Q2 2022 Intercept Pharmaceuticals Inc Earnings Call
Yeah.
Hello, Thank you for standing by and welcome to the second quarter intercept Pharmaceuticals earnings call. At this time all participants are in a listen only mode. After the speaker presentation there'll be a question and answer session to ask a question. During the session you will need to press star one.
One on your telephone please be advised that today's conference maybe recorded I would now like to hand, the conference over to your speaker today.
So Garry <unk> executive director of Investor Relations.
Please go ahead.
Thank you good morning, and thank you for joining us on today's call. This morning, we issued a press release announcing our second quarter 2022 results and business update which is available on our website at intercept 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.
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 of 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.
Some 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 are discussed in this morning's press release and in our periodic public filings with the SEC.
Today's call will begin with prepared remarks from our president and CEO , Jerry Durso, our Chief commercial Officer, Linda Richardson.
Our research and development and Chief Medical Officer, Dr. Michelle Berrey, Chief Financial Officer, Andrew stake.
We will then open the call to take questions. Please limit yourself to one initial question in order to allow time for all questions to be addressed.
Let me now turn the call over to our CEO Jerry Durso.
Thanks, <unk> and good morning, everyone. Thank you for joining us on our second quarter 2022 earnings Conference call.
As we move past the midway point of this transformational year for intercept I'm delighted with the milestones we've reached and the progress we've made to strengthen the foundation of our company.
We've built a strong and successful caliber franchise in PBC and we continue to break new ground. The showcasing what this treatment can bring for the appropriate patient populations, we're continuously generating and sharing new long term data about what caliber and looking ahead. We know there remains a substantial population of patients that could benefit from adding <unk> to their treatment.
Right.
This is evident in the performance we saw in the second quarter of the year, where we reported $71 $8 million of USO caliber net sales, representing 5% growth compared to the second quarter of 2021.
Importantly, the underlying dynamics supercalender indicate that we're moving past the forecasted implications, but last year's label change with prescribing and perception strengthening looking forward to good momentum throughout the rest of the year and beyond.
Turning to Nash I'm thrilled with the results of the topline readout, we announced last month concerning the long term use of OCA in patients with fibrosis due to Nash.
In addition to reinforcing the efficacy of OCA as an anti fibrotic with the second analysis. We now have the benefit of a deeper understanding of safety over a longer period of time.
Given the data we've gathered we're confident in the improved benefit risk profile of both <unk> and its potential role as the first therapy and theirs.
We had a constructive pre submission meeting with FDA in July and we look forward to resubmitting, our NDA by the end of this year.
At the same time, we are in the process of refining the planning of our commercial strategy now.
Now that we have data in here.
We expect to take a milestone driven approach to our commercial preparations and we'll speak more about that in the future.
Regarding our second phase III trial reverse which is evaluating <unk> in patients with compensated cirrhosis due to Nash, we expect topline readout in late third quarter.
Michelle will provide greater clarity on reverse and our other pipeline programs later in today's call.
Finally, the recent sale of our international business has significantly strengthened our balance sheet, which positions us well for future growth and success.
We're continuing to drive growth in our foundational business of O'callaghan PVC executing the next step in support of Oca's potential as the first therapy in Nash, including the Resubmission of our NDA and advancing our key pipeline programs.
With that I'll now turn the call over to Linda Linda.
Thanks, Jerry and good morning, everyone.
I'm pleased to share that we continue to drive sales growth in our PBC business in the second quarter of this year, we delivered worldwide Ocala, but non-GAAP adjusted net sales and PVC of $100 4 million and U S. Net sales of $71 8 million, representing 5% growth over the prior year quarter.
Given the completion of the sale of our international business I'll keep my comments focused on the U S performance to date and moving forward in 2022 as we have previously stated the impact of the label update should be fully completed as we enter the second half of 2022, meaning that in Q3 and Q4.
We will be evaluating comparable PBC population for the first time since the label changed back in June of 2021.
Our expectation is that we will see an acceleration of underlying growth during the next six months.
As we reach the midpoint of the year performance is where we expected it would be and we see several positive signals in our foundational caliber business.
Our unit demand was strong in the latter half of the quarter. This is partially related to an uptick in retail rates over the past few quarters, which we believe indicates patient satisfaction with the caliber.
