Travere Therapeutics Inc

NASDAQ:TVTX

Earnings Call Analysis

Travere Shows Strong Progress in Q3 2023

In Q3 2023, Travere Therapeutics reported significant achievements with the launch of FILSPARI for IgAN after its accelerated approval. The company's strategic financial management led to a notable transition from a previous net loss to a substantial net income of $150.7 million, buoyed by higher interest income and divestiture proceeds. With a strong cash position of $634.6 million, Travere is well-prepared to support ongoing and future operations, including the development of pegtibatinase into Phase III, aiming to extend their financial runway beyond 2026.

Developing a Breakthrough: Sparsentan's Path and Safety Profile

In a compelling session at a major scientific meeting, the full Phase III DUPLEX study results of sparsentan were unveiled, painting a picture of a drug that shows a consistent and durable effect in reducing proteinuria—with more patients achieving complete remission—than irbesartan, its comparator. On the endpoint of eGFR, despite not meeting statistical significance, the data echoed a positive trend, including fewer patients reaching kidney failure. Importantly, the study reaffirmed sparsentan's safety profile, a vital aspect for patient care.

Filling Unmet Needs: FILSPARI's Journey and FDA Discussions

The company is navigating an uncharted territory with no FDA-approved treatments for FSGS, highlighting the immense unmet need in this space. Progress continues on track for FILSPARI with the promise of delivering an update on FDA regulatory discussions within the current quarter.

Forward Momentum: Pegtibatinase's Potential and Readiness for Phase III

At an international conference, further data from the Phase I/II COMPOSE Study showcased pegtibatinase, offering a meaningful reduction in total homocysteine and potential quality of life improvements for patients. The successful end of Phase II discussion with the FDA sets the stage for the pivotal Phase III study, expected to begin by the end of the year.

Commercial Prospects: The Rise of FILSPARI and Market Reactions

The launch of FILSPARI has been met with growing interest from over 5,600 nephrologists, resulting in new prescribers and increased physician demand. In the third quarter, this led to a nearly 1,000 patient start forms since the launch began. Despite slowed summer months, growth resumed post-summer, with positive market research indicating incorporating the PROTECT 2-year data is expected to boost FILSPARI utilization over the next three months. As patient education and support efforts ramp up, 67% of the US lives gained coverage by end of Q3, and FILSPARI net sales hit $8 million for the quarter.

FILSPARI's Future Trajectory: Building upon Solid Fundamentals

Confidence stewards the future prospects for FILSPARI, bolstered by its superior treatment profile and increasing demand from nephrologists. Remarkable growth in payer coverage now sees two-thirds of lives covered. Adherence and patient experience exhibit positive outcomes, where high compliance and persistence among patients on FILSPARI indicates its potential for becoming a cornerstone therapy for IgAN.

Financial Milestones and a Bright Outlook

Amidst strong financial positioning, the company reports a substantial uplift in revenue—$33.9 million for Q3, marking a significant jump from $25.4 million in the same period last year. The increase is primarily driven by FILSPARI's launch. Thiola products also contributed robustly to the quarter with $25.9 million in net product sales. Managing a solid balance sheet, the company is positioned to support operations well beyond 2026.

Investing in Innovation: R&D and SG&A Expenses

R&D and SG&A expenses climbed to $60.6 million and $67.8 million respectively, reflecting the continued investment in pegtibatinase's clinical advancement and increased headcount, alongside FILSPARI's marketing and administration allocations. Meanwhile, net income made a noteworthy turnaround, from a loss of $55.3 million to substantial gains on both GAAP and non-GAAP adjusted bases, mirroring the company's trajectory of growth and its capable management of operations and finances.

Closing Remarks: A Commitment to Rare Disease Innovations

The executive team highlighted the team's achievements and their successful quarter in promoting FILSPARI. Looking ahead, they remain determined to see FILSPARI gain traditional approval for IgAN, to finalize FDA discussions on IgAN and FSGS, and to advance pegtibatinase's Phase I/II COMPOSE Study results, signaling hope for groundbreaking therapies in rare disease segments.

Earnings Call Transcript 2023-Q3

[Operator]

Good day, and welcome to the Travere 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, Naomi Eichenbaum. Please go ahead, Naomi.

[Naomi Eichenbaum, executive]

Thank you. Good afternoon, and welcome to Travere Therapeutics third quarter 2023 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. Eric will be joined in the prepared remarks by Dr. Jula Inrig, our Chief Medical Officer; Peter Heerma, our Chief Commercial Officer; and Chris Cline, our Chief Financial Officer; Dr. Bill Rote, Senior Vice President of Research and Development, will join us for the Q&A session.Before we begin, I would like to remind everyone that statements made during this call regarding matters that are not historical facts are forward-looking statements within the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not guarantees of performance. They involve known and unknown risks, uncertainties and assumptions that may cause actual results, performance and achievements to differ materially from those expressed or implied by the statement.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 7, 2023, and Travere 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?

