Kendra Adams - Senior Director, Investor and Public Relations of Agios David Schenkein - CEO Chris Bowden - Chief Medical Officer Andrew Hirsch - Chief Financial Officer Scott Biller - Chief Scientific Officer

Anupam Rama - JPMorgan John Newman - Canaccord Eric Schmidt - Cowen and Company Yatin Suneja - SunTrust Michael Schmidt - Leerink

Good morning, and welcome to Agios' First 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 of Agios. You may begin.

Thank you, Kevin. Good morning everyone and welcome to Agios' first quarter 2017 conference call. You 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. David Schenkein, our Chief Executive Officer, who will review business updates and key milestone for 2017, Dr. Chris Bowden, our Chief Medical Officer, who will provide an update on our clinical development activities and Andrew Hirsch, our Chief Financial Officer, who will summarize Agio's first quarter and full 2017 financial results. Dr. Scott Biller', our Chief Scientific Officer will also be joining for Q&A. Before we begin, I would like to remind you that today's discussion will include statements about the Company's future expectations, plans, and prospects that constitute forward-looking statements for the purposes of the Safe Harbor provisions under the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors including those discussed in the Risk Factors section of our Annual Report on Form 10-K, which is on file with the SEC. In addition, any forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. While we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so, even if our views change. With that, I'll turn the call over to David.

Thanks, Kendra. Good morning everyone, and thanks for joining us today. I’d like to begin by highlighting the tremendous progress we made in advancing our portfolio of novel investigational medicines and executing against our 2017 priorities. Notably, in February NDA for enasidenib whose brand name is IDHIFA was accepted for priority review. We expect IDHIFA to be the first oncology product from our internal discovery engine to launch later this year which is an important company milestone and start of the next phase of our partnership with Celgene. This will be followed by the planned NDA submission of our wholly owned IDH-1 inhibitor, ivosidenib by year end 2017. We have a seat at the table for all regulatory interactions for IDHIFA which is helping inform the process for the ivosidenib NDA submission. We're also working closely with Celgene on launch preparation and co-commercialization activities. The Agios sales force has been hired and training is underway to ensure launch readiness later this quarter. Our medical science liaisons are also hired, trained and are active in the field having scientific discussions. We will expand these efforts in 2018 to prepare for the potential launch of ivosidenib. As a physician, it's an exciting time in the treatment landscape for AML with several new agents in development, including our IDH inhibitors which had the potential to change the treatment paradigm for this disease. Turning to our work in creating novel therapies for rare genetic diseases. We're focused on developing AG-348 as the first disease modifying treatment for pyruvate kinase deficiency. Our key program milestones are on track. As you saw in a press release, updated data from the DRIVE PK study has been accepted for an oral presentation at EHA. Last week, the FDA granted AG-348 Fast Track designation for PK deficiency. This is important as we work with the FDA on the pivotal program design and we remain on track to share our plans with you in the third quarter. Our EU regulatory discussions on the AG-348 pivotal design are complete. Once we conclude our FDA interactions we will integrate the feedback and finalize the program design for a worldwide registration in pyruvate kinase deficiency which we expect to initiate in the first half of 2018. Even as we had important commercial capabilities this year, Agios remains an organization that is fuelled and driven by our first in class research and a team of dedicated scientists. We continue to invest in research, knowing that our scientific expertise in the field of cellular metabolism will be instrumental to our future growth as a long-term independent biopharmaceutical company. We had several exciting developments in research in the past few months, data on our approach to the treatment of MTAP-deleted tumors were presented at the Keystone Tumor Metabolism Meeting in March. MTAP is a metabolic gene deleted in 15% of all cancer which is upwards of 98,000 new patients a year in the US. We're very excited to see this program moving closer to clinical development. The presentation at Keystone showed the first data demonstrating that we can potentially treat MTAP-deleted tumors with small molecules. Also in March, Celgene designated AG-270, our lead molecule in the MTAP pathway program as a development candidate under our 2016 research agreement. We are on track to submit an IND for AG-270 by the end of this year. This will represent the sixth IND that come from the Agios research lab since inception in 2009. This month, we also signed a global license agreement with the Oragene [ph] for an advanced discovery program in cancer metabolism. This is a program rooted in novel Agios biology and the chemical matter we licensed from Oragene will enable us to accelerate our preclinical program. We continue to focus on discovering and developing novel programs in-house as we've always done and will evaluate strategic licensing opportunities to create a complementary avenue to continue to grow our pipeline. To close, our recent financing provides important funding as we explored new R&D programs, advanced multiple programs into pivotal development and prepare for expected commercial launches. This is an exciting time for the company as we work to develop truly important medicines for patients. I'll now turn it over to Chris to discuss our clinical activities.

