Q4 2023 Travere Therapeutics Inc Earnings Call

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Operator: Good day, and welcome to the Travere Therapeutics fourth quarter and full year 2023 Financial Results and Corporate Update Conference Call. Today's conference is being recorded. At this time, I would like to turn the conference call over to Anne Cotto. Please go ahead.

Good day and welcome to the severe therapeutics fourth quarter and full year 2023 financial results and corporate update conference call. Today's conference is being recorded at this time I would like to turn the conference call over to Ann caught out. Please go ahead ma'am.

Anne Cotto: Jenny, good afternoon, and welcome to Travere Therapeutics' fourth quarter and full year 2023 financial results and corporate update call. Thank you all for joining. Today's call will be led by our President and Chief Executive Officer, Dr. Eric Dube. Eric will be joined in the prepared remarks by Dr. Julea Enrig, our Chief Medical Officer; Peter Herma, our Chief Commercial Officer; and Chris Cline, our Chief Financial Officer.

Ann: Thanks, Jenny good afternoon, and welcome to Trier Therapeutics fourth quarter and full year 2023 financial results and corporate update call. Thank you all for joining today's call will be led by our President and Chief Executive Officer, Dr. Eric debate, Eric will be joined in the prepared remarks by Dr. Julie <unk>, our Chief Medical Officer.

Ann: Peter Hermann <unk>, our Chief commercial officer, and Chris Klein, Our Chief Financial Officer, Dr. Bill Rote Senior Vice President of research and development will join us for the Q&A session.

Anne Cotto: Dr. Bill Roat, Senior Vice President of Research and Development, will join us for the Q&A. Before we begin, I'd 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 Security of Litigation Reform Act of 1995. Forward-looking statements 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 forward-looking statements. Please see the forward-looking statement disclaimer on the company's press release issued earlier today, as well as the risk factor section in our Forms 10-Q and 10-K filed with the FGC. In addition, any forward-looking statements represent our With that, let me now turn the call over to Eric. Okay?

Ann: Before we begin I'd 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.

Ann: Forward looking statements are not guarantees of performance.

Ann: Both 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. Please.

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

Ann: In addition, any forward looking statements represent our views only as of the date such statements are made February 15th 2024, and traverse specifically disclaims any obligation to update such statements to reflect future information events or circumstances.

Eric Dube: With that let me now turn the call over to Eric Eric.

Eric Dube: Thank you, Anne, and welcome everyone. 2023 was a year of many great achievements for Travere as we worked towards our goal of breaking down barriers in treating rare diseases with historically little innovation. At the start of 2023, we gained the first approval from our pipeline, delivering Sparsentin or Silspari as the first and only non-immunosuppressive treatment option for people living with IgA nephropathy or IgA. For decades, people living with IGAN, most of whom are diagnosed in their 20s and 30s and on average face kidney failure in 10 years, had limited treatment options.

Eric: Thank you Ann and welcome everyone 40, 23 was a year of many great achievements for <unk> as we work towards our goal of breaking down barriers and treating rare diseases with historically little innovation.

Eric: At the start of 2023, we gained the first approval from our pipeline delivering sports Center and also sport is the first and only non immunosuppressive treatment option for people living with Iga nephropathy.

Eric: For decades people living with I guess, most of whom are diagnosed in their 2030 and an average face kidney failure at 10 years has limited treatment options.

Eric Dube: We are proud to help lead the growing evolution of the treatment paradigm that we believe will ultimately see patients get diagnosed and initiate treatment earlier, and where physicians will ultimately utilize Fils-Bari as a foundational treatment with its superior progenery reduction and accrual of kidney preservation benefits. Following the grant of accelerated approval, our team quickly initiated our comprehensive commercial launch plan and worked throughout the year to lay a strong foundation for Pillsbury uptake. I am very pleased with our results.

Eric: We are proud to help lead growing evolution of the treatment paradigm, but we believe we'll ultimately see patients get diagnosed and initiate treatment earlier and where physicians will ultimately utilize those Barry I think foundational treatment with its superior proteinuria reduction.

Eric: Accrual of kidney preservation.

Eric: Following the granted accelerated approval are seeing quickly initiated a comprehensive commercial launch plan and worked throughout the year to lay a strong foundation for the uptake.

Eric: I'm very pleased with our results, we continue to make substantial progress and physician demand payer coverage and revenue the key aspects of the launch.

Eric Dube: We continue to make substantial progress in physician demand, payer coverage, and revenue, the key aspects of the launch. Of note, Pillsbury is the only recent launch in the rare kidney space that has seen consistent growth in demand each quarter in its first year, and we saw a meaningful inflection in NIST product sales to close out 2020. Last year, we encountered a challenge in our pursuit of a better outlook for the FSGS community. Specifically, the duplex study of sparsentin in FSGS did not achieve the results we had hoped.

Eric: So as far as the only recent watching the rare kidney space, but its been consistent growth in demand each quarter in its first year.

Eric: A meaningful inflection in net profit.

Eric: Sales to close out 2023.

Eric: Last year, we encountered a challenge in our pursuit of a better outlook for the SGS community specifically the duplex study of Sports Center.

Eric: Not achieved the results we'd hoped and following our FDA engagement. It was clear we would not be in a position to submit an S&P at that time based on the duplex results alone.

Eric Dube: And following our FDA engagement, it was clear we would not be in a position to submit an FMDA at that time based on the duplex results alone. I am incredibly grateful and proud of how our colleagues at Travere learn and quickly adjust to it. We move quickly to align our investment in this program, implement a strategic restructuring of our organization to focus our resources and concentrate our efforts, and collaborate with regulators with the goal of identifying a potential regulatory path forward in the future. As for our peg-to-batinase development program for classical homocysteineuria, or HCU, we achieved important milestones in 2023. Globally, we believe there are 7,000 to 10,000 patients diagnosed with HCU who are not in full control of their homocysteine levels.

Eric: Incredibly grateful and proud of how our colleagues at <unk> and quickly adjusted.

Eric: Moved quickly to align our investment in this program.

Eric: And then a strategic restructuring of our organization to focus our resources and concentrate our efforts to collaborate with regulators with the goal of identifying a potential regulatory path forward in the future.

Eric: As smart pig about next development program for Costco home assistant urea or <unk>, we achieved important milestones in 2023 globally. We believe there are seven to 10000 patients diagnosed with <unk>, who are not in full control of their home a sustained levels.

Eric Dube: With better diagnoses and a future where an effective treatment is available, we believe this may grow by 50% or more over time. Last year, we generated additional exciting data from our Phase I-II Composed Study, which further demonstrates the potential for PEG-2-batinase to become the only disease-modifying therapy for HCU. With these data, we worked closely with regulators to align on a Phase III program, utilizing total homocysteine reduction as a primary endpoint, and initiated that study before year-end. All of our efforts last year positioned us to start 2024 with focus and a plan for execution across the board.

Eric: With better diagnosis at a future where an effective treatment is available. We believe this may grow by 50% or more overtime.

Eric: Last year, we generated additional exciting data from our phase one two proposed study, which further demonstrates the potential for <unk>.

Eric: The only disease modifying therapy for HD here with these data we worked closely with regulators to align on a phase III program utilizing total homes assisting reduction as the primary endpoint and initiated that study before year end.

Eric: All of our efforts last year positioned us to start 2024 with focus and a plan for execution across the board.

Eric Dube: Strong launch performance at Fioskari remains our top priority for 2024, and we expect the momentum in our launch from the second half of 2023 will continue into the new year. We are also executing on three additional priorities aimed at broadening access to Fils-Fari. Of note, we are on track to submit our SNDA this quarter to support conversion of Fils-Fari from accelerated approval to full approval for IGAN in the U.S. Together with our partner CSLV4, we expect an opinion on conditional approval of Fils Fari in Europe from CHMP later this quarter, and we're optimistic that this will be positive. And with our recent agreement with Rinalis, we are looking forward to aiding their development plans to ultimately enable access to phosphori in Japan and other regions in Asia, where Igan is an even more prevalent disease and leading cause of kidney failure. And importantly, we are excited about the opportunity we have with PEG-DiBatinase, our novel investigational enzyme replacement therapy being evaluated for the treatment of classical homocystinuria,

Eric: Strong loss performance equals far remains our top priority for 2024, and we expect the momentum in our watch from the second half of 2023 will continue into the new year.

Eric: We are also executing on three additional priorities aimed at broadening access to bill start of note. We are on track to submit our NDA this quarter to support conversion I feel sorry for accelerated approval to full approval for <unk> in the U S.

Eric: Together with our partner CSL before we'd expect an opinion on conditional approval of <unk> in Europe from <unk> later this quarter.

Eric: We're optimistic that this will be positive.

With our recent agreement with re Dallas, we are looking forward to eating their development plans to ultimately enable access to pillsbury in Japan and other regions in Asia, where again, even more prevalent disease and a leading cause of kidney failure.

Eric: And importantly, we are excited about the opportunity we have would take about our novel investigational enzyme replacement therapy being evaluated for the treatment of classical publicists in urea or HCM.

Jula: In 2024, our focus will be on enrolling our Phase III Harmony trial and raising awareness of the need for innovative treatments for this rare disorder. Let me now turn the call over to Jula for a clinical update.

Eric: In 2024, our focus will be on enrolling our phase III <unk> trial, and raising awareness of the need for innovative treatments for this rare disorder. Let me now turn the call over to Jim for a clinical update July.

Jula: Thank you, Eric, and good afternoon. I am very pleased with the progress made on our clinical and medical affairs initiatives for 2023. With our achievements last year, we are well-positioned to ultimately deliver two new treatment standards in rare diseases with limited options available. As for Filspari, we completed the two-year double-blind dosing periods for our studies in FSGS and IGAM. It's important to highlight that our studies are the only ones in the space that use a maximally optimized active comparator, setting the bar highest in the field.

Jim: Thank you Eric and good afternoon.

Jim: Very pleased with the progress made on our clinical and medical affairs initiatives in 2023.

Jim: With our achievements last year, we are well positioned to ultimately deliver to new treatment standards in rare diseases with limited options available.

As for fuel sorry, we completed the two year double blind dosing periods for our studies in <unk>.

Jim: <unk>.

Jim: It is important to highlight that our studies are the only ones in this space that use maximally optimized active comparator, putting them are highest in the field.

Jula: The results, which clearly demonstrated robust proteinary reduction and preservation of kidney function in Igans, were simultaneously presented as late-breaker presentations at ASN and published in world-renowned medical journals, The Lancet and New England Journal of Medicine. Following those data presentations, we have received positive feedback from nephrologists about the foundational role that Fils-Bari can play in long-term kidney function preservation for patients with IgA nephropathy. What has resonated with nephrologists is that Fils-Pare is the only approved non-immunosuppressive treatment for IGAN, and it's the only molecule that works by simultaneously blocking the two key pathogenic pathways in the kidney, Endothelin-1 and Angiotensin-2, that both work together to drive damage and kidney function loss.

Jim: The results, which clearly demonstrated robust preliminary reductions and preservation of kidney function and again, we're simultaneously presented at a late breaker presentation with ASI and published and world renowned medical journals, the Atlanta, and New England Journal of Medicine.

Jim: Following those data presentations, we have received positive feedback from Nephrologists about the foundational role that <unk> can play in long term kidney function preservation for patients with Iga nephropathy.

Jim: What has resonated with Nephrologist is that so far is the only approved non immunosuppressive treatment for IBM and it's the only molecule that works by simultaneously blocking the Q key pathogenic pathways in the kidney.

And there will be one one and angiotensin II.

Jim: Both work together to drive damage and kidney function loss.

Jula: SILFARI's dual mechanism of action is critical to inhibiting the damaging pathways in the kidney in order to achieve sustained protein reduction and long-term kidney function preservation that accrues over time. Unlike intermittent therapies, which may have short-term benefits on kidney function, DILSPARI has demonstrated a long-term accrual of benefit on EGFR. In the PROTECT study, at one year, there was a 1.7 mL per minute favorable effect on absolute EGFR with philsipari compared to maximally titrate herbacartin, and that benefit increased the 3.7 mils per minute greater EGFR at two years. Importantly, the rate of loss of kidney function in year two compared to year one was significantly slower for Filspari treated patients, suggesting a potential additive benefit with longer-term treatment. This year over year accrual of benefit is important for a patient who has ongoing kidney injury over their lifetime and may otherwise be facing kidney failure less than 10 years from diagnosis.

Jim: So far its dual mechanism of action is critical to inhibiting the damaging pathways in the kidney in order to achieve sustained pulmonary reduction and long term kidney function preservation that accrues over time.

Jim: Unlike intermittent therapy, which may have short term benefits on kidney function. Thus far has demonstrated a long term accrual of benefit on Egfr and.

Jim: In the protect study at one year. There was a 1.7 1000 per minute favorable effect on absolute Egfr with Phil sorry, compared to Mac might titrate irbesartan.

