Q3 2021 Intercept Pharmaceuticals Inc Earnings Call

Okay.

Ladies and gentlemen, thank you for standing by and walk through the Q3 2021 intercept pharmaceuticals earnings call. At this time all participants are in listen only mode. After the speaker's presentation there'll be a question and answer session to ask a question during the session need to press star one on your telephone if you require any further assistance. Please press star Zero I would now like to turn the call over to your host Mr de <unk>.

ESCO SVP Investor Relations and corporate Affairs, you may begin.

Okay.

Thank you good morning, and thank you for joining us on today's call.

We issued a press release announcing our third quarter 2021, they call and financial position, which is available on our website at www Dot intercepts pharma dot com before we begin our discussion I'd like to note that during our call we will be making forward looking statements, including statements regarding our approved product and clinical development program.

Regulatory matters, and our strategy prospects financial guidance and future commercial and financial performance.

Listeners 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. These.

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.

But not necessarily 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.

Discussed in this morning's press release and in our periodic public filings with the SEC.

Today's call will begin with prerecorded prepared remarks from our president and CEO, Jerry Durso, Our Chief Commercial Officer, Linda Richardson, President of research and development and Chief Medical Officer, Dr. Michelle Berrey.

And Chief Financial Officer, Andrew sake. Additionally, available today for Q&A purposes are Dr. Gail Cockwell Senior Vice President Medical Affairs safety, and Pharmacovigilance and Dr punishment Senior Vice President regulatory Affairs. 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 Jerry Durso Jerry.

Thanks, Lisa and good morning, everyone. Thank you for joining us on our third quarter 2021 earnings Conference call.

As we near the close of 2021, and my first year as CEO of intercept I would like to start by reflecting on the great progress that we've made against the main objectives that we set out to achieve at the start of this year.

First to continue growing our foundational PVC business window caliber.

Second to execute on our clinical and regulatory goals, including progressing our clinical development program and advanced fibrosis due to Nash.

And third to expand our portfolio and advance our internal pipeline and finally to improve our operational and our financial foundation to support our path forward.

Regarding our first objective driving growth in our PVC business, we continue to see the strength and resiliency of Ocala.

As a reminder, the third quarter was the first full quarter since updates to the U S label were finalized at the end of May.

We reported third quarter sales growth of 17% over third quarter last year and as a result have increased our sales guidance for the year.

In a few minutes blended Andrew will share additional details about our commercial performance and our outlook for the remainder of the year.

Now that we've worked through a label update in the U S. A strong conviction in our ability to continue to expand and grow this business long term.

We've also made great progress executing on our clinical and regulatory goals in our Nash program, we remain on target to generate the largest data package in the field to support a potential resubmission of our NDA for OCA for the treatment of advanced fibrosis due to Nash. These important data we will determine our path forward in Nash, we anticipate the data.

Generation process could continue into the early part of next year and if we believe the data support accelerated approval. Our goal would be to have a pre submission meeting with FDA during the first half of 2022.

We also anticipate top line data from our phase III reverse trial, which is assessing <unk> in patients with compensated cirrhosis due to Nash near the end of this year.

We've also been working to expand our portfolio by advancing our pipeline and looking for opportunities to leverage our strengths.

As we announced last quarter, we've initiated the first in human study for our next generation <unk> agonist.

787% and continued to advance our phase two work for the OCI beds of Fibroid combination program in PVC.

Michelle will share more details on our progress across these programs.

Importantly, in addition to making great progress on this year's objectives. We've also significantly strengthened our operational and financial Foundation, we remain prudent with our expenses and reduced our cost structure, resulting in the narrowed operating expense guidance that we announced this morning.

We also successfully exchanged the majority of our near term debt to address the maturity of 2023 convertible notes.

Are there more we've significantly reduced our burn rate and we are in a strong cash position with another cash positive quarter.

These are critical steps because we entered the next phase of intercepts journey.

As we've previously said, we will be making data driven decisions and defining the strategic path for the company's future.

This path could be supportive of either the pursuit of accelerated approval in Nash or if the data do not supported our focus on our profitable and growing rare disease business.

Our solid foundation will allow us to focus on becoming a strong successful company over the long term.

With that I'm going to turn it over to Linda who will talk about our commercial performance this quarter.

Michelle will then provide an update on our regulatory and R&D activities and Andrew will conclude with a review of our financial performance.

Linda.

Thanks, Jerry and thank you to everyone, who is making time to join US today as you saw on our press release. This morning, our foundational PVC business. Once again demonstrated solid performance in both the U S and international markets in the third quarter and year to date periods. During our last earnings call. We indicated that we expect.

Good to see the impact of our label change in the U S business in the third quarter and I'll be providing some commentary on this now.

The U S commercial and medical affairs teams did a great job as they work to educate health care professionals on the new label, we effectively reached our prescribing targets within the first three months following the receipt of the revised label and now our sales team has fully pivoted back to promote it'll caliber for eligible patients.

<unk>.

Second our data show that many of the patients who are discontinuing caliber on a treatment regimen of once or twice weekly dosing, which has a lower volume impact.

These are the patients who should discontinue given our revised labeling.

Third we have not seen a significant impact beyond the labeled population, which you can sometimes encounter with implementing the label update.

We've undertaken market research to assess health care provider reactions to our revised label and the feedback has been consistent physicians report that they are aware of the new label and understand who the appropriate patients for treatment with a caliber.

Furthermore, through discussions with our sales team community Gastroenterologists and particular noted that they were not typically treating patients with compensated cirrhosis before the label change. Therefore, there is less impact on their patient selection post label change.

At the time the label was updated earlier this year, we had estimated that 10% to 15% apparel caliber population could be impacted we anticipate that this ultimately will be at the lower end of that projected range.

Based on current trends, we believe that the impact of the label update on existing O'connell the patients will be largely realized by the end of this year.

Moving forward, we are now focused on new patient starts, which we have seen weakened since the beginning of Covid and through the label change we continue to see significant opportunity in our core PVC business given the vast majority of patients requiring second line therapy remain eligible for treatment with O caliber.

The ability to share our compelling new data with our PVC prescriber community is fundamental to our beyond <unk> messaging and <unk>.

September we began sharing educational materials that highlight new data from our cohort of <unk> patients who remained in the open label extension phase of the poise trial. These data show a stabilization of fibrosis over five years and the progressive disease like PVC stabilization is resonating with our health care.

Items and feedback has been very positive.

Just a quick word on our compelling international business performance as we had another solid quarter with sales up 25% over last year, we continue to experience increasing growth in new patient starts and adoption of Ocala that as compared to last year multichannel execution has been a strong focus for us and we see.

Excellent engagement with our customers across regions, we do anticipate a label change in our international markets in late 2021 with implementation to follow in 2022.

The overall strong performance of the commercial teams through the third quarter has led us to increase our sales guidance for the year, which Andrew will discuss in his section of this call.

At this time I'll turn the call over to Dr. Michelle Berrey Michelle.

Thank you Linda and good morning, everyone I'd like to provide a few key updates today.

First I'll provide you with an update on our Nash data generation and regulatory interactions, which remain on track.

Second I'll share some important progress regarding our post marketing requirements in PVC and.

And lastly, I'll preview some exciting data, we'll be sharing at the upcoming liver meeting and update you on where we are with some of our other pipeline activities.

I'll begin with Nash.

Pleased to say, we're currently on track with the important data generation, we outlined last quarter.

Our safety database for OCA and Nash will now include more than double the patient exposure of our initial interim analysis with more than 6000 patient years.

On the efficacy front, we're currently reading all baseline in month 18, liver biopsies using our new consensus panel reading methodology that we outlined last quarter.

We are in the midst of generating the largest data package ever created in the Nash field to support a potential resubmission of our NDA in Nash fibrosis, and we expect this process to continue into the early part of 2022.

As a reminder, we are.

Generating these data from the regenerate study in pursuit of an accelerated approval for FCA in the U S. As the first compound to treat advanced fibrosis due to Nash.

We have also begun breeding liver biopsies for our second large phase III Nash study reverse studying <unk> in patients with compensated cirrhosis.

We expect that process to be complete and topline data from reverse to be available around the end of this year.

As long as the data support it we expect we will be able to hold a pre submission meeting with FDA in the first half of 2022.

While our top priority remains generating important data to support a potential resubmission in the U S. Our MAA in Europe for Nash fibrosis also remains on file.

We had requested and were subsequently granted a clock stop for our EMA application.

Is this sort of just take advantage of the data generation, we were conducting for our NDA.

We are now planning to respond to our day 180 questions. This month.

We've made progress and attempted to align these processes. Our day 180 responses will not include all the data we're generating in the U S. Given that this data generation will continue into 2022.

And as a reminder.

EMA has outlined a high bar for efficacy.

For the initial and overall Nash development guidance and their draft reflection paper from 2018.

And they expressed a preference for seeing statistically significant and clinically relevant efficacy in both reversal of fibrosis, and Nash resolution or a two stage fibrosis improvement.

They also clearly stated that they will be looking at the totality of the clinical dossier submitted and that their final position would be data driven following review of regulatory filings.

The unmet need for anti fibrotic therapy in Nash has never been clearer.

The NIH is Nash clinical research network or CRM recently published results from a prospective study in the New England Journal of Medicine that again reinforces the strong association between advanced fibrosis, and an increased risk of liver related complications and death in patients with Nash.

And now I'd like to provide an update on our PVC post marketing commitments.

Discussions regarding our two post marketing clinical outcome studies remain ongoing with both the FDA and EMA and we've made some important progress.

As a reminder, since the time of the Ocala approval for PVC in 2016.

We have acknowledged the potential difficulties in recruiting and retaining patients and these blinded placebo controlled studies when if calibre is commercially available.

