified interim efficacy analysis that the study doesn't seem to be feasible as currently designed.

And so that's you know.

That that is now going to catalyze discussion with boats ft, any M&A with respect to any any.

Any appropriate modifications you open label designed with external control historic control.

Is is.

Option that could make sense under such circumstances.

Great. Thanks, again for taking the question.

Sure.

Our next question comes from Thomas Smith with STB Leerink. Your line is now open.

Hey, guys. Good morning, Thanks for taking the questions.

In Nash I know you have a large number of patients who are enrolled beyond the interim analysis cohort and regenerate.

Should be coming up to their 18 month biopsy can you just clarify if you're planning to analyze and submit the 18 month biopsy data from this cohort to the agency as part of the Resubmission and then some.

Secondly, on the Nash marketing application in Europe.

I understand you've asked for an extension you are to try to align your responses and your approach between the two agencies, but can you comment on how closely the day 120 questions near some of the questions raised on the FDA review are there any notable differences and the feedback between FDA and EMA. Thanks.

Sure. Thanks for the question yes.

Yes. The answer is so with respect to monkey teen on biopsy data, we do have.

Additional biopsy data were blinded to it.

Right now from the cohort the outcomes a cohort of patients in.

And we are considering a whether you know it could.

Incrementally add to the.

The efficacy dataset right.

That that we currently have in hand book, but you know that that is going to take a little bit of time to think about with respect to M&A.

Again, you know we're we're relatively speaking early in the review of the data. They want 20, I think that the you know the the review issues will come into better focus on with day 180.

But the opportunity that we have with the extension that we requested is in fact to align.

Our approach one thing I will say is that M. and this is very helpful and aligned to our approach in the with the FDA <unk> EMA is quite focused on fibrosis and fibrosis improvement.

As a recognized.

You know more clinically relevant.

Histologic feature.

Of of Nash.

And so that that's that's very much aligned with with our approach.

As an anti fibrotic drugs.

Across both U.S. and in Europe.

Got it thanks, Mark for taking the questions, yes sure.

Our next question comes from the line of Geoff Meacham with Bank of America. Your line is now open.

Hey, guys, it's Aspen on for Jeff I. Appreciate you taking my question just.

Just a quick one on PVC understanding that it is early in the FDA investigation and.

And that the focused population for the nest is relatively small how do you guys see any impact to two ocala sales either in that focused population or or or outside of it and any any anecdotal feedback from patients or physicians would be greatly appreciated. Thanks.

Jerry can you take that.

Yeah, I would say to date in the time since the the nets has a has appeared on the website we.

Don't see anything in the in the ongoing trends, which would be representative of any sort of immediate effect from that.

That concludes today's question.

And answer session I'd like to turn the call back to Mike Krzyzewski for closing remarks.

Thanks, operator, thank you everyone for listening in today, Yeah. It's obviously been an eventful quarter. We're we're very pleased with where we are in our foundational PVC business.

And we're also very pleased to have.

Begun our reengagement with with FDA.

With respect to next steps on getting too.

Potentially.

Resubmission next year I'm, assuming we of course get too.

Sufficient alignment with the agency on the basis of a resubmission.

But but it is.

Yeah. It is it is constructive that the agency appears to be open to our spending based on our month 18 biopsy data with safety update we'll continue to review the review process in Europe, and we'll look forward to providing you with updates across.

Across our Nash program as appropriate going forward, thanks very much.

Ladies and gentlemen, this concludes today's conference call. Thank you for participating you may now disconnect.

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Ladies and gentlemen, thank you for standing by and welcome to the intercept Pharmaceuticals third quarter 2020 earnings call.

At this time all participant lines are in listen only mode. So if you require operator assistance. Please press Star then zero.

After the speaker's presentation, there will be a question and answer session to ask a question during the session you'll need to press Star then one on your telephone keypad.

Please be advised that today's conference maybe recorded.

Oh it down the conference over to your host today. They said you Francesco head of Investor Relations. Please go ahead.

Thank you good morning, and thank you for joining us on today's call. This morning, we issued a press release announcing our third quarter 2020 years old and financial position and also posted accompanying slides, which are available on our website at www dot intercept pharma dot com.

Before we begin our discussion I'd like to note that during the call we will be making forward looking statements, including statements regarding our approved product in clinical development program.

Certain regulatory matters, including the potential approval of CA for liver fibrosis student, Josh and I started the prospects financial guidance and future commercial and financial performance lift.

Listeners are cautioned not to place undue reliance on these forward looking statements.

Speak only as of the date of this call.

<unk> undertakes no obligation to update such statements except as required by law. These forward looking statements are based on estimates and assumptions that although believed to be reasonable are inherently uncertain and subject to a number of risks and uncertainties, some but not all the risk factors that could cause our actual results to differ materially from our historical results.

Or those anticipated or predicted by our forward looking statements are discussed in this mornings press release, and our periodic public filings with the SEC.

Today's call will begin with prepared remarks from our CEO Dr. Mark Pruzanski.

By the time, our Chief operating officer, Jerry door, So and our Chief Financial Officer, Sundeep capacity as well then open the call to take your questions. Please limit yourself to one initial question in order to allow time for all questions to be addressed.

Let me now turn the call over to our CEO Dr. Mark was asking.

Thanks, Lisa and good morning, everyone. Thank you for joining us on our third quarter 2020 earnings Conference call.

