Q4 2020 Travere Therapeutics Inc Earnings Call

Good afternoon, ladies and gentlemen, and welcome to drove ear therapeutics fourth quarter and full year 2020 financial results on corporate update at this time all participants are in a listen only mode. Later, we will conduct a question and answer session and instructions will follow at that time is on the one change.

Operator: Good afternoon, ladies and gentlemen, and welcome to Travere Therapeutics' fourth quarter and full year 2020 financial results and corporate update. At this time, all participants are in a listen-only mode.

Operator: Later, we will conduct a question-and-answer session, and instructions will follow at that time. If anyone should require assistance during the conference, please press star zero on your touchtone telephone. As a reminder, this conference call is being monitored. I would now like to turn the conference over to your host, Mr. Chris Cline. Thank you.

Corner assistance during the conference. Please press Star Zero on your Touchtone telephone as a reminder, this conference call is being recorded I would now like to turn the conference over to your host Mr. Chris Cline. Thank you. Please go ahead Sir.

Christopher Cline: Thank you, Katrina. Good afternoon, and welcome to Travere Therapeutics' fourth quarter and full year 2020 Financial Results and Corporate Update call. Thank you for joining us. I hope you all remain well. Today's call will be led by our Chief Executive Officer, Dr. Eric Dube. Eric will be joined for prepared remarks by our Chief Medical Officer, Dr. Noah Rosenberg, Peter Heerma, our Chief Commercial Officer, and our Chief Financial Officer, Laura Klage.

Thank you Katrina good afternoon, and welcome to severe therapeutics fourth quarter and full year 2020 financial results and corporate update call.

Thank you for joining us I hope you all remain well today's call will be led by our Chief Executive Officer, Dr. Eric Dube day, Eric will be joined from the prepared remarks by our Chief Medical Officer, Dr. Rosenberg, Peter Hermann <unk>, our Chief commercial officer, and our Chief Financial Officer, Laura Lake.

Christopher Cline: Dr. Bill Rote, Senior Vice President of Research and Development, will join us for the Q&A session. Before we begin, I would like to remind everyone that statements made during this call regarding matters that are not historical facts are forward-looking statements within the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not guarantees of performance. They involve known and unknown risks, certainties, and assumptions that may cause actual results, performance, and achievements to differ materially from those expressed or implied by the statement.

Dr. Bill Rote senior Vice President of research and development will join us for the Q&A session.

Before we begin I would like to remind everyone that statements made during this call regarding matters that are not historical facts are forward looking statements within the safe Harbor provisions of the private Securities Litigation Reform Act of 19 on spot forward looking.

Payments are not guarantees of performance they involve known and unknown risks uncertainties and assumptions that may cause actual results performance and achievements to differ materially from those expressed or implied by the statements.

Christopher Cline: Please see the forward-looking statement disclaimer in the company's press release issued earlier today, as well as the risk factor section in Reform's 10-Q and 10-K file with the SEC. In addition, any forward-looking statements represent our views only as of the date such statements are made, March 1, 2021, and Travere specifically disclaims any obligation to update such statements to reflect future information, events, or circumstances. With that said, let me now turn the call over to Eric.

Please see the forward looking statement disclaimer on the company's press release issued earlier today as well as the risk factors section on our forms 10-Q, and 10-K filed with the SEC.

In addition, any forward looking statements represent our views only as of the date such statements are made March one 2021, and <unk>, specifically disclaims any obligation to update such statements to reflect future information events or circumstances.

Let me now turn the call over to Eric Eric.

Eric Dube: Thank you, Chris, and good afternoon, everyone. We were very pleased with the beginning of the year on a high note, with the duplex study recently achieving its interim proteinuria endpoint, and we look forward to discussing a bit more about that with you shortly. First, I would like to reflect on the excellent execution that we had in 2020. This is a direct result of our team members' hard work and dedication to our mission of identifying, developing, and delivering life-changing therapies to people living with rare diseases.

Thank you, Chris and good afternoon, everyone.

We were very pleased with the beginning of the year on a high note with the duplex study recently, achieving its interim proteinuria endpoint and we look forward to discussing a bit more about that with you shortly.

First I would like to reflect on the excellent execution that we had in 2020.

This is a direct result of our team members' hard work and dedication to our mission of identifying developing and delivering life changing therapies to people living with rare disease.

Eric Dube: Our key objectives last year were focused on three areas aimed at strengthening our position as a leader in the rare disease community. The first was advancing our two Pivotal Phase III programs for Sparcentin in FSGS and IJ nephropathy. In doing so, our goal was to continue to position Sparsantan to potentially become a new treatment standard for these two rare kidney disorders if approved. Despite the ongoing pandemic, our clinical and operational teams did a phenomenal job of ensuring patient safety and continued high quality in both the duplex study in FSGS and the PROTECT study in IJ nephropathy.

Our key objectives last year, we're focused on three areas aimed at strengthening our position as a leader in the rare disease community.

But first with advancing our two pivotal phase three programs for sports Center and S SGS and Iga nephropathy.

In doing so our goal was to continue to position Us force sensor to potentially become a new treatment standard for these two rare kidney disorders if approved.

Despite the ongoing pandemic, our clinical and operational teams have done a phenomenal job of ensuring patient safety and continued high quality in both the duplex study in F. S Geos and the protect study in Iga nephropathy.

Eric Dube: Furthermore, their efforts led to both studies achieving the key enrollment milestones necessary to enable top-line readouts from the interim pro miria endpoints, including PROTECT, which is now well ahead of its original schedule. Both of these interim readouts are designed to support potential accelerated approval and conditional marketing authorization submissions in the U.S. and Europe beginning this year. The second key objective was building upon our established commercialization capabilities to identify new patients that may benefit from our approved products as well as to begin preparing our organization for a successful launch of Sparcentin if it is approved.

Furthermore, there are efforts led to both studies, achieving the key enrollment milestones necessary to enable top line readouts from the interim from your year end points, including protect which is now well ahead of its original schedule.

Both of these interim Readouts are designed to support potential accelerated approval and conditional marketing authorization submissions in the U S and Europe beginning this year.

The second key objective was building upon our established commercialization capabilities to identify new patients that may benefit from our approved products as well as to begin preparing our organization for successful launch of sparse sensor if approved I am pleased to report that we maintain supply and access.

Eric Dube: I am pleased to report that we maintained supply and access for our patients throughout the pandemic last year. We also continue to identify new patients for all of our approved products. In preparation for a potential launch of Sparsensin, we furthered our understanding of the patient journey for both FSGS and IJ nephropathy, which includes a deeper understanding of patients' needs. Where Patients May Be Identified, The Therapeutic Profile Physicians Desire for Their Patients, and the future role that earlier diagnosis can play

For our patients throughout the pandemic last year.

We also continued to identify new patients for all of our approved products.

In preparation for a potential launches force sensing, we furthered our understanding of the patient journey in both <unk> and Iga nephropathy.

This includes a deeper understanding of patients need where.

Where patients may be identified the therapeutic profile physicians desire for their patients and the future role that earlier diagnosis can play.

Eric Dube: Together with our established commercialization capabilities, we believe that these deeper insights provide us with a clear pathway to be successful in delivering Sparsantan if approved. Our third key objective was to further diversify our pipeline through our disciplined business development efforts. In the fourth quarter of last year, we added TVT-058 to our pipeline, a novel investigational human enzyme replacement therapy that is currently in phase 1-2 development for the treatment of classical homocystinuria, or HCU.

Together with our established commercialization capabilities, we believe that these deeper insights provide us with a clear pathway to be successful in delivering sparse sensitive if approved.

Our third key objective was to further diversify our pipeline through our disciplined business development efforts in the fourth quarter of last year, we added to our pipeline TVT 058, a novel investigational human enzyme replacement therapy that is currently in phase one to development for the treatment of classical home.

On the system urea or HCM.

Eric Dube: Current treatment options for HDU are limited and ineffective for many. Preclinical data suggest that TBT-058 has the potential to be the first disease-modifying therapy for HCU. We believe this program is an ideal fit for our mission and expertise. It allows us to leverage our late-stage development and commercialization capabilities to potentially deliver a new treatment option for people living with HCU, and it provides the potential for meaningful growth on top of sparseness.

Current treatment options for HD, you are limited and ineffective for money.

Preclinical data suggest that TVT 058 has the potential to be the first disease modifying therapy in H C U E.

We believe this program is an ideal fit for our mission and expertise.

It allows us to leverage our late stage development and commercialization capabilities to <unk>.

Potentially deliver a new treatment option for people living with H C U.

And it provides the potential for meaningful growth on top of Sports Center.

Eric Dube: I am incredibly pleased with our organization's performance in 2020, which is even more notable given the challenges that we have all faced in adjusting to the COVID-19 pandemic. This execution led us to meeting or exceeding our objectives for last year, and importantly, it set us on a path for a potentially transformative year in 2021. This potential is driven by multiple exciting catalysts anticipated from our pipeline.

I'm incredibly pleased with our organization's performance in 2020, which is even more notable given the challenges that we have all faced in adjusting to the COVID-19 pandemic.

This execution led us to meeting or exceeding our objectives for last year and importantly, it set us on a path for a potentially transformative year in 2021. This.

This potential is driven by multiple exciting catalysts anticipated from our pipeline this year.