Thanks, David. I'll start by reviewing our IDH heme programs. First, as David mentioned, the NDA for IDHIFA was granted priority review with PDUFA date of August 30th 2017. At this time there is no ODAC expected. Updated IDHIFA Phase 1, 2 expansion data and relapse refractory AML has been accepted for an oral presentation at ASCO, data from this trial supports the NDA currently under review by the FDA. Turning to the IVH-1 program, the ivosidenib NDA submission is on track for year end 2017. We recently completed enrolment of the ivosidenib 125 patient expansion cohort. We plan to present the first data from the expansion phase of the ongoing Phase 1 trial and relapse refractory AML in the second half of the year. For both IDH programs we expect the EU regulatory strategy will take shape throughout 2017. In addition to our near-term focus on relapse refractory AML, we continue to pursue a speed and breadth strategy to secure a set of labels that would enable physicians to use IDH inhibitors across multiple lines of treatment in AML. We have a wide range of trials planned are already underway to support our move to the frontline. For the Phase 1 7+3 combination trial with ivosidenib or IDHIFA, we plan to present early data primarily safety and tolerability with a preliminary look at efficacy in the second half of the year. As we announced last quarter, both the 7+3 and VIDAZA Phase 1 combination trials have cleared a safety hurdle and the dose escalation component, demonstrating the ability to combine full dose VIDAZA or ivosidenib with full dose standard of care therapies. This sets the stage for agile, our Phase 3 trial with ivosidenib and VIDAZ which is on track to begin this quarter. We are also actively planning for a Phase 3 in the frontline fit population with ivosidenib and 7+3 which will be an important combination for those frontline patients eligible for standard of care chemotherapy with IDH-1 positive AML To round out our speed and breadth strategy, we are also exploring ivosidenib with other novel agents in AML and plan to support several investigator sponsored trials. We continue to learn more about the potential for our IDH ideation and solid tumors. Recall, our IDH inhibitors work in AML by releasing the block and cellular differentiation. We are working to elucidate the mechanism of the clinical activity of IDH inhibitors and solid tumors, including understanding the role that differentiation might play. Thus far we are encouraged by the level of disease control that we have seen in the Phase 1 study. Cholangiocarcinoma is a devastating disease, where we believe we can have a meaningful impact delaying tumor growth with a targeted well-tolerated oral medicine. There are few effective and no approved therapies in cholangiocarcinoma and the median progression free survival and the second line setting is short. The first data from the ivosidenib Phase 1 cholangiocarcinoma expansion cohort will be presented in a poster at ASCO next month. This trial has enrolled approximately 70 heavily pre-treated patients. We continue to add new sites for the Phase 3 ClarIDHy study in cholangiocarcinoma and more are slated to open in the US, Europe and Asia over the course of 2017. We designed this trial to be randomized and placebo controlled to confront the early efficacy signal seen in the Phase 1 study. We will share additional information on the ClarIDHy study design with the trials in progress poster at ASCO. The goal for ClarIDHy is to lead to global registration and last week the FDA granted ivosidenib orphan drug designation in this indication. Turning now to glioma. This is an indication where we have the potential to help a large number of patients who currently rely on surgery, radiation and chemotherapy as treatment options. We are working in collaboration with the Neuro Oncology community to better characterize the clinical outcomes in subsets of IDH Mutant to the patients and assess how they develop novel endpoints to better determine the impact of either ivosidenib or AG-881 on tumor growth and patient outcomes. For ivosidenib, we plan to present an update on the dose escalation phase, including updated safety, tolerability and imaging data in the second half of the year. Understanding the safety and tolerability profile are essential in this disease setting and the potential for patients to be on therapy for many years. For AG-881, as we reported on our Q4 call, we are currently exploring additional doses to confirm a recommended Phase 2 dose. Moving to our wholly owned rare disease program, we are committed to leading the science and driving disease awareness for pyruvate kinase deficiency, as we work to initiate a pivotal development program for AG-348. Data from our Phase 2 study of AG-348 DRIVE PK have been accepted for an oral presentation at EHA in June. We will present updated clinical data on all 52 pyruvate kinase deficiency patients. If you recall, enrolment to this trial was completed in November of 2016. Based on our last ride PK updated ASH 2016, we and physicians remain encouraged by the robust hemoglobin responses seen in many of these patients who are in need of a disease modifying therapy for this serious anemia. In addition, we in conjunction with Boston Children's Hospital plan to present an update on the pyruvate kinase deficiency natural history study in the second half of 2017. The study is now closed for enrolment at 258 patients. Additional data from DRIVE PK study will also be presented in the second half of the year, as patients continue to receive therapy in the extension phase. On the regulatory front, we were pleased that AG-348 has been granted FDA Fast Track designation for pyruvate kinase deficiency. Fast Track is designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. We remain on track to provide a third quarter update on the planned registration program for AG-348, once our regulatory discussions are complete. The key aspects of the clinical development plan under consideration of patient population trial size, dose and endpoints. Our MSLs are actively engaged in educational efforts with physicians to support local patient recruitment as we prepare to launch the registration program in the first half of 2018. I'm now going to turn the call over to Andrew to review our financials.