Pleased to report our core PBC business performed well during the quarter, which I will summarize shortly but I want to focus first on providing a comprehensive regulatory update starting with Nash.

Last month, we had our tight they end of review meeting with the FDA to discuss the agencies benefit risk assessment in the CRL based on its review of the available data as well as our proposed basis for resubmitting, our M.D.A. seeking accelerated approval, although CA for Nash fibrosis.

As you know we we prepared extensively for this meeting with the objective of re framing our efficacy and safety data supporting benefit risk of Oceania Nash patients with advanced fibrosis based on the phase three regenerate 18 month interim analysis, and a refined risk management approach for appropriate patient selection and monitor.

The end of review meeting was constructed and based on the final meeting minutes. We recently received.

He has provided us with helpful guidance regarding supplemental data, we can provide to further characterize obvious use efficacy and safety profile, which could in fact support resubmission based on our 18 month biopsy data together with the safety update from our ongoing studies.

We are advancing accordingly, and plan to hold additional meetings with the agency with the goal of achieving sufficient alignment to proceed on this basis and potentially resubmit, our India next year.

Our work generating additional efficacy and safety data is ongoing and we remain focused on reinforcing means to identify the segment of Nash patients with advanced fibrosis score at most risk of progression to cirrhosis and could therefore, most benefit from overseas that helped spark roddick effects.

While achieving appropriate management of pathetic safety and other potential safety issues in treated patients.

As we have stated we believe this can be achieved based on appropriate labeling and standard noninvasive assessments used by specialists physicians to assess and monitor the functional status of their patients.

As we've often pointed out Nash patients with advanced fibrosis, typically have comorbidities take various medications and experience intercurrent illnesses that taken together render them, particularly vulnerable to acute progressive chronic injury to their liver.

So we and Ft I had been particularly focused on working to gain a thorough understanding although she does have attic safety profile in this population and the identification of patients who may potentially be at greater risk.

As we previously have shared we conducted a comprehensive assessment of the Paddick safety relatively late in the NDA review.

Yeah. It did not have a chance to fully review it.

We did have a chance to review some of the data at our end of review meeting and as a first order of business. We look forward to engaging in a more focused review of the data with the agency.

A word on some of the work we're doing on the efficacy side.

There is growing interest in digital pathology tools that are able to quantitatively score fibrosis and other histopathological features of interest in biopsy specimens and provide more accurate resolution that is supportive of pathologists assessments well.

While these innovative tools remain exploratory we.

We believe there is interest on the part of the FDA and that such data might bring those years and taught by product benefit into even clearer focus.

In addition of course as part of any safety update from our ongoing studies, we will have the benefit of assessing the longer term durability of those years treatment effect on a variety of noninvasive markers.

With that we very much look forward to continuing to engage with the FDA with the hoped for objective to position us for Resubmission of R. and D.A. next year, and we will of course update you on any important developments as appropriate.

A quick update now on our M&A seeking conditional approval of O'shea for Nash fibrosis in Europe.

As you May recall, we submitted the EMEA at the end of 2019 and our application is under review.

In the third quarter, we were granted an extension to respond to the day 120 questions. We received from the gamut with our responses now do this coming January.

We requested the extension to help ensure consistency in our approach and both of Us and Europe.

It's useful to pull back and remind you that based on recent literature Nash is now the most rapidly increasing indication for liver transplant in the U.S. and there is an urgent unmet medical need for the treatment of advanced fibrosis due to Nash, where there are no approved therapies.

Unfortunately for patients the Nash field has seen more than its fair share of failures in recent years and she is the only drug to have succeeded in a phase three trial today, having reproducibly demonstrated its ability to improve fibrosis we.

We remain committed to the Nash patient community with regenerate currently ongoing through clinical outcomes with the goal of confirming clinical benefit on a post marketing basis.

As a reminder, we are also conducting the phase three reverse study in Nash patients with compensated cirrhosis with read out of the double blind phase expected by the end of next year.

With regenerate and reverse are fully enrolled with patient retention continuing to track well despite the ongoing endemic.

As a final note on our Nash program, our conviction in the potential for associated becoming the first drug approved and an important treatment for patients with advanced fibrosis is shared by many stakeholders in the liver community.

Putting patient groups opinion, leading physicians and others passionate about advancing medical innovation.

So I am excited to note that money subramanian, the former therapeutic area head of liver disease that deal yet we successfully led efforts over a decade long tenure to secure a number of drug approvals has agreed to join our effort to help steer associate to approval.

Pivoting now to PBC our performance during the third quarter was strong once again.

We reported worldwide Ocala, net sales of $79.5 million, reflecting impressive growth versus the prior year quarter.

We believe the growth opportunity for our PVC business remains attractive over the long term.

As a reminder for those of you not familiar with the regulatory history.

Caliber was approved in May 2016 in the U.S. as a second line treatment for patients with PBC under the accelerated approval pathway based on a reduction in alkaline phosphatase as a surrogate endpoint reasonably likely to predict clinical benefit.

It also received conditional approval for PBC from it from Yemen in December 2016.

Full approval of that caliber for PBC is contingent upon among other post marketing requirements. The confirmation of clinical benefit in our ongoing phase four outcome study cobalt.

Cobalt is a placebo controlled multicenter study designed to evaluate clinical outcomes in more than 400 PBC patients.

Given the challenge in successfully completing multi year post marketing placebo controlled studies in a rare disease setting.

