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Yvonne Greenstreet

Thanks, Christine, and thank you everyone for joining the call today.
2025 is off to a strong start at our island. In the first quarter, we made notable progress towards our goal of becoming the global TTR leader, which will play a critical role in driving sustainable growth and value creation this year and beyond.commercially, we delivered $469 million in combined to net product revenues, and this represents 28% growth year over year.
This was driven primarily by the robust 45% year over year growth of our USTTR franchise, which in the first quarter consisted solely of continued uptake in the hereditary polyneuropathy population.
We also have several exciting portfolio advancements in the border, most notably the expanded indication fromtra in ATTR cardiomyopathy, with approvals in the US and Brazil. And earlier this week, we received a positive CHMP opinion in the EU.
We also saw approval of the 6th are 9 undiscovered RNA therapeutic filia, for hemophilia A or B secured by our partners at Sanofi.
Lastly, we we are reiterating our guidance for the EN, underscoring our confidence and continued growth and a strong launch in ATTR cardiomyopathy. This also includes our goal of achieving sustainable non-gap profitability in 2025.
Now before I move on, I'd like to take just a brief moment to acknowledge the uncertainty that exists related to potential evolution in certain policies, including tariffs, FDA personnel, reorganization, and other biotech industry initiatives being discussed.
While much is yet to be clarified and finalized, we've taken a comprehensive look across our business, and we believe that our land is well positioned and pretty well insulated from any potential impacts associated with the key initiatives that have been announced to date.
We feel that we're completely able to focus on the key tasks at hand.
Executing on a strong launch in ACTR cardiomyopathy and continuing to advance our robust high value pipeline.
Our achievements in early 2025 underpin the three core elements of our business that we believe will drive sustainable growth and value creation for years to come.
The first is TTR leadership. Tolga will provide color on our launch of Ambura and ATTRCM, but at a high level we're very pleased with our early progress, which is focused on securing broad access, driving awareness, and supporting treatment initiation for patients in the initial few weeks since approval.
The next is growth through innovation, including a pipeline with numerous multi-billion dollar opportunities and an R&D engine set up to deliver sustainable innovation and value creation.
The third element is strong financial performance with robust commercial delivery and a disciplined approach to capital allocation to enable us to sustain profitability going forward.
And of course all of this is underpinned by a best in class team and our award winning culture.
And this all represents tremendous progress against our nylon piece 5 by 25 goals, and we continue to work to turn these goals into reality by the end of the year. Doing so will further establish Al Nylem as a unique top tier biotech company delivering sustainable innovation to patients for years to come. With that, let me now turn the call over to Tolga for a review of our commercial performance. Tolga.

