Q1 2024 Travere Therapeutics Inc Earnings Call

Participants

Anne Crotteau; Manager, Investor Relations; Travere Therapeutics Inc

Eric Dube; President, Chief Executive Officer, Director; Travere Therapeutics Inc

Jula Inrig; Chief Medical Officer; Travere Therapeutics Inc

Peter Heerma; Chief Commercial Officer; Travere Therapeutics Inc

Christopher Cline; Chief Financial Officer; Travere Therapeutics Inc

Anupam Rama; Analyst; JPMorgan Chase & Co.

Tyler Van Buren; Analyst; TD Cowen

Joseph Schwartz; Analyst; Leerink Partners LLC

Carter Gould; Analyst; Barclays Bank PLC

Jason Zemansky; Analyst; BofA Securities, Inc.

Maury Raycroft; Analyst; Jefferies LLC

Yigal Nochomovitz; Analyst; Citigroup Inc.

Vamil Divan; Analyst; Guggenheim Securities, LLC

Alex Thompson; Analyst; Stifel Financial Corp.

Laura Chico; Analyst; Wedbush Securities Inc.

Ed Arce; Analyst; H.C. Wainwright & Co., LLC

Allison Bratzel; Analyst; Piper Sandler

Presentation

Operator

Good day, and welcome to the Trevena Therapeutics First Quarter 2024 financial results and corporate update conference call. Today's call is being recorded. At this time, I would like to turn the conference call over to the Manager of Investor Relations, Anne Crotteau. Please go ahead, Anne.

Anne Crotteau

Thank you, Rachel. Good afternoon, and welcome to Trevi Therapeutics First Quarter 2024 financial results and corporate update call.
Thank you all for joining today's call will be led by our President and Chief Executive Officer, Dr. Eric Dube. Eric will be joined in the prepared remarks by Dr. 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 statements. Please see the forward-looking statement disclaimer on the company's press release issued earlier today, as well as the risk factors section in our 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 May sixth, 2024 Entergy or 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

Thank you, Anne, and good afternoon, everyone. This year, our organization is focused on executing on the key priorities that will drive sustainable growth for Traveo in 2024 and the years ahead.
I am pleased to report that we made significant progress on all fronts. Our commercial launch of cell spar in the US is continuing to reach new highs. We successfully achieved multiple regulatory milestones with Phil Sparks and the first patients were dosed in the pivotal HARMONY study. It pegged about MACE. I'll begin with a still spotty launch in the U.S. following a strong close to 2023. Our team continued to elevate performance in quarter one. Importantly, this was demonstrated across all key aspects of the launch, increased patient demand, new and repeat prescribers, faster time to reimbursement and broader payer access. We continue to have the highest demand amongst recent rare renal benchmarks, and we achieved 35% growth in revenue over last quarter despite the typical New Year headwinds with gross-to-net adjustments. Notably, we are seeing the strength continue in the second quarter. This respect and reflects strong execution by our commercial team, but also the underlying demand for a superior foundational treatment. Peter will provide further detail on the Q1 performance and our outlook shortly start 2024. Our regulatory team achieved important milestones in our journey to deliver Phil Sparks to more patients globally. Today, we are very pleased to report that our submission to convert Phil Sparks from accelerated approval to full approval has been granted priority review by the FDA. This marks a critical step forward for full approval, which we expect would include a label enabling us to reach a broader set of patients living with IGA nephropathy in the U.S. outside of the US, our partners made important progress with the recent conditional marketing authorization or CMA, I feel sorry for again in Europe and submission of an IND for a Phase three trial and again, patients in Japan. Julia will provide further detail on our regulatory engagements and milestones for the rest of the year. We also made good progress on our paper Batten's program, which provides an opportunity for significant growth for Traveo beyond Phil sorry, this program is the only late-stage development candidate for HCU and the only medicine in development for HCU that has the potential to be disease modifying with successful efforts. We anticipate that peak about and they could become a new treatment standard in the market that we expect to grow well beyond $1 billion. We initiated the Phase three HARMONY study at the end of last year, and we are pleased to have dosed our first patients in the study. Overall, we remain on track to report Phase top3 line results in 2026.
Now let me turn the call over to Jula for her update. Jula?