[Eric Dube, executive]

Thank you, Naomi, 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 FILSPARI and IgAN and reported two-year data from the PROTECT Study that we believe will position FILSPARI to play an important foundational role in the IgAN treatment landscape.Additionally, we completed a successful end of Phase II meeting for our pegtibatinase program, putting us on track for the Phase III study initiation of pegtibatinase by year-end, and we completed the divestiture of the bile acid product portfolio, enabling us to further focus on our key priorities. Regarding the ongoing launch of FILSPARI, we continued to execute our strategy for FILSPARI to become a new foundational treatment in IgAN. In the third quarter, we helped to reach even more patients. And every week, we hear stories from physicians and patients on how well FILSPARI is working for them.Over the course of the quarter, we identified that additional patient education and support can improve the performance of the launch, specifically in onboarding new patients after patient start form has been submitted, and we quickly adjusted. Notably, we are seeing early positive trends from these adjustments through October, and Peter will provide additional details shortly. Overall, 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 the FILSPARI launch.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 sparsentan and IgAN and FSGS presented as late-breaker oral presentations and published simultaneously in the Lancet and New England Journal of Medicine, World-renowned peer-reviewed scientific journals. Key opinion leaders who were at the Congress spoke positively about these groundbreaking results and recognize the role up for sparsentan in providing deep and durable reductions in proteinuria and kidney function preservation compared to an active comparator for patients with IgAN and FSGS.This in conjunction with the Lancet publication on the PROTECT Study should further lay the groundwork for potential inclusion into KDIGO guidelines for IgAN and should enable FILSPARI to become a new foundational therapy for this disease. Consistent with previous guidance regarding our U.S. regulatory engagements, we remain on track to provide updates for both FSGS and IgAN this quarter. In parallel, our team is compiling the supplemental New Drug Application or sNDA for IgAN so that we're in a position to submit in the first half of 2024 for full approval in the U.S. In Europe, the conditional marketing authorization and valuation for sparsentan and IgAN is progressing.Together with our partner CSL Vifor, we continue to anticipate a review opinion around year-end from the CHMP. Regarding our exciting pegtibatinase program, we are on track for an expected Phase III study initiation by year-end. 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, the ability to improve diet and improved testing was incredibly clear and we feel the sense of urgency to execute our Phase III program.Our confidence in the potential for pegtibatinase to become the first and only disease-modifying therapy for people living with classical HCU, continue to grow, and we're looking forward to sharing additional updates on the program in the near term. Lastly, during the quarter, we completed the sale of the bile acid portfolio to Mirum Pharmaceuticals. This transaction further strengthens our balance sheet and our focus on our key priorities of achieving success with FILSPARI and advancing pegtibatinase into Phase III.Let me now turn the call over to Jula for a clinical update. Jula?

[Jula Inrig, executive]