Tolga Tanguler

Thanks, Yvonne, and good morning, everyone. I am particularly excited to share our commercial update on this call today.
I am as encouraged as I've ever been, not only by the impact we're already having for patients affected by the conditions our medicines are indicated to treat, but also by the potential that is just beginning to unfold.
Now that our ATTRCM launch is on the way in the US.
I'll review our performance in Q1 and also provide some early perspective on our ATTRCM launch, which only begun in the final days of this quarter and will take shape over the quarters ahead.
Our Q1 performance continues to be strong.
Altogether, our portfolio delivered nearly half a billion dollars in combined net product revenues, representing 28% growth year over year and 4% versus Q4 2024.
This is tremendous growth across our portfolio, several years after our initial launches.
Quite simply, this means helping more patients affected by each of these devastating diseases.
Before we dive into our TTR franchise and the exciting progress with our new CM launch, let me briefly update you on our rare disease franchise.
A rare franchise give Lari Okuma together delivered $109 million in combined product sales in the first quarter, representing 8% growth compared with the first quarter of 2024.
On a year over year basis, the growth in gulari patients on therapy was approximately 15% and growth in Ouma patients on therapy was approximately 20%.
Revenue growth for Olumo was less than growth in patients on therapy, primarily due to gross adjustments in European markets and the timing of orders in partner markets.
We continue to expect full year product sales growth of approximately 15% for our rare franchise, consistent with the midpoint of our 2025 rare product sales guidance.
Moving now to our TTR franchise, we continue to see strong performance in Q1.
The franchise delivered $359 million in global net revenues, representing a 36% increase compared with the first quarter of 2024.
Importantly, this represents continued and robust growth from our base business in hereditary ATTRPN since the CM indication approval came in the final days of the quarter.
In the US, combined sales of Oparo and Ambutra in the first quarter increased by a robust 45% compared with the first quarter of 2024.
Continue to drive strong growth momentum.
The 45% year over year growth was primarily driven by the following.
A 32% increase in demand driven by the strength of ongoing on patient uptake.
We are pleased with the growth in demand, which has been consistent over the past five quarters, despite new competition entering the market at the end of 2023, which we believe is reflective of the leadership position we have established in a growing.
Pan market over the last 6 years.
The remaining growth in the quarter, 13%, is related to favorable adjustments in gross to net deductions, combined with stocking dynamics as inventory in the distribution channel modestly increased in Q1.
I will share additional detail on our piano performance in the US on the next slide.
Now, let me turn to our international markets for just a quick moment, where the TTR franchise grew 24% compared with the first quarter of 2024.
Similar to the US, the year over year growth was primarily driven by increased demand for Alustra as patient uptake remained robust.
Bottom line, our TTR based business is very strong and continues to grow.
Before I provide additional color on early days of our TTRCM launch, let me touch briefly on the dynamics we're seeing in the US HATTRPM markets.
A full year after the launch of a new competitor, Almutra remains the clear market leader in the US, maintaining a majority of new patient starts, with Almutra capturing approximately 70% of new patient starts in the first quarter of 2025.
This results from a strong brand value proposition, coupled with continued discipline execution by our commercial teams.
What's more, as anticipated, we are finding that in categories where the majority of patients remain untreated, more treatment options mean more voices helping to raise disease awareness, ultimately accelerating category growth and increasing the number of patients on therapy.
In other words, this continues to be a growth story.
And patients are benefiting.
With similar dynamics anticipated across HATTRPN and ATTRCM, we believe about 80% of the global addressable population remains untreated.
This bodes well for the opportunity ahead in ATTRCM.
Now on to our new indication.
Momentum is building fast and the team is laser focused on delivering a successful launch.
On March 20th, we received FDA approval for Abutra as the first and only silencer approved in the US for ATTRCM, and the only treatment indicated in the US for both the pulmon neuropathy manifestations of hereditary ATTR and cardiomyopathy manifestations of ATTR.
Though it's still early days, we are very encouraged about what we're seeing.
Our first priority out of Yates was the access setup, and we're pleased to say it's progressing exactly to plan, thus enabling the second half growth story that we have described on our prior calls.
Though it's of course, early to quantify trends.
I would like to share some examples of the very encouraging progress we're already seeing.
Particularly with regard to the access and health system formulary reviews that we have shared would be the early priorities and key enablers of our second half launch momentum.
Let me explain why we believe this launch is of an exceptional start with some specific examples.
First, we're seeing robust patient initiations across all payer segments, Medicare fee for service, Medicare Advantage, and commercial.
We are continuing payer engagements, and a majority of contracted lives are covered by value agreements that include the cardiomyopathy line accession.
As expected, the majority of our motor patients to date pay $0 co-pay in HTTRCM like with HATTRPM and we continue to have widespread payer coverage.
Exactly in line with our expectations.
Seconds, and this is important, about 80% of CTR volume flows through approximately 170 health systems.
Our team's focused efforts enabled inclusion of our mutronn formulary in more than half of these health systems within short 4 weeks of label expansion. In fact, the majority of these accounts have already initiated a motor treatment for ATTRCM patients, underscoring that with the proper setup, these accounts do indeed come online.
And finally, in terms of treatment choice, we're seeing healthy demand across both prior ambutra prescribers as well as first time am prescribers, and what we're hearing from prescribers is that the Albutra disruptive value proposition resonates and is enabling this early and encouraging launch momentum.
Early feedback from patients and physicians indicates clear excitement for a new mechanism of action in ATTRCM that can rapidly knock down TTR.
HCPs further highlighted that Albutra clinically and statistically significant benefits in stand-alone all cause mortality coupled with demonstrated preservation of functional capacity and quality of life where ambura makes significant impact on KCCQ and 6 minute walk distance are highly differentiating. Furthermore, physicians they appreciate how quarterly. HCP administered dosing gives peace of mind for verified adherence.
In terms of early utilization, here too, we are very pleased by early signals. We see broad views in line with our expectations. More specifically, we're seeing Abutra using first line. We're also seeing stabilizer, progressive patients switch to Albura.
We're seeing broad utilization, including an academic and community settings, supported by the broad alternate site of care networks that's been established.
Simply put, The mechanism of action and the well established safety and tolerability of Abura hit home.
Our consistent data speaks volumes. HCP administered, verify adherence is real, and patients are getting on therapy on Ambura, most with zero co-pay. In conclusion, the launch is off to an exceptional start.
These are, of course, the early days of launch.
We will continue to share more as the launch progresses, including both qualitative and quantitative launch indicators.
We've provided full year guidance, projecting robust 36% year over year growth in RTTR franchise revenues at the midpoint of the guidance.
This reflects our confidence in the launch and the future potential of this franchise.
Now with a few early weeks of experience since launch, we remain as confident as ever.
In conclusion, we are pleased with the results in the 1st quarter with both our TTR and rare franchises delivering strong growth in patients on therapy as well as delivering robust year over year growth in revenues, giving us confidence in our ability to deliver substantial growth, achieve profitability. And most importantly, deliver our highly differentiated and transformative medicines to more patients in need around the world.
With that, I will now turn it over to Pushka to review our recent R&D and pipeline progress. Pushka.