After gathering feedback from regulators.

Our next step in that process is to close out the cobalt study.

We won't collect available placebo controlled data from cobalt and include it as one element of a broader evidence package that will also include real world data and outcomes data from the poise long term extension study.

This evidence package will inform our dialogue with FDA and EMA as we work to fulfill our post marketing commitments and obligations.

We expect the data generation process to take several quarters and plan to submit this data package in 2022.

And on that note, we're proud to share today that one of our abstracts have been selected not only for a late breaker podium presentation at the liver meeting.

But as a best of <unk> 2021 abstract.

The abstract entitled patients with primary biliary cholangitis treated with long term a beta cologuard. It in a trial setting demonstrate better transplant free survival than external controls from the global PVC and UK PBC study group.

We are all excited about sharing these data with you on November 15th.

I hope it remains the only second line agent approved for use in PBC and continues to demonstrate a benefit to patients with this devastating disease.

We are committed to working closely with regulators to come to a resolution regarding our post marketing commitments and I'm encouraged by the progress thus far.

Turning to our pipeline.

Phase two OCA plus specified trial is continuing to enroll outside the U S. As.

As we've shared previously published data supporting the benefit of Bezeq Library, and PVC are encouraging and reinforced the potential for this novel combination to reduce elevated.

And bilirubin associated with improved survival.

We plan to study a broader range of batches of the combination and an additional phase two trials that will be initiated in the U S. We.

We remain committed to progressing therapies for individuals living with PBC.

Additionally, our phase one study of our next generation ethics are agonist Int 787 is ongoing.

We plan to select a target indication for Int 787, and early 2022.

Overall I'm pleased with the progress our R&D team has made and I look forward to sharing updates on our pipeline programs as we kicked off 2022.

Before I turn the call over to Andrew I would like to let you all know that unfortunately, I will not be able to join the Q&A session today due to an unavoidable personal matter I've asked Mr. Gil <unk> Senior Vice President Medical Affairs, and Pharmacovigilance and Dr. Paul <unk>.

Senior Vice President regulatory affairs for my team to help answering your questions I look forward to following up with you next week when I'm back in the office.

Now I'll turn the call over to Andrew for a financial update.

Andrew.

Thank you Michelle and good morning, everyone I would ask to please refer to our press release that was issued earlier today for a summary of our financial results for the third quarter ended September 32021.

Beginning with sales performance this quarter, we recognized worldwide <unk> net sales of $92 8 million. This compares to $79 5 million in the prior year period, and $96 6 million in the second quarter of this year.

As a reminder, the third quarter of 2021 as the first quarter. Following the implementation of our new Ocala label, which was finalized in may of this year.

Our worldwide caliber sales are comprised of U S net sales of $66 $6 million.

Ex U S net sales of $26 $2 million.

This represents growth of approximately 14% and 25% respectively versus the prior year quarter.

Our U S business performed well because Linda discussed earlier.

In our international business group over the last year was driven by increased demand and the benefit from country mix relative to prior year.

Overall results reflect a solid global business performance.

GAAP operating expenses for the quarter totaled $99 million.

Which was a decrease of $35 7 million versus the third quarter last year.

Non-GAAP adjusted Operation operating expenses were $89.6 million for the third quarter, a decrease of $28 5 million versus the prior year period.

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

Cost of sales for the third quarter were $7 million.

Compared to $1 $8 million in the prior year period.

This decrease reflects the timing of purchases of API packaging labeling and other related expenses during the period compared to the prior year.

SG&A expenses were $53 3 million for the third quarter. The decrease of $4 4 million from the second quarter of this year and a decrease of $17 $3 million versus the third quarter of 2020.

Our R&D expenses in the third quarter were $45 million, a decrease of $3 8 million from the same period last year.

We expect the operating expenses will be higher in the fourth quarter of 2021 relative to Q3 and relative to what we anticipate for next year.

Due to a higher than normal spend in R&D as we prepare the data sets for release later this year and early next year as discussed go ahead Michelle.

For the nine months ended September 32021, total R&D expenses were $133 $6 million with Nash related R&D expenses, representing approximately two thirds of this cost.

We ended Q3 at a higher cash position in Q2, adding.

Adding $3 million in cash from operations, which excludes the net impact of the debt exchange, new debt issuance and stock repurchased during the quarter.

This increase was driven by our strong sales performance in both U S and international and our continued focus on managing operating expenses.

Even with our large Nash R&D investments, we were cash positive for the second consecutive quarter, which highlights the profitability of our foundational PVC franchise.

Our cash cash equivalents restricted cash and investment securities as of September 32021 totaled approximately $428 $8 million.

As a result of our strong global performance and with the <unk>.

Is that the impact of the label change will be on the low end of our expectations.

We're increasing our ocala with net sales guidance to $355 million to $370 million from the previously shared $325 million to $340 million.

We are also narrowing our operating expense guidance and now expect operating expenses to be between 303 hundred $95 million as compared to our previous guidance of $380 million to $410 million.

Lastly, we were able to successfully execute our convertible note exchange to manage the near term maturity of our debt.

Between the debt exchange subsequent repurchase of $38 million of notes in private transactions, we lowered our 2023 maturity due $114 million, which allows us to manage our near term debt with cash on hand.

It gives us the ability to focus on growing our PVC business and generating important data in Nash to define our path forward.

Since joining intercept earlier this year. It has been one of my top priority is to ensure that we remain financially strong and well positioned for growth.

We have derisked, our balance sheet significantly this year and we will continue to utilize our cash prudently and ensure that we have a strong balance sheet to support our foundational PVC franchise.

Executing on our clinical and regulatory milestones and have the flexibility to expand our portfolio and pipeline.

Now I'll turn it back over to the operator to start the Q&A.

Ladies and gentlemen, if you have a question or a comment at this time. Please press. The Star then the one key on your Touchtone telephone question Thats been answered or you wish to move yourself from the queue. Please press the pound key and we also rest that you limit yourself to one question to accommodate everyone feel free to get back into queue.

Our first question comes from Ritu borrow with Cowen.

<unk>. This is under the answer with you. This morning, congrats on the great quarter and you wanted to get some details on the progress of the leading of biopsies from the regenerate trial could you comment on how many biopsies have you reevaluated, thus far and how many patients do you have the 48 month follow up safety data to date.

Thank you.

Yes, hi, thanks for the question.

And thanks to the team at intercept tiara, who is doing a lot of work in the areas that.

That you mentioned so.

So the work is ongoing as you know as we stated in the prepared.

Our remarks and as we outlined.

Last quarter the biopsy reads are ongoing the focus.

The ongoing work as we are.

Really stay towards.

The discussion on potential accelerated approval has been reads on baseline an 18 month biopsy. So thats. The bendy. The work again that is ongoing at the same time.

The safety data.

Again that we outlined last quarter is.

For the <unk>.

Population.

And the accumulation of that is more than twice the database that was in the initial.

Analysis.

Back in 2019, so all of that work is ongoing we are as you would expect.

Monitoring that on an ongoing basis on a weekly basis and as we sit here today. The work continues and we do expect that that work will continue and ultimately.

<unk> in this data package that we've outlined being.

Completed into the early part of 2022.

Great. Thank you.

Yeah.

Our next question comes from you asked me to Rahimi with Piper Sandler.

Great. Thanks. This is putting it on before yes, just one question for us.

And U S. In the late breaking abstract you show that the event rates are significantly lower for the PBC patients on OCA treatment I think it's like 50 854 lower than the global PVC in UK PBC patients.

So can you tell us how many of these patients with <unk> and what kind of putting through can be catalysts can redraw the ongoing mesh biosciences database.

So thanks for the question I'll turn that over to Gail as of course, we look forward to the important discussions coming at <unk>.

Thanks for the question so.

In that study.

We looked at both an internal database to poise long term safety extension study that study was largely an earlier PVC population and so at baseline in that study.

There are few but some cirrhotic patients over the course of filing the study there were more but still the numbers of cirrhotic patients were relatively low in that study overall when.

When we matched to the external control we were very careful to both use the inclusion and exclusion criteria from the place study, who you are comparing like for like and to propensity score match to again provide.

A L M into sort of pseudo randomization as you can in that setting. So we feel like the results are interesting and we look forward to sharing them in more detail in just over a week at a S. L T.

Thank you.

Thanks.

Our next question comes from Michael Yee with Jefferies.

Hi, Thanks, good morning.

My question.

Can you hear me.

Yes Yep.

Okay, Great Hey, guys. Yeah. My question is on the.

F Q3.

Alex just you guys are doing in hand.

Networked early 'twenty two my question is.

With all of that reassessment and the inclusion of more patients can you remind us you would expect that the data could be the same.

The effect could be better or greater if that could be less less efficacious.

Efficacious can you just remind us of how that could play out and you just expect to put out a press release on that information and we will digest the data at that time and that's what you would be submitting to the FDA and could you just maybe put some color around around that and contextualize that thank you.

Yeah, Mike. Thanks for the question. So I can I can start on that one I think importantly, the new analysis.

I'm wondering if you could give us any update on this on the ongoing safety analysis.

Our understanding is that some of the cardiovascular arena won't have had a good <unk> of Aes, we're going to start to that was going to start to rolling around now. So just wondering your level of confidence on the safety side and as you look at the totality of efficacy and safety, what's gonna be guiding your decision as to whether or not to go back to the FDA is there is there any sit.

<unk>, where you would not approach the FDA for Presubmission meeting thanks.

So thanks, Brian I'll start on that one and then perhaps Paul can can remind everyone of of the ongoing work in the areas on adjudication.

As a reminder, the overall question that was posed by by the FDA at the time of the complete response letter was around overall risk benefit.

And so it's really been against that context that we first.