Jim: That benefit increased to three 7000 per minute greater Egfr at two years.

Importantly, the rate of loss of kidney function in your Q compared to year, one was significantly slower brookdale sparry treated patient.

Suggesting a potential additive benefit with longer term treatment.

Jim: This year over year accrual of benefit is important for a patient with ongoing kidney injury over their lifetime and may otherwise be facing kidney failure lasting 10 years from diagnosis.

Jula: Our two-year data from the PROTECT study in IGAN shows that psilocybin is superior to historical RAS inhibitors and it's safe for chronic use, which is critical in treating patients for life. Community and academic nephrologists are continuously highlighting to us the early clinical experience with Fils-Pare, where they see significant reductions in proteinuria and the ability to safely use Fils-Pare with their patients' chronic kidney disease. We believe this cements the role that filfari can play by replacing RAS inhibitors as foundational care for those at risk of rapid disease progression due to uncontrolled proteinuria.

Jim: Our two year data from the protect study and again shows that Youll sorry.

Jim: Periodically historical RAF inhibitors, and a state for chronic use which is critical in treating patients for life.

Community and academic Nephrologist are continuously highlighting to us the early clinical experience with <unk>, where they see significant reductions in proteinuria and the ability to safely use so far with our patients chronically.

Jim: We believe this limits the role that Phil Barry can play by replacing RAF inhibitors as foundational care for those at risk of rapid disease progression due to uncontrolled proteinuria.

Jula: Following the positive results from PROTECT, we successfully completed a pre-NDA meeting with FDA to discuss our plans to submit an SNDA to convert fuel sparrows from accelerated approval to full approval for Iganda. Importantly, we aligned with the FDA on the data analysis to support our submission and to support potential broader labeling. I'm pleased to report that we remain on track to submit the SNDA this quarter. We are at an exciting juncture in the evolution of the IGAN treatment paradigm. We believe that nephrologists are focused on treating the damage in the kidney and then preventing further damage systemically.

Jim: Following the positive results from protect we successfully completed a pre NDA meeting with FDA to discuss our plans to submit an <unk> to convert fuel side from accelerated approval to full approval for <unk>.

Jim: Importantly, we are aligned with the FDA on the data analysis to support our submission and to support potential broader labeling.

Jim: I'm pleased to report that we remain on track to submit the NDA this quarter.

Jim: We are at an exciting juncture in the evolution of the IGN treatment paradigm.

Jim: We believe that Nephrologist are focused on treating the damage in the kidney and then preventing further damage systemically.

Jula: Our goal is to ultimately have PhilSPAR used as the foundational care in IgAN, essentially replacing the historical role of RAS inhibitors, and then other medicines can be added as needed. As this evolution continues, there are a number of factors that we expect will help PhilSPAR achieve this goal. With full approval from FDA, we would expect a broader label that reflects the full study population and the results. This would provide nephrologists and patients with greater flexibility to choose Pilspari when seeking treatment options that can provide long-term kidney function preservation.

Jim: Our goal is to ultimately have to acquire users the foundational care and IBM essentially replacing the historical rule of rasp inhibitors.

Jim: And then other medicines can be added as needed.

Jim: As this evolution continues there are a number of factors that we expect will help <unk> achieve this goal.

Jim: With a full approval from FDA, we would expect a broader label that reflects the full study population and the results.

Jim: This will provide nephrologist and patients with greater flexibility to choose spill sorry, when seeking treatment options that can provide long term kidney function and preservation.

Jula: Additionally, we believe Fils-Pare's likely inclusion in the soon-to-be-released KDGO guidelines should further standardize use of Fils-Pare for the nephrology community and potentially result in earlier treatment. As positioned in up-to-date and recent peer-reviewed IBM treatment articles, we anticipate Philspari will be described as a foundational treatment in the KDECO guidelines. We also believe that the proteinuria target for treating IGANT overall will be lowered, which would support earlier diagnosis, more aggressive treatment to avoid long-term damage, as well as combination treatment in the future. Furthermore, later this year, we expect to generate longer-term data from our ongoing Spartacus and Spartan studies, which are designed to show Filspari can be safely used in combination with other medicines, such as FGLT2 inhibitors, and that patients may benefit from earlier use of Filspari.

Jim: Additionally, we believe feels far as likely inclusion in the soon to be released <unk> guidelines should further standardized use of milk price within nephrology community and potentially result in earlier treatment.

Jim: <unk> positioned and up to date and recent peer reviewed <unk> treatment article we anticipate zelle, Scott just far you'll be described as a foundational treatment in the <unk> guidelines.

Jim: We also believe that the proteinuria target for treating <unk> overall will be lower which would support earlier diagnosis more aggressive treatment to avoid long term damage as well as combination treatment in the future.

Jim: Furthermore, later this year, we expect to generate longer term data from our ongoing Spartacus and Spartan studies, which are designed to shelf. So far it can be safely used in combination with other medicines such as <unk> two inhibitors.

Jim: Patients may benefit from earlier used to feel sorry.

Jula: Such data will further support the progress towards FILSPARI achieving foundational care. Beyond the U.S., we have continued to work closely with our partners at CSLV4 on the Conditional Marketing Authorization application that is currently under evaluation in the UA, and EU. Following a procedural clock stop to review the two-year data, we believe that we are well positioned for a positive CHMP opinion this quarter and an approval decision next quarter. Beyond the CSLV4 territories, our recent agreement with Rinales provides Philsipari with a regulatory pathway that has the potential to deliver Philsipari across a number of Asian countries in the coming years. Overall, we are very pleased with the important groundwork laid in 2023, and we see a clear roadmap for increased utilization of FieldSparry for Adyant in 2024 and beyond. Turning briefly to FSTS, with no approved therapies for tens of thousands of patients with this condition and the high rate of progression to kidney failure, we are committed to trying to find a path forward for sparsentin and FSTS.

Such data will further support the progress towards <unk>, achieving foundational care.

Jim: Beyond the U S. We've continued to work closely with our partners at CSL before on a conditional marketing authorization application that is currently under evaluation in the U S. EU.

Jim: Following a procedural clock stop to review the two year data. We believe that we are well positioned for a positive <unk> opinion this quarter and an approval decision next quarter.

Jim: Beyond the CSL before territories, our recent agreement with <unk> provides <unk> with a regulatory pathway that has the potential to deliver pillsbury across a number of Asian countries in the coming years.

Jim: Overall, we are very pleased with the important groundwork laid in 2023, and we see a clear roadmap for increased utilization and I feel sorry for again in 2024 and beyond.

Jim: Turning briefly to <unk> with no approved therapies for tens of thousands of patients with this condition and the high rate of progression of kidney failure. We are committed to trying to find a path forward for <unk> and FX, yes.

Jula: We are taking a measured approach to evaluating our data sets and working with the community to reengage the FDA later this year toward the goal of ultimately being able to submit to have an FSGS indication added to the Philspari label. We anticipate being able to provide an update on this work later in the year. As Eric highlighted earlier, our enthusiasm and peg to batonnets continues to grow. We were pleased to achieve alignment with regulators on the design of our phase 3 program and to reach our goal of initiating the phase 3 Harmony Study before year end. This study employs an innovative design with measurements very similar to our highly successful Phase 1-2 study, which we believe provides a high probability of success as a registration-enabling study. The Phase 3 Harmony Study is designed to recruit up to 70 patients with HCU and evaluate change in total HOMO-15 from baseline to week 6 to 12 as the primary endpoint. This is the measurement for which we saw a 67% reduction in the highest dose cohort in the Composed Study.

Jim: We are taking a measured approach to evaluating our datasets and working with the community to Reengage. The FDA later this year towards the goal of ultimately being able to submit to have an FX, Jeff indications added to the self barring label.

Jim: We anticipate being able to provide an update on this work late in the year.

Jim: As Eric highlighted earlier, our enthusiasm is pegged to bat needs continues to grow.

Jim: We were pleased to achieve alignment with regulators on the design of our phase III program and to reach our goal of initiating the phase III Harmony study before year end.

Jim: This study employs an innovative design with measurements very similar to our highly successful phase one two study, which we believe provides a high probability of success as a registration enabling study.

Jim: The phase III Harmony study is designed to recruit up to 70 patients with HBU and evaluate change in total <unk> from baseline to week six to 12 as the primary endpoint.

Jim: This is the measurement for which we saw a 67% reduction in the highest dose cohort and are composed study.

Jula: Patients will be followed in the double-blind period for 24 weeks in total to establish durability of effect and a robust safety database. To maximize consistency, there is a 10-week screening and diet stabilization period prior to randomization and harmony. And patients who complete the full double-blind period will be eligible to enroll in an open-label study called Ensembl, where there is a protocolized diet liberalization sub-study for eligible patients who have well-controlled total homocysteine.

Jim: Patients will be followed in the double blind period for 24 weeks in total to establish durability of effect and a robust safety database.

Jim: Maximize consistency there is a 10 week screening and diet stabilization period prior to randomization in harmony.

Jim: And patients who complete the full double blind period will be eligible to enroll into an open label study called ensemble, where there is a protocol like diet liberalization sub study for eligible patients who have well control total home office team.

Peter: This portion of the study is designed to generate data throughout the life of the program, and we believe it will ultimately be able to help patients understand how they may be able to increase protein intake while taking pegtobatinase, a key area of need for patients living with HCU. As we move through 2024, we will be focused on ramping up enrollment in the Harmony Study and scaling our PEG-to-Batinase manufacturing activities to support the full program and future commercialization. We look forward to top-line data in 2026, with potential approval in 2027. I'll now turn the call over to Peter for the commercial update. Peter?

Jim: This portion of the study is designed to generate data throughout the licensed the program and we believe it will ultimately be able to help patients understand how they may be able to increase protein intake, while taking pegged batteries are.

Jim: A key area of need for patients living with HBU.

Jim: As we move through 2024, we will be focused on ramping up enrolment in the harmony study and scaling our pegged to bat Nathan manufacturing activities to support the full program and future commercialization.

Jim: We look forward to top line data in 2026 with a potential approval in 2027.

Jim: I'll now turn the call over to Peter for the commercial update Peter.

Peter: Thank you all. Looking back on 2023, we made robust progress on what we had outlined during our launch call in February last year, physician Phyllis Bowery and IJM as the future foundational gap for patients at risk of rapid progression through educating our nephrology target, securing broad access, and ensuring a positive initial sales buy experience for patients and physicians. And I'm really proud of the progress our commercial team has made in the past year, especially while adapting to the initial promotional restrictions that come with accelerated approval and an unexpected advance program for liberal monetary policy. By the end of 2023, we will reach 5,700 nephrologists with our sales team in regular face-to-face educational interactions. That is 95% of our target base of 6,000 nephrologists that we believe treat about 85% of the addressable IgM patients in the US. These efforts resulted in strong and steadily increasing demand, with increasing breadth and depth of prescribing nephrology. In particular, in the fourth quarter, we built strong momentum to fulfill SPARI demands, and I couldn't be more pleased with how we ended the year.

Peter Hermann: Thank you.

Peter Hermann: Looking back on 2023, we made robust progress on what we had outlined during our launch call in February last year.

Peter Hermann: Precision feel fit.

Peter Hermann: You will see a foundational care for patients at risk of rapid progression to educating our nephrology targets.

Speaker Change: During broad access.

Speaker Change: Positive initial field experience for patients and physicians.

Speaker Change: And I'm really proud of the progress our commercial team has made in the past year.

Speaker Change: Especially while adapting to initial promotional restrictions that come with accelerated approval.

Speaker Change: Unexpected events programs illiberal monitoring.

Speaker Change: 2023, nearly 5700, nephrologist with our CLC and regular face to face educational interactions that is 95% of our target base well 6000, Nephrologists that we believe tweet about 85%.

Speaker Change: Addressable <unk> patients in the U S.

Speaker Change: These efforts resulted in strong and steadily increasing demand with ingredient, increasing breadth and depth of prescribing nephrologists.

Speaker Change: And particularly in the fourth quarter, we built strong momentum fulfill spotty demands and I couldnt be more pleased with how we ended the year.

Peter: It was encouraging to see further growth in New Patients Platforms, or PSFs, after ASN Kidney, where the confirmatory protracted study results were presented and published. Importantly, we also received further validation of the shelf's parity profile from squad leaders, which was evidenced by an increase in key opinion leader prescribers. We ended the fourth quarter with 459 new PSFs, which demonstrated quarter-over-quarter growth for each period in 2023.

Speaker Change: It was encouraging to see further growth in new patients start forms or PSS.

Speaker Change: Hey isn't getting weak what a confirmatory study results were presented and published.

Importantly, we also received further validation of the Saudi profile from thought leaders, which was evidenced by an increase in key opinion leader prescribers.

Speaker Change: We ended the fourth quarter was 459, new PSS, which demonstrate quarter over quarter growth each period in 2023.