Pushkal Garg

Thanks, Tolga and good morning everyone. To echo my colleagues, I'm very excited about the launch of Ambutrin and ATTRCM at the end of Q1, and that we've hit the ground running to educate physicians and patients and drive awareness. And I'm delighted by the early progress that Toll had just described, which is based on great execution by our commercial and medical teams and the impressive heliose B results summarized here.
In a population representative of today's ATTRCM patients, nearly half of whom were already being treated with a stabilizer, we saw a substantial benefit invo on cardiac outcomes, including a 35% to 36% reduction in the risk of all-cause mortality alone.
We saw broad benefits on a series of other important clinical parameters such as cardiac biomarkers, echocardiographic measures, and disease progression.
These, together with an encouraging safety profile and an infrequent HCP administered dosing regimen that enables a high degree of adherence, support the potential for ambutra to become a first-line therapy in this disease.
Based on these exceptional data, we quickly submitted filings to regulatory agencies in key geographies, and we're pleased with the pace of progress thus far. We of course achieved US approval of the SNDA in March, followed shortly thereafter by approval in Brazil. And earlier this week, we announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending approval of Uriucerran and ATTRCM. This should enable the European Commission to approve Abutra. In Europe in Q3, and possibly in Q2. So things are progressing swiftly and we look forward to launching other important territories in the coming quarters.
Now beyond those primary results that discussed a moment ago, we continue to share additional insights from the Helio speed data set. At ACC last month, we shared a few new analyses that further support withre Saran's compelling profile.
In one, we highlighted echocardiographic data which demonstrated that treatment with Bryceran led to significant improvements in diastolic function and attenuation of declines in left ventricular and right ventricular systolic function at month 18 compared to placebo.
These indicate that Vitri is favorably impacting cardiac function, which is truly remarkable.
We also shared an exploratory subgroup analysis which demonstrated res and reduced all causes mortality and recurrent CV events across a range of baseline heart failure severity in patients with this disease.
And lastly, a separate analysis confirmed that Boutriran significantly maintained or improved functional capacity and patient reported health status and quality of life compared to placebo over 30 months. These last two analyses were also published in the Journal of the American College of Cardiology.
We look forward to continuing our analysis of this landmark study and educating the TR amyloidois community about the differentiated profile of ambutra.
Further to our leadership and commitment to innovation.
In this disease and to these patients at R&D Day in February, we shared updated plans for pivotal studies of nuresan, our next generation RNA therapeutic targeting TTR with the potential for deeper knockdown and biannual dosing.
Triton CM will be a randomized double blind events-driven outcome study in ATTRCM patients with either hereditary or wild type disease and a medical history of symptomatic heart failure. NYHA class 1 through 3. All patients will be allowed to be on background stabilizer therapy. Approximately 1,200 patients will be randomized, and the primary endpoint will be a composite of all causes mortality and CV events. The primary analysis will be event-driven and will for a minimum of 24 months after the last patient enrolled.
If successful, we target launching new increaseRN in ATTRCM around 2030.
In parallel, we have the goal of bringing decrease end to patients as quickly as possible and see an opportunity to do so in hereditary ATTRPN. Though we're not yet prepared to discuss the full details of Triton PM, we plan to initiate the pivotal study by the end of this year and anticipate the potential to launch in this indication several years ahead of ATTRCM. We look forward to sharing more details in due course.
R&D Day also showcased a number of exciting advancements earlier in our pipeline that underscore the bright future for RNA therapeutics across a broad range of diseases.
Key among these updates, we disclosed 2 new clinical programs.
ALN 4,324 targets GRB 14 for the treatment of type 2 diabetes with a novel mechanism of action. It acts as an insulin sensitizer, addressing a tremendous unmet need in diabetes where insulin resistance is a major issue.
We're pleased to announce today that we've initiated the phase one study for ALN 4,324.
The second program That targets liver derived plasminogen, and this molecule represents a potential universal hemostatic agent.
For the treatment of bleeding disorders without the risk of thrombosis.
Another key highlight was our update on delivery solutions with best in class potential for adipose, muscle, heart, and kidney tissue, as well as a new approach to crossing the blood-brain barrier.
As we announced in our R&D day, our goal is to achieve delivery of RNAI therapeutics to every major tissue by 2030.
Lastly, I'd like to congratulate our partners at Sanofi for securing FDA approval for Citlia Fuserran for hemophilia A or B, with or without factor 8 or 9 inhibitors. With this approval, cufilia becomes the 6,000 island discovered RNAI therapeutic approved by the Food and Drug Administration.
In summary, this remarkable and unique pace of innovation puts us in a great position to have a deep, self-sustainable pipeline that can continue to deliver meaningful impact to patients for many years to come.
And with that, let me now turn it over to Jeff to review our financial results and upcoming milestones. Jeff.