Thank you, Eric, and good afternoon, everyone. Before walking through our recent data presentations at ASN Kidney Week, I'd like to recognize and thank our internal team and external collaborators. 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. This rapid dissemination of data will help educate nephrologists on the strong clinical profile of FILSPARI and expeditiously provide the published data required for inclusion in clinical practice guidelines, such as an up-to-date mKDIGO.We are empowered by the data shared in the 11 ASN abstract, including two high-impact late-breaker oral presentations with simultaneous publication on the Phase III studies of sparsentan and IgAN and FSGS. Dr. Rovin, a globally recognized rare kidney disease expert presented our late-breaking Phase III PROTECT Study data that demonstrated the significant effect of FILSPARI in slowing disease progression in IgA nephropathy. These results were met with broad support by the nephrology community and provides us with increasing confidence and FILSPARI's prospective position as a foundational treatment in IgA nephropathy.Simultaneously published in the Lancet, these data demonstrate that long-term treatment with FILSPARI has the potential to preserve kidney function and thereby significantly delay the time to kidney failure. Based with limited space effective and approved therapies without significant side effects for IgAN patients, this represents a significant medical advance. Let me highlight select data from the presentation and publication. Treatment with FILSPARI provided patients with an absolute 3.7 mls per minute higher eGFR at two years versus irbesartan.This, in conjunction with a minus 2.7 and minus 2.9 mls per minute per year chronic and total eGFR slope, respectively, tells us that treatment with FILSPARI can provide patients with meaningfully slower rate of kidney function declines, particularly when compared to historical or recent Phase III IgAN trials. Additionally, these treatment effects on eGFR slope were consistent across baseline eGFR and proteinuria, supporting the potential for FILSPARI as a foundational treatment across different stages of kidney disease. Treatment with FILSPARI demonstrated lower rates of the composite kidney failure endpoint, a 40% decline in EGFR, kidney failure or death compared to irbesartan.FILSPARI resulted in a significant reduction in proteinuria and higher rates of complete remission compared to irbesartan and the reduction in proteinuria with FILSPARI was durable over the two-year study. The role safety profile of sparsentan 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. We also presented important new data at ASN that we believe help further build understanding and confidence in the clinical profile of sparsentan.These include the SPARTAN Study, which is evaluating sparsentan in newly diagnosed RAS-naive IgAN patients. Initial results to-date indicate treatment with sparsentan was well tolerated, and we've seen an approximately 80% reduction in proteinuria over 36 weeks and with minimal to no change in kidney function. In the ongoing PROTECT open-label extension, when SGLT2 inhibitors are added to stable FILSPARI treatment, the combination has been well-tolerated with a consistent safety profile and showed incremental proteinuria reduction benefit.These data strengthen the growing body of evidence that sets FILSPARI apart from standard of care in IgAN, suggesting early initial treatment with FILSPARI therapy alone or in combination with other medications has the potential to preserve kidney function with this benefit accruing over time in patients with IgAN. 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 a broader population and long-term benefits of the FILSPARI.Also at ASN, [ Dr. Rove ], a leading rare kidney disease expert, presented the full Phase III DUPLEX study results in a late-breaker oral session that was also simultaneously published in the New England Journal of Medicine. The broader results show a consistent and durable effect of sparsentan on reducing proteinuria, greater rates of complete remission, positive trends on eGFR, including fewer sparsentan-treated patients reaching the kidney composite endpoint, including kidney failure as compared to irbesartan. While the DUPLEX Study didn't meet statistical significance on the eGFR endpoint, the totality of data continue to build on our previously announced clinically meaningful results and showed a consistent and a well-tolerated safety profile.With no FDA-approved medicines indicated for FSGS and a growing incident, the unmet need in FSGS is incredibly high. We remain on track to provide an update on our regulatory discussions this quarter. Shifting to pegtibatinase for the treatment of classical homocystinuria, or HCU, we made advancements on our clinical and regulatory objectives. As the leading International Metabolic Conference, or SSIEM, we presented additional data from the Phase I/II COMPOSE Study that showed that pegtibatinase provides a clinically meaningful reduction in total homocysteine of 67.1% and that the treatment effect was consistent across patients. One patient achieved normalization of total homocysteine to less than 15%.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. Additionally, our teams have the opportunity to engage with global HCU thought leaders who are eagerly anticipating the study initiation. We 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 year-end. 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 for [Technical Difficulty].

[Peter Heerma, executive]