Do you have for example to patient dropouts and placebo crossover to commercial drug overtime probably.

Prior to initiating cobalt, we discussed with regulators potential conditions under which it might be converted to an open label study negotiate compared to a historic case matched control from available natural history data sets.

Well, we've been enrolling cobalt globally in more than 30 countries. We've continued discussions with both FDA and EMA concerning the merits of potentially converting to an open label study design.

And both agencies advised that we revisit this possibility if warranted after a pre specified interim efficacy analysis by our data monitoring committee or DMC, which was recently completed.

The analysis included DMC review of Unblinded safety data and no safety concerns were reported resulting in no changes recommended to study conduct.

However, the GMC did conclude that it doesnt seem feasible to continue cobalt as designed.

Of course, we remain blinded to data in the ongoing study and as is typical with such DMC interactions focused on maintaining data integrity. There was minimal additional detail provided as to the relative impact of confounding factors. It served by the DMC, including patient Discontinuations and placebo crossover to commercial O'callaghan.

We've notified both at FDA and in May of the DMC. His conclusion and further respected recommendations plan on holding a meeting with the FDA early in the new year, while seeking formal you scientific advice.

There are examples of other confirmatory outcomes open label studies relying on historic controls for rare disease drugs approved on an accelerated basis and we of course remain committed to working with the FDA and the M&A to come to resolution on a potential modification of cobalt as soon as possible.

I also wanted to address the quote newly identified safety signal or NIS four ocala of up in the PBC post marketing setting that was posted on the FDA website last month.

For background FDA has long conducted safety evaluations in the post marketing setting and in recent years has taken steps to increase the transparency with respect to such reviews.

In our case as we previously disclosed the agency notified us that it had initiated in this regarding liver disorder that classifies as a quote potential risk the lowest level of risk.

Hertz guidance at FDA estimates up to a 12 month timeline for the evaluation of this kind of Miss that's compared to a more rapid timeline for evaluating and this FDIC determines is either an important potential risk for an emergency.

We understand that this potential caliber rest can PVC was identified in the course of fts routine safety monitoring activities based on a search of the fairest database and other available external sources and FDA has further informed us that business is focused on a subset of cirrhotic or more advanced PBC patients, taking ocala and.

The broader PBC population.

As you would expect as part of our standard Pharmacovigilance activities. We've worked with the FDA to reconcile our internal safety database with the fares database and are now conducting a comprehensive assessment of all the available data.

Moving data from our completed clinical trials blinded reviews from ongoing studies, such as cobalt unblinded reviews of ongoing clinical trial data by the DMC most.

Post marketing data and natural history data.

The FDA has acknowledged the limitations of post marketing data and stated that safety data from controlled clinical studies will be of most value to inform any final assessment of the potential risk.

So it is reassuring that as mentioned our DMC recently reviewed unblinded safety data from patients enrolled in cobalt, including cirrhotic patients who comprise the majority of the study population.

And stated that no acute safety concerns were observed.

We are working to complete or complete comprehensive safety assessment with respect to the newness within the coming months and intend to continue to work with the FDA to complete the review.

It's important to note that we have over 14000 patient years of post marketing exposure in PBC patients treated with Ocala, and our view of its benefit risk remains positive.

We continue to engage the physician community and are pleased to see the continued strong interest in PBC. It sells you this year.

Where multiple abstracts evaluating o'shea for the treatment of PBC will be presented.

In particular, we look forward to the presentation of OTI is durable efficacy and safety data in PBC patients treated for up to six years.

Meanwhile, we continue to be committed to fostering innovation for patients with this disease and I'm pleased to report that we have resumed enrollment in our phase two study evaluating associate in combination with as a fiber it.

In addition to the strong net sales we reported in our PBC business in the third quarter we.

We also took swift steps to right size, our organization in light of our receipt of the CRL industry fibrosis.

This morning, we announced that we are narrowing our 2020 financial guidance within the high end of our previously announced Ocala net sales range and within the lower end of our previously announced non-GAAP adjusted operating expense guidance range.

This will put us in a strong position as we enter 2021 to support the continued growth and advancement of our foundational rare liver disease business and the potential resubmission of our India in Nash fibrosis next year.

Now I'd like to turn the call over to Gerry will provide an update on our global PVC business and commercial activities Jerry.

Thanks, Mark and good morning, everyone.

I'll start by discussing our caliber results for the quarter and then provide you with an update on our commercial organization long with a summary of our current efforts in PBC.

In the third quarter, we reported $79.5 million in worldwide, Calvin net sales, which represent a growth of 29% versus the prior year quarter and is our highest quarterly sales to date.

In the U.S., we achieved net sales of $58.6 million in the third quarter.

We saw continued end market demand growth for our caliber has us total prescriptions based on acute via data increased by approximately 14% versus the prior year quarter.

The International region, we achieved ex U.S, so Calvin net sales of $20.9 million in the third quarter.

These results reflect the continued strong performance in our key international markets.

Our global account business continues to be resilient. Despite the challenges, resulting from the COVID-19 pandemic and we've been pleased with our ability to maintain patients on therapy.

The overall slowdown in patient visits persist in the GI segment globally, and while we saw some recovery in the third quarter trends are still below the pre pandemic levels.

We continued to experience a lower level of new patient starts during the third quarter and.

And although the new patient segment represents a small portion of our business. The cobot impact Weve seen in 2020 is expected to have an impact on our future quarterly growth rate versus the prior year period.

