Q4 2021 Agios Pharmaceuticals Inc Earnings Call

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Operator: Today's conference call is scheduled to begin shortly. Good morning and welcome to IGF's fourth quarter 2021 conference. At this time, all participants are in the... There will be a question and answer session. This call is being recorded.

Good morning, and welcome to Rga's fourth quarter 2021 conference call. At this time all participants are in listen only mode. There will be a question and answer session at the end.

Please be advised that this call is being recorded request.

Holly Manning: I would now like to turn the call over to Holly Manning, Senior Director. Thank you, Operator. Good morning, everyone, and welcome to Agios' fourth quarter 2021 conference call. You can access slides for today's call by going to the Investor section of our website, agios.com.

I would now like to turn the call over to Holly Manning Senior director of Investor Relations.

Thank you operator, good morning, everyone and welcome to Rga's fourth quarter 2021 Conference call you can access slides for today's call by going to the investors section of our website at <unk> Dot Com with me on the call.

Holly Manning: With me on the call today with prepared remarks are Dr. Jackie Faust, our Chief Executive Officer, Dr. Sarah Gheuens, our Chief Medical Officer, Richa Poddar, our Chief Commercial Officer, Jonathan Biller, our Chief Financial Officer and Head of Corporate Affairs, and Dr. Bruce Carr, our Chief Scientific Officer, who will join for Q&A. Before we get started, I would like to remind everyone that some of the statements we make on this call will include forward-looking statements.

Today with prepared remarks are Dr. Jackie Fouse, our Chief Executive Officer, Dr. Sarah <unk>, our Chief Medical Officer, Richard <unk>, Our Chief Commercial Officer, Jonathan Biller, Our Chief Financial Officer, and head of corporate Affairs and Dr. Bruce <unk>, Our Chief Scientific officer, who will join for Q&A.

Holly Manning: Actual events and results could differ materially from those expressed or implied by any forward-looking statements as a result of various risks, uncertainties, and other factors, including those set forth in our most recent filings with the SEC and any other future filings that we may make with the SEC. With that, I will turn the call over to Jackie. Thank you, Holly.

Before we get started I would like to remind everyone that some of the statements. We make on this call will include forward looking statements actual events and results could differ materially from those expressed or implied by any forward looking statements. As a result of various risks uncertainties and other factors, including those set forth in our most recent filings with the SEC.

And any other future filings that we may make with the SEC with that I will turn the call over to Jacky.

Jackie Faust: Good morning, everyone, and thanks for joining our fourth quarter 2021 results call. As I reflect on 2021, I'm reminded of this time last year when we had just recently announced our decision to divest our oncology business and were in the thick of creating a plan for the next chapter of Agios focused solely on genetically defined diseases. Today, 12 months later, I'm astounded at what we've been able to accomplish together with our teams across all areas of the business, and I'm incredibly optimistic about the future that we are building towards.

Thank you Holly and good morning, everyone and thanks for joining our fourth quarter 2021 results call.

As I reflect on 2021 I'm reminded of this time last year. When we had just recently announced our decision to divest our oncology business and we're in the thick of creating a plan for the next chapter of our Geos focused solely on genetically defined diseases.

12 months later on the stay on that what we've been able to accomplish together with our teams across all areas of the business.

I'm incredibly optimistic about the future that we are building toward.

Jackie Faust: On the heels of our FDA approval of PyroKind last week, our commercial team is off to the races, engaging with physicians and educating on PK deficiency. Richa, who joins us for her first earnings call in her new role as chief commercial officer, will provide more insight into our commercial launch strategy.

On the heels of our FDA approval of powered Con last week, our commercial team is off to the races, engaging with physicians and educating on PK deficiency Richa, who joins us for her first earnings call in her new role as Chief commercial officer, who will provide more insight.

So our commercial launch strategy.

Jackie Faust: Our clinical team is moving full speed ahead, enrolling our thalassemia and sickle cell disease pivotal studies, while also working through start-up activities for our pediatric PK deficiency pivotal trials, the AG946 Phase I sickle cell disease cohort, and the AG946 MDS study. As always, our research organization continues to focus on the next wave of discovery and preclinical programs, which we laid out at our Investor Day back in November. Importantly, because our oncology business divestiture provided us with significant cash and a strong balance sheet that supports our near and long-term business strategy, we can remain focused on executing against our business priorities during a time when financial markets are volatile and uncertain.

Our clinical team is moving full speed ahead, enrolling our thalassemia and sickle cell disease pivotal studies, while also working through startup activities for our pediatric PK deficiency pivotal trials.

The aging non 46 phase one sickle cell disease cohort and the AG noncore six Mds study.

As always our research organization continues to focus on the next wave of discovery and preclinical programs, which we laid out at our Investor day back in November .

Fortunately, because our oncology business divestiture provided us with significant cash and a strong balance sheet that supports our near and long term business strategy. We can remain focused on executing against our business priorities. During a time when financial markets are volatile and.

Uncertain.

Jackie Faust: Last year we reduced our share count by more than 23% through our share repurchase program while retaining financial flexibility to accelerate programs in our pipeline and potentially pursue complementary business development opportunities that could arise. As we look ahead to this year, we're committed to continuing our track record of strong execution across research, clinical, and commercial. With that, I'll turn it over to Sarah. Thanks Jackie.

Last year, we reduced our share count by more than 23% through our share repurchase program, while retaining financial flexibility to accelerate programs in our pop line.

And potentially pursue complementary business development opportunities that could arise.

As we look ahead to this year, we're committed to continuing our track record of strong execution across research clinical and commercial with that I'll turn it over to Sarah.

Sarah Gheuens: The productivity of our clinical organization over the last year has truly been remarkable as we've completed two pivotal trials, initiated three others, advanced a new molecule into its first in-human study, begun startup activities for numerous other trials that will initiate this year, and submitted two regulatory files. I'll start with pyruvate kinase deficiency, where we are proud to be the first company to have created a treatment for this lifelong hemolytic anemia. Last week, the FDA approved PyroKind for the treatment of hemolytic anemia in adults with PK deficiency.

Thanks Jackie.

The productivity of our clinical organization over the last year has truly been remarkable as we've completed two pivotal trials initiated three others advanced a new molecule into its first in human study begun.

Startup activities for numerous other trials that will initiate this year and submit the two regulatory filings.

I'll start with pyruvate kinase deficiency, where we are proud to be the first complete who have created the treatment for this lifelong hemolytic anemia.

Last week, the FDA approved <unk> for the treatment of hemolytic anemia in adults with PK deficiency.

