Q1 2024 Travere Therapeutics Inc Earnings Call
Good day and welcome to the traverse 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 and Croteau. Please go ahead Anne.
Thank you Rachel good afternoon, and welcome to trim ear 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 do that Eric will be joined in the prepared remarks by Dr. Julie <unk>, Our Chief Medical Officer, Peter Herma, Our Chief Commercial Officer, and Chris Klein, Our Chief Financial Officer, Dr. Bill Rote Senior Vice President of research and development will join us for the Q&A session.
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.
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 Form 10-Q, and 10-K filed with the SEC.
And any forward looking statements represent our views only as of the date such statements are made may six 2024 interfere 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.
Thank you Anne and good afternoon, everyone. This year our organization is focused on executing on the key priorities that will drive sustainable growth pictured here in 2024 and the years ahead.
I'm pleased to report that we made significant progress on all fronts, our commercial launch at <unk> in the U S is continuing to reach new highs we.
We successfully achieved multiple regulatory milestones with pillsbury and the first patients were dosed in the pivotal harmony study pegged about base.
I'll begin with the <unk> launch in the U S.
Following a strong close to 2023, our team continued to elevate performance in quarter one.
Accordingly, this was demonstrated across all key aspects of the watch 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.
With respect reflect strong execution by our commercial team, but also the underlying demand for a superior foundational treatment, Peter who will provide further detail on our quarter, one performance and our outlook shortly.
To start 2024, our regulatory team achieved important milestones in our journey to deliver field sparring to more patients globally.
Today, we are very pleased to report that our submission to convert feel sorry for an 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 breach a broader set of patients living with Iga nephropathy and the U S.
Outside of the U S. Our partners made important progress with our recent conditional marketing authorization or CMA I feel sorry for again in Europe and.
And submission of an IND for a phase III trial in <unk> 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 pegged at Bath <unk> program, which provides an opportunity for significant growth for <unk> and feel sorry.
This program is the only late stage development candidate for <unk> and the only medicine in development for <unk> that has the potential to be disease modifying.
With successful efforts, we anticipate that pegged that and this could become a new treatment standard in the market that we expect to grow well beyond $1 billion, we initiated the phase III 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 III top line results in 2026, now let me turn the call over to Julia for her update July.
Good afternoon, I'll start with Iga nephropathy, where our medical activities for 2024 are focused on ensuring we achieve full approval I feel sorry, and providing the education and support to enable fuel storage replace rasp inhibitors as foundational care.
Julia: It is important to remember that patients living with Iga nephropathy faced a high lifetime risk of kidney failure.
And the time to meeting kidney replacement therapy is even shorter so those with persistent proteinuria.
<unk> is caused by over activation and 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 over activity in the kidney this.
This has been the role Ras inhibitors have played in.
And second addressing systemic inflammation with steroids for select patients.
We're at an exciting juncture, where we are seeing improvements in the option addressing both of these approaches independently.
And the future will include using both of these in tandem and more effective ways.
This is critical as there is no single medicine approved or in development that will arrest the progression or effects of Ikea and nephropathy.
We are most excited about the evolution of the treatment paradigm because just Barry is the only medicine that is in position to replace the foundational role of rasp inhibitors.
This is because they'll sorry is the only approved non immunosuppressive medicine, but I guess that directly targets kidney injury known as hit four and.
And protects the kidney from further structural damage.
And most importantly, so sorry is the only treatment that has been evaluated head to head against RAF inhibitors, specifically irbesartan.
So clear superiority and proteinuria reduction along with clinically meaningful long term kidney function preservation.
Everything else has been added on top of rasp inhibitors, <unk> targeting elsewhere in the disease Cascade.
But unfortunately, not comparing directly to what works on that similar pathway.
As we move ahead, we believe Nephrologist will use still sperry as a foundational kidney targeted therapy, and then add upstream immune mediated medications as needed.
Perhaps not surprisingly we are continuously hearing from nephrologist as they are gaining more experience with feel sorry that theyre, making the choice to utilize still sorry, that's foundational care for their eligible <unk> patients.