Eric Dube: As I mentioned earlier, our duplex study in FSGS achieved its pre-specified interim FSGS partial remission of proteinuria endpoint, or FPRE, after 36 weeks of treatment. Based on the data from the interim analysis, we intend to pursue submissions for accelerated approval of Sparsantan for FSGS in both the U.S. and Europe. With the interim readout behind us, our focus turns to preparing for our upcoming regulatory interactions and further building towards our goal of delivering Sparsantan as a new treatment standard in FSGS, if approved.

As I mentioned earlier, our duplex study <unk> achieved its pre specified interim F. S. T. A partial remission of proteinuria endpoint or F. PRA after 36 weeks of treatment.

Based on the data from the interim analysis, we intend to pursue submission for accelerated approval of sports Center for F. S. Yes on both the U S and Europe.

With the interim readout behind us our focus turns to preparing for our upcoming regulatory interactions and further building towards our goal of delivering sports center as a new treatment standard in F. S. GFS if approved.

Eric Dube: We look forward to engaging with regulators in the coming months and continuing our preparations for NDA and MAA submissions later this year. The interim assessments from Duplex and FSGS have also increased our confidence in the potential for sparsantin to have a meaningful treatment effect on proteinuria in IJ nephropathy.

We look forward to engaging with regulators in the coming months and continuing our preparations for NDA and MAA submissions later this year the interim assessments from duplex in F. S. Chia has also increased our confidence in the potential per sparse that tend to have a meaningful treatment effect on proteinuria.

In Iga nephropathy.

Eric Dube: The ongoing Pivotal PROTECT study in IgA nephropathy remains on track to report top-line results from the Interim Proteinery Assessment in the third quarter of this year. If successful, this could be the next significant step towards potentially reaching our goal of delivering sparsensin as a new treatment standard in both FSGS and IJ nephropathy. While we certainly have a number of important updates planned for Sparsentine this year, we do also expect preliminary data from our ongoing Phase I-II proof of concept study of TBT058 in HCU to become available later this year.

The ongoing pivotal protect study in Iga nephropathy remains on track to report top line results from the interim proteinuria assessment in the third quarter of this year.

If successful this milestone could be the next significant step towards potentially reaching our goal of delivering sports center and the new treatment standard in both <unk> and Iga nephropathy.

While we certainly have a number of important updates planned for spar center on this year. We do also expect preliminary data from our ongoing phase one two proof of concept study of TVT O five eight in HCA you to become available later this year we.

Eric Dube: We are excited to have this program now fully in-house and to advance our understanding of the candidate and its potential in HCU. Our goal throughout the year will be to identify the most expeditious path forward to help address the significant unmet need for patients in this community. I will now turn the call over to Noah for an update on our clinical programs.

We are excited to have this program now fully in house and to advance our understanding of the candidate and its potential in HCM.

Our goal throughout the year will be to identify the most expeditious path forward to help address the significant unmet need for patients in this community.

On the call over to Noel for an update on our clinical programs Noah.

Noah Rosenberg: Thank you, Eric, and good afternoon. I continue to be very pleased with the advancement of our pipeline programs and the execution of our clinical and operations teams. As Eric mentioned earlier, we are excited about the recently reported results from the pre-specified interim assessment in the ongoing phase three duplex study of sparsantan and FSGS. Since the top line announcement, we've engaged academic and community leaders in nephrology and patient advocacy. Many of these leaders have been responsible for directing and participating in clinical research for decades with the hope of driving advancements in FSGS. The feedback we have heard since announcing the top line data has been overwhelmingly consistent.

Thank you Eric and good afternoon, I continue to be very pleased with the advancement of our pipeline program and the execution of our clinical and operations teams.

Eric mentioned earlier, we are excited about the recently reported results from the Prespecified interim assessment in the ongoing phase III duplex study of sports Force yes.

Since the top line announcement, we've engaged academic and community leaders <unk> and patient advocacy. Many of these leaders have been responsible for directing and participating clinical research for decades with the hope of driving advancements in FCS. The feedback we have heard since announcing the top line data has been.

Volume was consistent for years, there has been a lack of innovation in treatment for rare kidney disorders, and while there is still much to be contributed to the understanding about this yes. There is a tremendous excitement for the potential that sports center offers.

Noah Rosenberg: For years, there has been a lack of innovation in treatment for rare kidney disorders, and while there is still much to be contributed to the understanding of FHDS, there is tremendous excitement for the potential that Sparsantan offers. Today, we will not be providing additional details from the interim analysis as our need to continue to preserve trial integrity for the ongoing duplex study remains. I would, however, like to highlight some key aspects of the program that have helped formulate our view over time.

We will not be providing additional details from the interim analysis as on.

Our need to continue to preserve trial integrity for the ongoing duplex study remains I would however, like to highlight some key aspects of the program that have helped formulate our view overtime.

Noah Rosenberg: First, sustained progeria reduction has long been recognized as a primary treatment goal amongst nephrologists treating FSDS, and it is not easily achieved. When designing the duet study and subsequently the duplex study, we worked closely with the Neptune Consortium to derive the clinically meaningful FSGS partial remission of proteinuria endpoint, or FPRE. This is defined as urine-protein-to-carotene ratio, UPC, less than or equal to 1.5 grams per gram and a greater than 40% reduction in UPC from baseline.

First sustained proteinuria reduction has long been recognized as the primary treatment goal amongst the prologis is treating Fcs.

And it is not easily achieved.

When designing the duet study and subsequent to the duplex study we worked closely with the Neptune consortium to derive the clinically meaningful FX, yes, partial remission of proteinuria endpoint or F. P. R E.

<unk> is defined as urine protein creatinine ratio UPC lesser equal to one five gram per brand and a greater than 40% reduction in UPC from baseline.

Noah Rosenberg: This foundational work demonstrated that in pooled analyses of four FHDS cohorts from independent trials, patients achieving FPRE or complete remission had meaningfully better kidney survival. Importantly, this provided for the establishment of a clinical measurement that would provide a strong link between primary reduction and preservation of EGFR for kidney survival and potentially support regulatory submissions for accelerated approval. It also allowed us to create sufficient modeling with SportsNet 10, to design our Phase 3 duplex study with confidence in the link between FPRE at 36 weeks and EGFR following 108 weeks of treatment.

This foundational work demonstrated that in pool analyses of four cohorts from independent trials patients achieving CRE or complete remission has meaningfully better kidney survival. Importantly, this provided for the establishment of a critical measurement that will provide a strong.

On link between partner reduction and preservation of Egfr or kidney survival and potentially support regulatory submissions.

Accelerated approval.

It also allowed us to create sufficient modeling was unfortunate debt.

<unk>.

To design, our phase III duplex study with confidence in the way between CRE at 36 weeks and Egfr following a 108 weeks of treatment with <unk>.

Noah Rosenberg: We now have encouraging interim data from duplex, the largest interventional study ever on in FSGS. It showed that treatment with sparsantan demonstrated a statistically significant response on this clinically meaningful FPRE measurement compared to the acid-controlled herbicartin, which is considered one of the standards of care but not approved for FSGS.

Now have encouraging interim data from duplex the largest interventional study ever on NFS, yes.

It showed that treatment with <unk> has demonstrated a statistically significant response on this clinically meaningful PRA measurement compared to the active control Irbesartan, which is considered one of the standards of care, but not approved for FCS Oh, no the interim analysis.

Noah Rosenberg: Of note, the interim analysis reported that treatment with sparsantan resulted in a 60 percent greater relative likelihood of achieving FPRE compared to herbicartin. These results are consistent with the data generated from our Phase 2 DUET study in FHDS. In DUET, SportsSensei demonstrated an increasing response in FPRE and a durable and sustained protein reduction out to 84 weeks of treatment in the open-label extension. This reduction in proteinuria was associated with a stabilization of EGFR over an extended period in duet.

Alex's reported that treatment with sports day again resulted in a 60% greater relative likelihood of achieving a PRA compared to irbesartan. These.

These results are consistent with the data generated from our phase two duet study net per share into.

Indoor Sports center, demonstrating increasing response, FERC and the durable and sustained poor air reduction out to 84 weeks of treatment and the open label extension.

This reduction in proteinuria.

Associated with the stabilization of Egfr over an extended period into what we.

Noah Rosenberg: We also have a strong understanding of Sparsantan's safety and tolerability profile to date. We are fortunate to be able to draw from a comprehensive safety database of both ongoing and completed studies that extend beyond 600 subjects in multiple indications throughout the program's clinical history. In the Duet open label extension, we have followed patients for a median of more than four years, with some going out beyond six years. This has provided critical insight into the drug's mechanism and how it performs over an extended period.

We also have a strong understanding of <unk> safety and Tolerability profile to date, we are fortunate to be able to draw from a comprehensive safety database of both ongoing and completed studies that extend beyond <unk>.

600 subjects in multiple indications throughout the program's clinical history in the duet open label extension, we have followed patients for immediate on more than four years with some going out beyond six years. This has provided critical insight into the drugs mechanism and how it performs.

Over an extended period.

Noah Rosenberg: And most recently, the interim assessment for duplex indicated that Sporcenten has been generally well tolerated, and the overall safety profiles in the study to date have been generally comparable between treatment groups. This is very encouraging interim data from this ongoing phase three study. Finally, Spercentine acts as a high-affinity, dual-acting antagonist of both the endothelin type A and angiotensin II type I receptors.

Most recently the interim assessment from duplex indicated for center has been has been generally well tolerated and the overall safety profile. In this study to date have been generally comparable between treatment groups. This is very encouraging interim data from this ongoing phase III study.

So <unk> acts as a high affinity dual acting antagonist of both the Endothelin type a and angiotensin two type one receptors.

