Agios Pharmaceuticals, Inc. (AGIO) Earnings Call Transcript & Summary

Welcome, everyone, to the 44th Annual JPMorgan Healthcare Conference. My name is Tess Romero, and I'm one of the senior biotech analysts here at JPMorgan. Our next presenting company is Agios, and presenting on behalf of the company, we have CEO, Brian Goff. Brian, over to you.

All right. Thank you, Tess, and good morning, everybody. It is great to be back at JPMorgan, and I'm really excited to share our outlook for 2026 and why we're so excited about the path forward for Agios. Before I get started, I'll just remind everybody that I will be making forward-looking statements, so I'd encourage you to take the time to read through the details of this slide. This is a pivotal moment for Agios. We're at a major growth inflection point. And it really comes down to 3 key components that I'll talk about this morning. The first is that our PK activator, pyruvate kinase activator franchise is proving itself to advance as the standard of care across a range of hemolytic anemias. And it also serves as the foundation for our leadership in rare hematology at Agios. Secondly, we continue to advance our early and mid-stage pipeline, and this gives us the potential to unlock further value ahead. And third, especially based on the very recent approval that we've achieved for thalassemia, which I'm excited to talk about, we now see a clear path to profitability with our existing commercial portfolio. So the takeaway here is we are not just preparing for the short term. We're building a really exciting growth future at Agios ahead. Now our pipeline is such that Agios has a long legacy of discovering, developing and delivering very differentiated medicines that ultimately achieve approval. And the foundation of this, as I noted, is our pyruvate kinase activation franchise, this is really anchored on mitapivat, which is already approved for pyruvate kinase deficiency as well as now at the end of last year, thalassemia, we continue to pursue sickle cell disease. We also have another exciting asset in our PK activation franchise, tebapivat, where we're also pursuing sickle cell disease as well as low-risk MDS. Earlier in the pipeline, we have 2 other assets, AG-181 that's built on our cellular metabolism expertise. We're pursuing this for the treatment of phenylketonuria, and AG-236, which is a TMPRSS6 inhibitor that we're pursuing for polycythemia vera. Now our pipeline is advancing beyond ultrarare diseases, which is really the current anchor point we have in pyruvate kinase deficiency. And if you look at each of the subsequent indications that we're pursuing in our pipeline in totality, these represent market potential by 2030 in excess of $10 billion. PYRUKYND, as I mentioned, is already approved as of 2022. Thalassemia now is our next approval. This is under the brand name AQVESME, which we achieved at the end of last year. And this alone, on a worldwide basis, represents in excess of $1 billion in market potential. We are very well prepared for this launch. On the bottom of the slide, you see 3 key components: First, we have already deployed our highly experienced rare disease expert field force. Secondly, we have the myAgios patient support program. This has been in place since the beginning of our parkin PKD launch and is really geared to help patients onboard to therapy and stay on therapy for the long term. And lastly, we've been very thoughtful about how to expand globally to capture the ex-U.S. opportunity. And we've had a very thoughtful selection process with full service distributors in both Europe as well as in the Gulf region. That has allowed us to be very capital efficient and focus our investments in the U.S., which is clearly our most significant market, which brings me to our strategic priorities for 2026. There are 4, and the first -- and I'm going to go through each of these in discussion this morning. The first is this exciting high-potential high-impact launch of AQVESME for thalassemia. Secondly, expanding our PK activation franchise into these other areas like sickle cell disease and low-risk MDS which just those 2 alone represent worldwide market potential in excess of $7 billion. Third, unlocking future value, as I noted, with hematology as well as expanding beyond with our earlier-stage assets. And then lastly, as always, focused on continued financial discipline to ensure long-term sustainability and growth for Agios. So I want to begin with a deeper discussion on our execution for this high-impact thalassemia launch. And the point I'd like to make here is, first of all, it was at the very end of last year on December 23, that we received FDA approval for AQVESME for thalassemia. This is in so many ways, a historic approval for the thalassemia community that has waited for this for decades. It also is, of course, a significant point of pride for Agios as we continue to solidify our leadership in rare hematology. I will note that this is a separate brand from PYRUKYND. And the advantage of that is this allows us to isolate the REMS with thalassemia and provide regulatory clarity that in the case of PKD with PYRUKYND, there is not a REMS. Now this launch or this approval, I should say, establishes a series of very significant first in thalassemia. The first one is we have a very broad label. This is the first ever approval in thalassemia for both key genotypes, alpha and beta thalassemia regardless of transfusion burden. Secondly, this is the first oral medicine approved. And with our twice daily dosing, this is, as you can imagine, significantly less burdensome for patients then frequency of transfusions or subcutaneous once-weekly therapy, which is currently approved only for beta thalassemia. Third, this is a disease-modifying therapy for nontransfusion-dependent patients. And the highlight of that is from a quality of life measure, we were really pleased to have this significant improvement in fatigue as demonstrated in the ENERGIZE trial. And lastly, in the transfusion-dependent focused