Jula Inrig

Good afternoon. I'll start with IgA nephropathy, where our medical activities for 2024, our focus on ensuring we achieve full approval appeal story and providing the education and support to enable fuel storage replace Ras inhibitors as foundational care. It is important to remember that patients living with IGA nephropathy face a high lifetime risk of kidney failure and the time to median kidney replacement therapy is even shorter for those with persistent proteinuria. Again, it's caused by overactivation in both the kidneys and the immune system. As a result, clinicians have historically focused on two complementary ways of treating IGA nephropathy. First, with foundational care directly addressing the overactivity in the kidney. This has been the role RASP inhibitors have played, and second, addressing systemic inflammation with steroids for select patients. We are at an exciting juncture where we are seeing improvements in the options addressing both of these approaches independently and the future will include using both of these in tandem in more effective ways. This is critical as there is no single medicine approved or in development that will arrest the progression for effects of IGA nephropathy. We are most excited about the evolution of the treatment paradigm because still Spark is the only medicine that is in position to replace the foundational role of RASP inhibitors. This is because the story is the only approved non immunosuppressive medicine for IGM that directly targets kidney injury, known as HIT for and protects the kidney from further structural damage. And most importantly, CellStar is the only treatment that has been evaluated head to head against RASP inhibitors, specifically Urba certain and shown clear superiority in proteinuria reduction along with clinically meaningful long-term kidney function preservation. Everything else has been added on top of Roundup inhibitors and or is targeting elsewhere in the disease cascade. But unfortunately, not comparing directly. So what works on that similar pathway as we move ahead, we believe nephrologists will use still story as a foundational kidney targeted therapy and then add upstream immune mediated medications as needed. Perhaps not surprisingly, we are continuously hearing from nephrologists as they are gaining more experience with Phil Sparks, but they're making the choice to utilize the story as foundational care for their eligible IDN patients. And this is further validated by increasing recommendations and treatment guidelines and algorithms to replace RASP inhibitor therapy with Pillsbury in patients who remain at risk for progression. We also continue to generate additional supportive data. At the recent World Congress of Nephrology Meeting, we presented new data describing subgroup analyses from the PROTECT study, demonstrating that treatment with dose. Barry had a clinically meaningful benefit on long-term kidney function preservation at two years across a broad range of baseline proteinuria subgroup. This signifies that so far, it can have a positive impact in a wide range of proteinuria levels, and we believe it is supportive for potentially broadening our label at full approval.
We also presented data from our SPARTAN study examining newly diagnosed Ras inhibitor naive patients, which showed an 80% reduction in proteinuria and stable EGFR out to 36 weeks. Some of the most impressive again, data to date, these results show that if you treat again patients early enough with Phil Sparks, you stabilize EGFR and can get two thirds of patients into complete remission. Additionally, we presented data that showed adding SGLT2 inhibitors to fill sorry, is safe and can further reduce proteinuria. Collectively, these results are supportive of earlier and broader use, and we look forward to providing longer-term results at upcoming congresses as the IDN treatment paradigm continues to evolve. We also hear from thought leaders and hold the Blease ourselves that the field is moving towards earlier diagnosis and treatment of patients earlier in their disease. This is widely anticipated to be recognized in the upcoming KDGO. guideline revision. This will support intervening earlier with foundational care and following full approval, provide a good opportunity for us to further educate on the lifetime risk for these patients. They don't have time to wait every day. They're losing kidney function Now turning to our the key regulatory milestones to start the year. As Eric highlighted earlier, we were very pleased to receive priority review for our MDA with an assigned produce a target action date of September 5th of this year. Additionally, the FDA has communicated that they do not plan to have an advisory committee meeting to discuss the application. We look forward to continuing to work with FDA throughout the review process, including engaging on the REMS for liver monitoring. We are also pleased with the recent European Commission decision to grant conditional marketing authorization to fill sorry, in Europe. It is important to note that so far it is the only medicine for IGA nephropathy, three, STEVE SDMA for patients with proteinuria greater than one gram per day or greater than 0.75 grams per gram.
Next step in Europe is transitioning to full approval, and we are presently supporting the submission preparation process in partnership with CSL Vifor. We also recently announced that our partner in Japan for analysis has made progress with an IND submission and advancing their study to support ultimate approval in Japan and other Asia Pacific regions. I'll provide a brief update on FSGS. Our efforts in FSGS continue in the background, and we remain hopeful that we will be able to identify a path forward for an additional indication for Phil Sparks.
In parallel with our efforts, Paris Sol, which is a public-private partnership with Nest here, the FDA, EMA and academia, it bringing together FSGS data sets from around the world to help define the relationship between proteinuria, EGFR and kidney outcomes. Their goal is to align on an endpoint that would support approval of new therapies for FSGS patients and they plan to present their data at ASN in late October. We will continue to compile our data and reengage with FDA at the appropriate time once the parallel work is near to completion.
Now let me discuss our HC. program in Phase three development. We continue to be very excited about our potential to deliver pet tobacconists as the first disease modifying therapy for HCU. We recently engaged with HCH., the thought leaders and patient advocates at ad boards and medical conferences. And there is significant enthusiasm about the potential for pet about knees to positively change the lives of people living with HCU. The available treatment options do not address the underlying cause of HCU, nor did they help patients address the risk of thrombotic events or address the need for low protein dye. These often require drinking medical formula to help achieve adequate nutritional intake and can negatively impact many social aspects of daily life. We believe that PEG to that name as the only therapy directly targeting the key enzyme defect and HD., you can change that if approved we are pleased to have achieved the first patient dosed in the pivotal HARMONY study. As we've discussed, we are metering enrollment in the earlier stages as we ensure we have high quality adherence to our protocol and continue to scale our supply for the duration of the program and commercial use. So far, we're getting positive feedback from our sites, and we continue to anticipate top line data in 2026. This quarter, we will also begin to transition patients from our Phase one two composed trial onto our open-label Ensemble study. This will allow for eligible composed patients to enter into our protein tolerance or diet modification substudy and start generating data for this important exploratory endpoints.
In summary, we are pleased with the progress in each of our programs, which is a testament to the talented team at Revere who are passionate about working to deliver life-changing therapies for people living with rare diseases.
Let me now turn it over to Peter for a commercial update. Peter?