Thank you, Jula, and good afternoon, everyone. We continue to make sound progress in establishing the commercial fundamentals for FILSPARI to achieve our ambition of making it a new foundational therapy for IgA nephropathy patients at risk of rapid progression. Since the beginning of the launch in February, we have engaged with over 5,600 nephrologists while becoming increasingly notable on the promising clinical profile of FILSPARI. These face-to-face interactions have resulted in new prescribers and additional uses within practices. Physician demand continues to increase. And in the third quarter, we had 430 new Asian start forms.This represents nearly a 1,000 patient start forms since the initiation of the launch. This speaks to the confidence nephrologists have in the clinical profile of FILSPARI and how they are using it to help reduce their patient's proteinuria. Notably, these patients start form growth occurred even with the slower summer season when fewer patients typically see their physicians and as is common dynamic observed in benchmark launches and we observed growth following the summer months. As you heard from Jula, 13 of medical science [indiscernible] have received faster feedback than the recent 2-year results from the PROTECT Study and that is consistent with our market research.In fact, recent market research conducted after the top line press release of the PROTECT 2-year data analysis shows that after reviewing the 2-year data, a significant number of nephrologists have described FILSPARI expect to increase their utilization. And 60% of surveyed nephrologists that do not yet have the prescriber experience indicate the plan to prescribe FILSPARI in the next three months based on this new data. Nephrologists also mentioned that they are encouraged by the rapid and sustained proteinuria reduction and that the eGFR results indicate a currently meaningful long-term benefit on kidney function and delay in disease progressing.The market research also indicates that the 2-year safety profile could provide confidence for physicians, furthering their intent to prescribe. This feedback gives us confidence that we will continue to see growing demand through the balance of the year and into 2024. During the quarter, we also continued our progress in payer engagement with 67% of the U.S. lives covered for FILSPARI by the end of Q3. Importantly, we nearly doubled our FILSPARI-specific formularies from 50 by the end of the second quarter to more than 90 by the end of Q3. And we continue to be very pleased with the quality of these specific formularies and authorization criteria.From a revenue perspective, we reported FILSPARI net sales of $8 million for the third quarter. We are beginning to see the expected upward inflection in revenue, but it is not yet closely matching demand seen from patient start forms. The main component of this is that the intersegment of patients who, without increased education and support on the REMS, either have not yet initiated therapy or have taken longer to receive their first shipments. Importantly, our teams recognize the need for additional patient education and support in the fulfillment process for this segment of patients, and we adjusted quickly during the quarter.We enacted targeted approaches to enhance communication and increase patient support, including precision guidance materials for their conversation with patients that are candidates for FILSPARI. We provided educational patient-friendly communication materials in print and online. An additional patient support [indiscernible] educators toward patients through the REMS certification process. Notably, we are seeing early signs that these efforts on providing additional support for this segment of patients are working. Both the number of patients completing their REMS certification shortly after receiving a patient start form and patients initiating paid therapy have been increasing.As we discussed on our approval call in February, FILSPARI's launch would be a rolling month that enforce over the first 9 to 12 months punctuated by important milestones, such as the 2-year data and payer reviewed publications. Looking ahead, we see further growth opportunity with the growing body of sparsentan evidence at in combination with SGLT2. The potential inclusion in prescribing [indiscernible] to be updated next year and most importantly, the planned submission of an sNDA for the full approval of FILSPARI in IgAN in the U.S.To close, we have great confidence in the future [ launch ] trajectory of FILSPARI based upon key fundamentals. First, FILSPARI's profile. FILSPARI has a superior treatment profile compared to active compared to irbesartan and addresses the needs of patients with IgAN and risk of rapid progression; two, demand from nephrologists, [indiscernible] are excited about the FILSPARI profile, which is demonstrated by the high patient start forms and the increasing new and repeat prescribers. Three, the payer progress.Quarter-over-quarter, we have shown increasing payer coverage growth. Now two-third of the lives are covered, and we're seeing high level of payer approvals for FILSPARI. And four, patient experience and adherence. We continue to hear feedback that patients on therapy have positive clinical results in their proteinuria levels. And once the patient starts FILSPARI, we are seeing that both compliance and persistence is high. Importantly, our team is focused on delivering a strong fourth quarter and we will continue to adjust based on ongoing learnings to achieve our ambition on FILSPARI becoming the foundational treatment for IgAN patients at risk of rapid progression.Let me now turn the call over to Chris for the financial update. Chris?

[Chris Cline, executive]

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 revenue, and we focused our investments for the future. We also completed the bile acid portfolio transaction, which has brought forward several years of value from the product and meaningfully strengthened our balance sheet. 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 FILSPARI in IgA nephropathy. Thiola and Thiola EC also continued to perform well and contributed to $25.9 million in net product sales in the third quarter. This growth continues to be driven by organic patient demand. 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. Research and development expenses for the third quarter of 2023 were $60.6 million compared to $57.1 million for the same period in 2022.The difference is largely attributable to the continued advancement of the company's pegtibatinase clinical program as it prepares for Phase III initiation, including clinical trial expenses and manufacturing as well as increased headcount. 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. 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.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. Total other income net for the third quarter of 2023 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. 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.On a 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 $0.86 per basic share for the same period in 2022. As of September 30, 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 bile acid portfolio divestiture.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 FILSPARI launch and advancing pegtibatinase into Phase III 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?

[Eric Dube, executive]

Thank you, Chris. The Travere team has accomplished and executed on a remarkable number of milestones, making significant progress towards delivering innovative treatments for patients with rare diseases. Overall, for the third quarter, I remain incredibly proud of our team's execution. We have successfully delivered a quarter demonstrating demand for FILSPARI and with the PROTECT Phase III data in hand, we remain confident in our goal of enabling FILSPARI to ultimately become the foundational therapy in IgAN. Feedback from the scientific community at ASN is deeply encouraging as we continue our FILSPARI launch and continue our plans to pursue an sNDA to confer FILSPARI for traditional approval.We remain on track to provide an update on our FDA engagement for both IgAN and FSGS this quarter. Additionally, the data packages from the Phase I/II COMPOSE Study for pegtibatinase 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. As we approach the end of the year, our efforts are concentrated on finishing strongly. We are focused on executing continued progress with the FILSPARI launch, advancing pegtibatinase 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 over to Naomi for the Q&A questions. Naomi?

