Agios Pharmaceuticals Inc (AGIO) 2021 Q2 法說會逐字稿

Good morning, and welcome to Agios Second Quarter 2021 Conference Call. (Operator Instructions) Please be advised that this call is being recorded at Agios' request. I would now like to turn the call over to Jessica Reninkan, Director of Corporate Communications.

Thank you, operator. Good morning, everyone, and welcome to Agios Second Quarter 2021 Conference Call. You can access slides for today's call by going to the Investors section of our website, agios.com.

With me on the call today with prepared remarks are Dr. Jackie Fouse, our Chief Executive Officer; Dr. Chris Bowden, our Chief Medical Officer; Darrin Miles, our Chief Commercial Officer; Jonathan Biller, our Chief Financial Officer and Head of Legal and Corporate Affairs; and Dr. Bruce Car, 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. 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.

Thanks, Jesse. Good morning, everyone, and thanks for joining our second quarter 2021 financial results call. We are pleased to report another quarter of strong progress at Agios, the first full quarter since the close of the sale of our oncology business to Servier. The team is focused, energized and excited for the future as we continue to advance our pipeline in genetically defined diseases led by mitapivat across its 3 initial indications in hemolytic anemias.

We achieved significant recent milestones with the submission of our NDA for mitapivat in adults with Pyruvate kinase deficiency in June as well as with the submission of our MAA to the EMA the same month. We look forward to working with the FDA and EMA as they complete their reviews.

With these 2 filings, we are 1 step closer to delivering the first potentially disease-modifying therapy for people with Pyruvate kinase deficiency. These regulatory submissions are supported by strong Phase III data from the ACTIVATE and ACTIVATE-T studies. Full results from both were recently presented at the European Hematology Association, or EHA Virtual Congress in June.

Our preparations for the commercial launch of mitapivat in PK deficiency continued to advance, and we remain on track for anticipated approval and launch in 2022. In addition, we would like to extend our congratulations to the Pyruvate Kinase Deficiency Foundation and the Thrive with Pyruvate Kinase Deficiency Organization both of which recently launched as the first 2 U.S.-based advocacy organizations dedicated to PK deficiency. Both organizations are patient-led and it's very exciting to see how this community has coalesced and the momentum they are gaining in raising awareness and advocating for those living with this disease.

Beyond PK deficiency, we are also making excellent progress with the late-stage development of mitapivat in thalassemia and sickle cell disease. At EHA, we presented positive results from our Phase II open-label study of mitapivat in adults with nontransfusion-dependent alpha or beta thalassemia. These data continue to validate the potential of PK activation as an entirely new mechanism for treating thalassemia and represent the first clinical data generated in alpha thalassemia patients.

We remain on track to initiate our 2 registrational Phase III trials, ENERGIZE and ENERGIZE-T in not regularly transfused and regularly transfused adults with thalassemia, respectively, this year. In sickle cell disease, we also remain on track to initiate a pivotal Phase II/III trial of mitapivat by the end of the year.

Beyond mitapivat, we are building on our expertise in PK activation and cellular metabolism and are advancing our earlier-stage research programs in genetically defined diseases to position us for sustainable growth and momentum. In the fourth quarter, we plan to host an Investor Day to share more information about our commercial launch planning for mitapivat and PK deficiency and talk more in detail about our research and development pipeline.

Before I turn the call over to Chris to provide an update on our clinical development programs, I wanted to take a moment to share that Chris has decided to retire from his role as Chief Medical Officer at Agios after a terrific 7 years on our leadership team. After a transition period to his successor over the coming months, I'm very pleased that Chris will remain part of our team as a strategic adviser through at least the end of 2022. We are excited for him in the interest of this new chapter of his life and want to thank him for his leadership and many years of service at Agios.

Among his many accomplishments and contributions, he oversaw the build-out of our medical and clinical development organizations, acted as Agios' lead medical representative internally and externally, navigated complex regulatory interactions in order to bring important drugs to patients and played a key role in the evolution of our organization and culture. He has been an integral part of our team, and his work will continue impacting the lives of patients for many years to come. On behalf of everyone at Agios, I wish Chris all the best in the future.