And this is further validated by increasing recommendations and treatment guidelines and algorithms to replace the Ras inhibitor therapy, with Pillsbury and 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 just Barry a clinically meaningful benefit on long term kidney function preservation at two years.
That's a broad range of baseline proteinuria subgroups.
This signifies that so far I can have a positive impact and 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 RAF inhibitor naive patients, which showed an 80% reduction in proteinuria and stable Egfr out to 36 weeks some of the most impressive data to date.
These results show that if you treat <unk> patients early enough with Bill Sperry.
These stabilized egfr and can get two thirds of patients into complete remission.
Additionally, we presented data that showed adding <unk> two inhibitors to feel sorry is safe and can further reduce proteinuria.
Collectively these results are supported earlier and broader use and we look forward to providing longer term results at upcoming Congresses.
I mean, I guess treatment paradigm continues to evolve we also hear from thought leaders and hold the belief ourselves at 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 K Diego guideline revision.
This will support intervening earlier with foundational care.
And following full approval provided a good opportunity for us to further educate on a lifetime risk for these patients.
Don't have time to wait at everyday they're losing kidney function.
Now turning to our Reg key regulatory milestones to start the year.
As Eric highlighted earlier, we were very pleased to receive priority review for our S. M. D E within assigned could do with a target action date of September 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're also pleased with the recent European Commission decision to grant conditional marketing authorization to feel sorry in Europe.
It is important to note that so far is the only medicine for Iga nephropathy to reach.
Our CMA for patients with proteinuria greater than one gram per day or greater than zero point 75 grams per gram.
The next step in Europe is transitioning to full approval and we are presently supporting the submission preparation process and partnership with CSL before.
We also recently announced that our partner in Japan, when Alice 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 <unk>.
Our efforts in that first you have to continue in the background and we remain hopeful that we will be able to identify a path forward for an additional indication for <unk> sorry.
In parallel with our efforts parasol, which is a public private partnership with nest cure, the FDA EMA and academia.
Together Atlas GF datasets from around the world to help define the relationship between proteinuria and Egfr and kidney outcomes.
Their goal is to align on an endpoint that would support approval of new therapies for <unk> patients.
And they plan to prevent their data at ASN in late October.
We will continue to compile our data and reengage with FDA at the appropriate time once the Paris all work is near to completion.
Now, let me discuss our HCV program in Phase III development, we continue to be very excited about our potential to deliver pegged to bat Naas adds the first disease modifying therapy for HBU.
We recently engaged with H C. H these thought leaders and patient advocates at AD boards and medical conferences.
And there is significant enthusiasm about the potential for peg to bat needs to positively change the lives of people living with H C U.
The available treatment options do not address the underlying cause of H C U.
Nor do they help patients address the risk of thrombotic events or address the need for low protein diet.
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 pegged the bad news is the only therapy directly targeting the key enzyme defect in HCA 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 onshore open label Ensemble study.
This will allow for eligible composed patients to enter into our protein tolerance or diet modification sub study and start generating data for this important exploratory endpoint.
In summary, we are pleased with the progress in each of our programs, which is a testament to the talented team at <unk>, 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.
Thank you.
Afternoon, everyone.
When we bought was going to be an exciting vehicle fuel as we are building upon the 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 continue to see slow and growing demand from physicians and their patients.
This is evidenced by the continued increase in both breadth and depth of prescribers during the quarter.
Notably we have no more than 2000, Nephrologist, who were enrolled and certified in the Pilbara UMC program.
Most of these positions are or installed prescribing sales volume.
<unk> inhibition.
And maybe the pension benefits for patients in a meaningful way and this number continues to grow with the market demand is expected to remain below.
This growing prescriber base and persistent demand resulted in a continuation of growth in new patient start forms to placement of 11 in the first quarter.
We have now seen sequential growth in basic thoughts of them sort of suicide floors of loans and exceeded the sites and the patients thoughtful.
Mark faster than any of our Vince Watson, Belgium and landfills.
From a credit perspective, Fortunately, 95% of the U S basins have a pathway for reimbursement of those bonds.