[Naomi Eichenbaum, executive]

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

[Operator]

[Operator Instructions] And we will now take the first question from Joseph Schwartz with Leerink Partners.

[Analyst, analyst]

This is [ Will ] on for Joe. So 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 group syndications that seem to appreciate the totality of the data more as compared to those who may not be fully comfortable with the profile yet? And then I have a quick follow-up to this.

[Eric Dube, executive]

Will, 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, why don't you share what you heard?

[Jula Inrig, executive]

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 sparsentan has the potential to preserve kidney function and significantly delay the time to kidney failure. And the other important thing that was demonstrated is the rapid and durable and sustained reduction in proteinuria -- 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 in patients with IgA nephropathy.And I would say -- and the additional thing that I would say is looking to the future, the additional data that we showed with regard to earlier treatment were from the SPARTAN Trial data that shows if you treat people early, even before they've seen ACE inhibitors or ARV, you see even more reduction in proteinuria and preservation of kidney function. And if you use it in combination with [Technical Difficulty] 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.

[Analyst, analyst]

Great. And then just a quick follow-up here. Given the literature suggests that the 40% reduction in proteinuria should lead to around 2.7 ml per mg benefit on eGFR, but we saw a bit of a different relationship in 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 may have drove this outcome.

[Eric Dube, executive]

Jula, I'll pass that one over to you.

[Jula Inrig, executive]

Yeah. Happy to answer that. When you look at the meta analysis and all the data and combination, you're looking at drugs with different mechanisms of action, some that acutely increase eGFR and some that decreased. This is a 2-year study where over 2 years, we saw an absolute difference and benefit of 3.7 mls after 2 years, favorable for sparsentan, and that's a really important point to take into consideration.Obviously, the slope data is model treatment effect, where we see an annual benefit of greater than 1 ml 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. So each year, you get a benefit at 1.1 and 1.2 in 2 years, it's 3.3 the next year. That's the important take-home message that you get. It accrues over the long term, which is very different than other drugs, which might increase the eGFR [Technical Difficulty].

[Operator]

And our next question will come from Anupam Rama with J.P. Morgan.

[Anupam Rama, analyst]

On the patient start forms, maybe you can give us a little bit more color beyond the opening marks on what you're seeing on the month-over-month growth year. Was there any particular headwind in the quarter beyond the summer seasonality that you talked about or was there a group of physicians that were kind of on the sidelines to like sell the 2-year PROTECT eGFR? Maybe give us a little bit more color on that.

[Eric Dube, executive]

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

[Peter Heerma, executive]

Yes. Thanks, Anupam. I would say, overall, we see a good continuation of growth during the quarter. And we had a little July inflection when less patients see their physician as I commented on the prepared remarks. But overall, we're seeing continued growth from both new prescribers as well as repeat prescribers. And most of these patients are being managed through the community physicians, and that's why 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 headwind, and I'm really pleased with the continued growth that we show today in continuation of demand.

[Operator]

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

[Maurice Raycroft, analyst]

I think Jula just alluded to benefit accruing over time in the PROTECT Study. Since patients on sparsentan and PROTECT washout prior to starting the open-label extension, how does this impact ability to show that treatment effect accrues beyond the 2-year period in case FDA asked for a longer-term data like this? I guess is there a way you can account for the washout.

[Eric Dube, executive]

Maury, thanks for the question. Jula, I will pass that one over to you.

[Jula Inrig, executive]

Yeah, Maury, it's a fair question because in reality, that's not how we're going to treat pace over the long term. You would keep them on, but that was a question that wanted to be asked because of the acute hemodynamic effects. 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 overall favorable eGFR in patients in sparsentan washout. Now we can continue to monitor those patients when they resume sparsentan.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 were on irbesartan versus switch over to sparsentan. So it will be incrementally important information that we'll provide over the long term. 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.

[Operator]

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

[Greg Harrison, analyst]

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 FILSPARI in light of the data?

[Eric Dube, executive]

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

[Peter Heerma, executive]

Yes. Thanks for the question. I would say, first of all, the patients start forms of 430 in the third quarter, I think is a really good number that a little like a 1,000 patients [indiscernible] the first 7.5 months. I think we're making really good progress there. To Eric's point, it's too early after the top line data announcement to see any change in [ deflection ].But I think overall, what we saw in the market research, and this was a closed market research right after the press release of the top line is that there is good confidence in the profile of FILSPARI and having the [indiscernible] having had many of the conversations with physicians, I think there was a really good reception of the FILSPARI profile, the totality of the data and what FILSPARI can mean for those physicians' patients. So I think overall, good reception and yeah, more to go.

[Operator]

And our next question will come from Vamil Davin with Guggenheim Securities.