Peter: In fact, this is the first recent rare nephrology product that has shown a continuation of growth in demand during each period in the first year of launch. In total, we received more than 1,450 patient spot forms in 2023, which clearly indicates Gilstaria is helping fill a significant need in the nephrology community. On the payer front, we established a strong base allowing broad patient access. By the end of the year, culverts reach about 70% of U.S. lives.

In fact this is the first reason random for all of your products. It has shown a continuation of growth in demand during each period.

Speaker Change: The first year of launch.

Speaker Change: In total we received more than 1450 patients platforms in 2023, which clearly indicates <unk> is helping fill a significant need for the metrology community.

Speaker Change: On the payer front, we established a strong base, allowing broadband access.

Speaker Change: Until the year Golar has reached about 70% of U S launch.

Peter: In the fourth quarter, we added about 180 new Philspari-specific formularies. And overall, more than 1,000 formularies have included Philspari, with authorization criteria that are generally consistent with the Philspari label, and IfWeAccounts, for plans that didn't yet include a FIOSPARI but have a clear pathway for coverage, that total is about... 89% of the U.S. population lives. Following our team's quick adjustments to improve patient education and provide further support for the liver monitoring ramps in the second half of the year, we saw continued progress in our lead measures of ramp certifications in the first 14 days after receiving a patient's doctor form. This has also led to a growing number of reimbursed patients initiating therapy during the converse. And we are hearing almost on a daily basis from patients and physicians how impressed they are with the results that they are seeing with Shell Spiraling.

Speaker Change: In the fourth quarter, we added 180, new feels very specific forming formularies and overall more than a thousand formularies have included fuel spotty. This authorization criteria that are generally consistent traditional stobie label.

Speaker Change: Okay.

Speaker Change: So plants that didn't yet included skills.

Speaker Change: Let's have a clear pathway for corporates net total is about.

Speaker Change: 89% of U S lives.

Speaker Change: Following our tubes, which adjustments to improve patient education provides further support for the liver monitoring ramps in the second half of the year. We saw continued progress in our lead measures of Rems certifications in the first 14 days after receiving a patient staff for this.

This also led to a growing number of reimbursed patients initiating therapy during the quarter.

Speaker Change: And we are hearing almost on a daily basis from patients and physicians how impressed they are with the results that <unk> was still slightly.

Peter: These results are consistent with what was observed in the PERFECT trial, with rapid and sustained proteinuria reductions with a safety profile similar to ACE inhibitors and ARBs. This is encouraging for patients that started using cell sparing and likely why we are seeing high compliance rates so far in the long term. All these accomplishments resulted in a significant increase in natural spirit sales. In the fourth quarter, we reported approximately $15 million in net product sales, which resulted in nearly $30 million for the year.

Speaker Change: These results are consistent to what was observed in the protect trial with rapid and sustained proteinuria reductions with a safety profile similar to Ace inhibitors are these.

Speaker Change: This is a good thing for patients that started using <unk> and likely why we are seeing HIFU compliance rates so far in the launch.

Speaker Change: All of these accomplishments we sold a significant increase in Nashville fiery sales in the fourth quarter, we reported approximately $50 million of net product sales, which result in nearly $30 million for the year.

Peter: Viola and Viola EC also remain steady, contributing approximately $25 million in net product sales in the fourth quarter. We recently learned of the approval of a generic version of Viola with a narrower label, and we will continue to monitor what impact that may have throughout the year. Overall, we end 2023 with solid execution, and this provides us with a robust foundation for strong performance in 2024. In fact, in the first six weeks of the new year, I'm pleased to see our strong Phil Sparley performance continue.

Speaker Change: <unk> I'll, let you see also remained steady.

Speaker Change: <unk> approximately $25 million and net product sales in the forest Walter.

Speaker Change: We recently learned of an approval of a generic <unk> was a narrower label and we will continue to monitor what impact that may have throughout the year.

Speaker Change: Overall, we ended 2023 with solid execution and this provides us with a robust foundation for strong performance in 2024.

Speaker Change: In fact in the first six weeks of the new year I am pleased to see our strong field performance continue.

Peter: Our team is ready to show the true potential of Shospari in this new year, and we have multiple inflection points throughout 2024 that provide confidence in continuing growth. Let me highlight the four areas that I am particularly excited about in the coming year. First, if we achieve full approval as targeted for later this year, we anticipate that an updated and potentially broader label would provide greater support for physicians to prescribe psilocybin to more of their patients. Thank you. As Jula mentioned earlier, we anticipate that Shospari will be included in the Global Cadego Guidelines, scheduled to be updated this year.

Speaker Change: Our team is ready to show the true potential of <unk>.

Speaker Change: New year, and we have multiple inflection points throughout 2024 that provides confidence in continuing growth.

Speaker Change: Let me highlight four areas in particular the size of the bulk in the coming year.

Speaker Change: Sure.

Speaker Change: If we achieve full approval is targeted for later this year, we anticipate that the operators and potentially broad label will provide greater support for physicians to prescribe for aspiring to more of their patients.

Speaker Change: Second.

Speaker Change: As Julia mentioned earlier, we anticipate that <unk> will be included in the global could EU guidelines scheduled to be updated this year.

Peter: This will potentially provide uniform guidance for physicians to choose Fiospari as an early treatment for their patients. Third, Additionally, if the guideline revision emphasizes earlier intervention by lowering the proteinuria target, it would likely amplify the urgency to diagnose and treat patients earlier. We believe this would increase the number of patients that would be eligible for Fils-Pari. And importantly, a broader label, together with a potentially lower target to treat earlier in the guidelines, would allow us to establish Fils-Pari as the foundational treatment in a larger, addressable patient population, and Forrest. We expect the additional clinical evidence you highlighted earlier will ultimately provide additional support for physicians to treat earlier-stage thyroid disease and use it in combination with other available medicines for patients that may need more progressive treatment. With all of this in mind, I could not be more excited about Phil Sparry's prospect in this new year.

Speaker Change: This would potentially provide uniform guidance for physicians to choose <unk> as an early treatment for their patients.

Speaker Change: Third Additionally.

Speaker Change: Additionally, if the guideline revision emphasizes familiar intervention by lowering the proteinuria targets.

Speaker Change: Likely amplified urgency to diagnose and treat patients earlier.

Speaker Change: We believe this would increase the number of patients that would be eligible fulfil study and importantly, a broader label together with a potentially lower target to treat earlier and the guidelines would allow us to establish <unk> as a foundational treatment in a larger addressable patient population.

Speaker Change: And fourth we expect the additional clinical evidence <unk> highlighted all year.

Speaker Change: Ultimately provides additional support for physicians to treat earlier was still sorry and use it in combination with other affordable medicines for patients that may need more aggressive treatment.

Speaker Change: With all of this is money.

Speaker Change: I could not be more excited about <unk> prospects in this new year and we feel strongly that we are well positioned for significant growth in 2024.

Chris Cline: And we feel strongly that we are well-positioned for significant growth in 2024. Let me now turn the call over to Chris for the financial update. Thank you, Peter, and good afternoon, everyone.

Speaker Change: Let me now turn the call over to Chris for the financial updates.

Yes.

Chris Klein: Thank you Peter and good afternoon, everyone.

Chris Cline: Following our fourth-quarter results, we're in a strong financial position. From an operational perspective, we continue to grow revenues, and we focus our investments on the ongoing launch of Philsipari and IgA nephropathy and the advancement of our Phase III Pact of Adenase program. For the fourth quarter of 2023, net product sales were $39.9 million, compared to $25.8 million for the same period in 2022

Chris Klein: Following our fourth quarter results were in a strong financial position from an operational perspective, we continue to grow revenues and we focus our investments on the ongoing launches thus far in Iga nephropathy, and the advancement of our phase III <unk> program for.

Chris Klein: For the fourth quarter of 2023 net product sales were $39 9 million compared to $25 8 million for the same period in 2022.

Chris Cline: The increase is attributable to growth in net product sales from the ongoing launch of Phil Sparri and IJ Nefrop. During the quarter, we also recognized $5.1 million of license and collaboration revenue, which results in $45.1 million of total revenue reported for the period, compared to $29.3 million of total revenue reported for the same period in 2022. Research and development expenses for the fourth quarter of 2023 were $59.7 million compared to $58.1 million for the same period in 2022. The difference is largely attributable to the continued advancement of our PEG-to-Batinase clinical program, partially offset by reduced investment in our Philospor A Phase III programs following the readouts from the two-year end. On a non-GAAP-adjusted basis, R&D expenses were $55.3 million for the fourth quarter of 2023, compared to $52 million for the same period in 2022. Selling general and administrative expenses for the fourth quarter of 2023 were $63.6 million, compared to $57.1 million for the same period in 2022.

Chris Klein: The increase is attributable to growth in net product sales from the ongoing launch thus far in Iga nephropathy.

Chris Klein: During the quarter. We also recognized $5 1 million of license and collaboration revenue, which results in $45 1 million in total revenue reported for the period compared to $29 3 million in the same period in 2022.

Chris Klein: Research and development expenses for the fourth quarter of 2023 were $59 7 million compared.

Chris Klein: Compared to $58 1 million for the same period in 2022.

Chris Klein: <unk> is largely attributable to the continued advancement of our <unk> clinical program, partially offset by reduced investment in our first foray phase III programs. Following the readouts from the two your endpoints.

Chris Klein: On a non-GAAP adjusted basis, R&D expenses were $55 3 million for the fourth quarter of 2023 compared to $52 million for the same period in 2022.

Chris Klein: Selling general and administrative expenses for the fourth quarter of 2023 were $63 6 million.

Compared to $57 1 million for the same period in 2022. The difference is largely attributable to the commercial launch related activities. Following accelerated approval, thus far in February of 2023.

Chris Klein: On a non-GAAP adjusted basis, SG&A expenses were $49 7 million for the fourth quarter of 2023 compared to $44 $3 million from the same period in 2022.

Chris Klein: During the fourth quarter, we recognized $11 4 million in restructuring fees related to the strategic reorganization that was announced in December.

Chris Cline: The difference is largely attributable to the commercial launch-related activities following the accelerated approval of FOSFARAE in February of 2023. On a non-GAAP-adjusted basis, SG&A expenses were $49.7 million for the fourth quarter of 2023, compared to $44.3 million for the same period in 2022. During the fourth quarter, we recognized $11.4 million in restructuring fees related to the strategic reorganization that was announced in December. Total charges related to the reorganization are expected to amount to between $12 and $14 million. So the other income net for the fourth quarter of 2023 was $5.7 million, compared to $1.1 million in the same period in 2022. The difference is largely attributable to an increase in interest income during the period. The net loss, including from discontinued operations, for the fourth quarter of 2023 was $90.2 million, or $1.18 per basic share, compared to a net loss of $65.8 million, or $1.03 per basic share, for the same period in 2022. On a non-GAAP-adjusted basis, the net loss, including from discontinued operations, for the fourth quarter of 2023 was $71.8 million, or $0.94 per basic share, compared to a net loss of $46.9 million, or $0.73 per basic share, for the same period of 2022.

Chris Klein: Total charges related to the reorganization are expected to amount to between 12 and $14 million.

Chris Klein: Total other income net for the fourth quarter of 2023 was $5 7 million compared to $1 1 million in the same period in 2022.

Chris Klein: The difference is largely attributable to an increase in interest income during the period.

Chris Klein: Net loss, including from discontinued operations for the fourth quarter of 2023 was $90 2 million or $1 18 per basic share compared to a net loss of $65 8 million or $1 <unk> per basic share for the same period in 2022.

Chris Klein: On a non-GAAP adjusted basis net loss, including from discontinued operations for the fourth quarter of 2023, with $71 8 million or <unk> 94 per basic share compared to a net loss of $46 $9 million or <unk> 73 per basic share for the same period 2022.

Chris Klein: As of December 31, 2023, the company had cash cash equivalents in marketable securities of $566 9 million.

Chris Klein: Looking ahead, we expect meaningful growth in net product sales, but thus far in 2024, and we look to achieve non-GAAP operating expenses below $400 million for the year. We also anticipate meeting milestones thus far impacted bad names that will result in us, making expected net payments of approximately $50 million during the year.

Chris Klein: With our strong balance sheet expected growth in <unk> revenues and measured investments. We currently expect that our cash balance can support operations into 2028.

Chris Klein: I will turn the call back over to Eric for his closing comments Eric.

Eric: Thanks, Chris we are entering a new phase of growth for <unk>. Our organization is well positioned with a strong financial foundation to continue advancing so far pegged about base as potential future treatment standards for their respective rare kidney and metabolic disorders. Moreover, These global markets collectively are.

Our projected to exceed $10 billion in the coming years.

Chris Cline: As of December 31st, 2023, the company had cash, cash equivalents, and marketable securities of $566.9 million. Looking ahead, we expect meaningful growth in net product sales at PhilSpara in 2024, and we look to achieve non-GAAP operating expenses below $400 million for the year. We also anticipate meeting milestones with both PhilSpara and PEG2Batinase that will result in us making expected net payments of approximately $50 million during the year. With our strong balance sheet, expected growth in POSFAR revenues, and measured investments, we currently expect that our cash balance can support operations into 2028. I'll now turn the call back over to Eric for his closing comments. Okay, Eric?