Continue to be pleased with the quality authorization criteria, which are largely in line with label language and guideline recommendations.
I'm pleased that this will in the launch we have achieved such a high level of <unk>.
And the pace of transitioning to continuously do.
Since we made in the second half of last year.
And we now see that about 80% of the patients.
With stripes will story.
In the Rems program was in 14 days, please install a form of disease.
Quality, our quality number of NUPLAZID shipments could be used to Glenn.
Okay.
Let the $19 8 million in revenues.
For the first quarter.
We are pleased with deals in question revenue.
This will be the first of the year, where we experienced elevated gross to net adjustments.
Two thoughts.
Yeah.
The strong start of 2024 locations.
I think significantly blow smoke and salary this year.
Although outperforming the benchmark metrics for the second year of loans.
In addition to the goes to the consistent patient thoughtful growth. We are also leading to higher growth rates in revenue since the initial launch will be compared to benchmarks.
And of note. This strong sales trend has continued through the second quarter so far.
I had spoken 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.
We anticipate full salary will be included in <unk> guidelines, which are expected to be available for public review in the coming months.
Additionally.
And the increasing body of evidence that proteinuria is directly toxic to the kidneys, and therefore relevant risk market progressing towards kidney failure.
We anticipate a more ambitious both of your your targets in the guidelines.
Excluding the urgency to treat patients earlier and more aggressively.
The bulk of the digital full approval in September we anticipate an expanded label.
To provide greater support for physicians to prescribe <unk> to a broader patient population.
This could be particularly you will find as <unk> digest, the <unk> guideline and begin to diagnose and treat their patients.
We also expect additional clinical evidence that <unk> highlighted earlier.
We will ultimately provide additional support for the physicians to please but really it was still fun and to use it potentially in combination with other medicines for patients that may be more aggressive treatments.
These milestones will support our ambition to make those filings the foundation.
Isolating the salt basins.
The potential for global complementary modalities, if approved could be added.
Julia: On top in the future.
As with Biola and cellulite and see these medicines remains contributing approximately $20 million.
Net sales in the fourth quarter.
Those being the typical gross to net resets at the beginning of the year.
As previously reported we saw generic approval earlier this year.
Continuing to evaluate how the market may be as a result.
Let me close out by reiterating.
Really pleased with the execution often best we can work with you.
And the clearly positive results in the first quarter of the year.
All of this.
<unk> always been a strong foundation for growth leading towards anticipated approval later this year.
Continued openness with Costar, even has the potential to be bold.
Most of the things.
Let me now transfer the goal to Bristlecone installed base rich.
Thank you Peter and good afternoon, everyone.
Started the year with strong operational performance illustrated by the continued growth of first party and reduced operating expenses for.
For the first quarter of 2024 net product sales were $40 million compared to $24 2 million for the same period in 2020 through the.
The increase was attributable to growth in net product sales for the ongoing launch of Pillsbury and Iga nephropathy.
Julia: During the quarter, we also recognized $1 $4 million of license and collaboration revenue, which resulted 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, $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 for 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 from the first quarter of 2024 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.
Largely attributable to the restructuring enacted in December and reduced clinical expenses as a percentage of the phase III studies advance towards completion.
Total other income net for the first quarter of 2024 was $3 5 million compared to <unk> 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, it was $136 1 million or $1.76 per basic share compared to a net loss of 80 686 million $86 3 million or $1 27 per basic share the same period.
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On a non-GAAP adjusted basis net loss, including from discontinued operations for the first quarter to 24 was $116 2 million or $1 51 per basic share compared to a net loss of $62 9 million or 92 cents per basic share for the same period in 2023.
Julia: In the year, we achieved a number of milestones with their programs that will result in a corresponding milestone payments during.
During the first quarter, we recognized a onetime in process research and development for our IP R&D expense of $65 million. This was triggered by achieving the first patient dosed in the phase III 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 $17 $5 million milestone payment from CSL deepwater upon conversion of the CMA to full approval and we also anticipate receiving an additional milestone payment of $2 25 upon achievement of market access milestones in certain countries.
