Kendra Adams - Senior Director, IR and Public Relations David Schenkein - CEO Chris Bowden - CMO Andrew Hirsch - CFO Scott Biller - Chief Scientific Officer.

Eric Schmidt - Cowen and Company Anupam Rama - J.P. Morgan Kennen MacKay - RBC Capital Markets Alethia Young - Credit Suisse Unidentified Analyst - Goldman Sachs Michael Schmidt - Leerink Partners Yatin Suneja - SunTrust Robinson Humphrey.

Good morning and welcome to Agios' Third Quarter 2017 Conference Call. At this time, all participants are in a listen-only mode. There will be a question-and-answer session at the end. Please be advised that this call is being recorded at Agios' request.

I would now like to turn the call over to Kendra Adams, Senior Director, Investor and Public Relations..

Thank you Shannon. Good morning everyone and welcome to Agios' third quarter 2017 conference call. You could access slides for today’s call by going to the Investors section of our website, agios.com. With me on the call today are Dr. David Schenkein, our Chief Executive Officer, who will review key business updates and milestone for 2017; Dr.

Chris Bowden, our Chief Medical Officer, who will provide an update on our clinical development activities; Andrew Hirsch, our Chief Financial Officer, who will summarize Agios third quarter 2017 financial results; and Dr. Scott Biller, our Chief Scientific Officer will join for Q&A.

Before we get started, I’d like to remind everyone that 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 the Risk Factors section of our most recent Form 10-Q filed with the SEC and any other filings that we may make with the SEC.

In addition, any forward-looking statements made on this call represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to update or revise any forward-looking statements. With that, I'll turn the call over to David..

Thanks Kendra and good morning everybody and thanks for joining us today. Our third quarter accomplishments demonstrate focused execution across our IDH and PKR development programs as well as IND preparations for AG-270, our most advanced research program.

We're on track to achieve all of our remaining 2017 milestones including the NDA submission for our wholly owned IDH1 inhibitor ivosidenib.

The August approval and launch of IDHIFA for patients with IDH2 mutant relapsed refractory AML validates our precision medicine approach and completes the speed component of our speed and breadth strategy for IDHIFA.

Our team is incorporating important learnings from the IDHIFA regulatory review process into the ivosidenib NDA including a combined CR+CRh end-point and transfusion data.

Next month at the American Society of Hematology Meeting in Atlanta we will prevent new data in relapsed refractory AML patients from the expansion cohort of the Phase 1 trial that support the NDA. In addition we are excited to share ivosidenib and enasidenib frontline AML combination data for the first time at ASH.

Early data from these Phase 1 trials reinforce ongoing efforts at Agios and Celgene to advance the IDH inhibitors into the newly diagnosed setting. In total three Agios led abstracts from our IDH program and one from PKR have been accepted for presentation at ASH.

The abstracts will be available online later this morning and Chris will highlight key components of our planned presentations in his remarks. Turning now to our ongoing development of AG-348 in pyruvate kinase deficiency.

With the AG-348 pivotal design finalized the team is focused on global operational preparations to begin enrolling patients in the first half of 2018. In addition we are planning to initiate a global patient registry in pyruvate kinase deficiency to increase understanding of the long-term disease burden from this chronic anemia.

Chris will outline our plans in further detail later in the call. As we head into year-end we remain on track to submit the IND for AG-270, our molecule for the potential treatment of MTAP-deleted tumors. The necessary pre-clinical work is complete and supportive of our IND submission.

If accepted AG-270 will represent the sixth IND to come from the Agios Research Labs in less than nine years. I will now turn it over to Chris to provide an update on our clinical programs. .

Thanks David. I'm excited to highlight several important clinical data sets from our IDH and PKR programs that have been accepted for presentation at ASH next month. I will start by reviewing the three ivosidenib abstracts. First, updated clinical data from the Phase 1 trial and relapsed refractory AML will be featured in an oral presentation.