Jeffrey Poulton

Thanks, Pushkal. Good morning, everyone. I'm pleased to be presenting a summary of our island's Q1 2025 financial results and discussing our full year guidance.
Before turning to the details on our Q1 financial performance, I'd like to further some of Tolga's comments on the early observations of our cardiomyopathy launch.
I'm extremely pleased with the commercial execution demonstrated by the US TTR team thus far.
They have guided CM revenue being a second half story with the 2nd quarter focusing on continuing to build awareness, unlocking patient access, and supporting the supporting treatment initiation for patients.
Given the early progress that Tolga described, I am confident in reiterating our financial guidance, including TTR product sales, which I will discuss later.
With that, let's begin with a summary of our P&L results for Q1 2025 compared with prior year.
Total product revenues for the quarter were $469 million or 28% growth versus last year, driven by the 36% growth in our TTR franchise, with particularly strong performance in the US market as Tolga described. As Tolga also noted, Inboer was approved for ATTR cardiomyopathy with only 1 week remaining in the first quarter, so did not contribute to our Q1 results.
Collaboration revenue for the quarter was $99 million or 16% decrease compared to the first quarter of last year. The decrease was primarily driven by the $65 million dollar Roche milestone achieved Q124 related to the first patient being dosed in the cardiac 3 study, partially offset by the $30 million dollar milestone achieved from VR and reimbursements from our collaboration with Regeneron in Q125.
Royalty revenue for the quarter was 26 million, representing a $16 million increase compared to last year, driven by Novartis's increased Latvia sales.
Gross margin on product sales was 85% for the quarter, which was consistent with the first quarter of 2024, as the Ambutra royalty rate payable to Sanofi recess at the beginning of each calendar year. For the balance of the year, our gross margin on product sales is expected to decrease as the Ambutra average royalty rate escalates, driven by annual sales of Ambutra reaching higher royalty tiers.
Our non-gap R&D expenses were 241 million were in line with prior year, as increases in clinical trial expenses associated with our cardiac re study for LB saran and the myvelcaran Phase 2 CAA study were offset by reductions related to the wind down of the Helios B Phase 3 study. We do expect that R&D expenses will increase compared to 2024 for the balance of the year as phase 3 studies for both Salviciaran and the increaseseran ramp up.
Our non-gap SGA expenses increased 12% in the first quarter compared to the same period last year, primarily driven by increased investments in support of Ambutra for the cardiomyopathy launch.
Our non-gap operating profit for the quarter was $75 million representing a $73 million dollar improvement compared to last year, driven by the strength of our top line growth combined with more moderate growth in operating expenses.
Finally, we ended the quarter with cash equivalents, and marketable securities of $2.6 billion compared to $2.7 billion at the end of 2024.
Now turning to our guidance, where as I previously mentioned, we are reiterating our 2025 guidance as presented during our last earnings call and is summarized on our guidance slide.
Additionally, I'd like to provide two additional points of perspective.
Our guidance continues to assume foreign exchange rates as of December 31, 2024, which are noted in the footnote of our guidance slide.
As you are aware, the US dollar has weakened considerably in recent weeks. If the current FX rates continue through the remainder of the year, we expect currency upside relative to our current product sales guidance of approximately $50 million.
We will re-evaluate our full year guidance for FX 62.
Secondly, I'd like to make some brief remarks on the potential impact of recently announced tariffs, as well as pharma tariffs that are currently being contemplated.
As it relates to the tariffs that are now in place, we do not see a material impact on our business and believe we can absorb any resulting cost increases within our existing 2025 financial guidance.
As it relates to the pharma tariffs that are being considered, there's obviously still uncertainty as we await the drafting of the final rules. However, we are comfortable sharing some high-level perspective that reflects our positioning as a company.
Our commercial supply chain is global in nature, but the majority of our products are manufactured through third-party contract manufacturing organizations in the US.
Additionally, our intellectual property is also primarily based in the US.
We think both of these factors position as well in terms of limiting exposure to potential future pharma tariffs. We will provide further updates as we get more clarity on tariff policy.
Let me now turn from financials and discuss some key goals in upcoming 2025 milestones.
We intend to initiate the Triton CM phase 3 study of NRA and ATTRCM in the first half of 2025. Triton PM is expected to initiate by the end of 2025.
We expected additional approvals of bambootra and ATTR cardiomyopathy in Japan in Q2 and the European Union in Q3.
Plan to report data from the cardia 3 phase 2 trial of the albis around in the second half of the year.
These results will help inform the final design for the phase 3 CO of Zombi-in, which we also expect to initiate in the second half of 2025.
Let me now turn it back to Christine to coordinate our Q&A session. Christine.

Christine Lindenboom

Thank you, Jeff, operator. We will now open the call for your questions to those dialed in. We would like to ask you to limit yourself to one question each and then get back in the queue if you have additional questions.

Question and Answer Session

Operator

(Operator Instructions) Tazeen Ahmad, Bank of America.

Tazeen Ahmad

Hi guys, thanks for taking my question. I'm sorry if I missed this on the prepared remarks, but I just wanted to get a little bit of additional color of the initial patients that are starting treatments. Who are the prescriber based? Are they people that have already had previous experience with Sambutra, or are you seeing a mix of doctors that are also completely new to the drugs? Thanks.

