Q2 2023 Intercept Pharmaceuticals Inc Earnings Call
Hello, and thank you for standing by welcome to intercept pharmaceutical second quarter 2023 earnings Conference call.
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<unk>, Sir you may begin.
Good morning, and thank you for joining us on today's call to review intercept a second quarter of 2023 financial results.
Our second quarter, 2023, and press release and accompanying slide on our website <unk> Dot com.
Before we begin our discussion I'd like to note that during our call you won't be making forward looking statements, including statements regarding our <unk> product.
Product in clinical development program, certain regulatory matters, and our strategy prospect financial guidance and future commercial and financial performance.
So as soon as a caution not to place undue reliance on these forward looking statements.
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 I believe to be reasonable are inherently uncertain and subject to a number of risks and uncertainties.
Some but not necessarily all the risk factors that could cause our actual results to differ materially from our historical results or those anticipated or predicted by a forward looking statements are discussed in this morning's press releases and our periodic public filings with the SEC.
Today's call will begin with prepared remarks from our president and CEO , Jerry <unk>, Chief Financial Officer, Andrew sake, Chief commercial offer Linda Richardson.
Are pregnant or research and development and Chief Medical Officer, Dr. Michelle theory that.
Then opened the call for questions.
I mean, now turn the call over to our C E O <unk> ourselves.
Thanks Dragon Good morning, everyone. Thank you for joining us on our second quarter of 2023 earnings Conference call.
And the second quarter, all caliber business and PVC again performed well delivering double digit growth for the fourth consecutive quarter $83.7 million in Ocala net sales with 17% growth over the prior year quarter. This outstanding sustained performance as a result of the execution of our commercial team and the <unk>.
Trust and value that Herpetologist gastro neurologist place in Ocala.
More than seven years on the market positive patient and physician experience and strong outcomes data in multiple real world analyses.
<unk> role as a preferred improving second line agent for PVC continues to expand.
The double share more about the dynamics driving our sales growth as well as our positive outlook on the account of a business.
Turning to our pipeline, we continue to Prioritise investment in our <unk> combination program and PVC.
We were pleased to share positive data from the first of our two phase two studies at the Easel Congress this past June .
These data illustrate the combinations best in class potential to deliver biochemical responses across a range of biomarkers that predict improve clinical outcomes PVC.
We look forward to sharing more details from this program and expect to have all the necessary data to submit a request in 2000 twenty-three Fernanda phase two meeting with the FDA.
Finally, we are aggressively implementing the plan that we communicated on June 23rd to restructure our business strengthen our focus on rare and serious liver diseases and deliver profitability quickly.
We have discontinued all Nash related investments and fully expect to meet our targeted reductions in operating expenses.
We are making rapid progress and evolving our organization and reducing our cost basis.
Andrew will discuss our progress in more detail shortly.
The shift we have made puts intercepted the best position to create value for shareholders, while supporting our patient driven mission.
I believe that the actions, which are now well under way will improve our ability to drive long term growth and leadership for a PVC business develop innovative new medicines and achieve meaningful profitability in 2024.
That I will now turn the call over to Andrew.
Thank you Jerry and good morning, everyone.
I will begin with an update on our customer reduction efforts and organizational restructuring that we announced in June .
As previously discussed this work is aimed significantly reducing our cost structure by discontinuing all naturally the investment and reducing the size of our company to support our focus on rare and serious liver diseases.
These actions will allow us to visit the profitability by year end, which will help ensure our longterm growth and provide us with strategic flexibility as we take the company forward.
The closeout process for the regenerate study is well underway and is expected to be substantially complete by the end of this year.
Do you expect to have all clinical sites shut down by your EM with some final activities and spend extending into the first quarter of 2024.
Since our restructuring announcement, we have stopped all other natural related spending throughout the company.
Removal of these costs from our operating expenses as an important contributor to our ability to move toward profitability as quickly as possible.
With regard to reducing our workforce, we have completed the first wave of notifications, which impacted commercial in general administrative functions a.
The second wave of notifications, which will impact the R&D and medical affairs functions will be completed in the next few weeks and the reorganization will <unk> be materially finished by the end of this year.
As previously stated we plan to maintain the scale of our current field sales organization to support the growth of a calva.
With respect to up X. This year in June we lowered guidance for 2023, non-GAAP adjusted operating expenses to $350 million to $370 million.
This guidance includes expenses to wind down the regenerate study and all other Nash related activity as well as estimated one time charges related to our workforce reduction.
As a result of these changes and after the restructuring activities or complete we expect to achieve meaningful profitability in 2024 and to be in a position to grow our PVC franchise with a significantly lower cost structure than our current memory.
Specifically, we are targeting a net reduction in annual none yet adjusted the upper you expenses of approximately $140 million relative to our update of 2023 non-GAAP adjusted operating expense guidance.
