Q3 2023 Travere Therapeutics Inc Earnings Call

Please standby.

Speaker 1: Good day and welcome to the Travier Therapeutics 3rd quarter 2023 Financial Results and Corporate Update Conference Call. Today's conference call is being recorded. At this time I'd like to turn the conference over to the Vice President of Investor Relations, Naomi Iconbaum. Please go ahead, Naomi.

Good day and welcome to the <unk> Therapeutics third quarter 2023 financial results and corporate update conference call. Today's conference call is being recorded at this time I'd like to turn the conference over to the Vice President of Investor Relations.

I mean I can bomb. Please go ahead.

Speaker 2: Thank you. Good afternoon, and welcome to Travier Therapeutics third quarter 2023 financial results and corporate update call. Thank you all for joining. You're listening to Travie saving the planet.

Thank you good afternoon, and welcome to trivia Therapeutics third quarter 'twenty to 'twenty three financial results and corporate update call. Thank you all for joining today's call will be led by our Chief Executive Officer, Dr. Eric Dube Bay, Eric will be joined in the prepared remarks by Dr. Julie <unk>, our Chief Medical Officer.

Speaker 2: Today's call will be led by our chief executive officer, Dr. Eric Dubay. Eric will be joined in the prepared remarks by Dr. Jule Enrig, our chief medical officer, Peter Herma, our chief commercial officer, and Chris Klein, our chief financial officer. Dr. Bill Roet, senior vice president of research and development, will join us for the Q&A session.

Peter Herma, 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.

Speaker 2: Before we begin, I would like to remind everyone that statements made during this call, regarding matters that are not historical facts, are forward-looking statements within the safe harbor provisions of the Private Security's Litigation Reform Act of 1995. Forward-looking statements are not guarantees of performance. They involve known and unknown risks on certainties and assumptions that may cause actual results, performance and achievements to differ materially from those expressed or implied by the statement.

Before we begin I would like to remind everyone that statements made during this call regarding matters that are not historical facts are forward looking statements within the safe Harbor provisions of the private Securities Litigation Reform Act of 1995 forward looking statements are not guarantees of performance they involve known and unknown risks uncertainties.

Ts and assumptions that may cause actual results performance and achievements to differ materially from those expressed or implied by the statement.

Speaker 2: Please see the forward-looking statements disclaimer on the company's pressure leaks issued earlier today, as well as the risk factors section in our forms 10Q and 10K files of the FCC. In addition, any forward-looking statements represent our views only as of the date, such statements are made November 7th, 2023, and Treviere specifically disclaims any obligation to update such statements, to reflect future information events or circumstances. With that, let me now turn the call over to Eric. Eric earths.

Please see the forward looking statements disclaimer on the company's press release issued earlier today as well as the risk factors section in our forms 10-Q, and 10-K filed with the SEC. In addition, any forward looking statements represent our views only as of the date such statements are made November 7th 2023, and <unk>, specifically disclaims any obligation.

To update such statements to reflect future information events or circumstances with that let me now turn the call over to Eric Eric.

Speaker 3: Thank you, Diamy, and good afternoon, everyone. During the third quarter, we executed our key corporate priorities to further strengthen our leadership position in the rare disease community. Notably, during the quarter, we made progress with our launch of PhilSparry and IGAN and reported two year data from the Protect Study that we believe will position PhilSparry to play an important foundational role in the IGAN treatment landscape.

Thank you Darby and good afternoon, everyone.

During the third quarter, we executed our key corporate priorities to further strengthen our leadership position in the rare disease community, notably during the quarter, we made progress with our larger thus far you know again and reported two year data from the protect study that we believe will position <unk> to play an important foundational role.

Landscape.

Speaker 3: Additionally, we completed a successful end of Phase 2 meeting for our PEG to batonase program, putting us on track for the Phase 3 study initiation of PEG to batonase by year end. And we completed the divestiture of the bile acid product portfolio, enabling us to further focus on our key priorities.

Additionally, we completed a successful end of phase two meeting or pick the bad news program.

Are you guys on track for the Phase III study initiation of pegged about make by year end.

And we completed the divestiture of the bile acid product portfolio, enabling us to further focus on our key priorities.

Speaker 3: Regarding the ongoing launch of Pilspari, we continue to execute our strategy for Pilspari to become a new foundational treatment in eye cancer.

Regarding the I'll go and watch your Pittsburgh, we continued to execute our strategy. Thus far as you become a new foundational treatment I get in.

Speaker 3: in the third quarter, we help to reach even more patients. And every week we hear stories from physicians and patients of how well Fils-Farré is working for them.

In the third quarter, we hope to reach even more patients and every week, we hear stories from physicians and patients.

So far he's working for them.

Speaker 3: Over the course of the quarter, we identified that additional patient education and support could improve the performance of the launch. Specifically, an onboarding new patient after a patient's start form has been submitted, and we quickly adjusted.

Over the course of the quarter, we identified additional patient education and support could improve the performance of launch specifically on Onboarding new patients. After a patient start form has been submitted and we quickly adjusted.

Speaker 3: Notably, we are seeing thoroughly positive trends from these adjustments through October , and Peter will provide additional detail short.

Notably we are seeing early positive trends from these adjustments through October.

Peter will provide additional details shortly.

Speaker 3: Overall, we have built a solid foundation of physician demand with growth in new patient star forms and payer coverage. And together with the initial signs that are positive impacts from our enhancements in the quarter, we have confidence in the successful future of the Phil Sparimont.

We have built a solid foundation of physician demand with growth in new patient start forms and payer coverage and together with the initial signs of a positive impact from our enhancements in the quarter, we have confidence in the successful future of until Smart watch.

Speaker 3: We are just returning from ASN Kidney Week, the largest Nephrology Congress of the year.

We are just returning from ASN kidney week, the largest nephrology Congress of the year.

It was truly exciting and humbling to have both of our phase III studies of <unk> and I guess <unk> presented as a late breaker oral presentation and published simultaneously in the lancet.

In New England Journal of Medicine World renowned peer reviewed scientific journals.

Speaker 3: The opinion leaders who were at the Congress spoke positively about these groundbreaking results and recognized the role of Sparcentin in providing deep and durable reductions in pro-Nuria and kidney function preservation compared to an active comparator for patients with IGAN and FSGF.

Key opinion leaders, who were at the Congress spoke positively about these groundbreaking results and recognize the role of sports center, and providing deep and durable reductions in proteinuria and kidney.

Kidney function and preservation compare to an active comparator for patients with <unk> and <unk>, yes.

Speaker 3: This in conjunction with the Lancet publication on the PROTECT study should further lay the groundwork for potential inclusion and to take EGO guidelines for IGAN and should enable Syspari to become a new foundational therapy for this disease.

This in conjunction with the lancet publication of the protect study.

To lay the groundwork for potential inclusion into it you go guidelines for again.

Should enable us to aspire to become a new foundational therapy for this disease.

Speaker 3: consistent with previous guidance regarding our US regulatory engagement.

Consistent with previous guidance regarding our U S regulatory engagements, we remain on track to provide updates for both <unk> and again this quarter.

Speaker 3: We remain on track to provide updates for both SGS and IGAN this quarter. In parallel, our team is compiling the supplemental New Drug Application or SNDA for IGAN.

In parallel our team is compiling the supplemental new drug application or S. MBA for I guess, so that we're in a position to submit in the first half of 2020 for full approval in the U S and.

Speaker 3: So the worrying of positions is to submit in the first half of 2024 for full approval in the US.

Speaker 3: In Europe , the conditioning, conditional marketing authorization, evaluation for sparsons in the night again is progressing. Together with our partner CSLB4, we continue to anticipate a review opinion around year and from the CHMB.

In Europe, the conditioning conditional marketing authorization evaluation for <unk> again, it's progressing together with our partner CSL before we continue to anticipate a review opinion around year end from the stage IV.

Speaker 3: Regarding our exciting peg to baton ace program, we are on track for an expected phase three study initiation by Europe .

Regarding our exciting picked a bad news program. We're on track for an expected phase III study initiation by Europe.

Speaker 3: In late October , FDA hosted a patient-focused drug development panel on Classical HCU. We are grateful for the HCU patients and their caregivers for sharing their stories about living with HCU. The need for better therapy-

In late October FDA hosted a patient focused drug development panel, a classical H C U.

We are grateful for the HCV patients and their caregivers for sharing their stories about living with HCV.

Need for better therapies.

Speaker 3: The ability to improve diet and improve testing was incredibly clear. And we steal the sense of urgency to execute our phase three program.

The ability to improve diet.

An improved testing was incredibly clear and we feel their sense of urgency to execute our phase III program.

Speaker 3: are confidence in the potential for pectin bad news to become the first and only disease modifying therapy for people living with classical hcu continues to grow and we're looking forward to sharing additional updates on the program in the near term.

Our confidence in the potential for pegged about needs to become the first and only disease modifying therapy for people living with classical HCA continues to grow and we're looking forward to sharing additional updates on the program in the near term.

Speaker 3: Lastly, during the quarter we completed the sale of the biologic portfolio to near-infarm suitable. This transaction further strengthens our balance sheet and our focus on our key priorities of achieving success with Hillsbury and advancing Pekta Batnace into phase 3.

Lastly, during the quarter, we completed the sale of the bile acid portfolio to mirror pharmaceuticals.

This transaction further strengthens our balance sheet and our focus on our key priorities of achieving success with pillsbury and advancing pegged it back into phase III.

Speaker 3: Let me now turn the call over to Jua for a clinical update. Jua. Thank you.

Let me now turn the call over to Julie for a clinical update.

Thank you Eric and good afternoon, everyone.

Speaker 4: Before walking through our recent data presentation at ASN Kidney Week, I'd like to recognize and thank our internal teams and external collaborators.

Before walking through our recent data presentation at ASN kidney week.

Like to recognize and thank our internal teams and external collaborators.

Speaker 4: Their significant efforts led to us achieving an impactful ASN Kidney Week and world-renowned peer-reviewed publication of both Duplex and Protect in a very short period of time.

Our significant efforts led to record achieving and impactful ASN kidney week and world renowned peer reviewed publication of both duplex and protect.

Very short period of time.

Speaker 4: This rapid dissemination of data will help educate nephrologists on the strong clinical profile of Phil Spari and expeditiously provide the published data required for inclusion in clinical practice guidelines such as an up-to-date NKDGO.

This rapid dissemination of data will help educate nephrologist on the strong clinical profile of you'll sorry, and expeditiously provide the published data required for inclusion in clinical practice guidelines, such as an up to date and Katy go.

Speaker 4: We are empowered by the data shared in the 11 ASN abstract, including two high-impact, late-breaker oral presentations with simultaneous publications on the Phase Three studies of Spark Sentan, and IGAN, and FSTF.

We are empowered by the data shared in the 11, a S N abstract including two high impact late breaker oral presentation with simultaneous publication on the phase three studies are fantastic and Ikea and FX, yes.

Speaker 4: Dr. Rovan, a globally recognized rare kidney disease expert, presented our late breaking phase 3 protect study data that demonstrated the significant effect of field sparring in slowing disease progression and Igaine apropathy.

Doctor Roven, a globally recognized rare kidney disease expert presented our late breaking phase III protect study data that demonstrated the significant effect of pillsbury and slowing disease progression and Iga nephropathy.

Speaker 4: These results were met with broad support by the nephrology community and provide us with increasing confidence in Filspari's prospective position as a foundational treatment in IgA nephropathy.

These results were met with broad support by the Nephrology community and provides us with increasing confidence and feel sorry prospective position as a foundational treatment in Iga nephropathy.

Speaker 4: Simultaneously published in The Lancet, these data demonstrate that long-term treatment with Vilspari has the potential to preserve kidney function and thereby significantly delay the time to kidney failure.

Simultaneously published in Atlanta that these data demonstrate that long term treatment with bill Sperry has the potential to preserve kidney function and thereby significantly delay the time to kidney failure.