This series of interactions with FDA that we outlined.

Earlier in the year and I think that put us in a position to make good decisions about which data we we're going to generate and now we're in that.

Data generation process, and obviously, it's going to be the comprehensive pick.

Picture that will need to complete and then assess based on what we see in the data obviously.

The step after that which would be an important step with data in hand, we would interpret the data and the potential discussion of interpretation.

With the agency would be in a potential presubmission that we would expect if we're in the past in the first half of the.

Of of 2022, so importantly, understanding and digesting the picture that we believe this dataset.

Will give us will be the the important.

Move for us.

Paul maybe you want to remind on.

The the areas of of adjudication, which continue to be part of the ongoing work here.

Yes, Thank you Jerry so.

Right, we will have.

And are having adjudication ongoing and the cardiovascular hepatic and the renal arena.

Really at this point there is nothing we can share about that it's work ongoing unless Jerry has.

Highlight it's a couple of times now it's all about the benefit risk that we will be able to assess.

Early next year.

Fair enough. Thanks, so much thanks, Brian.

Our next question comes from Leith, you're young with character Fitzgerald.

Hi, This is Emily unfriendly. Thanks for taking a question I'm just curious about your latest thoughts on the reverse study and what date are you looking to see their given the new consensus approach. Thank you.

So.

Thanks for the question Emily May be just a couple of words from me and then maybe Paul can can remind of.

Of the study we look at reverse obviously is an important.

Data said, it's an important high risk population. These are.

Patients with cirrhosis that are well compensated.

That work is ongoing in parallel so the reeds are are happening as we've outlined we are utilizing a consensus approach again consistent with what we talked about in the regenerate.

Context.

I think that the last point for me is just that.

This is again ongoing work we're monitoring closely we do the fort forward.

To this important data set if the data is positive we think it gives us.

Some real options and again importantly, this as a patient where the the the risk is high and the unmet need is is.

As clear and evidence so we look forward to understanding the potential role of OCI. In this population Paul perhaps you can you can give us a thumbnail on the.

The design as we look forward to the readout to comment and I believe there is.

Additional information that Asl D.

On the reverse study design.

Yes, Jerry Thank you. So S. S. You said already refers is this study it's a phase III saw the in line home birth of 19 patients with mesh with well compensated cirrhosis.

The primary endpoint is histology at 18 months.

And looks for a great or equal then Walden stage fibrosis improvement.

She said the Doctor I'll see all will have a pollster.

At Azole. The two described to study this study uses.

Three dose groups. One is a straight 10 milligram one is a titration arm off said I'm going to 25 and and it's placebo controlled.

[noise]. Thank you Emily.

Thanks.

Our next question comes from dose of string repeated one company.

Hi, Thanks for taking my questions.

Question on PVC here, just curious if you can give us a sense for what your current.

Operating margins are specifically for Oh C, a and PVC and maybe do you have.

An idea of what those could be sort of going forward you see you could improve those over the next couple of quarters or or a couple of years. Thank you.

Thanks for the question, we obviously feel good about the performance in PVC.

In the quarter.

We have also described the fact that on a standalone basis, the PVC franchise.

Is a profitable one Andrew maybe you can give some additional color on that front, yeah, certainly and thanks for the question.

So we don't break out.

Through the PVC business as a business per se.

You can obviously see the sales and the cost of sales on our P&L does a thoroughly products. So those are clean numbers. We also stated before that the.

Majority of our R&D expenses are related to Nash.

As of Q3 year to date R&D expenses were 133 6 million approximately two thirds of those are Nash related.

So that should give you sufficient information to break out uhm, what business would look like without the Nash uhm significant phase III trials that were currently.

In the process of providing data for at the end of the quarter hopefully that helps.

Yes, thanks for taking our questions first.

First.

Our next question comes from shopping Register with Goldman Sachs.

Good morning, Thanks for taking my question.

You just help us understand.

Right.

What might be presented at the upcoming liver meeting and whether there can be any read through here today reevaluation data.

So so gail.

I'll I'll turn that to Gill sure I'm happy they're happy to take that question.

Hi, Thank Michelle said initially recently excited that some of our data will be Nasl. These specifically.

The first PVC outcomes data with the data color Catherine and it's Michelle said earlier accepted as an oral presentation lately K invested 11 meeting asked at.

We will have input new data on the biopsy reading methodology used an ash this is not data.

Feeling outcomes that showing has a biopsy leading methodology work.

And we will provide some transparency there and finally, we will also have.

Some data unreimbursed methodology, and baseline data, which will be in advance of course of reverse data release coming late error.

It does so gratifying that we saw several independent and stats and debated kotalik acid. This is notable Windsor medicine is well established that people start doing independent research and.

And there was some interesting things are for example at Stanford University abstract that notes that Liberty transplant weightless mortality among patients with PVC empty compensated to races is lower since accounted for approval compared to before or kalispell that approval. So this is of course encouraging while.

While not definitive that it makes Britain, a pairing with our own work on the place long term safety extension and external control data.

And that I think we'll have to see what else comes up at the meeting but.

I think on the Nash side is little of notable excitement and mainly work that emphasizes that necessarily hartfield to be successful at it in the clinical trial setting.

Thank you.

Our next question comes from your lame artworks UBS.

Hi, Thanks for taking my question just on on Nash.

Perhaps he resolves the additional patients can you remind us what your plans for must've testicle perspective, or I can analyze this data I guess on that translation and paper S. F X.

Thanks for the question, Paul perhaps you can give a little.

A reminder of the approach there are the primary endpoint.

Yes, Thank you Jerry yet.

We're really viewing this as a new analysis is a.

A much more robust dataset longer patients follow up.

More patient numbers as Michelle said, it's more than twice the patient exposure.

And we're actually looking at.

All four six Halden dripped subjects, who have been on treatment for four years or more in the by now.

So we'll see.

Same with the liver biopsy the efficacy analysis, we're really seeing this as a new.

Fresh look at these data.

Hope that helps.

Yeah, just I guess any commenting on the power Ang are there to check the cost analysis and break I care. If you can.

Will completely replicate the analyses went into the original.

Interim analysis.

Yeah, that's all thanks.

Thanks.

<unk>.

Our next question comes from Jeff Meacham with Bank of America.

Hey, guys in class from for Jeff. Thanks for the questions just a couple in the pipeline actually.

Can you talk about the decision to study abroad go strange for the <unk> as a combo.

Is that to look at higher doses lower doses both.

Is there any any we added that you've seen so far this kind of informing that decision or is that maybe.

Just just part of the inherent protocol and then for I am to 787.

Can you talk about some of the target indication sure considering that asset that you're looking to communicate make sure is that going to be dependent on on the FDA feedback and Nash or you already have a cassette let's say you're thinking about thank you.

So Gail perhaps you can start on the bed five right and then I can I can comment on 77% afterwards. Thanks for the question sure happy to do so any okay business, a great combination induced ranging.

Always important in phase two zero dose ranging attempting SDA and other regulators absolutely expects going from dos is that show no efficacy that that low.

Doses that are higher than you may intend.

When you do a combination product that adds a level of complexity of course, the senior managing two days is so our study is designed to meet regulatory requirements and regulatory needs and to ensure we have what we need to progress our program and so it includes a full range of dose ranging.

So on 787 so.

So the phase one work is ongoing we're progressing.

Through the dose escalation work.

We are looking with interest at several areas of unmet need.

And I think doing the right work now to be in a position.

As Michelle indicated in the prepared prerecorded that.

The remarks that we would expect to select that target indication in the first part of of 2022 again focus for us as.

Some some interesting areas of unmet need that we feel that this compound.

Have a have an interesting role in but some more work to do and will come back next year as we've outlined.

Thank you.

Our next question comes from Matthew, which you luchini with BMO.

Hi, Thanks for taking the question and for the comprehensive update.

Just wanted to ask I guess about how to think about reverse in the context of regenerate and I guess, what I'm into cyclically is.

If for some reason reverse were to be successful by the re analysis.

Didn't pan out or give you. The results you were hoping for to move to support Resubmission.

Would you consider moving forward with them more narrow label, how do we how should we be thinking about that type of potential scenario take care.

Yeah. Thanks for the question as I said earlier reversed for us as an important.

Data set for for <unk> I think also for the field and clearly for the patients.

That are suffering.

Our dialogue with the FDA. This year that we've outlined in previous calls has been primarily focused on regenerate and getting ourselves to a point, where we were able to outline the kind of data we felt appropriate to generate an regenerate and now we're in that in that process now I think as we get closer and <unk>.

Work towards having the reverse.

Data in hand.

And once we have that data will clearly be regrouping.

With the agency I think.

If the data is positive it provides us good options in several different scenarios and that's the way that we look at the data again is an important population there's high unmet need.

This is a patient group that.

And all of the customer work, we've done over the years and Nash is one that.

Tends to be of high concern, obviously to the patients themselves, but also to the.

To the healthcare practitioner. So we do feel if the reverse data is positive we'd have some good optionality, we'll see how all the pieces fit together.

With data in hand.

Thank you. Our next question comes from Thomas Smith SBB lyric.

Hey, guys. Thanks for taking the questions maybe just.

A follow up there as we think about the upcoming reverse trial read out pretty.

Pretty wide range of placebo response rates and the competence Robert Nash population can you provide any color on the trial powering and what you've assume carpal tunnel response on the one stage improvement on fibrosis without worsening and ash primary endpoint.

Paul perhaps you can pick up that one.

Yes. Thank you.

The powering has been the standard.

Hello.

Five.

This one with with 90 hour or two.

To read significance I.

Do not have to be too full of what the expected placebo response rules.

Ooh.

Thomas we can follow back up with you.

On that one okay.