[Vamil Divan, analyst]

I'm just curious if you can share some more feedback on the REMS and safety side of things? I think you said you've now touched about 5,500 nephrologists, I believe, was the number you shared, can you share anything in terms of how many nephrologists are now sort of work their way through the REMS program are certified to prescribe it? And then again, just kind of the theme of some of the other questions, any feedback on the safety side of things now that we've seen [indiscernible] full data, both on PROTECT as well as DUPLEX?

[Eric Dube, executive]

Vamil, thanks for the questions. Before I hand it over to Peter, what I'll just share is that we can provide some qualitative and directional feedback on 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 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?

[Peter Heerma, executive]

Yeah, certainly Eric. And I think we were referring to the amount of nephrologists that we have seen in face-to-face interactions. But indeed, I just call out 5,600 nephrologists that we have seen in face-to-face interactions with our field force is [indiscernible]. And that is, I think, a very good progress because as we announced during the launch call, we are consistently want to call on about 6,000 nephrologists that bring about 85% of the patient population. And so I think we've been making really good progress. And we are at the early days from overall nephrology perspective. With regards to the safety profile, I think that was the second part of your question, maybe Jula, that's more an appropriate question for you to answer.

[Jula Inrig, executive]

Yeah. I think that I would respond significant reassurance with regards to the safety profile around sparsentan across the program to-date, both PROTECT and DUPLEX, where we saw the exact same safety profile with regards to the liver elevations of 3x upper limit of normal and really no new elevation since our interim from PROTECT. And so where physicians rapidly move to is -- can this be changed over time, which, of course, will readdress this as we continue to accrue data and go back, but that's where physicians quickly move to. So we feel reassured of that safety profile at this time.

[Eric Dube, executive]

Vamil, 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 represcribing information, what a [ box morning ] is and what a REMS. And in fact, many nephrologists have familiarity and are accustomed to REMS.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 an [ ACE or an ARM ] 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 information, education and support. And so there is a segment, as we referred to, where the REMS 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 all patients the information that they need to be able to move from patient start forms 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.

[Operator]

And our next question will come from Liisa Bayko with Evercore ISI.

[Liisa Bayko, analyst]

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?

[Eric Dube, executive]

Chris, why don't we have you go through gross to net? And Liisa, I'll say that we are not yet in a position to be able to comment on a number of patients on therapy or other types of KPIs that 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 as well as just working their way through the reimbursement process. So we're not in a position to be able to comment in at this point. But I can say is that we continue to see very strong demand. We continue to see that inflection 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 gross to net?

[Chris Cline, executive]

Sure. So Liisa, consistent with our prior guidance, we expect a stable state sparsentan or FILSPARI gross to net to be mid- to high teens, and 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 Eric highlighted, the different elements of reimbursement, etcetera, 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.

[Liisa Bayko, analyst]

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

[Eric Dube, executive]

We did not report on numbers of patients on therapy because, again, during the first part 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 since that we shared and guided to on -- in February, patient start forms, 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.

[Liisa Bayko, analyst]

Okay. And then any commentary on -- or update on the new guidelines coming out at KDIGO guidelines?

[Eric Dube, executive]

Jula, do you want to take the latest on the guidelines?

[Jula Inrig, executive]

Yeah. We're very pleased that we were able to get our PROTECT results published and then peer reviewed. We knew that our interim data was going to be included in the KDIGO 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 published -- or public commentary in the very first quarter of 2024.

[Liisa Bayko, analyst]

Okay, great. And then just final question for me. Kind of as we see the landscape evolving, I was really kind of struck by the eGFR results that Otsuka presented for [indiscernible], which is one of the B-cell modulators targeting [ April ]. I guess in the context of having is 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 eGFR relatively flat or is there still like you can do better and what about proteinuria and all those other things? But just curious how you're thinking about kind of sparsentan in the context of kind of that kind of a remarkable change in eGFR?

[Eric Dube, executive]

Yeah. I'll have Jula talk about the view of maybe her 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 FILSPARI 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 RAS inhibition that occurs -- to address the over-activation in the kidney. I think now what we've seen with our 2-year data is the superiority of FILSPARI 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 in the positioning, and that's what we mean by that foundational therapy. I know that a lot of this data is early, but Jula, 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?

[Jula Inrig, executive]

Yeah. I think it's important, as Eric said, you need a foundational treatment. When you get diagnosed with IgA nephropathy, you have already damaged its ongoing, and you need to reduce the proteinuria to preserve kidney function. And what we demonstrated with PROTECT is if you replace your RAS inhibitor with sparsentan, you can get incrementally closer to a normal kidney function in the twos. 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 [indiscernible] data, that's 1-year data. 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 IIs to further out. But I do believe that sparsentan 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.