I'm equally excited to announce that Dr. Sarah Gheuens, who has up to now served as our Head of Clinical Development for genetically defined diseases will assume the role of Chief Medical Officer effective September 1. Sarah has been with Agios for almost 2 years and has been an impactful and energizing leader across the organization during her tenure.

Among Sarah's most significant accomplishments at Agios. She played an integral role in the work associated with the PK deficiency filings and the design and strategy for our sickle cell disease pivotal programs. She knows all aspects of our programs inside and out and has a genuine passion for serving people with genetically defined diseases. Prior to Agios, Sarah held roles of increasing responsibility at Biogen in safety and risk management, medical affairs and clinical development, and she is a urologist by training. We look forward to continuing to see great things from her as she takes on this new level of responsibility.

With that, I will now turn the call over to Chris.

Thanks, Jackie. As Jackie mentioned, we are excited about the potential we have to impact the lives of individuals with genetically defined diseases. We achieved important milestones for both Agios and the PK deficiency community this past quarter with the submission of our global regulatory filings for mitapivat in the U.S. and EU.

We're pleased to share that our MAA has pass validation, which triggered the start of the MAA review procedure. For the NDA, the FDA has 60 days from submission to determine whether the application is accepted. So we expect to hear from them in mid-August. Information about whether the application is accepted, whether mitapivat has been granted priority review and the PDUFA date will all be communicated by the agency at that time.

Overall, we are very pleased with our progress and believe we have significant momentum as we look to a busy second half of 2021. At EHA, we presented full data from the ACTIVATE and ACTIVATE-T Phase III studies evaluating mitapivat in adults with PK deficiency who are not regularly transfused and those who are regularly transfused, respectively. Both studies met their primary and secondary endpoints, including patient-reported outcomes that address symptom burden and quality of life impact of PK deficiency. Mitapivat is generally well tolerated and the safety profile observed in both studies was consistent with previously published data.

During our EHA investor event, we also heard from Dr. Andreas Glenthøj, who highlighted the significant impact PK deficiency has on patients' quality of life, the limitations of the current PK deficiency treatment landscape and the potential for mitapivat to serve as the first disease-modifying therapy for these individuals.

Moving to thalassemia. We also presented data at EHA on all 20 patients in the core period of our Phase II study of mitapivat in nontransfusion-dependent alpha and beta thalassemia. Consistent with previously announced proof-of-concept data, the study met its primary endpoint with 16 of the 20 patients achieving a hemoglobin increase or greater than or equal to 1 gram per deciliter from baseline at 1 or more assessments during weeks 4 through 12.

In addition, a sustained hemoglobin response and improvements in hemolysis and ineffective erythropoiesis were observed in both alpha and beta thalassemia patients treated with mitapivat. Mitapivat was also well tolerated with the safety profile consistent with previous studies. We believe these results underscore the potential of mitapivat to meaningfully improve hallmarks of thalassemia, including hemolysis and ineffective erythropoiesis.

We are also excited to see data generated for the first time in alpha thalassemia, demonstrating an increase in hemoglobin from baseline in all 5 patients in this subgroup. Our 2 global placebo-controlled pivotal trial of mitapivat in thalassemia, ENERGIZE and ENERGIZE-T are on track to initiate this year as we continue the process of submitting these trial protocols globally and prepare sites for enrollment.

Now turning to sickle cell disease. We remain on track to initiate our pivotal Phase II/III clinical trial by the end of this year. The Phase II/III study of mitapivat in sickle cell disease will include patients who are 16 years of age or older, have had between 2 to 10 sickle cell crises in the past 12 months and have hemoglobin within the range of 5.5 to 10.5 grams per deciliter during screening.