Eric: Our unrelenting drive is based on our desire to deliver life changing therapies to people affected by IGN, HBU and potentially SGS, who historically have had little to no innovation for their condition we.

Eric: See near term and long term growth through the following.

Eric: Continued strong execution of our <unk> launch.

Eric: The expected conditional approval of <unk> in the EU and full approval of <unk> for <unk> in the U S with potential broader labeling.

Eric: Updated <unk> treatment guidelines.

Eric: And further data generation to reach the growing number of patients in need of a better therapy.

Eric: Finally, I am, particularly excited about the advancement of our development program for <unk> is the only potential disease modifying therapy in a market that is expected to grow meaningfully over time. This year, we look forward to raising awareness of HBU and enrolling the phase III harmony study with the goal of achieving top line data in 2000.

Eric Dube: Thanks, Chris. We are entering a new phase of growth for Travere. Our organization is well-positioned with a strong financial foundation to continue advancing Fils-Fari and PEG-dibatinase as potential future treatment standards for their respective rare kidney and metabolic disorders. Moreover, these global markets are collectively projected to exceed $10 billion in the coming years.

Eric: 26.

Eric: Let me now turn the call over to Ann to open up the lines for Q&A.

Ann: Thank you Eric we can now open the line up for Q&A journey.

Okay.

Ann: Thank you if you'd like to ask a question. Please signal by pressing star one on your telephone keypad. If you are using a speaker phone. Please make sure. Your mute function is turned off to allow your signal to reach our equipment. As a reminder, we ask that you limit yourself to one question. If you have another question. Please rejoin the queue.

Ann: We will now take the first question from the line of Joseph Joseph Schwartz from Leerink Partners. Please go ahead.

Joseph Patrick Schwartz: Great. Thanks, very much and congrats on all the progress.

Eric Dube: Our unrelenting drive is based on our desire to deliver life-changing therapies to people affected by IGAN, HCU, and potentially FSGS, who historically have had little to no innovation for their condition. We see near-term and long-term growth through the following: continued strong execution of our FieldSparry launch, the expected conditional approval of Sparsenten in the EU, and full approval of Vilspari for IGAN in the U Updated IGANT treatment guidelines and further data generation to reach the growing number of patients in need of a better therapy.

Joseph Patrick Schwartz: I guess I'll ask on.

Joseph Patrick Schwartz: Sorry, how much does the higher hurdle.

Joseph Patrick Schwartz: <unk> had in the protect trial seem to resonate with the prescribing community do they appreciate that patients in the control arm were so well managed does this impress them or do you have more education to do in order for them to.

Joseph Patrick Schwartz: I appreciate <unk> relative to performance and protect.

Joseph Patrick Schwartz: Yes.

Speaker Change: Sure. Thanks, so much for the question Peter why don't I turn that over to you and perhaps you could also comment on what we saw coming out at HSN, where there was much more discussion about that.

Anne Cotto: Finally, I am particularly excited about the advancement of our development program for PEG-2-Batinase as the only potential disease-modifying therapy in a market that is expected to grow meaningfully over time. This year, we look forward to raising awareness of HCU and enrolling the Phase III Harmony Study with the goal of achieving PropLine data in 2026. I will now turn the call over to Anne to open up the lines for Q&A.

Peter Hermann: The protect trial and trial design.

Peter Hermann: Yes, I'll take that question, Joe I would say that the conversations I've had with.

Peter Hermann: With physicians and I think it's also being on the line as the market research.

Peter Hermann: Results that we saw.

Peter Hermann: Outline the study design of protest.

And the understanding of like an active control arm is a new students there is really like great appreciation for the.

Peter Hermann: For the very robust results that we had you have highlighted really Nicole.

Operator: Thank you, Eric. We can now open the line up for Q&A. Thank you. If you'd like to ask a question, please signal by pressing star 1 on your telephone keypad. Please make sure your mute function is turned off to allow your signal to reach our equipment.

Peter Hermann: One seven.

Peter Hermann: Minutes per year.

Peter Hermann: And then the second thing is actually three 7000 per minute per year. So accumulation will benefit over time and I think that is something that the physicians.

We signed really.

Peter Hermann: And Kyle.

Joseph Patrick Schwartz: As a reminder, we ask that you limit yourself to one question. If you have another question, please rejoin us. We will now take the first question from the line of Joseph Schwartz. From larynx partners, please go ahead.

Speaker Change: Okay, great. Thank you want to comment.

Kyle: Thank you Joe Joe is there anything that you'd like to comment from your team engagement with thought leaders on that trial design.

Speaker Change: The high bar.

Peter: Great. Thanks very much, and congratulations on all the progress. I guess I'll ask Phil Sparey, how much does the higher hurdle that Sparey had in the PROTECT trial seem to resonate with the prescribing community? Do they appreciate that patients in the control arm were so well managed? Does this impress them, or do you have more education to do in order for them to appreciate Phil Sparey's relative performance in PROTECT? Joe, thanks so much for the question. Peter, why don't I turn that over to you?

Joe: Yes, I think it does take some agitation because all the other trials are comparing Q are not fully optimized standard.

Speaker Change: Now historically, 50% in really all the other trials.

Speaker Change: <unk> got a higher hurdle and so well.

Joe: See the comparison in the slopes most of which they don't look at in their clinical practice. It takes some education to look at the benefit and then also the accrual of benefit that we should see we only get a two year snapshot, but you know that if you have a benefit that's better in year two versus tier. One then that's going to continue to improve year over year.

Peter: And perhaps you can also comment on what we saw coming out of ASN where there was, you know, much more discussion about the PROTECT trial and trial design. Yeah, I have to take that question, Joe. I would say that the conversations I've had with physicians, and I think that it's also underlined by the market research results that we saw. But if we outline the study design of PROTECT and the understanding of an active control arm is understood, there's really great appreciation for the very robust results that we have. You highlighted early in the goal 1.7 mL per minute per year improvement. And then in the second year, it's actually 3.7 mL per minute per year.

Joe: So it does take some time, but they get it once they spend some time with the data and information.

Joe: And I think this is going to be under a very important part of why we're eager to have full approval and a label that will allow us to talk about that long term benefit and how the trial designed really does help explain why we see such great results throughout the two years.

Speaker Change: Very helpful. Thanks.

Speaker Change: Okay.

Speaker Change: And our next question is going to come from Greg Harrison from Bank of America. Please go ahead.

Greg Harrison: Hey, guys. Good afternoon, congrats on the progress and thanks for taking the question.

Greg Harrison: Just thinking through the again treatment landscape.

Peter: So an accumulation of benefit over time. And I think that is something that physicians, if they understand the design, really speak highly of. Thank you, Jill.

Greg Harrison: And when it comes to the comparing different treatment options, especially in light of recent data is it fair to say that the.

Speaker Change: Focus for investors should be.

Jula: Jill, is there anything that you'd like to comment on your team's engagement with thought leaders on that trial design and the high bar? Yes, I think it does take some education because all the other trials are comparing to a not fully optimized standard, which we know historically 50% and really all the other trials aren't. But yes, we have a higher hurdle. And so when they initially see the comparison and the slope, most of which they don't look at in their clinical practice, it takes some education to look at the benefit and then also the accrual of benefit that we can see.

Greg Harrison: The Egfr benefit or is there a better way to think about it.

Speaker Change: Great. Thanks, so much for the question I think the very short answer is no, but I'm going to let Julie talk a bit more about what she is a nephrologist and what you're hearing from thought leaders about the evolving treatment landscape and the importance of Egfr at proteinuria jeweler.

Julie: First I'll start with with Proteinuria and Egfr both matter for how we take care of patients and I'll highlight that proteinuria is really critical for nephrologist for patients and for regulators for evaluating and looking at risk as well as response to treatment over time.

Jula: We only did a two-year snapshot, but you know that if you have a benefit that's better in year two versus year one, then that's going to continue to improve year over year. So it does take some time, but they understand it once they spend some time with the data and the information. And I think this is going to be, Joe, a very important part of why we're eager to have full approval and a label that will allow us to talk about that long-term benefit and how the trial design really does help explain why we saw such great results throughout the two years. Very helpful. Thanks. And our next question is going to come from Greg Harrison from Bank of America. Hey guys, good afternoon.

Julie: As the proteinuria changes can occur more quickly versus GFR changes require many years to show effect.

Julie: And I would say importantly, multiple datasets show a strong correlation between throat.

Julie: Gary reductions overtime and risks of kidney.

Julie: That's why it's an approvable endpoint for accelerated approval.

Julie: We also know that we need to get patients as close to normal as possible. When you look at the rate.

Julie: <unk> remain at risk if they are at that 0.44 grams per day, so getting patients closer to normal with regards to Maria is very important realized we saw one three patients.

Julie: Also sorry, and protect achieve complete remission of proteinuria and so far as just both reductions in proteinuria and Egfr preservation that accrues over time. So I think all of those are important factors to take into consideration.

Greg Harrison: Congratulations on the progress and thanks for taking the question. I'm just thinking through the IGAN treatment landscape. And when it comes to comparing different treatment options, especially in light of recent data, is it fair to say that the focus for investors should be on the EGFR benefit, or is there a better way to think about it? Greg, thanks so much for the question. I think the very short answer is no, but I'm going to let Jula talk a bit more about what she thinks as a nephrologist and what she's hearing from thought leaders about the evolving treatment landscape and the importance of EGFR and proteinuria.

Speaker Change: Got it that's helpful. Thanks, a lot.

Speaker Change: Thanks, Greg.

Speaker Change: I'm sorry go ahead.

Speaker Change: No no. Please go ahead I was just thinking the lessons.

Speaker Change: First one.

Speaker Change: Okay. Our next question is going to come from <unk> Rama from Jpmorgan. Please go ahead.

Rama: Hey, guys. Thanks, so much for taking the question.

Rama: Get a little bit more of a kind of an acute question as we think about <unk> in the first quarter any guidance about how we should be thinking about payer reauthorization any seasonality.

Rama: Considerations in the quarter.

Rama: Paul Thanks for the question, let me just first say that Peter's team has done a really great job starting the year strongly and we've seen good good performance Peter why don't I turn it over to you to talk a bit more about what we expect to see in those dynamics for Q1, recognizing that we have not and will not be providing guide.

Jula: Thanks. First, I'll start with proteinuria and EGFR. Both matter for how we take care of patients, but I'll highlight that proteinuria is really critical for nephrologists, for patients, and for regulators for evaluating and looking at risk as well as response to treatment over time, as proteinuria changes can occur more quickly versus the EGFR changes, which require many years to show effect.

Rama: So I think certainly Peter can talk about some of those some of those dynamics in more detail here.

Peter Hermann: Yes, happy to Eric Yes, as I mentioned earlier I think.

Jula: And I would say, importantly, multiple data sets show a strong correlation between protein area reductions over time and risk of kidney failure. That's why it's an approvable endpoint for accelerated approval. And we also know that we need to get patients as close to normal as possible. When you look at the rate, they can still remain at risk if they've got 0.44 grams of sugar per day. So getting patients closer to normal with regard to their protein area is very important, and Filspari in PROTECT achieves complete remission of proteinuria. And Filspari shows both reductions in proteinuria and EGFR preservation that accumulates over time.

Peter Hermann: Cross the three golar fundamentals of launching a product that we made really substantial progress.

Peter Hermann: In particular like it is in I think really allowed for building get momentum that we saw late in <unk>.

Peter Hermann: <unk> prescriptions in particular film thought leaders, but we also saw a good.

Peter Hermann: Progress in our pull through and getting patients home based product and I think across the fundamentals we see that continue.

Peter Hermann: A continuation of progress in the first six weeks of this year as well I think to your more specific questions like what is the insurance resets and reauthorization criteria, meaning 40 gross to net in the first quarter. While this is the first year, we relaunched youll salaries, that's going to be a new earnings. So we don't know that yet, but if I look at the fundamentals.

Jula: So I think all those are important factors to take into consideration. Yeah, that's helpful. Thanks a lot. Thanks, Greg. Sorry, go ahead. No, no, no, please go ahead. I was just thinking the last one, versatile.

Peter Hermann: Really pleased with the progress we have been making.

Speaker Change: Thanks, so much for taking the question.

Speaker Change: Thank you.

Speaker Change: And our next question is when it comes from Tyler Van Buren.

Speaker Change: From TD Cowen. Please go ahead.

Speaker Change: Hey, guys. Good afternoon, thanks for taking the question.

Speaker Change: So as part of the NDA submission by the end of the first quarter for the full approval for <unk> does that include a request to have the black box and rubs warning removed.