As we discussed last quarter after receiving the complete response letter for Nash, we were able to take advantage of the flexibility we have built into our commercial plan to quickly prioritize our commercial activities and turn our focus back towards PVC, while postponing our Nash launched efforts and importantly, lowering our operating expenses.

Moving forward.

Subsequently in the third quarter, we restructured our commercial and medical affairs organizations.

The resulting targeted footprint in the field has been re sized and is focused on maximizing the growth of our core PVC business.

Through this transition we have retained a strong team with deep experience in hepatology and GE segments. Our teams are fully trained and now dedicated back the PVC.

As our field teams navigate their outreach given the current pandemic, we're actively leveraging technology to increase the impact of our customer interactions.

Complementing the efforts of our field teams, we've seen a positive response to our digital educational programs. For example, we recently trained our speakers to deliver education that included the results from our poise five your open label extension study.

Overall, we have continued to experience progressive growth both in the U.S. internationally as Weve established a caliber has the first new therapy for PBC at over 20 years.

As our commercial efforts pivot back fully to PBC, we remain confident that there is an opportunity for continued expansion in this market over the long term.

And now I will turn the call over to our Chief Financial Officer, Sandeep capacity for a financial update.

Indeed.

Thank you Jerry and good morning, everyone.

Please refer to our press release issued earlier today for a summary of our financial results for the quarter ended September Thirtyth 2020.

We reported strong Q3 results and made solid progress in our efforts to reduce operating expenses going forward.

These efforts resulted in the narrowing of our 2020 guidance towards the higher end of our Calvin net sales guidance range at the lower end of our non-GAAP adjusted operating expense range.

Beginning with our commercial performance.

In the third quarter, we recognized 79.5 million Calvin that sale, our highest quarter to date up.

Up from $61.5 million in the third quarter of 2019.

Our third quarter Calvin net sales comprised of us that sale of $58.6 million.

Net sales of 20.9 million.

This represents growth of approximately 30% and 28% respectively versus the prior year quarter.

As a reminder, in Q3 2019, we did experience a drawdown and trade inventories in the U.S.

Our GAAP operating expenses for the third quarter were 134.7 million.

And our non-GAAP adjusted operating expenses were 118.1 million.

As a reminder, our non-GAAP adjusted operating expenses, excluding stock based compensation and depreciation.

Non-GAAP adjusted operating expenses as a non-GAAP financial measure under SEC regulation.

Please refer to our press release issued earlier this morning for a full explanation and reconciliation of it.

Our cost of sales for the third quarter were $1.8 million compared to 0.5 million in the prior year quarter.

Our selling general and administrative expenses, but third quarter was 70.6 million.

This represents a decrease of $6.2 million versus the prior year quarter and was driven by our initiatives to reduce costs, including the postponement of the NASS launch.

Our research and development expenses increased to $48.9 million in the third quarter of 2020.

16.2 million in the prior year quarter.

The decrease was primarily driven by lower NASS development costs, including the conclusion of enrollment activity that regenerate and reversed.

Prior to the third quarter of 2020 and reduced costs related to our preparation for NAF regulatory interactions.

Restructuring expenses were $13.4 million for the three months ended September Thirtyth 2020.

These expenses include costs related to the previously announced restructuring.

As of September Thirtyth 2020, we are well positioned with cash cash equivalents restricted cash and investment securities available for sale of approximately 496.8.

And now turning to our updated financial guidance for the year.

As I mentioned earlier, we took the necessary steps to lower our costs.

How about franchise as profitable continues to grow and is expected to provide strong financial foundation for our future.

We are able to narrow our full year 2020 guidance range for both net sales and non-GAAP adjusted operating expenses.

We now expect full Calvin net sales in the range of 310 million, but 320 million up from our previous range of 300 million to 320 million.

We now expect 2020 non-GAAP adjusted operating expenses in the range of 460 to 480 million down from the previous range of 460 500 million.

As we close the year and look forward to 2021, we remain focused on top line growth and prioritization of our investments going forward.

Overall, I'm pleased with our strong commercial performance, which together with the initiatives, we've taken to reduce costs put us in a strong cash position.

Well positioned to support our nath regulatory process, but the fund.

Fund, our ongoing clinical trial and continue to invest in the growth of our power business.

So with that I'd like to turn it over to the operator for any questions.

Operator.

Ladies and gentlemen, if youd like to ask a question at this time. Please press. The Star then the number one key on your Touchtone telephone.

To withdraw your question press the pound key.

Again, that's star then one if you'd like to ask a question at this time.

Our first question comes from the line of Michael Yee with Jefferies. Your line is now open.

Hey, Thanks, good morning, and thanks for the very comprehensive update Mark.

Our two questions relate to just clarifying.

The discussions with the agency as much as you can in terms of what specifically is it.

Wired for the safety component of things and on the efficacy.

It sounded like a detailed discussion I public safety and said that warning about a point, where if you all bad so maybe is that kind of what.

Really the game pardon the safety side and the efficacy side it sounded like a lot less stuff. So maybe just talk to those two sides again and then on Europe can you just clarify what your any discussions at all its really where they focus first on okay. Thank you.

Sure. Thanks, Mike, Yes, so as I mentioned in my prepared remarks, we are happy to have the the end of review meeting.

With the agency, we received the final meeting minutes and as we anticipated. This was to start re engagement with the agency with respect to potential resubmission.