Noah Rosenberg: Both the ERA and the ARV components of Sports Antenna are well characterized and act on independent pathways that are well understood by the nephrology community. There has been a consistent and growing body of evidence, including the recent inner analysis from Duplex, that supports the importance of targeting not just one but both of these pathways together to optimize treatment for patients. There is a clear need for new treatment options in FHDS, and we believe the Interim Protonary Assessment supports the potential for sports antigen to become a new treatment.

Both the El Rey in the RV components of sports fans here are well characterized and act on independent pathways that are well understood by the nephrology community. There has been a consistent and growing body of evidence.

The recent interim analysis from duplex that supports the importance of targeting not just one but both of these athletes together to optimize treatment for patients.

As a clear need for new treatment options and <unk> and we believe the interim proteinuria assessment supports the potential per person.

To become a new.

Noah Rosenberg: Treatment Standard, and FHDS if approved. We look forward to engaging in the coming months with both U.S. and European regulators on our plans for accelerated approval and conditional marketing authorization submissions. In parallel, we are continuing to prepare these applications with the goal of entering submissions for FSGS in the second half of 2021. As Eric mentioned, the interim proteinuria data also provide us with further confidence in our approach to developing Scorcentam for the treatment of IgA nephropathy. As we've outlined previously, we believe FSGS and IgA nephropathy share a common pathway where proteinuria plays a key role in both diseases.

Treatment standard and <unk> if approved.

We look forward to engaging in the coming months with both U S and European regulators on our plans for accelerated approval and conditional marketing authorization submissions.

In parallel we are continuing to prepare these applications with the goal of edgren submissions for <unk> in the second half of 2021.

Eric mentioned the interim preliminary data also provide us with further confidence in our approach developing sports center for the treatment of Iga nephropathy as we've outlined previously we believe <unk> and Iga nephropathy share a common pathway, where proteinuria plays a key role both diseases and this is important due to the <unk>.

Noah Rosenberg: And this is important due to the fact that ERA blockade on top of running angiotensin inhibition has been demonstrated to lower proteinuria in multiple renal populations. We believe these facts, combined with the anti-inflammatory properties of Sparcentin that have been seen in our preclinical work in hygiene and prophecy, will play an active role in the disease and provide a strong rationale for Sparcentin to be successful. We continue to see strong enthusiasm from the nephrology and patient communities for a new non-immune suppressant-based treatment option to slow the progression of the disease.

Fact that DRA blockade on top of running angiotensin inhibition has been demonstrated to lower proteinuria in multiple populations. We believe these facts combined with the anti inflammatory properties of Sportsnet team that have been seen in our preclinical work Iga nephropathy will play an active.

Role in the disease and provide a strong rationale for sports on tends to be successful.

We continue to see strong enthusiasm from the nephrology and patient communities.

A new non immune suppressant based treatment option to slow progression of disease.

Noah Rosenberg: As a result, our pivotal Phase 3 PROTECT study in IgA nephropathy continues to advance, and the study continues to enroll towards completion. Importantly, we remain on track to report top-line data from the interim primary assessment in the third quarter of this year. Finally, the TBT-058 program continues to advance in the Phase I-II dose escalation study. Our goals for this program will be to gain a better understanding of optimal dosing, to understand its potential to meaningfully reduce homocysteine levels, and to identify the best regulatory path forward that would allow us to address the significant unmet need for patients in this community as quickly as possible.

As a result, our pivotal phase III protect study in Iga nephropathy continues to advance and the study continues to enroll towards completion importantly, we remain on track to report top line data from the interim proteins Proteinuria assessment in the third quarter of this year.

Finally, the TVT <unk> program continues to advance in the phase <unk> dose escalation study our goals for the TVT Op IV program.

To gain a better understanding of optimal dosing to understand its potential to meaningfully reduce homeless cystine levels and to identify the best regulatory path forward that would allow us to address a significant unmet need.

For patients in this community as quickly as possible.

Peter Heerma: Similar to our other clinical trials over the last year, we are continuing to monitor the potential impact of COVID-19 on the TBT058 study, which could result in an adjustment in the timing of any data becoming available. Based upon what we know today, we continue to anticipate preliminary data later this year. Overall, I am incredibly pleased with the progress we have made with our clinical programs and with how our execution has positioned our studies to potentially generate meaningful hope for patients that desperately need new treatment options. I'll now turn the call over to Peter for the commercial update. Peter?

Similar to our other clinical trials over the last year, we are continuing to monitor the potential impact of COVID-19 on the TV <unk> study, which could result in adjusted to the timing of any data becoming available.

Based upon what we know today, we continue to anticipate preliminary data later this year.

Overall.

I'm incredibly pleased with the progress we have made with our clinical programs and our execution has positioned our studies to potentially generate meaningful hope for patients desperately need new treatment options.

Now turn the call over to Peter for the commercial update Peter.

Peter Heerma: Thank you, everyone. Our commercial organization had one of its strongest performances yet in 2020. The members of our sales team are driven by their passion to make a difference for the patients we serve, and as a result of their hard work, we have quadrupled the number of patients treated with our approved products over the last six years. Despite the ongoing challenges of COVID-19, we have maintained our patient-inspired focus and ensured an uninterrupted supply of our approved therapies and steady support and access for patients.

Thank you Noah.

Our commercial organization has one of its strongest performances in 2020 day.

The members of our sales team on driven by debt passion to make a difference for the patients we serve.

And as a result of the hard work, we have quadrupled the number of patients treated with our approved products over the last six years.

Despite ongoing challenges of COVID-19, we have maintained our patient inspired focus and ensured the uninterrupted supply of our approved therapies and steady support and access to patients and.

Peter Heerma: And we continue to effectively identify new patients through virtual engagement with ATP. Our organic growth in 2020 was consistently driven by new patients initiating therapy across all approved products, as well as a moderate increase in patient compliance. This translated to a 13% increase in net product sales over 2019, exceeding our guidance of mid-single-digit growth set at the beginning of 2020. The Math for Easy Formulation of Style Lab Remains Steady

And we continue to effectively identifying new patients through virtual engagement was hep's.

On what we're getting growth in 2020 was consistently driven by new patients initiating therapy across all approved pumps as well as a modest increase in patient compliance.

This translated to a 13% increase in net product sales on the 2019 exceeding our guidance of mid single digit growth in the beginning of 2020.

You may ask what EC formulation will fail remains steady.

Peter Heerma: The Bile Asset Portfolio remains strong, and Colbam continues to see demand driven by the cumulative efforts of our Colbam team to educate pediatric geneticists on the importance of treating the hepatic involvement of cell worker spectrum disorder, as well as our commitment to provide genetic screening to colostatic patients. Looking ahead, we will continue to monitor for any COVID-19-related impact on potential shifts in patient insurance coverage, as well as patients' ability to see their physician, as has been typical for us in the years past. We anticipate uneven growth in net product sales throughout the year, including anticipated higher gross to net discounts in the first quarter driven by insurance coverage changes in the beginning of the new year.

The vinyl assets portfolio remains strong and Goldbaum continues to see demand driven by cumulative efforts on our global team to educate pediatric geneticists.

Important of treating the hepatic emboldened sell Vegas spectrum disorders, as well as our commitment to provide genetic screening to call a steady patients.

Looking ahead, we will continue to monitor for any COVID-19 related impacts on potential shifts and patient insurance governance, as well as patients' ability to see deficit issues.

Has this been difficult for us in the years past, we anticipate even gross and the net product sales throughout the years.

Including anticipated higher gross to net discounts from the first quarter driven by insurers cover changes in the beginning of the new year.

Peter Heerma: Importantly, we believe there will be continued demand for our approved therapies and that we can achieve mid-single-digit growth for the full year of 2021. We continue to see our continued success with both Biola and Colbam as strategic strengths to leverage for future commercialization of our development programs, if approved. To this end, we were pleased to recently enter into a co-promotion agreement with Alvaredo for the Fexibad product in the U.S. if approved.

Importantly, we believe there will be continued demands for our approved therapies that we can achieve mid single digit growth for the full year of 2021.

We continue to fuel our continued success with both Biola and Goldbaum as strategic strengths to leverage for future commercialization of our development programs.

Bruce.

To this end we were pleased to recently entered into a co promotion agreement with <unk>.

On the fixed debt.

In the U S. If approved.

Laura Kathryn Chico: This agreement will allow our COBAM team, comprised of 12 sales representatives, to leverage their demonstrated capabilities and leadership position to deliver an innovative new treatment option for patients living with PFAC. They will also simultaneously strengthen existing relationships with pediatric hepatologists and gain current launch experience to apply to future launches from our pipeline. Throughout 2021, we plan to focus our efforts on preparing the organization to leverage our success, the deep experience of our teams, and our established infrastructure to effectively launch and deliver SPAR Center next year, if approved. We look forward to sharing more with you about our progress in the coming quarter. I'd like to turn the call over to Laura now for the financial update. Laura? Thank you, Peter. During the fourth quarter,

This agreement will allow our goal bumping comprised of 12 sales representatives to leverage demonstrated capabilities and leadership position to deliver an innovative new treatment option for patients living with Stephen.

It will also simultaneously strengthen existing relationships with pediatric herpetologist ending current loans experience to apply to future launches from our pipeline.

So on 2021, we plan to focus our efforts on preparing the organization to leverage our success to deep experience from our teams and how established infrastructure to effectively loans and deliberate sponsor from next year if approved.

We look forward to sharing more with you about our progress progress in the coming quarters.

I'd like to turn the call over to Laura now the financial update.

Laura.