Anupam Rama: Okay, our next question is going to come from Anupam Rama from J.P. Morgan. Please go ahead. Hey guys, thanks so much for taking the question. A little bit more of a kind of acute question as we think about Phil Sparri in the first quarter, any guidance about how we, We're talking about pair reauthorizations and any seasonality considerations in the quarter. Anupam, thanks for the question. Let me just say that Peter's team has done a really great job starting the year strongly, and we've seen good performance. Peter, why don't I turn it over to you to talk a bit more about what we expect to see in those dynamics for Q1, recognizing that we've not and will not be providing guidance, but I think Peter can talk about some of those dynamics in more detail. Peter?

Speaker Change: So can you describe to us how you supported that request.

Speaker Change: So thanks, so much for the questions Hi, there Joe why don't I first turn to you to talk about the data that we've seen from a safety standpoint, and then Bill certainly you can add what we're thinking in terms of engagement with FDA during the <unk> process.

Bill Rote: So I want to highlight that across our development program and first year of commercial launch, including patients who we've had in some of our trials on treatment for up to 10 years, we have had a couple cases Rodriguez.

Speaker Change: Perfect.

Speaker Change: Now I would note that there is at historic repressed removal of the monitoring I'm sure that we certainly are going to advocate for the best prospects for patient switch.

Peter: Yeah, happy to Eric. Yeah, as I mentioned earlier, I think across the three core fundamentals of launching a product, I think we made really substantial progress. And in particular, like ASN, I think really allowed for building that momentum; we saw an increase in prescriptions, in particular from pod leaders. We also saw good progress in our pull through and getting patients on paid products. And I think across the fundamentals, we see that continuation of progress in the first six weeks of this year as well. And on your more specific question, like what is the insurance reset and reauthorization criteria we need for growth to materialize in the first quarter? Well, this is the first year we launched SoftVirus. That's going to be a new learning experience.

Rodriguez: Entering the fleet.

Rodriguez: Bill.

Rodriguez: Further on our process.

Speaker Change: Yes with the <unk>.

Speaker Change: The anniversary of the approval, we will be submitting our first annual rems uptake, which will highlight the data that we've collected around liver safety and we will also be submitting the NDA this quarter, which will give the full two year data.

Speaker Change: In the protect study both of those give us.

Speaker Change: A launching point to begin the dialogue.

Speaker Change: Around a potential modification of the Rems program.

Speaker Change: At the end of the day, we need to start this dialogue, we don't know what the Fda's response will be.

Peter: So we don't know that yet. But if I look at the fundamentals, I'm really pleased with the progress we have been making. Thanks so much for taking our questions. Thank you. And our next question is going to come from Tyler Van Buren, from TD Cowan. Please go ahead. Hey guys, good afternoon.

Speaker Change: But it's really important for us to have the data that we have now and to begin the conversation and these interactions with the agency.

Speaker Change: Okay.

Speaker Change: Okay and our next question will come from Carter Gould from Barclays. Please go ahead.

Carter Gould: Good afternoon, and thanks for taking the question and congrats on the.

Tyler Van Buren: Thanks for taking the question. So as part of the FNDA submission by the end of the first quarter for full approval of Asfari and IGAN, does that include a request to have the black box and REMS warning removed? And if so, can you describe to us how you supported that request?

Carter Gould: Pick up in sales.

Carter Gould: What I mentioned of momentum an inflection on the call there.

Carter Gould: Then you start form increase was somewhat more modest.

Carter Gould: I guess I'm trying to understand.

Carter Gould: Is that sort of mid single digit increase in new start forms probably a fair characterization of what we should expect going forward until those inflection points that Peter mentioned sort of hit it does seem like those are back end weighted.

Jula: So, thanks so much for the questions, Tyler. Jula, why don't I first turn to you to talk about the data that we've seen from a safety standpoint? And then, Bill, certainly you can add what we're thinking in terms of engagement with FDA during the S&DA process. Thanks. So I want to highlight that across our development program and first year of commercial launch, including patients who we've had in some of our trials on treatment for up to 10 years, we have had full cases of drug-induced liver cancer with Sparsan. Now I do want to note that there isn't historical precedent for removal of the lupus monocytogenes disjuncture, but we certainly are going to advocate for the best process for patients, which may include changing the frequency of testing.

Speaker Change: Any color commentary would be appreciated thank you.

Speaker Change: Carter. Thanks, so much for the question.

Carter Gould: I would say that Peter can speak to some of the qualitative and directional approach that we expect to see throughout the year for both patient start forms and demand we will not be providing guidance on those for the year, but we certainly do expect to see a strong year of our.

Performance, particularly in revenue, but Peter why don't you talk in a bit more detail, but what we can expect to see moving forward.

Jula: So Bill, do you want to comment further on our process? Yeah, with the anniversary of the approval, we will be submitting our first annual REMS update, which will highlight the data that we've collected around liver safety, and we'll also be submitting the SNDA this quarter, which will give the full two-year data from the PROTECT study. Both of those give us a launching point to begin the dialogue around a potential modification of the REMS program. At the end of the day, we need to start this dialogue.

Peter Hermann: Yes. Thank you Scott for the question I think it's the correct position that you have.

Peter Hermann: You have to take it into context of.

Peter Hermann: A prescriber base that has very little innovation in the last 30 to 40 years and so I think the adaptation it takes time to educate the broader community.

Peter Hermann: And get to the prescriber base and within that context, I think the growth that we're showing in Q4 and basically in every quarter in the first year and I think what I called out really here is that this.

Bill: We don't know what the FDA's response will be, but it's really important for us to have the data that we have now and to begin the conversation and these interactions with the agency, and our next question, from Carter Good, from. Go ahead. Good afternoon.

Peter Hermann: This is the first reason ran for LG launched where you see this continual growth.

Peter Hermann: That is something that is the data we expect each year the guidelines to be updated and there is a good momentum to show continuation of growth in basic thoughts forms and more importantly, ultimately in revenue as well.

Carter Good: Thanks for taking the question and congrats on the pickup in sales. A lot of mentions of momentum and inflection on the call there. The new start form increase was somewhat more modest. I guess I'm trying to understand, you know, is that sort of mid-single-digit increase in new start farms probably a fair characterization of what we should expect going forward until those inflection points that Peter mentioned sort of hit, because it does seem like those are back-end weighted. Any caller or commentary would be appreciated.

Speaker Change: I think I understand your question, but I think you have to think gets into consideration with an audience that is may.

Maybe not used two different innovation and really requires education.

Speaker Change: With the experience that they are gaining and thats. What we are seeing right. Now is the best advocates for further use and fill the prescription and yes, where we are right now so I think in the first set of loans to have the continued growth that we saw and really pleased with.

Speaker Change: Very helpful. Thank you.

Murray Raycroft: Our next caller is gonna be Murray wrote Raycroft from Jefferies. Please go ahead.

Murray Raycroft: Hi, Congrats on the progress and thanks for taking my question.

Peter: Thank you. Carter, thanks so much for the question. You know, I say that Peter can speak to some of the qualitative and directional trends that we expect to see throughout the year for both patient start forms and demand. We will not be providing guidance on those for the year, but we certainly do expect to see a strong year for our performance, particularly in revenue. But Peter, why don't you talk in a bit more detail about what we can expect to see moving forward? Yeah, thanks for that question. I think it's the characterization that you have chosen.

Murray Raycroft: For the EU you initially had filed for conditional approval and it sounds like that's what you were expecting this quarter, but then you submitted the two year data to the EU, which led to the clock stop.

Murray Raycroft: Is it possible you could get full approval in the EU I guess is there any possibility for that or will it still be conditional and has EMA provided any feedback after reviewing your two year data.

Speaker Change: Good morning. Thanks, so much for the question Bill I'll pass that over to you.

Peter: You have to take it into context of a prescriber base that has had very little innovation in the last 30 to 40 years. And so I think the adaptation takes time to educate the broad community and reach the prescriber base. And within that context, I think the growth that we're showing in Q4, and basically in every quarter in the first year, and I think what I called out earlier is that this is the first recent rare nephrology launch where you see that completely low growth.

Bill Rote: Sure well, we remain optimistic about the positive <unk> decision there'll be made this this first quarter.

Bill Rote: The two year data I think it was helpful for the EMA and making their decision because it essentially removes the regulatory risk associated with their equivalent of accelerated approval. There wasn't discussion of potential full approval and there are aspects of the data package that they don't have yet.

Peter: I think that with the data we expect this year, the guidelines to be updated, that there is good momentum to show a continuation of growth in patient thought forms, and more importantly, ultimately, in revenue as well. So I think I understand your question, but yet, I think you have to take into consideration an audience that is maybe not used to that much innovation and really requires education and with the experience that they're gaining, and that's what we are seeing right now, is the best advocate for further use and further prescription, and that's where we are right now. So I think in the first year of long-term health, the continual growth that we saw, I'm really pleased with that. Very helpful. Thank you. And our next caller is going to be Murray Raycroft from Jefferies. Please go ahead.

Bill Rote: The full <unk>.

Bill Rote: Tables figures in listings warrant provided more of a top line.

Bill Rote: Look at the two year data, so I wouldn't expect a full approval with this round.

Speaker Change: Got it and his DMA provided any feedback after seeing the two year data that they've seen.

Speaker Change: No there wasn't an opportunity in the process for feedback from that.

Speaker Change: At this point in time I'm sure will have dialogue as we go toward full.

Speaker Change: Full approval.

Speaker Change: Got it okay. Thanks for taking my questions.

Maury Raycroft: Hi, congrats on the progress, and thanks for taking my question. For the EU, you initially filed for conditional approval, and it sounds like that's what you're expecting this quarter. But then you submitted the two-year data to the EU, which led to the clock stopping. So is it possible you could get full approval in the EU? I guess, is there any possibility for that?

Speaker Change: Certainly thank you.

Speaker Change: Our next person is going to be Tim Lugo from William Blair. Please go ahead.

Speaker Change: Taking him this is John on for Tim. Thanks, So much for taking our question.

Speaker Change: So just wondering if you have any sense on if the agency might require an AD com to discuss conversion to full approval.

John: And as a follow up if you have any sense on the last date that you might be informed.

Bill: Or will it still be conditional? And has EMA provided any feedback after reviewing your two-year data? Maury, thanks so much for the question. Bill, I will pass that over to you.

John: Some might be required.

John: Yeah.

John: John Thanks for the questions Bill I'll pass it back to you.

Bill: Sure. Well, we remain optimistic about the positive CHMP decision that will be made this first quarter. The two-year data, I think, was helpful for the EMA in making their decision because it essentially removes the regulatory risk associated with their equivalent of accelerated approval. There wasn't any discussion of potential full approval, and there are aspects of the data package that they don't have yet. The full tables, figures, and listings weren't provided.

John: Sure.

John: I don't think that this is the type of <unk>.

John: <unk> decision, where the agency would seek advice from an advisory Committee.

John: The data is quite clear so there isn't a need to go out to additional external experts to help interpret trial results and I think also there is a controversial aspect of this so I don't anticipate that the agency will panel an advisory committee certainly if they do we.

Bill: It's more of a top-line look at the two-year data, so I wouldn't expect a full approval with this round. Got it. And has VMA provided any feedback after seeing the two-year data that they've seen? No, there wasn't an opportunity in the process for feedback from that. At this point in time, I'm sure we'll have dialogue as we go toward full approval.

John: We will be ready.

John: Your the second part of your question was the timing generally the agency will let sponsors know within 60 days of submission.

John: Whether or not theyre going to have an AD com or not so if we submit in the first quarter by mid to late <unk>.

Bill: Okay, thanks for taking my call. Certainly. Thank you. Tim Lugo from William Blair, please go ahead. Hey, team, this is John on behalf of Kim.

John: Second quarter, we will know whether or not we're going to be going for an ad com.

Speaker Change: Very helpful. Thanks.

Speaker Change: Certainly.

And our next question is going to come from Lisa <unk> from Evercore ISI. Please go ahead.

John: Thanks so much for taking our question. So, just wondering if you have any idea on if the agency might require an adcom to discuss conversion to full approval. And as a follow up, if you have any sense on the last date when you might be informed that an adcom might be required. John, thanks for the questions. Bill, I'll pass that back to you. Sure, but I don't think that this is the type of regulatory decision where the agency would seek advice from an advisory committee. I think the data is quite clear, so there isn't a need to go out to additional external experts to help interpret trial results. And I also think there isn't a controversial aspect to this. So I don't anticipate that the agency will set up an advisory committee.

Lisa: Hi, Thanks for taking my questions do you have any more.

Lisa: More <unk>.

Lisa: Mueller on when the new guidelines there will be relief.

Lisa: July.

Lisa: We know they're working on it now, but I can't provide any more color other than we are anticipating potentially this quarter and that means that would be finalized later in the year.

Lisa: But we know like networks.

Lisa: Okay.

Lisa: You mentioned the compliance rate for good.

Lisa: And can you speak to kind of where you are with compliance and also.

Lisa: So.