Thanks, Chris. Today we are in a strong financial position to support the significant activities that David and Chris just outlined. Let me start by walking you through the first quarter P&L. We recognized approximately $11 million dollars of collaboration revenue in the first quarter compared to $31 million for the same period in 2016. If you recall, during the first quarter of 2016 we recognized a $25 million milestone from Celgene for the initiation of the Phase 3 IDENTIFY trial with IDHIFA. So that accounts for the decrease when comparing the period. Also, it's important to note that while we earned an $8 million milestone in the first quarter, due to Celgene’s designation of AG-270 as a collaboration development candidate, we only recognized about $2 million of that amount in the first quarter of 2017. So our balance of this milestone payment will be added to the deferred revenue line and our balance sheet and recognized in proportion to the achievement of our deliverables under the Celgene agreement as outlined in our 10-K. Research and development expense during the first quarter of 2017 was $63 million compared to $44 million for the same period in 2016. The year-on-year growth in R&D expense was primarily driven by increased costs related to the initiation of the ivosidenib Phase 3 ClarIDHy [ph] file, the plan to ivosidenib Phase 3 AGILE trial and research related to AG-270, our program focused on MTAP deleted cancers. In addition, a significant portion of the increase in R&D expense was due to the fact that Celgene supported 50% of the R&D costs for ivosidenib in the first quarter of 2016. As of August 2016, Agios is responsible for 100% of the R&D costs for ivosidenib going forward. General and administrative expenses were $15 million for the first quarter of 2017, compared to $11 million for the same period in the prior year. The year-over- year increase was largely due to increased headcount and other professional expenses to support our growing commercial infrastructure. Now let me turn to our cash position and runway guidance. We ended the first quarter with cash, cash equivalents and marketable securities of approximately $503 million. This compares to approximately $574 million at the end of 2016. This decrease in cash was driven by expenditures to fund our operating activities of $79 million during the first quarter. These expenditures were offset by an increase in cash of $5 billion in program funding received from our partner Celgene and $4 million dollars received from the exercise of stock options. On April 28, we completed a follow on offering resulting in net proceeds of approximately $270 million dollars. Importantly, these proceeds allow us the financial flexibility to invest across the business through at least the end of 2019. This provides runway through and beyond the number of important milestones critical to reaching our vision for the company, including the initiation of multiple Phase 3 trials of ivosidenib and AG-348, build out of our commercial capabilities and infrastructure to support the anticipated product launches of our IDH inhibitors and AML advancement of AG-270, our program in MTAP-deleted cancers into Phase 1 clinical trials and the continued funding of our robotic discovery research engine which is on track to put six development candidates into clinical trials in just eight years. I will now turn it back to David to wrap up.

Thanks, Andrew. As we finished the call, I’d like to leave you with the vision we have for Agios that we articulated at the beginning of the year. We have proven our ability to discover novel biology and translate those discoveries into precision medicines in areas of high unmet need. IDHIFA is just the start, as we expect to launch ivosidenib in 2018 and continue to fund R&D to build our capabilities to do this again and again. I'd like to thank all the tremendous employees at Agios for their dedication and their passion to make a difference for patients. I also want to thank all of the patients, the caregivers and the physicians who participate in our clinical trials and to thank our partner Celgene. And with that operate I'll turn it back to you for questions.

[Operator Instructions] Our first question comes from Anupam Rama, JPMorgan.