Thank you Peter.

During the fourth quarter.

Laura Kathryn Chico: Net product sales from our commercial portfolio grew to $51 million, a 9% increase over the same period in 2019. For the full year 2020, We reported 198.3 million in net revenue; we reported a gap net loss of $121.6 million for the fourth quarter of 2020. This includes approximately $97 million of IPR&D expense directly related to the acquisition of QDC-058 in the orphan technology transaction completed in the fourth quarter of last year. For the full year 2020, the gap's net loss was $169.4 million.

Net product sales from our commercial portfolio grew to 61 million a 9% increase over the same period in 2019.

For the full year 2020.

We reported $198 3 million in net reported sales.

We reported a GAAP net loss of $121 6 million for the fourth quarter of 2020.

This includes approximately 97 million of IP R&D expense directly relate directly related to the acquisition of <unk>.

Likely orphan technologies transaction completed in the fourth quarter of last year.

For the full year 2020, GAAP net loss was $169 4 million.

Laura Kathryn Chico: The increase over 2019 is largely attributable to higher expenses to support our ongoing clinical and product development efforts, as well as the TVT 058 transact. After adjusting for non-cash expenses and income tax, we reported a non-gap net loss of $112.9 million for the fourth quarter and $137 million for the full year 2020, on a gap day. R&D expenses were $38.4 million for the fourth quarter and $131.8 million for the full year.

The increase over 2019 is largely attributable to higher expenses to support our ongoing clinical and product development efforts.

As well as the TVT or eight transaction.

After adjusting for non cash expenses and income tax we reported a non-GAAP net loss of $112 9 million for the fourth quarter and $137 million for the full year 2020.

On a GAAP basis, R&D expenses were $38 4 million for the fourth quarter and $131 8 million for the full year 2020.

Laura Kathryn Chico: The decrease compared to 2019 is largely attributable to the discontinuation of the Phosphate Pantotenate Development Program in the fourth quarter of 2019. On an adjusted basis, R&D expenses were $35.7 million for the fourth quarter and $121.2 million for the full year 2020. Relevant non-cash expenses for the fourth quarter included $2.7 million of stock-based compensation and amortized on a gap day. Selling general and administrative expenses for the fourth quarter were $35.7 million and $135.8 million for the full year 2020.

The decrease compared to 2019 is largely attributable to the discontinuation of the plasma panto generic development program in the fourth quarter of 2019.

On an adjusted basis R&D expenses were $35 7 million for the fourth quarter and $121 2 million for the full year 2020.

Relevant non cash expense for the fourth quarter included $2 7 million of stock based compensation and amortization.

On a GAAP basis.

Selling general and administrative expenses for the fourth quarter were $35 7 million and $135 8 million for the full year 2020.

Laura Kathryn Chico: The increase over the same period in 2019, is largely attributable to increased compensation expense to support the growth of our organization and higher professional fees. On an adjusted basis, SG&A expenses for the fourth quarter were $25.5 million, and $98.2 million for the full year 2020. Significant non-cash adjustments for the quarter consisted of $10.29 in stock-based compensation and depreciation and amortization.

The increase over the same period in 2019 is largely attributable to increased compensation expense to support the growth of our organization and higher professional fees.

On an adjusted basis SG&A expenses for the fourth quarter were $25 5 million and $98 2 million for the full year 2020.

Significant non cash adjustments for the quarter consisted of $10 2 million in stock based compensation and depreciation and amortization.

Laura Kathryn Chico: As we look ahead to 2021, we anticipate that operating expenses will increase quarter over quarter and year over year, as our two pivotal studies of sparsentin continue to advance to the EGFR confirmatory endpoints in 2023, and as we continue to develop CBT 058. We will also be investing this year to further prepare for two potential launches of Sparcentin in 2022, if approved. Our financial foundation to support this activity remains strong until the end of the year. 361.6 million in cash and cash equivalents.

As we look ahead to 2021, we anticipate that operating expenses will increase quarter over quarter and year over year.

Our two pivotal studies.

We continue to advance.

On the Egfr confirmatory endpoint from 2023.

And as we continue to develop TVT outside day.

We will also be investing this year to further prepare for two potential launches.

In 2022 if approved.

Our financial Foundation to support this activity remains strong.

We ended the year.

On a $61 6 million in cash and cash equivalents.

Laura Kathryn Chico: In February, we completed a common stock offering that resulted in net proceeds of approximately $189 million, which is not yet reflected in the balance sheet as of the end of the year. Notwithstanding additional business development, this total cash balance is expected to support our operations beyond the next two years. This includes the ongoing Phase III studies in FSGS and IgE Nephropathy, as well as plans for the anticipated launch of Parcenten in FSGS next year and the TVT 058 Development Program. I will now hand the call back over to Eric for his closing comments. Excellent. Thank you, Laura. And happy birthday, Laura. What a way to spend your day today with us.

In February we completed a common stock offering.

Also on the net proceeds of approximately 189 million.

It is not yet reflected in the balance sheet as they put on there.

For the year.

Notwithstanding additional business development. This total cash balance is expected to support our operations beyond the next two years.

This includes the ongoing phase III studies in <unk>.

And Iga nephropathy as well as plans for the anticipated launches per sentence and FSD is next year and the TVT.

Elegant program.

I will now hand, the call back over to Eric for his closing comments great.

Excellent. Thank you, Laura and happy birthday Laura.

A way to spend your day today with us.

Eric Dube: 2020 was a year of excellent execution for Travere. I would like to thank each and every one of our team members and partners for their contributions and for their continued dedication to our common goal of elevating science and service for patients living with rare diseases. Their efforts have shown how when we come together with a clear focus on our objectives, we can be incredibly successful in achieving our goals for patients, even in the face of a global pandemic. We are carrying the same dedication and purpose into 2021.

<unk> thousand 20 was a year of excellent execution ports severe.

I would like to thank each and every one of our team members and partners for their contributions and for their continued dedication to our common goal of elevating science and service for patients living with rare disease.

Their efforts have shown how when we come together with a clear focus on our objectives that we can be incredibly successful in achieving our goals for patients even in the face of a global pandemic.

We are carrying the same dedication and purpose into 2021.

Eric Dube: In this new year, we will focus on continuing our positive momentum in the Spar Centen programs through upcoming regulatory interactions and continued high-quality study conduct. We will also focus on further strengthening our commercialization capabilities so that we can effectively meet the diverse needs of patients living with FSGS and IJ nephropathy if Spar Centen is approved. And we will continue to focus on advancing programs such as TBT-058 to build our sustainable growth as a leader in the rare disease community. With that, I will turn the call back over to Chris for Q&A. Chris?

In this new year, we will focus on continuing our positive momentum in the spar Simpson programs through upcoming regulatory interactions and continued high quality study conduct we will also focus on further strengthening our commercialization capabilities. So that we can effectively meet the diverse needs of patients living with <unk> and.

Iga nephropathy, if <unk> is approved and we will continue to focus on advancing programs such as TVT O five eight to build our sustainable growth as a leader in the rare disease community.

With that let me turn the call back over to Chris for Q&A Kris.

Alright. Thank you Eric Katrina can we please go ahead and open up the lines for Q&A.

Christopher Cline: Great. Thank you, Eric. Katrina, can we please go ahead and open up the lines for Q&A? Ladies and gentlemen, if you have a question at this time, please press the star and then the number one key on your touchtone telephone. If your question has been answered or you wish to remove yourself from the queue, please press the pound key.

Ladies and gentlemen, if you have a question at this time. Please press the star and then the number one key on your Touchtone telephone. If your question has been answered or you wish or moved or yourself from the queue. Please press the pound key.

To your first question comes from the line on for Greg Harrison from Bank of America. Your line is open.

Greg Harrison: Your first question comes from the line of Greg Harrison of Bank of America. Your line is open. Hey guys, congrats on the progress. And thanks for taking our question. You know, as you approach the potential launch of SparseSense and how are you thinking about leveraging your existing commercial infrastructure and then what investments beyond your current infrastructure would you need to make to launch the product and then also to educate physicians about the availability of a new treatment for FSGS and potentially IGA nephropathy also? Hi, Greg, thank you very much for the question.

Hey, guys. Congrats on the progress on thanks for taking on a question.

As you approach the potential launch of <unk> and.

How are you thinking about leveraging your existing commercial infrastructure.

And then what investments.

On your current infrastructure would you need to make to lots of product and then also to educate.

Physicians about the availability of a new treatment for <unk> potentially.

Hygiene nephropathy also.

Hi, Greg. Thank you very much for the question and before I turn it over to Peter for his thoughts on on our preparation for the launch I think one of the unique aspects of <unk> is the infrastructure that we already have with our commercial portfolio, including <unk>.

Eric Dube: And before I turn it over to Peter for his thoughts on our preparation for the launch, I think one of the unique aspects of Travere is the infrastructure that we already have with our commercial portfolio, including for physicians that serve the cystineuria community and treat with phylo-EC. So many of them are nephrologists, and we have a strong set of relationships already with many nephrologists in the U.S. Peter, do you want to talk a little bit more about how we would look to expand and what that investment profile would look like for the launch? Yeah, absolutely, Eric, and thank you, Greg, for your question. Yeah, to Eric's point, so we have a full force of two teams.

Or physicians that serve the cystinuria community and our.

Treat with <unk> you see so many of them are nephrologist and we have a strong.

Net of relationships already with many nephrologists in the US Peter do you want to talk a little bit more about how we would look to expand and what that investment profile would look like for the launch.

Yes, absolutely.