Okay, Yeah that would be great and then maybe just.

One one follow up question I was thinking about the.

In Europe I.

I guess any additional color you can provide on the decision to respond to the day 180 questions rather than wait for the outcome of the U S data generation of the regenerate re analysis would be helpful. Thank God.

Thanks.

As.

Michelle.

Said in the prepared remarks, we are current plan we're working towards.

The the response to the day 180 questions. This month.

Maybe Paul you can give.

A summary of kind of the process as as we move forward there and again.

For Us, we'll we'll work through the process as it as it unfolds here.

Yes, Thank you Jerry so.

Purely hypothetically.

Fiercely Tempe at this juncture could choose to.

Give an opinion based on our day will <unk> responses, plus or minus an oral explanation.

They cooks.

Although that this bolt very.

Very frequent they could push us into another day, one round of questions, which would allow wall Street ability.

Ability to.

Even further align our data sets.

Between us and Europe.

And obviously.

As always.

Applicants have the ability to withdraw at any point in time.

His staff help.

Yeah.

That's helpful. That's helpful. Thank goodness.

Alright.

Our next question comes from my men to me with be Riley Securities.

Good morning, Congrats D. One tracking nicely on booked up and bottom line Uhm, and then especially fitting ahead of expectations.

Added to that he said last year just quick quick question for Linda on the PVC dynamics.

How should we think about the Dwayne Dwayne to outlook here as we are nearing the end of impact in U S, but but maybe not so much in the U N and then maybe help us think about the new patients Dodd dynamic verses.

Sort of now that you are at all and you understand penetration market penetration and also in fact some other.

Clinical trials that are ongoing and then Andrew if you can.

Bring the picture together on this cash flow positive like N B C that kind of sustained over over the next few quarters.

Okay.

Well. Thank you for the question and obviously, we're very pleased with how the messaging in the education when on the label changes in communication, there and I think that being able to do that in person with representatives that we're familiar with.

Physician prescribing days, which was very helpful. In communicating and the label also gave clarity on who was in in here right now and as we stated we believe that we're near the end of that transition by year end on the existing patient. So we feel that that is pretty much through and there shouldn't be.

As we look at the label impact in Europe. In 2022, we don't have that label in hand of course, but we would perceive that he compensated patients would also likely be not indicated further in that population only looked at the impact.

Have estimated 10% to 15% of the.

Population available to <unk>.

And what we're finding is that was really down on the lower end and some of the discontinuation, which we expected to see given we had to change in population were taking fewer doses and that fewer doses are usually associated with E compensated patients, but what we realized and something to our customers with that man.

Any of our customers take we're taking a cautious approach to patients who were compensated for roddick.

To where some of them were on a once or twice weekly dosing. So we do feel confident that the right patients are coming off now as I said in my previous comment to focus now is very much on getting back to business and new patients start listing from depression with that over the Covid period, and I think frankly as people waited they were.

Whereby the pending label change as they waited to see what the <unk> on the patient population with an and that's very clear no change in dosing just one regiment and you can go from there with the new data that we're sharing new data drives I think conviction and a and a client and how can I explain it to help my patients when frankly.

We only have one second line and natural Canada. So you look at the fibrosis data and that came again from our poise and extended.

The label extension and you see in those patients Ah stabilization of hyperspace.

When you have a progressive Liberty. This is an important element only top to physicians underlying it's not just about <unk>. It is the underlying health of the liver and preserving that for as long as possible that resonate that the higher Leonard uncle.

So you take that data and now with this totally and presentation data coming out comparing a cohort of patients is that cobalt late nation is we're fully thank patients who are earlier on in the progression of their disease and start to get that information out at the at the best of abstract.

I think that you can see there is a fair amount.

New new communication that can go out to support yokel of business and we are very much slipping at growth in the market and a return to growth beginning in 2022.

Andrew Yeah. Thanks.

So I'll try to answer your question.

But they can.

So first off I'll, just say look we're really.

Happy with the sales performance, both in the us and international and with our ability to manage expenses.

Two consecutive quarters of cash growth slash neutrality.

Is a terrific womb for the company and I think again, just highlight from profitability of our underlying PVC franchise.

We're not prepared to give guidance.

For next year, but I will make some comments.

In my prepared remarks, I mentioned that in the fourth quarter, we're going to be increasing expenses to help repair the datasets that Michelle and various others have discussed on this call.

But I also indicated that that will be higher than what we've had this year and higher than what we expect next year.

So what you can expect us to continue to manage our expenses into next year prudently.

Regardless of which direction. We go with the match application to the FDA, we are not expecting an increase in expenses next year relative to this year. We also expect that our PVC business will continued growth.

Some of those we're very happy with where we are and will likely give gateway. We will give guidance next year at the end of our conference call with the urine.

I hope that helps.

Are they helpful. Thank you.

Thanks.

Our next question comes from J also with Oppenheimer.

Oh, Hey, congrats on the quarter and thank you for taking the question.

About.

You've spoken about running a profitable rare disease business in the event that Nash doesn't work out.

Can you talk about the timeline in gating factors that would lead you to exercise that option and then may be related to that is there any color on when and under what circumstances, you would consider pursuing PSE indication for O C. A or is that an opportunity you are saving for 70 87 or the O C. As a firebreak combo.

Thank you.

Thanks for the question J as as we've said a couple of times, which I think is.

You know the at the center of all this is that the dictator the I'm sorry, the data is going to dictate.

Our path forward, our path forward and Nash ultimately be an important driver in the strategic decisions as you can imagine with any company. It's important as you look at major milestones that.

Contingency planning is ongoing I think importantly.

As we've tried to.

Remind this morning, we've been trying to take the right steps along the way this year to solidify the foundation with what we're doing from a cost management standpoint.

Andrew outlined how we looked at the <unk>.

Convertible debt.

And making sure that we're solidifying the PVC business. So all of this work.

Is to ensure the.

Right strong foundation.

For the future as we importantly get the data in hand to make the right decisions and I think I'm always encouraged by the fact that we.

We have strengthened this company to to leverage we are deep in the liver community. We know the players I think another quarter of illustration of our commercial capability.

R&D expertise around around liver and the success so.

Again, I think for me, it's about ensuring that.

We're focused on the Readouts, we're going to use the data to make the right decisions.

Moving forward on behalf of our company and our shareholders in.

That's really the way that we look at the next phase in the company.

Certain questions and Yale was on PFC, yes. It maybe you can sure I'm happy to take that so.

With regards to PSE, let me start with your second part which was about 78 seven as we said earlier, we're looking at a number of high unmet need areas.

And then I would certainly agree EPS is one of many high unmet need areas, but it's still ongoing work and we will tell them more about that next year. After we've completed our work there PSC. We were pleased he ran a positive phase two study with PSC with a beta kotalik.

Acid.

Which was based on alkaline phosphatase reduction and we saw a nice outlet today's productive. Unfortunately, pst's an area, where biomarkers are not as straightforward as they are in PVC with some other areas.

Which adds a degree of complexity in studying this area.

Great. Thank you very much.

Thanks.

Our next question comes from Brian scoring with bears.

Hey, good morning, everyone. Thanks for setting me and I didn't hear any questions on regenerate re route. So I have a question on that.

So I I understand the focus on trying to fibrotic endpoint. All my question is more on the re read and whether or not you're looking at the national resolution endpoint. In addition to the first one and I'm just wondering if given the additional patients uhm that are being evaluated it.

Even the absolute difference remains the same that we saw in the initial cost of regenerate if.

That would be our statistical significance I think the original P values 0.13 on an item of 931 and just based on statistical protocol or you were able to evaluate natural resolution for statistical significance or has any value on resolution nominal at this point. Thanks.

Yeah, So as Paul indicated earlier, the the readout will be on the same two primary endpoints that the initial.

Analysis.

Was red on which is in both the improvement no fibrosis with no worsening of Nash and the Nash resolution.

And point Paul anything further on that obviously as we said, it's a larger number of patients in this in this.

Analysis than the original being red with the new methodology, Paul anything you want to you want to add into that.

Thanks, Gerry mobile really.

As we said that the study hasn't changed so overpowering is identical to what it was it is a larger patient population the larger sample size and therefore.

You can draw conclusions from love as you will.

It's too early to speculate we really need to wait until we see the data.

Okay.

Thank you. This concludes the Q&A portion of the conference I'd like to turn the call back over to our host for any closing remarks.

Yeah. Thanks, everybody for the conversation today, maybe just to summarize what we share today.

I feel good about the fact, we've executed well against the objectives that we set out in the beginning of the year are global PVC business with Ocala continues to deliver remains strong under the new label and I'm confident in our ability to grow this business in the long term.

Second we're on track with the important data generation and Nash, which I believe will allow us the ability to make the critical decisions regarding our path forward.

Flying programs continue to advance and importantly, we've made great progress strengthening our financial foundation, which will support a successful intercept and allow us to focus on creating shareholder value over the long term definitely look forward to providing further updates as we continue what's a busy period.

Ross the clinical commercial and regulatory activity in last and certainly not least I want to thank the team at intercept for their strong execution their commitment and for all the work they're doing in their dedication to the patients. We serve so thanks, a lot and we look forward to more conversation along the way have a great day.

Ladies note almost does conclude today's presentation, you may know disconnected have a wonderful day.

[music].

[music].

[music].

Ladies and gentlemen, thank you for standing by and walk through the Q3 2021 intercept pharmaceuticals earnings call. At this time all participants are in a listen only mode. After the speaker's presentation. There will be a question and answer session to ask a question. During the session you need to press star one on your telephone if you require any further assistance. Please press star zero I would now like to turn the call over to you.

This would be for Cisco SVP Investor Relations and corporate Affairs, you may begin.

Yeah.