Sarah Gheuens: The label, which we reviewed in detail on our Approval Investor webcast, encompasses all genotypes and transfusion status. While this is a significant milestone for each of us at Agios, we know our work in PK deficiency is far from over. Our marketing authorization application for adult PK deficiency is under review in the EU and we remain on track to receive a decision from the EMA in the second half of 2022. In addition, our team is actively working through startup activities for two pivotal trials in pediatric patients with PK deficiency who are not regularly transfused and those who are regularly transfused. We expect Activate Kits and Activate Kit C to initiate in mid-2022.

The label, which we reviewed in detail on our approval investor webcast and come back with all genotype and transfusion status.

While this is a significant milestone for each of us at odds yields. We know are working PK deficiency is far from over.

Our marketing authorization application for adult PK deficiency is under review in the EU and we remain on track to receive a decision from the EMA in the second half of 2022.

In addition, our team is actively working through startup activities for two pivotal trials in pediatric patients with PK deficiency, who are not regularly transfused and those who are regularly transfused, we expect to activate and activate T to initiate in mid 2022.

Sarah Gheuens: A key priority for us is to continue to elucidate the burden of PK deficiency and understanding the long-term impact of treatment with pyrokines. At ASH in December, we were pleased to share new data that highlighted the maintenance of response for patients in the extension studies, as well as SpiroKind's ability to reduce iron overload and improve ineffective erythropoiesis. Our Adult PK Deficiency Extension Studies, as well as the PEAK Registry, are ongoing and we look forward to sharing additional insights from these trials at future medical meetings. Beyond PK deficiency, we believe PK activation has the potential to play an important role in the treatment of thalassemia and sickle cell disease.

A key priority for US is to continue to elucidate that the burden of PK deficiency and understanding the long term impact with treatment with cytokine.

At Ash in December we were pleased to share new data that highlight that the maintenance of response for patients in the extension studies as well acquire kinds of ability to reduce iron overload and improve ineffective erythropoiesis.

Our adult PK deficiency extension studies as well as the peak registry are ongoing and we look forward to sharing additional insights from these trials at future medical meeting.

Beyond PK deficiency, we believe speak activation has the potential to play an important role in the treatment of thalassemia and sickle cell disease.

Sarah Gheuens: At the end of last year, we initiated our two global placebo-controlled pivotal trials of pyrokines in thalassemia, ENERGIZE and ENERGIZE-C, as well as the Phase II portion of our Phase II-III study in sickle cell disease RISUP. The first patients have been dosed in all three trials and our team is focused on continuing global site activation and patient enrollment efforts. Our goal is to complete enrollment in the Phase II portion of RISEUP and enroll a meaningful portion of patients in ENERGIZE and ENERGIZE-T by the end of the year. At ASH, we share important new data in both disease areas. Notably, we presented the first extension data supporting long-term use of pyrokines in both alpha and beta non-transfusion-dependent thalassemia.

At the end of last year, we initiated our two global placebo controlled pivotal trial for <unk> in thalassemia energized and energized.

As well as the phase two portion of our phase II study in sickle cell disease right.

The first patients have been dosed in all three trials and our team is focused on continuing global site activation and patient enrollment efforts.

Our goal is to complete enrollment in the phase two portion of rise up and enroll a meaningful portion of patients who are energized and energized by the end of the year.

At Ash, we shared important new data in both disease area.

Notably we presented the first expansion data supporting long term use of prioritizing both Alfa and bet on non transfusion dependent thalassemia.

Sarah Gheuens: And our collaborators at the NIH shared a complete data set from the core periods of their phase one study, and our collaborators in the Netherlands shared the first analysis from their investigator-sponsored trial, including data on point of sickling. Together, these data continue to demonstrate that pyrokine has the potential to meaningfully impact these hemolytic anemia. Leveraging our pioneering expertise in PK activation, we're also advancing our novel PK activator HA946.

Our collaborators at the NIH shared the complete data set from the core periods over their phase one study and our collaborators in the Netherlands shared the first analysis from their investigator sponsored trial, including data on point of quickly.

Together these data continue to demonstrate the bioscience has the potential to meaningfully impact these hemolytic anemia.

Leveraging our pioneering expertise in PK activation, we're also advancing our novel PK Activator AG 906.

Sarah Gheuens: AG946 is currently being evaluated in a phase 1 study with a healthy volunteer component followed by a sickle cell disease component. We continue to enroll healthy volunteer multiple ascending dose cohorts and plan to initiate the sickle cell disease cohort in the first half of this year. At our IR day in November, we shared our plans to explore AG946 in anemia associated with low-to-intermediate-risk MDS. The Phase 2A trial will initiate by the end of this year. I will now turn the call over to Richa, our Chief Commercial Officer. Thank you, Sarah.

$89 six is currently being evaluated in a phase one study with a healthy volunteer component followed by a sickle cell disease component.

We continue to enroll healthy volunteer multiple ascending dose cohorts and plan to initiate the sickle cell disease cohort in the first tackle this year.

At our IR day in November we shared our plans to explore <unk> in anemia associated with low to intermediate risk Mds.

Phase II <unk> trial will initiate by the end of this year I.

I will now turn the call over to rich, our chief commercial officer.

Richa Poddar: It's an exciting time for the commercial organization as we launch our first therapy for a genetically defined disease. In the last week, our field team has been actively engaging with physicians and educating on the first approved treatment for thyroid kinase deficiency. As we laid out at our approval investor event, our commercial launch strategy focuses on disease education, raising awareness of the benefit of pyrokines for eligible patients, and ensuring patients that are eligible have access and can stay on therapy.

Thank you Sarah is an exciting time for the commercial organization as we launch our first tier b for genetically defined disease in the last week. Our field team has been actively engaging with physicians and educating on the first approved treatment for <unk> kinase deficiency as we laid out the approval investor than a commercial launch strategy.

Focuses on disease education, raising awareness of the benefit of Baidu <unk> for eligible patients and ensuring patients that are eligible have access and can stay on therapy. We believe that proximity what 1500 to 4000 people living with PK deficiency in the United States and we have focused our prelaunch educational efforts on the.

Richa Poddar: We believe there are approximately 1,500 to 4,000 people living with PK deficiency in the United States, and we have focused our pre-launch educational efforts on the diagnosis of PK deficiency. However, given that it is under-diagnosed, we believe we'll have a better understanding of prevalence as we get further into the launch. Having a treatment available provides a compelling reason for physicians to consider PK deficiency when diagnosing patients. Of these patients, we believe approximately 30% are currently diagnosed and 80% are adults.