Thanks for your question.

So we have a few force two teams we have a mutual of Euro <unk> and then we have the more ultra rare.

Peter Heerma: We have a neurology team, and then we have the more ultra-rare, Rare Hepatology. So currently, we are calling on about 2,000 nephrologists already, so I think we have a good footprint in nephrology there. We will certainly be expanding that in preparation for the Sparks Center launch. I think we have a solid footprint that we can build on. With regard to how we think about the market and education, I think that was the second part of your question. We are planning to see state education.

Total GP.

So currently we are calling on about 2000 neutral on this already so I think we have a good footprint any flow through there.

We will certainly be extending debt in preparation for this force simple.

We haven't sold.

But that we can that we can build upon.

With regards to how we think about the margin education I think that was the second part of your question.

We are lending disease state education and on old No no way if you want to give some color on that with regards to medical affairs speechless.

Peter Heerma: And I don't know, Noah, if you want to give some calls on that with regard to medical affairs. Yeah, thank you, Peter and Greg. So the way we approach medical education, especially important this year, in the pre-launch year, is just to make sure that there's a clear understanding with physicians about the link between proteinuria and EGFR and overall outcomes. I think that's an area that we've pointed out. There's quite a bit of literature on that, and that's clearly being borne out in our data set.

Yes, Thank you Peter.

And Greg So the way we approach medical education, especially important this year in the prelaunch here just to make sure that there's a clear understanding with physicians and in the link between proteinuria and Egfr and overall outcomes I think that's an area that we pointed to on there is quite a bit of literature.

On that and that's clearly being borne out in our dataset.

Peter Heerma: So that'll be really one important area. The other area I think that we're focused on is real-world evidence and generating and building that data set and ensuring that, you know, we've got the right global and regional data sets to help ensure that the right data is out there and people's questions are addressed with regard, again, to the link between proteinuria and outcomes and overall understanding of FSGS and progression and how devastating this disease really is. Thanks, that's very helpful.

So that'll be really one important area. The other area I think that we're focused on is real world evidence and generating in building that dataset and ensuring that we've got the right both.

Global and regional datasets to help ensure that the right data is out there and people.

<unk> are addressed with regard again to the linker proteinuria and outcomes and overall understanding of the efficacy and progression and how devastating this disease.

Disease really is.

Thanks, that's very helpful.

Sure.

Noah Rosenberg: Your next question is from... Carter Gould from Barclays. Your line is open. Good afternoon, guys, and congratulations on all the progress. I guess the first one, just as we think about those conversations with FDA, can you maybe just give us a rough idea on how you intend to communicate the outcomes of those meetings, if you'll wait for minutes, and if we should expect that, I guess, to be communicated by a press release.

Your next question from <unk>.

Carter Gould from Barclays. Your line is open.

Great. Good afternoon, guys and congrats on all the progress I guess the first one just as we think about those conversations with FDA can you maybe just give us a rough idea on how you intend to communicate the outcomes of those meetings. If you wait for minutes and if we should expect that I guess.

It would be fully communicated via press release and then.

Noah Rosenberg: And then on the Spartan study, we haven't really talked much about that in the past, how you see that, I guess, what you intend to learn from that, and if we should expect any other sort of additional LCM plans to pop up over the course of the year. Thank you.

On the Spartan study, we haven't really talked too much about that in the past kind of how you see that I guess, what do you intend to learn from that.

And if we should expect any other sort of additional LCM plans.

To pop up over the course of the year. Thank you.

Carter Lewis Gould: Sure, thank you Carter for the questions. Let me take the first one with regard to the FDA engagement or communication plans. We do have obviously very important meetings with regulators coming up, and our focus would be to communicate after we receive the minutes to ensure you know full alignment and clarity from the FDA and so you know what you can expect in the first half of this year, and and you know further updates as they progress towards our submission that is planned in the second half of this year. Noah, would you like to talk a little bit about the Spartan study, the status, and really why that That's a great question.

Sure. Thank you Carter for the question, let me take the first one with regard to the FDA engagement. Our communication plan. We do have obviously very important meeting with regulators coming up and our focus would be to communicate after we receive minutes to ensure full alignment and clarity from.

The from the FDA and so you can expect that in the first half of this year and.

Further updates as they as they progress towards our <unk>.

Submission that is planned in the second half of this year.

No what would you like to talk a little bit about the <unk> study the status and really why that studies being conducted.

That's a great question. So when you look at pretax.

Noah Rosenberg: So when you look at PROTECT in an IgANE population, we've got a study, you know, a large study that's going to give us really answer an important question about protein reduction in that population and understand again that link to EGFR that we've talked about. I think what SPARTAN does, layers on top of there, it's also an IgANE population, and it's a partnership with Lester and Dr. John Barrett, who, as you know, is a luminary in this field. And what the SPARTAN study does is it helps us understand why. Why are these changes happening?

And you know again population.

We've got a study large study that's going to give us really answer an important question about proteinuria reduction in that population and understand again that leads to egfr that we've talked about I think what sport does layers on there.

Also on IGN populations of partnership with Westar.

John Barrett, who as you know its luminary in this field and what the Spartan study does it helps us understand the why why are these changes happening what are the mechanistic changes that are occurring at a cellular level that are leading to these improvements in proteinuria and stabilization of Egfr. So in Spartan. It's a small study, but it is very densely packed.

Noah Rosenberg: What are the mechanistic changes that are occurring at a cellular level that are leading to these improvements in proteinuria and stabilization of EGFR? So in SPARTAN, it's a small study, but it's very densely packed with imaging, multiple biopsies, and it's really a rare opportunity to look at serial biopsy patients and see what the physiologic changes are on an anatomic level? You know, we've talked about the effects of sparsentin on inflammation; we've seen that in animal models, we've seen improvements in apoptosis, and mesangial hypertrophy.

Imaging multiple biopsies, it's really.

A rare opportunity to look at serial biopsy patients see what the physiologic changes are on an anatomic level, we've talked about on the effects of <unk>.

On inflammation.

We've seen that in animal models, we've seen improvements made proptosis Ms. Angela hypertrophy. These are the kinds of things that we'd like to be able to show and see in those.

Noah Rosenberg: These are the kinds of things that we'd like to be able to show and see in those, in SPARTAN, in those serial measures, and again, also MRI, real MRI, very robust measures of anatomy, physiology, and how the function of the drug is working. So I think it'll be important to all those involved, and it's a really great partnership. We're very proud of it and thrilled to be, you know, part of it. Your next question is from Joseph Schwartz from SV Billerink. Your line is open.

Important in the cereal measures and again also MRI real MRI at very.

Robust measure of.

Anatomy physiology.

And how the how the function of the drug is working so I think it'll be important gold those blankson and it's a really great partnership we're very proud of and thrilled to be part of it.

Thank you.

Your next question is from Joseph Schwartz from SBB Leerink. Your line is open.

Hi, Thanks, very much I was wondering given your.

Success, so far in the primary <unk>, what your latest thoughts were on.

Joseph Patrick Schwartz: Hi, thanks very much. I was wondering, given your success so far in the primary FSGS, what your latest thoughts were on whether you would have a sense of when the right time to study secondary FSGS, if at all. Thank you. Joe, thanks for the question. I would say, first and foremost, our priority is to complete the programs that we have so far, and we certainly recognize the broader utility or the potential broader utility of our center. Maybe Noah can share a little bit about his thoughts and maybe some of the feedback from the pathology community. Yeah, it's an excellent question.

Whether you would.

Have a sense of when the right time to study secondary S. SGS SGS if at all.

Thank you.

Joe Thanks for the question.

I would say first and foremost our priority is to complete.

On the programs that we have so far and we certainly recognize the broader utility of the potential broader utilities percentage, maybe Noah can share a little bit about his thoughts.

And maybe some of the feedback from the nephrology community.

Yes, it's an excellent question and it really speaks to the common pathway right across these disease states on that.

Eric Dube: It really speaks to the common pathway, right, across these disease states that we've talked about. You know, if you look across multiple disease states, you'll see that ERAs have shown, on top of razz inhibition, to improve proteinuria, you know, stable, and even improve outcomes in some diseases. So I think it really speaks to that.

<unk> talked about if you look across multiple disease states youll see that <unk> has.

As shown on top of.

<unk> inhibition to improve.

An area stable if already been improved outcomes in some diseases. So I think it really speaks to that I think thats.

Noah Rosenberg: I think that's secondary. FSGS is an area that we've looked at. We've been asked about it quite a bit. We will have, you know, pretty robust access programs, and we're going to look at that, obviously, very carefully. To Eric's point, our primary focus is to ensure that, you know, duplex is completed, and it's done at high quality, and we get that study, you know, finished. But I think we've already looked at some other mechanisms.

Secondary efficacy.

It is an area that we've looked at we've been asked about it quite a bit.

We will have.

Pretty robust.

Access programs and we're going to look at that obviously very carefully to Eric's point, our primary focus is to ensure that.

Duplex is completed in its.

Done with high quality and if we get that study.

Finished but I think we've looked at some other mechanisms some of the other opportunities are things like investigator sponsored trial.

Noah Rosenberg: Some of the other opportunities are things like investigator-sponsored trials, you know, different ways that we can look at this. But clearly, there's a demand; there's an interest. I think with secondary FSGS, it's important to treat the underlying risk factors. But what's very interesting is that many patients with FSGS have hypertension, so there's quite a bit of overlap there as well. And there's no reason we wouldn't believe that this drug wouldn't offer potential benefit. It's just a matter of Eric's point, the timing, and what we want to generate from that data set.