We are pleased that the single agent ivosidenib data you have seen an abstract this morning are consistent with data presented on the IDH inhibitors to date. With significantly more patients and longer follow up ivosidenib continues to demonstrate terrible remissions for IDH1 and mutant patients with advanced AML.

The efficacy analysis will focus on the 125 relapsed refractory AML patients from both the dose escalation and expansion portions of the Phase 1 trial. All 125 patients were treated at a dose of 500 milligrams once daily with a minimum of six months follow up prior to the May 2017 data cutoff.

A combined CR+CRh end-point where H stands for hematological improvement is included in our efficacy analysis in order to capture the clinical benefit patients are deriving outside of the pure CR. These data formed the core of the efficacy analysis for our planned NDA submission.

At ASH we will prevent additional data from the Phase one trial using the same May 2017 data cutoff. These include transfusion independence, overall survival, mutational burden data, and preliminary efficacy and safety data in treatment naive AML and MDS patients.

Both Phase 1 frontline trials combining ivosidenib or enasidenib was 7+3 or VIDAZA have also been accepted for oral presentations. The primary objective of these studies is to establish the safety and tolerability combining full dose ivosidenib or enasidenib with full dose 7+3 or VIDAZA.

The early data is encouraging and validate our existing and planned late stage efforts in the front line setting. As we disclosed earlier this year we have cleared the safety hurdles to combine full dose ivosidenib with azacitidine which led us to initiate the AGILE Phase 3 trial comparing ivosidenib and VIDAZA to VIDAZA alone.

We are also in the planning stages of a Phase 3 study combining ivosidenib and 7+3 for patients eligible for induction consolidation chemotherapy and we expect to update you on that study early next year.

Moving to the solid tumor setting I will now review our ongoing work in Cholangiocarcinoma and then provide an update on next steps for our Glioma program. Translational data for ivosidenib in Cholangiocarcinoma was presented last week at the AACR-NCI-EORTC triple meeting.

The data demonstrated the treatment with ivosidenib induces morphologic and molecular changes in a subset of IDH1 Mutant Cholangiocarcinoma patients and appears to be associated with increased progression free survival. We expect to further explore the biological and clinical significance of these findings in future studies.

We continued to open a new trial sites and enroll additional patients into Phase 3 clarity study and previously treated IDH1 mutant Cholangiocarcinoma. Enrolment remains on track to complete in 2019.

Turning now to Glioma, you have heard us mention this is an indication where we have the potential to help a large number of patients who are diagnosed at a relatively young age and currently rely on surgery, radiation, and chemotherapy as treatment options.

Today we are showing the next step for this program, a perioperative study which I will describe shortly. The decision to conduct this study prior to designing a pivotal trial is based on the data we have to date on our two potential molecules in this indication, Ivosidenib and AG-881.

The first AG-881 preclinical data were presented last week at the triple meeting and demonstrated the molecule can suppress 2HG in brain tissue in animal models. As we have previously mentioned we observe the dose limiting toxicity with AG-881 in the phasal [ph] and solid tumor study.

We have now completed additional dose expansion and exploration work and have selected a dose to bring forward. We plan to present the Phase 1 data in 2018.

For ivosidenib updated Phase 1 Glioma data will be presented at the SNO Meeting later this month and we will focus on the subset of low grade Glioma patients with non-enhancing disease that we presented at last year's meeting with longer follow-up and additional volume metric imaging data.

The data demonstrated ivosidenib continues to be well tolerated in this patient population and the median treatment duration has increased meaningfully since our last update.

In order to finalize our Glioma pivotal trial plan including molecule selection we will conduct a perioperative or window study with both ivosidenib and AG-881 to further investigate their effects on brain tumor tissue.

The study is designed with the following objective, to determine the amount of drug penetration in the brain, to confirm the magnitude of IDH2 target engagement as measured by 2HG levels in brain tumor tissue. To assess the impact of IDH inhibition on differentiation in epigenetic profiles in tumor tissue and to assess the safety of both molecules.