Our new cost structure will be effective upon completion of the restructuring includes out of the regenerate study, which is expected to be materially complete by the end of 2023.
Turning to revenue we are raising the lower end of our guidance range and have updated our full year 2000, twenty-three o'callaghan net sales guidance to $320 million to $340 million.
As Jerry mentioned, we are pleased with our strong sales performance this quarter fruit caliber recording $83.7 million in net sales compared to $71.8 million in the prior year quarter.
This represents 17 per cent growth is our fourth consecutive quarter with double digit growth.
Selling general and administrative expenses were $53.3 million in the second quarter of 2023, compared with $40 million in the prior year quarter.
The increase in Q2 was primarily driven by Nash related spending which has now been removed from our expense base.
As a direct result of the actions taken last year to strengthen our balance sheet and reduce our outstanding debt interest expense in the quarter ended June 30th 2023 was $2.8 million down from six $7 million during the same period last year.
We reported a net loss from continuing operations $5.8 million in the second quarter of 2023, a decrease compared to a net loss from continuing operations of $23 million in the second quarter of 2022.
As of June 30th 2000, twenty-three intercept had cash cash equivalents restricted cash and investments securities available for sale of $450 million and the company was net cash positive by possibly $80 million.
As previously disclosed the 2023 convertible notes matured on July 1st and we made a cash repayment for the total principal amount due of $109.8 million.
For a more detailed summary of our financial results I encourage you to look at our press release for the second quarter ended June 30th 2023 <unk>.
In closing I am proud of our performance this quarter and the strong underlying financial foundation of company.
Both of those factors are important enablers of our ability to reshape intercept and achieve meaningful profitability in 2024.
Now turn the call over to Linda.
Good morning, everyone.
Andrew I have noted our commercial performance is Claire was very strong we reported account of a net sales and $83.7 million in the second quarter, representing a 17% increase compared to the same period last year.
Several factors are driving Ah repeated double digit sounds <unk>.
First we continue to attract new first time account of writers specifically five out of 10 prescribers of new patients in the second quarter of 2023 were first time caliber riders.
Second we continued to see volume crowd brand.
Grand prescriptions for nearly 25% during the same time period as reported by a Q B S national prescription ordered and during this quarter. We reached an all time high in monthly you to demand clearly airfield task force is delivered messages that resonate with PVC prescribers.
These important factor show that we continue to expand our account the prescriber community and add new patients to our base business Ah medications, we maintain a strong on time resell rate of approximately 90%. This dynamic is driven by support from our interconnect type program and specialty pharmacy network.
As well as on the ground with our field reimbursement manager team he's.
He's established capabilities will continue to be valuable drivers, even with the potential for new therapeutic options in the future.
I'd like to know share new insights from recent prescribed very patient market research that provide support for our confidence in the future about <unk> M. P. B E.
Patient feedback shows that satisfaction auto calendar remains high with approximately 86 per cent being satisfied to extremely satisfied with their therapy.
We also found that 92% of patients enrolled in interconnect patient support program indicated that they expect it to continue on account of that.
70% were still on account of that at 12 months as important background approximately three inquiry Calvert patients are enrolled in interconnect. These.
These customer insights demonstrate high levels of satisfaction with a call back and we know that patients who are satisfied with their therapy I typically inclined to remain on it. Despite the potential for new options disbelief is supported by persistent C data for patients taking account of persistent <unk> is in line with and in some cases better than.
In multiple analogues for chronic disease therapies. This includes products and diabetes.
<unk>, notably status and stroke prevention at intervals from three months to two years.
Moving forward one of our key promotional platforms will be the highlight recent scientific presentations, which emphasize that the amount of time, a PVC paycheck. It means above target levels for select biomarkers leads to an incremental risk it the panic decompensation and liver transplant for death.
Second half of 2023, we will emphasize the totality of <unk> impact on these additional biomarkers such as a S. K a L. T. G. G T in total bilirubin a.
A side and a corporate presentation, Oh, Canada has a beneficial impact on the same biomarkers all of which contribute to assessing total Deborah help.
L P. As an important factor in PVC management, but just one of several elements of total liver help that should be monitored.
Of course, what matters, most impede V C. R outcomes and another correct market research study approximately 85 per cent of Hcp's survey stated that preventing disease progression and avoiding the longer term complications from liver disease are the most important attributes of a PVC therapy.
Where where all the evidence has shown ocala visibility slow disease progression and help patients avoid longterm complications in fact, there are now five independent real world datasets that show this improved survival.
Utilizing appropriate avenues to create greater awareness of this railroad evidence supporting these Calvin C. B C is it important differentiator versus future competitors and part of our long term strategy to demonstrate the unique benefits of account with that.
The data that I reviewed today illustrates the stability of durability upper based business and the commercial team's ability to drive further adoption of a Taliban.