Speaker 4: Faced with limited, safe, effective, and approved therapies without significant side effects for IgAN patients, this represents a significant medical advance.

Faced with limited safe effective and approved therapies without significant side effects, where again patients. This represents a significant medical advances.

Speaker 4: Let me highlight select data from the presentation and publication.

Let me highlight select data from the presentation and publication.

Speaker 4: Treatment with Vilspari provided patients with an absolute 3.7 mils per minute higher EGFR at two years versus Irbisartan.

Treatment with til, sorry, providing patients with an absolute 3.7 1000 per minute higher egfr.

Two years versus Irbesartan.

Speaker 4: This in conjunction with the minus 2.7 and minus 2.9 mils per minute per year, chronic and total EGFR slope respectively, tells us that treatment with Dilsipari can provide patients with meaningfully slower rates of kidney function decline, particularly when compared to historical or recent phase three IgAN trials.

This in conjunction with the minus two seven and minus two 9000 per minute per year, chronic and total egfr slope respectively.

US that treatment with bill sorry can provide patients with meaningfully slower rate of kidney function decline.

Particularly when compared to historical our recent phase III <unk> trials.

Speaker 4: Additionally, these treatment effects on EGFR slope were consistent across baseline EGFR and proteinuria, supporting the potential for Filsbari as a foundational treatment across different stages of kidney disease.

Additionally, these treatment effects on Egfr slope were consistent across baseline Egfr and proteinuria supporting the potential for Phil sorry, as a foundational treatment across different stages of kidney disease.

Speaker 4: Treatment with Dilsipari demonstrated lower rates of the composite kidney failure endpoint, a 40% decline in EGFR, kidney failure or death compared to Irbisartan.

Treatment with til, sorry demonstrated lower rates of the composite kidney failure endpoint, a 40% decline in egfr kidney failure or death compared to Irbesartan.

Speaker 4: Philsipari resulted in a significant reduction in proteinuria and higher rates of complete remission compared to herbicartin. And the reduction in proteinuria with Philsipari was durable over the two-year study.

You'll sorry resulted in a significant reduction in proteinuria and higher rate of complete remission compared to Irbesartan and the reduction in proteinuria with Pillsbury was durable over the two year study.

Speaker 4: The safety profile of sparsantin was consistent across all clinical trials conducted to date and comparable to herbicartin. Importantly, with no drug-induced liver injury and no safety concerns related to fluid overload.

The safety profile. The safety profile of course mentioned was consistent across all clinical trials conducted to date and comparable to Irbesartan importantly, with no drug induced liver injury and no safety concerns related to fluid overload.

Speaker 4: We also presented important new data at ASN that we believe help further build understanding and confidence in the clinical profile of sparsentine.

We also presented important new data at ASN that we believe help further build understanding and confident in the clinical profile of <unk>.

Speaker 4: These include the SPARTAN study, which is evaluating sparsentin in newly diagnosed RAS-naive IgAN patients.

These include the <unk> study, which is evaluating <unk> in newly diagnosed Ras naive patient.

Speaker 4: Initial results to date indicate treatment with sparsentin was well tolerated, and we've seen an approximately 80% reduction in proteinuria over 36 weeks.

Initial results to date indicate treatment with <unk> was well tolerated and we've seen an approximately 80% reduction in.

In proteinuria over 36 weeks.

Speaker 4: and with minimal to no change in kidney function.

With minimal to no change in kidney function.

Speaker 4: In the ongoing protect open label extension, when SGLT2 inhibitors are added to stable field spari treatment, the combination has been well tolerated with a consistent safety profile and showed incremental propinary reduction benefits.

And the ongoing protect open label extension <unk> two inhibitors are added to stable feel sorry treatment. The combination has been well tolerated with a consistent safety profile and showed incremental proteinuria reduction benefit.

These data strengthen our growing body of evidence that that's still sorry, apart from standard of care and IGN, suggesting early initial treatment with still sorry therapy alone or in combination with other medications has the potential to preserve kidney function with this benefit accruing overtime and <unk>.

Patients with ICANN.

Speaker 4: Looking to next steps in IgA nephropathy, we believe these data from PROTECT should support an SNDA for traditional approval, potentially with label expansion to reflect the broader population and long-term benefits of Fils-Phares.

Looking to next steps and Iga nephropathy, we believe these data from protect should support an S N da for traditional approval potentially.

Potentially with label expansion to reflect the broader population and long term benefits I feel sorry.

Speaker 4: Also at ASN, Dr. Rowe, a leading rare kidney disease expert, presented the full phase three duplex study results in a late breaker oral session that was also simultaneously published in the New England Journal of Medicine.

Also at ASM Doctor row, a leading rare kidney disease expert presented the full phase III duplex study result in a late breaker oral session that was also simultaneously published in the New England Journal of Medicine.

Speaker 4: The broader results show a consistent and durable effect of sparsentin on reducing proteinuria.

The broader results show, a consistent and durable effect of <unk> on reducing proteinuria.

Speaker 4: greater rates of complete remission, positive trends on EGFR, including fewer Sparsantan-treated patients reaching the kidney composite endpoint, including kidney failure, as compared to Irbisartan.

Greater rates of complete remission.

Positive trends on Egfr, including fewer <unk> treated patients, reaching the kidney composite endpoint, including kidney failure as compared to Irbesartan.

Speaker 4: While the duplex study didn't meet statistical significance on the eGFR endpoints, the totality of data continued to build on our previously announced clinically meaningful results and showed a consistent and a well-tolerated safety profile.

While the duplex study didn't meet statistical significance on the Egfr endpoint. The totality of data continued to build on our previously announced clinically meaningful results and showed a consistent and a well tolerated safety profile.

Speaker 4: With no FDA-approved medicines indicated for FSGS and a growing incidence, the unmet need in FSGS is incredibly high.

With no FDA approved medicines indicated for <unk> and a growing incidents.

Unmet need in Appalachia is incredibly high.

Speaker 4: We remain on track to provide an update on our regulatory discussion this quarter.

We remain on track to provide an update on our regulatory discussions this quarter.

Speaker 4: Shifting the peg to baptomy for the treatment of classical homocystinuria, or HCU, we made advancements on our clinical and regulatory objectives.

Shifting to peg to bat and eight for the treatment of classical home office didn't already at four H B U we made advancements on our clinical and regulatory objectives.

Speaker 4: at the leading international metabolic conference, or SSIEM, we presented additional data from the Phase I-II Composed Study that showed that PEG-tobaptenase provides a clinically meaningful reduction in total HOMO-15 of 67.1 percent, and that the treatment effect was consistent across patients.

At the leading international metabolic conference or Ssi, and we presented additional data from the phase <unk> study that showed that pegged to about may provide a clinically meaningful reduction in total almost 15 of 67.1% not.

And that the treatment effect was consistent across patients.

Speaker 4: One patient achieved normalization of total homo-15 to less than 15.

One patient achieved normalization of total almost 15 to less than 15.

Speaker 4: This threshold allowed for increased dietary protein, which can significantly enhance quality of life for patients.

This threshold allowed for increased dietary protein, which can significantly enhance quality of life for patients who are otherwise on highly restrictive low protein diet.

Speaker 4: who are otherwise on highly restrictive, low-protein diets.

Speaker 4: Additionally, our teams have the opportunity to engage with global HCU thought leaders who are eagerly anticipating the study initiation.

Additionally, our teams had the opportunity to engage with global H. These thought leaders who are eagerly anticipating the study initiation.

Speaker 4: We've recently completed a successful end of phase 2 meeting with the FDA, and final preparations are underway in anticipation of a pivotal phase 3 study initiation by year end.

We've recently completed a successful end of phase II meeting with the FDA and final preparations are underway in anticipation of a pivotal phase III study initiation by yearend.

Speaker 4: At that point, we will also look forward to sharing the key study design element. With that, I'll turn the call over to Peter for the first time.

At that point, we will also look forward to sharing the key study design elements.

With that I'll turn the call over to Peter.

Yes.

Thank you Joe and good afternoon, everyone.

Speaker 5: We continue to make sound progress in establishing the commercial fundamentals for phosphorus pharynx to achieve our ambition of making it a new foundation of therapy for IJ and CROPD patients at risk of rapid progression.

We continue to make solid progress in establishing the commercial fundamentals that feels fun to achieve our ambition of making it more foundational therapy for Iga nephropathy patients at risk of rapid progression.

Since the beginning of the launch in February.

Speaker 5: We have engaged with over 5,600 metrologists who are becoming increasingly knowledgeable on the promising clinical profile of your spine.

We have engaged with over 600, patrologist, well, becoming increasingly knowledgeable almost even political.

Biofuels farming.

Speaker 5: These face-to-face interactions have resulted in new prescribers and additional uses within practice.

So you still face interactions have resulted in new prescribers and additional usage within practices.

Speaker 5: Physician demand continues to increase, and in the third quarter, we have 430 new patient stops.

Precision demand continues to increase.

The third quarter, we have 430, new patients start forms.

Speaker 5: This represents nearly a thousand patient's start forms since the initiation of the month.

This represents nearly a thousand patient start forms since the initiation of demands.

Speaker 5: It speaks to the confidence nephrologists have in the clinical profile of the Aspari and how they are using it to help reduce their patients' proteinuria.

He speaks to the goldmans pathologist has legal profile of <unk> and how they're using it to help reduce their patients both Amelia.

Notably these patients thoughtful growth.

Speaker 5: Notably, this patient's transform growth occurs even with the slower summer season when fewer patients typically visit physicians, as is.

Was the slower summer season.

Patients typically visit physicians as is.

Speaker 5: And as is common, a common dynamic observed in benchmark launches, and we observed growth following the summer.

Global the global dynamic of citizens Densmore launches.

Gross following the summer months.

Speaker 5: As you heard from Zula, her team of medical science liaisons have received positive feedback on the recent two-year results from the PROTECT study, and that is consistent with our emerging research.

As you heard from Jewell, who team of medical Science Liaisons have received positive feedback from the reasons do originals from Apotex Buddy.

And that is consistent with our mortgage insurance.

In fact.

Speaker 5: Recent market research conducted after the top-line press release of the Protect two-year data announcement.

Recent market research could button.

He will talk my press release of the protect two year data analyses.

Speaker 5: shows that after reviewing the two-year data, a significant number of nephrologists that prescribe Tlostary expect to increase their utilization.

After reviewing the two year data the significant number of Nephrologist that prescribed Jill Slattery expect to increase the utilization.

Speaker 5: and 60% of surveyed nephrologists that do not yet have the prescriber experience indicate the plan to prescribe psilocybin in the next three months based on this new data.

And 60% of surveys and so I'll just do not yet have the prescriber experience indicates the Atlanta stripes Youll start in the next three months based on this new data.

Speaker 5: Nephrologists also mentioned that they are encouraged by the rapid and sustained cotinuria reduction and that the EGFR results indicate a clinically meaningful long-term benefit on kidney function and delay in disease progression.

So I'll just also mention that they are encouraged by the rapid and sustained got newly a reduction and the egfr results indicate a clinically meaningful benefit in kidney function and delay in disease progression.

Speaker 5: The market research also indicates that a two-year safety profile could provide confidence for physicians furthering their intent to prescribe.

The market research also indicates that the two year safety profile.

Revised Gulf of the surface issues shattering.

Two prescribed.

Speaker 5: This feedback gives us confidence that we will continue to see growing demand through the balance of the year and into 2024.

This feedback gives us Gulf coast, but we will continue to see growing demand suite available of the year and into 'twenty 'twenty four.

Speaker 5: During the quarter, we also continued our progress in payer engagement with 67% of the U.S. lives covered.

During the globally also continued our progress in payer engagement with 67% of U S lives covered.

Well starting by the end of Q3.

Speaker 5: Importantly, we nearly doubled our PhilSparis specific ordinaries from 50 by the end of the second quarter to more than 90 by the end of Q3.