Peter Heerma

Thank you, Jula, and good afternoon, everyone. When you do report is going to be an exciting year fulfills file as we are building upon a solid foundation that was created in 2023. And I'm pleased to report that we started the year with strong performance in the first quarter. We continued to see strong and growing demand from physicians and their patients, as evidenced by the continued increase in both breadth and depth of prescribers during the quarter. Notably, we have now had more than 2000 nephrologists who have enrolled in certified nickel's value REMS program. Most of these positions have already started prescribing So expiry and have witnessed how dual inhibition of endothelial and a defensive benefits their patients in a meaningful way. And this number continues to grow with signals that demand is expected to remain below the growing prescriber base and persistent demand resulted in a continuation of growth in new patient start forms to 511 in the first quarter, we have now seen sequential growth in patient start forms for the first five quarters of loans and exceeded the 500 patient starts for Mark faster than any of our benchmark comparisons and ran 4G from a payer perspective, approximately 95% of the U.S. patients have a pathway for reimbursement of satisfying. We continue to be pleased with the quality of the authorization criteria, which are largely in line with label language and guideline recommendations. I am pleased that this early in the launch, we have achieved such a high level of progress in the phase of transitioning now into Phase three. It must continuously improve. The enhancements we made in the second half of last year are working, and we now see that about 80% of the patients that are prescribed tools. Valley are enrolling in the REMS program within 14 days of phasing stores, pharmacies in our quality and our quality number of new plate shipments continues decline. Our collective efforts led to $19.8 million in revenue sales for the first quarter. We are pleased with the continued increase in revenue, especially in the first quarter of the year, where we experienced elevated gross-to-net adjustments as is typical to start to see real strong start to 2024 adds to our confidence in driving significant growth for conspiring this year in our goal of outperforming the benchmark metrics for the 2nd year of launch. In addition to the constant sort of consistent patient starts on growth, we have also maintained a high loss rates in revenue since the initial launch curve compared to benchmarks. And of note, the strong sales trend has continued for the second quarter so far.
Please add programs to our belief that we will drive continued revenue growth quarter over quarter as we move to some of the key inflection points later this year that can further accelerate our growth. To this end, we anticipate first filing will be included in our latest EU guidelines, which are expected to be available for public review in the coming months. Additionally, based on the increasing body of evidence that proteinuria is directly toxic to the kidney and therefore prominent risk marker of progression towards certain failure. We anticipate a more ambitious proteinuria target in the guidelines, which will further increase the urgency to treat patients earlier and more aggressively upon potential for approval. In September, we anticipate an expanded label, which would provide greater support for physicians to prescribe to aspiring to a broader patient population this could be particularly well-timed as the pause and digest Picogiga guidelines and begin to diagnose and treat their patients through earlier. We also expect additional clinical evidence, the deal I highlighted earlier, we'll definitely provide additional support for physicians to treat earlier. We're still starting and to use it potentially in combinations, other preferred other medicines for patients that may need more aggressive treatments. These milestones will support our ambition to make first following the foundational treatment option for IGA nephropathy patients. What is the potential for novel complementary modalities if approved, to be added on top in the future. As for Thiola entire light, you see these medicines remain steady, contributing approximately $20 million in net product sales in the first quarter, while 1,000 being the typical gross to net reset at the beginning of the year. As previously reported, we saw generic approval earlier this year and are continuing to evaluate how the market might evolve as a resource.
Let me close out by reiterating that I'm really pleased with the execution of our fantastic diversity in the clearly positive results in the first quarter of the year for their efforts have resulted in strong foundation for growth leading towards anticipated full approval later this year and the continued confidence that transpiring has the potential to become a blockbuster therapy.
Let me now transfer the call to Chris for a financial update. Chris?