It will be harder momentum in the first half of 2023 I'm confident in the strength of account is market position and our plans to continue growing or PVC franchise.
Now turn the call over to Doctor, Michelle Berry for regulatory and clinical update including how our long term opportunity in P. D. C is amplified by our okay that the thyroid combination program.
Thank you Linda and good morning, everyone I'll start with an update on our okay intensified right combination program, which we believe offers the potential to establish best in class clinical benefit.
We know that the most important calls and PVC treatment remain improved transplant free and decompensation free survival.
How it comes that have been demonstrated in multiple analyses from real world patients taking account with that.
<unk> data from the phase two combination program, Okay, and Versify right have shown that achieving biochemical remission and more than half a patient of D. V. D is possible with the potential to prevent progression today's clinical outcomes in the future.
We have to phase two studies exploring a range of therapeutic doses at this time.
We have now completed enrollment both studies and a shared data for my planned interim analysis of our first study study two and three and easily in Vienna.
We're very encouraged by these initial data, which showed that the combination of ochre and 400 milligrams of <unk>, whereas effective and normalizing key biochemical markers associated with P. B C N DS liver damage.
No significant is that nearly 60% of patients and the higher dose combination arm achieved biochemical information that is patients in this great. Some normalization is all key biomarkers a M. P. Total bill ever been a L. T E S T and G. G T.
These compelling data demonstrate the potential synergy between ethics are agonous M. P part agonists, which we believe reframe the parameters for efficacy and P. B C.
Analyses from both of our Phase two studies in addition to our large phase one study in preclinical data.
Serve as the basis for an interface to meeting with the F D. A.
We expect to have data in hand to submit a request in 2023 for this important meeting.
We look forward to sharing more information about this program, including the planned interim analysis from our second phase two study 72 and four later this year.
Turning into account events as previously communicated and in alignment with the F. D. A we remain on track for submission of R. S. N D. Eight this year and support a fulfilling cause marketing requirements.
The submission will include data from our post marketing study cobalt, which will likely be the F. D. A primary basis for evaluation as well as supplementary real real evidence for large datasets can the U S and you're at.
After you've described previously we believe that cobalt with a flawed study database ability challenges and did not provide a placebo controlled great that reflects the well no natural history of P. B C.
Our analyses of railroad datasets are completed in accordance with all requirements specified by the F. D A's issue draft guidance.
Importantly, these analyses demonstrate a consistent improvement and transplant free and decompensation free survival the ultimate goals M. P V C treatment.
We believe that the population and guidance and our current label reflects a positive benefit risk for patients with P. P C.
We are committed to working with the F D. A regarding our post marketing commitments and have been engaged with the agency.
Finally within our earlier stage pipeline, we continue to progress our proof of concept fresh study evaluating 787 in patients with severe alcohol associated hepatitis also known as S. H <unk>.
We are encouraged by the efficacy of I N 2787 at demonstrated in preclinical assessments and the safety and Tolerability and are single and multiple a sending days first and human study.
We look forward to hearing additional at days ask this program advances.
In closing I'm proud of the progress being made by our R&D great.
With that I'll turn back to Jerry.
Thank you Michelle for the <unk>.
Fourth consecutive quarter intercept delivered strong double digit sales growth pro caliber. We also made considerable progress with the O C. A <unk> thyroid combination program, including presenting new data that suggests best in class potential in PVC. This exceptional performance along with our restructuring plan to significantly reduce costs.
<unk> well on the way to work quickly achieving profitability, while advancing our leadership in rare and serious liver disease.
I will now turn it over to the operator for questions.
Operator.
Thank you.
He's an gentleman as a reminder to ask the question. Please press star one one on your telephone and then wait to hear your name announced to withdraw your question. Please press star one one again please.
Please stand by while we compiled the Q&A mastiff.
Our first question comes from the line up yeah.
Sandler.
<unk>.
Mm good morning team. Thank you so much for the update.
I just wanted to understand a little bit more about.
What are the possible outcomes and you guys are having your end of phase two meeting with the empty in regards to the fixed dose combo.
Is there an opportunity to me the expedited you know the phase three development.
Maybe walk us through you know sort of the scenarios.
And I know that we don't <unk>, we will get more car without coming months that would love to hear how we should be thinking about what the next communication will be around that discussion and what could be sort of a best case scenario and I'll jump back into the queue for a follow up.
And thank you again.
Yeah. Good morning afternoon, and thanks for the question obviously from our prepared remarks, we're encouraged by what we've seen thus far from the initial data set on fixed dose combination is Michelle outline more to calm Michelle maybe you can give a little more color around how we're looking at the accumulation of the.
Data and the opportunity to get with with the agency on <unk>.
Sure Yep, Thanks, and good morning, yes.
So we do plan to have all of the data pulled in from the P. K and drug drug interaction data from our large face Wednesday, any as well as the plan data room analyses from two and three and two went for US you know we're looking at Biochemistries were looking at Tolerability and some key safety cream.