[Operator]

[Operator Instructions] And our next question will come from Mohit Bansal with Wells Fargo.

[Analyst, analyst]

This is [ Adam ] on for Mohit. Would you briefly touch upon the early persistence data you have for patients on FILSPARI and how you think REMS contributes to this? And then separately, I would appreciate an update on what you're seeing in terms of step edits and prior ops that you have more formularies covering FILSPARI?

[Eric Dube, executive]

Yeah. Peter, I'll turn to you in just a moment to talk about what -- to explain a little bit more about the persistence compliance as well as a -- but before I do, I want to share a story that I've 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 FILSPARI. 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. What he shared and I think was really an aha 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 regular check-ins from his physician.So actually, that may be for many patients, a 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 was 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. Peter, do you want to share anything further on the persistence as well as the payer coverage?

[Peter Heerma, executive]

Yeah, certainly, Eric, and thanks, Mohit, 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 REMS if I understood you correctly. So let me go one by one. I think really pleased with the payer approval rate that we are seeing for FILSPARI, which closely matches the progress we're making in the overall coverage as well.So I think we have made really good progress there and also the compliance and persistence, patients that are on products in clinical results and remain on [Technical Difficulty]. I know this is one of the questions initially with the monthly monitoring, all patients remain on therapy. What we are seeing so far and it's still early days, we see strong compliance and persistence rates. With regard to the REMS and patient perception on the REMS, I think for a large amount of patients the process is working very well, and these patients received FILSPARI well within benchmark numbers.But as Eric mentioned earlier and as I alluded to that in the prepared remarks, there's also a segment of patients that needs a little more handholding through education and support. I think you have to realize that it was only until the second half of June is we had the opportunity to educate physicians and patients other than the packaged insurers as far as the FDA guidance for accelerating approval. So really, by the end of June, we were able to provide the additional educational support for patients. And with additional support, we are seeing that the early REM certification for that group of patients is already improving. That also translates then into an increase in FILSPARI shipments to patients.

[Operator]

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

[Edwin Delfin, analyst]

You've got Edwin Delfin on the line for Carter Gould. We have a question on pegtibatinase for HCU. I know you've completed the end of Phase II meeting, but have you guys received clarity from the agency on the amount of follow-up and any impacts on clinical measures beyond the biomarker impact for the primary endpoint?

[Eric Dube, executive]

Edwin, thanks so much for the question, and we are really excited about our HCU 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 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.

[William Rote, executive]

Certainly, now that I'm off to you. We've completed the end of Phase II, 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 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. Once the study starts, we'll give you a full picture of the Phase III program. And I think you also asked around overall study duration. If you -- if we look at the range of other enzyme replacement therapy studies, the period of observation ranges from 6 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, and we'll have more once the studies has started.

[Operator]

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

[Laura Chico, analyst]

I wanted to go back to the patient start form for a moment for FILSPARI and 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 Tarpeyo's launch, I believe they peaked out at 589 enrollment during the first four quarters. So curious as to whether you think you can actually grow this much more beyond 430?

[Eric Dube, executive]

So Laura, I think the question is unequivocally, yes. 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 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, 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, 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.

[Peter Heerma, executive]

Yeah. Thanks, Eric, and thanks, Laura, for that question. I think there's really three components here that I would like to highlight. To answer your question, like how far can you go and how you basis are out there. The first one is, I would say there have been limited innovation in the product in the last 30 to 40 years. And that's what you see as well with physicians in nephrology are relatively conservative in adaptation of the new medicine. And part of that is also 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 at the last earnings call, and Jula can provide a little more context on that really is providing that increase in urgency to treat because historically, a lot of the physician part like IgA nephropathy is a relatively slow progressive disease. 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 and new guidance. 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 7.5 months of FILSPARI. And I see with all the continued investments and education and community there is a recognition that these patients should be treated more early and more urgently. So Jula, you can provide a little more context on your perspective on, for example, RADAR.

[Jula Inrig, executive]

Yeah. I think that as we educate the physician and they realize that what they historically understood and were trained in their educational program 10, 20, 30 years ago that IgAN is a benign disease and they can send them back to their primary care physician and see them every few years is not the case. And that patients even with 500 milligrams of proteinuria are at risk of progressing to kidney failure within their lifetime.We had additional data presented at ASN that confirmed the RADAR data, and this is U.S. registry data that showed similar results. 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 increases. And to Peter's point, then that translates into the need to treat them with the foundational medication such as FILSPARI, which reduces proteinuria preserve kidney function.

[Operator]

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

[Analyst, analyst]

This is [ John ] on for Tim. Thanks so much for squeezing us in. So with the recent atrasentan 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?