Yvonne Greenstreet

Yeah, that's a great question and one to talk, but I think what's really encouraging, about the launch and cardiomyopathy is that really kind of all the indicators are flashing green and we're really seeing, broad and balanced views across all aspects, but perhaps you can speak specifically to the prescriber base.

Tolga Tanguler

Yeah, I mean, the way we see this is a really good broad uptake. We see cardiologists that I've been familiar with. The product, but we're also seeing a pretty good uptake in terms of those cardiologists that have not tried ultra. So that's really encouraging. But the most I think encouraging part is that what I highlighted, our number one priority, which was at the gate to set up and enable second health momentum by actually setting up these institutions to be formally ready.
And within a short 4 weeks, we've been able to get into formulary of half of those accounts, and that to me is really opening up an incredible opportunity for us.

Yvonne Greenstreet

Thanks, Suzine.
Next question.

Operator

Gena Wang, Barclays.

Gena Wang

Thank you. So I think we, saw first full quarter revenue, from, I think 79 million for teatomus and the $37 million for a rub in ATR cardio biopsy. So which one do you think it's a good benchmark for in vitro. Quarter revenue and also my quick calculation for your ATPR franchise this quarter versus the last quarter of roughly 170 million quarter over quarter growth, any revenue was contributed from AT ATTR cardio biopsy revenue.

Yvonne Greenstreet

Well, I think that's really for you. It was actually quite hard to hear you, Gina, but I'll TRY, I think there was one question around how we think about benchmarks for the, CM CM launch.

Tolga Tanguler

Yeah. I'm happy to take that, Gina. Look, first and foremost, we've already laid out our year-end guidance, so that's really important to demonstrate and that the mid-year point of the midpoint of the total growth is going to be about 36%. That's obviously our goal is to meet and hopefully exceed that year-end guidance. Now in respect to the first quarter results of those two stabilizers, I think it's really important to highlight the categories growing. If you take out the IRA impact of fameters, both products have grown. In fact, I think tefamis had let that growth. So that's a clear, good early sign of how this category remains untapped in terms of growth.

Yvonne Greenstreet

So I mean, that's great talk. I mean, look, we really are excited to be in a class of our own in this market with a sort of orthogonal mechanism and a differentiated profile.
So, I'll just come back to you because I'm not sure, I heard all of your questions.

Gena Wang

Sorry, yeah, so I think that, yeah, sure. Can you hear me better now? Okay, so. Yeah, the second question is regarding the this quarter number, quarter over quarter growth, when we look at the ATTR franchise, it's about 170 million. Just wondering any revenue contribution from the ATTR cardio biopsy.

Yvonne Greenstreet

No, we actually made those points in our prepared remarks. It's it's all, it's all teaching our polyneuropathy, and I think that this speaks to again the profile of Atra that we have in polyneuropathy and the quality of commercial execution. I'm really delighted actually by the strength of our polyneuropathy business with terrific growth. Togo, do you want to add anything?
Thank you, Gina.
Next question.

Operator

Greg Harrison, Scotiabank.

Greg Harrison

Hi, everyone. Good morning. This is Teresa Vitale on for Greg Harrison. Congrats on all of the progress this quarter and thanks for taking our question. Curious to hear how you're leveraging your commercial expertise and maybe what additional strategic efforts are you making on the commercial front to be competitive in capturing the family professors. Thanks.

Yvonne Greenstreet

It's a great question. So I think it's goes straight to you.

Tolga Tanguler

Yeah, I mean, first and foremost, as I indicated, we come with an entirely new mechanism of action that clearly sets us apart in terms of any stabilizers are out there, given that we work in upstream. And that rapid knockdown clearly actually manifested itself with helios B results where half the patients were both on placebo, as well as on the study arm, were actually already on a stabilizer, and the results are obviously quite compelling. But frankly, when you think about the disease itself, Given that it's a rapidly progressing fatal disease, physicians are first and foremost interested in treating the disease early, and actually treating with the best possible option they have. In that case, we believe actually Albutra provides a real clear first line option.
Now in terms of those physicians who are considering a switch, we're already seeing that in our broad patient uptake, and we believe that's going to continue to be the case given that half the patients in the most recently published ACC study that shows that patients do progress on stabilizer. So we believe actually we're going to remain a very important option for those patients are progressing on any stabilizer.

Yvonne Greenstreet

Thank you, Zora.
Next question.

Operator

Eliana Merle, UBS.

Eliana Merle

Hey hey guys, thanks for taking the question and congrats on the early launch progress. Just in terms of ambutra, I guess what do you expect or what are you seeing in terms of the use of the first injection free versus those going straight to paid drug, maybe assuming that more would go straight to pay drug considering your comments on the formulary access. And then just a follow up on your commentary on formulary. Access, I guess since you're already on formula and more than half of these, 170 priority centers, are you seeing any change to the price, used for polyneuropathy from these centers and just your latest expectation on how this pricing will play out between polyneuropathy versus cardiomyopathy? Thanks.