Christopher Cline

Thank you, Peter, and good afternoon, everyone. We've started the year with strong operational performance, illustrated by the continued growth story and reduced operating expenses. For the first quarter of 2024, net product sales were $40 million compared to $24.2 million from the same period in 2023. The increase is attributable to growth in net product sales from the ongoing launch of Pillsbury in IGA nephropathy. During the quarter, we also recognized $1.4 million of license and collaboration revenue, which results in $41.4 million in total revenue reported for the period compared to $30.9 million in the same period in 2023.
Research and development expenses for the first quarter of 2024 were $49.4 million compared to $58.2 million for the same period in 2023. On a non-GAAP adjusted basis, R&D expenses were $45.8 million for the first quarter of 2024 compared to %51.3 million in the same period in 2023.
Selling, general and administrative expenses for the first quarter of 2024 were $64.2 million compared to $66 million for the same period in 2023. On a non-GAAP adjusted basis, SG&A expenses were $48.2 million in the first quarter of 24 compared to $49.5 million for the same period in 2023. The approximate 11% decline in non-GAAP R&D and SG&A expenses compared to last quarter is largely attributable to the restructuring enacted in December and reduced clinical expenses as a percent in Phase three studies advance towards completion.
Total other income net for the first quarter of 2024 was $3.5 million compared to $0.9 million in the same period in 2023. The difference is largely attributable to an increase in interest income during the period.
Net loss, including from discontinued operations for the first quarter of 2024 was $136.1 million or $1.76 per basic share compared to a net loss of $86.3 million or $1.27 per basic share for the same period into 2023.
On a non-GAAP adjusted basis, net loss, including from discontinued operations for the first quarter of 24 was $116.2 million or $1.51 per basic share compared to a net loss of $62.9 million or $0.92 per basic share for the same period in 2023.
To begin the year, we achieved a number of milestones with our programs that will result in corresponding milestone payment. During the first quarter, we recognized a one-time in-process research and development or RIP. R & D expense of $65 million. This was triggered by achieving the first patient dosed in the Phase three HARMONY study and is expected to be paid in the second quarter of this year. With the recent conditional approval so far in Europe, we expect to receive a $17.5 million milestone payment from CSL Vifor upon conversion of the CMA to full approval. And we also anticipate receiving an additional milestone payment in 2025 upon achievement of market access milestones in certain countries also related to the CMA approval, we expect to pay Ligand Pharmaceuticals a one-time milestone payment of $5.75 million in the second quarter of this year. As of March 31st, 2024, the Company had cash, cash equivalents and marketable securities of $441 million. Cash used during the first quarter included approximately $61 million of nonrecurring items related to the strategic reorganization announced in December, delivery of inventory, corporate performance payout and pass-through receivables to Mirum pharmaceuticals as a result of the bile acid products transaction last year. Importantly, we anticipate operating cash use to decline meaningfully through the balance of 2024, with our current strong cash balance expected significant growth until sorry, continued expense management and anticipated incoming future milestone payments. We continue to expect that our balance sheet can support current operations into 2028.
I'll now turn the call back over to Eric for his closing comments. Eric?

Eric Dube

Thank you, Chris. We are in a differentiated position to drive value and growth. We are excited. I'm sorry, we are executing very well on the commercial launch of Safari, which is targeting it outperformed benchmark launches in year two and continue to grow significantly in the years ahead. So Spark also has the potential for a second indication for FSGS, which would be the only approved medicine for a rapidly progressing kidney disorder with little else in development. And we are advancing picked about nice and innovative enzyme replacement therapy in a Phase three program that could deliver the only disease-modifying therapy for a devastating rare condition affecting an estimated addressable population of 7,000 to 10,000 patients worldwide. With these opportunities to create significant value. We are acutely focused on executing in 2024. We have started the year by achieving all of the milestones anticipated thus far, and we expect to continue that trend through the balance of 2024.
For now, let me turn the call back over to and to open up the lines for Q&A. Anne?

Anne Crotteau

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

Question and Answer Session

Operator

(Operator Instructions) Anupam Rama, JPMorgan.

Anupam Rama

Hey, guys. Thanks so much for taking the question and congrats on all the progress on the quarter.
I just had a quick question for Phil. Sorry. Can you talk about any sort of seasonal headwinds you saw in the quarter from reauthorizations or otherwise that we should be considering. Thanks so much.

Eric Dube

Yes. Thank you for the question. And certainly that's something that you would typically expect at the beginning of the year. Peter, why don't I turn that over to you to share some of the dynamics that we would see in Q1?

Peter Heerma

Yes, certain things on pump for that question. So overall, I would say we have those strong performance across the board, both from a demand perspective as well as some of their employees who are prospective. The only seasonality that I could speak to is the gross-to-net. As you would expect in the beginning of the year, you'll have an impact of gross-to-net we have to do with the reauthorization process insurance plans by reporting the rebates which we pay a co-pay buydowns, but it's typical for all products and others, and that's typical for 4Q. As far as we have seen, it also resolves latest data to our Now overall, I would say, very strong performance in Q1.

Operator

Tyler Van Buren, TD Cowen.

Tyler Van Buren

Hey, guys. Great studio. So thanks for taking the question. So the last couple of quarters, patient start forms increased by like around 15 to 20 forms quarter over quarter, and now we've seen an increase of over 50 quarter over quarter for Q1. So just curious to hear you elaborate on that specifically and what's changed or improved? Is it simply just a better REMS enrollment as mentioned? Or what are other factors leading to the increase in the patient start forms?

Eric Dube

Thanks so much for the question. I'll turn this one also over to Peter.