[Eric Dube, executive]

Yes. I mean we certainly expect that there are going to be additional data, potentially new therapies that are going to be approved. I think it's hard for us to comment because there were no data disclosed. And so I think we'll have to wait to see what is presented from atrasentan 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 demonstrated that with PROTECT with sparsentan, 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.

[Operator]

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

[Alexander Thompson, analyst]

I guess in the past, you commented 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 the impact at all of stocking in the revenue this quarter?

[Eric Dube, executive]

Yes. 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 is that I'm incredibly proud of the progress that we've made on the FILSPARI 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 half of this year, we'll start to see revenue track more closely with that underlying demand with the number of patient start forms.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 going to make that progress in the fourth quarter. And in fact, when we look at other rare renal launches, 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 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.

[Operator]

And our next question comes from Allison Bratzel with Piper Sandler.

[Allison Bratzel, analyst]

Just one on the SPARTAN study update at ASN, and this is kind of a follow-up to a prior question and prior discussion. But just based on your interactions with nephrologists and KOLs, could you help us understand what kind of additional clinical data you think you need to generate to really catalyze or just drive widespread first-line use of FILSPARI in IgAN or just earlier line use more broadly?

[Eric Dube, executive]

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 our focus right now is within under accelerated approval we've got to focus very much on the label at hand. We would expect that with traditional approval that we would expect to see that expansion. But Jula, do you want to comment on what additional data you're hearing from nephrologists? And Peter, then perhaps further what you're hearing in market research?

[Jula Inrig, executive]

Well, to Eric's point, right now, we're primarily being utilized in prevalent IgA nephropathy patients who remain at risk for progression per our label. Physicians are very excited about the SPARTAN data because we're one of the only ones that's generating this data. Patients who are newly diagnosed who haven't failed RAS inhibitors yet and the potential for sparsentan to be used as a first-line treatment and the magnitude of proteinuria reduction and kidney function preservation. So I think that the SPARTAN data can incrementally show that.The other important data that we're going to have in this with some of the biomarker data, the fluid data, the biopedence 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 biopsies 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 sparsentan can play in patients with IgA nephropathy.

[Peter Heerma, executive]

Yes, thanks Jula and building on that I would say we have very strong data now for patients that basically have failed RAS inhibition both As and Rs. And we know from market research that over half of the patients that are on As and Rs are not getting to the target levels of proteinuria as a physician you'd like to. So we have still a lot of patients to go in that segment.But now we also have patient information and very strong data in patients that are RAS naive. And then I think the third category is really building upon the evolving treatment landscape and being prepared for combination therapies as Jula was mentioning. And I think the combination data that we presented last week at ASM with SGLT2 provides additional context as well. So I think we are building the data in the evidence across a broad patient population that could benefit from FILSPARI treatment.

[Operator]

And we'll take a question from Ed Arce with H.C. Wainwright & Company.

[Antonio Arce, analyst]

Thanks for squeezing me in. And Peter and Jula, it's great to see this weekend in Philadelphia. Three questions for me. First of all, in one of the sessions at the conference, I saw Aliza Thompson discuss the chronic versus total slope and basically acknowledge that there's a hemodynamic effect there early on. And so in light of that, I'm just wondering if you could discuss your thoughts as you approach the meeting with the FDA and discuss all the other supportive data in the context of the totality of the data for full approval.And then two more just in terms of the ongoing launch of FILSPARI. Firstly, can you discuss the PFS in October, if there is any further acceleration from the third quarter? And then lastly, I'm wondering if you can discuss the conversion time line from PFS 2 treatment initiation, perhaps now and then also eventually steady-state expectations.

[Eric Dube, executive]

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 conversion. Bill?

[William Rote, executive]

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 how is the agency looking at assessing all the different drugs that are in Phase III studies now for approval or moving toward that. And her remarks, one, they were very consistent with the discussion that we've had over the years around endpoints that there are different ways to measure kidney function. eGFR, as you pointed out, is a surrogate in itself, but it's a validated surrogate. And for those patients with a high risk of kidney progression, 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 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 we have with the chronic slope, the total slope, measurements pre and post, the overall absolute difference at 2.5 years, the reduction in hard endpoints, the kidney failure endpoints, the increase in patients that get to complete remission, all of this on a background of a very safe therapy it's clear mechanistically, there's 2 things going on in these kidneys, energy ascension 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.

[Eric Dube, executive]

All right. Peter, would you like to comment on the direction of what we're seeing in October and the conversions, which we're not providing metrics on directionally.

[Peter Heerma, executive]

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

[Naomi Eichenbaum, executive]

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.

[Operator]

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