Different ways that we can look at this but clearly there is a demand there is an interest I think the secondary upper shifts its important to treat the underlying risk factor, but what's very interesting is secondary many patients with average does have hypertension. So there is quite a bit of overlap there as well and there's no reason we wouldn't believe that this drug will offer potential benefit. It's just a matter of to Eric's point the tie.

And what we want to generate that dataset.

Right, Yeah that makes sense, thanks, and then.

Another one on scores on 10 I was intrigued by some comments recently that it's.

Joseph Patrick Schwartz: Right, yeah, that makes sense. Thanks. And then another one on spars and pans.

Highly protein bound and so patients with Iga nephropathy may not need as higher doses those with <unk>.

Joseph Patrick Schwartz: I was intrigued by some comments recently that it's highly protein bound, and so patients with IgA nephropathy may not need as high a dose as those with FSGS. I was just wondering if you could expand on that hypothesis a little bit and tell us what you know or believe will be the case with that phenomenon in terms of anything that's known as far as PKPD or, or any other inferences you can make on that in that regard. Certainly, Joe. Why don't, Bill, you take that question eternally with you? FSGS and IGA nephropathy; one of the key differences between the two is just the frank level of proliferase.

I was just wondering is there.

You could expand on that hypothesis, a little bit and tell us what what.

No.

We believe we will be the case with.

With that.

Phenomenon in terms of.

Anything thats known as far as like PK PD.

Or any other in for instance, you can make from there.

In that regard.

Certainly Joe why don't Bill you take that question.

Certainly with <unk>.

<unk> and Iga nephropathy, one of the key differences between the two is just the Frank level three assets.

William E. Rote: With the wasting of premium and greater in the S.G. patient, we can observe in some patients an albuminuria; they're actually losing enough protein that the albumin level goes down in, with, and that was one of the rationales, one of the driving rationales behind using the 800 milligram dose of the FSG to provide additional drug to offset any that was lost being bound to protein that's, and, positive in urine. From a PKP standpoint, there is a lot of exposure response. Unknown Speaker With Sparsant at 200, 400, and 800 milligrams in volume.

With the what are you seeing a period and greater in the patients.

We can observe in some patients in albuminuria.

Actually losing enough protein that the albumin level goes down.

Yeah.

With and that was that was one of the rationales one of the driving rationale behind using the 800 milligram dose SSG to provide additional drug to offset any debt was launched.

Being balance approach.

It's positive in Europe.

From a PK day, PK PD standpoint.

Lot of exposure response.

On data.

<unk> at 200, 400 800 milligrams.

William E. Rote: 100 and 800 are, you know, large numbers that are different numerically. When we look at the exposure and the PK values, there's a high degree of overlap. So the difference between the two is not large, and they are significantly overlapped. It's just that 800 provides an additional buffer for those patients who might be in an albuminoric state. Right, yeah, okay, that helps connect some dots. Thank you for taking my questions. Sure, thank you, Joe. Your next question comes from Tim Lugo at William Blair. Your line is open.

Paul.

100 800 are.

Laurie.

Our different numerically when we look at the exposure and the PK values. There's a high degree of overlap. So the difference between the two is not large day.

Our significantly overlap.

Just the 800 provides.

An additional buffer those patients might be in an albumin <unk> state.

Right Yeah, Okay that helps connect some dots. Thank.

Thank you for taking my questions.

Sure. Thank you Joe.

The next question comes from Tim Lugo from William Blair. Your line is open.

Timothy Francis Lugo: Hi guys, this is John on behalf of Tim. Thanks for taking my question. I wanted to say congratulations on the recent collaboration with Alvareo. We know Ron and the rest of the team over there really well and think that they're going to be a really great partners.

Hi, guys. This is John on for Tim. Thanks for taking my question I wanted to say congrats on the recent congrats on collaboration with Alberta Al We know Ron on the rest of the team over there really well I think that theyre going to be a really great partner.

John Boyle: I just wanted to get some of your thoughts on your expectations for Otavixabat and, as a follow-up housekeeping question, how we should think about incorporating the deal into our models. Thank you.

Just wanted to get some of your thoughts on your expectations relative to that and as a follow up housekeeping question. How we should think about incorporating the deal into our models. Thanks.

Sure.

Thank you John for that we're really pleased to have the collaboration and Embraer.

Eric Dube: We're really pleased to have the collaboration, and in rare diseases, collaboration is such a critical part of reaching these patients who are so often underserved. I'll ask Peter to talk a little bit about our thoughts, and we'll obviously need to be very careful and limit our thoughts on the broader opportunity, and I think we should really rely on Ron and his team to provide that. But I think we can talk about strategically where we see this opportunity sitting for us. Peter?

In rare disease collaboration is such a critical part of reaching these patients who are so often underserved.

Ask Peter to talk a little bit about our thoughts and.

We'll obviously need to be very careful and limit.

Our thoughts on the broader opportunity and I think really rely on Ron and his team to provide that but I think we could talk about strategically where we see this opportunity sitting for us Peter.

Peter Heerma: Yeah, thanks, Eric. And it's indeed a great, great question. And we're very pleased with the collaboration opportunity with Alberio. And I think to Eric's point. I mean, we see mainly its strategic value for us. I think this collaboration demonstrates and sort of strengthens our leadership position in the rare hepatology field. But thinking about our pipeline and the products that we are planning to launch in the next few years, I think it's a great opportunity as well for us to further sharpen our experience of launching new products in the field, new molecular entities, which will be helpful for us for SparkSense next year, if approved, but also for our CTX indications for kinadol and later on PBT05A.

Yes, Thank you Eric.

Great Great question, and we are very pleased with the collaboration will proceed with you with mobility.

Can you explain maybe see mainly the strategic value for us I think this collaboration.

Demonstrates and so it strengthens our leadership position in delay on herpetology fields.

Thinking about our pipeline in a product line two loans in the next few years I think it's great on consumers as well for us too soon as sharpen our experience.

It's launching new products in the field new molecular entity.

Which is helpful for us those functions on next year.

Bruce but also from our CTX indication for Keane.

<unk> and later on PBT whole funds. So I think it's an important capability in particular, when you think about COVID-19 and the post COVID-19 environment.

Peter Heerma: So I think it's an important capability, in particular when you think about COVID and the post-COVID environment that we are playing in. And so I think this collaboration also allows us continued access to our core stakeholders in the hepatology community. That's very helpful.

And so I think this collaboration also allows us continued access to our core stakeholders.

Typical what you can do.

That's very helpful. Thank you.

Peter Heerma: Thank you. Your next question is from Michelle Gilson, Kanakor, Genevieve. Your line is open. Hi, thanks for taking my question. I'm just wondering if you've had any preliminary payer discussions and if you could maybe comment on how strong your value proposition might be for Spurs-Centan and FSGS with just proteinuria data. Or would you expect, I guess, that immature EGFR data that we've talked about previously to be in a future label? I guess that's two questions.

Your next question is from Michelle Gilson from Canaccord Genuity your line.

He is open.

Hi, Thanks for taking my question.

Just wondering if you've had any preliminary per discussion and if you can maybe comment on how strong your value proposition might be first person kennan assets geos.

With just proteinuria data.

Or would you expect I guess, Scott immature Egfr data day.

How can that previously to be.

Future label.

I guess, that's two questions.

Michelle Gilson: And then do you anticipate the value proposition would change between the interim protein area results and a potential, I guess, accelerated approval to, you know, having full confirmatory EGFR data? Michelle, thanks so much for the questions, which are certainly very important as part of the work that Peter and Noah and their teams are doing to prepare for commercialization. I think the answer is clearly yes; there have been ongoing discussions with payers both in the U.S. and Europe to make sure that we understand, with this emerging rare renal field, how do we ensure that we have a strong value proposition for access and reimbursement for what we see as the addressable population.

And then do you anticipate the value proposition would change between the interim proteinuria results.

And a potential I guess accelerated approval too.

Total confirmatory Egfr data.

Michelle Thanks, so much for the questions and certainly very important as part of the work that Peter and Noah and their teams are doing to prepare for commercialization I think the answer is clearly yes. There has been ongoing discussions with payers both in the U S and Europe to make sure that we understand.

With its emerging rare renal field, how do we ensure that we have a strong value proposition for for access and reimbursement for.

What we see as the addressable population Peter why don't you talk a little bit about how we see value proposition and the role that proteinuria would play in that assessment.

Michelle Gilson: Peter, why don't you talk a little bit about how we see the value proposition and the role that Proneri would play in that assessment. Yeah, absolutely. And thanks for your question, Michel. A very good question and very important to make sure that the value of SparkSenta and how that translates in the longer term are well characterized.

Yes, absolutely.

Thank you for your question Michelle.

Very good question and very important to make sure that the value of supply.

And how that translates into longer term as well.

Excellent.

Eric Dube: I think value comes from several components. I mean, at the R&D day in December, we spoke about the innovative mode of action of sparse syndrome, the ability to delay progression towards end-stage kidney disease. But we also talked about quality of life and how we integrate quality of life into our modeling. And then you have the safety component, like the steroid-sparing proposition potential.

I think the only comes from.

Several components at the R&D day in December we spoke about the innovative modal external source income you ability to delay towards interest kidney disease, who also talks about quality of life and how do we integrate quality of life in all our modeling and then you have from safety component perspective, Mike.

Still on stirring proposition potentially.