In fact, our most recent market research shows 85% of Colonel caliber users are extremely satisfied with OCA.
Care to approximately 60% to 70% for ourselves.
Also impacting the increase in units with the largest script size, which indicates that we are treating appropriate PBC patients as the lower script sizes were indicative of the more advanced patient populations. Additionally.
Additionally, new patient enrollments were up markedly over June of last year, which is when we began educating health care professionals on the new label, we're seeing similar trends in July and believe that these are clear signals that the PVC business will begin rebounding nicely in the second half of 2022.
Lastly, patient Dropbox have returned to levels seen prior to the label update suggesting that we are no longer seeing an impact carryover on existing patients.
Recent market research provides additional context on some of these dynamics.
The latest wave of our ongoing tracking study indicates that believe in Ocala that and intend to prescribe have both increased following the label change our peer to peer programs are largely in person and attendance has been strong showing that hcp's are still interested in learning about caliber.
Furthermore, we will be launching new promotional campaigns for both health care professionals and patients in the next few weeks and we are preparing for a strong presence at the upcoming fall Congresses, especially at the liver meeting in November .
We're actively preparing for a Nash launch using a measured approach I'm pleased to share that we will be displaying our Nash disease awareness campaign at this year's <unk> meeting as part of a resumption of prelaunch Nash initiatives. We're also focused on ensuring that we have the right commercial strategy play this.
This will involve assessing current market dynamics and understanding how these learnings will inform our commercial decision making for Nash. It is truly exciting to have the commercial team engaged in these efforts again.
Closing, we remain confident in our ability to drive growth increase market penetration and maintain a positive long term outlook for our PVC business. The long term outcomes data and real world evidence, we are generating <unk> in PBC is both compelling and important to patients and prescribers.
We know that there remains a sizable market segment of patients who potentially could improve with the addition of ocala that to their PBC treatment plan and our commercial organization remains focused on reaching physicians with important data that can continue to drive growth and expansion of accountable.
We're also looking forward to a potential launch in Nash and bringing OCA to many patients who currently have no options.
I'll now turn the call over to Dr. Michelle Berrey Michelle.
Thank you Linda and good morning, everyone.
By providing updates on our Nash development program and outlined some of the key data we've been generating to support <unk> and PVC and then discuss updates on our broader pipeline.
Looking first at Nash, we were thrilled to announce positive results from the new interim analysis of our phase III regenerate study.
Now the second time OCA is messy agreed primary endpoint of improvement in liver fibrosis without worsening of Nash at 18 months. These.
These results have now been demonstrated using two different biopsy reading methodologies, including the consensus reding inline with recent FDA guidance.
Subjects randomized to OCA 25 milligrams had double the response of subjects on placebo, a highly statistically significant and clinically meaningful results.
Over the last few years fibrosis has been shown to be the strongest predictor of liver related morbidity and mortality. We believe this new analysis reaffirms. The OCA can play an important role for people living with fibrosis due to Nash.
We were also pleased to see the safety and Tolerability results from this new interim analysis, which included more than 8000 patient years of safety data compared to 2400 in the prior submission and importantly, nearly 1000 patients who have reached four years in regenerate.
This new larger safety database allows a more robust assessment of the safety and tolerability for therapy likely to require chronic administration.
Just on what we've seen thus far we believe the safety and Tolerability that support potential chronic treatment with OCA is well defined monitor evolved and manageable.
We look forward to sharing the details of the safety and efficacy data at scientific conferences. This fall.
The consistency across these analyses gives us confidence in the totality of data for the benefit risk of OCA in fibrosis due to Nash.
In late July we had a productive pre submission meeting with FDA in which we reviewed the plans content of our NDA and the timing of our submission by the end of 2022.
As a class II Resubmission. This NDA will have a six month review period. In addition, we anticipate an advisory committee meeting as part of this process.
We're also continuing to work toward a topline data readout in late Q3 from our phase III reverse study the only active late stage study in compensated cirrhosis due to Nash as a reminder, this would be a separate NDA for this rest of syndication should the data support it.
We will assess the regulatory opportunities for reversed when we have our topline data in hand.
Overall, the amount of data we are generating in Nash is unprecedented and ultimately upon completion of these analyses we will have accumulated the largest phase III clinical trial data set in the field.