Also related to the CMA approval, we expect to pay ligand pharmaceuticals, a onetime milestone payment of $5 $75 million in the second quarter of this year.
As at March 31, 2020 for the company had cash cash equivalents in 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.
Pharmaceuticals, as a result of the bile acid products transaction last year.
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.
2020.
I'll turn the call back over to Eric for his closing comments there.
Thank you, Chris we are in a differentiated position to drive value and growth we're excited.
Sorry, we are executing very well on the commercial logical smart which is targeting to.
Foreign benchmark launches in year, two and continued to grow significantly in the years ahead.
It also has the potential for a second indication for <unk>, which would be the only approved medicine for a rapidly progressing kidney disorder with little else in development and we are advancing pegged at that base and innovative enzyme replacement therapy in our phase III program that could deliver the only disease modifying therapy for a devastating rare.
<unk> affecting an estimated addressable population of 7% to 10000 patients worldwide with.
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.
Now, let me turn the call back over to Ann to open up the lines for Q&A.
Yeah.
Thank you Eric Rachel you can now open the lineup for Q&A.
Thank you if you have dialed in via the telephone and we'd like to ask a question. Please signal by pressing star one on your telephone keypad. If you are using a speaker phone. Please make sure. Your mute function is turned off to allow your signal to reach our equipment.
As a reminder, we ask that you limit yourself to one question. If you have another question. Please rejoin the queue.
Please press star one to ask a question.
We will now take the first question from the line of <unk> Rama.
With J P. Morgan.
Hey, guys. Thanks, so much for participants.
Sorry can you hear me.
Yes, hi, its Bob.
Oh, 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.
Can you talk about any sort of seasonal headwinds you saw in the quarter from re authorizations or otherwise that we should be considering thanks. So much.
Yes. Thank you for the question and certainly Thats 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 quarter one.
Yes, certainly things bump predictor that question.
So overall I would say, yes that was strong performance across the board both from a demand perspective as well as prospective.
Perspective.
Thank you only.
The seasonality that I can speak to it.
Gross to net.
In the beginning of the year, you haven't been but also growth and yet we have to do with the reauthorization process insurance plans.
Julia: We rebase.
Julia: The copay buy downs.
And other than that.
Sure.
We have seen that also resolver, ladies and pillar. So no overall I would say very strong performance in Q1.
Thanks, so much for taking the question.
Thank you. Thank you.
Next question comes from the line of Tyler Van Buren, with TD Cowen Tyler Van Buren. Your line is open.
Hey, guys great to see the results. Thanks for taking the question.
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 whats changed or improved is it simply.
<unk> just a better.
Rems enrollment has mentioned or what are other factors leading to the increase in the patient start forms.
Hi, there. Thanks, so much for the question I'll turn this one also over to Peter.
Yes. This is a question xylem.
Youre right I mean, we saw a strong demand in the previous quarter.
I would say is ethane is and last November when we presented the <unk> fault.
Two year datasets, we really built the momentum pools filings.
Also resulted into an inflection in demand and disciplined basically continued in Q1. So we saw a 511 <unk>.
New things installed homes in the first quarter fluids is like $450 million in Q4 last year.
With both the breadth.
Drivers as well as depth with groups.
And I think most importantly is the also the majority of the thought leaders in milk declined slightly.
Thank you.
<unk> question comes from the line of Joseph Schwartz with Leerink Partners Joseph Schwartz. Your line is now open.
Thank you and congrats on the priority review designation so the Salisbury.
Joseph Patrick Schwartz: So I'm.
I'm wondering if you can provide some more color on the data package that you submitted to the FDA to support the us specifically how much.
Safety data from real World clinical trials were submitted and how are you feeling about the potential for the rins to be adjusted.
Based on.
Additional data that you submitted.
Yes, thanks for the questions I will turn this one over to Julia to answer.
Thanks for the question Jeff.
So we did submit the safety data from the two year protect trial and we will give us four months 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 that program.