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 2021, legal and financial position, which is available on our website at www dot intercept pharma dotcom.

Before we begin our discussion I'd like to note that during our call, we'll be making forward looking statements, including statements regarding our approved product and clinical development program certain regulatory matters, and our strategy prospects financial guidance and future commercial and financial performance listeners are cautioned not to place undue reliance on these forward looking statements, which speak only as.

The date of this call and we undertake 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.

But not necessarily 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.

Discussed in this morning's press release and in our periodic public filings with the SEC.

Today's call will begin with prerecorded prepared remarks from our president and CEO, Jerry Durso, our Chief Commercial Officer, Linda Richardson President.

Research and development and Chief Medical Officer, Dr. Michelle Berrey.

And Chief Financial Officer, Andrew stake. Additionally, available today for Q&A purposes, our Doctor Gail Caldwell Senior Vice President Medical Affairs safety, and Pharmacovigilance and Dr. Paul Eisman Senior Vice President Regulatory Affairs. 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 Jerry Decker Jerry.

Thanks, Lisa and good morning, everyone. Thank you for joining us on our third quarter 2021 earnings Conference call.

As we near the close of 2021, and my first year as CEO of intercept.

To start by reflecting on the great progress that we've made against the main objectives that we set out to achieve at the start of this year.

First to continue growing our foundational PVC business window caliber.

Second to execute on our clinical and regulatory goals, including progressing our clinical development program and advanced fibrosis due to Nash.

Third to expand our portfolio and advance our internal pipeline and finally to improve our operational and our financial foundation to support our path forward.

Regarding our first objective driving growth in our PVC business, we continue to see the strength and resilience CFO caliber as a reminder, the third quarter was the first full quarter since updates to the U S label were finalized at the end of May.

We reported third quarter sales growth of 17% over third quarter last year and as a result have increased our sales guidance for the year.

In a few minutes, Linda and Andrew will share additional details about our commercial performance and our outlook for the remainder of the year.

Now that we've worked through our label update in the U S. I have strong conviction in our ability to continue to expand and grow this business long term.

We've also made great progress executing on our clinical and regulatory goals in our Nash program, we remain on target to generate the largest data package in the field to support a potential resubmission of our NDA for OCI for the treatment of advanced fibrosis due to Nash. These important data will determine our path forward in Nash, we anticipate the data.

Generation process could continue into the early part of next year and if we believe the data support accelerated approval. Our goal would be to have a pre submission meeting with FDA. During the first half of 2022. We also anticipate top line data from our phase III reverse trial, which is assessing OCA in patients with compensated cirrhosis due to Nash.

At the end of this year.

We've also been working to expand our portfolio by advancing our pipeline and looking for opportunities to leverage our strengths.

As we announced last quarter, we've initiated the first in human study for our next generation <unk> agonist.

787, and continued to advance our phase two work for the OCI is a fibroid combination program in PVC.

Michelle will share more details on our progress across these programs.

Importantly, in addition to making great progress on this year's objectives. We've also significantly strengthened our operational and financial Foundation, we remain prudent with our expenses and reduced our cost structure, resulting in a narrowed operating expense guidance that we announced this morning.

We also successfully exchanged the majority of our near term debt to address the maturity of 2023 convertible notes.

Furthermore, we have significantly reduced our burn rate and we're in a strong cash position with another cash positive quarter.

These are critical steps as we enter the next phase of intercept journey, whereas we previously said, we will be making data driven decisions and defining the strategic path for the company's future.

This path could be supportive of either the pursuit of accelerated approval in Nash or if the data do not supported our focus on a profitable and growing rare disease business.

Our solid foundation will allow us to focus on becoming a strong successful company over the long term.

With that I'm going to turn it over to Linda who will talk about our commercial performance this quarter.

Michelle will then provide an update on our regulatory and R&D activities and Andrew will conclude with a review of our financial performance.

Linda.

Thanks, Gary and thank you to everyone, who is making time to join US today as you saw on our press release. This morning, our foundational PVC business. Once again demonstrated solid performance in both the U S and international markets in the third quarter and year to date periods. During our last earnings call. We indicated that we expect.

Good to see the impact of our label change in the U S business in the third quarter and I'll be providing some commentary on this now.

The U S commercial and medical affairs teams did a great job as they work to educate healthcare professionals on the new label, we effectively reached our prescribing targets within the first three months following the receipt of the revised label and now our sales team has fully pivoted back to promote it'll caliber for eligible patients.

<unk>.

Second our data show that many of the patients who are discontinuing caliber or on a treatment regimen of once or twice weekly dosing, which has a lower volume impact. These are the patients who should discontinue given our revised labeling.

Third we have not seen a significant impact beyond the labeled population, which you can sometimes encounter with implementing the label update.

We've undertaken market research to assess health care provider reactions to our revised label and the feedback has been consistent.

<unk> report that they are aware of the new label and understand who the appropriate patients for treatment with OCA caliber.

More through discussions with our sales team community Gastroenterologists and particular noted that they were not typically treating patients with compensated cirrhosis before the label change. Therefore, there is less impact on their patient selection post label change.

At the time the label with updated earlier this year, we had estimated that 10% to 15% of our o'callaghan population could be impacted we anticipate that this ultimately will be at the lower end of that projected range. Furthermore, based on current trends, we believe that the impact of the label update on existing.

Okay. All of the patients will be largely realized by the end of this year.

Moving forward, we are now focused on new patient starts, which we have seen weakened since the beginning of Covid and through the label change we continue to see a significant opportunity in our core PVC business given the vast majority of patients requiring second line therapy remain eligible for treatment with <unk>.

The ability to share our compelling new data with our PVC prescriber community is fundamental to our beyond <unk> messaging.

In September we began sharing educational materials that highlight new data from our cohort of book calendar patients who remained in the open label extension phase of the poise trial.

These data show a stabilization of fibrosis over five years and a progressive disease like PVC stabilization is resonating with our health care providers and feedback has been very positive.

Just a quick word on our compelling international business performance as we had another solid quarter with sales up 25% over last year, we continue to experience increasing growth in new patient starts and adoption of Ocala that as compared to last year multichannel execution has been a strong focus for us and we.

See excellent engagement with our customers across regions, we do anticipate a label change in our international markets in late 2021 with implementation to follow in 2022.

The overall strong performance of the commercial teams through the third quarter has led us to increase our sales guidance for the year, which Andrew will discuss in his section of this call.

At this time I'll turn the call over to Dr. Michelle Berrey Michelle.

Thank you Linda and good morning, everyone I'd like to provide a few key updates today.

First I'll provide you with an update on our Nash data generation and regulatory interactions, which remain on track.

Second I'll share some important progress regarding our post marketing requirements in PVC and.

And lastly, I'll preview some exciting data, we'll be sharing at the upcoming liver meeting and update you on where we are with some of our other pipeline activities.

I'll begin with Nash.

Please proceed we're currently on track with the important data generation, we outlined last quarter.

Our safety database for OCA and Nash will now include more than double the patient exposure of our initial interim analysis with more than 6000 patient years.

On the efficacy front, we're currently reading all baseline in month 18, liver biopsies using our new consensus panel rating methodology that we outlined last quarter.

We are in the midst of generating the largest data package ever created in the Nash field to support a potential resubmission of our NDA in Nash fibrosis, and we expect this process to continue into the early part of 2022.

As a reminder, we are generating these data from the regenerate study in pursuit of an accelerated approval.

In the U S. As the first compound to treat advanced fibrosis due to Nash.

<unk> also begun reading liver biopsies for our second large phase III Nash study reverse studying <unk> in patients with compensated cirrhosis.

We expect that process to be complete and top line data from reverse to be available around the end of this year.

As long as the data support it we expect we will be able to hold a pre submission meeting with FDA in the first half of 2022.

While our top priority remains generating important data to support a potential resubmission in the U S. Our MAA in Europe for Nash fibrosis also remains on file.

We had requested and were subsequently granted a clock stop for our EMA application.

We were.

Or just take advantage of the data generation, we were conducting for our NDA.

We are now planning to respond to our day 180 questions. This month.

We've made progress and attempted to align these processes. Our day 180 responses will not include all the data we're generating in the U S. Given that this data generation will continue into 2022.

And as a reminder.

EMA has outlined a high bar for efficacy.

Third the initial and overall Nash development guidance and their draft reflection paper from 2018.

Ian they expressed a preference for seeing statistically significant and clinically relevant efficacy in both reversal of fibrosis, and Nash resolution or a two stage fibrosis improvement.

But they also clearly stated that they will be looking at the totality of the clinical dossier submitted and that their final position would be data driven following review of regulatory filings.

The unmet need for anti fibrotic therapy in Nash has never been clearer.

The NIH is Nash clinical research network or CRM recently published results from a prospective study and the New England Journal of Medicine that again reinforces the strong association between advanced fibrosis, and an increased risk of liver related complications and death in patients with Nash.

And now I'd like to provide an update on our PVC post marketing commitments.

Discussions regarding our two post marketing clinical outcome studies remain ongoing with both the FDA and EMA and we've made some important progress.

As a reminder, since the time of the caliber of approval for PVC in 2016.

We have acknowledged the potential difficulties in recruiting and retaining patients and these blinded placebo controlled studies when his calibre is commercially available.

After gathering feedback from regulators.

Our next step in that process is to close out the cobalt study.

We won't collect available placebo controlled data from cobalt and include it as one element of a broader evidence package that will also include real world data and outcomes data from the poise long term extension study.

This evidence package will inform our dialogue with FDA and EMA as we worked to fulfill our post marketing commitments and obligations.

We expect the data generation process to take several quarters and plan to submit this data package in 2022.

And on that note, we are proud to share today that one of our abstracts have been selected not only for a late breaker podium presentation at the liver meeting.