The FDA and we got a lot of helpful guidance from from FDA with respect to elements that we.

We can address in support of ongoing discussion.

And that potential resubmission.

As you mentioned on the safety side.

As weve.

Long held I mean liver related safety in patients with advanced fibrosis is really important to get a handle on.

We mentioned before that both we and the agency.

Really tried to understand across this population.

Liver health status there are a lot of confounding features in a population like this.

As mentioned that lead to progressive disease acute exacerbations of tutsis et cetera.

So so it's a challenge and.

And we did conduct on this independent expert blinded assessment of liver safety.

Relatively late in the review cycle.

So the agents you didnt have a chance to really complete review of that.

So appetite Bay, we did have a chance to discuss this and.

And I do think that you do sort of the first order of business to follow up with the agency and really try to get a handle on.

And again part of any Resubmission would be a comprehensive safety update from from primarily regenerate and other ongoing studies.

And.

Assuming were in a position to resubmit next.

Next year.

Well essentially have the chance to.

Virtually double.

Safety database with respect to duration on study just for reference.

When when we think about the patients who comprise the month 18 interim cohort.

On average those patients are now nearing three years on study.

And those who are first enrolled in the study.

Our approaching five years, so so thats going to be a very rich safety update which is invaluable and a large disease population like this.

On the efficacy side I mentioned in my remarks on a growing interest in digital pathology tools.

And.

I personally in the context of.

Ongoing need for a liver biopsy think that these tools are going to also proved to have a lot of merit.

In addressing the well known variability that we see with colleges assessment that these semi quantitative cuts categorical.

Features histopathological features.

So while they continue to be exploratory.

I think that there is clearly growing interest in the community.

And that they can bring into clear focus.

The histologic benefit of a drug like CA.

That's just one example, and then obviously on the flip side of any such safety update is taking a look at the durability of response with respect to non invasive markers of efficacy.

Oh and then so that's on the FDA side on the European side, obviously, we're earlier in review.

We did get this extension to January for our day 120 responses that that allows us to align our approach.

Yes, both us and Europe.

And.

We're pleased to be under underway there.

But premature to comment on what.

What the issues will be.

Got it thank you very much.

Thanks, Mike.

Our next question comes from Yasmeen Rahimi with Piper Sandler Your line is now open.

Hi team. Thank you for that color two quick question, maybe first where he is.

Is that really an additional meeting necessary with the FDIC. It just had quite a lot of content from them on a path forward and if you could just maybe give a little bit more granular details on terms of whether we expect any filing first half of 21 or second her and that is there a potential that you could maybe.

Role and that cirrhosis that reverse data into the filing and thank you again for taking my questions.

Thanks, guys.

So yes.

We do need to have additional interactions with the agency and frankly.

Yeah.

We welcome that.

It's in our mutual interest to try to gain as much clarity and comfort with respect to this this large and complex dataset.

Prior to any any resubmission so yes.

I think that.

I think that and weve anticipated that that would be the case.

Coming off the Taipei meeting and the good news is that we're constructively engaged with the review division.

And have you know.

A lot of guidance with respect to things.

Things that date, they wish to look at.

I think with respect to your the second part of your question on timing. It is premature right now to to speculate on first half second half, we think because largely in part that we need to.

Yet our ducks in a row in terms of.

Timing of generation of.

Data.

They are the interactions with the FDA, which.

I think we can have on a timely basis, but also.

Is that a little bit at the discretion of the agency but.

But they they absolutely do want to continue the discussion and meet with us.

And again as I mentioned, assuming we.

Get to adequate alignment.

I think that could position us to to resubmit next.

Next year based on the month 18 biopsy data with the safety update.

With respect to reverse.

Again, we anticipate it reading out by the end of next year.

It is open under separately Andy.

But right now its not contemplated that we would wait for the result of reverse to to resubmit.

Thank you Mike.

Thanks, Yes.

Our next question comes from Joel Beatty with Citi. Your line is now open.

Hi, Thanks for taking the question one question. The first one is it has the next meeting with FDA already been requested.

As the next meeting been recruiting.

Well look again, we don't comment on any specific meetings or timing of beatings typically but.

We are right now lining up.

You know our next steps.

We just came off the meeting and just received the minutes. So we're still digesting.

Okay got it Thats helpful. And then one other question is on the potential of the unblinded outcomes data from regenerate as well as cobalt would be submitted to the FDA as part of the Nasri filing.

Yes look I mean.

It's a good question and that was what we were wondering after receiving the complete response letter but.

But.

What's which we're really pleased about coming off the Taipei meeting.

Now is that there appears to be openness on the part of the agency.

To a potential resubmission based on the month 18.

See data with the safety update of course and.

And so that would not necessarily include any kind of interim.

Outcomes data from the ongoing regenerate study remember we remain blinded.

Two two outcomes studies ongoing as I mentioned.

But but.

As of right now we anticipate you'll take.

Another three years or so until we get to a target number of outcomes to get to the end of the study.

Got it thank you.

Our next question comes from Brian Abrahams with RBC capital markets. Your line is now open.

Hi, guys. Thank you so much for taking my questions and thank you for the comprehensive update.

You mentioned some of the I guess on the efficacy side, you talked about the potential.

For our filing with greater clarification on the existing 18 months biopsy data set from regenerate just wonder if you could talk a little bit more about that have you mentioned this some digital assessments of histology is that are those analyses that you guys have already done and if not how long it might those take to do and then secondarily I'm wondering.