trial, ENERGIZED-T, what we demonstrated was that the transfusion reductions that those patients had was durable and lasted for up to 36 weeks. So we're really proud of this profile. It puts us in a great position to make AQVESME the standard of care in thalassemia. A little bit more on the launch dynamics there are approximately 4,000 adult patients in the United States that we would deem addressable at launch. The total patient population of adults is about 6,000 patients. Now we know this because there have been well-established ICD-10 and ICD-9 codes for many, many years in thalassemia. So this has been validated from a claims database standpoint as well as from in-depth account profiling. Supporting this effort is our sales force of approximately 40 people. They are highly trained, fully deployed and already generating demand. In fact, I'll just make a side note, we were really pleased that even before the close of 2025, we already generated our first prescription for AQVESME for thalassemia. In the middle, you can see the price point is a step-up from our pricing for PKD. It's $425,000 per patient per year in the U.S. And we really feel strongly this is reflective of the compelling value that we've demonstrated across both clinical studies for thalassemia. Now as I noted, supporting the patient journey, onboarding access and continuing on therapy is our very well-established myAgios program. So we're really excited about this launch. We are set up to deliver. And again, this is already underway and a really exciting part of the 2026 story. Next place I want to go is expanding our PK activation franchise into both sickle cell disease as well as lower-risk MDS. And before I do that, just a quick tutorial on what is PK activation. We're going to start with the red blood cell, which is the center point of the activity here, a normal lifespan for a red blood cell is about 120 days. But in the case of hemolytic anemias with both PKD and thalassemia, it's significantly shortened, as you can see, about 20 to 30 days. And in sickle cell disease, it's even worse than that. So moving to the right, how does PK activation work? It's really focused on the glycolytic pathway, which is the sole source of energy for the red blood cell. And at the very last step with pyruvate kinase activation essentially does 2 things. One is it increases ATP or energy for the red blood cell. And secondly, simultaneously decreases 2,3-DPG and which ultimately increases oxygen affinity for hemoglobin. The benefit of both of these activities is that the blood cell becomes healthier, better energized and last longer. And we know this is true because we have now completed 6 well-controlled trials across 3 different hemolytic anemias and have had remarkably consistent results. In the case of PKD, as I noted, we already have PYRUKYND approval for PKD as of early 2022. That was supported by 2 studies: thalassemia, I'm going to continue to brag about the fact that we now have approval as of the end of last year. And now the next place that we're very excited about moving into is sickle cell disease. And that's as a consequence of the data that we just read out towards the end of last year. So I'm going to start with a quick overview of sickle cell disease. And the reality here is the unmet need is glaring. It is profound and frankly, very sad for this community. In the U.S., there are approximately 100,000 adults and pediatric patients that have sickle cell disease. And the reality is all they have available in large part is hydroxyurea, which was introduced more than 25 years ago. It's basically a repurposed chemotherapy drug. So this community has been waiting and has had moments of hope which have then been taken away, and so we really have a lot of conviction in doing all that we can to advance our PK activation opportunity into sickle cell disease. And on that journey, in November of last year, we reported the results from our RISE UP Phase III study. The highlight here is, on the left side, you can see that we demonstrated a very strong anti hemolytic profile. There were nearly 41% of the patients that had the prespecified response of hemoglobin improvement. We also saw other markers of hemolysis improved. And if you take those responders in the middle column, you can see that they had further benefits of reduction in sickle cell pain crises as well as improvement in fatigue. The last point I'll make is that we're really pleased with the safety profile, namely, we did not see any of the cases of hepatocellular injury that match the pattern that we observed in thalassemia. And remarkably, and I think this is a really good proxy for how patients think about the profile more than 99% of the patients that were eligible to continue into the open-label extension trial elected to do so. So the next step for us, as we've already communicated is we will be sharing this data with the FDA in a pre-sNDA meeting this quarter. Now we have another PK activator tebapivat rounding out this franchise. This is a more potent PK activator, a few key features. One is that both important ISO enzymes PKR and PKM2 are bound longer and stronger with tebapivat than even mitapivat. Secondly, because of the enhanced metabolic activity of this product, or this asset, there are lower drug-drug interaction risks. And third is that given the longer half-life that we see the potential for once-daily dosing. So as I mentioned, we're pursuing different diseases, sickle cell disease and low-risk MDS, and I'm going to start with sickle cell disease. What we have seen here is established proof of concept in our Phase I study that demonstrated essentially that we have enhanced hemoglobin response. That's really what we're going after to again, widen the addressable opportunity in the sickle cell disease community. And importantly, this is well tolerated. And as we've advanced into the Phase II study, we're measuring 3 different doses, 2.5 milligrams, 5 milligrams, 7.5 milligrams daily. And we're really excited about reading out that data in the second