Joseph Patrick Schwartz: Also have additional commercial safety data that we periodically report and have continued to provide to the FDA is 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 will provide an update when that Sanjay is complete.
Okay. Thank you.
Thank you your next your next.
Question comes from the line of Carter Gould with Barclays critical to your line is now open.
Hi, good afternoon, thanks for taking the questions and congrats on the progress with <unk>, but maybe to flip it up a little bit and switch to HEU.
You talked about sort of metering enrollment is there a certain number of patients or timeline before that could be lifted and I guess along the same lines. You also spoke on manufacturing can you just kind of bring.
Bring us up to speed on sort of the efforts there to ramp on that side of things. Thank you.
Sure. Thanks, Carter I will turn this over to Julie to provide a bit more detail.
Certainly thanks, 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 diets.
The trial design as you May recall, we have a 10 week screening period and that is to help with diet stabilization and standard that to optimize our chance of success.
Just getting standard I think for the patient is getting the trials. So we have that can meet and then a 26 week double blind period now you recall, we've announced that we have about 70 patients and 50 sites. We do want each of our sites to be educated skilled and trained on some of the unique aspects and unique tools that we're providing it's Tom.
Part of it and so again, we are doing at slower in the beginning but we are going to have data as we said topline data in 2026 that has not changed thats part of our assumptions.
And then I'll comment a little bit about CMC. So as is typical in rare disease. When you go try to go fast from phase one to phase III, you're often doing your CMC work in parallel.
We're trying to upscale so that we're ready for that or we support the full study as well as commercialization.
Thank you.
Your next question comes from the line of Jason Szymanski with Bank of America, Jason Symanski. Your line is now open.
Perfect. Good afternoon, congratulations on the progress and thanks for taking our questions I wanted to circle back and follow up on Phil's foray here.
I'm just curious what you were hearing from specifically new prescribers regarding their experiences.
Especially now the discussion over to protect sort of continues to build.
I guess, what I'm trying to drive at here is where does near term momentum take you.
Joseph Patrick Schwartz: 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.
Yes, James Jason Thanks, so much for the question.
Welcome to.
Working with US are trivia, 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 the <unk> launch give us great confidence that we will see very strong revenue growth.
This year in <unk>.
Particularly this year quarter over quarter revenue growth and I think it certainly is in large part due to.
New physicians identifying patients Peter why don't you share a little bit more about what you're hearing from new prescribers and how you see the growth moving forward.
Yeah very good thanks, Jason for the question I would say overall, new prescribers. What we are hearing is we've seen consistency.
But really a reduction of about 50% consistent to what we saw in the protect study I think that by itself.
<unk> is the best effort this quarter.
With Scripps include a depth of prescription.
So.
For the rest of the year and I think we absolutely made some bonds that I called out in the prepared remarks has been one of the four.
Google that we know now with the <unk> date of September.
But also the new Sydney.
<unk> guidelines I think that allows for continued growth.
I'm expecting that we will see continuing growth for the remainder of the year and patient cohorts forms, but we also know that there may be variability quarter over quarter basis, thoughtful perspective, I would say from a revenue perspective, our goals that we will continue to have quarter over quarter growth for the remainder of the year.
Great. Thanks for the color and happy to be working with everyone.
Great. Thank you. Thank you.
Your next question comes from the line of Maury Raycroft with Jefferies.
Maury Raycroft your line is open.
Hi, Congrats on the progress and thanks for taking my question.
I was going to ask one on <unk> just wondering what additional analyses are you conducting to discuss with regulators. This year for potential path forward and can you clarify if you're engaging with the parasol group two and have insight into what they're doing or apparel, Paris, all independent and just for the sequence of events.
Wait to see what parasol shows at ASN and try to get an FDA meeting scheduled by yearend or I guess, what how could these events play out this year with that past yes.
Alright, thanks for the questions and Julia would you like to answer those.
Julia: Yes, so we're continuing to analyze our data in totality and also comparisons to external data that we haven't fully defined all of the analysis that we're doing but our work is in parallel with parasol.