Importantly, we nearly doubled our fuels borrower specific thornberrys from 50 budget until the second quarter to more than 90 by the end of Q2.

Speaker 5: And we continue to be very pleased with the quality of these specific formularies and authorization criteria.

We continue to be very pleased with the quality of these specific formularies and authorization.

Yes.

Speaker 5: From a regular perspective, Real Report is just powering net sales of $8.4 million.

From a revenue perspective.

The report is just borrowing mix, we also face helium.

Roger.

Speaker 5: We are beginning to see the expected upward inflection in revenue.

We are beginning to see expected upward inflection in revenue.

Speaker 5: but it is not yet closely matching the demands to infant patient's cost.

What gets closely matching demand seen from patients classrooms.

Speaker 5: The main component of this is that there is a segment of patients who without increased education and support on the ramps either have not yet initiated therapy or have taken longer to receive their first shipment.

Main component of this is that there is some segment of patients who without increased education and support for Williams.

Neither have not yet initiated therapy or have taken longer to receive.

The first shipments.

Speaker 5: Importantly, our teams recognize the need for additional patients, education and support in the fulfillment process for this segment of patients. And we adjusted quickly during the course.

Importantly, our teams recognize the need for additional patient education and support in the fulfillment process for this segment of patients.

Just quickly during the quarter.

Speaker 5: We enacted targeted approaches to enhance communication and increase and increase patient support, including precision guidance materials for their conversation with patients that accanded a scoffial style.

We elected towards that approaches to enhance communication and increase and increased patient support including precision guidance materials for their conversations with stations that are candidates for pure cloud.

Speaker 5: We provided educational, patient-friendly communication materials in print and online.

We provide educational patient friendly communication materials in print and online.

But an additional patient support Super via total peers nurse educators to walk patients through the Rems certification process.

Speaker 5: and additional patient support through Travear TurboCare's nurse educators to walk patients through the REMS certification process.

Speaker 5: Noting me, we are seeing clearly signs that these efforts from providing additional support for this segment of patients are working.

Notably we are seeing maybe size with these efforts in providing additional support for this segment of patients are working.

Speaker 5: Those with a number of patients completing their REM certification shortly after receiving a patient's thoughts course.

What was the number of patients completing their rems certification shortly after receiving a patient starts quorum.

Speaker 5: and patient-initiating state therapy have been increasing. As we discussed on our approval call in February , if studies launched, we'd be...

And patients initiating therapy have been increasing.

As we discussed on our approval call in February.

You'll stories loss would be enrolling well.

And so over the first nine to 12 months.

Speaker 5: punctuated by important milestones, such as the three-year data and peer-reviewed publications.

Ultra later, but important milestones such as the two year data daily viewed obligations.

Looking at it.

Speaker 5: We see further growth opportunity with the growing body of sparsan from evidence and in combination with SDLT2.

We see further growth opportunity was the growing body of slow central evidence.

The culmination SDLP too.

Speaker 5: the potential inclusion in prescribing guidelines, such as KADIGO, to be updated next year, and, most importantly, the planned submission of an SMBA for the full approval of Telstarian IgAM in the U.S.

The potential inclusion in prescribing guidelines such as cardio.

Update of next year.

Most importantly, the planned submission of an SMB for the full approval of <unk>.

In the U S.

Speaker 5: Too close. We have great compliments in the future of Projector Yachtil Spain based upon key fundamentals. First.

To close we are grateful for months in the future loss trajectory you'll feel fine.

<unk> key fundamentals.

She will start its profile.

Speaker 5: Bill Sparrow has a superior treatment profile compared to active compared to herbasalism and addresses the needs of patients with eye-again and risk of rapid progression.

<unk> has a superior treatment profile compared to active comparator irbesartan and addresses the needs of patients with IGN and risk of rapid progression.

Two.

Mansell Nephrologist.

Speaker 5: Prescribers are excited about the Fiospari profile, which is demonstrated by the high-patience platforms and the increasing new and repeat prescribers.

Prescribes are excited to announce that Youll start profiles, which is demonstrated by the high patient start forms and the increasing new and repeat prescribers.

Shree.

Clear progress.

Speaker 5: quarter over quarter, we have shown increasing payer coverage growth. Now two-thirds of the lives are covered and we're seeing high level of payer approvals for Phil Sparrow.

Quarter over quarter, we have shown increasing the coverage goes now to sort of the lifecycle and we're seeing high level of approvals for fuel storage.

Speaker 5: and four, patient experience and a health.

And for <unk>.

<unk> experience in the fields.

Speaker 5: We continue to hear feedback that patients on therapy have positive clinical results in their positive Neolion levels. And once the patient starts your sparring, we are seeing that those compliance and persistence is hard.

We continue to hear feedback patients on therapy.

Clinical results and therefore, Julian levels and once a patient thoughtful sorry, we are seeing that both compliance and persistence is high.

Speaker 5: Importantly, our team is focused on delivering a strong force forward, and we will continue to adjust based on ongoing learnings to achieve our ambition of philospory becoming the foundational treatment for IgM patients at risk of rapid progression.

Importantly, our team is focused on delivering a strong fourth quarter and we will continue to adjust based on ongoing learners to achieve our ambition will fuel story, becoming the foundational treatment for patients at risk of rapid progression.

Speaker 5: Let me now turn the call over for Chris over to Chris for the financial updates.

Let me now turn the call over hook risks over to Chris for the financial update.

Yes.

Speaker 6: Thank you, Peter, and good afternoon, everyone. Following our third quarter results, we're in a very strong financial position. From an operational perspective, we continue to grow revenues, and we focus our investments for the future.

Thank you Peter and good afternoon, everyone.

Following our third quarter results were in a very strong financial position from an operational perspective, we continue to grow revenues and we focused our investments for the future.

Speaker 6: We also completed the BioLaster portfolio transaction, which has brought forward several years of value from the product and meaningfully strengthened our balance sheet.

We also completed the bile acid portfolio transaction, which was brought forward several years of value from the products and meaningfully strengthened our balance sheet.

Speaker 6: In our financials, the transaction is being reflected as discontinued operations, and as a result, the following discussion will be focused on our continuing operations, unless otherwise noted. For the third quarter of 2023, net product sales were $33.9 million, compared to $25.4 million for the same period in 2022. The increase is primarily attributable to an increase in net product sales from the ongoing launch of Philspari and IGA Interproperty.

And our financial the transaction is being reflected as discontinued operations and as a result, the following discussion will be focused on our continuing operations unless otherwise noted for the third quarter of 2023 net product sales were $33 $9 million compared to $25 $4 million for the same period in 2022, the increase is primarily.

Due to an increase in net product sales from the ongoing launch of full sorry in Iga nephropathy.

Speaker 6: Diola and Diola EC also continue to perform well and contributed $25.9 million in net product sales in the third quarter. This growth continues to be driven by organic patient demand.

You see also continued to perform well and contributed $25 $9 million and net product sales for the third quarter. This growth continues to be driven by organic patient demand.

Speaker 6: During the quarter, we also recognized $3.2 million of license and collaboration revenue, which translates to $37.1 million in total revenue for the period, compared to $28.1 million for the same period in 2022.

During the quarter, we also recognized $3 $2 million of license and collaboration revenue, which translates to $37 $1 billion in total revenue for the period compared to $28 $1 million for the same period in 2022.

Speaker 6: Research and development expenses for the third quarter of 2023 were $60.6 million, compared to $57.1 million in the same period in 2022. The difference is largely attributable to the continued advancement of the company's PEG-to-Batinase clinical program as it prepares for Phase III initiation, including clinical trial expenses and manufacturing, as well as increased security.

Research and development expenses for the third quarter of 2023 were $60 $6 million compared to $57 $1 million from the same period in 2022. The difference is largely attributable to the continued advancement of the company's talked about and its clinical program as it prepares for phase III initiation, including clinical trial expenses and manufacturing as well as increased head count.

Speaker 6: on an on-gap adjusted basis, R&D expenses were $53.8 million for the third quarter of 2023 compared to $51.9 million for the same period in 2022.

On a non-GAAP adjusted basis, R&D expenses were $53 $8 million for the third quarter of 2023 compared to $51 9 million for the same period in 2022.

Speaker 6: Selling general and administrative expenses for the third quarter of 2023 were $67.8 million compared to $52.4 million for the same period in 2022. The difference is largely attributable to commercial launch-related activities following the accelerated approval of FILSPARI in February 2023, as well as legal fees.

Selling general and administrative experience expenses for the third quarter of 2023 were $67 $8 million compared to $52 $4 million for the same period in 2022.

The difference is largely attributable to commercial launch related activities. Following the accelerated approval of <unk> in February 2023, as well as legal fees.

Speaker 6: On a non-GAAP-adjusted basis, SG&A expenses were $51.8 million for the third quarter of 2023, compared to $43.5 million for the same period in 2022.

On a non-GAAP adjusted basis, SG&A expenses were $51 $8 million for the third quarter of 2023 compared to $43 $5 million for the same period in 2022.

Speaker 6: Total other income net for the third quarter of 2020-23 was $3.4 million compared to total other expense net of $1.3 million in the same period in 2022. The difference is largely attributable to an increase in interest income during the period.

Total other income net for the third quarter of 2000, 2023 with $3 $4 million compared to total other expense net of $1 $3 million in the same period in 2022.

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

Speaker 6: Net income, including from discontinued operations for the third quarter of 2023, was $150.7 million, or $1.97 per basic share, compared to a net loss of $69.7 million, or $1.09 per basic share for the same period in 2022.

Net income, including from discontinued operations for the third quarter of 2023 was $157 million or $1 97 per basic share compared to a net loss of $69 7 million or $1.09 per basic share for the same period in 2022.

Speaker 6: On non-gap adjusted basis, that income, including from discontinued operations for the third quarter of 2023, was $173.5 million, or $2.27 for basic share, compared to a net loss of $55.3 million, or $86 for basic share for the same period in 2022.

Our non-GAAP adjusted basis net income, including from discontinued operations for the third quarter of 2023 was $173 $5 million or $2.27 per basic share compared to a net loss of $55 $3 million or <unk> 86 per basic share for the same period of 2022.

Speaker 6: As of September 30th, 2023, the company had cash, cash equivalents, and marketable securities of $634.6 million. This includes gross proceeds of approximately $210 million received during the quarter in conjunction with the closing of the biolasset portfolio divestiture.

As of September 32023, the company had cash cash equivalents in marketable securities of $634 million $6 million. This includes gross proceeds of approximately $210 million received during the quarter in conjunction with the closing of the bile acid portfolio divestiture.

Speaker 6: To maintain our strong cash position, we're following a disciplined capital allocation approach that is expected to reduce our cost base from this year, while ensuring the appropriate investments are made in the ongoing Fios Fari launch and advancing PEC2BAT Nathan to phase 3 development. Importantly, with these efforts and our reported cash balance at the end of the third quarter, we believe we can manage our balance sheet to support operations beyond 2026. I'll now turn it back over to Eric for his closing comments. Eric?

Maintain our strong cash position were following a disciplined capital allocation approach that is expected to reduce our cost base from this year, while ensuring the appropriate investments are made and the ongoing <unk> launch and advancing picked about Nathan to phase III development.

With these efforts in our reported cash balance at the end of the third quarter. We believe we can manage our balance sheet to support operations beyond 2026.

Now I'll turn it back over to Eric for his closing comments Eric.

Speaker 3: Thank you, Chris. The TRIVIR team has accomplished and executed on a remarkable number of milestones, making significant progress towards delivering innovative treatments for patients with rare disease.

Thank you Chris.

The <unk> team has accomplished and executed on a remarkable number of milestones, making significant progress towards delivering innovative treatments for patients with rare diseases.

Speaker 3: Overall, for the third quarter, I remain incredibly proud of our team's execution. We have successfully delivered a quarter demonstrating demand for Phil Spari, and with the Protect Fade 3 data in hand, we remain confident in our goal of enabling Phil Spari to ultimately become the foundational therapy and I.