half of this year. Moving to MDS. What's encouraging here is that from our Phase IIa study, that we read out in late 2023, we saw a 40% response in the low transfusion burden patients with achieving transfusion independence. One thing I will really note here is that in the Phase IIa study, what we observed is that the 5-milligram dose tested, the exposure levels of tebapivat were significantly lower in the MDS patients than we had modeled. So in the Phase IIb study, which is now fully enrolled, we have significantly increased the doses of multiple of 10, 15 and 20 milligrams daily. And we're really pleased to be able to report out those results in the first half of this year. This one, I would say, because this is a bit different from a traditional hemolytic anemia but still carries forward the ineffective erythropoiesis components. We deem as higher risk, but obviously very high reward given the size of this market and the significant unmet need for these patients. So that brings me to our earlier-stage products in our pipeline. And I want to start here with our opportunity to expand within rare hematology focusing on polycythemia vera, this patient population is very significant. There are about 100,000 patients in the U.S. They're really limited to cytoreductive therapies hydroxyurea and really burdensome and I must say, very dated phlebotomy approaches. So our goal with our TMPRSS6 inhibitor is lower hematocrit and maintain that as a durable, sustainable result for these patients to get them out of these very frequent therapeutic interactions that they have to undergo. So we're going after 6-month dosing. And the mechanism here again is an anti-TMPRSS6 inhibitor. This is -- or TMPRSS6 inhibitor, I should say. This was in license from Alnylam and is built on their very well-established GalNAc platform. So we are looking forward to Phase I healthy volunteer for AG-236 in the first half of this year. Moving to AG-181. This is for phenylketonuria. So this is -- we're now moving beyond hematology into an area that builds on our expertise in cellular metabolism. The reality for these patients is that they're subjected to incredibly restrictive diets. And frankly, only a fraction of these patients are currently treated with pharmacologic agents. The mechanism that we are pursuing with AG-181 is very novel. This is a chaperone approach where AG-181 binds to phenylalanine hydroxylase in a way, it's similar to the action of pyruvate kinase activation. And this is the key translational step converting phenylalanine into tyrosine. So we are very much looking forward to getting these results of starting, I should say, our first patient dosed in the Ib trial and establishing proof of mechanism for this activity in the second half of this year. What we're going after on the patient's behalf is faster onset, durable response and ideally removing some of that dietary restriction that the patients are subjected to. So that brings me to the last of our key priorities here, which is all about financial discipline, a continued commitment from our organization. And a couple of points I want to highlight is that our financial discipline is really geared towards achieving long-term sustainability for Agios as a leading rare disease company. What that brings us to is despite the fact that we have a very important launch underway, we're continuing our commercialization in PKD. And we have a very exciting pipeline that we're advancing we're guiding towards keeping our 2026 operating expenses flat to 2025. Now depending on how the pipeline continues to read out, we may see even further operational efficiencies beyond 2026. The key components within this is, number one, we will ensure and we believe that we are fully funded to maximize the AQVESME, thalassemia launch opportunity. Two is just as we did with thalassemia, gating our investments until we had the strong data that read out, we're doing the same in sickle cell disease until we achieve regulatory clarity on our path ahead. And third, we're very focused on our actual operating model inside Agios and striving for continued efficiencies. So the net of all this is that we see a clear path to profitability just based on our current commercial opportunity of PKD and now thalassemia. And we think that's really important for investors to know as a base case scenario for Agios. So in closing, we're really excited about 2026 and beyond. I just want to do a quick reflection on 2025 without going through all these milestones, just to highlight the fact that, once again, I'm really proud of the team that I get to work with every day. We persevered through challenges as well as plenty of opportunities, and we delivered on every single one of our corporate milestones that we put forward. And so once again, I'll just remind the strategic priorities are really focused on 2 key aspects. One is master this launch for thalassemia, and 2 is advance our exciting pipeline and throughout maintaining that financial discipline. And I'm going to land on, okay, so what are -- what's the catalyst rich environment for Agios in 2026. The top half shows first half of the year, and there, as I noted, we're eager to have our pre-sNDA meeting with the FDA to discuss the mitapivat data for sickle cell disease. Secondly, getting that Phase IIb readout for tebapivat in low-risk MDS. And third, the Phase I healthy volunteer data for our TMPRSS6 inhibitor for polycythemia vera. Second half of the year will also be busy. There, we're looking forward to the tebapivat Phase II data for sickle cell disease as well as, very importantly, the Phase Ib proof of mechanism data for AG-181 for phenylketonuria. So it's an exciting year. You can count on us to continue to lean in on continued excellence in execution and with that Tess. I'm going to stop here. And for Q&A I'll invite the power team of Sarah Gheuens, who is our Head of R&D, Chief Medical Officer; Cecilia Jone, our Chief Financial Officer; and Tsveta Milanova, our Chief Commercial Officer. Thanks a lot, and over to you, Tess.