The nurse, including lipids for for those patients.
The plan for the interface to meeting we do have a proposed phase three design and we hope that we can come to to alignment with with the agency during that interface to meeting we have already been <unk>, making preparations to identify sites. So that as soon as we get.
City design finalize <unk> often running for enrollment in 2024, so you're very excited about the opportunity to.
To explore this combination we have had initial conversations with the agency about expected and points and what based on what we're seeing in your face you what they anticipate that we maybe thinking about for a potential in Kuwait.
Clearly the expectations are high for this combination given what we've seen so far in phase two.
We're all looking forward to today's discussions.
Thank you so much pain I jump back into the queue.
Thank you.
Please stand by for our next question.
Our next question comes from the line of my Yang maintaining with B Rally Security. Your line is open.
<unk>, thanks for taking our questions and congrats on strong <unk> studying the <unk> face to BBC protocols, and we're hoping if you'd come into how you might be measuring breidis.
And points leg and that is B S score and things like that and <unk> and then I have a quick follow up on the finances.
Hey, Michelle I need to take the first one and then I'm sure, we'll we'll take the the to.
Follow up on the financial with Andrew and I.
Yeah, good morning for that and thanks for the question. So yes, we are incorporating a couple of different assessment center, two and three and 214, so that we do have comfortability across.
The amount of therapy trials as well as some other prior trials conducted in the in the combination. So we look forward to sharing those data from both of the studies at 12 weeks from the two and four study to play in the interim analysis is also longer term data from two and three to study that we shared at easel.
Okay <unk>.
And then maybe I missed this how you got it <unk> you know grow with you have in the BBC business between you know contribution no penetration versus persistence to revenue growth and and as you think about his full approval you know how how do you think of the drivers to you.
Go ahead and started related should there be an outcome expected and I will need your full up who was a b B C. S. S. N da submission next year, you guys expecting there to be an AD Garland B B C next year.
So maybe I'll I'll start with that and then I will we can describe a little bit more about the growth. So we could expect and add comment the process. It could be a reasonable option. We haven't had any specific commentary on that directly from the agency, but it wouldn't be.
Unforeseen that there could be an AD com that the agency could ask for but obviously it will get more insight on that once the submission goes in and we have more of that dialogue on the growth this quarter Miaoke. If I understood. Your question one I think overall are.
Encourage that we continue to see the level of growth that we reported out and we you know clearly I expect to continue with our sales guidance and there'd be vision that we made on that underlying that is I believe Linda mentioned and did her prepared remarks.
Demand growled, so good prescription and unit growth underneath it was our our largest quarter in terms of the generation of demand which is.
Illustration of I'll vote, <unk> off by more physicians with more patience than at any given time.
And we're really continuing to focus on you know on both sides on expanding new patients and on ensuring that the ones that are on therapy. We're doing everything we can we can to keep them on and we are encouraged that satisfaction is high and while we do see some drop out as you were.
Expect with chronic medications again, it's in the range with.
We did include in the ended up prepared remarks, some of the analog work that we're doing and really while there's a lot of discussion around what happens to patients Sandy Ocala of a journey, we do see patients stay on at least as well as some of the chronic drugs that are typically considered good adhere.
<unk>, it's like anti diabetic medications, we thought that that comparison was useful for you to think about how we're we're kind of looking at that picture of of adherence over time.
Thanks.
Thanks for taking my question.
Thank you Sir thank you.
Thank you please stand by for our next question.
[noise]. Our next question comes from the lineup at R. C with H C. Wainwright Your line is open.
Great. Thank you good morning, and congrats on the strong quarter a couple of questions for me.
First I just wanted to clarify on the <unk> as a firebreak combination.
Firstly, the <unk> pruritus measurements that you mentioned before a couple of different measurements could you expand on what goes or if it's in a rash or something else just in terms of comparatively with your own prior data and other studies and then secondly on the 50.
8% complete remission.
I'm just wondering how you came to that number is that eight out of 15 or nine out of 50, and then I have a four hour. Thanks.
Shell.
Right Yep. So good morning, we are using the I V. A S and the address <unk>. We are also excluding patients with severe pruritus consistent with other large trials in the P. D C space.
The the 58 I believe with nine out of 15 off to pull that up and double check on that.
Those measures I will mentioned, we have an additional three basement to wear very quickly to normalization <unk> well over half of the patience I think again those are small datasets and we look forward to bringing a larger data set aside from the remaining pieces from two and three as well as.
Appointment bedroom analysis uhm.
<unk> analysis from 214, we should have all those W. M hand in time for our did you request <unk> at the end of the year.
Great. Thank you for that and then.
With the study is 2131214 and I recognize two and three would have longer term data.
These interim analyses later this year.