The PK deficiency.

However, given that it is under diagnosed we believe we'll have a better understanding of prevalence as we get further into the launch having a treatment available provides a compelling reason for physicians to consider PK deficiency when diagnosing patients.

Of these patients we believe approximately 30% are currently diagnosed and 80% on Doug.

Richa Poddar: Once a patient is diagnosed with PK deficiency, they're able to join the myRGS patient support service for disease education and support. This service is available to all people living with pyruvate kinase deficiency, regardless of their treatment regimen. For patients prescribed Pyrokine, MyRGS also works with the patient and provider to ensure access, provide drug-related education, and support long-term adherence. A few things to highlight. For eligible commercially or privately insured patients, the program lowers a copay coinsurance deductible to $0.

Once a patient is diagnosed with PK deficiency, the EBIT to join the <unk> piece.

<unk> supports could disease education and support. This this is available to all people living with pyruvate kinase deficiency, regardless of their treatment regimen.

<unk> described hi, Mike.

<unk> also works with the patient and provider to ensure access provide drug related education and support long term adherence a few things to highlight.

Eligible commercially a privately insured patients the program lowers our copay coinsurance deductibles to zero. The prescription is process to a single specialty pharmacy to give patients a seamless experience.

Richa Poddar: The prescription is processed through a single specialty pharmacy to give patients a seamless experience. Patients are immediately connected to a MyRGS patient support manager who can help them navigate insurance questions and provide adherence resources to ensure a smooth start on Pyrokine. For eligible, uninsured, or under-insured patients, we will offer bridge and patient assistance programs, PAP. As we've said before, it will take approximately 12 months to achieve optimal coverage, and that can differ depending on the insurance provider.

That immediately connected to our <unk> patient support manager, who can help them navigate the insurance questions and provide adherence resources to ensure a smooth startup cytokine.

Eligible uninsured or underinsured patients.

Often also bridge and patient assistance program path.

As we've said before it will take approximately 12 months to achieve optimal coverage and back ended for depending on the insurance provider.

Richa Poddar: Commercial patients will make up the majority of the expected patient mix, and we expect that to be the fastest to achieve optimal coverage, with Medicare and Medicaid lagging behind. This is consistent with comparable rare disease products we have studied. Prior to formulary coverage, patients will need to navigate the medical exceptions process in order to obtain pyrokine, which typically takes about 6-12 weeks.

Moshe patients would make up the majority of expected patient mix and we expect that will be the fastest to achieve optimal coverage with Medicare and Medicaid lagging behind this is consistent with compatible red meat products. We have studied.

Prior to formulary coverage patients will need to navigate the medical exceptions process in order to obtain pilocarpine, which typically takes about six to 12 weeks.

Richa Poddar: Given these dynamics, we anticipate limited revenues the first few quarters. In addition to peer dynamics, we are also cognizant of the impact that the current pandemic conditions have on our team's ability to interact with physicians and patient comfort levels with seeking medical attention at this time. As you would expect, physicians are prioritizing direct patient care and the most acute situations, and our team has developed a thoughtful cadence of interaction with this in mind.

Given these dynamics, we anticipate limited revenues the first few quarters.

In addition to payer dynamics. We are also cognizant of the impact of the current pandemic conditions have on our team's ability to interact with physician and patient comfort levels with seeking medical attention at this time.

You would expect physicians are prioritizing direct patient care and the most acute situations and our team has developed a thoughtful cadence of interaction with this in mind.

Richa Poddar: Importantly, as our team has been in place for the past few quarters, we have established relationships and scheduled appointments with physicians who treat PK deficiency to ensure that we can engage in a timely fashion now that we have approval. Additionally, we are connecting with the patient community through social media channels, patient webinars, and close collaboration with the advocacy organizations, both to raise awareness of the approval of PyroKind and also to help provide support in terms of navigating the disease.

Fortunately as a team has been in place for the past few quarters, we have established relationships with scheduled appointments with physicians, who treat PK deficiency to ensure that we can engage in a timely fashion now that we have approval. Additionally, we are connecting with the patient community to social media channels patient Webinars and close collaboration with the advocacy.

Patients go to raise awareness of the approval of <unk> guidance and also to help provide support in terms of navigating the disease.

Richa Poddar: Importantly, our commercial strategy, our knowledge base, and the connections we've made will help set us up to success as we continue to expand the applicability of pyrokines to other genetically defined diseases. With that, I'll now turn it over to Jonathan to review fourth quarter financials. Thanks, Richa.

Importantly, our commercial strategy, our knowledge base and the connections. We've made will help set us up for success as we continue to expand the applicability of cytokine two other genetically defined diseases.

With that I'll now turn it over to Jonathan to review fourth quarter financial.

Jonathan Biller: Our full year and fourth quarter 2021 financial results can be found in the press release we issued this morning, which I will summarize. More detail will be included in our 10-K filing later today. As a reminder, our fourth quarter financial results discussion only includes our continuing operations on a comparative basis, which excludes results from our Digestive Oncology. Turning to operating, R&D expenses for the fourth quarter were $73.3 million.

Thanks, Richa, our full year and fourth quarter 2021 financial results can be found in the press release, we issued this morning, which I'll summarize more detail will be included in our 10-K filing later today.

As a reminder, our fourth quarter financial results discussion only includes our continuing operations on a comparative basis, which excludes results from our divested oncology business.

Turning to operating expenses R&D expenses for the fourth quarter was $73 $3 million and $257 million for full year 2021, an increase of $36 2 million compared to the full year 2020.

Jonathan Biller: $257 million for full year 2021, an increase of $36.2 million compared to the full year 2020. This year-over-year increase in R&D was largely driven by, Startup costs for pyrokine pivotal studies, including ENERGIZE, ENERGIZE-T, and RISEUP, offset by closeouts of ACTIVATE and ACTIVATE-T studies. FDNA and EMA regulatory files, and increased workforce spend across all of our, Selling General and Administrative Expenses were $31.5 million for the fourth quarter and $121.4 million for the full year 2021.

This year over year increase in R&D was largely driven by startup costs were Pi recline pivotal studies, including energize energized.

<unk>.

Offset by Closeouts with activate and activate T studies.

SG&A in GMA regulatory filings and increased workforce spend across all of our R&D.

Selling general and administrative expenses were $31 5 billion for the fourth quarter.

$21 4 million for the full year 2021. This represents a $6 $3 million increase over full year 2020, driven primarily by <unk> launch prep and disease education, including field sales build training and marketing.