We are invited to the parasol group there is a meeting it's public that we're going to be meeting in person and then actually next month to look at the data sets and look at the endpoint. So we will have insights into what the endpoints that we're looking at to be able to then also look at our data as well and so.
Our timeline 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 and what they should be.
Got it and then you would after you reengage with the peso group than you would request a formal meeting with FDA.
Yes.
Okay.
And we're working and we're hearing what they are working on we're also analyzing our data in parallel.
After they publicly announced what that endpoint that would be the timeline at which we would be re engaging for potential filing.
Got it okay. Okay. Thanks for taking my question.
Your next question comes from the line of Tim Lugo with William Blair.
Your line is now open.
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 patients thought forms to actually getting on drug and both the time. It takes but also what kind of attrition. There is there and to the extent there is attrition what the sort of sticking points, where where you might be losing some patients.
Yeah, welcome and thanks for the questions I'll hand, this one over to Peter to provide a bit more detail on the launch dynamics.
Yes.
Peter: I would say since we implemented a digital patient education initiatives in the second half of the year.
We have seen continuing improvements in our fulfillment process and one of the message that I was talking about.
In the prepared remarks, the percentage of patients that certify the Rems program was in Austin.
Obviously, receiving their patients going for them.
And as I mentioned, we have now about 80% of the patients that are prescribed to Bali.
<unk> in rents within 14 days or placed in Stockholm.
I will say, we are very pleased with the continuing efficiencies that we are seeing including Google still feels Barry.
You're right as well was in rare disease based products and that gives me confidence that we will continue to see revenue growth quarter over quarter for the remainder of the year.
And last one 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 a patient is on therapy. We continue to see that which I think is an important aspect of this.
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.
Got it thanks.
Your next question comes from the line of Yigal <unk> with Citigroup.
<unk> Your line is now open.
Yeah, Hi, thanks, Congrats on the progress made missed it but did you comment on the 511 start forms what fraction of those 511 are on.
Commercial drug at this point.
Thanks.
Please go ahead.
Not provided those details in terms of number of patients at this point in the launch we will continue to provide those rates of PFS as well as revenue and access as we see those as the core components of <unk>.
<unk> performance in the first part of the the launch I think what we what we certainly youre seeing is a continued progress in terms of the number of patients that are treated as we move forward.
As outlined by Peter Peter was there anything more that you'd like to add.
No I think we're comfortable with it.
Thank you.
Thank you. Your next question comes from the line of Mohit Bansal with Wells Fargo.
That's all your line is open.
Thank you very much this is reid on from of it bundled my up My first question here is just on the Chicago guidelines could we see a.
Improvement for spy and the guidelines are ahead of that September date.
Sure.
Joe I'll turn that one over to you.
We anticipate the <unk> guidelines to be out soon and that is what we're hearing and with regards to how that could help with first party I would say that it's twofold, we anticipate that the key Diego guidelines will suggest that patients who remain at risk for.
For progression despite RAF inhibitors would be considered to switch to Phil sorry.
Just further reinforcing the foundational role that first foray should play if we know most patients have been on the Ras inhibitor or many predating their diagnosis until sorry, a superior Ras inhibitors that lowering proteinuria as we demonstrated in our phase II phase III head to head trial. The other aspect that goes beyond that.
Is that we anticipate that <unk> guidelines will lower the proteinuria treatment target that means that even more patients will need better treatment, which still sorry clearly offers.
Thank you. Your next question comes from the lineup Vanilla <unk> with Guggenheim Securities.
Your line is open.
Great. Thanks for taking my question. So I just had one I was going to ask but maybe to follow up on the <unk>.
Prior comment you made around the compliance and persistence.
Youre, having a high rate of compliance with persistent 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 at three months or six months after starting.
And then 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 of.
What percentage are going through is guilty twos before they might start something like bill sorry.
What percentage, maybe if you had to pay or are using this before.
And also I think previously you talked a little bit about the use in the community setting versus the academic.
Physicians, if you can provide any sort of update there in terms of just where these prescriptions are coming from and what's recipe.
Patients are being prescribed the product.