Is it possible to get any further granularity on the tiny perhaps at a medical meeting such as a S. O b. Thank you so much.
And certainly that would be a great opportunity is where all together later and and this year, that's hard to say definitively where we'll be able to present those data I can say alright. So much already we will be sharing at a minimum the top line data from that study as well as from the.
Longer term data as you point out we now have data from more than 12 months for many of the patients in the 213 studied given that it was initiated.
<unk> 24 months ago for the majority of patients.
Great. Thank you. Thank you.
Thank you.
Please stand by for our next question.
Our next question comes from the line of Brian Abrahams with RBC capital market <unk>.
Oh, Hey, guys. Good morning, Thanks for taking my my questions maybe for Linda curious if you could walk us through how you expect the P. P C market dynamics to play out with potential new entrants I'm wondering if there's gonna be if you're thinking about any changes to your commercial strategy or if your market research is really suggesting that the patients who are kind of naturally.
A drop off of O C. A will really be the ones, who would be trying in a new therapy and then maybe for Michelle what's the most important things that you think you'll need to do to combat any potential F. D. A skepticism around the use of real world data to support Ocala was maintenance on the market and P. B C.
Thanks.
Okay. So we'll start with with Linda on the commercial worked at as you say, Brian the <unk>.
<unk> Yep that's.
Okay. Thanks for the question in the morning.
15% increase in the number of P. B C patients receiving treatment and that's great across the board.
And that will also see what we believe to be an emergency a third line market. This will be evidence because there is no one product that even with the the race and efficacy rates were saying no. One product is necessarily going to be right for everyone. So his folks move through that paradigm there'll be a third line market that began.
<unk>.
We believed strongly from the market research and patient satisfaction scores and asking patients directly we expect that the majority of our existing patient to express my satisfaction and a willingness to stay on therapy will be on therapy and this is you know also supported by the persistent speed data and then.
The additional patient satisfaction wait and you'll be sure before so third we expect to continue driving driving new prescribed prayers and your patience by increasing the awareness of the data that we uniquely had we talk about the efficacy on five different biomarkers E. As I can see that we see emerging as.
Evidence and will continue to talk about those things as an organization.
And lastly, we believe that we have leverageable incumbent T moments and extra cheese that we'll be able to continue to drive our sales force has done a phenomenal job across the board that particularly disorder and then we look at our established Tom specialty networks, that's expanding and our existing.
Relationships with the happened G. I community those are things that we have well established and I think the totality of those four things will help secure our business.
Shell.
<unk> to the real World evidence I think that's the three things that are gonna be helpful. In addition to the draft guidance. That's been issued by the F. D. A which we are are following and and interacting with with the agency on on the specifics the three things that I think will make a big difference or <unk>.
Location of the data advocacy and the evolution of there's the standard of care.
So first to the replication of datasets, which we have seen across multiple analyses now as Linda pointed out initially with a.
Toys, that's been laid like Simpson, which was compared with both the UK P. B C and the global P. P C patient registries.
Only real World Komoto claims database analyses, which we call heroes, which showed a super an opposable benefit 70% benefit and it Ah decreased risk of progression to liver transplant or death, and finally, we we've seen this replicated across.
Completely independent analysis Uhm that was presented in early June before easily by the Italian patient registry group called Recapitulate, which again has been this consistency scientifically being able to replicate the exact same benefit across these multiple.
Databases patient <unk> <unk>.
Health care systems is is even more confirmation.
The the benefit the survival benefit that we know is critical to patience Uhm second does patient advocacy and physician advocacy based on the individual basis as well as the societies, we've heard over and over again from <unk> that they are unwilling to put their patients on placebo.
Four longterm follow up for progression to two outcomes.
And third the standard of care evolution and since 2017 and 2018 account that has been indicated is the only second line therapy, and we know that that that that that is the basis for for second line therapy and now has that additional benefit of showing these <unk>.
Outcomes.
Only compound that has been able to demonstrate that because we have that long term follow up uhm not modeled real data nail across multiple different data set so as the standard of care has evolved we have to be looking realistically about what we are asking patients to do for the longer term studies.
To to get to <unk>.
Thanks, so much for all the details it's really helpful.
Thank you Brian .
Thank you please stand back or our next question.
Our next question comes from the lineup J Olson with Oppenheimer. Your line is open.
Oh, Hey, congrats on the quarter and thank you for taking the questions.
Based on the early African C data you seem further okay pushed beds or combination would you consider running a pivotal trial and first line treatment of P. B C N maybe from a more for.
<unk> perspective, do you think it's possible to replace your D C. A and the first one I'm sorry.
[noise]. So maybe you start there yeah. It says.
Is a great question and certainly one that we have.
Not just for the sake stairs combination that really with the uhm continued emergence of survival data clearly it is important to look at getting patients quickly on therapy that we know in protest outcomes. The decisions on first or second line really will be driven by by data.