We also recorded <unk> income from royalties of $2 6 million in the fourth quarter and $6 6 million for the full year 2021.

Which is included within the gain on sale of oncology business line items in our income statement.

We ended the quarter with cash cash equivalents in marketable securities of approximately $1 3 billion.

With this cash balance we expect to be able to execute on our current operating plan.

Major catalyst to cash flow positivity without the need to raise additional equity.

Jonathan Biller: This represents a $6.3 million increase. Full Year 2020, driven primarily by pyrokine launch prep and disease education, including field sales build, training and market, We also recorded TIPSOBO income from royalties of $2.6 million in the fourth quarter. $6.6 million for the full year 2021, which is included within the gain-on-sale of oncology business line items in our, We ended the quarter with cash, cash equivalents, and marketable securities of approximately $1.3 billion. With this cash balance, we expect to be able to execute our current operating, through major catalysts into cash flow positivity without the need to raise additional equity. With that, operator, please open the line for questions. Thank you. You may ask a question at this time. Press star, then one, or each.

With that operator, please open the line for questions.

Thank you to ask a question at this time please.

Operator: Draw your question. Press the pound, by where we compiled the Q&A. Our first question comes from Mark Fram with Cowen. Thanks for taking my questions. Let me just start off with Richa and the launch.

Please press Star then one on you touched on the telephone.

To withdraw your question press the pound key please standby, while we compile the Q&A roster.

Our first question comes from Marc Frahm with Cowen Your line is open.

Thanks for taking my questions.

Maybe just start off.

With <unk> and the launch.

Richa Poddar: You know, I understand the first quarter or two are going to be not very meaningful from a sales perspective itself. But what launch metrics are you really going to be looking at to gauge whether the launch is going well? And I guess most importantly to listeners here, you know, which of those metrics do you intend to? Inform Us. Yeah, hi, Mark.

I understand the first quarter or two youre going to be pretty not very meaningful from a sales perspective itself, but what metrics are you really going to be looking at.

To gauge whether the launch is going well and I guess, most importantly to listening to you which of those metrics do you do you intend to ask him.

Inform us about.

Richa Poddar: So the way to think about it is the three pillars that we've talked about in terms of what is important for launch success, which is informed by the patient and provider journey. So that includes like ensuring accurate diagnosis, getting patients on, eligible patients on paracrine, and then ensuring that they have access and are able to stay on therapy. So with that in mind, the way we are thinking about the launch metrics and what we think will be most useful is to show how the disease similarity is improving, because this is a severely underdiagnosed disease, how patients are getting on treatment in terms of the next sales for paracrine, and then in terms of the formulary coverage and how that's progressing, that's kind of how we intend to track it. So it is very much in line with how we set up the strategy so that you can see how launch is progressing over the next few quarters. Okay, thanks. That's helpful.

Yes, Hi, Mike.

So the way to think about it is <unk>.

Below that we talked about in terms of what is important for launch which is informed by the patient will provide air Jordan.

That includes like enjoying accurate diagnosis getting patients on eligible patients on pilot line and then ensuring that we have aqua.

<unk>.

It would just be on therapy. So we bought in mind and believe we are thinking about the launch metrics on what we think will be most useful institutional.

How the disease co modalities, improving because this is a severely underdiagnosed disease.

All patients are getting on treatment in Toms the.

Net sales for Bioscience, and then in terms of the pulmonary club bridge and how that's progressing that's kind of how we intend good traffic can be very much in line with how we set up the strategy. So that we can see how largest progressing over the next few.

Few quarters.

Richa Poddar: And then just recognizing that, you know, as you said in your comments, you know, COVID is having some impact on patients coming into clinics and things like that. Where do you think it is today in terms of, you know, how frequently the typical previously diagnosed PKD patient is coming into a clinic where, you know, now Medifibit may be offered to them? And kind of where do you expect that to go as hopefully COVID impacts decline? Yeah, so I, it's very variable, Mark.

Okay. Thanks, that's helpful and then just.

Recognizing that.

As you said in your comments Covid is having some impact on patients coming into clinics and things like that.

Where do you think it is today in terms of how frequently the typical peak.

Obviously diagnosed <unk> patient is coming into our clinic.

Now many of you that may be offered to them.

Do you expect that to go is hopefully COVID-19 .

Impacts decline.

Richa Poddar: So what we've seen over the past year and more when we've studied the disease and talked to patients, caregivers and providers, the symptoms for the disease can present itself at various points in time. So we've seen everywhere from like seeing their physician once a year to like seeing their physician more frequently if they are more regularly transfused. In terms of when they will see their physician, I think right now, given that there's an approved therapy, that's why the number one goal for us is to make sure that as many physicians as possible, as well as the broader patient and caregiver community, is aware that the drug exists so that patients that are already diagnosed are coming into their doctor's office and having the conversations about whether they are eligible for clarifying or not. So that's the goal right now and will continue to be the goal for the next few quarters.

Yes.

Betty variable model, so what we've seen over the past.

You're any more than that EBIT disease and occupation stagger between providers.

And then with symptoms of disease can present itself at various points in time. So we've seen everywhere from nice seasoned acquisition once a yes to like seen deposition more frequently they are more than <unk> skus.

In terms of when they will see their physician.

I think right now given that there's an improved quality about quite the number one going for us is to make sure that as many physicians as possible as well as a broader issue on peg if a community is a bad at the drug exists so that patients that are diagnosed.

And today Doctor's office and having the conversations about whether they are visible.

Richa Poddar: So we are taking a very holistic approach to ensure that that happens. So it's not just through in-person interactions, but we have the team prepared and they're already out there having those conversations, but also using a very robust social media digital approach so that we can create that surround sound to raise awareness around the disease as well as the availability of the product. Okay, thank you. Our next question comes from Anupam Rama with Morgan, your line is open.

So that's the goal right now and will continue to be the board for the next few quarters. So we had signaled that include a stick approach to ensure that that happens. So it's not just to in person interactions, but do you have the team to prepare and they're already out there having.

Those conversations but also using all debt.

Robust social media digital approach, so that we can create that carrabba's to either banner around the.

The reason why.

Availability of the product.

Okay. Thank you.

Thank you. Our next question comes from <unk> Rama with Jpmorgan. Your line is open.

Richa Poddar: Hey guys, thanks so much for taking the question and congrats again on the approval last week. I got a quick question. So what are you hoping to learn from the sickle cell portion of the Phase 1 946 study, given I think the focus is really on low intermediate MDS Phase 2, which is supposed to start later in the year? Thanks so much. Yeah, hi, this is Sarah.