Peter Heerma

Yes, I think your question, Tyler, why don't you run the new? We saw a strong demand in the first quarter. What I would say is at a is in last November when we presented the put back to the full two year data set, we really built the momentum portables filing. And I think that's also resulted into an inflection in demand. And that trend basically continued in Q1. So we saw like 511 new patient starts homes in the first quarter versus like 459 in Q4 last year. And this includes both the breadth of prescribers as well as depth of prescriptions. And I think most importantly is that also the majority of the thought leaders are now prescribing transplants.

Operator

Joseph Schwartz, Leerink Partners.

Joseph Schwartz

Thank you. And congrats on the priority review designation for this whole story malignant this NDA.
I'm wondering if you can provide some more color on the data package that you submitted to the FDA to support the U.S. NDA specifically how much safety data from the real-world or clinical trials was submitted? And how are you feeling about the potential for the REMS to be adjusted based on additional data that you submitted.

Eric Dube

So thanks for the questions. I will turn this one over to Jula to answer.

Jula Inrig

Thanks for the question, just to and so we did submit the safety data from the two year PROTECT trial, and we will give a four-month safety update. That is, as is typical, which will be a compilation of our safety data and you specifically asked about the REMS, and I'll just reiterate that we have seen no cases of drug induced liver injury throughout the program, and we also have additional commercial and safety data that we periodically report and have continued we provide to the FDA as just part of our regular safety reporting. And we haven't seen anything concerning or different than what we've seen from a safety perspective in our clinical trials. And as you can imagine, we'll be engaging with the FDA through the review process for any potential modifications or changes to the liver monitoring REMS, and we'll provide an update when this NDA is complete.

Operator

Carter Gould, Barclays.

Carter Gould

Good afternoon and thanks for taking the questions and congrats on the progress with full story, but maybe to flip it up a little bit and switch to HCU., you talked about sort of metering enrollment.
Is there a certain number of patients or time line before that could be lifted?mAnd I guess along the same lines you also spoke on manufacturing. Can you just kind of bring us up to speed on sort of the efforts there to ramp on that side of things?

Eric Dube

Sure. Thanks. Further, I will turn this over to Jula to provide a bit more detail.

Jula Inrig

Certainly think so. I mean, we have a very exciting trial design to be able to show a difference in total home of 15 and then also look at a reduction in diet on the trial design. As you may recall, we have a 10 week screening period and that is to help with diet stabilization and to standard that to optimize our chance of success and getting standardized for the patients getting the trial. So we have that 10 weeks and then a 26 week double-blind period. Now we recall we've announced that we have about 70 patients in 50 sites. We do want each of our sites to be educated upskilled and trained on some of the unique aspects and unique tools that we are providing as part of it. And so again, we are doing it slower in the beginning, but we are going to have data, as we've said, top-line data in 2026. That has not changed. That's part of our assumptions. And then I'll comment a little bit about CMC So as is typical in rare disease, when you go kind of a path from Phase one to Phase three, you're off and doing your CMC work in parallel, and we're trying to upscale so that we're ready for that or we support the full study as well as commercialization.

Operator

Jason Zemansky, Bank of America.

Jason Zemansky

Perfect. Good afternoon.
Congratulations on the progress and thanks for taking our questions. I wanted to circle back and follow up on Phil Sparks here I was curious what you were hearing from specifically new prescribers regarding their experiences, especially now that discussion of Protech sort of continues to build. I guess what I'm trying to drive at here is where does near term momentum take you in terms of further acceleration of script growth for the rest of the year? And then what happens following potential full approval in September. Thanks.

Eric Dube

Yes, Jason, thanks so much for the question and welcome to one working with us at Revere. So I'll hand it over to Peter to give a little bit more detail before I do, I do want to reiterate something that Peter mentioned in his prepared remarks in that the dynamics that we're seeing across the board with this will spark launch, give us great confidence that we will see very strong revenue growth. And this year and onward, particularly this year, quarter over quarter revenue growth. And I think it certainly is in large part due to some new physicians identifying patients.
Peter, why don't you share a little bit more about the what you're hearing from new prescribers and how you see the growth moving forward?

Peter Heerma

Yes, very good. Thanks, Jason, for the question. I would say overall new prescribers, what we are hearing is the same consistency of strong, a reduction of about 50% consistent to what we saw in the Protect funds. And I think that by itself also is the best addresses forward for continued prescription and food as depth of prescription. So as I noted before, for the rest of the year. And I think we have some inflection points that I called out in the prepared remarks. I think one is the full approval that we know now with the maturity date of September fifth, but also the new and with the new guidelines, I think that allows for continued growth. And I'm expecting that we will see continuing growth for the remainder of the year in patients corresponds, but we also know that there may be variability quarter over quarter from a patient smartphone perspective. I would say from a revenue perspective, I'm confident that we will continue to have quarter-over-quarter growth for the remainder of the year.

Operator

Maury Raycroft, Jefferies.