Hey, guys. Thank you so much for taking the question. Just wondering on the updated glioma affected in the second half of the year, what will you be looking for in that data set to help you decide on next steps for that program and related are the next steps with AG-881 tied to these data? Thanks so much.

Yes, good morning Anupam. Thanks for your question, I'm going to have Chris talk to little bit more about glioma next steps.

Right. So, hi, Anupam its Chris here. We're doing a couple of things in low grade glioma there's really been very few new therapies for patients. And so one of the things we want to understand with 120 is further - obtain further safety and efficacy data that builds on what we presented [indiscernible] last year. One of the things that I pointed out in my remarks is that given the natural history of this disease we anticipate that patients would be on treatment for potentially long periods of time. So getting an understanding of how their disease behaves and how they tolerate the drug is really important. From the perspective of 881, we are still in dose escalation and dose finding and we'll look forward to presenting that information when we have a story to tell. So from our perspective we have two shots on goal if you will, two molecules to think about in this disease which really is in need of some new treatment options, so it's something we're really looking forward to.

Thank you for taking our question.

Yes, thanks.

Our next question comes from John Newman with Canaccord.

Hey. Good morning, guys. Thanks for taking the question. I just wondered if you could talk a little bit about what we might see in cholangiocarcinoma and ASCO, if that’s - with a little bit of efficacy or it was mainly focused on a safety side? Thanks.

Yeah, thanks, John. Again, I'll have Chris to give you an answer on that one.

Good morning, John. So at the triple meeting in 2015 we had data on 25 patients presented by [indiscernible]. And as I said in my remarks, we are getting – we’ve got approximately 70 patients now. So with the passage of time in additional patients we’ll have additional data from both an efficacy and a safety perspective. So you should expect to see both and again in an area where there's really high unmet need. Patients are in need of new therapies, and one other aspect that we are also working hard on and it’s around translational biology, understanding how an IDH inhibitor and an IDH Mutant patient and its mechanism of action will translate into patient outcomes.

Great. Thank you.

Our next question comes from Eric Schmidt with Cowen and Company.

Morning, and thanks for taking my questions. Maybe first for David, I see you got the Fast Track approval for – sorry the Fast Track status for 348. Is that in lieu of breakthrough designation or is breakthrough still possible?

Yes. Thank you, Eric. We're really pleased about the Fast Track, its independent of potential breakthrough. And as you know it's very encouraging and we're very pleased about getting the Fast Track, it’s very important for us. We’ve had no issues with communication with the agency and so this will even help speed that up even more and give us future advantages as we move the programs forward. So it's all good.

And then maybe for Chris on the upcoming ASCO presentation on enasidenib. You're saying Phase 1, 2 data, is that still just to a update of the dose escalation phase of the trial or will we see all the cohort expansions?

Well, I think that title is helpful in terms of giving you a sense of the – what patient population will be presented there. So the fact that there is dose escalation and expansion and that title means you should expect to see efficacy and safety surrounding both. That's a particular opportune time for that data to be presented given that 221 is currently under review for relapsed refractory and with a PDUFA date of August 30th.

And then maybe just one more also for you Chris, on the European approval outlook, I think you said you it would take shape in 2017 for the IDH-1 inhibitors. Can you clarify what that means, are you committed to giving some guidance this year or filing strategy?

Well, we haven't committed to providing guidance in 2017. Eric, and what we mean by that, what I meant by that in my remarks is that, we're pursuing various avenues that you have to interact with the agency, both at the EMA level and we're considering their options where you can consult at the country level as well. So those are the types of things we're pulling together you know, our first priority is in the US obviously given how we've talked in the regulatory environment here. So we want to get going on this and wanted to let you know we're starting to move forward on it, but that's about as much detail as I want to provide now.

Okay. Thanks. Congrats on the progress.

Okay. Thanks, Eric.

Our next question comes from Alethia Young with Credit Suisse.

Hi. This is [indiscernible] Alex on for Alethia. Thanks for taking the questions and congrats on the progress. Just had a quick question on PKD program. I was wondering if you could maybe comment on some of the similarities and differences between your discussions with the EMA versus the FDA in terms of when to focus et cetera?