Hey, guys. Thanks, so much for taking my question and congrats again on the approval last week.

I've got a quick question. So what are you hoping to learn from the sickle cell portion of the phase one.

Study given I think the focus is really on low intermediate Mds phase two which is supposed to start later in the year. Thanks, so much.

Sarah Gheuens: So in regards to the sickle cell disease portion, obviously, we're looking at any signal in the context of sickle cell disease, but also it applies to hemolytic anemia in general. And so that will give us a lot of optionality to decide what to do next, based on the phase one component of that trial in that context. And yes, of course, we're very excited about the MDS program. And that's the beauty of that phase one, because of the healthy volunteer study and the sickle cell disease component, it does allow us to move on to MDS, and it gives us a lot of optionality that way. Thanks for taking my question. Kenna McKay, Hi, thanks for taking the question and congrats again on the approval of PyroKind.

Yes, Hi, this is Sarah.

So in regards to the sickle cell disease portion obviously, we're looking.

Looking at any single in the context of sickle cell disease, but also it applies to hemolytic anemia in general and so that will give us a lot of optionality to decide what to do next based on the phase one component of that trial.

In that context, and yes of course, we're very excited about the Mds program and that's the beauty of that phase one because of the healthy volunteer study in sickle cell disease component that allows us to move on to Mds and <unk> gives us a lot of optionality that way.

Thanks for taking my question.

Okay.

Thank you. Our next question comes from Kennan Mackay will be seen capital markets. Your line is open.

Hi, Thanks for taking my question and congrats again on the approval of Pie returns for you.

Sarah Gheuens: Thinking about the expansion into sickle cell, can you maybe help us a little bit with what we should be looking for in that Phase 2 portion of the Rise Up study and really what that could inform for us? Thank you. Sure, so the RISE-UP study has two primary endpoints. One is focused on a hemoglobin response, and the other one is looking at a reduction in basal occlusive crises via sickle cell pain crises.

<unk>.

Expansion into.

Into sickle cell can you maybe help us a little bit.

What we should be looking for in that phase II portion of the rise up.

Study and really.

What that could inform price. Thank you.

Sure so.

The study has.

Two primary endpoints one is focused on the hemoglobin response and the other one is looking at a reduction in data occlusive crises.

Sickle cell pain crises.

Sarah Gheuens: So, the goal of this study is, of course, to provide a therapy that can, you know, hit on two components that are very important in this disease, which is both the hemolytic anemia component and the vasoclosive component, and the secondary endpoints also provide additional information on how patients feel and function. So, the way that trial is set up, it also gives us a lot of optionality in the different endpoints, and, well, obviously, we hope to provide a meaningful therapy for sickle cell disease after we get the results from RISUP. Sarah, I think that Kennan also wanted to know specifically what we're looking for from the Phase 2 portion of Rise Up that would then, Dovetail into phase three. Yeah, sure.

No.

The goal of this study is of course to provide a therapy that can.

You hit on two components that are very important in this disease, which is both the hemolytic anemia component and the base occlusive component.

And the secondary endpoints also provide.

Additional information on how patients feel and function. So the way that trial is set up it also gives us a lot of optionality in the different endpoints and.

Well, obviously, we hope to provide a meaningful therapy for sickle cell disease. After we get the results from <unk>.

Sarah I think Ken and also wanted to.

No specifically, what we're looking for from the Phase II portion of <unk> that would then.

Dovetail into phase III.

Sarah Gheuens: So for the Phase 2 specifically, it is, we're looking at safety and efficacy, efficacy as measured via a hemoglobin endpoint. There are in that Phase 2, two doses tested and placebo. And so it allows us to select the dose to move forward into Phase 3. Our next question comes from Alicia Young.

Yes, sure so for the phase II specifically it is we're looking at safety and efficacy efficacy as measured CIA hemoglobin endpoint.

There are in that phase two two doses.

And placebo and so it allows us to select the dose to move forward into phase three.

Thank you. Our next question comes from Alicia Young with Cantor Fitzgerald. Your line is open.

Richa Poddar: Cheryl Taylor, Hey guys, thanks for taking my question and congrats again on the MEDPIVA approval. So I guess my question is just a little bit, when you're reflecting on the oncology and divestiture, can you talk a little bit how you're thinking about business development right now and what opportunities you're seeing and what you think you might or may or may not need to do to add things to the pipeline, how do you think about diversifying that? You know, I guess, you know, obviously you've done the R&D day internally, but just, I guess more specifically, I mean, externally, thanks. Hi Alicia, it's Jackie.

Hey, guys. Thanks for taking my question and congrats again on the.

That approval.

So I guess my question is just a little bit when you were reflecting on the oncology and divestiture can you talk a little bit how you're thinking about business development right now.

Opportunities Youre seeing and what you think you might may or may not need to do to add pipeline. How do you think about diversifying that.

I guess, obviously, you've done the R&D day internally, but I guess more specifically enter I mean externally. Thanks.

Jackie Faust: I'll start and then others may want to jump in. I think one of the first things that I would point out is given the progress that we've made with our internal programs and the ongoing evolution of our insights into the biology of cellular metabolism, I think we have an even better idea today. And as other innovations may have... I think we see more with respect to potential complementarity of targets or mechanisms or ways that we could approach, moving some of our biological insights forward.

So while higher wages, Jackie I'll start and then others might want to jump in.

I think one of the first things that I would point out as given the progress that we've made with.

Our internal programs and the ongoing evolution of our insights into the biology of cellular metabolism, I think we haven't even better idea today and as other innovation may have.

Progressed outside of <unk>. So I think we will see more with respect to potential complementarity of targets where mechanisms are ways that we could approach.

Moving some of our biological insights forward. So I think that's one thing we've always at least.

Jackie Faust: So I think that's one thing we've always, at least here up to now, probably felt like our sweet spot for doing business development at Agios is on preclinical stage assets or early stage clinical assets, just given our scientific expertise as well as the expertise of our clinical development team, translational medicine, all that sort of thing. So that would typically be the stage that we would probably mostly be looking at, not that we would be opposed to doing later stage things, but I think that's where we probably add the most value.

Up to now probably felt like our sweet spot for doing business development at <unk> on preclinical stage assets. Our early stage clinical assets, just given our scientific expertise as well as the expertise of our clinical development team translational medicine, all of that sort of thing so.

That would typically be the stage that we would probably mostly be looking at not that would be opposed to doing later stage things, but I think thats, where we probably add the.