Peter Heerma: So just referring to our R&D day, I don't know if you remember, Dr. Barrett was showing some of his analysis of patient-level data where he showed that a 30% reduction in proteinuria actually translated into a 10.4 year delay towards end-stage kidney disease. So we are doing the same work right now for MPSDS. So we will have the translated value based on historical data but then also translating it to basic level data directly in precision alpha.

So just referring to.

D day.

On the most of you remember Dr. Derek plus we're showing some assist analysis on patient level data, where he showed 30 percentage reduction in proteinuria actually translated into a 10 four year delayed towards interest kidney disease. So we are doing the same work right now for Mds. So.

We will have to translate it.

Based on historical data, but then also translating to patient level data.

<unk>.

Peter Heerma: So that's how we are approaching the value proposition we have, to Eric's point, continuing dialogue with players. And, yeah. That's how we plan for the praise use. Okay, thank you guys for taking my question. Thank you, Michelle. Your next question comes from the line of Maurice Raycroft of Jeffries. Your line is open.

So thats, how we are approaching the value proposition we have.

Exports continuing dialogue with Sears.

Yeah.

That's how we plan for the price discussion.

Okay. Thank you guys for taking my question.

Thank you Michelle.

Your next question comes from the line of Maury Raycroft from Jefferies. Your line is open.

Maurice Thomas Raycroft: Hi everyone, congrats on the progress and thanks for taking my questions. First one, I just wanted to check in on an update that happened post-close with Fibrogen. They got a request from FDA for an ADCOM, which I think was unexpected based on what Fibrogen has said in the past.

Hi, everyone. Congrats on the progress and thanks for taking my questions.

First one I just wanted to check in on an update that happened post close with the fiber Jin.

They got a request from FDA for an AD com I think it was unexpected based on lot of Fibrogenesis said in the past. So just wondering what your thoughts are on the unexpected update if you can comment on whether you're interacting with FDA recently and how did those interactions go.

Maurice Thomas Raycroft: So, Maury, I'd just like to know what your thoughts are on the unexpected update and if you can comment on whether you've interacted with FDA recently and how those interactions went. I've not seen any details specifically on Fibrogen and wouldn't see our place to comment on any detail about their program.

So maury. Thank you very much for the questions I have not seen any details specifically on fiber Gen and wouldn't see our place to comment on any detail about their program.

Eric Dube: What I can say is that we've had and continue to have discussions with FDA, and I'll have Bill share a little bit about our plans and how his team is preparing for the submission and review. Certainly. We have a pre-NDA meeting coming up in the first half of the year, it will be agents' first opportunity to look at and evaluate the interim D. Interim Director of Data in Detail.

Can't say is that we've had.

Continue to have discussions with with FDA and I'll have bill share a little bit about.

Our plans and how his team is preparing for.

For the submission and review.

Certainly we have a pre NDA meeting coming up in the first half of the year.

The agents first opportunity to look at evaluate the interim deep.

Interim data in detail and overall objective of the meeting for us in that sense will be two line on off plans to these data for support H accelerated approval.

William E. Rote: And overall, the objective of the meeting for us, in that sense, will be to find out all plans to submit these data for subpart H accelerated approval. We'll be looking to align how we present the data, the current study as well as all the legacy data, and make sure that it suits their need for review. At that point, there may or may not be a discussion about panels to your question. And once we've had that meeting and have minutes, we, as Eric stated earlier, we'll communicate that out to the public. Great, that's really helpful.

We'll be looking to aligned on how we present the data.

The current study as well on the legacy data and make sure that their.

And their need for review.

Net point, there may or may not be a discussion about panels to your question.

And once we've had debt and then and half minutes, we as Eric stated earlier.

We will communicate that out.

Public.

Great that's really helpful.

Maurice Thomas Raycroft: Okay, well, thanks for taking my question. Thank you, Warren. Your next question comes from the line of Liisa Bayko from Evercore ISI. Your line is open.

Okay, well, thanks for taking my questions.

Thank you Martin.

Your next question comes from the line of <unk> <unk> from Evercore ISI. Your line is open.

Liisa Ann Bayko: Hi there, thanks for taking the question. Can you maybe just speak a little bit more about, now that you've had time to reflect on the data a little bit more, sort of the change in placebo, well not change, but we had about a 9% placebo rate in phase two. And then it went up to 26% in this study, which actually was kind of close to, in a way, what the original data was for sparsantan in the first study. So anyway, just curious about what kind of thinking you have about, and stop placebo, sorry, herbicartin. You know, why do we see that kind of gap up there?

Hi, there thanks for taking my question.

Just speak to now that you've had time to reflect on the day and a little bit more.

And sort of.

The policy change in placebo.

Well not change, but we had about a 9% placebo rate than the EM.

Thank you and then it went up to 26% in this study, which actually it was kind of close to in a way.

What the original data was.

For our San Tan.

And then in the first 90, so anyway, just curious on kind of your thinking of and it's on placebo sorry Irbesartan.

Why do we see that kind of GAAP op. There I have my own thoughts I'm curious on if you had any chance to think about that and then any other feedback you've gotten on the data sales arent be helpful. Thank you.

Eric Dube: I have my own thoughts, but curious if you've had any thoughts about that, and then any other feedback you've gotten on the data so far. It'd be helpful. Liisa, thanks for the questions. And I'll ask Noah to share his thoughts and perhaps some of the discussions with nephrologists around the FPRA data that we've seen. But I think before I turn it over to Noah, I'd say, you know, first and foremost, the results that we saw at 36 weeks were incredibly strong and, you know, support our belief that we have the data, one that's within our powering range, but two, sufficient for treatment effects for subpart H. I'll ask Noah to share a little bit about his thoughts on why we might have seen that.

Lisa Thanks for the questions and I'll ask Noah to share his thoughts and perhaps some of the discussions with nephrologist surround the <unk> data that we've seen but I think before.

I turn it over to Noah I'd say first and foremost.

The results that we saw at 36 weeks were incredibly strong and support.

Our belief that we have the data one that's within our powering but to sufficient for.

Treatment effects for Subpart, H I'll ask Noah to share a little bit about his thoughts on why we might have seen that.

Eric Dube: But I think certainly, you know, we're contributing a tremendous amount to the field in this being the largest and the longest trial conducted within FSGS, so very little information previously to go on beyond the eight weeks that we had in our phase two. Noah?

But I think certainly we're contributing a tremendous amount to the field in this being the largest and longest trial conducted within within STS. So very little information previously to go on beyond the eight weeks that we've had in our phase two Noah.

Noah Rosenberg: Yeah, I think to that point, Eric, and to Liisa's question, you know, if you look at the data that you're referencing, Liisa, at eight weeks, where we had the double-blind period for the phase two duet study, we saw, you know, a nine versus 28 percent achievement of FPRE at eight weeks. So that was at eight weeks. What we didn't know was how that would progress out to 36 weeks, and now, in duplex, we've got the 36-week data.

Yes, I think to that point art.

Until we get this question if you look at the data that you're referencing Lisa at eight weeks, where we had the double blind period for the phase two duet study.

We saw it.

Knowing versus 28.

Percentage, even about CRE.

So that was at eight weeks.

We didn't know was how that would progress after 36 weeks now on duplex. We've got the 36 week data and I just wanted to just sit back and reflect on something Eric said, which is duplex really is the largest in.

Noah Rosenberg: And I just want to take a step back and reflect on something Eric said, which is that duplex really is the largest and longest study in FHF and certainly has provided lots of insight in terms of how not only the charts progressed, but also the insight for the field. And in the 36-week data, duplex showed that Sforzante was consistent with the expectation of the OLE. If you go to the 36-week data point, it almost tracks perfectly to a 42 percent achievement of FPRE, which really speaks to the remarkable consistency of the drug.

As long as.

Studying <unk> and certainly as provides lots of insight in terms of how not all of these drugs progress.

Insight for the field and in the in the 36 week data duplex.

Showed that.

<unk> was consistent with the expectation at least so if you go to the 36 week data point it almost tracks perfectly to a 42% achievement of PRA, which really speaks to the remarkable consistency.

Noah Rosenberg: And it outperformed Irvisartan in a statistically significant manner, which tells you that this was within our powering assumptions. And I think we're, you know, and when you talk about kind of how we view it and then have validated this with the nephrology community and the inbounds of it, you know, they're incredibly encouraged by a 60 percent relative likelihood or greater relative likelihood of achieving FPRE, which we know is important clinically meaningful endpoint linked to EGFR stabilization with, and it's important to mention, a comparable safety profile between those two groups.

All of the drug and down and it's outperformed.

Irbesartan and a statistically significant manner, which tells you that this was within our powering assumptions.

And I think we're in.

When you talk about kind of how we view it and then a validated this with the nephrology community on what the inbounds of debt.

Credibly encouraged by 60% relative likelihood or greater relative likelihood of achieving F. PRA, which we know is important clinically meaningful endpoint linked to Egfr stabilization.

And it's important to mention a comparable safety profile between those two groups.

Noah Rosenberg: So, you know, in a sense, really, this is the strongest protein reduction that has been generated in this field, if you think about it, with a non-immune suppressive therapy. And I think that's a critical piece because there's been a, just a huge need, a huge unmet need for, you know, once a day, it's an oral treatment. And I think it's well-characterized through our phase two duet long-term data set. We understand fairly well how this drug works from an efficacy and safety standpoint.

So in a sense really this is the strongest part year reduction that has been generated in this field you can think about it with the non immune suppressive therapy and I think that's a critical piece because theres been a just a huge need a huge unmet need for once a day oral treatment.