Lisa: Can you describe growth for that for the year like what what kind of average for the year are expected to be thinking about or one with normalized.

Speaker Change: Sure that'd be helpful.

Speaker Change: Sure Peter I'll turn that over to you.

Peter Hermann: I'll take the question on nickel buys increase maybe you can take the gross to net them. So all of the compliance rate.

Bill: Certainly, if they do, we will be ready. The second part of your question was the timing. Generally, the agency will let sponsors know within 60 days of submission whether or not they're going to have an ad com or not.

Peter Hermann: If you look at benchmark for chronic disease without.

Peter Hermann: And non symptomatic disease overall compliance rates are very high we received was still story. So far it is actually really high.

Bill: So if we submit in the first quarter by, you know, mid to late second quarter, we will know whether or not we're going to be going for an ad. Very helpful, thanks. And our next question is going to come from Liisa Bayko from Evercore ISI. Hi, thanks for taking the question. Do you have any more color on when the new guidelines will be released? Good luck. We know they're working on it now, but I can't provide more color other than we were anticipating potentially this quarter, and that means it would be finalized later in the year. But we know it's in the works. Okay, you mentioned compliance rates were good, and can you speak to kind of where you are with compliance and also, you know, can you describe growth for the year? Like, what kind of average for the years that you'd be thinking about or what was normalized?

Eitan will be anticipated, especially when you also have a rems program with monitoring request linsley liver testing. So so far we see very strong compliance rates I think it speaks also experienced patients are heavy in the first foundation seed that being control to the target levels.

Peter Hermann: You have to take into considerations like a lot of those patients they feel that they are losing.

Peter Hermann: Over the course of their disease.

Peter Hermann: The time from the physician that.

Peter Hermann: On the target and I think no we're still salary they feel like Hey, you know what we are able to to reach that's already something that is motivated basis to continue to use the product.

Peter Hermann: And that's why I think we see also a high compliance rates.

Peter: Sure, Peter, I'll turn that over to you. I'll take the question on compliance, and Chris, maybe you can take the gross on that one. So, on the compliance rate, like, if you look at benchmarks for chronic disease without a non-tested symptomatic disease, overall compliance rates are not very high. But what we see with Schultz-Powry so far, it is actually really high.

Peter Hermann: And then just on the gross to net.

Peter Hermann: We've been pleased with how we've seen things meet our expectations of having a mid to high teens growth and that the only thing that I would say is for <unk> with the reset of the year, we may see that'd be a little bit higher as we have with some of our other products in the past, but overall for the year, we would expect it to remain in that mid to high teens level.

Peter Hermann: Okay.

Peter: It's higher than what we anticipated, especially when you also have a REMS program with, like, monitoring that requires monthly liver testing. So, so far, we see very strong compliance rates. I think it speaks also to the experience patients are having, and that's for the first time they actually see that they're being controlled to the target levels. And I think you have to take into consideration, like, a lot of those patients feel that they're losing. I mean, over the course of their disease, they hear every time from their physicians that they're not yet on target, and I think now with Schultz-Powry, they feel like, hey, you know what?

Peter Hermann: Okay.

Speaker Change: And then can you comment at all on like how many patients were on kind of exiting 2023 Anvil anvil sorry.

Speaker Change: So we've not provided guidance for any kpis on number of treated patients.

Speaker Change: Peter can talk about Directionally, what we were seeing.

Peter Hermann: As we ended the year, but at least we're going to continue to provide updates on TFS on.

Peter Hermann: Payer coverage and on revenue at this point in the launch.

Peter Hermann: Peter you want to provide any thoughts anything further to answer this question.

Peter: We are able to reach the target, and I think that is motivating patients to continue to use the product, and that's why I think we also see high compliance. And Liisa, just on the grossed-in-abs, we... We've been pleased with how we've seen things meet our expectations of having a mid to high teens gross net. The only thing that I would say is for 1Q with the reset of the year, we may see that be a little bit higher as we have with some of our other products in the past, but overall for the year, we would expect it to remain in that mid to high teens level.

Peter Hermann: As I mentioned earlier I think we are making robust progress on <unk>.

Peter Hermann: All the fundamentals, including the Bulls, who were getting based on based products.

Peter Hermann: I think the process is well within benchmarks, which you would expect from Muslim rare disease products.

Peter Hermann: So I think we will see that continuation and that will be reflected by revenue as well to Eric's point.

Speaker Change: Okay. Thanks.

Speaker Change: The question is going to come from <unk> <unk> from Guggenheim. Please go ahead.

Speaker Change: Great. Thanks for taking my question, maybe just a couple of follow ups on the payer side. So I think Peter I think you mentioned in your prepared remarks that it.

Speaker Change: Payers are there.

Chris Cline: Okay, and then can you comment at all on like, how many patients were kind of exiting 2023 on PhilSparry? So we've not provided guidance or any KPIs on a number of treated patients. I think Peter can talk about directionally what we were seeing as we ended the year. But Lisa, we're going to continue to provide updates on PSF on payer coverage and on revenue at this point in the launch. Peter, do you want to provide anything further to answer this question? Well, I think that's right, Erik.

Speaker Change: So I think generally consistent with the label in terms of the patient that they are.

Peter Hermann: Reimbursing third before I'm curious if maybe you can just give a little more detail there.

Terms of when they are deviating from the label sort of what issues. If any are they sort of raising and then the second question I had was more around the full approval assuming you get that sort of later in this year would.

Peter Hermann: Would you expect sort of a sort of immediate change in sort of payer behavior.

Peter Hermann: Or is that something we have to wait until sort of the.

Peter Hermann: 2020 for 2025 cycle starts up in terms of formulary status or.

Peter: As I mentioned earlier, I think we're making robust progress on all the fundamentals, including the pulse through getting patients on-page products. I think the process is well within both benchmarks, which you would expect from rare disease products. So I think we will see that continuation, and it will be reflected by revenue as well to a large point. Okay, thanks. Thank you. Where do you come from, from Mil-De-Val?

Peter Hermann: Authorizations.

Peter Hermann: Alright, Peter I'll hand, it over to you.

Peter Hermann: Yes, very good with regards to authorization criteria I mean, there's always certain payers.

Peter Hermann: Bayer is expecting to soon.

Peter Hermann: And so I think where we are is that especially in the beginning when we got the label and the label is going to save on patients with rapid progression of disease with regards to the newly added states like generally one five.

Peter: Go ahead. Great, thanks for taking my question. Maybe just a couple of follow-ups on the payer side. So I think, Peter, I think you mentioned in your prepared remarks that payers are acting generally consistent with the label in terms of the patients that they're reimbursing therapy for. I'm curious if maybe you can just give a little more detail there in terms of when they're deviating from the label, sort of what issues, if any, they are raising.

Peter Hermann: We are seeing that.

Peter Hermann: And most of the authorization criteria referred to the label, but also referred to refer to the <unk> guidelines and it has lower both Neil you have targets that allows for broader use and.

Peter Hermann: And just wanted to my earlier point and the goal.

Peter: And then the second question I have is more around the full approval, assuming you get that through later in this year. Would you expect sort of a sort of immediate change in sort of payer behavior on that? Or is that something we probably wait until sort of the 2024-2025 cycle starts up in terms of formulary status or authorization? All right, Peter, I'll hand those over to you. Yeah, very good.

Peter Hermann: With a further lowering of the profit targets.

Peter Hermann: <unk> the company is like a broader label fulfilled.

Allowed and also for the broader patient population that's eligible for <unk> products.

And then Peter what does your comment on.

Peter Hermann: The question around full approval and how payers will respond with full approval and how quickly they might be able to review.

Peter Hermann: Yes, so I think it speaks a little bit to what I said was a further lowering of southern <unk> targets and then also a broader label where there is no restriction in proteinuria.

Peter: With regard to authorizing criteria, I mean, there are always certain aspects that the payer is expecting to see. And so I think where we are is that, especially in the beginning when we got the label, and the label was kind of fake for patients with rapid progression of disease with regard to proteinuria, it states, generally, 1.5, when we are seeing that payers in most of the authorization criteria refer to the label but also refer to the Cadego guidelines, and it has lower proteinuria targets, so that allows for a broader use. And that's why, to my earlier point in the call, like, with a further lowering of the Propamiria targets within the Cadigo lines, a company with, like, a broader label for filasparin that would allow it to also market it to a broader patient population that is eligible for paid products.

Peter Hermann: That authorization criteria or almost thresholds from Yulia may disappear and so that allows for a broad patient population I think thats one aspect.

Peter Hermann: I think another aspect is.

Peter Hermann: I think your question may have been.

Peter Hermann: Referring to like the evolving competitive landscape as well as your competition coming in I think the lead times that we have and the strong base that we have in formularies provides a very strong position, especially since we have like the.

Peter Hermann: The highest standards for study design I mean this is the only study that has an exit comparator, which is basically the gold standards.

Peter Hermann: <unk>.

Speaker Change: There is.

Peter: And then Peter, what is your comment on the question around full approval and how payers will respond to full approval and how quickly they might be able to review it? Yeah, so it speaks a little bit to what I said. With a further lowering of potonuria targets and then also a broader label, where there is no restriction on potonuria, the authorization criteria on a threshold of potonuria may disappear, and so that allows for a broader patient population. I think that's one aspect.

Speaker Change: Evaluating new products. So I think we are in a strong position with regards to lead times as well as study design, how payers are evaluated yet bolting landscape.

Speaker Change: Okay. Thank you.

Speaker Change: Yeah.

Speaker Change: And our next question is going to come from Alex Thomson from Stifel. Please go ahead.

Alex Thomson: Hey, great. Thanks for taking my question I want to pivot a little bit to take the bad next year, maybe could you talk a little about the harmony study through the expectations around enrolling 70 patients or at least up to 70 patients based on your experience with the phase one two.

Peter: I think another aspect is, and I think your question may have been referring to the evolving competitive landscape as well, with new competition coming in. I think the lead time that we have and the strong base that we have in formulas provides a very strong position, especially since we have the highest standards for study design. I mean, this is the only study that has an active competitor, which is basically the gold standard for how a payer is evaluating a new product. So I think we are in a strong position with regard to lead time as well as study design and how payers are evaluating the evolving landscape. Okay, thank you. The next question is going to come from Alex, from Cypher.

Alex Thomson: How well identified to are these patients.

Alex Thomson: If this is a 12 week primary endpoint at the top line is it 2026 readout conservative at this point or how are you thinking about that thanks.

Alex Thomson: Alex Thanks, so much for the question and also for the focus on the piggyback based programs drove I'll turn that one over to you.

Alex Thomson: So.

Alex Thomson: We think this is an exciting trial design that focuses on changes in total <unk> 15, not just.

Alex Thomson: Six to 12 weeks, but also looking at durability of effect. So it is a 24 week study and then patients rollover to our open label, which is able to look at diet mobilization and to your point. We are looking to recruit 70 patients from more sites than we get from compose its about 50 sites overall, which will give us top line.

Alex: Yeah, great. Thanks for taking my question. I want to pivot a little bit to Peg the Bat this year.

Jula: Maybe you could talk a little bit about the Harmony study, your expectations around enrolling 70 patients, or at least up to 70 patients, based on your experience with the Phase I-II studies, you know, how well identified are these patients? You know, if this is a 12-week primary endpoint with the top line, is 2026, you know, readout conservative at this point, or how are you thinking about that? Thanks. Alex, thanks so much for the question and also for the focus on the Peg-to-Bat Mace program.

Alex Thomson: Later in 2026, and while we have started the trial and we do have a list of patients who are excited to participate.

Alex Thomson: We are intentionally moderating our enrollment initially to ensure we havent good experience with the sites and patients and also proper training at some of these sites some of which are research named and then also to ensure our CMC scale up to support the full study as well as commercialization.

Jula: Jula, I'll turn that one over to you. So, thanks. We think this is an exciting trial design that focuses on changes in total homocysteine, not just at 6 to 12 weeks but also looking at durability of effects. So it is a 24-week study, and then patients roll over to our open label, which is able to look at diet liberalization. And to your point, we are looking to recruit 70 patients from more sites than we did with Compose. It's about 50 sites overall, which will give us top-line data in 2026.

Alex Thomson: So I think perhaps if you can comment on the.

Alex Thomson: The enrollment period for <unk>.

Alex Thomson: Screening that it helps explain why the timeline, maybe a bit longer than what people were typically fixed but for this type of trial.

Speaker Change: Yes. Thanks, so because it is a six month trial plus we have a 10 week run in period, where patients get screened to make sure. They qualify as well as standardize their diet and thats really to try and optimize our chance of success that patient will have them understand the trial that they need to keep their diet, which clearly is going to impact you.

Jula: And while we have started the trial, and we do have a list of patients who are excited to participate, we are intentionally moderating our enrollment initially to ensure we have a good experience for the sites and patients, and also proper training at some of these sites, some of which are research-naive, and then also to ensure our CMC scale-up to support the full study as well as commercialization. So I think perhaps if you can comment on the enrollment period for screening, it helps explain why the timeline may be a bit longer than what people would typically think for this type of trial. Yes, thanks.