Yvonne Greenstreet

So two questions I think one about our Quick Start program and the second around formulary and yeah.

Tolga Tanguler

I mean, maybe I'll take the second question first. We have a single price and we don't see any price difference between our both of our indications, which are both rare conditions. Now, in terms of our, I think you're referring to our quick start program. Look, I mean, if you take a step back. We have a plethora of services that is actually developed by our in-house patient support program helping patients to actually navigate a very complex US healthcare system. And frankly, if you look at our track records, our conversion rates. When a patient comes into those patient op programs is actually very fast and it is very effective and patients stay on for therapy. Now that program itself it includes a quick start program, and we had it frankly for that program for years. And so far we're seeing a very limited use of this quick start program, as we have seen in neuropathy. And what we're really pleased is, frankly, those patients that are coming into the program across a different payer mix are getting on therapy, whether it's through Medicare fee for service, Medicare Advantage, as well as in commercial.
And I must also add, as we anticipated, those most of those patients are paying zero co-pay as we had seen in pulmon neuropathy as well. Yeah.

Yvonne Greenstreet

Very important. We're getting good patient access.
Next question.

Operator

Gary Nachman, Raymond James.

Gary Nachman

Great. Thanks for taking the question and congrats on the progress. So with the TruB in the early launch phase and getting some traction, is that creating a headwind from Boucher's launch in CM or is it helping create more noise for the entire category? So what, what's the early read on position receptivity to a new sound serve versus a new stabilizer out there?
And then just, maybe specifically on the reimbursement side, how are the dynamics playing out as a Part D drug versus the stabilizers that are Part D drugs.
Thank you very.

Pushkal Garg

Much.

Yvonne Greenstreet

Yeah, those are two great I think, Tolga has, made the point that we really are in a category growth story, and you know what we're just seeing is actually continued evidence of a large growing and frankly unsatisfied market, and I think, we're very excited to be able to participate in this market with a recent launch of and cardiomyopathy. I think the second question was around the Part B, Part D dynamics and how that plays through.

Tolga Tanguler

So look, I mean, I think a good example of how we've been managing Part D, Part B dynamics, frankly, is what we've already demonstrated in polaropathy.
We just shared with you in this past quarter, after one year of launch the Part B product, we've actually been able to achieve 70% of all new patients and continue to grow in an accelerated phase based from a larger base of business. Now, in terms of what we're seeing in this new Linux tension we have, we're seeing. No headwinds and thankfully with the value-based agreements we have and we're seeing this uptake across all payer mixes, so there are no signals that we can iterate right now that would suggest otherwise.
And in terms of in terms of the differentiation and whether we're actually seeing any headwinds, look, what really sets us apart is the strength of our data.
It's complete, consistent and cohesive.
We're presenting the full picture with scientific rigor. And in contrast, we're seeing some in the space selectively highlighting data points with creative interpretations.
And we already see and believe investors and physicians alike value the clarity and integrity of a comprehensive data set, and that's exactly what we're delivering.

Yvonne Greenstreet

And yes, and, what we've been doing for the past several years as we focused on meeting the needs of patients.
Next question.

Operator

Jessica Fye, JPMorgan.

Jessica Fye

Hey guys, good morning. Thanks for taking my questions. You mentioned providing additional launch indicators, with Q2 results. Can you just touch on what those will be? And then of those 170 priority health systems, I think you mentioned more than half already have ambutra on formulary. Can you just speak to your goal of where you want that number to stand maybe next quarter and by your end.

Christine Lindenboom

Thank you.

Tolga Tanguler

Yeah, look, I mean, I think we've been very consistent about how we're describing in the way we're updating the investors and in this case, our goal, frankly was to complete the the the the inclusion and formulary by year end.
As you can see, we're taking our progress has been faster and we're very pleased with that. So it's absolutely by, year end we want to be able to get there so that we have access. What's most encouraging, frankly, about the most recent development is A big majority of these accounts, not only included in the formulary, but those accounts that have included the formula are already actually initiating patients on therapy, and that's that's incredibly encouraging. Now in terms of our Q2 data, I think the biggest The update is going to be our revenue uptake and the pull through and how we're actually seeing then and obviously we're committed to providing additional color in terms of, the broad patient uptake and what that really looks like and and prescriber update and so on and so.
Forth. That's.

Yvonne Greenstreet

Great. Yeah, we're looking forward to showing much more to our next earnings call.
Next question.

Operator

Ritu Baral, TD Cowen.

Ritu Baral

Good morning guys.
Thank you.
You mentioned that you're seeing first line use use already. Tolga, can you speak a little to the type of patient, or profile of patient that is making up that first line use, and then I. Have a clarification on formulary inclusion.
When you have formulary inclusion, is that where any prior authorization requirements sort of get set for use in the health system as well? And if so, how should we be thinking about what you're seeing for prior offs in formulary inclusion?