Overall for the third quarter I remain incredibly proud of our team's execution, we've successfully delivered a quarter demonstrating demand peripheral sparring and with the protect phase III data in hand, we remain confident in our goal of enabling so far to ultimately become the foundational therapy and ICANN.

Speaker 3: The feedback from the scientific community at AXN is deeply encouraging as we continue our field spari launch and continue our plans to pursue an SNDA to confer field spari for traditional approval. We remain on track to provide an update on our FDA engagements for both IGAN and FSCS this quarter.

Feedback from the scientific community that he said is deeply encouraging as we continue our field <unk> launch and continue our plans to pursue an S. N D a to convert until sorry for.

It'll approval, we remain on track to provide an update on our F. F D. A engagements for both <unk> and <unk> this quarter.

Speaker 3: Additionally, the data packages from the Phase I-II Composed Study for PEG-DiBatinase continues to support its potential to become a transformative disease-modifying therapy for the HCU community. We are excited to continue our efforts in this program, and we remain on track to initiate a pivotal study by year end.

Additionally, the data packages from the phase <unk> study for pegged about nice continues to support its potential to become a transformative disease modifying therapy for the eight new community. We're excited to continue our efforts in this program and we remain on track to initiate a pivotal study by year end.

Speaker 3: As we approach the end of the year, our efforts are concentrated on finishing strongly. We are focused on executing continued progress with the Delspari launch, advancing PEG to Batinase forward, and remain committed to delivering on our promise of making profound differences in the lives of individuals living with rare disease.

As we approach the end of the year. Our efforts are concentrated on finishing strongly we are focused on execution executing continued progress with the <unk> launch advancing picked about next forward and remain committed to delivering on our promise of making profound differences in the lives of individuals living with rare disease I'll now pass the call.

Speaker 3: I'll now pass the call over to Naomi for the Q&A question. Naomi?

Tonight and me for the Q&A questions Naomi.

Speaker 2: Thank you, Eric. We can now open the line up for Q&A. Operator?

Thank you Eric you can now open the line up for Q&A.

Operator.

Speaker 1: Thank you. If you would like to signal with questions, please press star one on your touchtone telephone. If you're joined today 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. And we'll now take the first question from Joseph Swartz with their Rink Partners.

Thank you if you would like to signal with questions. Please press star one on your Touchtone telephone. If you are joining us today 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.

Another question please rejoin the queue.

And we'll now take our first question from Joseph Schwartz with Leerink partners.

Hi, all this is will on for Joe Thanks for taking our questions today to start for US are there any notable patterns among the nephrologist that you've interacted with after the protected read out just wondering if there are any groups of decisions that seem to appreciate the totality of the data more as compared to those who may not be fully comfortable with the pro.

Speaker 7: Kyle, this is Will on for Joe. Thanks for taking our questions today. To start for us, are there any notable patterns among the nephrologists that you have interacted with after the Protect Readout? Just wondering if there are any groups of physicians that seem to appreciate the totality of the data more as compared to those you may not be fully comfortable with the profile yet. And then I have a quick follow up to this.

Yeah, and then I have a quick follow up to this thanks.

Speaker 3: Well, thanks for the question. I will turn that over to Jula for her thoughts in the early reactions. What I can say is that I walked away from the ASN meeting with a very consistent view that nephrologists are excited about the profile. Jula, what did you share? What you...

Well. Thanks for the question I will turn that over to Judy for her thoughts and the early reactions. What I can say is that I walked away from the the ASN meeting with a very consistent view that nephrologist or excited about the profile Julio why don't you share what you have.

Sure.

Speaker 4: Yeah, I would agree with what Eric just said. I think people were excited to see the results and the full data presentation that shows that Sparcenton has the potential reserved kidney function and significantly delayed the time to kidney failure. The other important thing that was demonstrated is the rapid and the durable and sustained reduction in propnuria.

Yeah, I would agree with what Eric just said I think people were excited to see the results in a full data presentation that shows that <unk> has the potential preserved kidney function and significantly delay the time to kidney failure and the other important thing that was demonstrated a rapid and durable and sustained reduction.

In proteinuria and when people get to see the totality of the data they feel like it's very promising and has the potential to be foundational treatment in patients with Iga nephropathy, and I would say and the additional thing that I would say is looking to the future of the additional data that we showed with regards to earlier treatment where from the Barton.

Speaker 4: And when people get to see the totality of data, they feel like it's very promising and has the potential to be foundational treatment and patients with hygiene, apropathy. And I would say, and the additional thing that I would say is looking to the future, the additional data that we showed with regards to earlier treatment.

Speaker 4: We're from the Spartan trial data that shows if you treat people early, even before they've seen ACE inhibitors or ARB, you see even more reduction in protonary and preservation of kidney function. And if you use it in combination with S2, you've just presented some of that early data as well. It's safe and effective. So I believe we saw a fairly consistent response to what we were able to demonstrate and show.

<unk> trial data that shows if you treat people early even before they've seen ace inhibitors or a or b you see even more reduction in proteinuria and preservation of kidney function and have used it in combination with <unk>.

It was a fleet presented some of that early data as well, it's safe and effective. So we I believe we saw a fairly consistent response to what we were able to demonstrate and show.

Speaker 7: Great, thank you. And I just quick follow up here. Given the literature suggests that the 40% reduction in prone areas should lead to around a 2.7 mil per min per year benefit on EGFR, but we thought they'd have a different relationship and protect. Have you heard any concern from docs on this? And now that you have the published data and have had some more time to review the results, do you have a better idea for what may have drove this outcome? Thank you.

Great. Thank you and then just quick follow up here given the literature suggest that the 40% reduction in proteinuria should lead to around $2 7000 per minute for your benefit on Egfr, but we thought they'd have a different relationship and protect have you heard any concerns from docs on this and now that you have the published data and have had some more.

Time to review the results do you have a better idea for what might have drove this outcome. Thank you.

Sure I'll pass that one over to you.

Speaker 4: Yeah, happy to answer that. When you look at the meta-analysis and all the data and combinations, you're looking at drugs with different mechanisms of action, some that acutely increase EGFR and some that decrease. This is a two-year study where over two years we saw an absolute difference and benefit of 3.7 mills after two years, favorable for Sparcentin. And that's a really important point to take into consideration. It's a really important point to take into consideration.

Yeah happy to answer that when you look at the meta analysis and all the data in combination youre looking at drugs with different mechanisms of action. Some are acutely increase egfr and some of that decrease is the two year study.

Over two years, we saw an absolute difference and benefit of 3.7 mills. After two years favorable for <unk> and that's a really important point to take into consideration.

Speaker 4: Obviously, the slope data is a model treatment effect where we see an annual benefit of greater than one mil per minute per year. And with drugs that have a slight acute effect, we know that that stabilizes kidney function over the long term. And the important thing to take away is that benefit accrues over time.

Obviously, the slope data is modeled treatment effect, where we see an annual benefit of greater than 1000 per minute per year.

With drugs that have a slight acute effect, we know that that stabilizes kidney function over the long term and the important thing to take away is that benefit accrues over time.

Speaker 7: So, each year you get a benefit. It's 1.1 in one year, it's 2.2 in two years, it's 3.3 the next year. That's the important take-home message that you get, is it cruise over the long-term, which is very different than other drugs, which might increase the CFR and don't exceed that over the long-term. Great, thank you so much.

So each year, you get a benefit at one one and one.

In two years, it's $3 three the next year, that's the important take home message that you get at it.

Over the long term, which is very different than other drugs, which my inquiry.

Got it.

Yeah.

Great. Thank you so much.

Okay.

And our next question will come from <unk> Rama with JP Morgan.

Speaker 8: Thanks so much for taking a question. On the patient's start forms, maybe you can give it a little bit more color. Beyond the opening remarks on what you're seeing on the month of a month growth here. Was there any particular headwinding the quarter beyond the summer seasonality that you talked about or was there a group of physicians that were kind of on the sidelines, probably saw the two year protected GFR? I think it's just a little bit more color on that. Thanks so much.

Hey, guys. Thanks.

Thanks, So much for taking my question on the patient start forms maybe you can give us a little bit more color.

Beyond the opening remarks on what Youre seeing on the month over month growth here was there any particular headwind in the quarter beyond the summer seasonality, which you've talked about her.

Was there a group of physicians that were kind of on the sidelines until they saw the two year protect egfr.

It's a little bit more color on that thanks, so much.

Speaker 3: Yeah, thanks so much for the question. I will have Peter talk about what he is seeing in terms of prescribing.

Yeah. Thanks, so much for the question I will have Peter talk about what he is seeing in terms of prescribing.

Speaker 5: I would say overall we see good continuation of growth during the quarter and we had a little July inflection when less patients see their physician and that's what I commented on in the pre-prepared remarks. But overall we've seen continued growth from both new prescribers as well as repeat prescribers.

Yes, I think some of them.

I would say overall we.

C. Good continuation of growth during the quarter and we had a little July.

You wouldn't less patients to see their physician and that's what I commented on in the prepared remarks, but overall, we see continued growth from both new prescribers as well as repeat prescribers.

And most of these spaces of the minutes from the community physicians and that's why we see the majority of the prescriptions coming from Israel, but other than what I was talking about from a seasonality perspective, we didn't see any other headwinds and I'm really pleased with the continued growth that we showed today and a continuation of demand.

Speaker 5: And most of these patients are being managed through the community physicians, and that's where we see the majority of the prescriptions coming from as well. But other than what I was talking about from a seasonality perspective, we didn't see any other headwinds, and I'm really pleased with the continued growth that we show today in continuation of demand.

And our next question.

Speaker 1: And our next question will come from Mori Raycroft with Jeff.

And our next question will come from Maury Raycroft with Jefferies.

Speaker 1: Hi, thanks for taking my question. I think Jula just alluded to benefit occurring over time in the Protect Study. Since patients aren't as far as sent in and protect washout, prior to starting the open-level extension, how does this impact ability to show that treatment effect occurs beyond the two-year period in case FDA asked for longer-term data like this? I guess there's their way you can account for the washout. Ricky.

Hi, Thanks for taking my question I think Julian just alluded to benefit occurring over time in the protect study.

Since patients ons per cent and in protect wash out prior to starting to open label extension. How does this impact ability to show that treatment effect of cruise beyond the two year period and case FDA asked for a longer term data like this I guess is there a way you can account for the washout.

Yes.

Good morning, Thanks for the question, Joe I will pass that one over to you.

Speaker 4: Yeah, more, it's a fair question because in reality, that's not how we're going to treat patients over the long term. You would keep them on, but that was a question that wanted to be asked because the acute hemodynamic effect, and I would say the important thing is that what we saw was a durable treatment effect after patients went back to standard of care where you saw an absolute...

Yeah, Laurie it's a fair question because in reality, that's not how we're going to treat patients over the long term you would keep them on them, but that was a question that I wanted to be at because the acute hemodynamic effect I would say the important thing is that what we saw was a durable treatment effect. After patients went back to standard of care, where you saw it.

Absolute overall favorable egfr and patient persistence wash out now if we can continue to monitor those patients when they <unk> and I think the important data that we'll have that comes out of the open label.

Speaker 4: overall favorable EGFR in patients to wash out.

Speaker 4: Now, we can continue to monitor those patients when they resume Sparsantan, and I think the important data that we'll have that comes out of open label is what is the trajectory for those patients who are on Irbisartan versus when they switch over to Sparsantan. So, it'll be incrementally important information that we'll provide over the long term.

What is the trajectory for those patients who are on irbesartan versus when they switch over to star Santander. So it'll be incrementally important information that will provide over the long term, but to your point, we believe that the data that we have from the double blind will be submission.

Speaker 4: But to your point, we believe that the data that we have from the double blind will be supportive of our SNDA filing at this point in time.

<unk> of our S N D E filing.

At this point in time.

Got it okay. Thanks for taking my question.

Speaker 1: And our next question will come from Greg Harrison with Bank of America.