Great. Well, thank you so much, Brian, for the thorough presentation, and welcome everyone over to the stage here. So I thought maybe we would start with the slide that you presented this morning that lays out over $10 million in total estimated global market size for your current pipeline indications by 2030. Can you talk about the inputs there and underlying assumptions and what your framework is across the opportunities in terms of risk adjustment?

Sure. I can start and then the team can fill in here, too. We've certainly validated these estimates. This is -- I should have noted this is an estimate for 2030. And this is across each of these indications on a worldwide basis, looking at both current opportunities -- or current treatments rather, for these patients as well as our forward look as to others that will be entering the space and how these markets will grow. And again, I think the highlight is that what we have in front of us immediately is thalassemia which we've sized up to be $1 billion plus in worldwide potential. We expect to be a significant portion of that opportunity. And then beyond that, which I also talked about sickle cell disease and low-risk MDS, collectively on a worldwide basis are in excess of $7 billion. The risks are, for us, continuing to advance our pipeline, we believe we're very well positioned, particularly on the consistency of data that we've seen across these 3 hemolytic anemias.

And just talking a little bit more in more detail about that $1 billion number for PKD and thalassemia together. Maybe can you just break that down for us just in terms of from a geography standpoint?

Yes. I'll -- and this is a good place for Tsveta to weigh in on how we rank order the geographies in thalassemia specifically.

Absolutely. So we are obviously very excited to have the approval for AQVESME in the U.S. and that followed up the approval for PYRUKYND for thalassemia in the KSA and we expect to have an easy decision for PYRUKYND and thalassemia in Europe soon earlier this year. The way we look at the $1 billion opportunity is a combination of PK deficiency and thalassemia. The majority of that is thalassemia, on a worldwide basis with the highest priority market for us being thalassemia for the U.S. Given the approval and the power team behind the launch, we see that as a meaningful opportunity to scale up and U.S. leading the way, contributing to the majority of the $1 billion over time, as the pricing and reimbursement dynamics in Europe and the Gulf play out, we'll see the ex-U.S. contribution to start scale up. but that's going to come later in the launch trajectory. And when we look at ex U.S., we see the Gulf being the bigger opportunity followed up by Europe in certain selected geographies where we know the prevalence of thalassemia is higher.

Okay. And it sounds like, Brian, from your presentation, the priority of the company is really to maximize your launches and also continue to invest in your internal pipeline. Like what is your appetite for further BD in 2026?

Yes. Well, we're in a position of strength on many fronts. We have, as I noted, a very exciting internal pipeline. It really builds on as I said, our established credibility with discovering and developing very compelling assets. And so we'll continue to do that. Likewise, our ambition is to continue to grow and be a leading rare disease company. And so we're always looking on the outside for opportunities that would fit our capabilities, particularly our expertise in hematology as long as these are differentiated, have a real transformative potential for patients. But I think really importantly, from a discipline standpoint, whether it's internal or external, we maintain a very high bar and we always compare both sides against each other.