Tolga Tanguler

Yeah, I'm way too high. I'm grateful for your question. Let me take the last first, meaning the type of formulating and whether that would require actually prior off. So we're talking about two types of access here. One is the access where, you're dealing with the payers, that's the Medicare for service, Medicare Advantage, as well as commercial.
They actually all products go through a medical exception process and it's usually essentially if you're a Part D product, the prior authorization is in almost all circumstances that is required. What makes us unique is the Medicare fee for service. There are no prior art requests. The second part, which I was alluding to is the 170 healthcare systems, and these systems is just a question of the organization saying we're actually going to be buying this product because now it's actually included with this new indication that requires no prior authorization. So I just wanted to make that very clear. Now, in terms of The type of patients that we see in the first line.what's really exciting about this is when doctors believe actually that Almra and understand the Almusra's profile that is clearly differentiated as a rapid knockdown agent, they don't actually make a lot of differences in terms of what patients they want to put in. What they see is if the patient is progressing on a stabilizer, they immediately. Put that patient on. If they see a new patient, whether that's early onset or actually they're already progressive, they immediately put that patient on on the first slide. So it's not so much about the type of patient, but it's also whether the doctor have clearly understood the compelling data set that we get to present with helios any additional real world evidence.
Thank you.
Thank you.

Yvonne Greenstreet

Next question.

Operator

Salveen Richter, Goldman Sachs.

Salveen Richter

Hi, this is Tammy on for Salvine.
Thank you for taking our question.
We just want to confirm some of the metrics that he gave out, so 170 health systems over half on formularies and over 75 initiated, one per system around 65 patients, give or take, is that accurate to think about? And just to follow up, we're wondering if you're seeing some more standardized guidelines for identifying stabilizer progressors among HCPs now that we have new options.
Thank you.

Yvonne Greenstreet

Too, why don't you take the first question and then I think Pushka will take 1 2nd. Yeah.

Tolga Tanguler

I mean, just to be clear, we clearly laid those out on the slide which essentially says 80% of the TTR treatments are initiated through these 170 US healthcare systems. These are some regional networks, maybe local networks, as well as national networks.
Once those institutions include a product, because it's a buy and build product, in their formula, that means actually that institution can acquire and can initiate therapy. And what we're alluding to is Of those 170 within 3 to 4 weeks, those systems are already set up as online. Now the big majority of those systems are already initiating treatments in the setting. That's what we're referring to.
I don't know if that captures. I think.

Yvonne Greenstreet

That's the question. Maybe we get on to the second question.

Pushkal Garg

Tony, in terms of the stabilizer progressors, but maybe just a couple of points on this because it does come up not infrequently. Doctors are well-trained cardiologists to evaluate patients with heart failure and whether they're doing well or not well on therapy. That's why you've seen over the years, many studies that have said, hey, how are patients doing on stabilizers, and they report 30 to 50% of patients do progress on those therapies. And so that's, I think that's where that's coming from. And so I think they're well trained. I think if you look, for example, at ESC heart failure guidelines that were set up for ATRCM, they show that doctors look at factors like clinical symptoms or are they hospitalized? What's their walking ability, what's their shortness of breath? What's happening on imaging like echocardiograms, for example, what's happening with critical biomarkers like antiprob and P and troponin. And so I think doctors are well attuned to looking at those factors and examining and I think once again, really heartening heartening to us about the profile of Ambura is that on actually every one of those parameters.
We see a benefit in terms of delaying and favorably impacting these progression. I think that's a core aspect of this disease, as I mentioned, we just published data showing that actually there's actually improvements in aspects of cardiac function with this drug, which indicates the potential for a disease modifying profile. So that's what's compelling about this. I think there will be more guidelines, etc.
Around this, but I think really what we're seeing is that doctors know how to recognize heart failure and heart patients who aren't doing well, and then reaching for the best therapy for their patients.

Yvonne Greenstreet

Great, thanks for like next question.

Operator

Kostas Biliouris, BMO Capital Markets.

Kostas Biliouris

Thanks for taking our question and congrats on the progress. One question from us on ambura, I'll TRY to push my luck here a little bit for some more granularity. Bris Bao recently mentioned that they saw an impact from ambura loans on the number of Aros, and this impact was particularly from Swiss patients. So that said, I wonder whether you see the majority of the early Abuta coming from Swiss patients or new patients.
Any quantitative or directional call that would be very helpful.
Thank you.

Tolga Tanguler

I'll take that question. High cost that. Look, I think the way we best describe, given that still early days is broad. What I'm really excited is again, we're taking all kinds of patients, including definitely first line patients, as well as switch patients, and look, those physicians that choose to switch, they also start new patients on Albutra, and that's definitely an early trend that we start seeing.
By the way, before I, before we move on, I also want to take a quick moment since I know the team is always listening in to call out their phenomenal work, what they've done.
H1stly, what I've witnessed leading up to this launch and in these early days has been nothing short of world class. Our customer facing and patient support teams are really firing on all cylinders, bringing the exceptional profile to a patient community that's long waited for a breakthrough medicine, and the early momentum cost us as I shared, is strong, and all signs point to us being right on track to deliver something truly.