The Phase II will randomize 69 patients 1:1:1 to 50 milligrams mitapivat twice daily, 100 milligrams mitapivat twice daily or matched placebo. The primary endpoint in the hemoglobin response defined as greater than or equal to 1 gram per deciliter change from baseline to week 12. And the data will be used to establish a clear dosing paradigm for the Phase III portion. Phase III, which will commence after the Phase II analysis, will randomize 198 patients 2:1 to the selected Phase II dose of mitapivat or matched placebo. The study will have 2 primary end points. Hemoglobin response defined as greater than or equal to 1 gram per deciliter change from baseline to week 52 and a reduction in annualized rate of sickle cell pain crises.

We believe the design of this Phase II/III study minimizes risks to the approval path for mitapivat in this challenging disease and maximizes the likelihood of a label with a broad indication. In addition, we continue to work with our collaborators at the NIH and the University of Utrecht on their studies of mitapivat in sickle cell disease. Data from both studies are expected to be submitted for presentation at ASH in December.

At the NIH, Dr. Chen has completed enrollment in the core study with 17 patients and continues to enroll the extension study. We anticipate the data sets at ASH will provide additional efficacy, safety and translational data that supports the clinical development of mitapivat in people with sickle cell disease. Beyond mitapivat, we're also advancing our next-generation PKR activator, AG-946 in a Phase I healthy volunteer study. The trial began enrolling last year and we expect to submit data for presentation at ASH.

Our analysis of the totality of the AG-946 healthy volunteer data will inform next steps for the clinical development of this molecule. As part of our investor event this fall, we will talk in more detail about our research and development pipeline. Before I turn it over to Darrin to discuss our commercial activities, I want to thank all of my Agios colleagues for the privilege of working with you over the last 7 years. It has been so rewarding and fun and the accomplishments speak for themselves. My successor, Sarah Gheuens, is poised to lead our team to more great accomplishments, and I look forward to watching the Agios story continue to unfold. Darrin?

Thank you, Chris. We continue to make strong progress on commercial launch preparations for mitapivat in PK deficiency. All customer-facing and patient support infrastructure and talent are hired and fully trained. Our field team comprised of both sales representatives and credentialed nurse clinical educators are now fully engaged with physicians, potentially managing patients with PK deficiency across the U.S. and are focused on profiling accounts, raising disease awareness and executing patient support and profiling plans through disease education.

An important feature of their work is educating physicians on the availability of the Agios-sponsored genetic testing service, Anemia ID. With now well over 1,000 test kits requested, we expect Anemia ID to become an increasingly important program to help support patients seeking a definitive diagnosis of their hemolytic anemia and aid in accelerating our PK deficiency patient profiling efforts.

Our market research now shows that 70% of responding physicians routinely order additional diagnostic test for their patients with hemolytic anemias of unknown etiology. This is an important insight, which favorably pertains future adoption of genetic testing for accurate diagnosis of hemolytic anemias, including PK deficiency.

Response to the Anemia ID program has been very enthusiastic. And our research responding physicians indicated they are inclined to test a significant portion of their patients with hemolytic anemia of unknown etiology based on the breadth of mutations included in the panel and its relative ease of use.

In June, we also launched the reimagined myAgios patient support service dedicated to people living with PK deficiency and their caregivers, leveraging our learnings and much of the technical infrastructure from the oncology myAgios program while incorporating insights from PK efficacy patients and clinicians to create a customized program designed to meet the specific needs of this community. Enrolled patients and caregivers are connected with a dedicated and clinically trained patient support manager to provide ongoing tailored support, educational resources and opportunities to connect with other patients and caregivers in the PK deficiency community.

Amongst other educational efforts, our field team is educating physicians and their staff on the availability of the service and how they can support patients with enrollment. Following the disclosure of the ACTIVATE and ACTIVATE-T findings at EHA in June, we fielded new market research to update our insights into general physician awareness and understanding of PK deficiency and the potential implications for disease management, assuming mitapivat's approval next year.

We found that PK deficiency disease awareness metrics are improved over the same time period in 2020, with 85% of academic and community physician respondents now familiar with PK deficiency. And more than half indicating that they manage 1 to 2 previously diagnosed PK deficiency patients. This is encouraging because it indicates that physicians are increasingly recognizing and diagnosing PK deficiency, which we intend to continue to support with additional educational activities in the months leading up to approval in 2022.