Okay. And you talked a little bit about your recent approval of -- AQVESME.

AQVESME. We can practice together.

This is my first time using it on the stage here, so bear with me. What has been the early feedback from physicians upon approval here? And Tsveta, what are you most focused on getting right from a launch perspective?

Absolutely. I'm very excited to talk about the launch. And I can tell you that the clinician and the patient community is very excited about the potential of [ Equesmiand ] now having it available to the U.S. market. Our first priority for the launch is demand generation. The moment we got the approval in -- on the 23rd of December, the team was trained immediately, and they're already in the field connecting with the community. The second very important priority for Q1 right now is really to ensure the drug availability at the end of January. And the reason for that is we will just basically need to finalize the last aspects of the ramp, so we can put it in place and patients actually can start the therapy as well. We have engaged with the community and the excitement is palatable. We really got so many inbound requests to learn more about AQVESME. The team is out there educating and we really look forward to a very strong start of the launch and really providing that very meaningful therapy to patients in the U.S.

Okay. And can you talk a little bit about the initial marketing message here? And are there specific elements of the label or REMS for liver monitoring that you think you will need to educate physicians on?

So in terms of the positioning of the product, we see AQVESME the standard of care in thalassemia. And what allows us to communicate on that positioning is really the strength of the data from the energized program and the breadth of our label. We have a label which covers the totality of thalassemia, and that's really the first product for that community covering alpha, data, transfusion-dependent and nontransfusion-dependent thalassemia. The second aspect of it is really the strength of the clinical efficacy, which we've seen the trials delivered on a very clinically meaningful endpoint across both the transfusion-dependent and nontransfusion-dependent segment. And we hear from clinicians that, that data is really differentiating and will allow us to deliver on that standard of care and positioning for AQVESME. When it comes to the REMS really, the main education is going to be around the actual paperwork of the REMS rather than what the clinicians and patients need to do from a clinical kind of management perspective. Our REMS is very similar to what it is to actually start and manage patients on a new therapy in thalassemia initially. Basically, it requires liver monitoring on a monthly basis, for the first 6 months after the initiation of the therapy and what we hear from clinicians is that they would do that no matter of the REMS. They will monitor patients initially when they start on therapy for efficacy, they will monitor the liver parameters anyway for the thalassemia patients. And for us now is really ensuring that all of the elements of the REMS are in place. and then we can support the patients and the clinicians to getting certified and really going underway.

Really helpful. And how should we think about the ramp for AQVESME in 2026 on both revenues and new patient starts and which patients -- I think you've talked a bunch about this in the past, but who represents the best first candidates for the product?

So as Brian mentioned, we have identified about 4,000 patients who are our addressable patient population and we will target at launch. The way we see the launch trajectory early on is focused primarily on treatment initiation from the transfusion-dependent patients. The main reason for that is that these patients are in content contact with the health care system they go for their transfusions every 3 to 4 weeks. So they are very likely to hear and consider initiating therapy first. As the launch progresses, we expect the NTD patients, the nontransfusion dependent patients to become a more meaningful contributor and allow us to scale up the launch. From kind of a trajectory perspective, we don't expect to see bolus that will capture the majority of the patients earlier in the launch, and that's driven by 2 reasons. The first one, the drug is going to be available in January and it's going to take time from basically prescription to treatment initiation. So we'll actually see an increase in demand, but we wouldn't see a very meaningful bolus of patients initiating therapy first. The second reason for that is as with every rare disease launch, which is not imminently life-threatening. We wouldn't expect all the patients to start therapy first, but we'll see the first adopters and over time, a continued growth trajectory as the launch progresses.

Okay. I'm going to have to hop around here just because we don't have a lot of time. But switching gears to talk a little bit about sickle cell. You top line your -- the Phase III portion of RISE UP in December. And that study hit on hemoglobin response, but missed on the annualized rate of sickle cell pain crises. Big picture, what do you believe led to this outcome? And is it understood why certain patients were better hemoglobin responders than others and thus had better sickle cell pain crises related and promised fatigue outcomes?

I know Sarah is ready to go on this.

Sarah, over to you.