The study will include approximately 45 low grade Glioma patients with progressive disease. Patients will be randomized to either ivosidenib or AG-881 and treated for four weeks prior to surgery. An addition of five patients will serve as a control arm.

We expect to initiate the study in the first half of 2018 and we'll provide additional details at that time. Celgene has informed us that they will not be sharing the cost for the AG-881 component of the perioperative study. Celgene continues to co-fund the ongoing Phase 1 development.

In conjunction with this work we will also seek regulatory input next year that will help us design a pivotal trial in Glioma. I will close by reviewing our progress in pyruvate kinase deficiency. Updated data on all 52 patients enrolled in dry PK study will be presented in a poster session at ASH.

The ASH presentation will focus primarily on additional follow-up now that the six month core dosing period is complete for all patients. Updated data from the natural history study conducted by Boston Children's Hospital will also be at ASH.

With the natural history study fully enrolled our team has been preparing to launch a global patient registry to develop a greater understanding of the long-term clinical implications of pyruvate kinase deficiency including natural history of this chronic anemia, current treatments and associated outcomes, variability of clinical care, and disease burden.

In addition a patient reported outcomes will be implemented for the registry. Pyruvate kinase disease registry is set to open in the first half of 2018 and will include approximately 60 sites in 20 countries. Adult and pediatric pyruvate kinase deficiency patients are eligible and will be followed for at least two years.

We are also finalizing the trial protocols and patient recruitment efforts for the global AG-348 pivotal program. We will update you with additional details around timelines once these trials have initiated in the first half of next year. I will now turn the call over to Andrew to cover our financials. .

Thanks Chris. I will start by summarizing our third quarter financial results you can find in the press release we issued this morning. More details will be included in our 10-Q filing later today.

The IDHIFA launch is off to a strong start and I'm pleased that for the first time we're reporting revenue for an approved product that was discovered and developed by Agios. Revenue for the third quarter of 2017 was $11.4 million which included $10.7 million of collaboration revenue and $715,000 of royalty revenue from net sales of IDHIFA.

Revenue for the comparable period in 2016 was $9 million all of which was collaboration revenues. The third quarter year-over-year increase in collaboration revenue was due to approximately $900,000 in reimbursement by Celgene for the Agios U.S.

co-commercialization effort for IDHIFA and approximately $800,000 in progress against existing deliverables under our Celgene research collaboration. Research and development expense during the third quarter of 2017 was $73 million compared to $61 million for the same period in 2016.

The growth in R&D expense was primarily driven by increased costs related to the ivosidenib program including NDA submission costs and clinical trial activity. Third quarter R&D expense also increased on year-over-year basis as a result of IND enabling activities for AG-270 and ongoing research efforts across our discovery platform.

General and administrative expenses were $17.5 million for the third quarter of 2017, an increase of approximately $6 million from 2016 driven by increased expenses to support our growing commercial infrastructure for the launch of IDHIFA and potential launch of ivosidenib in 2018.

Turning to our cash position and runway guidance, we ended the third quarter with cash, cash equivalents, and marketable securities of approximately $642 million. In our press release this morning we reiterated our cash guidance that our current run rates through at least the end of 2019. With that operator please open the lines for questions..

[Operator Instructions]. Our first question comes from Eric Schmidt with Cowen and Company. You may begin..

Thanks for the question and congrats on all the progress. Maybe just starting with the ASH updates on the front line indications for IDHIFA and ivosidenib, what sort of response rate would you point us to as sort of standard of care response rate for either 7+3 or VIDAZA in these respective populations? Thanks. .

Yeah, good morning David here. Thanks for your question. I'm going to have Chris walk you through that and then we can talk further about it..

Eric it is Chris Bowden here. Good morning. I think when you think about 7+3 and that is in patients who are eligible for induction consolidation therapy, you want to think about it from the perspective of relatively younger patients and older patients. And in younger patients you can see CR rate is higher, somewhere in the 60% to 70% range.