Maury Raycroft

Congrats on the progress, and thanks for taking my question. I was going to ask one on FSGS. Just wondering what additional analyses are you conducting to discuss with regulators this year for a potential path forward? And can you clarify if you're engaging with the payer cell group to and have insight into what they're doing or as perils personnel independent and just for the sequence of events on will you wait to see what Paris all shows that AS. and tried to get an FDA meeting scheduled by year end? Or I guess what how could these events play out this year with FSGS.

Eric Dube

Maury, thanks for the questions. And Jula, would you like to answer those?

Jula Inrig

Yes. So we're continuing to analyze our data in totality and also comparisons to external data sets. We haven't fully defined all the analyses that we're doing, but our work is in parallel with Paris, all we are invited to the Paris all group. There is a meeting. It's public that we're going to be meeting in person in the next actually next month to look at the data set and look at the endpoints. So we will have insights into what the endpoints they're looking at, being able to then also look at our data as well. And so our time line is that we're working in parallel with our data as well as what they're working on to define the endpoint with the plan really to reengage, I would say at the end of this year, early next year after they have publicly announced what those endpoints should look like in what they should be.

Maury Raycroft

Got it. And then you would after you reengage with the Purcell group, then you would request a formal meeting with FDA?

Jula Inrig

Yes, (multiple speakers) when we're working and we're hearing what they're working on, we're also analyzing our data in parallel after they publicly announced what that endpoint that would be the time line at which we would be re-engaging for potential filing .

Operator

Tim Lugo, William Blair.

Hey, guys, this is Lachlan on for Tim. Thanks for taking the question. I was wondering if you could talk about the conversion rate you see from the patient start forms to actually getting on drug here, both the time it takes, but also what kind of attrition there is there and to the extent there is attrition, what are the sort of sticking points where where you might be losing some patients?

Eric Dube

Yes, Lachlan, thanks for the questions. I'll hand this one over to Peter to provide a bit more detail on the launch dynamics.

Peter Heerma

Yes.
I think what I would say since we implemented additional patient education initiatives in the second half of the year, we have seen continuing improvement in our fulfillment process. And one of the lead message that I was talking about in the prepared remarks, the percentage of patients that certify the REMS program within disease after receiving the patient start forms. And as I mentioned, we have now about 80% of the patients that are prescribed to us following that enroll in rents within 14 days of patient Stockholm. He talked I would say we are very pleased with the continued efficiencies that we are seeing, including payer approval. So first, barring I'll reiterate as well was in rare disease benchmarks and then business confidence, we will continue to see revenue growth quarter-over-quarter for the remainder of the year.

Eric Dube

And last, maybe one thing that I'll add that we've talked about in the past that Peter's mentioned is the high rate of compliance and persistence. Once the patient is on therapy. We continue to see that, which I think is an important aspect of this of this launch and what gives us great confidence that we will continue as we add more patients that it will the growth rate in revenue will continue to be strong as we move forward.

Operator

Yigal Nochomovitz, Citigroup.

Yigal Nochomovitz

Yes, hi, thanks. Congrats on the progress. I may have missed it, but did you comment on of the 511 start forms, what fraction of those 511 are on a commercial drug at this point. Thanks.

Eric Dube

We've got we've not provided those details in terms of number of patients at this point in the launch. We'll continue to provide those rates of PFS as well as revenue and access as we see those as the core components of launch performance in the first part of the launch, I think what we what we certainly are seeing is a continued progress in terms of the number of patients that are treated as we move forward.
As outlined by Peter, Peter, is there anything more that you'd like to add?

Peter Heerma

No, I think you covered it.

Eric Dube

All right.

Operator

Mohit Bansal, Wells Fargo.

Thank you very much. This is Reed on for Mohit Bansal. My up my first question here is just on DM Tigo guidelines. Could we see a improvement for cell spar in the guidelines ahead of that September fifth PDUFA date. Thank you,

Eric Dube

Jula, I'll turn that on over to you.

Jula Inrig

I'll turn that one over to you and we anticipate the KDIGO guidelines to be out soon. And that is what we're hearing.
And with regards to how that could help with so far, I would say that it's twofold. We anticipate that the KDIGO guidelines will suggest that patients who remain at risk and for progression despite RASP inhibitors would be considered to switch to fill story. And so just further reinforcing the foundational role that Phil story should play. If we know most patients have been on a Ras inhibitor, many predating their diagnosis and just various superior RASP inhibitors that lowering proteinuria as we demonstrated in a Phase two or Phase three head to head trial.
The other aspect that goes beyond that is that we anticipate that KDIGO guidelines will lower the proteinuria treatment target. That means that even more patients will need better treatment, which very clearly offers.

Operator

Vamil Divan, Guggenheim Securities.