And our next question will come from Greg Harrison with Bank of America.

Speaker 9: Hey guys, thanks for taking the question. Are you able to give any color on the volume of patient start forms in the periods before and after the announcement of the PROTECT data, and what feedback are you hearing from physicians on their appetite for prescribing FOSPARI in light of the data?

Hey, guys. Thanks for taking the question.

Are you able to give any color on the volume of patients start forms in the periods before and after the announcement of the protected.

And what feedback are you hearing.

From physicians on their appetite for prescribing Pillsbury in light of the data.

Speaker 3: Great, thanks for the questions. I would say before handing it over to Peter to provide a bit more.

Great. Thanks for the questions I would say before handing it over to Peter to provide a bit more.

Speaker 3: perspective on what he's hearing, including some market research that his team quickly did. It's really too early to be able to look at projections sort of before, after protecting terms of prescribing.

Perspective on what he's hearing, including some market research that his team quickly did it's really too early to be able to look at projections sort of before after protect in terms of prescribing what I can say qualitatively coming out of ASN, where there was much greater exposure to the actual data.

Speaker 3: What I can say qualitatively coming out of ASN where there was much greater exposure to the actual data was a real excitement, particularly for those that attended ASN, much more academic. Peter's team did some really great research quickly to understand that. So, Peter, why don't you share a little bit more about what your team learned?

Wasn't real excitement.

Particularly for those that attended ASN much more academic Peters team did some really great research quickly to understand that so Peter why don't you share a little bit more about what your team work.

Speaker 5: Yeah, thanks. Thanks for that question. I would say first of all, um, the patient's platforms of 430 in the third quarter, I think is a really good number and that leads to like a thousand patient platforms in only the first seven and a half months. I think we're making really good progress.

Yes.

Okay first of all the basic thoughts lumps of 430 in the third quarter I think is a really good number on that list.

Mr. Like thousands of patients for only the first seven and a half months I think we're making really good progress there.

Speaker 5: To the early point, it's too early after the problem data announcement to see any change in in question. But in overall what we saw in the market research, which was a total market research right after the press release,

At this point, it's too early after the topline data zones would you see any change in inflection.

What we saw in the in the market research, which was a total amount of accretion right. After the press release.

Speaker 5: of the top line is that there is good confidence in the profile of Phil Spirey. And having been at the ASN and having had many of the conversations with physicians, I think there was a really good reception of the Phil Spirey profile, the totality of the data, and what Phil Spirey can mean for those physicians' patients. So I think overall, good reception and, yeah, more to come.

Top line is it a.

Good confidence in the profile of Georgetown and having been at the ASN and haven't had many of the conversations with physicians I think it was a really good reception of the pillsbury profiled the totality of the data.

So as far as the need for those.

Those patients those physicians patients so I think overall with reception.

Multiple.

Okay.

Yeah.

Speaker 1: And our next question will come from Vamal Devon with Guggenheim Security.

And our next question will come from <unk> <unk> with Guggenheim Securities.

Speaker 10: I agree. Thanks for taking my questions. I'm just curious if you can share some more feedback on the REMS and safety side of things.

Hi, great. Thanks for taking my questions I'm just curious.

If you can share some more feedback on the Rems and safety side of things.

Speaker 10: I think you said you've now touched about 5,500 nephrologists, I believe, was the.

<unk>.

Now touched about 5500, Nephrologists I believe was the.

Speaker 10: Can you share anything in terms of how many nephrologists are now sort of, you know, worked their way through the REMS program or are certified to prescribe it? And then again, just kind of the theme of some of the other questions, just any feedback on the safety side of things now that we've seen, you know, the doctors in the full data both on protectant as well as duplicate.

Number you here can you share anything in terms of how many.

Colleges are now sort of.

Work their way through the Rems program or are certified to prescribe. It and then again just kind of a theme that somebody other questions just any feedback on the safety side of things now that we've seen and I'll just.

Doctors in the pool data, both unprotected as well as duplex.

Speaker 3: Vomal, thanks for the questions. I'll, before I hand it over to Peter, what I'll just share is that we can provide some qualitative and directional feedback on

Well, thanks for the questions I'll.

Before I hand, it over to Peter what.

What I'll just share is that we can provide some qualitative or.

Directional feedback on the.

Speaker 3: the REMS as well as the safety profile. We are not providing metrics on REM certification, but we continue to see that grow. Peter, why don't you talk a little bit about what the reaction and what directionally you're hearing, both from the physician and the patient perspective. And certainly, Jula, if there's anything further you want to add on reactions to safety coming out of ASN, by all means, add that. Peter?

The rems as well as the safety profile, we are not providing metrics on rems certification.

But we continue to see that grow Peter why don't you talk a little bit about what the reaction and what Directionally youre hearing both from the physician and the patient perspective, and certainly July you know if there's anything further you want to add on reactions to safety coming out of a S N biomass that Peter.

Speaker 5: Yeah, certainly, Eric. And I think you were referring to the amount of nephrology that we have seen in face-to-face interactions. And indeed, I did call out 5,600 nephrologists that we have seen in face-to-face interactions with our field force.

Yes.

And I think you were referring to the amount of nephrology that we have some face to face interactions.

<unk> 56 in the metrology that we have seen in face to face interactions with our field force since the loans and that is.

Speaker 5: And that is I think a very good progress because as we announced during the launch call,

Very good progress because as we announced during the launch goal. We are consistently you want to go on about 6000, nephrology with the skull bring about 85% of the patient population and so I think we're making really good progress.

Speaker 5: We are consistently on a call on about 6,000 nephrologists and it's covering about 85% of the patient population. And so I think we are making really good progress and we are nearly there from overall nephrology perspective.

We are really there from overall metrology perspectives with you.

Speaker 5: Which regard to safety profile, I think that was the second part of your question, maybe you might have more inappropriate questions to answer.

It goes to the safety profile I think that was the second part of your question maybe July.

More of an appropriate question to you to answer.

Yeah, I think that I would respond significant reassurance with regards to the safety profile around first hunton across the program to date, both protect and duplex, where we saw the exact same safety.

Speaker 4: significant reassurance with regards to the safety profile around Sparsantan across the program to date, both PROTECT and DUPLEX, where we saw the exact same safety profile with regards to the liver elevations of three times upper limit of normal and really no new elevations since our interim from PROTECT. And so where physicians rapidly moved to is

Safety profile with regards to the liver elevations of three times upper limit of normal and really no new elevation since our interim from protecting so where physicians rapidly moved to is.

Speaker 4: can this be changed over time, which of course we will readdress this as we continue to accrue data and go back, but that's where physicians quickly move to. So we feel reassured by the safety profile at this time.

Can this be changed overtime, which of course, we will readdress. It says we continue to accrue data and go back, but that's where physicians quickly move to so we feel reassured by the safety profile at this time.

Speaker 3: But maybe I can just add one other insight that I think is might be helpful and it's really behind some of the comments that Peter shared in his prepared comments. And that's really the reaction of physicians versus patients to the REMs. Most physicians are familiar with how to read prescribing information, what a box morning is, and what a REM is. And in fact, many nephrologists have familiarity and are accustomed to REMs.

Well, maybe I can just add one one other insight that I think might be helpful and it's really behind some of the comments that Peter shared in his prepared comments and that's really the reaction of physicians versus patients to the rems. Most physicians are familiar with how to read prescribing information about a box warning is.

And what a rems is and in fact, many nephrologist have familiarity and are accustomed to rems for.

Speaker 3: For patients on the other hand, some of them may just be accustomed to going to their local pharmacy and picking up a prescription for, you know, an ACE or an arm or others. So for some patients, it requires a bit more education, a bit more hand holding through the process. That segment of patients that Peter talked about, it really does require a bit more

For patients on the other hand, some of them may just be accustomed to going to their local pharmacy and picking up a prescription for you know an ace or an arb or others. So for some patients it requires a bit more education a bit more handholding through the process for that segment of patients that Peter talked about.

It really does require a bit more.

Speaker 3: information, education, and support. And so there is a segment, as we refer to, where the REMS does take a little bit more time. But overall, what we're hearing from physicians is.

Information education and support and so there is a segment as we referred to where the rents does take a little bit more time, but overall, what we're hearing from physicians is the rems doesn't take that much time, it's very straightforward for many patients. It works incredibly well, but I think we do need to make sure that we're providing.

Speaker 3: The REMS doesn't take that much time. It's very straightforward. For many patients, it works incredibly well, but I think we do need to make sure that we're providing all patients the information that they need to be able to move from patient start form to actually fulfilling their prescription. So I think that was the key insight and the pivot that we had this quarter to make sure that we're able to move all patients as quickly through the process as possible.

All patients the information that they need to be able to move from patient start forms to.

Actually fulfilling their prescriptions. So I think that was the key insight and the pivot that we had this quarter to make sure that we're able to move all patients as quickly through the process as possible.

Okay. Thank you.

Speaker 1: And our next question will come from Lisa Baker with Evercore ISI.

And our next question will come from Lisa <unk> with Evercore ISI.

Speaker 4: Can you just give us a little detail on things like gross to net, for example, where you're at there? And then, actually, how many patients did you have on therapy by the end of the quarter?

Hi, there. Thanks for taking my question can you just give us a little detail on things like gross to nets for example.

Where you are out there and then actually how many patients did you have on therapy by the end of the quarter.

Speaker 3: Chris, why don't we have you go through gross to net, and Lisa, I'll say that we are not yet in a position to be able to comment on number of patients on therapy or other types of KPIs that you might be looking for, because as you can imagine, you know, the first year of launch, it is quite variable. We've got patients that are on, you know, free drugs.

Chris why don't we have you go through gross to net and at least I'll say that we.

We are not yet in a position to be able to comment on number of patients on therapy or.

Other types of Kpis that you.

You might be looking for because as you can imagine the first year of launch it is quite variable you've got patients that are on free drug.

Speaker 3: as well as just working their way through the reimbursement process. So, we're not in a position to be able to come in at this point. What I can say is that we continue to see very strong demand. We continue to see that inflection in...

As well as just working their way through the reimbursement process. So.

We're not in a position to be able to come in at this point, but I can say is that we continue to see very strong demand we continue to see that.

Inflection and and revenue that we expect to continue and become more closely aligned with the underlying demand of patients start forms Chris do you want to comment on gross to net.

Speaker 3: in revenue that we expect to continue and become more closely aligned with the underlying demand of patient start forms. Chris, do you want to comment on Gristanet?

Speaker 6: Sure. So, Lisa, consistent with our prior guidance, we expect that stable states, Barsentin or Fils-Phari, Gros-Tenet, to be mid to high teens. And, you know, that's consistent with what we see today. There's going to be some variability quarter to quarter as we're getting all the processes, and as Eric highlighted, the different elements of reimbursement, et cetera, in place. But overall, we feel very confident that we're going to end up in that mid to high teen range, and that's consistent with how we're operating now.

Sure So Lisa consistent with our prior guidance, we expect that stable states were sent in her first foray gross to net to be mid to high teens and you know that that's consistent with what we see today, there's going to be some variability quarter to quarter as we're getting all of the processes and as Erik highlighted the different elements of reimbursement et cetera.

But overall, we feel very confident that we're going to end up in that mid to high teen range and that's consistent with how we're operating now.

Speaker 4: Okay, great. And how many patients did you have on at the end of the quarter?

Okay, great and how many patients did you have on them at the end of the quarter.

Speaker 3: We did not report on numbers of patients on therapy, because again, during the first parts of launch, it is variable, and so, you know, getting to a steady state would allow us to be able to report on a consistent basis to be able to project forward. So at this point, we're going to continue to report on those three metrics that we shared and guided to on, in February , patient start forms.

Roughly we.

We did not report on numbers of patients on therapy, because again during the first parts of launch it is variable and so getting to a steady state would allow us to be able to report on a consistent basis.

To be able to project forward. So at this point, we're going to continue to report on those three metrics.

We shared.

Sure and guided to on in February a patient start forms.