Our research also suggests that based on their understanding of the Phase III data, many physicians will consider prescribing mitapivat to PK-deficiency patients with different levels of disease severity, including with respect to transfusion history and hemoglobin level. While prescribing will be based on individual patient history, presentation and parameters of the approved label for mitapivat.

We are encouraged by these responses and the overall increase in physician understanding of the burden of disease. Overall, we're very pleased by the progress we've made with launch preparations across each function of Agios and the response from the treatment community to the broad disease education efforts. We expect this to accelerate in the coming months now that we have our full complement in the field and has excitement about what we'll be able to do for patients growth related to the ACTIVATE disclosures.

Now I'll turn it over to Jonathan to review second quarter financials.

Thanks, Darrin. Our second 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-Q filing later today. As a reminder, our second quarter financial results discussion only includes our continuing operations on a comparative basis, which excludes results from our divested oncology business.

Research and development for the second quarter was $62 million, an increase of $7.9 million compared to the second quarter of 2020. The year-over-year increase in R&D was driven primarily by start-up costs associated with the Phase III studies of mitapivat in thalassemia and sickle cell disease and the filing of our NDA and MAA for mitapivat in PK deficiency as well as our launch preparation efforts.

Selling, general and administrative expenses were $29.2 million for the second quarter, essentially flat compared to SG&A expenses for the second quarter of 2020. We also recorded $2 million in TIBSOVO income from royalties in the second quarter of 2021, which is included within the gain on sale of oncology business line item in our income statement. We ended the quarter with cash, cash equivalents and marketable securities of approximately $1.7 billion.

With this cash balance, we expect to be able to execute our current operating plan through major catalysts and to cash flow positivity without the need to raise additional equity. In Q2, we executed a $529 million of the up to $1.2 billion of share repurchases authorized by our Board of Directors, inclusive of the shares acquired from Bristol-Myers Squibb.

Specifically, we repurchased just under 10.5 million shares at an average price of $50.41 reducing our total shares outstanding by approximately 15% to 59.9 million shares at quarter end. As previously disclosed, the 10b5-1 plan we put in place in early Q2 provides for maximum additional share repurchases of approximately $415 million through year-end. The ultimate amount of additional share repurchases through year-end will depend upon the volatility of our share price over this time period.

Operator, please open the line for questions.

(Operator Instructions) Our first question comes from Alethia Young with Cantor Fitzgerald.

Congrats on all the progress. I wanted to talk a little bit about mitapivat and maybe just as you're doing some of the education for patient support. How frequently do these people kind of see their physicians? And like what kind of outreach and effort needs to be done there? Or is it more just kind of like a structural warehousing effect? Or is it actually a work that needed to be done to bring these people back under care?

Alethia, this is Darrin. The issue is not going to be necessarily getting patients to come back in because they're usually under -- for those who have been diagnosed and obviously attached to a physician, they're under some sort of monitoring plan, right? Those with more severe disease are going to see their physicians more regularly. Those with less severe disease, will have a little longer -- typically will have a longer time span between physician visits. But remember, they're continuing to have their iron load monitored, hemoglobin monitored. So the frequency of physician visits isn't necessarily where we want to -- where we would focus.

I think what we're doing now is focusing on the patient profiling, identification and physician education and patient education on the disease. And I think that's where we need to continue even post launch to focus much of our efforts. The physician patient relationship should be fine and we don't need to -- there's nothing there that we need to delve into. We just need to make sure that they're aware. And once that's done, I think everything else flows from there.

Our next question comes from Kennen MacKay with RBC Capital Markets.

First off, Chris, I'm sorry to hear about your departure, but looking forward to meeting your successor, Sarah. And glad to hear that you're staying on into next year with the transition. Maybe one quick question on the regulatory filings here for mitapivat, wondering which branch of the FDA you are interacting with those regulatory submissions in PKD, is that hematology or the rare disease division?