So we will have to hold off until we get the full datasets, we get a plan dinner of analyses, which of course, we're all I'm really encouraged by and look forward to today's discussions with the agency.
Alright, I think or what is.
At this point there Wednesday uhm the survival data that we have seen is in the the setting up at combinations moving patients quickly too.
<unk>, whether that's in addition to our ceremony impatient Super intolerant I think it has been a key message and then I think that'll carry forward for the six days combination with even more urgency I'm getting <unk>. So they can read the full benefit as early in their diseases part.
No.
Thank you.
<unk>.
Thank you.
Please stand by for our next question.
Our next question comes from a line of Michael <unk> with Jeffrey Your line is open.
Mmm.
Hi, good morning, Thanks for taking our questions. This is Diana from Mike with regard to the potential new products coming to P. P. C. How should we think about the profile of your account <unk> and specifically <unk>, it's a combo potentially sure <unk> <unk>. Thank you.
Jump.
<unk>, yes, Sir we are watching watching the space I I do think that will have those data again coming out in the fall. It is something that we are looking into and are certainly encouraged by that early data that we have seen and I I just need to discuss that there are multiple ways to itchy.
Uhm approvals and fixed days combination improvements on advocacy, which we've certainly seen initial implications for with improvements across the Biochemistries uhm, but also improvements in Tolerability and safety. So we are looking at <unk>, we saw very encouraged.
<unk> right for the initial two or three sandwich, we reported out in June are continuing to collect those data in a way that will allow us to do those those comparisons as much as it is appropriate I think the the short term answer is patience you're seeing on therapy.
We're very encouraged by those data.
So we'll look forward to sharing where in the fall.
[noise]. Thank you.
Please sign back for our next question.
[noise] Congratulant progress and thanks for taking my questions just hoping you could characterize what you consider meaningful profitability in 2024.
Yeah, John Thanks for the question as we indicated all things are progressing we had reference the hundred and 40 million dollar savings target in the last call in and as we framed we're well on track.
In terms of of the savings plan, Andrew maybe you can sketched out a little bit how we're thinking as we progress through this period of execution.
Execution of the savings plan towards next year will be out of work a steady state once once things are finished.
Yeah sure. Thanks for your and thanks for the question John So yeah as we looked at the next year, John and obviously, we have them give them guidance, yet we don't intend to give guidance until the end of the year and our normal course, but having said that with four quarters of consecutive growth. We anticipate a cow was a growing into next year.
We have current guidance range is 320 to 340, obviously, we're not giving guidance on next year, but we can expect it to continue to grow with regarding with regard to expenses, we indicated $140 million savings offer current estimate of 350 to 370 next year that should give you some pretty good visit.
<unk> and to what we expect our son to be next year that number includes things like a phase three study and fix dose right. So we we feel like we're headed for a very good year, we want to generate meaningful EBITDA next year, and we think it's achievable give me where we are.
[noise] taupe color affect us.
Thanks, John Thank you.
Please stand by for our next question.
Our next question comes from a line of Thomas Smith with the right partners. Your line is open.
Hey, guys. The morning, Thanks for taking our questions just walnut caliber pricing. It looks like you took a 5.9 per cent list price increase your on August 1st which is second price increase I think this year I don't I don't think there's been a year since hotel the launch where you've taken to price increases in Saint calendar here. So can you just talk.
About what prompted that how we should think about your pregnant strategy going forward.
Yeah Thomas Thanks for the question, obviously, we we don't comment in detail on our on our pricing strategy. Obviously, we're looking on an ongoing basis at the value that Oh caliber offers and prices accordingly.
You did the capture the the the action that we took in probably not more comment from me on that at this point.
Okay, and I guess, if I could sneak in one on <unk>.
You must be a visa combo. It it just it seems like a uric study took I took about two and a half years to enroll 72 patients can you just comment on some of the things that may have been packet enrollment there and then talk about how you were thinking about driving enrollment into a potential phase III program in a world that obviously has commercially available a calva, but then.
Also a potentially multiple competitor products.
Yep <unk> happy to address that one Ah, yes, we did have a slowdown in the European enrollment on two and three in the pandemic specifically that saw that that pick up over the last year and then what I will say it.
After the presentation of the plans <unk> and we've had had a dramatic pick I've completed enrollment in our second phase two and have already had felt signing up for the phase three and we've had lots of discussions as you might imagine about how to optimize enrollment.
Looking at site performance looking at at various countries for their enrollment how we can maximize our efficiency recognizing that this is a rare disease and that we need to go where the where the patients are and I think we've seen across therapeutic areas, though.
One thing that is very consistent and driving phase three enrollment as excitement about a real shift and probably best characterized by Fred Nevins closet.
He's always excited when you get in a therapeutic area, where you can finally crossed at 50 per cent, Mark and really start to see more than half of patients who are realizing six substantial benefits and a shift in their disease progression.