Speaker 3: payer coverage and revenue. And I think as you see from the revenue inflection that we had from Q3 to Q4, that we have many more patients that are on reimbursed medicine. And we would expect that only to continue through the fourth quarter and beyond.

Payer coverage and revenue, but I think if you as you see from the revenue inflection that we had from Q3 to Q4 that we have many more patients that are on.

Reimbursed medicine, and we would expect that only to continue through the fourth quarter and beyond.

Speaker 4: Okay. And then, any commentary on or update on the new guidelines coming out, the CADAGO guidelines?

Okay.

And then any commentary on.

Our update on the <unk>.

The new guidelines coming out of the Quebec because outline.

Julie do you want to take the latest on the guidelines.

Speaker 4: Yes, we're very pleased that we were able to get our PROTECT results published and peer-reviewed. We knew that our interim data was going to be included in the KDECO guidelines, and now that we have the complete data, they will also be able to be reviewed and included in the guidelines. Those will be available for public commentary in the very first quarter of 2024.

Yeah, we're very pleased that we were able to get our protect results published in peer reviewed we knew that our interim data was going to be included in the K G. Go guidelines and now that we have the complete data. They will also be able to be reviewed and included in the guidelines and those will be.

Available for publish our public commentary and the very first quarter of 2024.

Speaker 4: Okay, great. And then just a final question for me, kind of as we see the landscape evolving, I was really kind of struck by the EGFR results.

Okay, Great and then just final question for me kind of as we see the landscape evolving. So it was really kind of struck by the the Egfr result.

Speaker 4: that Osuka presented for civiprelimab, which is one of the B-cell modulators targeting April . I guess in the context of having that kind of effect on EGFR, how do you see the need for other mechanisms on top of that if you're able to keep EGFR relatively flat, or is there still like, you can do better, and what about proteinuria and all those other things? So just curious how you're thinking about

Otsuka per cent efforts of our problem now, which as you know one of the B cell modulator targeting April I guess in the context of having.

It was that kind of effect on Egfr like how do you see kind of the need for other mechanisms on top of that if you're able to keep each F are relatively flat or is there still like you can do better and and what about pulmonary and all those other things, but just curious how you're thinking about kind of you.

Speaker 4: in the context of that kind of a remarkable change in EGFR. Thanks.

Now as for Santana in the context of <unk>.

That kind of a remarkable change in egfr.

Speaker 3: Yeah, I'll have Jula talk about the view of maybe hers or of nephrologists in kind of the evolving treatment landscape. What I'll share is that the thing that really excites us about the profile of Hillsparry is the ability to combine with all of these new classes of therapies that are being developed. And each of them are being studied on top of

Yeah, I'll have Julia talk about you know the the view of maybe.

Maybe hurt or Nephrologist and kind of the evolving treatment landscape. What I'll share is the thing that really excites us about the profile of <unk> is the ability to combine with all of these new classes of therapies that are being developed in.

Each of them are being studied on top of Ras inhibition that occurs to.

Speaker 3: RAS inhibition that occurs, you know, to address the overactivation in the kidney. I think now what we've seen with our two-year data is the superiority of Fils-Pari versus RAS inhibition alone. So it really is the question of how and when and in what patients do you combine is really the way that we think about it.

To address the over activation in the kidney I think now what we've seen with our two year data is the superiority of <unk> versus Ras inhibition alone. So it really is the question of how and when and in what patients do combine is really the way that we think about it in the positioning and that that's what we mean by that foundational.

Speaker 3: in the positioning, and that's what we mean by that foundational therapy. I know that a lot of this data is early, but Julie, do you want to comment on how you view as a nephrologist and what you're hearing from your peers in this emerging treatment landscape?

<unk> therapy.

Know that a lot of this data is early but Julio do you want to comment on how you view it as a nephrologist and what Youre hearing from your peers in this emerging treatment landscape.

Speaker 4: Yeah, I think it's important, as Eric said, you need a foundational treatment. When you get diagnosed with IgA nephropathy, you have already damage that's ongoing and you need to reduce the protein area to preserve kidney function. And what we demonstrated with PROTECT is if you replace your RAS inhibitor with sparsantan, you can get incrementally closer to a normal kidney function in the tooth.

Yeah, I think it's important as Erik said you need a foundational treatment when you get diagnosed with Iga nephropathy, you have already damage, that's ongoing and you need to reduce the proteinuria to preserve kidney function and what we demonstrated with protect is that can you replace the RAF inhibitor with our center and you can get incrementally closer.

Two of normal kidney function in the twos.

Speaker 4: If you want to then add additional treatment on subsequently, if that patient either doesn't get into complete remission or continues to progress, certainly that's an alternative treatment option to add on. With regards to the CYP and PRISL-MADS data, you know, that's one-year data.

If you want to then add additional treatment on subsequently if that patient either doesn't get into complete remission or continues to progress certainly that's an alternative treatment option to add on with regards to the second prison that data now that's one year data.

Speaker 4: We showed similar 36-week data. If you start treatment very early, the SPARTAN trial data, 80% reduction in proteinuria, two-thirds of patients getting into complete remission and no change in EGFR, early data. So again, we do need to follow the data that we're seeing from these phase twos to further out. But I do believe that.

He said similar 36 week data if you start treatment very early the Spartan trial data, 80% reduction in proteinuria, two thirds of patients getting into complete remission and no change in Egfr early data. So again, we do need to follow the data that we're seeing from these phase twos just firm.

They're out, but I do believe that our sunshine as foundational treatment with the incremental other therapies, we want to preserve kidney function as much as we can and combination therapy is absolutely the future of treatment for patients with Iga nephropathy.

Speaker 4: sparsentine as foundational treatment with the increment of other therapies. We want to preserve kidney function as much as we can. And combination therapy is absolutely the future of treatment for patients with IgA nephropathy.

And as a reminder, please limit yourself to one question. Thank you.

Speaker 1: And as a reminder, please limit yourself to one question. Thank you.

Speaker 1: And our next question will come from Mohit Bansal with Wells Fargo.

And our next question will come from Mohit Bansal with Wells Fargo.

Speaker 11: This is the amount from Melha. Thanks for taking our question. Would you briefly touch upon the early persistent data you have for patient-sanfiltzbari and how you think REMS contributes to this? And then separately, we'd appreciate an update on what you're seeing in terms of step-hated, and prior ops that let you have more formula areas covering filzbari.

Hey, this is Sam on for Mohit. Thanks for taking our question would you briefly touch upon the early persistence data you have for patients on <unk> and how you think rams contributes to that.

And then separately would appreciate an update on what you're seeing in terms of step edits and prior off now that you have more formularies covering Phil sorry.

Speaker 3: Yeah, thanks for the question. Peter, I'll turn to you in just a moment to talk about, you know, what.

Yeah. Thanks for the question Peter I'll turn to you in just a moment to talk about you know what.

Speaker 3: explain a little bit more about persistence compliance as well as step edits. But before I do, I wanna share a story that I heard from a patient who really talked about their journey with IgA nephropathy. And he shared this at ASN last week, where I think initially he had some questions or really uncertainties about what a REMS would mean for him. And this was a patient that struggled to get his proteinuria down for years, and his physician offered him Tilsipari.

Explain a little bit more about the persistent compliance as well as a step at it but before I do I want to share a story that I've heard from a patient who really talked about there.

Johnny with Iga nephropathy, and he shared this at ASN last week, where I think initially he had some questions or really uncertainties about what a rems would mean for him and this was a patient that that struggled to get his proteinuria down for years and his physician offered him so far.

Speaker 3: And you can imagine that, like for many patients, having to go and do additional testing and starting a new therapy, there were many questions.

And you can imagine that like for many patients having to go and do additional testing.

And starting a new therapy there were many questions.

Speaker 3: what he shared and I think was really an aha for many of us in the audience.

He shared and I think it was really an all hub for many of US in the audience was that he looked forward to those monthly calls with the nurse from our total care center and the ongoing monitoring and support that he felt from our hub services, our patient services as well as those.

Speaker 3: was that he looked forward to those monthly calls with the nurse from our total care center.

Speaker 3: and the ongoing monitoring and support that he felt from our hub services, our patient services, as well as those regular check-ins from his physician. So actually, you know, that may be for many patients a real additional support.

Regular check ins from its physician so actually you know that maybe for many patients are real additional support for that longer term compliance persistence with therapy, and we know that for many patients, particularly those that are otherwise young healthy working busy it can be a challenge. So I think that it would really is that as a real benefit we've.

Speaker 3: for that longer-term compliance persistence with therapy. And we know that for many patients, particularly those that are otherwise young, healthy, working, busy, it can be a challenge. So I think that it really is a real benefit. We've heard lots of questions about the challenges of REMS. I think he did an incredible job to articulate what he found in value of that regular monitoring and really people looking after his health.

Heard lots of questions about the challenges of reps I think he did an incredible job to articulate what he founded value of that regular monitoring and really people looking after his health Peter do you want to share.

Speaker 3: Peter, do you want to share anything further on the persistence as well as the payer coverage?

Further on the persistence as well as the payer coverage.

Speaker 5: Yeah, thank you, Eric. And thanks, Moit, for that question. I think your question was on three components. One was on payer approval, one was on compliance persistence, and one was on rent, if I understood you correctly. So, let me go one by one. I think I'm really pleased with the payer approval rate that we're seeing for Phil's Filing, which closely matches the progress we're making in the overall coverage.

Yes, we can.

Thanks for the question I think your question was on three components.

One was on the approval one wasn't compliance persistence and one was in rents if I understood you correctly.

Let me go one by one I think really pleased with the payer approval rates that we're seeing fulfills failure, which closely matches the progress we're making in the overall coverage as well.

Speaker 5: So I think we have made really good progress there and also the compliance and persistence patients that are on products see clinical results and remain on product. And I know this is one of the questions initially with the monthly monitoring will patients remain on therapy and what we are seeing so far in the still early days we see strong compliance and persistence.

I think we have made really good progress there and.

Also the compliance and persistence patient that often products seem to nickel results and remain on book.

I know this is one of the questions. Initially maybe monthly monitoring low patients remain on therapy, when where you are seeing so far and it's still early days, we see strong compliance and persistence rates.

Speaker 5: With regards to the lens and patient perception of the lens, I think for a large amount of patients, the process is working very well, and these patients receive false priority well within benchmark numbers.

So the rems and patient perception of their lives.

Lots of modifications of the process is working very well and these patients receive <unk> body well with benchmark.

<unk>.

Speaker 5: But as Cary mentioned earlier, and I was alluding to that in the prepared remark, there's also a segment of patients that need a little more hand-holding through education and support.

But as Stuart mentioned earlier alluded to that in the prepared remarks. There's also segment of patients that need a little more handholding through education and support.

Speaker 5: I think you have to realize that it was only until the second half of June .

I think you have to realize that people still need until the second half of June since we had the opportunity to educate physicians and patients older than the package inserts that supported the FDA guidance for accelerated approval. So really by the end of June we were able to.

Speaker 5: if we had the opportunity to educate physicians and patients other than the packets insert as part of the FDA guide for accelerated approval. So really by the end of June , we were able to.

Speaker 5: provide that additional educational support for patients. And with the additional support, we are seeing that the early ramp certification for that group of patients is already improving. That also translates them into an increase in paid first priority shipments to patients.

With additional educational.

Sports locations.

Additionally, our support we are seeing this early Rem certification for that group of patients is already improving.

And place them into an increase in pesos probably shipments to patients.

Thanks, so much.

Speaker 1: And our next question will come from Carter Gold with Bark.

And our next question will come from Carter Gould with Barclays.

Speaker 1: Hey, guys, you've got Edwin Delfin on the line for Carter Gold. Thanks for squeezing us in here. We have a question on PEG-2 botanase for HCU. I know you've completed the end of Phase 2 meeting, but have you guys received clarity from the agency on amount of follow-up and any impact on clinical measures beyond the biomarker impact for the primary endpoint? Thanks.