I'll give you another reference which is the midostaurin approval where you're adding midostaurin to 7+3 and flip through the positive population and then CR rate was 54% for the 7+3 for the control group.

VIDAZA, one of the best controls -- historical controls is a study called the 001 study that was conducted in Europe and there VIDAZA was compared to -- the investigators had a choice of standard of care to give and the CR rate there was 19.5%.

So I think that gives you a general sense in the two populations what one can expect with current standards.

And we think that one of the reasons why we added 122 in both of these approaches is because there is a significant unmet need there in a way that improved outcomes and the purpose of the trials that we're going to be presenting I really don't understand feasibility..

And at the time of the ASH meeting will you be able to talk about a path forward including a registration design?.

So, Eric as you know, this David, we have the ongoing VIDAZA Phase 3 study, the AGILE study and certainly at ASH we will have an event and we'll give you an update as you know we've said that we're in the planning stages for a potential 7+3 registration study and we will try and give you an update there. .

Okay, and maybe just one more question if I may, just on IT side, I don't know what you're able to say given you're not controlling the commercialization but can you speak to the Q3 sales figure, did it include any stocking, do you have a sense of the slope of the adoption curve going forward and whether maybe you've learned anything that you could apply to ivosidenib in the future? Thanks very much..

Yeah, Eric this is Andrew, I will take that one. So it is a little bit early in the launch to comment. As you properly pointed out Celgene is the commercial leader, really it'll be up to them to determine what to communicate. So we're not really going to communicate much around that. We will be guided by their communications..

Okay, thank you. .

Thanks Eric. .

Thank you. Our next question comes from Anupam Rama with J.P. Morgan. You may begin. .

Hey guys, thanks so much for taking the question. With the pivotal trial designs for PKD program outlined, can you talk a little bit about the gaining factors given to you initially in the trial and if regulators have provided any sort of geographic breakdown in terms of the enrollment that they would like to keep? Thanks so much..

Yeah Anupam, David here. As we have said on the last call or so we're really pleased that the regulatory input we've had on both sides of the pond has allowed Chris and his team to complete the design of the two pivotal studies.

And really at this point as Chris said in his prepared comments it's really operational now where we are getting all the sites identified and all the operational aspects to open up two pivotal studies. I think it's fair to assume the regulators will not dictate what sites we open in what parts of the world.

But these will both be global studies in enrolling patients around the world. So right now the teams are cracking moving forward and we are looking forward to get these opened as quickly as we can..

Okay, thank you for taking my question. .

Thank you, our next question comes from Kennen MacKay with RBC Capital Markets. You may begin. .

Hey, thanks for taking my questions and congrats on the progress over the years, over the last couple years and the recent launch of IDHIFA. Just wanted to I guess start quickly with a question on the sort of gating factor for launching a trial of IDHIFA in combination with VIDAZA.

You have mentioned getting through sort of a safe and well really a sort of safe dosing in combo with VIDAZA enabling the start of the Phase 3 trial there for ivosidenib, but is that the gating factor for IDHIFA as well?.

Hey Kennen it is Andrew. So just if you recall Celgene is now the lead with IDHIFA and they control all commercialization and development. So that's really something that they will have to comment on what their plans are. .

Got you, and then thinking about the trial in combination with 7+3 again is safety sort of the gating factor for starting the Phase 3 there, are you really waiting to see more what kind of improvements you can have on top of the response rate from the CR rate there and then also just wanted to get your perspective if there was any consideration for combining with Vixio [ph] in the front line and I know it's sort of an early launch from just there but they'd guided to sort of a $10 million to $20 million 2017 number for that product and so it seems like it could be off to a pretty strong start, just wanted to get your perspective there?.

Thanks Kennen, David. I'll start with the first question and Chris take on the Vixio [ph] and maybe other novel therapy questions. So there's no question that if you look historically at combining novel therapies with aggressive chemotherapy like 7+3 followed by consolidation, safety is clearly the key initial gating factor.