Yeah, thanks for your question. You know, as you know we conduct regulatory meetings on both sides of the ponds in there and they are critically important. As we said in our prepared remarks we've concluded the discussions we've had with the European regulators. And I really can't provide any details from there, but our - and this is pretty common with regulatory packages, you get feedback from both sides and they're usually pretty aligned, but not always exactly aligned and our job will then be after we get our FDA interactions to integrate the two come up with the pivotal program that we're confident will support global registration. And so I can't share with you any details. We're very confident that we'll be able to integrate both those feedbacks and create the program that's in the best interests of both regulators and patients.

Okay, great. And another quick question on the MTAP program, I was wondering if you could help us – help frame for us in which specific tumor types is the biggest opportunity would be?

Yes. So it's a little bit too early to give you that guidance yet, as you know we're looking forward to submitting - Scott and his team will be submitting the IND later this year. And as we get ready to begin into the clinic you'll see the clinical trial design. So it's obviously a very exciting time for us, given how broad this metabolic gene deletion occurs across a wide range of both blood cancers and solid tumors. I think you can expect that our clinical trials will be restricted to patients with the appropriate genetic marker meaning a deletion of that metabolic gene, but how we’ll focus later after we've achieved proof of concept on which individual disease is just a little too early to comment.

Sure. And let me just ask a final question on commercialization for the IDH inhibitors. I was wondering if you could maybe help us – help frame for us what that expansion might look like in terms of going from commercial organization requirements for a 221 and then expanding to 120s launch in 2018? I am sorry...

Yes, hi. This is Andrew, I'll take that question. So as you know for IDHIFA we're responsible for a third of the commercialization effort or the field effort and we’ve certifying that where Celgene is, sales in MSO. So if you think about what a total effort would be, we would do 33% of that. So as we would move to the potential launch of ivosidenib, we would right-size that for a complete launch wholly on company launch. We've not really given any guidance and we're not prepared to do that yet at this stage in terms of specific numbers, but as we get closer we will have further discussions around that.

Okay, great. Thanks for taking the questions and congrats on all the progress.

Thank you.

The next question comes from Terence Flynn with Goldman Sachs.

Hi. This is Sameer on for Terence. Thanks very much for taking the question. One more on the cholangio data at ASCO. Can you remind us what stage of patient you enrolled in that trial? What's currently typically used to treat these patients? And what efficacy that generates?

Yes. So our patients that we have enrolled in this Phase 1 trial have generally progressed after prior chemotherapy and cytotoxic therapy is the standard. In general, globally the majority of patients get platinum based chemotherapy, usually platinum gemcitabine, of course, [indiscernible] plays a role here. The response rates tend to be in the 20% range or so and survival is generally less than a year. So that's in the frontline setting. After patients progress there's really no standard at that point. And so you're looking at single agent chemotherapy and clinical trials. So overall, the situation is pretty grim. So the patients that we enrolled in our Phase 1 trials have all had prior chemotherapy prior treatment. And then depending on how they initially presented they may have had surgery, radiation therapy is not used too often in this disease.

Okay. Thank you.

Our next question comes from Yatin Suneja with SunTrust.

Hey, guys. Thank you for taking my question. Just a couple of questions on the IDH program. Could you maybe help us understand how the re-factory are these patient population that you have enrolled in and what to do and then what is your expansion cohorts? And is that very well understood patient population and in the confidence that you have you know in approval comes from the fact that these are very higher patient population and you have very limited options? And then I have one more.

Sure, Yatin. Thanks for your question. I'll start this David and then I'll pass it over to Chris for more detail. So obviously we have a high degree of confidence in the data that we've generated both with what's now known as IDHIFA, AG-221 and also ivosidenib and that these are patients who had as you've seen from the prior presentations you'll see more at ASCO for IDHIFA and you'll see more in the second half of the year for ivo, these patients who have had multiple rounds of conventional chemotherapy if they're younger and probably HMAs if they're older and really have very few conventional options left and that we obviously think the data has been very compelling and we're very pleased obviously with the regulatory directives we've had to date. Obviously getting the priority review and the ODAC schedule gives us a high degree of confidence and we'll use that information as we build the ivosidenib it as well. Maybe Chris talk a little bit more about the refractory, remember this is - our trials have been for relapsed and refractory.