Kennen, this is Chris. The FDA teams that we're working with are on the cardiology, renal and the oncology, hematology divisions. The submission itself is in the cardiology renal. So it's an interesting setup actually because the people who've been most involved with us and are most active on the submission are on the hematology division.

That is just what I was going to sort of follow up with and just wonder around some of the interactions so far, is that division sort of up to speed on rare diseases and PKD? Or what have the interactions to date been like?

The group, the team that we've been working with FDA has been with the program for -- has been advising us and interacting with us since I joined the company. So they're very well acquainted with the disease and the special nature of what it takes when you're in a rare disease population. So I don't have any concerns there. And I think the consistency -- and I think, importantly, over the years, as you've heard us talking about the guidance and why we've designed the trials we have in an effort to provide them as much data as they're going to need to make a decision for us to demonstrate clinical benefit has been a consistent group of people

Our next question comes from Anupam Rama with JPMorgan.

Perhaps a broader strategic question. I think many of us on the street, we model a price cut for mitapivat longer term to account for the SCD indication. What threshold of peak sales in SCD does mitapivat have to meet in your view to justify a price cut versus say, maximizing the value of the product by keeping ultra-orphan pricing.

It would be premature to talk about what peak sales would be in sickle cell. What I can tell you is that it would require assuming you just wanted to at least breakeven, right, as you move from the first 2 indications and it's a sickle cell, then you account for a cut. What we think would be required would only require less than 4%, 3% share in that market to be able to at least break even across the whole program. So it doesn't take a whole lot because the size of sickle cell is significant for you to be able to accommodate that cut. That's why we're so optimistic about the incremental value, right, that we would be able to gain once we move into sickle cell despite competition.

And it's Jackie. I'm just going to jump in real quick. As we said many times, but I think both Chris and Darrin have said this often, it's -- we'll make those pricing decisions based on the totality of the clinical data that we have at that point in time and the product profile, of course. So you can imagine there's a lot going on when you think about that with respect to hemoglobin increase, VOC reduction, all the secondary endpoints and the patient reported outcomes and all of that. So lots of things to think about when we make that pricing decision at some point in the future

Our next question comes from Salveen Richter with Goldman Sachs.

This is Elizabeth on for Salveen. Could you just remind us if you intend to launch simultaneously in both the U.S. and EU for mitapivat and PKD? And then knowing that you're sort of discussing this at your Investor Day in 4Q. Maybe if you could just comment on the structure and size of the launch team and your progress in terms of identifying more patients and then how many patients with PKD have been identified to date?

Got you. All right. This is Darrin. There's a lot in there, so let me see if I can unpack that. Let me start with the structure question first. So as I mentioned in our prepared comments earlier, we fully hired our internal and external teams, right? That's about just under 20 representatives -- sales representatives and then a small contingent of nurse educators that will collaborate with them and that's for the U.S. team. For the EU, the -- as we've shared previously, we've got boots on the ground there already, right? So we have an MSL team that's established, and then we have a small group of experts that have been dedicated to building awareness and extending or advancing our patient profiling efforts in each of the major markets in the EU. And we continue to do the work, particularly on the critical path activities to ensure that we will be able to launch mitapivat in the EU shortly after approval.

But we've also shared that we're evaluating a number of options, right, considering the opportunity to be able to engage with a partner who's got a footprint that already exists in the EU and hopefully, outside of -- beyond the EU given the amount of value for mitapivat that extends -- patient value that extends beyond the major markets that can overlay mitapivat or include mitapivat in their existing infrastructure. And that's where we've been focusing our efforts. So the idea is keep things moving to enable a launch, particularly in Germany, where you can launch immediately with adequate repricing. And then -- but also be able to then transition that work to a potential partner once we find the sort of deal that we believe fairly reflects the value that mitapivat will bring.

Great. And then maybe if you could just comment on the patient identification efforts and the patients identified to date.