But as a best of <unk> 2021 abstract.

The abstract entitled patients with primary biliary cholangitis treated with long term a beta coli gas it in a trial setting demonstrate better transplant free survival than external controls from the global PVC and UK PBC study group.

We are all excited about sharing these data with you on November 15th.

I hope it remains the only second line agent approved for use in PBC and continues to demonstrate a benefit to patients with this devastating disease.

We are committed to working closely with regulators to come to a resolution regarding our post marketing commitments and I'm encouraged by the progress thus far.

Turning to our pipeline our phase two <unk> trial is continuing to enroll outside the U S. As.

As we've shared previously published data supporting the benefit of Bezeq vibrate and PVC are encouraging and reinforced the potential for this novel combination to reduce elevated.

And bilirubin associated with improved survival.

We plan to study a broader range of doses of the combination and an additional phase two trials that will be initiated in the U S.

We remain committed to progressing therapies for individuals living with PBC.

Additionally, our phase one study of our next generation ethics are agonist Int 787 is ongoing.

We plan to select a target indication for Int 787, and early 2022.

Overall I'm pleased with the progress our R&D team has made and I look forward to sharing updates on our pipeline programs as we kicked off 2022.

Before I turn the call over to Andrew I would like to let you all know that unfortunately, I will not be able to join the Q&A session today due to an unavoidable personal matter.

I've asked Dr. Gail Caldwell Senior Vice President Medical Affairs, and Pharmacovigilance and Dr. Paul <unk>.

Senior Vice President regulatory affairs for my team to help answer your questions I look forward to following up with you next week when I'm back in the office.

Now I'll turn the call over to Andrew for a financial update.

Andrew.

Thanks, Michelle and good morning, everyone.

Two please refer to our press release that was issued earlier today for a summary of our financial results for the third quarter ended September 32021.

Beginning with sales performance this quarter, we recognized worldwide <unk> net sales of $92 8 million.

This compares to $79 5 million in the prior year period, and $96 6 million in the second quarter of this year.

As a reminder, the third quarter of 2021 as the first quarter. Following the implementation of our new Ocala will label, which was finalized in may of this year.

Our worldwide <unk> sales are comprised of U S net sales of $66 6 million.

Ex U S net sales of $26 $2 million.

This represents growth of approximately 14% and 25% respectively versus the prior year quarter.

Our U S business performed well.

Linda discussed earlier.

In our international business growth over the last year was driven by increased demand and a bonus.

From country mix relative to prior year.

Overall results reflect a solid global business performance.

GAAP operating expenses for the quarter totaled $99 million.

Which was a decrease of $35 7 million versus the third quarter last year.

Non-GAAP adjusted operating operating expenses were $86 million for the fourth quarter, a decrease of $28 5 million versus the prior year period.

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

Cost of sales for the third quarter were $7 million.

Compared to $1 $8 million in the prior year period.

This decrease reflects the timing of purchases of API packaging labeling and other related expenses during the period compared to the prior year.

SG&A expenses were $53 3 million for the third quarter, a decrease of $4 4 million from the second quarter of this year and a decrease of $17 $3 million.

Versus the third quarter of 2020.

Our R&D expenses in the third quarter were $45 million.

The decrease of $3 8 million for the same period last year.

We expect the operating expenses will be higher in the fourth quarter of 2021 relative to Q3 and relative to what we anticipate for next year.

This is due to a higher than normal spend in R&D as we prepare the data sets for release later this year and early next year as discussed by Michelle.

For the nine months ended September 32021, total R&D expenses were $133 $6 million with Nash related R&D expenses, representing approximately two thirds of this cost.

We ended Q3 and a higher cash position in Q2.

Adding $3 million in cash from operations, which excludes the net impact of the debt exchange new debt issuance and stock repurchase during the quarter.

This increase was driven by our strong sales performance in both U S and international and our continued focus on managing operating expenses.

Even with our large Nash R&D investments, we were cash positive for the second consecutive quarter, which highlights the profitability of our foundational PVC franchise.

Our cash cash equivalents restricted cash and investment securities as of September 32021 totaled approximately $428 $8 million.

As a result of our strong global performance and with the knowledge that the impact of the label change will be on the low end of our expectations.

Increasing our Ocala net sales guidance to $355 million to $370 million from the previously shared $325 million to $340 million.

We are also narrowing our operating expense guidance and now expect operating expenses to be between 380 and $395 million as compared to our previous guidance of $380 million to $410 million.

Lastly, we were able to successfully execute our convertible note exchange to manage the near term maturity of our debt.

The debt exchange subsequent repurchase of $38 million of notes in private transactions, we lowered our 2023 maturity due $114 million, which allows us to manage our near term debt with cash on hand.

Gives us the ability to focus on growing our PVC business and generating important data in Nash to define our path forward.

Since joining intercept earlier this year. It has been one of my top priority is to ensure that we remain financially strong and well positioned for growth.

We have derisked, our balance sheet significantly this year and we will continue to utilize our cash prudently and ensure that we have a strong balance sheet to support our foundational PVC franchise execute on our clinical and regulatory milestones and have the flexibility to expand our portfolio and pipeline.

Now I'll turn it back over to the operator to start the Q&A.

Hello, Ladies and gentlemen, if you have a question or comment at this time. Please press. The Star then the one key on your Touchtone telephone. If your question has been answered or you wish to have yourself from the queue. Please press the pound key and we also ask that you limit yourself to one question to accommodate everyone feel free to get back in the queue.

Our first question comes from Ritu <unk> with Cowen.

Tim This is under the answer Richard This morning, Congrats on a great quarter and you wanted to get some details on the progress of the leading of biopsies from the regenerate trial could you comment on how many biopsies have you reevaluated, thus far and how many patients do you have the 48 month follow up safety data to date.

Thank you.

Yes.

Yes, hi, thanks for the question.

And thanks to the team at intercept tiara, who is doing a lot of work in the areas that.

That you mentioned.

So the work is ongoing as you know.

As we stated in the prepared.

Remarks, and as we outlined.

Last quarter.

<unk> reads are ongoing the focus.

The ongoing work as we.

Really stay towards.

The discussion on potential accelerated approval has been reads on baseline an 18 month biopsy. So thats. The bendy. The work again that is ongoing at the same time.

The safety data.

Again that we outlined last quarter is.

For the population.

And the accumulation of that is more than twice the database that was in the initial.

The analysis.

Back in 2019, so all of that work is ongoing we are as you would expect.

Monitoring that on an ongoing basis on a weekly basis and as we sit here today. The work continues and we do expect that that work will continue and ultimately.

Our results in this data package that we've outlined being.

Completed into the early part of 2022.

Great. Thank you.

Our next question comes from you asked me to Rahimi with Piper Sandler.

Great. Thanks. This is something that on before yes, just one question for us.

As in the late breaking abstract you show that the event rates are significantly lower for the PVC patients on OCA treatment I think it's like 50 54 lower than the global PVC in UK PBC patients.

Or can you tell us how many of these patients what is their uptake and what kind of read through can we automate catalysts can redraw the ongoing mesh cryo problems its database.

So thanks for the question I'll turn that over to Gail as of course, we look forward to the important discussions coming at <unk>.

And thanks for the question so.

In that study.

We looked at both an internal database the poise long term safety extension study that study was largely an earlier PVC population and.

So at baseline in that study.

There are few but some cirrhotic patients over the course is following this study there were more but still the numbers of cirrhotic patients were relatively low in that study overall when.

When we matched to the external control we were very careful to both use the inclusion and exclusion criteria from the poise study. So when you are comparing like for like and to propensity score match to again provide.

A element of sort of pseudo randomization as you can in that setting. So we feel like the results are interesting and we look forward to sharing them in more detail in just over a week at Aaas LG.

Thank you.

Thanks.

Our next question comes from Michael Yee with Jefferies.

Hi, Thanks, Good morning My question.

Can you hear me.

Yep.

Okay, Great, Hey, Hey, guys. My question is on the.

F Q3.

Now, let's just you guys are doing in hand.

And that worked early 'twenty two my question is.

With all of that reassessment and the inclusion of more patients can you remind us you would expect that the data could be the same.

The effect could be better or greater if that could be less less efficacious.

Efficacious can you just remind us of how that could play out and you just expect to put out a press release on that information and we will digest the data at that time and that's what you would be submitted to the FDA could you just maybe put some color around around that and contextualize that thank you.

Yes, Mike. Thanks for the question. So I can I can start on that one I think importantly, the new analysis.

Again as the work is ongoing is going to build on the prior <unk>.

HRM analysis, which we think was a robust result, with the robust methodology.

Nonetheless, we are re reading with the new methodology of interpretation.

Of those biopsies.

We do believe this is a robust method as we've outlined it it is a method thats consistent.

With the Fda's direction for <unk>.

A consensus approach of course, we won't have the complete picture until that work is completed.

Into into 2022 and of course, we'll share the appropriate information at the appropriate time once that work is completed importantly.

Well, we'll look forward to seeing the data set when thats complete.

Thank you. Our next question comes from Brian Abrams with RBC capital markets.

Hey, guys. Thank you very much for taking my question.

Good morning, if you could give us hey, good morning, if you could give us any update on this on the ongoing safety analysis.

Our understanding is that some of the cardiovascular renal and hepatic adjudication of Aes were going to start to that was going to start to roll in around now. So just wondering your level of confidence on the on the safety side and as you look at the totality of efficacy and safety.

What's can be guiding your decision as to whether or not to go back to the FDA is there is there any situation, where you would not approach the FDA for a pre submission meeting.

Okay.

So thanks, Brian I'll start on that one and then perhaps Paul can can remind everyone of.

The ongoing work in the areas on adjudication.