Now turning to PBC.
June we provided top line data from our phase four cobalt study as well as the first of our real World evidence studies we.
We will include these in our submission to the FDA later this year to meet our post marketing commitments and help demonstrate the clinical benefit of long term therapy with caliber.
As we shared previously cobalt was terminated early following conversations with regulatory authorities and guidance from the study data monitoring committee or DMC.
This trial had challenges in enrolling in maintaining patients in a placebo controlled study in a rare disease. When the study drug is commercially available.
As a result of these and other factors, we agreed with FDA to close the trial and compile the data, which as expected did not demonstrate a difference between the placebo and OCA arms.
We believe the data from patients randomized to OCA can form a significant component of our post marketing requirements, they will need to be compared to matched external controls individuals with PBC, who are not on OCA all of that from other databases, such as the kimono claims database.
In addition, we have initiated multiple real world evidence studies, including the hero studies.
These studies are providing consistent evidence of transplant free survival in patients receiving <unk> for PBC, the ultimate goal of PBC treatment.
This weight of the evidence submission will include results from cobalt the hero studies and data from our phase III Poise open label extension and will comprise the supplementary NDA. We plan to submit later this year, we remain committed to fulfilling our post marketing requirements.
Moving onto OCA, plus <unk> combination studies in PBC, we continue to screen patients and add clinical sites in our U S. Based phase II study. In addition, we continue to enroll our international Phase III study that is evaluating different dosing regimens of <unk> combination.
Our large phase one study in the U S to better characterize the exposure data as well as any potential drug drug interactions of the fixed dose combination has now completed enrollment.
Together. These three studies will inform the dose selection and study design for a phase III trial.
Our pharmacokinetic or drug level analyses are now underway, we anticipate selecting doses for the fixed dose combination later this year and sharing data with you from the planned analyses of the phase one and phase two studies.
Looking at our pipeline our comprehensive phase one study for our next generation FX <unk> agonist.
787 has progressed to the final cohort.
We look forward to sharing data from our phase one studies as well as our intended indication and development plans for Int 787 later this year.
Before turning the call over to Andrew I want to thank the intercept team for their incredibly hard work over the past few months as we generated unprecedented amounts of data across Nash and PBC.
All while continuing to advance our pipeline programs and proud of the progress we've made and look forward to sharing data in the coming months.
I'll now turn the call over to Andrew for financial update Andrew.
Andrew.
Thank you Michelle and good morning, everyone.
I will be providing an update of our financial results and I ask that you. Please refer to our press release issued earlier today for a summary of our financial results for the second quarter ended June 32022.
As a reminder, our second quarter 2022 results are reflective of our ongoing operations and the international business has been moved to discontinued operations in our financial statements.
In our press release issued this morning and in my statements today non-GAAP adjusted net sales and non-GAAP adjusted operating income operating expenses include the international business.
Reconciliation of our GAAP to adjusted non-GAAP numbers is provided in our earnings release issued earlier this morning.
Additionally, we had previously suspended our financial guidance for the year due to the sale of our international business. We are now reissuing guidance of non-GAAP adjusted net sales of $325 million to $345 million.
And non-GAAP adjusted operating expenses of $335 million to $365 million.
This guidance includes our international business for the first six months of the year and our ongoing business for the remainder of the year. In addition, our non-GAAP adjusted operating expense guidance includes expenditures related to Nash development and the pre commercial commercialization stem.
In the second quarter, we recognized $71 $8 million in U S. Net sales of $104 million and non-GAAP adjusted net sales as compared to $68 $2 million in U S. Net sales of $96 6 million and non-GAAP adjusted net sales in the prior year quarter.
We recorded $85 1 million and total operating expenses in the $89 8 million and non-GAAP adjusted operating expenses.
This compares to the quarter ended on June 30 of 2021, where we recorded $81 6 million and total operating expenses and <unk>.
$6 5 million.
non-GAAP adjusted operating expenses.
Our cost of sales were $23 million for quarters ended June 32022, and 2021 and consisted primarily of packaging labeling materials and other related expenses.
Our selling general and administrative expenses were $40.0 million in the second quarter of 2022 down from $43 9 million in the prior year quarter.