The most value from a therapeutic category standpoint, it's pretty clear that non malignant hematology.

Jackie Faust: From a therapeutic category standpoint, I think it's pretty clear that non-malignant hematology or classical hematology, as we call it, would be clearly an area that would be in our sweet spot, as well as other diseases of inborn errors of metabolism that I think we've learned even more about over the last few years with our research and discovery team, as well. So from a financial standpoint, those sorts of...

Sure.

Classical hematology as we call it would.

Would be clearly an area that would be in our sweet spot as well as other diseases of inborn errors of metabolism that I think we've learned even more about over the last few years with our.

Our research and discovery.

Yes.

As well so from a financial standpoint, those sorts of.

Jackie Faust: The deals that we think would probably be in our sweet spot would be totally manageable within the resources that we have, and we're working on a few things, and hopefully at some point we'll be able to talk about some of that, but we're quite keen to add to our pipeline with the complementary targets or mechanisms, and potentially partnerships with other companies in a variety of ways, including research partnerships. Thank you. Question comes from Greg Heron with Bank, Hi, good morning. Thanks for taking our questions. Just two quick ones on the launch.

Deals that we think will probably be in our sweet spot would be totally manageable within the resources.

We have and we're working on a few things and hopefully at some point, we'll be able to talk.

Talk about some of that but we're quite keen to.

To add to our pipeline with the complementary targets or mechanisms and potentially partnerships with other companies in a variety of ways, including research partnerships.

Thank you.

Our next question comes from Greg <unk> with Bank of America. Your line is open.

Hey, good morning, Thanks for taking our questions.

Just two quick ones on the launch.

Richa Poddar: First, what feedback have you gotten to this point from payers on the pricing that you announced last week? What does your research indicate as far as the enthusiasm for doctors to put their patients who are eligible on PyroKind, just trying to get an idea of what sort of trajectory we could expect once the launch is into full swing? Yeah, so a couple of things here.

First what feedback have you gotten to this point from payers.

Yes.

<unk> that you announced last week and then.

What does your research indicated as far as your enthusiasm for doctors to put their patients.

We're eligible on power kind of just trying to get an idea.

What.

What sort of trajectory, we can expect once you launch it into full swing.

Richa Poddar: So we've had peer conversations both prior to launch as well as post-approval as well, and they've been very positive. We came up with the price in concert, I should say, with having a very good understanding of both the disease, how it was valued in the context of the unmet need, and then how they value the clinical data, the context of disease. So we had all those conversations ahead of the approval so that we were coming up with a price that very much reflected the feedback that we had received from all sources.

Yes.

Couple of things. So we've had conversations both prior to launch as well as the court's approval as well and they've been very positive.

We came up with the price.

In con in concept I should say wait.

Having a very good understanding of both the disease, how it was valued in the context.

The unmet need and then how they value the clinical data the concept in disease. We had all those conversations ahead of the approval. So that we were coming up with a price that very much reflected.

The feedback that we have received from all sources.

Richa Poddar: So we've taken a very holistic approach to price. We've considered what our overall pricing and access philosophy is so we can both optimize access for patients that are eligible for treatment, but also ensure that we are continuing to invest in innovation. So in that context, the reception has been quite positive. So we are not anticipating significant pushback. I think the one thing that's worth mentioning and we've talked about before is that we have a very broad label, which we are very happy about. It's always better to have a broader label than not.

So we've taken a very holistic approach to pricing and today, what our overall pricing and access philosophy. So we can go to optimize access for patients that are eligible equal treatment, but also ensure that we are continuing to invest in innovation. So in that context. The reception has been.

Quite positive to be aligned.

Debating significant buschbaum will take the one thing that's worth mentioning and <unk> talked about before is that we did have do you have a very broad label, which we're very happy about it.

Not bad.

Richa Poddar: But we did exclude the double non-miscarriage patients, which is about 9% to 15%, as well as those patients that have a hemoglobin greater than 10 grams per deciliter. And both of these patient populations, because they were not included in our pivotal registration trials, there could be some payers that might restrict use in that particular patient population, although the label does allow for use in the broadest possible patient population of adults with PK deficiencies. So those are the conversations we are having. It would be very payer dependent, but the conversations have been quite positive.

We did exclude.

Non midtown patients, which is about 9% to 15% as well as those patients that are have a hemoglobin greater than 10 grams per deciliter and both of these patient populations because they were not included in our political registration trials, there could be some payers that mitral stripped.

And that particular patient population, although the neighborhood.

Now for use in the broadest possible patient population and also PK deficiency. So those are the conversations you're having.

We'll be about Epo dependent but the conversations have been quite positive.

Richa Poddar: As far as physicians are concerned, I think overwhelmingly positive. Again, both pre- and post-launch discussions, there hasn't been any treatment options. The first case of thyroid kinase deficiency was discovered in 1961, and all of the treatment options have been very much supportive in nature.

Acquisitions are concerned I think overwhelmingly positive again, both pre and post launch discussions there hasn't been any treatment options with the escape evaluate kinase deficiency was the top of the 961.

One is about treatment options have been very much supportive in nature, So you're clearly trying to control the symptoms.

Richa Poddar: So you're really trying to control the symptoms. This is the first and only approved treatment that's actually impacting the underlying cause of chronic hemolysis that you see with the disease. So we believe that they will trial it in the vast majority of their patients. Where some of the dynamics come in is in the context of peer reauthorizations, which we expect in the two- to six-month time frame.

First and only approved treatment that is actually impacting the underlying.

Cost of chronic hemolysis that you see with the disease. So we.

Believe that they will try that in the vast majority of the patients with some of the dynamics come in is in the context of Pov authorization, which we expect in the three to six month timeframe, but we expect physicians to try it for the vast majority of eligible patients which is about with pyruvate kinase deficiency.

Richa Poddar: But we expect physicians to trial it for the vast majority of the eligible patients, which is adults with thyroid kinase deficiency. Great, thanks for taking the question and congrats again on the approval. Our next question comes from Mark Bredenbach, Oppenheimer.

Great. Thanks for taking my question and congrats again on the approval.

Thank you. Our next question comes from Mark Breidenbach Oppenheimer. Your line is open.

Sarah Gheuens: Hey, good morning, and thanks for taking the questions. You know, since it really sounds like 2022 is going to be a year of patient accrual in the ENERGIZE and RISE UP trials, I just wanted to make sure we're not overlooking any upcoming clinical catalysts. So, should we be expecting any new clinical data from AG946 or maybe from the academic-sponsored studies of Minutepivot this year? And then the second question is really looking ahead to a potential launch of PyroKind in the EU.