As a reminder, the overall question that was posed by by the FDA at the time of the complete response letter was around.

Overall risk benefit.

And so it's really been against that context that we first.

This series of interactions with FDA that we outlined.

Earlier in the year, and I think that put us in a position to make good.

Good decisions about which data we were going to generate and now we're in that.

Data generation process, and obviously, it's going to be the comprehensive.

Picture.

That will need to complete and then assess.

Based on what we see in the data obviously.

The step after that which would be an important step with data in hand, we would interpret the data and the potential discussion of interpretation.

With the agency would be in a potential pre submission that we would expect if we're in that passed in the first half of the.

2022 so.

Fortunately understanding and digesting the picture that we believe this dataset will give us will be the important next move for us.

Paul maybe you want to remind on BD.

The areas of adjudication, which continue to be part of the ongoing work here.

Yes. Thank you Gerry so you're right we will have.

Our having adjudication ongoing in the car.

Cardiovascular hepatic and renal arena.

Really at this point there is nothing we can share about that it's work ongoing unless Jerry has highlighted a couple of times now it's all about the benefit risk that we will be able to assess.

Early next year.

Fair enough. Thanks, so much thanks, Brian.

Our next question comes from Alicia Young with Cantor Fitzgerald.

Hi, This is Emily on for Alethia. Thanks for taking our questions I was curious about your latest thoughts on the reverse study what data you're looking to see there given the new consensus approach. Thank you.

Okay.

So.

Thanks for the question Emily maybe just a couple of words from me and then maybe Paul can can remind of.

Of the study we look at reverse obviously is an important.

Data said, it's an important high risk population. These are.

Patients with cirrhosis that are well compensated.

That work is ongoing and in parallel so the reads are are happening as we've outlined we are utilizing a consensus approach again consistent with what we've talked about in the regenerate.

The context.

I think that the.

The last point for me is just that.

This is again ongoing work we are monitoring closely we do look for forward.

To this important data set if the data is positive we think it gives us some.

Real options and again importantly, this is a patient where the.

The risk is high and the unmet need is as.

It is clear and evident so we look forward to understanding the potential role of OCI. In this population Paul perhaps you can you can give us some nail on that.

The design as we look forward to the readout to comment and I believe there is.

Additional information that <unk>.

On the reverse study design.

Yes, Jeremy Thank you.

As you said, it's already a reverse is a study it's a phase III study in 919 patients with Nash with well compensated cirrhosis.

The primary endpoint is histology at 18 months.

And looks for a greater or equal than <unk> stage fibrosis improvement.

As you said the Doctor ROTC or will have a poster.

Awesome.

To describe the study this study uses.

Three dose groups.

<unk> is.

10 milligram, one is a titration arm often going to 25.

Its placebo controlled.

Thank you Emily.

Our next question comes from Joseph Stringer with Needham <unk> Company.

Hi, good morning, Thanks for taking our questions.

A question on PVC here, just curious if you can give us a sense for what your current.

Operating margins are specifically for <unk>.

OCA and PBC and.

Maybe do you have.

Idea of what those could be sort of going forward do you see you could improve those over the next couple of quarters or couple of years. Thank.

Thank you.

Thanks for the question, we obviously feel good about the performance in PVC.

In the quarter.

We have also described the fact that on a standalone basis, the PVC franchise.

<unk> is a profitable one Andrew maybe you can give some additional color on that front.

Certainly and thanks for the question.

So we don't breakout PVC, the PVC business as a business per se.

You can obviously see the sales and the cost of sales on our P&L. That's the only products. So those are clean numbers.

Also stated before that.

Majority of our R&D expenses are related to Nash.

As of Q3 year to date R&D expenses were $133 6 million approximately two thirds of those are in Nash related.

So that should give you sufficient information to breakout.

The business would look like without the Nash.

Significant phase III trials that were currently.

And in the process of providing data for at the end of the quarter hopefully that helps.

Yes.

Thanks for taking our questions.

Bruce.

Our next question comes from Sal <unk> with Goldman Sachs.

Good morning, Thanks for taking my question.

Can you just help us understand.

What.

What might be presented at the upcoming liver meeting and whether there could be any read through here to that reevaluation data.

So gail.

I'll I'll turn that to Gail sure Im happy to happy to take that question.

So I think as Michelle said initially we are certainly excited at some of our data will be at <unk> specifically.

The first PVC outcomes data with a bit of color gassen and as Michelle said earlier accepted as an oral presentation late breaker and best of the liver meeting.

We'll have important new data on the biopsy reading methodology used in Nash this is not data.

<unk> outcomes with showing how the biopsy reading methodology works.

And.

We will provide some transparency there and finally.

We will also have.

Some data on reversed methodology and baseline data, which will be in advance of course of reverse data release coming later.

It's also gratifying that we saw several independent Amstrad Santa Beta Cola gas Ed. This is notable winter medicine is well established that people start doing independent research.

There was some interesting things there for example, a Stanford University App stack that notes that liver transplant waitlist mortality among patients with PVC and heat compensated cirrhosis is lower since of caliper approval compared to before a caterpillar approval. So this is of course encouraging.

Well not definitive but it makes for a nice pairing with our own work on the place long term safety extension and external control data.

And I think we'll have to see what else comes up at the meeting but.

I think on the Nash side is little of.

Notable excitement and mainly work that emphasizes that Nash is certainly a heart fail to be successful at in the clinical trial setting.

Thank you.

Our next question comes from Eli Merle with UBS.

Hey, guys. Thanks for taking the question just on Nash.

Biopsy reads as well as the additional patients can you remind us what your plans from a statistical perspective are to analyze this data I guess on Nash resolution and fibrosis.

Thanks for the question, Paul perhaps you can give a little.

A reminder of the approach they are the primary endpoint.

Thank you Jerry.

We're really viewing this as a new analysis is a.

A much more robust dataset longer patient follow up.

More patient numbers as Michelle said, it's more than twice the patient exposure.

And we're actually looking at.

Over 600 subjects, who have been on treatment for four years or more in the by now.

So we'll see.

Same with <unk>.

Liquid biopsy the efficacy analysis, we're really seeing this as a new <unk>.

Fresh look at these data.

Hope that helps.

Yeah, just I guess any comment there on the powering or the statistical sort of analysis in particular, if you can.

We will completely replicates the analyses that went into the original.

Interim analysis.

Got it okay. Thanks.

Thanks Helane.

Our next question comes from Geoff Meacham with Bank of America.

Hey, guys, it's Aspen on for Jeff. Thanks for the questions just a couple on the pipeline actually.

Can you talk about the decision to study a broader dose range for the Otas as a combo.

Is that to look at higher doses lower doses both.

Is there any data that you've seen so far this kind of informing that decision or is that maybe just.

Just part of the inherent protocol and then for <unk> 787.

Can you talk about some of the target indications, you're considering that asset that youre looking to communicate next year is that going to be dependent on.

The FDA feedback in Nash or.

You already have like a set let's say you're thinking about thank you.

So Gail perhaps you can start on the <unk> and then I can I can comment on 787 afterwards, thanks for the question sure happy to do so.

<unk> <unk> combination in dose ranging.

He is important in phase two to do thorough dose ranging is something FDA and other regulators absolutely expects going from doses that show no efficacy that is that low.

Doses that are higher than you may intend when you do a combination product that adds a level of complexity of course, because you're managing two doses. So our study is designed to meet regulatory requirements and regulatory needs and to assure we have what we need to progress our program and so it includes a full range of dose ranging.

So on 787.

So the phase one work is ongoing we're progressing.

Through the dose escalation work.

We are looking with interest at several areas of unmet need.

And I think doing the right work now to be in a position.

As Michelle indicated in the prepared prerecorded.

Marks that we would expect to select a target indication in the first part of 2022 again focus for us is.

Some some interesting areas of unmet need that we feel that this compound.

However, having interesting role in but some more work to do and we'll come back next year as we've outlined.

Thank you.

Okay.

Our next question comes from Matthew.

Luchini with BMO.

Hi, Thanks for taking the question and for the comprehensive update I just wanted to ask I guess about how to think about reverse in the context of regenerate and I guess, what I am interested currently is.

If for some reason a reverse were to be successful, but the re analysis.

Pan out or give you. The result that you were hoping for it to move to support Resubmission.

Would you consider moving forward with a more narrow label how do we how should we be thinking about that type of potential scenario. Thank you.

Yeah. Thanks for the question as I said earlier, a reverse for US is an important.

Datasets for for OCI, I think also for the field and clearly for the patients.

That are suffering.

Our dialogue with the FDA. This year that we've outlined in previous calls has been primarily focused on regenerate and getting ourselves to a point, where we were able to outline the kind of data we felt appropriate to generate on regenerate and now we're in that in that process now I think as we get closer and work.

Towards having the reverse.

The data in hand.

And once we have that data will clearly be regrouping.

With the agency I think.

If the data is positive.

It provides us good options in several different scenarios and that's the way that we look at the data again, it's an important population there is high unmet need.

This is a patient group that.

And all of the customer work, we've done over the years in Nash is one that.

Tends to be of high concern, obviously to the patients themselves, but also to the.

To the health care practitioner. So we do feel if the reverse data is positive we would have some good optionality and we'll see how all the pieces fit together.

With data in hand.

Thank you. Our next question comes from Thomas Smith with SBB Leerink.

Okay.

Hey, guys. Thanks for taking the questions maybe just.

A follow up there as we think about the upcoming reverse trial readout soon a pretty wide range of placebo response rates in the compensated cirrhotic Nash population can you provide.

Provide any color on the trial powering and what you've assumed Hercules a response on the one stage improvement in fibrosis without worsening of Nash primary endpoint.

Paul perhaps you can pick up that one.