Well thanks for the questions Peter will have you cover these.
Yes, there were a lot of questions.
I believe in the questions. So let me try to to the size of them.
So it was the last one I think one of the questions work like our patients coming from community or it could be yes.
And if the dynamic Clydesdale and probably we need to cover a broad range of physicians to really get to all the addressable patient population.
This is mainly because the vast majority of these patients we size. It can even December so thats, where the majority of the basins control.
The other question was regarding what is the basic profile overall, a younger patient population.
And that's what we also see reflected.
In the face of it out and Pillsbury.
Basically basins in the Forty's dominantly male.
And then I think also from a from a coverage perspective coffee. This relevant this is about 70% of the patients who are crucial cohorts, which also speaks to their consumer patient population.
I think another part of the question was co medication.
Is the ERP tool will have a significant amount of space and defense solutions.
As the <unk> two inhibitors.
I think there is finally, becoming the gold standard consistent again already so you can put like a non immunosuppressive treatment option.
And I think the global standards of care moving forward is really feel sorry.
The loss in addition to Wolf Endothelin with also having this deal with Youtube and it's something that we are achieving in breakfast and then I think the last question, where you started with the compliance and persistence, we haven't spelled it out.
So the compliance rates are very high compared to what we would typically see in chronic use treatments in cardiovascular disease.
So pipelines right because we haven't specified the specific number after a certain amount of time.
I hope I covered all your questions on this one.
Okay, Yeah, Thanks, Peter Bommel.
Yeah. 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 area often.
Times these patients who are at high risk of progression drug or could see reductions in proteinuria that are meaningful with other therapies and so they are very pleased to see.
Those reductions with gold sorry that oftentimes happens very quickly after.
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 immunosuppressive 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 business upon which to grow over time.
Okay.
Thank you.
Your next question comes from the line of Alex Thomson with Stifel.
Alex Thomson Youre open.
Alexander Thompson: Great. Thanks for taking my question, I guess, a little bit more on the sort of broader.
Commercial dynamics could you provide a little bit of context around any inventory or pricing dynamics headwind or tailwind in the quarter. Thank you.
Sure Alex Thanks for the question Peter will have that one over to you.
Yes, I would say from an inventory perspective, I don't think we see any difference.
Better than what you would expect in the second year of loans.
Well I don't think there's too much to speak to on that one and then I'm missing the Oracle.
Also our pricing dynamics.
Yes other than the gross to net this sounds like you have a little higher in the first globally every year and it's among the industry. So I don't think it's typical wholesale sorry, I don't think we have seen.
Particular dynamic from a pricing perspective.
Great. Thanks.
Your next question comes from the line of Laura Chico with Wedbush Securities Laura Chico. Your line is now open hey.
Good afternoon. Thanks for taking the question I have one kind of a longer term outlook for <unk> Japanese competitor recently completed enrollment in our phase III <unk> study and we obviously have some other if your April targeted agents moving forward, but as you mentioned so.
So its probably will likely be in could you go updated guidelines. So I guess I'm trying to understand here in this kind of 'twenty five 'twenty six and beyond period. How are you still thinking about so far utilization as the treatment landscape is changing particularly if there is a pull forward in diagnosis and earlier treatment. Thanks very much.
Yes, Laura Thanks for the question. This is one where we're particularly excited about the long term outlook for <unk> given that it is a very unique position within the treatment landscape and how it works in the treatment of Iga nephropathy, I'll ask Julia to provide a bit more detail on.
Of that.
Yeah. Thanks, Laura I think it's really great to see innovation for a disease that has had very little innovation for many years and Additionally, I think it's exciting to see a potential replacement for their historical world 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.
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, just diagnosis and need to be treated long term and thats. What feel sorry offers they also as Peter said Theyre going to continue other supportive foundational medications because this is a lifelong disease and that might be in <unk>.
Two inhibitor for CTV, but essentially to aspire, replacing the rollover rasp inhibitors, and that's really aligned with what the Kols are saying that guidelines are saying is that you've got a treatment thats compared head to head to a historical foundational treatment until sorry is superior to that and then you can potentially add an additional.