Hey, good morning, and thanks for taking the questions.

Since it really sounds like 2022 is going to be a year of patient accrual in the energized and rise up Charles I just wanted to make sure we're not overlooking any upcoming clinical catalysts.

So should we be expecting any new clinical data for <unk> $9 six or maybe from the academic sponsored studies have made a pivot this year.

And then the second question.

Looking ahead to a potential launch of pirate claimed in the EU.

Sarah Gheuens: I'm wondering if you would consider a commercial partnership in Europe or partnerships in Europe, and also if you have a sense for how PKD patients are distributed in the EU, if there are any clusters of patients in specific territories or if they're kind of broadly distributed. Thanks for taking the questions. So I'll take the first question, this is Sarah, and then I'll hand it over to Richa for the second question.

I'm wondering if you would consider commercial partnership in Europe .

Our partnerships in Europe , and and also if you have a sense for how PKU patients are distributed in the EU. If there are any clusters of patients in specific territories or kind of broadly.

Attributed thanks for taking the questions.

I'll take the first question. This is Sarah and then I'll hand, it over to rich Sheffer the second question.

Sarah Gheuens: But in regards to the data catalyst... So we, you're right that we are very focused on execution for Energize and Rise Up right now. However, we will continue to communicate on the long-term extension data that we are continuing to gather on both for pyruvate kinase deficiency and for thalassemia at upcoming medical conferences. And that is actually really important because it does highlight a maintenance of response over time. It allows us to look at other signals that would take a longer time to appear, such as what we've just communicated at ASH around iron overload data.

In regards to the data catalysts.

No.

You are right Scott, we are very focused on execution for energizer and rise up right. Now. However, we will continue to communicate on the long term extension data that we are continuing to gather on.

Both for pyruvate kinase deficiency and for thalassemia.

Medical conferences and that is actually really important because it does highlight our maintenance of response over time. It allows us to look at.

Other signals that would take a longer time to appears to chassis.

Just communicated at ash around iron overload data, so things like that we will continue to to communicate on but you are right. It's a big year for us on the execution of our Super excited about that so more to come.

Sarah Gheuens: So things like that we will continue to communicate on. But you're right, it's a big year for us on execution and we're super excited about that. So yeah, more to come.

Sarah Gheuens: And then to address your Europe question. Sure. No, please, go ahead.

And then can you just sort of question.

Sure go ahead.

Yes. Please go ahead.

Richa Poddar: Yes, so to address your Europe question, so in terms of timelines, right, we filed in June of last year, so we are anticipating approval towards the end of this year. And then with the way the pricing and reimbursement environment works in Europe, it would take about 12 to 18 months before all of that is sorted. We are committed to patient access and ensuring that patients that need access to our therapy have the ability to do so. So we're evaluating all of our options in terms of how best to do that outside of the U.S. And we continue to maintain that building a commercial infrastructure at the U.S. is not the best approach.

Yeah, so to address your question.

The timeline <unk> filed in June of last year.

Anticipating approval towards the end of the CLO and then we believe the pricing and reimbursement environment in Europe . It will take about 12 to 18 months before Alibaba assorted.

We are committed to patient access and ensuring that patients that need <unk> be happy, but if you do so although we are evaluating all of our options in terms of how best to do that outside of the U S. And we continue to maintain that building a commercial infrastructure from the U S is not the best approach. So we are looking for Bob knows it could be a partner on Michael.

Richa Poddar: So we are looking for partners. It could be a partner or multiple partners, as you talked about, but we have a little bit of time to make some of those decisions as things evolve. And then with regards to the patient population, it's quite similar to the U.S. in that we don't really see clusters per se. There are some centers of excellence, but for the most part, the patient population is not concentrated in any one area. Okay, that's super helpful.

Bob could you talk about that if you are a little bit of time to meet some of those decisions.

As things evolve.

And then with regards to the patient population is quite similar to the U S and that you don't really see plus goes both ways.

<unk> bought some centers of excellence, but for the most part the patient population.

It's not concentrated in any one area.

Okay. That's super helpful. Thanks for taking my questions.

Thank you. Our next question comes from Savi <unk> Richter with Goldman Sachs. Your line is open.

Richa Poddar: Thanks for taking the question. Our next question comes from Salveen Richter with Goldman Sachs. Hey, thanks for taking the question. This is Matt on for Salveen.

Hey, Thanks for taking the question this is Matt on for solving.

Richa Poddar: Could you just elaborate a little bit on the pricing strategy for Purikind and Fickle Cell? And then also expand on patient eligibility if only one primary endpoint is met. Thanks a lot. Okay, so we have, so Sarah talked about before, we have two primary endpoints in the sickle cell program. One is hemoglobin, and the other one is the analyzed rate of renal exclusive crisis, right?

Could you just elaborate a little bit on the pricing strategy for <unk> in sickle cell and then also expand on patient eligibility if only one primary endpoint as Matt. Thanks, a lot.

So we have since that I've talked about before we have two primary endpoints in the sickle cell program on one is hemoglobin and the other one is the annualized rate of renal piece of crisis rates.

Richa Poddar: So it's two primary endpoints. We believe that if we hit both of those primary endpoints, it gives us a very compelling and competitively differentiated profile because the available treatments today only allow you to, only address one of the two primary challenges with the disease. So we have a lot of options once it comes to the data and how we think about pricing associated with that. So we think about sickle cell as optionality for us.

Stuart Permian going to believe that.

If we hit both of those primary endpoints.

This is a very compelling and competitively differentiated profile because the available treatments today only allow you to only address one of the two primary challenges. So we have a lot of options. When it comes to the data on how we think about pricing associated with that so.

Think about the Codell as Optionality for US, we have to wait and see what the data shows.

Richa Poddar: We have to wait and see what the data shows, and depending on what the data shows will determine how we think about pricing overall. We take a very similar approach to pricing in sickle cell that we have with PCD, which is a very holistic approach. We'll talk to the broader community, look at the data, show them the data, see how they evaluate the data in the context of the season, then make some decisions. If we only hit one of the primary endpoints.

Depending on what the data show is really with them and how we think about pricing, but we take a very similar approach to pricing as that goes out that we have with <unk>, which is a very holistic approach, we will talk to the broader community.

Look at the data show them, the data and see how they evaluate the need on the conduct of the fever, and then make some decisions.

Only had one of the primary endpoint.