Yes, yes. Yes, so we continue to do the work behind what we refer to as patient profiling efforts, right, being able to identify more patients. We previously shared that we've identified about 1,000 patients between the U.S. and the EU. And that's inclusive of pediatric patients, patients that are enrolled in our various clinical programs as well as patients, incidental patients that we come across as we're engaging with physicians. And it's an important number that I know everyone wants to hear more and more about, but -- and we do keep on top of that. That's not where I would focus though because particularly as we move closer to the launch here in the U.S., what you really need to do is be able to then attach each of those patients who are identified to us, right?

So when we don't know their personal -- they're identifying information. But you want to be able to attach them to an individual physician, you want to make ensure that they're getting tested, see if the physician is inclined to use Anemia ID to confirm the diagnosis even further. And then we've also made our patient support program available in the last month. And ideally, those physicians would then see value in referring their patients to the programs. And that helps you to get a better sense of the absolute confirmed patient population here in the U.S. So that's where we're focusing our efforts, right? Continuing to advance the diagnostic differential and get those patients the appropriate support that they need, get them the education that they can -- that myAgios can provide, which then will lead us up to and through the approval.

Our next question comes from Michael Schmidt with Guggenheim Securities.

This is Kelsey Goodwin on for Michael. Maybe actually building off of that in a bit. I guess, going forward, how do you kind of see the rate and slope of the PKD diagnosis kind of evolving as you continue these efforts. I guess what kind of assumptions do you kind of build in over the next near term, long term of this launch?

Yes. We have some indication from what we were observing with Anemia ID, which is still in its early days. And some indication from the Spanish IST, screening IST that reported about, I think about 20% of those hemolytic anemia patients that were screened that ultimately were diagnosed with PKD. We get a good sense for what your diagnosis rate may end up being amongst those patients who are tested, particularly those patients who have -- are diagnosed with hemolytic anemia of unknown etiology. The -- that I'm less -- I'm not concerned about that in terms of the ramp for the launch because I think we continue to -- we're doing everything that we need to do to facilitate testing.

I expect we'll see that accelerate now that we have a full contingent in the field to help educate practices and our myAgios support educate patients. The thing I am -- that's outstanding for me, and I think we're focused on better understanding is what the access profile will look like, particularly in those first 6 to 9 months of launch, right, where we know that for a number of payers, you're going to have a new-to-market block that will require physicians seeking medical exception. And that will then extend the time between when you're diagnosed and when you ultimately -- when treatment is ultimately made available to the patient.

So the demand, and we have this confirmed in our recent quantitative work, the demand is going to be there. So we have the desire to be able to treat broadly for these patients. We've got all the programs in place like Anemia ID, the work that we shared with you last time on 23andMe, to help increase overall awareness drive, support patients and having better testing options available to them. And then -- so the script, the opportunity for the patient to receive the treatment, I think, is going to be high. The question is, is the amount of time in those first months for the physicians to be able to work through the access challenges.

Our next question comes from Mark Breidenbach with Oppenheimer.

Congrats on the forward progress. And Chris, of course, we're sorry to see you go as well. I'm just wondering with regard to the pivotal trial in sickle cell disease, if you can comment on what the main gating items are that remain before this trial can be initiated. And in terms of the academic sickle cell trials with data that we might see later this year, can you maybe give us a sense for how many patients to expect from the Utrecht trial? And just remind us the main differences between this study and the NIH study.

Okay. It's Chris here. The -- launching any of the Phase III -- in thalassemia in the Phase II/III study, the global studies, the protocols are written and finalized and now we're in that heavy lift of operationalizing the studies. And that's a whole list of activities that involve regulatory agencies, sites, CROs. And in addition to the protocol, there's all the logistics that come with setting up your IVRS, that is your randomization systems, setting up all the translational medicine laboratory assays, how those things are going to flow. So it's a very complicated series of activities that are -- some of them can run -- many of them run in parallel. But in each individual country and within each individual country at individual sites, you're contracting and going through just a number of activities.