The decrease was driven by our ongoing efforts to manage our operational costs.
Our research and development expenses were $44 $8 million in the second quarter of 2022 up from $37 7 million in the prior year quarter.
The increase was a result of a reduction in U K R&D tax credits recognized in the current period.
Interest expense in the quarters ended June 32022, and 2021 was $6 7 million and $12 $6 million respectively.
For the quarter ended June 32020 to interest expenses related to the principal amount outstanding for the convertible unsecured notes.
No longer includes an accretion of discounts upon adoption of ASU 2026.
For the quarter ended June 30 of 2021 interest expense is related to the principal amount outstanding for the convertible notes.
In the second quarter 2022, we reported a net loss of $7 5 billion.
A decrease compared to a net loss of $11 1 million in the second quarter 2021.
As of June 32022, we had cash cash equivalents restricted cash and investment securities available for sale of approximately $412 3 million.
With the addition of the $366 $5 million in cash received from the completion of the sale of our international business. The company has cash cash equivalents restricted cash.
<unk> debt securities available for sale of well over $700 million.
In summary, I am pleased with our commercial performance and the positive impact that the transformational sale of our international business.
Liquidity and financial position on a pro forma basis, we now have cash well over $700 million.
Which gives us the ability to manage the company through the potential launch of OCA in Nash and gives us a great deal of freedom in how we manage our debt.
We also have the financial flexibility to continue investing in the growth of the Calvin PVC and supporting our other development programs.
An exciting time for the company and I am pleased that we are well positioned financially to drive our growth into the future.
With that I'd now like to turn it over to the operator for any questions operator.
Thank you as a reminder to ask a question you will need to press star one one on your telephone please standby, while we compile the Q&A roster.
Our first question comes from Yasmin Rahimi with Piper Sandler you May proceed.
Good morning, Tim and thank you so much for taking my question.
It would be wonderful if you could give us to the extent you can some color about how the pre NDA submission one.
You know maybe the sediment that the FDA shared with you.
In regards to you know.
How comprehensive the packaging of the data needs to be any detail that could be helpful for us.
And specifically as our clients are listening.
Sure.
How excited with the FDA on the data.
Submission package in the depths of it.
So much for taking my question and I'll jump back in the queue to allow my colleague staffs that questions as well.
Thanks, Yes.
As we said in the prepared remarks, so it was a constructive good step for us.
Michelle perhaps Ken can give some of the flavor around.
Important discussion that we had.
Yes, hi, good morning, and congrats to you guys.
A very productive meeting and we now have a clear path forward for our Resubmission DFT.
The FDA acknowledged the vast amount of data that we've been collecting.
Especially on the safety front over the last couple of years.
We intend to submit by the end of 2022 as we stated in our prepared remarks, we.
We did get some additional clarity.
I'm not.
Safety specific safety events and how the agency would like for these data to be included in the submission. So again it was a very productive meeting and helped us in planning for our submission later this year.
Thank you so much.
Thanks.
Thank you one moment for questions.
Our next question comes from Michael Yee with Jefferies. You May proceed.
Hi, This is <unk> on for Michael just want to ask about scenarios surrounding the timing of CT readout.
And the NDA submission.
But in terms of.
What happens and how do you see that scenario, if the readout are positive or negative and whether the FDA would take that into account.
When you're filing for the <unk> three NDA understanding that you said, it's a separate process, but just trying to understand on the FDA side. I think there is any read through between the data that for trial and two or three NDA filings.
Okay, great. Thanks for the question, maybe I'll start and then Michelle Ken can add as we as we indicated we continue to work towards a top line readout for reverse switches.
<unk> study that you referenced late in the third quarter.
We have said for a while and continues to be the case it is a separate IND.
If in fact that study is positive and we intend to file that would be a separate filing and importantly, and I think this continues to be.
Consistent with the <unk>.
Planning that were doing our filing in fibrosis.
It's going to be based on regenerate and isn't dependent on reverse of course as you would expect we're going to reassess next steps.
On the <unk>.
Compensated cirrhosis indication once we have that data in hand, but all of the work on the <unk>.
First filing, which we're guiding towards the end of the year on.
Fibrosis is.
Is in process and is not dependent on that second important.