Yvonne Greenstreet

Impactful.
So, thanks for those perspectives.
Next question, please.

Operator

Luca Issi, RBC Capital Markets.

Luca Issi

So much for taking my question. Congrats on the progress. Maybe I a quick one here on access, at least based on our checks, it sounds like stepped its are likely going to be implemented for commercial patients but are much less likely on the Medicare fee for service patients. One, is that a fair characterizations, and 2, if so, how should we think about the Medicare Advantage patients, the one kind of in between the two buckets? Are they conceptually closer to commercial patients where step edits are likely, or are they closer to peer service patients where steppedits are less likely? Any thoughts there are much appreciated.

Tolga Tanguler

Yeah, I know, I appreciate the question. Look, first and foremost, what we've already seen is a very nice broad uptake on all payer mix. So we're really not seeing any headwinds in terms of any restrictions on the product. Now, when it comes to people for service, surely, there won't be any limitations. So definitely half of the Medicare patients will be able to have access very seamlessly and we're seeing that.
With zero co-pay, I must say, in most of the patients. In terms of commercial and Medicare Advantage, we're not seeing any step at it so far, and we obviously have established a great infrastructure through our value-based agreements that enables us to be able to actually demonstrate clinical value. And that clinical value provides us that similar similar advantage. Now if there were to be any step at this, we certainly have the tools to be able to address that if that were to be the case. But look, we have seen it in poneuropathy. We're now seeing in CM. We have the patients getting on treatment in a very quick short amount of time and staying on treatment thanks to again the product profile and the support that we provide.

Yvonne Greenstreet

So this are 21, okay, next.
Next question please.

Operator

Paul Matteis, [Alma Lane].

Paul Matteis

Alright, thanks Paul from Stifel. I appreciate you taking the time. As it relates to uptake so far, Tolga, when we had dinner 5 weeks ago, you talked about how there are certain physicians who they actually can use the drug without going through a P&C committee. Any metrics there like 1% of the prescriber base. That and what have you seen from that population. And then as it relates to Medicare fee for service patients, given the ease of access, is this the kind of thing where over time you think a patient who has, who's insured who's covered by Medicare fee for service could actually get drug, the first dose of drug the same day that it's prescribed?

Pushkal Garg

Thank you.

Tolga Tanguler

Yeah, I mean, maybe I'll take care of your last question first. Look, at the end of the day, this is a healthcare professionally administered product, which requires actually injection by and bill, and that requires some level of coordination. So it will never be a. Sunday, administration, but it's certainly very quick, given the kind of support that we provide and we obviously track those patients. What's also very encouraging is whether you're a fee for service advantage or commercial patients. These patients come in through a start form where we don't actually see any distinction based on their insurance coverage. We are neutral to the to the to the payer mix, and despite that, those patients start getting on therapy. And the main reason is, and I really want to underline this, whether it's step it or prior, this is a rare and a very severe disease that rapidly progressing. And because of this, we see really great coverage of this category as a whole, and given what we have to offer, and based on the value-based agreements that we've established, we believe actually we have the ability to to have the appropriate patients put on therapy as the physician requires.

Yvonne Greenstreet

Thanks so. I think we've got time for one last question.

Operator

Mike Ulz, Morgan Stanley.

Michael Ulz

Good morning. Thanks for taking the question. Maybe just another one, cardiomyopathy. I wonder if you can talk about the rate of diagnosis and maybe if you've noticed a shift since the beginning of the year, now that there's two additional products on the market. And then maybe just secondly, with about 20% of patients currently diagnosed, what do you think that could look like at the end of the year? Thanks.

Yvonne Greenstreet

Two great question.

Tolga Tanguler

Now, yeah. No, thank you. Look, I think we actually have empirical evidence now. What you see in poll neuropathy, from 50% growth rate to 60% just with another product in pouropathy already accelerated that, and we remain the market leader. Now when you look at actually the one results of both stabilizers. Actually, in the US, the stabilizer has grown the fastest ever in the quarter. I think that's somewhat somewhat also supported by IRA changes as well, but we see this category growth only accelerating. We used to provide analogies with multiple sclerosis and other products. Now we see it. In our own category. So there's definitely evidence of that. Now in terms of how large the category and how much diagnosis rate is going to go up, it's going to be very difficult for us to predict that now, but I think we will all see, and I'm sure all voices in this category is going to help accelerate that in the future.

Pushkal Garg

Good.

Yvonne Greenstreet

Okay. Well, look, thank you, everyone, for joining us on the call. As you can hear, 2025 is off to a great start at our island, and we look forward to providing you with further updates as the year progresses. Thanks, everybody.

Operator

Ladies and gentlemen, this is your conference call for today. We thank you for participating and we ask that you please disconnect your lines.