And I think that has really driven a lot of the interest and we're excited about getting the program up and running.
Got it that makes sense. Thank you. Thank you.
Okay.
Thank you please stand by for our next question.
Our next question comes from the lineup Elaina Merrill with you B S. Your line is open.
Mmm.
Thanks, So much for taking my question just in terms of some of the commercial transfer seeing uhm, what's the average three <unk>, okay, and I see that you and your <unk> and your sides have 72 persistence C. Right at six months just curious if you can provide any color over a longer period of time and then.
Just a second question can you comment on what proportion of patients that are still experiencing provide us even just as part of the underlying PVC disease and any info on that severity. Thanks.
So I'll I'll just start with persistence see if that's okay. I think that you know what we see.
Across the board with our persistence is greater than 50, you know we have 50 per cent of patients on the drug at two years, which is very comparable is that you know superior to the average up a lot of classes looking at M. S stroke prevention type two diabetes and status. So we do.
Have that dynamic going on for us and we're we're quite close to what you would say is just a normal kind of patience dynamic across many chronic conditions. We we are impacted by that is S. I think that our country compared to some of the other factors that you see in X U S.
Country. So there's there's just that dynamic in general now when you talk about <unk>.
Remember that provide this is about 70 per cent of patients who have P. B C. Also report for writers. So we see that dynamic is part of the condition. When we have the vast majority of providers that was seen in trials with <unk> is mild to moderate.
Right and it can be managed and when you see it in the real world, it's half of that so about 29%.
And then you'll get to the management techniques that you can implement at anytime if someone's having a <unk> a period of for writers you can cut down on the dosing you can go off for two weeks there are various management strategies articulated in the label itself have knowing how many it it depends on how far out there so.
The people, who have really intolerable providers for any reason I would imagine art on the product. So I can't really speak to how many people who are continually just be on the drug <unk>.
Have that issue I would imagine if it was something that was rate limiting they they wouldn't stay on for two years.
Got it thanks, so much for that card.
You're welcome.
Please stand by for our next question.
[noise]. Our next question comes from Atlanta Branch Corny <unk> New line is open.
[noise] Hey, guys. Good morning. This is Charlie on for Brian We had a question about the potential pickles study for the best Library combination specifically when you're looking at the comparator arms would you have.
Arms of Okay naive patients each starting okay, and then one arm also getting specified right and then one getting placebo or would you do patients already on Oprah with not adequate responses as your patient population is just kinda how are you thinking about those enrollment criteria. Thanks.
Thanks, Charlie Michelle.
Hi, Good morning, Yeah, we do anticipate that and order a checkbook fell all the requirements for ethics days combination that you have sufficient data I'm showing the contributions of each independent agent and now whether or not that has to come from your phase three or from the phase Tuesday.
<unk> work from other sources that something will be discussing with the agency.
Are going in assumption is that at least one arm is mono therapy, probably the best <unk> therapy Uhm, but we may have two arms as monotherapy as as we go in there's the placebo study again, that's a big topic in in P. B C where.
Patience, you know, whether that's <unk> or a placebo <unk> again with the changing standard of care over the last seven years difficult to ask patients to stay on placebo certainly for for more than the 12 months.
Uhm double-blind portion so stay tuned on that but yes, I would expect at least one mono therapy arm.
Great. Thank you.
Thank you Charlie.
Thank you please stay on <unk>.
[laughter].
Our next question comes from Milan, as Steve Seedhouse with Raymond James Your line is open.
Good morning. This is Ryan definitely P C S.
Get your current thoughts on how you're seeing the potential impact of mechanisms that specifically target providers and the T V and the P C space.
Such as I bet inhibitors, and then also wanted to ask you if you've had any updated guidance on what sort of timeline, we can expect to see.
Data from the outcomes poor shape for January 6th.
So maybe I'll take the first one and then.
Linda can can take the second one the iPad square and if it gets a little early yet, but obviously, we're we're we're working on that in the background. So as we said in our announcement to discontinue.
The the work with regenerate will capture the available data data and communicate appropriately at the right time on that so again the focus of the work of the team is on all of the important closeout activities as we said.
You know, we do anticipate that the site will be closed and the material costs will and this year there might be a little bit of some final thing cause that flow into the beginning part of next year, but part of the clothes out is to appropriately captured the data of course, you know we're we're.
Working with the sites to make sure that the all as clear as the closeout N. As we capture that data we would communicate back appropriately based on a good practices.
Sure I think the I that story is an interesting one in that if you're addressing the symptoms ma'am no not an expert on <unk> by any means are there all the details of their programs that they may have in the future.
But I do think that with the incidents of providers as part of the disease State P. B C.
Having something that can help patients moderate or address that it is an important quality of life element and if that were to come to bear in the marketplace I'm not aware that at this point they've shown disease modifying opportunities. So it would be something to address the disease.