Richa Poddar: Hemoglobin, for example, we could consider maintaining the price that we have for PKD and TAO, and then just go for a salvage patient population. But again, given the size of the patient population and the overall value creation, we still think it would be positive overall, even if you have to take a price that across all three indications. And if we have the full data package, then we again have another, we have a different option of considering how we want to think about price.

Hemoglobin for example, we could consider maintaining the price that we have for GBM.

Then just go for a positive patient population, but again, given the size and the patient population and the overall value creation, we still think it'll be positive overall, even if you have to take a price silica oncology indications.

And as we have before data pockets when we again have another rehab a different option considering how we want to think about price, but overall because lots of optionality have to wait and see what the data suggests one take a holistic approach to determining what the best approach to pricing.

Richa Poddar: But overall, sickle cell, lots of optionality, have to wait and see what the data suggests and then take a holistic approach to determining what the best approach to pricing would be. Great, thank you. Exactly, I mean, I think, I just wanna make sure this is like abundantly clear, right? When you're coming to market with a drug where you potentially can have multiple indications over time, these label expansions, it's always better to start with the rarest disease and then make your way through those potential label expansions because it gives you more flexibility on how you deal with price over time.

Great. Thank you.

Yes, I mean, I think I just wanted to make sure. It is abundantly clear Ryan.

When you are coming to market with a drug where you potentially could have multiple indications overtime. These label expansions, it's always better to start with the rarest diseases and then make your way through those potential label expansions because it gives you more flexibility on how you deal with price overtime, so were totally comfortable with.

Richa Poddar: So we're totally comfortable with where we are in PKD and how, based on the totality of the clinical data for each indication as they play out, we would deal with that price over time. So we have a lot of flexibility in that regard.

We are in PK and how based on the totality of the clinical data for each indication as they play out we would deal with that.

Price over time, so we have a lot of flexibility in that regard.

Got it thank you.

Thank you.

Our next question from Danielle Brill with Raymond James Your line is open.

Richa Poddar: Got it, thank you. Thank you. Question from Danielle Brill with Raymond James, Yolanda... Hey guys, it's Madison, all for DENIA.

Yes.

Hey, guys this medicine for Danielle.

Richa Poddar: I was just wondering if any patients have been prescribed the drug yet. I believe last week you said it would probably take about two weeks, for our distribution to play out, so just seeing if any changes to that. Thanks. Yes, so we've been having interactions. As a reminder, we just got approved on Thursday, right? So it's early still, but lots of positive interactions with payers and physicians. You're right, drugs will be in channel in two weeks or within two weeks, but it doesn't impact physician prescribing behavior per se, but from a payer dynamic standpoint, reimbursement will take about 6 to 12 weeks early on till the drug gets on formulary. Lots of positive momentum.

Just wondering if any patients have been prescribed the drug yet I believe last week, you said it would probably take about two weeks.

For distribution to play out so just seeing if any changes to that.

Thanks.

Yeah. So we've been having interactions as a reminder, we just got approved.

So it's early still but lots of positive interactions with payers and physicians, you're right, Doug Libyan channel in two weeks.

Within two weeks.

But it doesn't impact physician prescribing behavior per se, but from a payer dynamics that going reimbursement would take about six to 12 weeks or the onto the jump off point honestly.

Richa Poddar: Physicians are excited and patients are too about having this treatment option available. Great, thanks guys. Thank you. Our next question comes from John Neumann.

But lots of positive momentum physicians excited in patients onto about having this treatment option available.

Great. Thanks, guys.

Thank you. Our next question comes from John Newman with Canaccord Your line of business.

Sarah Gheuens: Hi, guys. Good morning. Thanks for taking my question. Just had a question on the dose titration for pyrokine. Obviously, this is nothing new.

Hey, guys. Good morning, Thanks for taking my question.

Just had a question on the dose titration for pirate kind. Obviously this is nothing new we've known about this you've done a nice job establishing.

Sarah Gheuens: We've known about this. You've done a nice job establishing the dose profile in your pivotal studies. Just curious if you think that the titration might have any effect on adoption, or is this simply something where because of the severity of the disease and the lack of available therapies and the physician's experience, it's probably not likely to have much of an effect? Thanks. Yes, hi, this is Sarah.

The dose profile and your pivotal studies just curious if you think that the.

Titration might have any effect on adoption or is this simply something where because of the severity of the disease.

<unk> of available therapies and the physician experience.

It's probably not likely to have much of an effect. Thanks.

Sarah Gheuens: So exactly the last part, what you mentioned is what we've heard, right. So we haven't seen any problems or issues with this dose titration in our clinical trial program. And indeed, the hematologists are pretty used to having medications in which they have to do a dose titration with, you know, a variety of methods. So this is actually a pretty straightforward dose titration schedule.

Yes, Hi, this is Sarah so exactly the last part.

You mentioned this what we've heard right. So we haven't seen any problems or issues with this dose titration in our clinical trial program and deeper hematologists are pretty used to having medications in which they have to do a dose titration with a variety.

Method. So this is actually pretty straightforward dose titration schedule. So we haven't heard any concerns.

Sarah Gheuens: So we haven't heard any concerns. Okay, thank you. Yep, we'll come. Thank you. And I'm currently showing no further questions at this time.

Okay. Thank you.

Okay.

Thank you and I'm currently showing no further questions at this time I'd like to turn it back over to Jackie Fouse for closing remarks.

Operator: I'd like to call back over. Thank you very much. Thanks, Operator. Thank you, everyone, for all of the great questions this morning. As always, I would like to end by thanking my Agios colleagues for their dedication and passion for making a difference for patients. We're extremely excited about the approval of Pyrokind and PKD. I also want to thank all of the patients, caregivers, and physicians who partner with us in so many ways, and especially those participating in our clinical trials across all of the indications. We couldn't do this, and we wouldn't be here without patients, caregivers, and physicians. Our connections across, Thank you everyone for joining us today. Thank you everyone, have a wonderful day.

Thank you very much.

Thanks, operator, and thank you everyone for all of the great questions. This morning, as always is that we'd like to end by thanking my <unk> colleagues for their dedication and passion for making a difference for patients. We're extremely excited about the approval.

Power Condon TKD I also want to thank all of the patients caregivers and physicians, who partner with us in so many ways and especially those participating in our clinical trials across all of the indications. We couldnt do this then we wouldn't be here without.

Patients caregivers and physicians are connections across.

And I'm sorry, it looks like we've lost Jackie at this time.

Thank you everyone for joining US today. This concludes today's conference call everyone have a wonderful day you may now disconnect.

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