Vamil Divan

Great.
Thanks, for taking my questions. I just had one has been asked, but maybe to follow up on the prior comment you made around the compliance and persistence. And I think you said you just you having a high rate of compliance and persistence. I'm just wondering if you can quantify that a little bit more for us in terms of what percentage of patients are still on therapy for three months or six months after starting for the My main question was really just around the types of patients that are getting treated. Now, if you can provide a little more visibility on that in terms what percentage are going through SGLT twos before they might start something like fill, sorry. And what percentage maybe of used to pay or are using this before IPO? And also, I think previously you talked a little bit about the use in the community setting versus academic physicians. If you can provide any sort of update there in terms of just where these prescriptions are coming from and what sorts of patients are being prescribed the product?

Eric Dube

Well, thanks for the questions. Peter will have you covered these?

Peter Heerma

Yes, there were a lot of questions, I believe, in your question. So let me tried to decipher them to start with the last one, I think was the question was like a patient coming from community or academia will have a dynamic pricing of property unit maybe cover a broad range of positions to lead that to all the addressable patient population. And that is mainly because the vast majority of patients reside in community centers, and that's where the majority of the patients come from.
Another question was regarding what is the patient profile, what is overall a younger patient population. And that's what we also see it reflected in the patient at Alten shows, Paris are basically patients in their 40s, predominantly male from a fee. And then I think also from a from a coverage perspective of the relevant business, about 70% of the patients ahead for our commercial workovers, which also speaks to the consumer patient population?
Well, I think another for the question was cold medications and SGLT2. Well, we have a significant amount of patients that received from the other two inhibitors. I think there is kind of becoming the gold standard. Physicians are generally seeking for like a normal immune suppressive treatment option. And I think the mobile standard of care moving forward is really fills Fiery. That includes the loss in addition to world endothelium, but also adding this new tool is something that we are achieving in practice. And then I think the last question where you started with was compliance and persistence. We haven't spelled it out, but it's the compliance rates are very high compared to what we would typically see in chronic use treatments in cardiovascular disease or oncology. So type of lines rates that we haven't specified the specific number after a certain amount of time. So I hope I covered all your questions in this room.

Vamil Divan

Yeah. Thanks, Peter.

Eric Dube

Vamil, yes, thank you. Maybe just a little bit of context for what we're hearing consistently from patients once they start therapy they have a very positive experience. They appreciate the level of support that our patient services provide. But perhaps even more important, they are seeing a very consistent reduction in their proteinuria oftentimes these patients who are at high risk of progression, struggle to see reductions in proteinuria that are meaningful with other therapies. And so they're very pleased to see those reductions with Phil, sorry, that oftentimes happen very quickly in after initiating, which we believe is a core part of that compliance rate. Of course, it's a very easy once a day oral therapy non immunosuppressant, all things that we know are important to patients. And we believe that's going to be a core part of building a very robust base of business upon which to grow over time.

Operator

Alex Thompson, Stifel.

Alex Thompson

Thanks for taking my question. I guess a little bit more on sort of broader commercial dynamics. Could you provide a little bit of context around any inventory or pricing dynamics, headwinds or tailwinds in the quarter? Thank you.

Eric Dube

Sure, Alex, thanks for the questions. Peter, I hand that one over to you.

Peter Heerma

Yes, I would say from an inventory perspective, I don't think we see any difference or better than what you would expect in the 2nd year of launch. So I don't think there's too much to speak to on that one and then pay missing the other component of pricing dynamics on your older than the gross-to-net. This sounds like you have a little higher in the first quarter of every year and it has a prolonged industry. So I don't think it's typical fulfills Pillsbury. I don't think we have seen in particular dynamic from a pricing perspective.

Operator

Laura Chico, Wedbush Securities.

Laura Chico

Hey, good afternoon. Thanks for taking the question. I have one on kind of a longer-term outlook for fluorspar. A Japanese competitor recently completed enrollment in their Phase three against study.
And we obviously have some other anti-APRIL targeted agents moving forward.
But as you mentioned, so far, we will likely be in the kidney go updated guidelines. So I guess I'm trying to understand here in this kind of 25, 26 and beyond period, how are you still thinking about story utilization as the treatment landscape is changing, particularly if there is a pull forward in diagnosis and earlier treatment. Thanks very much.

Eric Dube

Yes, Laura, thanks for the question. This is one where we're particularly excited about the long-term outlook for Spark, given that it is a very unique position within the treatment of landscape and how it works in the treatment of IgA nephropathy.
I'll ask Jula to provide a bit more detail on that.

Jula Inrig

Yes. Thanks, Laura. I think it's really great to see innovation for a disease that's had very little innovation for many years. And additionally, I think it's exciting to see a potential replacement for the historical role that steroids have played. And I think that's a lot of what we're going to be utilizing these add on treatments in the future.
But I would say, first and foremost, as I said in my comments, you've got to address the activation and injury in the kidney that is present at diagnosis and needs to be treated long term, and that's what Phil Ferrari offers. They also, as Peter said, they're going to continue other supportive foundational medications because this is a lifelong disease and that might be an SGLT2 inhibitor for CKD, essentially thus start replacing the role of RASP inhibitors. And that's really aligned with what the KOLs are saying that guidelines are saying is that you've got a treatment and compared head-to-head to historical foundational treatment and so far is superior to that. And then you can potentially add on additional medications, just like we've added on steroids historically to RASP inhibitors, you can add on a B-cell or complement inhibitor on top of the foundational role that aspires.