So there are too many to name, but it's a well-described and well acknowledged that it's a complicated series of activities that our team has done several times now successfully and it takes some time to get everything up and running. The key piece that we're focused on in all of that is identifying sites that have patients throughout the world. These will be global studies and to really look to everything we can do to make the trials accessible for patients and have maximum terminal velocity. So the first patient in is very important and the last patient now is perhaps even more important. So that's that piece and that's one of the fun things about doing this job.

And the second piece in terms of the sickle cell, the Utrecht study will enroll up to 10 patients. That group is very skilled and well known in terms of their ability to look at both red cell metabolism as well as using the oxygen scanner to look at point of sickling and other components that are important biomarkers in the sickle cell area. That trial starts patients at 20 milligrams and then they can go to 50 milligrams and then go up to 100 milligrams. And then they're on study for at least a year. So that's different from the NIH study, where that was -- the NIH study was the first study in adults with sickle cell disease, where they started at 5, 20, 50 and then they made the amendment to 100. So it's a total of 8 weeks of treatment and then there's this taper and then patients who are willing and able, can then go into an extension.

So I think there's a lot of similarities in terms of understanding the important endpoints that we've talked about and you get a sense of efficacy and safety from both. The Utrecht study, I think, gives you immediately over time, some further understanding of chronic dosing that the NIH study doesn't give you quite immediately because those patients are on 8 weeks of therapy. And then we'll definitely get more long-term data from patients who go into the extension, but we don't know yet how many of those patients that -- at the end of the day, going to be. So I'll stop there.

Okay. Super helpful. And just a very quick follow-up. Is the Phase II/III going to be inclusive of African trial sites?

Yes.

We have a question from Danielle Brill with Raymond James.

I guess, first, can you remind us what your expectations are for an ADCOM meeting and maybe what your internal expectations are for priority review. And then, Darrin, I wanted to clarify something from your prepared remarks, excuse me. Did you say that your market research indicates 70% of providers already order genetic testing for anemia of unknown etiologies or that they would like to?

Let me answer the second one, and then I'll leave the room for Chris to be able to answer you on the first. So the 70% number refers to the proportion of physicians who are routinely ordering more tests to try to be able to get to a more definitive diagnosis for those patients who are diagnosed with hemolytic anemia but of unknown etiology, right? Which means that they're inclined to either order enzyme test or a genetic or a genetic panel or both, which some may do reflexively. And the reason why I mentioned I provided that insight is because then it means that we have a highly receptive audience then to Anemia ID and give us an indication of what further uptake will look like, particularly now that we've got more folks out there educating the community about it. So with that, let me turn it over to Chris.

Your question was with regards to priority review for the Pyruvate kinase deficiency submission, right?

Yes.

Yes. So we'll find out the FDA review on that, their decision 60 days from when we file. So that should be some time in the August time frame, middle of August or so.

Okay. And I guess...

Sorry. We lost you.

What are your thoughts on advisory from the meeting?

On ADCOM, too early to tell. You -- sometimes you get some signals early on, but we're early in the stage yet, so it's too early to know.

Thank you. And there are no other questions in the queue. I'd like to turn the call back to Jackie Fouse for closing remarks.

Thank you, operator, and thank you, everyone, for the questions this morning. As we move into our very bright future as a transformed Agios, we look forward to seeing a meaningful difference in the lives of patients with genetically defined diseases, starting with our potential launch in PK deficiency next year. I would like to thank my Agios colleagues for their dedication and passion for making a difference for our patients. I also would like to thank all of the patients, caregivers and physicians who partner with us in so many ways.

And today, a special thanks to Chris, we will have more interactions with him, I'm sure with you all over the next couple of months. We're very, very happy and pleased that he's willing to stay engaged with us at Agios through the end of 2022, at least as a strategic advisor because we'll continue to benefit from his wisdom and insight. So thank you very much, Chris, and we look forward to a few parties over the next couple of months before your next chapter. Thank you, everybody, for joining us today. You may now disconnect. Take care.

This concludes today's conference call. Thank you for participating. You may now disconnect.