And as you know on a previous call we announced that we had shown that we can combine full dose ivosidenib with full dose of 7+3. And so that is an important gating factor. Again that is primarily the gating factor, there are a lot of operational issues and so we will give you an update when we're ready to talk about how that moves forward.

But if you look at midostaurin trial you know there was no impact on CR rate with the addition of midostaurin be a source of idle advantage. So safety really is critical. Obviously we look at the early efficacy as well.

And then the other important factor is given the compelling single agent data we've seen with both ivosidenib and enasidenib, so now you're combining active 7+3 with another active drug and that makes us very optimistic about thinking about planning that study. Let me have Chris talk about novel combinations..

So, Ken and I think that the way I think about this is we've talked about speed rather than part one of breadth is standard of care combination approaches.

Part 2 is now thinking about how we can combine IDH inhibitors with what is really exciting to us at Agios for patients which is the number of new drugs that we've seen coming into the armamentarium for patients with AML whether it has been at a class or Vixios as you mentioned midostaurin now.

So that's going to be a really interesting challenge for us and we're certainly thinking about various ways of how we approach this both from not just a clinical development scenario but also in terms of how you operationalize the trials because you can do these from investigative response to trial, you come up with the cooperative group, you can do company sponsored studies.

So these are the things that we're considering as we get ready to -- as we are in the planning stages of thinking about how to activate this base of clinical development, still more to come there. .

Got you, thanks David and Chris. If I can squeeze in just one more question on the perioperative Glioma study. I guess this -- I thought you resolved some of the brain penetration challenges that have AG-120 which historically could have given AG-881 sort of an advantage there.

But I guess just wanted to hear a little bit more of sort of the rationale for the head-to-head trial of 120 versus 881, why not if you're paying for the trial why not trial 120 essentially against the placebo there?.

So Kennen, Chris again. I would think about this a little bit if you will all about our cholangiocarcinoma data.

So we have got over the years we have presented safety and efficacy data and then recently -- well, initially we presented a little bit of molecular data and then recently we presented more molecular data at the triple meeting in cholangiocarcinoma.

We would like to do the same thing with both drugs in Glioma and it is not so easy to -- we can't measure 2HG in the -- patients with Glioma. So in order to make a molecule selection which is the important component because we want to bring the best molecule forward that has the highest probability of improving outcomes for patients with the disease.

So using a placebo of one drug might cause us to put one drug aside. So while 881 has been optimized for brain penetration pre-clinically we really want to understand the two drugs in the scenario of the clinical setting where we're going to test them ultimately in a pivotal trial.

So that's why it's important to do that comparison to understand what their impacts are in 2HG genetic profiles and some of the other components that I spoke to in my remarks.

Because I think that there's a lot of -- there's a lot of questions around brain penetration and we really need to understand how 881 and 120 may be differentiated from each other. .

Kennen let me just add one thing, so as Chris said in his prepared remarks there will be some patients in that trial who are not getting either drug that will be used essentially as control. .

Oh, got you. Okay, thank you.

And that is just IDH1 mutant patients or IDH2 mutant patients eligible for the 881?.

It is one only, IDH1. That is the vast majority of patients who have Glioma..

Thank you again for taking my questions..

Thank you, our next question comes from Alethia Young with Credit Suisse, you maybe begin..

Oh hey guys, thanks for taking my questions. Congrats on the progress.

Maybe for me just, can you talk a little bit about your expectations around PKD enrollment to get the 80 to 100 patients, maybe there's some sort of precedent we should think about? And then also on the MTAP program, just curious kind of to delve a little bit more into the scientific hypothesis around what tumors that should work and just so that we can frame how to think about maybe over the next 12 to 18 months when you start to generate data from that program? Thank you..

Yes, so maybe I will tackle the PKD because we really can't say too much about enrollment at this time obviously and now I will turn it over to Scott to talk about MTAP. Obviously this is a rare disease. We have a lot of experience with dry PK.