Operator

Ed Arce, H.C. Wainwright & Co.

Ed Arce

Thanks for taking my questions and congrats on your strong quarter of progress.
Three questions for me. Hopefully, this doesn't get too long. I mean, one is really about on what seems likely coming out of Contigo and then you're due for date on the 5th of September, given there's no cases of daily rental monitoring could be softened and likely with proteinuria as in the EU and given the Contigo guidelines are looking that way, all of this points to a much more a accepting a label going forward.
And so the question really if those do come to pass, what would be your view on the potential for an acceleration further from the growth rates that you're seeing so far? And then just a couple of quick questions on the model on first around the Ola I think the decrease this quarter was largely impacted by the generic entry earlier this year. Just wanted to confirm that that's your view.
And then lastly, the $65 million in-process R&D, I think you said that was due to a first patient enrolled in the HCU. study and just wanted to confirm that. Thanks so much.

Eric Dube

All right. Thanks so much.
So first question, we'll hand over to Peter.
So Peter, how do we see Contigo and the labeling I'm driving growth as we move forward?

Peter Heerma

Yes, I would say it allows for a broadening of the base of the addressable patient population. I mean, it's right now the US real estate spaces that are at risk of rapid progression is in general for the yearly target of 1.5. I'm expecting that would go down in our label when we have the full approval.
And then I think additionally, to your point on the V-Go. And Joel, as you alluded to earlier, we are anticipating a more aggressive treatment target with regards to proteinuria and also allows for even broader view of the patient population and Will mentioned earlier, like the evolving landscape, you have more interest that may come into the market, which is really a market in development, I would say was more controlled confirmatory biopsies more early on. And I think that allows for greater growth, continued growth opportunity for us playing in is Itemfield.

Operator

Thank you.

Eric Dube

And the second question.
Thank you, Peter. Sorry, Operator, we've got two additional questions from from the last questioner. So Chris, I'll hand these over to you. So can you explain the file a generic dynamics on revenue as well as the $65 million anticipated payments?

Christopher Cline

Yes, thanks for the questions. That on the first lien sale, that's not actually related to equity isn't related to the generic entry at this point. What we see right now is the typical gross to net adjustments in the first quarter of the year that we've seen in historical years. So that's really the driving difference in Q4 to Q1, and we would anticipate that that levels out similar as it has in years past.
And then on the second one, as you have it right at the $65 million IP. R & D expense this quarter is related to the first patient dosed in the Phase three HARMONY study of ecabet.

Operator

Allison Bratzel, Piper Sandler.

Allison Bratzel

Good afternoon and congrats on a nice quarter and thanks for squeezing me in on you mentioned the recent Sparton study update in newly diagnosed again, patients.
I'm just hoping you could talk about your KOL and nephrologist reaction to that end. Just is it your sense that docs need to see any additional clinical data to really catalyze or drive widespread earlier line use of first-party?
Thanks.

Eric Dube

Yes. So Allison, maybe I'll just comment on one thing that Peter mentioned on this call as well as on our prior call, we're very pleased to see that the majority of thought leaders within the U.S. are are currently prescribing bill sorry to patients with again in their in their practice. And I think that that gives us great confidence in the overall profile.
Jula, why don't you talk a little bit more about the potential impact or the reaction that you're hearing to the on the Spartan results to date?

Jula Inrig

Thanks for the question. I think it's very exciting to see the data that we are generating across our program, which is not just Spartan, which is earlier treatment, but also combination treatment. And that supports that. We believe that so far it should be foundational care and also that patients should be treated earlier in their disease. I think people are very excited about what we've put out around sparsentan that newly diagnosed patients who have not been treated earlier in their disease course, even slightly lower ranges and higher EGFR. And that if you treat early that you can get patients two thirds into complete remission, stable EGFR nearly 80% reduction in proteinuria. People are very excited about this data, and we're going to continue to publish more. We've done 36 weeks. We'll have one year data and further data as well as biopsy data. And it really places and reiterate that Phil story isn't just targeting damage that's already occurred and helping with the remodel. But it can help prevent the damage that occurs if you have IGA nephropathy deposition because we are treating very early in the disease and it shouldn't be spared for patients who just have advanced stage kidney disease. So a lot of encouragement around that and excitement as more data comes out later this year around it.

Operator

Ladies and gentlemen, this concludes the question-and-answer session of today's conference call. I'll hand the call back over to Anne.

Anne Crotteau

Great. Thank you, everyone, for joining us for our first quarter 2024 financial results call. We look forward to providing additional updates on our progress. Have a great rest of your day.

Operator

This does conclude today's call. Thank you for your participation. You may now.