Hey, guys, you've got Edwin Delphine on the line for Carter Gould. Thanks for squeezing us in here, we have a question on <unk> for each for you I know you've completed the end of phase two meeting, but have you guys received clarity from the agency on amount of follow up and any impacts on clinical measures beyond the biomarker impacts of that.

Primary end point thanks.

Speaker 3: Edward, thanks so much for the question. And we are really excited about our HCU program and moving into phase three here very soon. Bill, why don't you take that question to share a little bit more to answer those questions. But before I turn it over to Bill, I will say that we'll be sharing much more detail once we initiate the trial on aspects of the trial design. But certainly Bill can share what we've shared publicly at this point.

Thanks, So much for the question and we are really excited about our HCV program and moving into phase III here very soon bill why don't you take that question to share a little bit more.

To answer those questions, but before I turn it over to Bill I will say that will be we'll be sharing much more detail. Once we initiate the trial on aspects of the trial design, but certainly bill can share what we've what we've shared publicly at this point.

Certainly now that I'm off mute.

Speaker 12: We've completed the end of phase two, as you noted. We had very collaborative discussions with the agency, and I'm happy to report that we've aligned, as we intended to all along, on total homocysteine as the primary endpoint for the study. There are various aspects of...

We've completed the end of phase II as you noted.

Collaborative discussions with the agency and I'm happy to report that we are aligned as we intended to all along on total homeless sustain as the primary endpoint for the study.

There are various aspects of.

Speaker 12: the program that look at clinical benefit. Some of those are measures of function. Some of those are quality of life. Some of those will be looking at what we're able to do with diet. And as Eric said, we're going to have more detail about this.

The program that look at clinical benefit.

Some of those are measures of function. Some of those are quality of life. Some of those will be looking at what we're able to do with diet and as Eric said, we're going to have more detail about this.

Speaker 12: Once the study starts, we'll give you a full picture of the Phase III program.

Once the study starts we will give you a full picture.

The phase III program and I think you also asked around overall study duration.

Speaker 12: And I think you also asked around overall study duration. If we look at the range of other enzyme replacement therapy studies,

If you if we look at the range of other enzyme replacement therapy studies the period of observation ranges from six months to 18 months and it.

Speaker 12: The period of observation ranges from six months to 18 months, and we'll be in that window and most of those studies are less than 100. So I think that gives you kind of a ballpark of where we're headed.

It will be in that window and most of those studies are less than 100. So I think that gives you a kind of a ballpark of where we're headed and we'll have more once the study has started.

Speaker 12: And, you know, we'll have more once the study has started.

I appreciate that that's helpful. Thank you.

And our next question.

Speaker 1: And our next question comes from Laura Chico with Wedbush Security.

And our next question comes from Laura Chico with Wedbush Securities.

Hey, good evening guys. Thanks, very much for fitting me in here I wanted to go back to the patient start forms for a moment for Phil sorry, and 430 over for 17 I guess the question I've got is have you plateaued in terms of how high you can go with patient start forms if I look back for example at the first year of our payrolls launch I believe.

Speaker 13: Hey, good evening, guys, thanks very much for fitting me in here. I wanted to go back to the patient start forms for a moment, for feel sorry. And, you know, 430 over 417, I guess the question I've got is, have you plateaued in terms of how high you can go with patient start forms? If I look back, for example, at the first year of TARPEO's launch, I believe they peaked out at 589 enrollments.

They peaked out at 589 enrollment during those first of all quarters. So I'm curious as to whether you think you can actually grow that's much more beyond 430.

Speaker 7: during those first four quarters. So curious as to whether you think you can actually grow this much more beyond 430. Thank you very much. So Laura, I think the question is.

It very much.

So Laura I think the question is unequivocally yes.

Speaker 3: We have nearly 1,000 patient start forms through the third quarter of this year. And as we think about the number of patients that we believe are addressable, that will increase. I'll turn it over to Peter, but I wanna be able to emphasize our confidence and be able to identify those patients. But equally, the enthusiasm that we hear from nephrologists, not just that anticipate prescribing,

We have nearly a thousand patient start forms through the third quarter of this year and as we think about the number of patients that we.

We believer are addressable.

That that will increase I'll turn it over to Peter but I want to be able to emphasize our confidence and be able to identify those patients, but equally the enthusiasm that we hear from nephrologists not just that anticipate prescribing.

Speaker 3: But those that have prescribed, we're seeing repeat prescriptions and new prescribers added every month. That's a really important lead measure for any launch. In my experience, those are critical, those and the clinical experience, the feedback anecdotally we're hearing.

Those that have prescribed we're seeing repeat prescriptions and new prescriptions, new prescribers added every month, that's a really important lead measure for any launch in my experience. Those are critical those and the clinical experience of feedback anecdotally. We're hearing we are seeing really positive results. There. So we do expect it to grow.

Speaker 3: we are seeing really positive results there. So we do expect it to grow, and Peter can talk a little bit more about what he's seeing and where we expect to go from here.

And Peter can talk a little bit more about what he's seeing and where we expect to go from here.

Yes, I think so.

Thanks, Laura for the question.

Speaker 14: I think there's really free components here that I would like to work on.

I think there's really three components here that I would like to highlight.

Speaker 10: to answer your question like how far can you go and how do you page it?

To answer your question like how far can you go how many patients out there.

Speaker 5: The first one is, I would say they have limited innovation in the cloud in the last 30 to 40 years.

First one is I would say the had been limited innovation in the probably in the last 30 to 40 years.

Speaker 5: And that's what you see as well with physicians. Nephrologists are relatively conservative in adaptation of new methods.

What you see as well as physicians nephrology are relatively.

The Conservatives and adaptation of new Medicine.

Speaker 10: And part of that is also the education. In particular, in IJ nephropathy, where there have been little investments in education. And I think the radar publication that we discussed, actually, at the last earnings call, if you want to provide a little more context on that, really is providing that increase in urgency to treat.

And what is the source of the education in particular in Iga nephropathy, where there has been little investments.

In education, and I think the radar publication that we discussed actually velocity school George can provide a little more context on that really is providing the <unk>.

Greece and urgency to treat.

Speaker 5: because historically a lot of the physician thought like Igenoproposic is a relatively slow progression, progressive disease. But what we are seeing right now based on new data and registry research is that those patients actually progress much more rapidly. So I would expect that the patient population over time will be increasing. Also with new guidelines.

Because historically a lot of the physician thought like Iga nephropathy is a relatively slow progression.

Progressive disease, but what we're seeing right now based on new data registry.

Our research is that those actually progressed much more rapidly. So I would expect that the patient population over time, we'll be introducing also with new guidelines.

In your guidance. So it isn't that go with I would say I'm really pleased with the progress we have been making to Eric's point, we have no nearly a thousand patients in sort of seven five months of suicide and IC was all the continued investments in education community.

Speaker 10: So within that context, I would say I'm really pleased with the progress we have been making. To Eric's point, we have now nearly 1,000 patients in the first seven and a half months of SARS-CoV-2. And I see with all the continued investments and education in the community, there is that recognition that this patient should be treated more early and more urgently. So Joe, maybe we can provide a little more context on your perspective on, for example, radar.

Exploration at this station should be treated more easily and more urgently.

We can provide a little more context on your respective schools for example arena.

Speaker 4: Yeah, I think that as we educate the physicians and they realize that what they historically understood and were trained in their educational program 10, 20, 30 years ago, that Igans a benign disease and they can send them back to their primary care physician and see them every few years is not the case.

Yeah I think.

As we educate the physicians and they realize that what they historically understood and were trained and their educational program 10, 2030 years ago that I cans of benign disease and they can send them back to their primary care physician and see them. Every few years is not the case.

Speaker 4: and that patients even with 500 milligrams of proteinuria are at risk of progression to kidney failure within their lifetime.

And that patient even with 500 milligrams of proteinuria are at risk of progression to kidney failure within their lifetime.

Speaker 4: We had additional data presented at ASN that confirmed the radar data, and this was US registry data that showed similar results.

We had additional data presented at ASN that confirmed the radar data necessary U S. Registry data that showed similar results patients even with lower ranges of proteinuria arent rest of progressing to kidney failure that dissemination.

Speaker 4: Patients even with lower ranges of proteinuria are at risk to progression to kidney failure. That dissemination of information needs to get out to the community physicians who don't always go to these kidney meetings and don't always read the journals. And as they see this information, that urgency to then treat their patients.

The information needs to get out to the community physicians, who don't always go to these kidney meetings don't always read the journal and as they see this information that urgency to then treat their patients increases and to Peter's point and that translates into the need to treat them with the foundational medications such.

Speaker 4: increases. And to Peter's point, then that translates into the need to treat them with a foundational medication such as Filspari, which reduces proteinuria and preserves kidney function.

So sorry, but reduces proteinuria and preserved kidney function.

Speaker 1: And our next question will come from Tim Lugo with William.

And our next question will come from Tim Lugo with William Blair.

Speaker 15: Hi, this is John on for Tim. Thanks so much for squeezing us in. So with the recent author sensing data, I was wondering if you could just give us some thoughts on that data and how you might think that might impact the regulatory landscape moving forward.

Hi, This is John on for Tim. Thanks, So much for squeezing out then.

So thats the reason the answer of sensitive data I was wondering if you could just give us some thoughts on that data and how you might think that might impact the regulatory landscape moving forward.

Yes, I mean, we certainly expect that there are going to be additional data potentially new therapies that are going to be approved.

Speaker 3: Yeah, I mean, we certainly expect that there are going to be additional data, potentially new therapies that are going to be approved. I think, you know.

I think you know.

Speaker 3: It's hard for us to comment because there were no data that disclosed. And so I think we'll have to wait to see what is presented from atrocenten for us to be able to comment. I mean, our working assumption is that it is an endofelan blocker, so it should show benefit. We certainly have demonstrated that with protects with sparsentin, and we've seen that proof of concept with other endofelan blockers. But we've got to see the data on benefit and safety before we can comment.

It's hard for us to comment because there were no day to disclose and so I think we'll have to wait to see what is presented from from Astra Center for us to be able to comment I mean, our working assumption is that it is an endothelin.

Blocker. So it should show benefit we certainly have seen demonstrated that with protect with spar sets in and we've seen that proof of concept with other endothelin blockers, but we've got to see the data on benefit and safety before we can comment.

Speaker 1: And our next question will come from Alex Thompson with Steve.

And our next question will come from Alex Thomson with Stifel.

Speaker 16: Hey, yeah, great. Thanks for taking my question. I guess in the past you've commented through with this uptick in sales in the second half of the year that you're comfortable with consensus numbers for the year, which I think on Bloomberg are in the low 30 million range at this point. I guess maybe if you could reiterate your confidence there, that would be great. And then could you also maybe comment on, you know, the impact at all of stocking in the revenue this quarter? Thanks.

Hey, great. Thanks for taking my question I guess in the past you've commented drilled with this uptick in sales in the second half of the year that youre comfortable with consensus numbers for the year, which I think on Bloomberg or in the low $30 million range. At this point I guess, maybe if you could reiterate your confidence there that'd be great and then could you also maybe <unk>.

Comment on.

The impacted all of.

Stocking in the revenue this quarter. Thanks.

Speaker 3: Yeah, thanks, thanks, Alex. I'll take the first part of that question and then I'll turn it over to Peter to talk about. I'll take the first part of that question and then I'll turn it over to Peter to talk about.

Yeah. Thanks, Alex I'll take the first part of that question and then I'll turn it over to Peter to talk about the impact of stocking throughout the year, what I can say that I'm incredibly proud of the progress that we've made on the <unk> launch and the ability to continue to grow demand.

Speaker 3: the impact of stocking throughout the year. What I can say is that I'm incredibly proud of the progress that we've made on the Phil Sparrow launch and the ability to continue to grow demand, to be able to show the early signs of that inflection that we expect. And as we've guided in the back path of this year, we'll start to see revenue track more closely with that underlying demand or the number of patient start forms.