The key initial factor is getting these sites around the world through the regulatory authorities and getting these sites opened. Obviously as Andrew has mentioned previously we have colleagues now working for us around the world identifying patients, we have the natural history study.

So we are going to do everything we can to enroll this as effectively as we can. But this is a rare disease and we need to make sure that we find these patients and we will do that. Scott maybe you can talk a little bit about MTAP..

Sure, so the MTAP program is basically deleted tumors, tumors that have this gene deleted and both the wheels are susceptible to the inhibitors we've created. And they're found in about 15% of -- these deletions are found in about 15% of all tumors not evenly distributed.

For example a very high percentage of glioblastoma has MTAP deletion and some other tremors we are interested in is esophageal cancer, lung cancer, DOBCL as well as pancreatic cancer has a high percentage of deletions of MTAP.

So, we haven’t discussed at all what the initial trials will look like but suffice it to say we will focus only on patients that have this MTAP deletions in both glios [ph]. .

Thank you, our next question comes from Terence Flynn with Goldman Sachs. You may begin. .

Hey guys this is Jason for Terence. The PKD program, can you talk a little bit about your plans to address the younger population, I mean the plan to take forward a lower dose of 348 or maybe develop a second gen drug? Thanks. .

Yeah, thanks Jason, David here. As we have talked about before obviously our first goal is to get AG-348 approved around the world for adults not the majority of the patients with this disease. But we do have a commitment to try and move this into pediatrics and help these children as well.

As you know in the pivotal study we're exploring a much lower dose of AG-348 than we did in dry PK and the initial dose is a tenth of what we have used in dry PK.

So we'll need to understand what the aromatase data looks like which as you know was pretty mild in adults and the question is what will it look like at this much lower dose and will that allow us to move into pediatrics. If not do we bring another molecule forward given the strength we've had in our chemistry portfolio around this target.

So more to come over time but our focus right now is to get the pivotal studies up and running in adults..

Alright, thanks.

And then just a quick follow-up on OPEX cadence, so with the IDHIFA launch you have a little ramp in OPEX for this year but is the 4Q OPEX run rate something that we could maybe use going forward for 2018?.

Yes, this is Andrew. I mean we typically we haven’t provided guidance so I think we will obviously be expanding our commercial effort right now or are sized to just co-promote which is about a third of the field effort when we moved to launch our [indiscernible] we will have complete ownership of that commercialization effort.

And so we would -- I would expect that to increase over 2018 as that comes into place..

Alright, got it, thanks. .

Thank you, our next question comes from Michael Schmidt with Leerink. You may begin. .

Hey guys, thanks for taking my question.

I just had one more on the Phase 1 trial of the IDH inhibitor in combination with 7+3 in AML and I guess my question is, I was wondering if you could comment some more on the considerations on dosing, I mean just asking because the chemotherapy center of care has a very complex dosing schedule including consolidation, induction consolidation, maintenance phases, potential transplant, I was just wondering how you see the IDH to be potentially used in combination and what the Phase 1 trial results will tell you around that? Thanks.

.

So Michael, we -- as we articulated before our goal and you'll see the data in the abstract shortly was to combine full doses of the IDH inhibitors with full doses of 7+3 consolidation. And the way the trial is designed, patients get both drugs for the induction with 7+3.

Some patients as you know get a second induction, they stay on the IDH inhibitor, they go through their cycles of consolidation and then will go on in maintenance phase of their IDH inhibitor unless they go to transplant.

And so our goal is to combine full doses of the IDH inhibitors with full doses of aggressive chemotherapy consolidation and maintenance..

And how should we think about potential treatment duration in the frontline setting then?.

Well, obviously it's too early to comment on that but if you look at the protocol that Chris and his team designed that you'll see the abstract for shortly, patients potentially are on drug depending on how many cycles of induction and consolidation they have.