Data set which we'll see on the reverse side.
Got it. Thank you Michelle Michelle anything further you want to add there.
Thank you covered it Gary.
Okay. Thanks.
Thank you one moment for questions.
Our next question comes from Brian Abrahams RBC you May proceed.
Hi, This is Steve on for Brian . Thanks for taking my question, maybe shifting gears, a little bit to the <unk>.
Earlier programs can you share a bit more on your thinking around how sub 97 might be differentiated and where do you think the best opportunities there.
Thanks.
Thanks, Steve, we'll let Michelle take that one.
Hi, Good morning, Steve. So we are looking forward to sharing more of the planned indications for 708.
The preclinical data and our phase one data in the next few weeks are really excited about this compound and how it is differentiated from OCA. So again it'll be a next few weeks, but we look forward to having data.
Clinical data that we can share with you at that time as well as the indication and our development plans. Thanks for the question.
Great. Thanks.
Thank you one moment for questions.
Our next question comes from Steve said House with Raymond James You May proceed.
Hey, good morning, Thanks for taking my question I wanted to ask you about your.
Just.
Thoughts on.
The market in Nash launch strategy.
Years ago, you had discussed prioritization of certain patients with advanced fibrosis under tariff oncologist.
Et cetera, and I am just curious if that.
Thinking has evolved at all and also just any preparation that you need to do in the next year. Given this is only a six month review cycle hiring et cetera that it needs to be done for a launch. Thank you.
Yes. Thanks, Thanks, Steve I'll start and then and then Linda Ken Ken.
Ken add in I think as we indicated and as you would expect.
We have the updated.
Top line readout in hand, so we're already working on.
What I would call is refinement and an update on our commercial strategy. So we're taking advantage of all of those learnings historical work that we've done that you mentioned I think there's probably a couple of important elements that are still going to guide us.
Open for that updated view that we will be doing.
In terms of the updated prescriber and payer and patient view.
I think.
We will continue to focus on the anti fibrotic effect as the main differentiator when we think about introducing.
And I do think that generally.
<unk>.
Advanced segment and the focus on the specialist Sam those patients that are already than we did in the past talk about.
A reasonable number of patients with advanced fibrosis due to Nash, who are already identified and under treatment of the special and so I do think that will continue to be our initial.
Focus, but a lot of important work to do to refine that and as you would expect look we'll provide updates as our work progresses and I'm sure as we move towards.
And and Resubmit will have important updates on the commercial side as Linda and the team do.
Do the work I guess the second half of your question was just on kind of a general preparation overall and how we're thinking about that as we move through these.
These next several quarters and Linda can give you our current thinking on that yeah. Thanks, Jerry I think it's really important that we look at what we hold to be true and patient population and looking at where the label is looking where we've demonstrated efficacy. So I think that Jerry very nicely covered off where we're focusing on a kind of patient.
<unk> prioritization as well as where your audience is what I think we need to do is look at the context of the environment, where are we now a lot of that work was done frankly three years ago.
<unk> that we take into consideration, what whereas the context of where we find ourselves presently in terms of competitive set in terms of the environment and market access and pricing and a lot of focus will need to be on making sure that we have the right value proposition and that were prepared to go to market strongly and supporting the brand.
Currently we already have what we believe to be very strong prelaunch materials, which I talked about and Thats focused a lot on disease education, the role and importance of fibrosis in Nash and as I mentioned, we'll be rolling that out as soon as <unk> again, so we will take measured steps to use that which.
As appropriate now and also update our thinking to make sure that we launched properly and with the right kinds of insights.
To have a successful launch of our patient target group.
Thanks, Steve.
Thank you one moment for questions.
Our next question comes from Thomas Smith with SBB Securities You May proceed.
Hey, guys. Good morning, Thanks for taking the question.
Just one on the.
The pre submission meeting.
You previously talked about this.
As more of an administrative meeting I guess could you just elaborate on how much discussion there was a the actual regenerate re analysis datasets. During this meeting ended.
Did the FDA explicitly commit to holding an AD com during this meeting.
Michelle.
Hi, Yes, good morning Thomas.
As is typical for these meetings the majority of the discussion was focused on the logistics and on the submission itself.
As I said it was a really productive meeting with some clarity on some of the specific safety events, how they wanted to.