Speaker Change: Endpoint and we wanted to maximize our chance for success at the end so it's a bit longer than what you first stated.

Speaker Change: Yes, we will certainly look to move swiftly on this but we.

Speaker Change: For all of the reasons that you have explained.

Speaker Change: We have been very thoughtful around the timelines that we've put out there Alex the only other thing that I would mention that that gives us confidence in the enrollment is that as we see.

Jula: So because it is a six month trial, plus we have a 10 week run-in period where patients get screened to make sure they qualify, as well as standardize their diet. And that's really to try and optimize our chance of success, patients have to understand the trial that they need to keep their diet stable, which clearly is going to impact your endpoint. We want to maximize our chance of success at the end. So it's a bit longer than what you first stated.

Speaker Change: The increased awareness within the community there are more and more patients that are being identified and we would absolutely expect that there will be a growth in the number of patients identified diagnosed in the overall market growth. So this is something that we believe will certainly be a tailwind for us with the harmony trial and.

Speaker Change: Even more so as we look to reach these patients once we have approval.

Eric Dube: Yeah, and we'll certainly, you know, look to move swiftly on this, but we, you know, for all of the reasons that you've explained, we've been very thoughtful around the timelines that we've put out there. Alex, the only other thing that I would mention that gives us confidence in the enrollment is that, you know, as we see increased awareness within this community, there are more and more patients that are being identified. And we absolutely expect that there will be a growth in the number of patients identified, diagnosed, and overall market growth. So this is something that we believe will certainly be a tailwind for us with the Harmony trial and even more so as we look to reach these patients once we have approval. I guess, you know, how many patients do you feel like you need to enroll to feel confident in driving if it's not 70? Bill, why don't you talk about the powering?

Speaker Change: Yes.

Speaker Change: How many patients do you feel like you need to enroll to feel confident in powering if it's not 70.

Speaker Change: Bill why don't you talk about the powering but I can say, we absolutely are confident in finding these patients I think we've been able to help in thinking through where these patients are which sites et cetera. So I think julie's team has done a really great job.

Speaker Change: Ensuring how we can enable success in the harmony trial I think bill you can talk about a high level of the powering.

Bill Rote: Yeah, No certainly and I. Appreciate the question, we're very confident in the powering of the study and recall in July initial remarks, she mentioned the 67% reduction in total home assisting that was observed in phase II.

Bill: But I can say we absolutely are confident in finding these patients. I think, you know, we've been able to help in thinking through where these patients are, which sites, et cetera. So I think, you know, Jula's team has done a really great job of ensuring how we can achieve success in the Harmony trial. But I think, Bill, you can talk about a high level of power.

Bill Rote: So with that level of efficacy, even with a significant diminishing in the treatment effect.

Bill Rote: Or a reduction in the overall total sample size, which we don't anticipate we certainly are in a good place to still achieve the endpoint.

Bill: Yeah, no, certainly, and I appreciate the question. We're very confident in the powering of the study, and recall in Jula's initial remarks, she mentioned the 67% reduction in total homocysteine that was observed in phase two. So, with that level of efficacy, even with a significant diminution in the treatment effect or a reduction in the overall total sample size, which we don't anticipate, we certainly are in a good place to still achieve the end point. So I'm confident that we'll get there. Great, thank you. Jenny, can we move to the next question, please? Yes, we have Mohit Bansal.

Bill Rote: So.

Bill Rote: Im confident that we will get there.

Speaker Change: Great. Thank you.

Speaker Change: Okay.

Speaker Change: Jamie can we move to the next question. Please.

Jamie: Yes, we have Mohit bansal.

Jamie: Jeremy.

Mohit Bansal: Yes, I guess, we know Ken.

Speaker Change: Okay perfect.

Speaker Change: So I did not hear you at that quite excited about that.

Speaker Change: Yeah.

Speaker Change: Thank you very much for taking my question and congrats on the progress.

Speaker Change: Just wanted to understand I mean, I know you don't provide the patient count, but if I look at the average number of patient form somebody from third quarter second quarter third quarter, and then third quarter to fourth quarter. It seems like the 57% increase but then there is a substantial increase in revenues so.

Mohit Bansal: Can you hear me? Yes, I can. Yes, we now can. Okay. Perfect. So, I did not hear you at that point. Sorry about that.

Peter: Thank you very much for taking my question and congratulations on the progress. Just wanted to understand, I mean, I know you don't provide the patient count, but if I look at the average number of patient forms, I mean, from second quarter to third quarter and then third quarter to fourth quarter, it seems like there's a 57% increase, but then there's a substantial increase in revenue. So, is this because you are converting a lot more of those patient forms into paid patients, or is there a stocking part involved here? Could you help us understand that?

Is this because you are converting a lot more of those patients fall into.

Speaker Change: Into paid patients.

Speaker Change: There are stocking.

Speaker Change: Budd involved here could you. Please help us understand that and then last second question is on the price increase I think you took a price increase in January should we expect some benefit in 2024 due to the banks price increase thank you.

Peter: And then last, my second question is on the price increase. I think you took a price increase in January. Should we expect any benefit in 2024 due to that price increase? Thank you. Okay, thanks so much for the questions. Peter, I will turn that over to you.

Speaker Change: Alright. Thanks, so much for the question Peter I will turn that over to you.

Speaker Change: Yes.

Peter: Yeah, so thank you, Mike, for that question. So, as I mentioned, one of the core fundamentals is making sure that patients' platforms transition ultimately to patients' own products and, in particular, patients' own paid products so you continue to increase revenue. And I think what you saw in this quarter is that we made robust progress, in particular in the pocket of patients that we described in the earlier quarter, which required some additional hand-holding and education with regard to the REMS process. And I think we, as I mentioned, like patient REMS certification within the first 14 days has increased quite substantially, and that allowed patients to go through the process and get to a paid product more quickly. So we have made good progress there.

Speaker Change: That's the question.

Peter Hermann: So as I mentioned like one of the core fundamentals is making sure that patient platform transition ultimately to pay.

Peter Hermann: Patients on products and participation based products. So will you continue to increase the revenue.

Peter Hermann: And I think what you saw in this quarter is that we that we made robust progress.

Peter Hermann: In particular also in the pocket of spaces that we described in the earlier quarter.

Peter Hermann: Which that required some additional handholding in education with regards to the wrench losses I think the as.

Peter Hermann: As I mentioned like the patients Rems certification within the first 14 days has increased quite substantially.

Peter Hermann: <unk> patients to go through the process and get to based product more quickly. So good progress there.

Peter: To Eric's earlier point, we don't provide further details on how many patients we have on the product, but I think that transitioning from patients to our phone to ultimately get patients on a paid product, we made significant progress. On the second question with regard to price and price increase, indeed, we had a price increase at the beginning of the year. Now that we have the confirmatory data and you see that the proteinuria reduction, the robust proteinuria reduction, provides longer-term EGFR and kidney preservation as well. So we thought it was justified to have a price increase for this year. I got it. And maybe just one final thing, Mohit, for your question on inventory. That has been stable, so there has been no pattern of stocking.

Peter Hermann: Alex earlier point, we don't provide further details on <unk>.

Peter Hermann: <unk> patients, we have one product, but I think the transition from patients thoughtful to ultimately get patient pay product we made significant progress.

Peter Hermann: And the second question with regards to price and price increase indeed, we have a price increase at the beginning of the year now that we have the confirmatory data and you'll see that proteinuria reduction.

A reduction the robust portfolio of introduction.

Peter Hermann: Longer term egfr and taking preservation as well.

Peter Hermann: So we thought it was justified to have a price increase for this year.

Got it and maybe just one final thing Mohit for your question on.

Peter Hermann: Inventory that has been stable so there has.

Peter Hermann: We expected to see a greater inflection in revenue as our teams are able to help those patients through the process you would imagine that that is going to continue that trend this year with faster growth in revenues than perhaps what we see in patients start forms, but we'll certainly apprise.

Eric Dube: So I think Peter's absolutely right. We expect to see a greater inflection in revenue as our teams are able to help those patients through the process. You would imagine that that trend is going to continue this year with faster growth in revenues than perhaps what we see in patient start forms. But we'll certainly tell you how we're doing at the end of Q1. Thank you. And our next question is going to come from... Gill, on Monday. City

Peter Hermann: You.

Peter Hermann: We're doing it.

Peter Hermann: The end of Q1.

Speaker Change: Thank you.

Speaker Change: Okay.

Speaker Change: And our next question is going to come from.

Speaker Change: Gil.

Gil: They will come of it.

Peter: Please go ahead. Hi, Travere team. Thank you very much for taking the questions. I had one on FSGS.

Gil: City please.

Gil: Please go ahead.

Gil: Hi, Tahira team. Thank you very much for taking the questions I had one on <unk>. Just curious if there were any recent updates with regard to the work, but I believe the FDA is doing in collaboration with you on defining some of the optimal endpoints for <unk>, whether there is some variations of the egfr slope endpoint that may be more approach.

Jula: I'm just curious if there have been any recent updates with regard to the work that I believe the FDA is doing in collaboration with you on defining some of the optimal endpoints for FSGS, whether there are some variations of the EGFR slope endpoint that may be more appropriate based on some of the data cuts that you're exploring. And then secondly, on the broader landscape, and again, just wondering, obviously, there's been a lot of visibility around some of the newer mechanisms, anti-B cell mechanisms. I wonder whether Filspari, given its position as a foundational therapy, may benefit from a combo study using B cell modulators on top of Filspari at a future point. Thank you. Great Thank you for the questions. And, Jula, I will turn those over to you.

Gil: Based on some of the data cuts that you're exploring and then secondly on the broader landscape and again just wondering obviously, there's been a lot of visibility around some of the newer mechanisms anti b cell mechanisms wondering whether phil's forehead, given its position as a foundational additional therapy may may benefit from <unk>.

Gil: A combo study.

Gil: The b cell modulators on top with thus far at a future point. Thank you.

Speaker Change: Great. Thank you for the questions in June July will turn those over to you.

Jula: So thanks. As far as FSGS is concerned, we are continuing to do our analysis with our data and then external data sets, putting our trial data into historical context. With regard to the FDA, this is a partnership with Nefcure, which is a patient organization with academics and the FDA, and it's called Parasol. There's a website, it's public, and it's really about defining the endpoints.

June: Thanks as far as <unk>, we are continuing to do not just with our data and then external datasets, bringing our child in the historical context.

June: With regards to the FDA. This is.

June: Our partnership with <unk>, which is a patient organization with academics and the FDA and it called parasol, There's a website it's public.

June: Really to redefine the endpoint than what they've recently announced that they are really looking at alternative proteinuria based endpoints to help enable the regulatory pathway for F. F G.

Jula: And what they've recently announced is they're really looking at alternative proteinuria-based endpoints to help enable the regulatory pathways for FGS. We plan to reengage the FDA following their final analysis and decision on what those endpoints should be under this Parasol group, and they're targeting ASN for that timeline. And then your second question is around some of the newer agents and how PhilSpari should be placed.

June: Yes.

June: We plan to re engage the FDA following their final analysis and decision on what those endpoints should be under this parasol group and Theyre targeting ASN for that timeline.

June: And then second question is around some of the newer agents and how <unk> should be placed and I think it's really going to be an exciting few years for Iga nephropathy patients with some of these new therapies.

Jula: And I think it's really going to be an exciting few years for IgA nephropathy patients with some of these new therapies, most of which target different parts of the injury cascade contributing to IgA. And hopefully, they'll become available outside the context of a clinical trial. But we're a few years away from that.

June: First of which target different parts of the injury Cascade contributing to IGN and hopefully they'll become available outside the context of a clinical trial, but we're a few years away from that but I would add that all additional immune modulating agents are being used on top of standard of care Foundation of treatment and that's where so far a place of foundation overall tar.

Jula: But I would add that all additional immune modulating agents are being used on top of standard of care foundational treatment. And that's where PhilSpari plays a foundational role because it targets the injury in the kidney and the response to GDI-IgA deposition and protects against further damage. And we're really aligned with the KOLs.

June: Vicki injury in the kidney and the response to the <unk> deposition and protects against further damage and really weren't really aligned with the Kols you need to target to think ongoing damage in the kidney with foundational treatments and to your point you could potentially add another agent that targets upstream pathways.

Jula: You need to target two things, ongoing damage in the kidney with foundational treatment. And to your point, you could potentially add another agent that targets upstream pathways. That's an additive.

June: It's additive.