But you may still need something to really look at lowering a L. P. A S. T. A L. T bilirubin other markers so while it could pave the way to improve that kind of symptom of P. B C. I imagine right now there's still a need for therapy.
To look at lack of stopping the progression of the disease itself.
So at at this point I think you know that could be potentially beneficial to <unk> that became part of a you know an ongoing strategy to address that part of patients experienced a P. B C.
Got it thank you very much.
Thank you.
Please stand by for our next question.
Our next question comes from the <unk> with Colin Your line is Hilton.
Good morning, guys. Thanks for taking the question. So shall I just wanted to round back on something you mentioned in the prior questions about what will serve as the control arm for the phase III combination at least as you will propose it Gillingham you mentioned there was the amount of therapy on I think he left over.
The possibility that there could be at least a shorter term placebo arm, which one at this point do you think.
Would serve as the control for.
Testicle.
Statistical analysis of the primary endpoint and I guess.
If it was placebo would that have to change with full approval.
With phone just to make sure I understand.
My Tech full approval without <unk> Alright C. Okay.
It has accelerated yeah right right right. So yeah. So you do bring up a good point that while you're still under accelerated approval and it cannot serve as the only compare it or if you have to continue to compare back to your policy should we get to alcohol approval with fulfillment of our pets.
Marketing requirement and that does shift your standard of care and one of the interesting question J a M. P. B C. Though is utility of external controls and we have continued to build out these patient registry and and claims databases, but really that the most.
Full patient registries, where we have now established.
The natural history of the disease, we have limited data and should be able to pull some of those data uhm. We've seen some great presentations on how to incorporate external controls uhm, either as a basis for powering the study or even within the study. So I think this is an evolving space and.
When that hopefully can decrease the proportion of patience you would have to go on to your policy better for that for that day, three again, hopefully that could just be for the short double blind portion and not require patient see beyond placebo three two liver transplant or.
Four decompensation or gotcha.
That's a shifting expectation in the field and when that were <unk>.
We're happy to be supporting.
Being created on those designs.
Got it in a very quick follow up Linda you mentioned something about having <unk>.
Data.
The real world to support <unk>.
Can you can you elaborate a little bit on what sort of silly reuben benefit or or data you'll have in hand for commercialization I'm sorry for for continued competitive commercialization.
Well, we have data from both 12 weeks and 52 weeks, where you can look at that and and knowing Billy Ruben is a very important element of progression of disease. So if you start to see that move that's not good for a patient and even in her open label extension, we showed that Billy.
We were able to not only maintain fibrosis, but also bilirubin without progression. So these are things are very important to physicians Michelle anything else that.
You can pick up on on Billy Yeah, I think it's it's part of this overall appreciation.
That the story is not just about a L. P that it is important to look at the other elements. The other biochemistries and in particular in patients who are in.
Progressed, more who were perhaps not started on account of the early enough who are already starting to see some burn out and they're a L. P. N elevation and their total bilirubin uhm. It says it's really part of a bigger story uhm looking at the contributions.
Biochemistry L. P doesn't tell the whole story uhm no doubt looking at G. G G and Billy Ruben are also really critical elements. We now have those data across 567 years and from that point I had been label extension that these large patient registries somebody <unk>.
Forward to sharing it additional data on that front and how that correlates with the improved outcomes that we've we've demonstrated that into your account with us.
Great. Thanks.
Thank you.
Please sandbox for our next question.
[noise] final question comes from a line of Salving richer with Goldman Sachs. Your line is open.
Hi, Thanks. This is metal for solving on the hundred and 40 million expense guidance could you give any more details on the breakdown between us to name a R. D. And then could you just remind us how far the ochre postpose a combo would extend IP. Thank you.
Yeah, So maybe I'll take the first one and I P as in Andrew can.
So lovely D O C five right.
That's always been a two fold opportunity for US one is the therapeutic opportunity and it's great to see that the data that we're starting to read out the appointment to the real potential for last year second was yes on lifecycle management. So.
<unk>, a new chemical entity.
In the in the U S market is it's never been filed or or approved here. We have the first pass this issue through 2036 on the combination which covers a broad range of.
Of doses N P V C. We do what we would anticipate the bolt additional I P and the probability for past perfect stitches yellow. So let me think about that as a real long term.
Her middle opportunity for US Andrew maybe you take the last question on the auto.
Okay, Yeah sure so with regard to the office reductions for next year.
I would think about is hurting Nash or do you spend has always been about a third of our expense properly set out of $60 million in <unk>.
The R&D wines here.
The the rest of it would be a combination of reductions throughout the rest of your day one.
Got it thank you.
Thank you.
Thank you.
Ladies and gentlemen, I'm I'm showing no further questions in the queue that concludes today's conference call. Thank you for your participation you may now disconnect.
Mmm.
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