Presented even very specific tables, so again on the how of the submission.
We have been discussing with the agency the calendar given that we have.
This submission coming in at the end of the year and with that.
Type two resubmission there is that ability to have an advisory committee.
Which we have shared with the agency that we would welcome the opportunity to have an advisory committee in the first half of 2023, So I think I would.
We anticipate that for early next year.
Okay got it thanks for taking the questions. Thank you.
Thanks, a lot. Thank you.
One moment for questions.
Our next question comes from John Weldon with JMP Securities You May proceed.
Hey, good morning I.
I guess, maybe just one follow up on Michelle's. Prior comments can you give any more details on which specific safety events FDA.
More clarity on in the Resubmission.
Sure. So we have previously discussed the actor.
After the CRA all they wanted more specific information on hepatic cardiovascular and acute kidney injury. So we set up three independent adjudication committees a lot of discussion with the agency about who exactly they wanted on those committees their backgrounds their independence.
And the ability to review all of the blinded events. We also specifically went through with the agency. The trigger terms. So those types of events that would be reviewed by each of the independent adjudication committees and then what the output from those.
The reviews was and how that was to be included in the submission.
There's three specific events, where once that they had interest in either from the onset of the trial because of the higher risk of the patient population that is enrolled in our advanced fibrosis population.
Increased risk of type two diabetes increased obesity and other co morbidities and why why they wanted to make sure that there is.
Since we're adequately characterized through the trial.
So that was that was the the specifics around those events.
That day one it included in the in the trial.
Excuse me in the submission.
Very helpful. Thanks, Michelle Thank you.
Thank you and as a reminder to ask a question you will need to press star one one on your telephone.
I'm in for questions.
Our next question comes from Miami from Tony with B Riley Securities You May proceed.
Good morning team. Thanks for taking my question and congrats on a strong quarter.
Regarding the Opex management could you talk through how the SG&A came down 20% quarter over quarter.
When you invest in phase two with <unk>.
PVC and working towards do with NDA filing within this year and then just under constructive FDA Resubmission meeting just curious.
Michelle.
The requested safety the buckets data will be available at any of these conferences and if any of the divorce safety data with all relevant.
The first <unk> Resubmission, if you could comment on that.
Okay. Thanks, Mike we'll have Andrew start on the Opex question and then we can flip back to Michelle for for the follow up on the <unk>.
The safety.
Data.
Yes. Thanks for the question so with regard to Opex.
And again with moving our international business too.
To discontinued operations.
We have to be very clear on what numbers, we're talking about so our numbers that you're used to seeing including the international business. Our non-GAAP operating expenses were $90 million. So those are in line with our expectations right. So our GAAP operating expenses were $85 million.
That does not include the international operations from the second quarter.
As far as Opex management, we're right, where we expect it to be we did have a $3 million tax credit during the quarter, which also reduced our opex by a bit but.
In general from an operating expense standpoint are right in line with where we expect it to be for the quarter.
Okay second question was on weather.
Michelle we should expect additional safety data to come from regenerate later in the year and then the second part of the question, Mike because I understood. It was.
Reverse safety has relevance in the context of the initial filing.
Yes, so thanks for the question.
We look forward to sharing.
Data on the safety.
At the fall conferences.
So again looking after the safety on those three key adverse events of special interest debt.
We ran through with the top line the kidney events, which are balanced across the arms that cardiovascular events, which were balanced across all three arms.
The core mace and a handful of events and they expanded.
Mace that were generally driven by Revascularization and then the hepatic events as we've discussed before were mostly microbes.
Which means there's an elevation in transaminase says or our cross without jaundice.
So we will be going through all of those with the smaller number of events. We can go into the specifics even in those broker.
Our presentations. So yes, we did look forward to sharing that data at the phone conferences and have that would be helpful to understand why we are so enthusiastic about this new dataset with regard to reverse.
The reverse safety data will be submitted as we'll have top line data, which will share we.
Dissipate, having those data at.
Later in the third quarter and would have the safety and efficacy at the same time, we do.
Don't anticipate submitting the safety data from reverse just such a separate IND and best a separate NDA.