Jula: As far as other trials go, I think it's important to realize that every other trial is studying a new agent on top of standard of care. And many of those trials now, because of PhilSpari's superiority over ACEs and ARBs, they're being allowed as part of the foundational standard of care. So we will get data over time from these trials as they read out about the combination and them being used together, and we certainly are interested in, you know, that combination and generating additional data. I'm very proud of Julie's team, where we do have two ongoing studies looking at the combination of Pilspari plus SGLT2. So, you know, I think some of the few combination studies that have yet been initiated, we would expect that that could potentially increase as other therapies are actually approved. Thank you very much. And our next question is going to come from Ed Arquette, and Wendy Wainwright, please go ahead. Hello everyone.

June: As far as other trials I think it's important to realize that every other trial is studying a new agent on top of standard of care and many of those trials now because the sales sorry superiority over aces and arbs theyre being allowed as part of the foundational standard of care. So we will.

June: Data over time from these trials as they read out about the combination and then being used together.

June: And we certainly are interested in that combination of generating additional data I'm very proud of Joe's team, where we do have two ongoing studies looking at the combination of <unk> plus <unk>. Two so I think some of the few combination studies that have yet been initiated we would expect that that could potentially increases.

June: Other therapies are actually approved.

June: Yes.

Speaker Change: Alright, Thank you very much.

Speaker Change: And our next question is going to come from Ed Arce from H C. Wainwright. Please go ahead.

Alex Arfaei: Hello, everyone. Thanks for taking my questions and congrats on another quarter of progress.

Alex Arfaei: A couple of quick questions for me Firstly with regards to the SMB.

Alex Arfaei: Thanks for taking my questions and congratulations on another quarter of progress. A couple of quick questions for me. Firstly, with regard to the SNDA later this quarter for FISPARI full approval, just wondering if you could confirm the length of the review period that you would expect. 6 or 8 months, or would that roll into sometime next year?

Later this quarter for aspiring for approval just wondering if you could confirm.

Alex Arfaei: The length of the review period that you would expect six or eight months or would that roll into sometime next year.

Bill: And then secondly, as I look at the PSFs quarter over quarter so far this year, um, and as those go up for a bit. I'm wondering if you can discuss some of the two inflection points mentioned before, later this year, the legal guidelines and the upcoming data analysis from ongoing trials, especially the SGLT2 combo, what impact, and I guess this is a question more for Peter, but what sort of subjective impact would you expect those to have on treating physicians as they get more experience. And thanks for the questions. Bill, why don't you take the regulatory question, and then Peter, you can take the PSF Outlook question. Yeah, we expect to have priority review for this SNDA that will be consistent with how the agency treated a predecessor that went just recently before us. In that case, it would be a six month review. So you'd have a Q3 decision. If we were a standard review, it would take till the end of the year. So, in either case, we have a decision to make this year. I'll uh...

Alex Arfaei: And then secondly, as I look at the PFS PFS quarter over quarter, so far in last year.

Alex Arfaei: And as those growth rates.

Alex Arfaei: Moderate a bit I'm wondering if you can discuss.

Alex Arfaei: Some of the two inflection points that have been mentioned before later this year that legal guidelines and the upcoming data analysis from ongoing trials.

Alex Arfaei: Especially the <unk> combo.

Alex Arfaei: What impact.

Alex Arfaei: Yes.

Peter Hermann: Question more for Peter.

Speaker Change: Sort of.

Speaker Change: Objectively what impact would you expect those to have on treating physicians.

Speaker Change:

Speaker Change: Get more experience with the drug.

Speaker Change: Thanks for the questions Bill why don't you take the regulatory question and then Peter you can take the Psf outlook question.

Okay.

Speaker Change: Yes, we expect to have priority review out of for this NDA that will be consistent with how the agency treated a predecessor that went just recently before us in that case it would be a six month review so you'd have a Q3 decision if we were standard.

Speaker Change: Review it would take too.

Speaker Change: To the end of the year.

Speaker Change: So in either case, we have a decision this year.

Peter: I'm going to pass over to Peter for the rest of your questions. Yeah, thanks for that question. I think there are really two elements that I would like to point to, with regard to the evolving landscape, with regard to the Cadeau guidelines, as well as a broader label, and what that would mean for the potential for patient platforms in the future. I think there are two core elements.

Speaker Change: Ill.

Speaker Change: Pass over to Peter for the rest of your question.

Peter Hermann: Yes. Thanks for the question I think there's really two elements that I would like to point you to with regards to.

Peter Hermann: The evolving landscape with regards to the could you guidelines as well as a broader label than what it would have meaningful.

Speaker Change: <unk> four.

Peter Hermann: Patient thoughtful arms in the future I think there's two core elements. One is the urgency to treat or better the urgency to change with further emphasis has to go lower.

Peter: One is the urgency to treat, or better, the urgency to change. With further emphasis, we have to go lower. Proteinuria at the level of one is still not where you need to be. I think last year the radar data got published in the UK.

Peter Hermann: <unk> is the level of loan is still not where you need to be and I think last year. The radar data published from the UK, It's broad registry data and it showed that even with a plus of newly all nine of those patients actually had doubled progress to end stage kidney disease compared to patients that have brought to the unit level of an average of four.

Peter: It's world registry data, and it showed that even with a proteinuria of 0.9, those patients actually had double the progress to end-stage kidney disease compared to patients that had a proteinuria level average of 0.44. So I think these kinds of data and then a reinforcement in the guidelines further amplify the urgency to change for those physicians and change that foundation that is currently ACE and ARFs and replace it with a much more efficacious treatment like Philspari. And just to recall, I mean, the propanuria benefit that Philspari had after nine months was threefold, 15 versus 15. But after two years, it was actually tenfold.

Peter Hermann: <unk> four.

Peter Hermann: So I think these kind of data and then reinforced in the guidelines.

Peter Hermann: Amplifies the urgency to change for those decisions and change that foundation that is currently ancient arps and replace it with a much more efficacious treatments like sales model just two.

Peter Hermann: To resolve the proteinuria a benefit of <unk> after nine months was.

Peter Hermann: Three folds 50.

Peter Hermann: <unk> hundred 50.

Peter Hermann: But after two years it was actually 10 falls.

Peter: So I think that is an important aspect. The urgency to change, I think, is one aspect. The second one is that it allows for a broader patient population. And what we have highlighted earlier is that, at launch, we expect to have an addressable patient population for Philspari between 30 and 50,000. We think with the broadening of the label, as well as further highlight of the Cadeau guidelines to go to a lower proteinuria target, there are up to 70,000 addressable patients for Philspari.

Peter Hermann: So I think that is an important aspect so the urgency to change the thing as walnuts at the second one is really it allows for a broader patient population than what we had highlighted earlier is that we set at launch we expect to have an addressable patient population for fuel story between 30 and 60000, we think was a broadening of the label as well as <unk>.

Peter Hermann: Another highlight of the <unk> guidance due to a lower target. We think there is up to 70000 addressable patients fulfill sorry. So I think those are the two core aspects I just want to highlight with regards to evolving landscape and would it be for the addressable patient population potentially based in Stockholm fulfill sorry.

Peter: I think those are the two core aspects I want to highlight with regard to the evolving landscape and what it means for the addressable patient population and, potentially, patient scores for Philspari. Thank you, Peter. Jewel, is there anything that you'd like to add?

Joe: Thank you Peter Joe is there anything that you'd like to add.

Jula: Yeah, thanks. I think we have a couple of inflection points. And Peter nicely highlighted KDGO to treat patients earlier and diagnose them earlier. And then the STLT2 combination, we know that combination therapy is going to be important in the future. So we think those are two things.

Joe: Yeah. Thanks, I think if we have a couple of inflection points and Peter nicely highlighted kinky go to treat patients earlier and diagnose them earlier.

Joe: Nasty LTC combination, we know that combination therapy is going to be importantly, jarrod.

Joe: Sure. So we think those are two things, but the third thing that up on a point out is with regards to the earlier treatment, we have a trial called Spartan wherever utilized.

Jula: But the third thing that I want to point out is with regard to earlier treatment. We have a trial called SPARTAN, where we utilize filifari early after patients first get diagnosed with RAS-9E. We presented some of that data at ASN, and it shows the earlier we see an 80% reduction in proteinuria, most of the patients going into complete remission, and no change in EGFR over 36 weeks. That trial has been continuing.

Joe: Our early after they first get diagnosed and the RASK naive we presented some of that in at ASN and it shows.

Joe: Earlier, we can't 80% reduction in proteinuria, most of the patients getting into complete remission and no change in Egfr over 36% that trial has been continuing we will have additional data on that over the years, but I think thats, an additional point as far as treating patients earlier in their disease course.

Jula: We'll have additional data on that over the years, but I think that's an additional point as far as treating patients earlier in their disease course. Yeah, thank you, Peter and Jule. Maybe if we just take a step back for a moment, if we put ourselves towards the end of 2024, and you assume that we have a full approval with a potential broader label, just as the Cadego Guidelines could potentially lower the target and really increase the dynamism in the treatment of patients with IGN nephropathy, we really will be at the right place at the right time. And if you think about all of the clinical experience that physicians are getting with Philspori, there's one thing that we know from this launch and hearing from physicians and their patients who are on Philspori: it is a very rapid and consistent reduction in proteinuria.

Speaker Change: Yes. Thank you Peter Andrew maybe if we just take a step back for a moment.

Speaker Change: If we put ourselves towards the end of 2024 and you assume that we have a full approval with a potential broader label.

Speaker Change: Just as that could do go guidelines could potentially lower the target and really increase the dynamism in the treatment of patients with Iga nephropathy, we really will be at the right place at the right time and if you think about also all of the clinical experience that physician.

Speaker Change: <unk>.

Speaker Change: Getting with thus far there's one thing that we know from this launch and hearing from physicians and their patients.

Speaker Change: <unk> It is a very rapid and consistent reduction in proteinuria, we believe it will be in the right place at the right time, but I think our goal is to make sure that we continue to expand for new physicians to be able to get that clinical experience and we believe that positions us very strongly for future growth.

Eric Dube: We believe that we'll be in the right place at the right time. And I think our goal is to make sure that we continue to expand for new physicians to be able to get that clinical experience. And we believe that positions us very strongly for future growth. Great. Thank you so much. That's very helpful.

Speaker Change: Great. Thank you so much that's very helpful.

Speaker Change: And our next question is going to come from Laura Chico from Wedbush Securities. Please go ahead.

Laura M. Clague: And our next question is going to come from Laura Chico from Wedbush Securities. Please go ahead. Hey guys, thanks very much for taking the question. Um, I'd like to shift gears and ask one on PEG versus Vatnase.

Hey, guys. Thanks, very much for taking the question.

Laura M. Clague: I'd like to shift gears and ask one on pegged Aboutness and Eric your comments, there about kind of the phenomena, we see with orphan disease.

Eric Dube: And Eric, your comments there about the kind of phenomena we see with orphan diseases and the expansion of patient populations over time. I apologize if I've missed this, but do you plan to keep a patient registry with respect to HCU? And kind of related to that, would you be able to disclose an identified patient number as you go along? Thank you. Great questions, Laura. Yes, we do have a registry, and we do continue to, we plan to continue that. We think that that's an incredibly important source of information for the community, and it's really a great question around sharing patient information or identification.

Laura M. Clague: And the expansion of patient populations over time.

Laura M. Clague: Well, Jason I have missed this but do you plan to keep a patient registry with respect to H C. H C U and kind of related to that would you be able to disclose an identified patient number as you're going along thank you.

Jason: Great questions. Laura Yes, we do have a registry and we do continue we plan to continue that we think that that's an incredibly important source of information for the community.

Speaker Change: And it's really a great question around sharing patient information or identification is certainly something we know others have done we'll be looking at the potential for us to be able to do that as well can commit to it today, but absolutely something that our team is looking at.

That's certainly something we know others have done, and we'll be looking at the potential for us to be able to do that as well. Can't commit to it today, but it's absolutely something that our team is looking at. Thanks very much, guys. And that will conclude the question and answer session of today's conference call. I'll hand the call back over to Ann. Please go ahead. Great. Thank you, Jenny, and everyone, for joining us for our fourth quarter and full year 2023 financial results call. We look forward to providing additional updates on our progress. Have a great rest of your day. 2020 University of Georgia College of Agricultural and Environmental Sciences UGA Extension Office of Communications and Creative Services, And this concludes our call. Thank you for... Mike Gbernik, Adam Chapman, Alan Gill, Cristina Morales, Mike Hu, David Gerrum, Alexander Scott, Roman Van Pepta, Rick Melachmin, Chris McKinnon Thank you for watching!

Speaker Change: Thanks, very much guys.

Speaker Change: And this will conclude the question and answer answer session of today's conference call I'll hand, the call back over to Anne. Please go ahead.

Anne: Great. Thank you Jenny and everyone for joining us for fourth quarter and full year 2023 financial results call. We look forward to providing additional updates on our progress have a great rest of your day.

Anne: Yes.

Anne: Alright.

Anne: Okay.

Speaker Change: And this concludes our call. Thank you for your.

Speaker Change: Participation you may now disconnect.

Speaker Change: Yeah.

Speaker Change: [music].