Thank you. First, the RISE UP trial generated for the third time, the third indication, a very strong anti-hemolytic profile. So the hemoglobin response is very consistent. The hemolysis improvement is very consistent with other hemolytic anemias, and that's important because hemolysis fundamentally drives a lot of the pathophysiology in the disease. And so while we didn't observe the sickle cell pain crisis endpoints statistically in the overall patient population, we did observe a trend. But when we looked at the hemoglobin responders, we actually saw clinically meaningful benefits across all of the different endpoints. So the sickle cell pain crisis-related endpoints and the fatigue. And so therefore, we're very excited about the data package generated that combined with the safety package is very compelling. And so we're looking forward to engage with the agency in Q1.

Okay. And Sarah, just on this engagement with the agency, can you elaborate a little bit more on that for us. What is the exact feedback or kind of line of questioning you're hoping to have with the FDA in that meeting?

Sure. So this is the sort of classic pre-sNDA meeting that we're having in Q1 of this year. And so what you do is you engage on the data generated. Again, there's a compelling data package here to discuss with them. So we're looking forward to gain their feedback.

And okay, thinking a little bit about prior history here, before the trial read out, did you ever speak to the FDA about a potential accelerated approval path based on hemoglobin response i.e., similar to what was done for Oxbryta? And why would or wouldn't the FDA allow you to have a similar move forward for that program?

Yes. So I think the situation with Oxbryta and us is different. We -- now this is a supplement. This is a supplemental NDA in which we have now are coming with very consistent data for the third time, which is very different from when Oxbryta for the first time went. And we fundamentally believe that we have a clinically meaningful package with the data generated in the RISE UP of Phase III. So that's what we're looking forward to discuss with them. You're right that even recently, the FDA has said that hemoglobin by itself can be a surrogate endpoint, so which in that situation, can lead to an accelerated approval pathway, but that is something that would be discussed in the meeting. Our intent, based on the data that we have is to go in for a full approval.

Okay. And how are you thinking about informing all of us post this meeting, are you going to wait? Are there going to be minutes? Are we going to have to wait for the minutes and then you'll make a disclosure. If it's a material for Agios, do you have to make the disclosure right away? Like how are you thinking about it?

Yes. I think first steps first, first have the meeting and then determine the pathway, but then we would,, in due time, of course, give an update on the regulatory path.

Okay. Okay. well, where else do I go in 3 more minutes? Okay. What pipeline milestones in 2026 matter the most for Agios?

All of them.

Yes. I think, Tess, you can imagine we triage for this presentation. And so the 5 that you have represented here on this slide, our 2026 catalyst, we believe all of these are significant. And I should have noted, it's not a pipeline milestone, but the banner on the bottom of our catalyst slide indicates that -- what's exciting about 2026 is, we're going to do 2 things simultaneously. As we advance our pipeline, we will continue to deliver on this exciting launch opportunity with AQVESME and thalassemia, but we refused to pick favorites at this time.

Okay. And you talked about flat OpEx in 2026 versus 2025. I did have a clarifying question. Just on what visibility do you have on how the launch of vorasidenib is going for Servier?

Well, they're a private company, and we're definitely. I must say, because of the legacy of Agios in discovering vorasidenib, we are cheering for Servier. We're really cheering for the patients. And periodically, we will, I'm sure, receive updates with how their launch is going even as a private company to guide us on the residual royalty that we retain. And anecdotally, we hear that not surprisingly, they continue to do well.

Okay. And last question just on tebapivat in the sickle cell disease program there. Is there a scenario that program doesn't move forward to Phase III? Or like what -- how are you thinking overall about how that program really fits in now given all the other things that you have going on?

Maybe Tsveta can speak on that one, too. As I said, we keep a high bar for all of our assets in development, and we'll continue to assess that as we go. Tsveta, do you want to comment?

Absolutely. So sickle cell disease is a disease of high unmet need and really no many therapeutic options. We hear it loud and clear from the clinical communities that they won't need many treatment options because not every patient is going to respond to every therapy. Having said that, I think the timing for the tebapivat data is perfect for us because we will know so much more about the sickle cell disease landscape to make an informed decision. If we were to move the product forward how to move it in the best possible way, so it adds value to the community. We'll obviously start having interactions with FDA, and we are going to learn so much more as we continue to dig deeper into mitapivat data. We might have some updates from etavopivat, which is the Novo-Nordisk PK activator as well on their HIBISCUS study. And we'll continue to monitor the competitive environment as well and see how we can position the product. So it can add value both to patients and physicians.

Great. Well, the clock is telling me that we're basically done here. So I want to thank the entire Agios team so much for being here. We really appreciate it. And thanks to all the listeners for joining as well.

Thanks a lot, Tess. Thanks, everybody.