It's pretty clear that they consider these two very separate populations one preventing the progression to cirrhosis and then the reverse study the reversal of cirrhosis, bringing those patients back from an asset or two in <unk>. The safety data will be submitted along with those efficacy data.
Not with the regenerate submission.
But we didn't have that conversation just for clarity with the agency and the pre submission meeting and that remains there their perspective.
Thanks, very much I appreciate the color. Thank you Mike.
Thank you one moment for questions.
Our next question comes from Ellie Merle with UBS you May proceed.
Hey, guys. Thanks, so much for taking the question just in terms of like cost management and thinking about strategic outlook I guess, if there were to be a negative outcome from.
The re filing later this year how are you thinking about the speed with which you can adjust expenses given the.
The Nash study is ongoing and outcomes for many years and how you would approach that.
Strategically.
Yes, so I mean, obviously, we're excited to be moving.
Towards the Resubmission by the end of the year.
As we've always indicated.
Would expect we do our contingency planning appropriately.
And if we were in a situation with a negative outcome on Nash we have a good idea of what we would need to do and we've always discussed kind of the fact that with large ongoing trials like regenerate you normally have a couple to three quarter period, where.
You would make that kind of move if you were in that potential scenario I think importantly, underscoring the relevance of the we've always described our underlying <unk> business as a profitable franchise that remains true and in fact.
With the move and now the focus on the U S commercial presence only after the sale of international.
We are in a strong position regarding our commercial efforts and the productivity and efficiency of those efforts on PBC in the U S.
Got it thanks, so much for the color.
Thanks Ali.
Thank you one moment for questions.
Yeah.
Our next question comes from <unk> Richter with Goldman Sachs. You May proceed.
Hey, Good morning, this is Matt on for Sterling.
I was hoping you could talk a little bit about.
Patients for the reverse readout.
In terms of what benefit do you want to see is the bar lower here or how does that compare to what we've seen in regenerate and then could you also just discussed relative size. These opportunities. Thank you.
Okay. Thanks.
So we're excited about the important data to come with reverse maybe Michel Ken Ken frame.
How we're thinking about the readout and then I'll make I'll make some follow up on the potential opportunity there in market.
Sure. So thanks for the question.
We're looking at the F. Four population and again the only ongoing study in these advanced patients.
We are really excited to see the data again per day.
Bladder half of that of the third quarter.
Have not seen a difference and the ability of OCA to impact fibrosis.
As we compare <unk> to <unk> for example, we continue to see that benefit in the <unk>. So we don't have any expectations that we would see a a lower ability of the drug to act as an anti fibrotic again that we don't have any prior data for many.
Other agents to base that on we can look at other therapeutic areas in which you have a reduction.
The reduction or elimination of the injury and haven't seen the livers ability too.
To regenerate and we are looking forward to seeing those data I do think that this is a really critical population to understand.
Is there a point of no return.
As as has been postulated but.
Again, we have not seen that in our earlier data for patients who have more advanced fibrosis.
We believe that an anti fibrotic mechanism is the right approach for these more advanced patients and look forward to sharing data with you as soon as its available later this year.
Thanks, Matt I'll take the second half of the question Michel indicated its an important population that has a high risk population.
We've described in the past the fact that we estimate there is several hundred thousand patients.
Patients with compensated cirrhosis due to Nash who are with specialists.
And importantly, not only.
A pretty sizeable number but these tend to be patients that the understanding of the risks and the urgency to treat when a therapy comes.
<unk> is most obvious to the treaters right. So it's.
Pretty well defined group of patients that are out there and the payers and the physicians understand that when and if therapies come. This is a group that they would have a reasonable amount of urgency to treat.
Obviously, let's let's see what the data looks like and then we'll talk about what the what the opportunity is once we have data in hand.
But we look forward to seeing that important dataset.
Great. Thank you very much.
Matt.
Thank you and now I will turn the call back over to Jerry Durso for any closing remarks Jerry.
So thanks, everybody for joining us today.
I am definitely extremely proud of the progress that we've made in the first half.
I believe we're in a strong position as we work through this transformative year for intercept.
Important milestones to come that we feel we're in a good position to manage definitely look forward to the important updates to come as things progress and so have a great rest of the day and enjoy the rest of your summer.
Okay.
Thank you. This concludes today's conference call. Thank you for participating you may now disconnect.
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