No medications just like we've added on steroids historically to RAF inhibitors, you can add on a b cell our complement inhibitor on top of the foundational role that thus far.
Yeah.
Thanks very much.
Thank you for your next.
Your next question comes from the line of Ed Arce with H C Wainwright and co Ed Arce. Your line is now open.
Great. Thanks for taking my questions and congrats on the strong quarter of progress.
Three questions for me hopefully this doesn't.
Too long.
One is really about.
Yes.
What seems likely coming out of <unk> and then your <unk>.
On the fifth of September given Theres, no cases of daily and the Rins monitoring could be softened.
Unlikely with proteinuria as in the EU and given the <unk> guidelines are looking that way all of this points to it.
Much more.
<unk>.
Accepting label going forward and so the question really is if those do come to pass what would be your view on the potential for.
Acceleration further from the growth rates that youre seeing so far.
And then just a couple of quick questions on the model.
First.
Around I think the decrease this quarter was largely impacted by the generic entry earlier. This year I 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 the first patient enrolled in the HBU study and just wanted to confirm that thanks. So much.
Alexander Thompson: Alright. Thanks, so much. So first question, we'll hand over to Peter So Peter how do we see <unk> and.
The labeling drew.
Driving growth as we move forward.
Yes, I would say it allows for a broadening of the pace of your addressable patient population.
Right now you.
U S label stage spacing.
At risk of rapid progression as a general newly authority of a $1 five I am expecting that would go down.
Enable when we have the full approval.
Additionally to your point on the video and <unk>.
Moving to earlier, we are anticipating a more aggressive treatment target with regards to Bulgaria.
The broadening of the patient population.
Bill mentioned earlier evolving landscape you have more interest that may come into the market. This is really a market in development I would say was more.
February biopsies.
And I think that I'll, hopefully greater continued growth opportunity for us.
Alexander Thompson: Playing in this item tools.
Thank you.
And the second question. Thank you Peter sorry, operator, we got two additional questions from from the last.
Questioner.
So Chris I'll hand, this over to you. So can you explain the file.
Generic dynamics on revenue as well as the $65 million anticipated payments.
Yes. Thanks for the question Doug on the first one on sale, that's not actually related to the activity 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 or is it hasnt your staff and then on the second one you have it right that the $65 million of IP R&D expense. This quarter is related to the first patient dosed in the phase III Harmony study and thank you Beth.
Great. Thanks, so much.
Your next question comes from the line of Allison <unk> with Piper Sandler.
Allison Your line is open.
Hey, good afternoon, congrats on a nice quarter and thanks for squeezing me in.
You mentioned the recent Spartan study update and newly diagnosed <unk> patients I'm, just hoping you could talk about Kols nephrologist reaction to that and just is it your sense that docs need to.
Any additional clinical data to really catalyze or drive widespread earlier line use of <unk>.
Thanks.
Yeah, So Allison maybe ill 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 currently prescribing thus far in two patients with IGN and they're in their practice and I think that that good.
As a great confidence in the overall profile Julia why don't you talk a little bit more about the potential impact of the reaction that you are hearing to the the Spartans results to date.
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 barton, which is earlier treatment, but also combination treatment and that supports that we believe that so far I should be foundational care and also that patients should be treated earlier in their disease I.
I think people are very excited about what we put out around <unk> that is newly diagnosed patients who have not been treated earlier in their disease course, even slightly lower range is that correct 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, but it really places and reiterate that so far he isn't just targeting damage that's already occurred and helping with the remodel but it can help prevent the damage that occurred.
As you can have Iga nephropathy deposition, because we are treating very early in the disease and it shouldnt 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.
Ladies and gentlemen, this concludes the question and answer session of today's conference call.
The call back over to Ann.
Great. Thank you everyone for joining us our first quarter 2020 core financial results call. We look forward to providing additional updates on our progress have a great rest of your day.
Speaker Change: This does conclude today's call.
Thank you for your participation you may now disconnect.
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Speaker Change: Yes.
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