They may be on drugs for between one and two years because of the maintenance phase and the variable length of induction consolidation, etc. And then obviously as we move forward to later stages of development then Chris will articulate when we're done what the design looks like for late stage trial. .

Okay, perfect, great, thanks for the update..

Thank you, our next question comes from Yatin Suneja with SunTrust. You may begin. .

Hey guys, thank you for taking my question and congrats on all the progress.

Maybe on the low grade Glioma, I think you mentioned you might seek for regulatory input to maybe sometime next year, so could you maybe tell us what sort of a bar you are looking to meet or maybe exceed before you could move into a pivotal, so what the expectations are and I do have another one?.

Yatin it is Chris here. So it's a great question and I guess it's not just the question, the treatment effect you'd be looking at but what are the endpoints. So when we engage with health authorities next year it will be a combination of things they will want to discuss.

We want to show them the data that we have, what the forward plan looks like, outlining unmet need and then have some discussions around trial designs and end points and get their feedback because they'll be thinking about this disease much the same way we are from a clinical perspective as we think there's a case to be made for a high unmet need and there are some considerations in designing a trial given the relatively long natural histories that we will need to discuss with them.

So more to come there and while I can talk about the specifics of what we will be doing at this point, we know that those parameters of a high unmet need and considerable dataset we will have to discuss with them will be the things that will be on the table at that time. .

And remember Yatin that we will show more ivosidenib Phase 1 single agent data at the SNO Meeting in San Francisco later this month..

Got it, thanks. And then on ivosidenib, so the U.S.

NDA is on track for later this year, how should we think about the European regulatory strategy, what the update is or when should we anticipate an update there and how are you thinking of pursuing that? And maybe if you could comment on IDHIFA's similar perspective if you could give on the European side as well?.

Yeah, so obviously we're really pleased Chris and his team are getting ready. We're looking forward to submitting the NDA for ivosidenib by the end of the year and that is very much on track.

As we have said earlier in the year both Celgene and Agios are seeking European regulatory input and we've been doing that and that's an ongoing effort between the two organizations to crystallize the regulatory strategy.

Obviously with the approval of IDHIFA, the full regulatory approval and so we're encouraged and we look forward to the conversations and articulating to you when we've completed those discussions with the E.U. regulators about what the path forward is there. Obviously the two options are filing on the same data set that we used for the U.S.

regulators or whether we need to have additional data from later stage trials like Phase 3 trials. So more to come. Well, we have to complete those discussions before we can talk about that. And Celgene I'm assuming will do the same. .

Got it, maybe just one final question on the IDHIFA, could you on the commercial front, could you maybe comment on the gene panel testing, the rates that you are seeing maybe at the community setting versus the academics, and then for Andrew are you going to disclose royalty tiers at some point? Thank you so much..

Yeah so, let me just take the first question. Nothing specific on testing is related to IDHIFA that we can share, you know, what we have said and what we expected is that the testing rate in the academic centers are immediately higher in the community and that's really proved to be the case and that's really the focus of the field team.

But one of the focuses is really improving that testing rate in the community as we pointed to if you look at analogs like [indiscernible] inhibitors where there is a complain diagnostic that typically takes two to three years to get those testing rates up to the 90% range. And so we will work on that over the course of the next couple years.

As it relates to tiers right now and we're not able to dispose the tiers but as we kind of get closer to one we will likely do that. .

Great, thank you so much for taking the questions..

Thank you, I am showing no further questions at this time. I would like to turn the call back over to David Schenkein for closing remarks. .

Thank you and we appreciate your support as we launch our first product and advance our late stage pipeline and bring additional novel compounds from our productive research engine to the clinic. As always I want to thank all the Agios employees and all the patients and their caregivers who participated in our clinical trials.

And we're looking forward to a very busy end of the year and hope to see many of you at ASH and with that that concludes today's call..

Ladies and gentlemen this concludes today's conference. Thanks for your participation and have a wonderful day..