How much the discussion with the agency is centered around a potential.

Now going up the population maybe closer to this.

At risk advanced population that you guys have always talked about is framing.

Framing from a commercial standpoint versus the broader regenerate population. Thanks.

Okay.

Brian We may have bought Mark just stand by while we welcome back.

Okay.

We have marked back on the line now.

Well the juice.

My line dropped.

Fine can you repeat your question.

Yes sure Mike My first question was just on the digital assessment of Histology that you guys have talked about.

As the weather you've done some of those analyses at yet and if not how long those might take to conduct and then secondly, just wondering the degree to which your discussions with the agency or centering around potential narrowing of the label maybe closer to this at risk population of advanced fibrosis patients that that patient that you guys have always talked about when framing.

Potential commercial.

Effort versus the broader regenerate population. Thanks.

Thanks, Brian.

Sorry to drop there.

So with respect to digital pathology that work is ongoing.

But I don't think it will be represent critical that with respect to.

Yes, getting to a potential resubmission next year.

And by the way I would point out that there are a number of abstracts at this year's a SLB starting towards the end of next week that's it.

To look out for just just to if you're interested to look at these the power of the technology.

With respect to second part of your question on narrowing label I mean, it's it's premature to speculate on on labeling but.

Yeah, I mean, we've been very consistent.

With respect to our intend to focus and that is on patients with advanced fibrosis score at most risk.

And you know that clearly represents a narrower segment than the population we studied overall.

Got it thanks.

Our next question comes from a leading our young with Cantor Fitzgerald. Your line is now open.

Hey, guys. Thanks for taking my questions.

The first one can you just talk a little bit about like how.

How you think about the macro environment that being around that I mean is it like a question of you know sort of education that you're having to provide early start are people going to more Gary you know doesn't you guys are like there have been some failures in a safe and on the second question is that you know when you when you think about like PB, saying that that's crazy question now.

You know how do you think about potentially being more aggressive there and taking share in light of you know what's going on with passion you know the fact that like that and perhaps like hopefully not in the group I think also now Pvp of I think that clear marketing focus and the thing is tied mostly to play that thanks.

Yes look at least here with respect to the first question.

No I mean, obviously there was a tremendous unmet need in Nash, it's a large population as I mentioned on my remarks, it's now become.

Become the fastest growing region for for liver transplant with no approved therapies. You know that said you know I think it's appropriate for for F.D.A. too you know really scrutinize every drug that comes through I mean at the end of the day you know we all acknowledge.

Just that.

Or that the these endpoints as high as the bar is.

Our surrogate endpoints reasonably likely to predict clinical benefit and so you know you need to really rigorously assess but both sides of benefit risk I do think that on that that F.D.A.. Andy you may continue to be committed.

Two on two Nash too high to the potential for surrogate endpoints to support accelerated and conditional approvals respectively.

But clearly the buys the bar is high and you know where she is the only drug as you know to have succeeded in phase three on certainly the only drug to reproducibly shown in itself I brought up benefit.

But the leading care wells compare you know to kind of antibiotic effect that you see with parametric surgery, and Nash, which is the only reference standards.

So you know we're confident in in in the drug, but clearly more work needs to be done in updating our safety and efficacy data and reviewing it with the FDA to put us up hopefully back in position for Resubmission on the second part of your question on the P.

D.C. side, you know look like you know we we clearly are very pleased with growth that we've seen in the BDC business globally I.

I mentioned that you know we're now.

Past 14000 years of exposure, we've got long term safety Tolerability safety and efficacy.

Data in the population we continue to innovate.

And be committed to the population maybe you know Jerry could ask or answer more specific question about your penetration.

Yeah, Hi, Lisa it's Jerry I think clearly we believe that there is considerable potential left for us to access in PBC I would not at all consider that we're at the late stage of the lifecycle at this point, we should be able to continue to access more of the patients that are eligible for.

Okay, Eleva and Havent been started yet I think when we look at the market research that we continue to do on a regular basis.

Significant opportunities for growth remain I think if you look at every quarter even in the period like we're in now where where cobalt has some some disruption in the market, we're seeing new prescribers come on board.

For the first time, which is not always the case when you're several years into the launch I think it just speaks to the need for us to continue to educate the market and as you said importantly, now.

Our commercial and medical field teams are now refocused and dedicated and frankly, I think and I've been really pleased with the level of engagement on our teams as we've made the pivot over the last several months from a a lot of the preparatory education for Nash back fully focused commercially to all Calvin PBC, So well continue.

To.

You know to ensure the right focus to drive the growth, but again the key message for me is a considerable opportunity remains.

In PBC.

Thanks.

Hi, guys.

Our next question comes from Steve seat House with Raymond James Your line is now open.

Yes, Hi, this is actually more of a lot of on for Steve See House and we have a couple of questions. So in terms of NIS. When do you expect to provide data analysis results to the FDA and then could you remind us what portion of your PBC patients are cirrhotic. Thank you.

Sure. So second part of your question what proportion are our cirrhotic, but the vast majority of patients are not cirrhotic, we estimate up to 85%.

So we're talking about a pretty narrow segment of the population with respect to the work that's ongoing I mean, its comprehensive safety assessment on cross post marketing and clinical data as I mentioned in my prepared remarks.