And I think it's well characterized through our phase two duet long term dataset, we understand fairly well how this drug works from an efficacy safety standpoint, So I think thats really what has really.

Eric Dube: So I think that's really what has really led to the excitement. I think the only other thing, Noah, that I would add is that some of the feedback that we've heard from nephrology thought leaders is also that the results are not surprising. And while there was a greater increase from eight weeks to 36 weeks, this is consistent with clinical practice. So I think the consistency that we see between this trial and clinical practice, but as Noah mentioned, the consistency of the sparse sentence profile on this endpoint from phase two to phase three is incredibly encouraging. And I think that's one of the, You know, themes of the feedback that we're hearing from KOL.

Led to the excitement.

I think the only other thing I would add is that some of the feedback that we've heard from nephrology thought leaders is also that the results are not surprising.

And while there was a greater increase from eight weeks to 36 weeks.

But this is consistent with clinical practice, so I think the consistency that we see between this trial clinical practice, but no I mentioned that consistency of spar sentence profile on this endpoint from phase II to phase III is incredibly encouraging and I think that's one of the feet.

Themes of the feedback that we're hearing from Kols.

Liisa Ann Bayko: Okay, thanks. And I know there's a CKD3 conferences coming up later this week, and I noticed you're going to be giving a talk there. Will that include any updates or details on the trial so far, the data, anything like that? No, it will not provide any additional data. It will be, you know, an additional presentation of what we know to date and what we have announced publicly to date. Okay, great, thanks.

Okay, Thanks, and I know there.

The CK day, three conferences coming up later this week and I noticed youre going to be giving a talk there will that include any updates or details on the.

On the debt debt.

The trial, so far the data on anything like that.

No it will it will not provide any.

Additional data it will be an additional per.

Presentation of what we know to date and what we have announced publicly to date.

Okay, great. Thanks.

Liisa Ann Bayko: And then just, if you could talk a little bit about TBT 058, is this trial slightly delayed? I thought we were maybe expecting data earlier in 2021 and then, but whenever we get data, could you just frame up, you know, what we should be looking for and expecting in that data set. And that's my final question.

And then just.

If you could talk a little bit about TVT O five eight.

Is this trial is it slightly delayed I thought we were maybe expecting data earlier in 2021 and then.

Whenever we get data if you could just frame up what we should be looking for and expecting from that.

And that's my final question. Thank you okay. Thanks Lisa.

Liisa Ann Bayko: Thank you. Okay, thanks, Liisa. And the program continues to progress. And I'll ask Bill to share a little bit about the status and what we'll be looking for from that trial later this year.

The program continues to progress and I'll ask bill to share a little bit about the status on what we'll be looking for from that trial later this year.

Certainly thanks for the question Lisa.

William E. Rote: Thanks for the question, Liisa. As Eric said, the study continues to advance, and we do expect to have preliminary data this year. Based on what we want to or expect to see from that, we're going to be evaluating the selection of the right dose or the effect of the medicine across different doses, looking primarily at reductions in plasma homocysteine, and additionally, we're going to be working to develop a regulatory strategy going forward

As Eric said the study continues and.

And we do expect to have preliminary data this year from what we want to.

We expect to see from that we're going to be evaluating.

The selection of the right dose for the effect of the medicine across different doses moving primarily at reductions in plasma homocysteine.

And Additionally, we're going to be working to develop the regulatory strategy going forward. Thanks.

William E. Rote: I think some of the caution that you're hearing in our link. It's just that with a smaller study, the potential for impact, I think, is greater than in something like a duplex with sites in different regions. Additionally, in this case, we have a biologic as opposed to a small molecule. And the contract manufacturing space in the biologic world is impacted right now quite broadly with COVID vaccine manufacture.

I think some of the caution that you're hearing in our language.

With a smaller study the impact the potential impact I think is greater than something like duplex with.

Sites in different regions. Additionally.

In this case, we have a biologic as opposed to a small molecule.

And the contract manufacturing space in the biologic World.

As impacted right now quite broadly with Covid vaccine manufacturer.

William E. Rote: And while we have contingency plans in place and we are on track, it's an area that we continue to monitor. Okay, thank you. Thanks, Richard. Your next question comes from the line of Laura Chico from Red Bush Securities. Your line is open.

While we have contingency plans in place and we are on track.

Debt, we continue to monitor.

Okay. Thank you.

Thanks Lisa.

Your next question comes from the line of Laura Chico from Wedbush Securities. Your line is open.

Laura Kathryn Chico: Thanks very much for taking the time to answer the question. I just wanted to circle back on one to clarify, and that's with respect to protein binding. So, I think you mentioned earlier that, Well, dosing in the FSGS trial is permitted to go up to 800 milligrams, excuse me, but in PROTECT, you're only dosing up to 400 milligrams. And in terms of clarifying, I just wanted to make sure I understood, was the decision to use the lower dose in PROTECT versus DUPLEX purely based on the drug's protein-binding properties, or are there other factors that kind of came into the decision-making process there?

Thanks, very much for taking the question.

I just wanted to circle back on I wanted to clarify and Thats with respect to the protein binding so of course on I.

I think you mentioned earlier that.

Dosing in the <unk> trial is permitted to go up to 800 milligrams excuse me, but and protect your only dosing up to 400 milligrams in terms of clarifying I just wanted to make sure I understood was the decision to use a lower dose and protect versus duplex purely based on the <unk> protein binding properties or are there other.

Factors that kind of came into the decision making process. There and then perhaps one quick follow up question for Lora, perhaps and happy birthday.

Eric Dube: And then perhaps one quick follow-up question for Laura, perhaps, and happy birthday. While we have the DUPLEX top-line results in hand, obviously, the study is going to be continuing, and I was just wondering how we should be thinking about the cadence of spend on the R&D line this year with two pivotal studies continuing. Thanks very much. Thanks, Laura. Maybe I'll mention very briefly protein binding and ask Bill to provide anything that I've missed. I think one of the other aspects that came into play is from the DUET study, albeit that it is in FSGS; we do see that both doses of 400 and 800 are quite effective in proteinuria reduction.

It seems like top line results in hand, obviously, the study is going to be continuing and just wondering how we should be thinking about the cadence of spend on the R&D line. This year with two pivotal studies continuing thanks very much.

Thanks, Laura maybe al mentioned very briefly about the protein binding and ask bill to provide anything that I've missed I think one of the other aspects that came into play is from the duet study, albeit that is in <unk>, we do see debt.

Both doses of 400, 800 are quite effective and proteinuria reduction and.

Bill: And, you know, we believe that we would not be compromising much efficacy. And I think, as Bill alluded to, the dose response is more sigmoidal. And at 400, you're getting close to the top of that S curve. And so, you know, that was a very important component of some of the decision making about what dose to select. So, yes, it was about protein binding and serum protein levels, but it was also about the degree of efficacy conferred at those doses.

We believe that we would not be compromising much efficacy and I think as bill alluded to that.

The dose responses is more sigmoidal and at 400, Youre getting close to the top of that S curve and so.

That was a very important component of some of the decision, making about what dose to select so yes. It was about protein binding and serum protein levels, but it was also about the degree of efficacy conferred at those doses bill anything further that you'd want to add on that.

Bill: Bill, anything further that you'd want to add to that? No, I think that's the right area. Okay, and Laura. Yeah. Hi Laura. Thanks for the birthday wishes. You can expect to see R&D... Over the current quarter level, for a lot of the reasons we've been describing, think about maybe more traditional phase three, where once the studies reach out, your R&D expenses could technically start to trend downward. In our case, with the subpart H pathway, we still have to run studies out to the full 108-week confirmatory EGFR endpoint.

No I think that's exactly right Eric.

Okay and Lora.

Alright, Yeah, Hi, Laura Thanks for the first day wishes.

You can expect to see R&D percentage increase.

Over in the current quarter level.

For a lot of the reasons, we've been describing how we think about that.

Maybe more traditional phase III, where once the studies read out your R&D expense it could technically start to trend downward in our case with the subpart H pathway, we still have to run studies out to the full 108 week confirm it free Egfr endpoint.

Laura Kathryn Chico: In addition to that, we'll be investing in our new program, PBT 058, and also building up for commercial scale with our supply chain. So those are significant investments that we'll all be happy about. So definitely expect some modest increases in R&D as we go quarter over quarter compared to now. Thanks very much. Thank you, Laura. I am showing no further questions at this time. I would now like to turn the conference back to Mr. Chris Cline. Great. Thank you, Katrina.

In addition to that we'll be investing in our new program PBT O five eight and also sales.

FERC commercial scale with our supply chain. So those are significant investments that will all be happy.

So definitely.

The modest increase in R&D as we go quarter over quarter.

Compared to current level.

Thanks very much.

Thank you Laura.

I am showing no further questions at this time I would now like to turn the conference back to Mr. Chris Cline.

Great. Thank you Katrina. Thank you everyone for joining us this afternoon to talk about our many accomplishments in 2020 and our exciting outlook for 2021. This concludes our call for the day, we look forward to providing updates on the near future I Hope you all have a great rest of the week.

Christopher Cline: Thank you, everyone, for joining us this afternoon to talk about our many accomplishments in 2020 and our exciting outlook for 2021. This concludes our call for the day. We look forward to providing you with updates in the near future.

Operator: I hope you all have a great rest of the week. Ladies and gentlemen, this concludes today's conference. Thank you for your participation and have a wonderful day. You may all disconnect.

Ladies and gentlemen. This concludes today's conference. Thank you for your participation and have a wonderful day you may all disconnect.

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