To be able to show that the early signs of that inflection that we expect and as we've guided in the back half of this year, we'll start to see revenue track more closely with that underlying demand or the number of patients start forms.

Speaker 3: I think as Peter alluded to, we still have some room to go in terms of aligning that more closely. We expect that we're gonna make that progress in the fourth quarter. And in fact, when we look at other rare renal launches,

I think as Peter alluded to.

We still have some.

Some room to go in terms of our lighting that more closely we expect that we're going to make that progress in the fourth quarter and in fact, when we look at other rare renal launches.

Speaker 3: we've seen that there's a meaningful proportion of their first year sales in that fourth quarter. We fully expect that to be the case with us as well. We've seen the inflection so far. And in terms of providing specifics on guidance, we've not provided that this year. We won't for the rest of the year. But we are confident in the continued inflection of both patient start forms and of revenue.

We've seen that there's a meaningful proportion of their first year of sales in that fourth quarter, we fully expect that to be the case with us as well we've seen the inflection so far and.

And in terms of providing specifics on guidance, we've not provided that this year, we won't for for the rest of the year, but we are confident in the continued inflection.

Ah patient start forms and kind of revenue.

Speaker 1: And our next question will come from Allison Brotzel with Piper Sands.

And our next question will come from Allison <unk> with Piper Sandler.

Speaker 13: I get afternoon guys and thanks for the update and for taking my question. So it's one on the Spartan study update at ASN and this is kind of a follow up to to a prior question and prior discussion. But just based on your interactions with nephrologists and K.O.O.

Hi, Good afternoon, guys and thanks for the update and for taking my question six one on the Spartan study update at ASN and this is kind of a follow up to a prior question in prior discussion, but just just based on your interactions with Nephrologist and Kols.

Speaker 13: Could you help us understand what kind of additional clinical data you think you need to generate to really?

Could you help us understand what kind of additional clinical data you think you need to generate to really.

Speaker 13: catalyze or just drive widespread first-line use of FOSBARI in IGANN, or just earlier line use more broadly. Thanks.

Catalyze or just drive widespread first line.

You said first Barry and N I M or just earlier line use more broadly thanks.

Speaker 3: So, first, let me take part of that, and I'll turn it over to Jula and then to Peter. What I would say is, you know, our focus right now is under accelerated approval, we've got to focus very much on the label at hand. You know, we would expect that with traditional approval that we would expect to see that expansion. But, Jula, do you want to comment on, you know, what additional data you're hearing from nephrologists? And, Peter, then perhaps, you know, further what you're hearing in market research.

So first let me, let me take part of that and I'll turn it over to to July and and then to Peter.

What I would say is our focus right now is within under accelerated approval. We've got our focus very much on the label at hand.

No we would expect that with a traditional approval that we would expect to see that expansion, but you will do you want to comment on what additional data you are hearing from Nephrologist and Peter then perhaps further what youre hearing in market research.

Speaker 4: Well, to Eric's point, right now, we're primarily being utilized in prevalin IJ nephropathy patients who remain at risk for progressions per our label.

Well to Eric's point right now, we're primarily being utilized and prevalent Iga nephropathy patients who remain at risk for progression per our label.

Speaker 4: Physicians are very excited about the Spartan data because we're one of the only ones that's generating this data.

Physicians are very excited about the Spartan data because we don't want are the only ones that are generating this data patients who are newly diagnosed who haven't failed RAF inhibitors yet.

Speaker 4: patients who are newly diagnosed, who haven't failed RAS inhibitors yet, and the potential for sercentin to be used as a first line treatment, and the magnitude of protonary reduction and kidney function preservation. So I think that the spartan data can incrementally

Potential for smart pension to be used as a first line treatment and the magnitude of proteinuria reduction in kidney function preservation and so I think that the certain data can incrementally. So that's the other important data that we're gonna haven't missed some of the biomarker data that the fluid data the bio impedance that shows the safety.

Speaker 4: show that the other important data that we're going to have in this is some of the biomarker data, the fluid data, the biompedance that shows the safety profile, as well as some of the novel data that's going to come out from this study is the repeat kidney biopsy in these patients. So incrementally, the information that's going to come out of Spartan will further give confidence with regards to the place of therapy that our sentient can play in patients with hygiene and chemotherapy.

File as well as some of the novel data that's going to come out from this study is the repeat kidney biopsy in these patients. So incrementally the information that's going to come out of Spartan will further give confidence with regards to the place of therapy that are sent home can play in patients with Iga nephropathy.

Speaker 5: I will say we have very strong data now for patients that they still have fill through

Yes.

Building on this.

I would say we have very strong data now for patients that they see have Phil Ross inhibition, Most Asian arms, and we know from market research with over half of the patients.

Speaker 10: post-Asian ARS and we know from market research that over half of the patients that are on Asian ARS are not getting to the target levels of protein-milia as the position we like to. So we have still a lot of patients to go in that set.

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Not getting to the targeted levels of proteinuria.

We liked it so we have still a lot of patients to go in that are in that segment.

Speaker 5: But now we also have patients' information and very strong data in patients that are lost, naive.

We also have patients inflammation and very strong data in patients without loss not us.

Speaker 10: And then I think the third category is really building upon the evolving pre-pand landscape and being prepared for combination therapies as Julea was mentioning. I think the combination data that we presented last week at ASN, we had the R2 to provide that additional context as well. So I think we are building the data and the evidence across a broad patient population that could benefit from transparency.

I think the third category is really building upon the evolving treatment landscape and be there for combination therapies at ULA was mentioning and I think the combination data that we presented last week at Aegean with a.

<unk> to provide additional context as well. So I think we are we are building the data and the evidence across a broad patient population that could benefit from James bond coupons.

Speaker 1: And we'll take a question from Ed Arce with HC Wainwright and

And we'll take a question from Ed Arce with H C Wainwright and company.

Speaker 17: Great, thanks for squeezing me in and Peter and Jua, it's great to see you this weekend in Philadelphia. Three questions for me, first of all, in one of the sessions at the conference, I...

Great. Thanks for squeezing me in and Peter in July it's great to see this weekend in Philadelphia.

Three questions for me first of all in one of the sessions at the conference.

Speaker 17: if you'd like to respond to that.

So Lisa Thompson discuss the chronic versus total slope and basically knowledge that there's a hemodynamic effect there early on and so in light of that I'm just wondering if you could.

Speaker 17: you know, discuss your thoughts as you approach the meeting with the FDA.

Discuss your thoughts as you approach the meeting with the FDA.

Speaker 17: and discuss all the other supportive data in the context of the totality of the data for approval.

And discuss all the other supportive data in the context of the totality of the data for full approval.

Speaker 17: And then two more just in terms of the ongoing launch of Phil Spari. Firstly, can you discuss the PFF?

And then two more just in terms of the ongoing launch of feel sparring.

Firstly.

Can you.

Discuss the PFS in October if there is any further acceleration from the third quarter.

Speaker 17: In October , if there is any further acceleration from the third quarter.

Speaker 17: And then lastly, I'm wondering if you can discuss the conversion timeline from

And lastly, I'm wondering if you can discuss the conversion timeline from PFS.

Speaker 17: to treatment initiation, perhaps now and then also eventually steady state.

Two treatment initiation.

Perhaps now and then also eventually steady state expectations. Thanks, so much.

Speaker 3: Okay, thanks Ed. So Bill, I'll have you comment on the regulatory perspective and how we are thinking about the totality of data. And Peter, you can talk about, directionally what we're seeing in October as well as the Converse.

Okay. Thanks, Ed So bill I'll have you comment on the regulatory perspective, and how we are.

Thinking about the totality of data and and Peter you can talk about you know directionally, what we're seeing in October as well as conversion.

Speaker 12: Bill? Certainly. Thanks for the questions, Ed. I thought that was a very good session on IGA nephropathy endpoints, and the question was put to Dr. Thompson about, you know, how is the agency looking at assessing all the different drugs that are in

Phil certainly thanks, thanks for the questions and I thought that was a very good session on Iga nephropathy endpoints and the question was put too.

Dr. Thompson about how is the agency looking at assessing all of the different.

Drugs that are in.

Speaker 12: Phase three studies now were moving toward that. And her remarks, one, they were very consistent.

Our phase III studies now for approval, we're moving toward that.

In her remarks, one they were very consistent with the discussion that we've had over the years around end points.

Speaker 12: with the discussion that we've had over the years around

Speaker 12: that there are different ways to measure.

That you know there are different ways to measure them.

Speaker 12: kidney function. EGFR, she pointed out it is a surrogate in itself, but it's a validated surrogate. And for those patients with a high risk of kidney progression,

Kidney function Egfr, she pointed out as a surrogate in itself, but it is a validated surrogate hum and for those patients with <unk>.

Our high risk kidney progression.

Speaker 12: They want to see a compound showing a meaningful effect on the rate of loss across the body of evidence. And they're also.

They want to see.

Compounds, showing a meaningful effect on the rate of loss across the body of evidence.

And they're also looking for.

Speaker 12: compounds that show an accumulation of benefit across various stages of the disease, whether they are early in the disease progression or later in that. And I think that the data package that

Compounds that show an accumulation of benefit across various stages of the disease, whether they are early in the disease progression or later than that and I think that the.

The data package that we have with the chronic slow the total slow measurements pre and post the overall absolute difference at two and a half years.

Speaker 12: with the chronic slow, the total slow measurements pre and post.

Speaker 12: The overall absolute difference at two and a half years, the reduction in hard endpoints, the kidney failure endpoints, the

The reduction in hard endpoints, the kidney failure and points.

The increase in.

Speaker 12: in patients that get to complete remission, all of this on a background of a very safe therapy.

In patients that get to.

A complete remission all of this on a background of a very safe therapy.

Speaker 12: We're, you know, mechanistically, there's two things going on in these kidneys. Angeotension and the thielin both driving negative effects and blockade of both together is really required to have the best outcomes in these patients. Some very confident in the fact that we have a very strong case to make with the agency. And I look forward to the review.

It's clear you know Mechanistically, there's two things going on in these kidneys.

Angiotensin and Endothelin, both driving negative effects and blockade of both together is really required to have the best outcomes. In these patients. So I'm very confident in the fact that we have a very strong case to make with the agency.

And I look forward to the review.

Speaker 3: All right, Peter, would you like to comment on the direction of what we're seeing in October and.

Alright, Peter would you like to comment on.

Directionally, what we're seeing in October and.

Speaker 3: the conversions, which we're not providing metrics on, but direction.

The conversions, which we're not providing.

Metrics on but directionally.

Speaker 10: Yeah, I would say to your point, Eric, we have to practice not to comment on metrics within the quarter. With regards to demand, I would say that we see a continuation of new patient fast funds coming in. So I'm really pleased with that. And also to what I mentioned in the prepared remarks, we start to see like an increase in patient shifts. So I'm really pleased with the progress and also expect to have that further inflection on revenue in the fourth quarter and moving into 2024.

Yes, I would say to your point, Eric we have to practice as much incremental metrics within the quarter.

With regards to demand I would say that we see a continuation of new patients start forms coming in so we were pleased with it.

Also to what I mentioned in the prepared remarks, we start to see likely increase.

Thank you chip.

So I'm really pleased with the progress and also expect to have that.

Collection of revenue enforced water and moving into 2024.

Speaker 1: And that does conclude the question and answer session. I'll hand the call back over to you.

And that does conclude the question and answer session I will hand, the call back over to you.

Speaker 2: Thank you, everyone, for joining us for our third quarter 2023 financial results call. We look forward to providing additional updates on our progress. Have a great rest of your day, and thank you.

Thank you everyone for joining us for our third quarter 2023 financial results call. We look forward to providing additional updates on our progress have a great rest of your day and thank you.

Thank you and that does conclude today's conference. We do thank you for your participation and have an excellent.

Speaker 1: Thank you and that does conclude today's conference. We do thank you for your participation and have an

Okay.

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