We're working as expeditiously as we can to complete that work.

Which we expect to happen over the next few months and you.

And that will then facilitate discussion with with F.D.A.

With respect to.

Any any resulting recommendations.

Okay. Thank you for that and then on on Cobalt could you clarify what was the main reason cobalt cannot consignors a blinded study. Thank you.

Yeah, so you're referring to the DMC is conclusion coming off the interim efficacy analysis.

And as I mentioned I mean, you know we've long been aware as others have the.

FDA and EMA may the challenge of conducting these multi year placebo controlled outcome studies in a rare disease setting and in the post marketing a post marketing basis.

You know weve clearly doing our utmost to enroll cobalt over the last few years as I mentioned, you know in over 30 countries.

Countries and also its important context to know that it's not only that we're studying a rare disease population, but this is primarily a more advanced ER segment the population right. So.

Majority of the patients and cobalt are already cirrhotic or when they entered the study so it's an exceedingly.

Tough.

Study to enroll and takes many many years.

And the concern of course going in is that overall over the years of course, you're going to get just continue patient discontinuations and you're going to get patients crossing over to commercially available drugs. So.

So and this is a concern not not unique to cobalt of course I think it's it it's a more generalizable.

Challenge for anyone who follows us in PBC and frankly another.

Chronic rare diseases. So.

It is something we've had an ongoing dialogue with Ftn you may on and as I mentioned, you know we will in the in the new year be following up with stuff with Sta getting scientific advice in Europe, but to see what we can do but we remain committed of course to confirming a benefit.

But.

You know again, you need to see where the where the regulators would like to go with respect to modifications to the study.

Okay. Thank you very much Marc.

Thanks.

Our next question comes from re Tubaro with Cowen. Your line is now open.

Hi, guys. Thanks for taking the question I wanted to ask you about what you were thinking as far as your strategy for your 2023 Cooper.

Is that going to be wholly dependent on.

Your conversations with X y or can you sort of have a standalone strategy regardless.

On how to deal with those and then my follow up is on your beaten Fibrate study.

You mentioned, one can you talk about the data timing and and potentially regulatory path.

[music].

Beyond the current study and if you could as well could you just walk us exactly to the rationale for that.

Comparing our arms, because it's just a little confusing on Clin trials, there. So there's a bunch of them if.

If we kind of the same but not really.

Sure Richard So somebody could you take the first part on convert.

Sure Hey, Rick. Thanks. Thanks for the question I think we took a lot of the initial steps obviously to reduce our operating expenses I'm very pleased with the progress that we've made so far.

First maturity on the convert is not until 2023 and so we're always.

Evaluating options you know, we're always thinking proactively and strategically ways to manage our future capital capital needs. I think you know, we'll certainly as we understand better the timelines for Resubmission you know.

And and in the coming months you know, we can continue to sort of evaluate and provide provide you an update there.

And he was a partner in.

Yeah, Richard with respect to the combo goes if I read so just a reminder to everybody that.

That's a fibrate is a pan people are agonist on thats been on the market in a number of countries ex U.S. for for many many years and there's been a lot of interest in bed.

In PBC, specifically around the world in fact, among many days.

Datasets at the recent European liver meeting useful.

The first abstract in the general session was on tenure outcomes data from Japan.

In PBC showing.

And outcomes benefit with with best a fibrate.

Treatment as compared to Urso alone. The first line treatment, they're there have also been.

Several combination datasets clinical data sets out of Europe, there's been presented at various meetings I'm looking at kind of a combination of Oh CA with that's a fibrate, which again look look quite promising and support the potential for the combination.

As a follow on.

Treatment for Fourq.

For PBC. So the phase two study that is currently enrolling.

I think retool its premature I mean, it was on hold during the bad you know a lot lot of the pandemic I'm happy that you know we're now.

We initiated enrollment, but but it's a bit premature to try to project on the timing of read out in terms of where you know what the regulatory path would look like.

You know that there is guidance of course for combination product development.

Typically you have to characterize component a versus component b versus component versus eight lets be hopefully, we'll be able to do a lot of that characterization in phase two.

But ultimately phase three design will be a function of our discussions but at the end you may at the time [noise].

The other development of the fixed dose combination is going well from a product development standpoint, and we currently don't see any major insurmountable challenges there.

So I'll stop there.

And so the current study doesn't answer that's actually a question that play.

Well lot.

That will come afterwards.

Well you know typically typically in in in Phase two you do Ah you know part of the guidance you do do the factorial you do do the a versus b versus say, let's be but but again there are exceptions to that.

I think we'll just have to see and you know again I think we will want to leverage as much as possible the available data.

You know that's why I mentioned to you know all of you know all of the data sets that currently out there published et cetera.

Got it thanks for taking the questions. Thanks Richard.

Our next question comes from Jay Olson with Oppenheimer. Your line is now open.

Oh, Hey, thanks for taking the questions I had two of them starting with the Nash CRL I think at the time you received the CRL you suggested a timeline of about six months to resubmit your and dealing with a six month review and potential Nash approval mid two.

Only 21.

And I was wondering it.

It just seems like today's language sounds like could potentially longer timeline. So now that you've met with the FDA what changed why does the timeline seen longer now and was there something incrementally more time consuming that you've got some you're at the meeting.

And then I had to PBC question, I'm kind of surprised to intercept would want to convert cobalt to an unblinded design since Ocala has repeatedly been a victimless unwarranted safety concerns which were all these uncontrolled safety records. So why would you want to deliberately give up an ideal.