Yes. Thank you.

Okay.

The powering has been the standard.

<unk>.

055.

This one with most with 90% power.

Reed significance I do not have the details.

Or what do you expect that placebo response rules.

Okay.

Thomas we can follow back up with you.

On that one okay.

Okay, Yeah that would be great and then maybe just.

One follow up question I was thinking about the.

The MAA in Europe.

So any additional color you can provide on the decision to respond to the day 180 questions rather than wait for the outcome of the U S data generation in the regenerate re analysis would be helpful. Thanks, guys.

Thanks.

As.

Michelle.

In the prepared remarks, we our current plan we're working towards.

The the response to the day 180 questions.

<unk>.

Maybe Paul you can give.

A summary of kind of the process as as we move forward there and again.

For us we'll work through the process as it as it unfolds here.

Yes, Thank you Gerry.

Purely hypothetically.

Obviously see HMP at this juncture could choose to.

Give an opinion based on our data will may see responses.

Remind us on or electrical imation.

They could.

Although the symbols.

Very frequent.

It could push us into another day, one round of questions, which would allow us the.

Ability to.

Even further align our data assets.

Between U S and Europe.

And obviously.

As always.

Applicants have the ability to withdraw at any point in time.

Does that help.

Yeah.

Yes.

That's helpful. That's helpful. Thanks, guys.

Thanks, Tom.

Our next question comes from Mike <unk> with B Riley Securities.

Good morning, Congrats team on tracking nicely on both top and bottom line.

And then, especially if you're adding ahead of expectations.

Relative to the reset last year just quick quick question for Linda on the PVC dynamics.

How should we think about the Duane Duane to outlook here as we are nearing the end of impact in the U S. But maybe not so much in the U S and and maybe help us think about the new patient start dynamic wishes.

So now that you are in the rule and you understand penetration market penetration and also impact from.

The other clinical trials that are ongoing and then Andrew if you can.

Bringing the picture together.

This cash flow positive.

Can we see that kind of sustained over over the next few quarters.

Yeah.

Okay.

Thank you for the question.

Obviously, we're very pleased with how the messaging and the education win on the label change the communication there.

And I think that being able to do that in person with representatives that we're familiar with.

Physician prescribing base going out was very helpful. In communicating and the label also gave clarity on who was in and who was out and as we stated we believe that we're near the end of the transition by year end on the existing patients. So we feel that thats pretty much through and there shouldnt be.

As we look at the label impact in Europe. In 2022, we don't have that label in hand of course, but we would perceive that he compensated patients would also likely be not indicated further in that population and when they looked at the impact.

<unk> has estimated 10% to 15% of our eyes.

The population available to <unk>.

And what we're finding is it was really down on the lower end and some of the discontinuation, which we expected to see given we havent change in population, we're taking fewer doses and that fewer doses are usually associated with D compensated patients, but what we realized in talking to our customers was that many of our <unk>.

<unk> take we're taking a cautious approach to patients who were compensated cirrhotic.

They too where some of them were on a once or twice weekly dosing. So we do feel confident that the right patients are coming off now as I said in my previous comments. The focus now is very much on getting back to business and new patient starts and we've seen some depression with that over the Covid period, and I think frankly as people waited they were away.

But at the upcoming label change as they waited to see what the clarity of the patient population with Eon and Thats very clear no change in dosing just one regimen and you can go from there, but the new data that we're sharing new data drives I think conviction.

At a product and how can I use this to help my patients when frankly, we only have one second line chronic the natural calendar. So you look at the fibrosis data and that came again from our poise extended open.

The label extension and you see in those patients a stabilization of fibrosis when.

When you have a progressive liver disease. This is an important element. So when we talk to physicians underlying it's not just about <unk>. It is the underlying health of the liver and preserving that for as long as possible that resonate with the higher levered up though so you take that data and now with this totally impressed.

Location data coming out comparing a cohort of patients.

Patients is that cobalt limitation is we're poised like patients who are earlier on in the progression of their disease and start to get that information out at <unk> as the best of abstract I think that you can see there is a fair amount.

New New communications that can go out to support the business and we're very much looking at growth in the market and a return to growth beginning in 2022.

Andrew Yes, thanks Linda.

So I'll try to answer your question.

But they can.

So first off I'll, just say look we're really happy with the sales performance both in the U S and international and with our ability to manage expenses.

Two consecutive quarters of cash growth slash neutrality.

It is a terrific win for the company and I think again, just highlight the profitability of our underlying PVC franchise.

We're not prepared to give guidance.

For next year, but I will make some comments.

In my prepared remarks, I mentioned that in the fourth quarter, we're going to be increasing expenses to help prepare the datasets that Michelle and various others are discussed on this call.

But I also indicated that that will be higher than what we've had this year and higher than what we expect next year.

So what you can expect us to continue to manage our expenses into next year prudently.

Regardless of which direction, we go with the Nash application to the FDA, we are not expecting an increase in expenses next year relative to this year. We also expect that our PVC business will continue to grow.

So with those we're very happy with where we are and we will likely give guidance. We will give guidance on next year at the end of our conference call at the year end.

I hope that helps.

Very helpful. Thank you.

Thanks.

Our next question comes from Jay Olson with Oppenheimer.

Oh, Hey, congrats on the quarter and thank you for taking the question.

Thanks, sorry about.

You've spoken about running a profitable rare disease business in the event that Nash doesn't work out.

Can you talk about the timeline and gating factors that would lead you to exercise that option and then maybe related to that is there any color on when and under what circumstances, you would consider pursuing a PSC indications for <unk> or is that an opportunity or saving for 787 or the otas, because if I read combo.

Thank you.

Thanks for the question Jay.

As we've said a couple of times, which I think is.

The at the center of all this is that the dictate the I'm sorry, the data is going to dictate.

Our path forward our path forward in Nash ultimately be an important <unk>.

Driver in the strategic decisions as you can imagine with any company. It's important as you look at major milestones that.

Contingency planning is ongoing I think importantly.

As we've tried to.

Remind this morning, we've been trying to take the right steps along the way this year to solidify the foundation with what we're doing from a cost management standpoint.

Andrew outlined how we looked at.

Our convertible debt.

And making sure that we're solidifying the PVC business. So all of this work.

Is to ensure the.

Wright's strong foundation.

For the future as we importantly get the data in hand to make the right decisions and I think I'm always encouraged by the fact that we.

We have strengths in this company to to leverage we are deep in the liver community we know the players.

Think another quarter of illustration of our commercial capability.

R&D expertise around around liver and then the success so.

Again, I think for me, it's about ensuring that.

We're focused on the Readouts, we're going to use the data to make the right decisions.

Moving forward on behalf of our company and our shareholders.

That's really the way that we look at the next phase in the company.

Yeah.

Second question was on PFC, Yes, maybe you can sure happy to take that so.

With regard to PSC, let me start with your second part which was about 787 as we said earlier, we're looking at a number of high unmet need areas.

And I would certainly agree PSC is one of many high unmet need areas, but it's still ongoing work and we will tell more about that.

Next year after we've completed our work there.

PSC. We were pleased we ran a positive phase III study with PSC with a beta kotalik acid.

Which was based on alkaline phosphatase reduction and we saw a nice upland plus today's production. Unfortunately, PSC is an area, where biomarkers are not as straightforward as they are in PVC or some other areas.

Which adds a degree of complexity and studying this area.

Great. Thank you very much.

Thanks.

Our next question comes from Brian <unk> with Baird.

Hey, good morning, everyone and thanks for fitting me in I didn't hear any questions on the regenerate reroute so.

Matt.

So I understand the focus on sort of a fibrotic endpoints, but my question is more on the re read and whether or not youre looking at Nash resolution endpoint. In addition to the farm for US one point I'm just wondering if given the additional patients.

That are being evaluated.

Even the absolute difference remains the same that we saw in the initial of regenerate.

That would be our statistical significance I think the original P value was <unk> three on an N of $9 31, and just based on statistical protocol are you able to evaluate Nash resolution for statistical significance or is there any P value on resolution nominal at this point. Thanks.

Okay.

Yes, so as Paul indicated earlier.

The readout will be on the same two primary endpoints that the initial enel.

Analysis.

Read on which is in both the improvement in fibrosis with no worsening of Nash and Nash resolution.

And point Paul anything further on that obviously as we've said, it's a larger number of patients in this.

This.

Analysis than the original being read with the new methodology, Paul anything you want to you want to add into that.

Thanks Jerry.

Yeah.

As we said the study Hasnt changed so the powering is identical to what it was it is a larger patient population the larger sample size and therefore.

You can draw conclusions from that as you will.

It's too early to speculate we really need to wait until we see the data.

Okay.

Okay.

Thank you. This concludes the Q&A portion of the conference I would like to turn the call back over to our host for any closing remarks.

Yes, thanks, everybody for the conversation today, maybe just to summarize what we shared today.

I feel good about the fact, we've executed well against the objectives that we set out in the beginning of the year, our global PVC business with the caliber continues to deliver remained strong under the new label and I'm confident in our ability to grow this business in the long term.

Second we're on track with the important data generation in Nash, which I believe will allow us the ability to make the critical decisions regarding our path forward. The pipeline programs continue to advance and importantly, we've made great progress strengthening our financial foundation, which will support a successful intercept and allow us to focus on creating shareholder value over.

The long term definitely look forward to providing further updates as we continue what's the busy period.

<unk>, the clinical commercial and regulatory activity and last and certainly not least I want to thank the team at intercept for their strong execution their commitment and for all the work theyre doing and their dedication to the patients. We serve so thanks, a lot and we look forward to more conversations along the way have a great day.

Ladies and gentlemen, this does conclude today's presentation. You may now disconnect and have a wonderful day.