Source its controlled safety data.

Which you could use to potentially ensures a clean safety profile of locales.

Sure So with respect to the first question on timeline, you know right on the heels of the CR letter.

You know I put out speculatively, what a best case could look like in response to the CRL that are obviously that was created in the first instance by on timing of the first interaction that type a end of review meeting, which which we just had.

Had last month so.

I think that you know we've adjusted our thinking about potential timeline. Accordingly. In addition, you know as as we contemplated at the time, we knew that this was the Taipei meeting was an opportunity to reengage with the agency and whats helpful. Here is that there was a mutual desire on.

On our part nephews part to get together again and have substantive interactions on to try to gain further clarity and comfort.

With respect to first and foremost safety data, including ultimately safety update that I've mentioned in my remarks.

And of course additional efficacy data, but but you know what what we're pleased about is that you know number one we're constructively engaged with reviewed edition number two.

That they've expressed an openness to potential resubmission based on the month 18 biopsy data with safety update.

And that in fact was was was our AR was and remains our hope for objective here on the TV side.

Look you know as I mentioned, we've been 100% committed to conducting cobalt globally.

On on an ongoing basis is a placebo controlled study and Andy you know as I mentioned also with respect to addressing.

The.

Yes. That's currently currently being looked at we believe that the safety data from that controlled study and again, just just to punctuate point right. The majority of the patients in that study our cirrhotic patients.

That will be the by far the most valuable source of safety data that we will tap and we have.

Pretty extensive safety data at this point given how long. This study has been ongoing.

So it with respect to you know on a forward looking basis then.

Converting it took the label it's not necessarily that that was our our intent kits that you know we we have long been aware as have ftn DNA of the challenge of successfully completing a placebo controlled confirmatory.

Outcome study in this kind of rare disease setting taking many years in the post marketing setting. So we now have a DMC conclusion based.

Based on a pre specified interim efficacy analysis that the study doesn't seem to be feasible as currently designed.

And so that's you know.

That that is now going to catalyze discussion with boats ft, any M&A with respect to any any.

Any appropriate modifications you open label designed with external control historic control.

Is is an option that could make sense under such circumstances.

Great. Thanks, again for taking the question.

Sure.

Our next question comes from Thomas Smith with STB Leerink. Your line is now open.

Hey, guys. Good morning, Thanks for taking the questions.

In Nash I know you have a large number of patients who are enrolled beyond the interim analysis cohort and regenerate.

Should be coming up to their 18 month biopsy can you just clarify if you're planning to analyze and submit the 18 month biopsy data from this cohort to the agency as part of the Resubmission and then some.

Secondly, on the Nash marketing application in Europe I.

I understand you've asked for an extension year to try to align your responses and your approach between the two agencies, but can you comment on how closely that they won 20 questions near some of the questions raised on the FDA review are there any notable differences and the feedback between FDA and EMA. Thanks.

Sure. Thanks for the question yes.

Yes. The answer is so with respect to monkey King biopsy data, we do have.

Additional biopsy data were blinded to it.

Right now from the cohort the outcomes a cohort of patients in.

And we are considering whether it could.

Incrementally add to the.

The efficacy dataset right.

That that we currently have in hand, but but you know that that's going to take a little bit of time to think about with respect to M&A.

Again, we're relatively speaking early in the review the data they want 20, I think that the you know the the review issues will come into better focus on with day 180.

But the opportunity that we have with the extension that we requested is in fact to align.

Our approach one thing I will say is that yeah man. This is very helpful and aligned to our approach in the with the FDA <unk> EMA is quite focused on fibrosis and fibrosis improvement as.

As a recognized.

You know more clinically relevant.

Histologic feature.

Of of Nash.

And so that that's that's very much aligned with with our approach.

As an anti fibrotic drugs.

Across both the U.S. and in Europe.

Got it thanks, Mark for taking the questions, yes sure.

Our next question comes from the line of Geoff Meacham with Bank of America. Your line is now open.

Hey, guys, it's Aspen on for John I. Appreciate you taking my question.

Just a quick one on PVC understanding that it is early in the FDA investigation.

And that the focused population for the nest is relatively small.

Have you guys seen any impact to two ocala sales either in that focus population or or or outside of it and any any anecdotal feedback from patients or physicians would be greatly appreciated. Thanks.

Gerry could you take that.

Yeah, I would say to date in the time since the the nets has a has appeared on the website we.

I don't see anything in the in the ongoing trends, which would be representative of any sort of immediate effect from that.

That concludes today's.

Question and answer session I'd like to turn the call back to Mike Krzyzewski for closing remarks.

Thanks, operator, thank you everyone for listening in today.

Yes, it's obviously been an eventful quarter. We're we're very pleased with where we are in our foundational PDC business.

We're also very pleased to have.

Begun our reengagement with with FDA.

With respect to next steps on getting too.

Potentially.

Resubmission next year I'm, assuming we of course get too.

Sufficient alignment with the agency on the basis of a resubmission.

But but it is.

Yeah. It is it is constructive that the agency appears to be open to our risk spending based on our month 18 biopsy data with safety update well continue review the review process in Europe, and we'll look forward to providing you with updates across our Nash program as appropriate.

Going forward, thanks very much.

Ladies and gentlemen, this concludes today's conference call. Thank you for participating you may now disconnect.