Yes. So the definition for the 120 expansion cohort the option is relapse refractory AML in second greater relapse, patients who’ve relapsed after stem cell therapy. Those patients who are refractory induction or re-induction and/or relapse within one year. So from a clinical perspective in a patient need perspective it's a very bad patient population. And then when you think about this from what other options are these patients have there are very few and so they really fulfil that definition of unmet needs. When we redefine that patient population we did it very carefully for that expansion cohort to isolate if you will a group of patients who really have no approved therapies and that's really important. And to David's point you know we've been very gratified with the data that we've seen both in terms of response duration of response, as well as the overall safety profile and we think we're going to be able to meet an unmet need there. The other thing I would point out that that gets missed sometimes is, as bad a shape as these patients are, we've seen around 10% of the overall patient population go to transplant. So they achieve CR after despite the fact that they're in is really bad – have a very bad prognosis with 126,500 milligrams daily. So that gives you a sense of how refractory these patients are and why we think that we have a good new treatment option with both drugs.

Got it. That's helpful. And then on 120, so you've completed the enrolment in the expansion cohort. I mean is there a particular median duration of follow up that you are targeting or what should we anticipate in terms of median duration of follow up that you file on and how does that compare to IDHIFA?

Yeah. So, Yatin, David, here. We can't give you any of those details at this time, but we can tell you is that we remain on track to submit our NDA by the end of this year - near the end of the year for ivosidenib. And that's based on our conversations with the agency around the type of follow up that we expect to have on the patients in our package. And I think we're pleased with the follow up we've had, particularly in this setting for both ivosidenib and for IDHIFA and so I think that's based on our regulatory interactions and our understanding of what they would like to see.

Okay. That's very helpful. Thank you so much. Good luck with the job.

Thank you.

Our next question comes from Michael Schmidt with Leerink.

Good morning. Thanks for taking my questions. I had a couple of questions regarding the Front Line AML opportunity and my first question is your decision to move into a Phase 3 trial in combination with VIDAZA, with ivosidenib, was that based purely on safety today or have you seen already efficacy data from the Front Line Phase 1 study to support this decision. And can you remind us of the benchmark in Front Line AML for either of 7+3 and VIDAZA. And where do you need to get IDHIFA to place in terms of efficacy? Thanks.

Yeah. Thanks, Michel. So our desire and long-term goal from the very beginning given the novel mechanism of action here and the compelling data we've seen in the relapse refractory, as you've heard us articulate in the past is the strategy of speed and breath and the breadth part is really moving the drug into the Front Line setting, so that patients - any patient with an IDH Mutation, either IDH-2 or IDH-1 can have the opportunity to receive one of the drugs in the Front Line setting and follow them through. And so the decision to move ahead to the Phase 3 first beginning with VIDAZA and then after that we'll be with 7+3 is based on our preclinical scientific hypothesis that shows a unique mechanism of action which is not overlapping with conventional therapy. The safety profile we've seen of the single agents which has really been very favourable and again doesn't overlap with conventional therapies. And then some of the early data that we've seen from the ongoing Phase 1 studies obviously helps us shape all of that. So it's a combination of all of that. In terms of what to expect with conventional therapy, remember with 7+3 in the newly diagnosed fit patient a very high percentage of them have a complete remission and is actually cured of potential in the small number of those patients. And so our goal would be obviously to improve the long-term survival of those patients and even increase the cure rate for some of those patients. For the HMAs particularly for VIDAZA in a single agent, newly diagnosed patients who aren't fit. You expect about a 20% complete remission rate and then overall survival of about 10 months and there really is very little curative potential. So there's a big opportunity to make a big impact in patients lives in that setting as well. And we plan to go after both.

Okay. Thanks, David. And one question regarding the cholangiocarcinoma pivotal study that's planned, and I guess my question is, there were some activity in this disease with FGFR inhibitors and I was wondering if the IDH patient population if there's an overlap between those and the FG positive patients and if you also could remind us of the percentage of patients with IDH-1 Mutation in cholangiocarcinoma? Thank you.

So the frequency is around 20% to 25% of patients with the diagnosis of cholangiocarcinoma have an IDH Mutation. You're asking is there an overlap between FGFR receptor or amplified patients in an IDH. And I don't have the exact numbers, but they tend not to – but limited data there is, I haven't been impressed, there's a lot of overlap there. From the perspective of the ClarIDHy study, we're emphasizing what you are - you must be have an IDH Mutation documented. We'll certainly look at other co-occurring mutations and other aspects of their molecular components of their tumor.

And Michael, just to clarify, the ClarIDHy study, you mentioned planned, it actually began in December and is ongoing opening sites in enrolling as we speak today.

Perfect, thanks. And then one last question, a commercial one, you already commented on your plans to build out the commercial infrastructure. And my question is really around you - activities going forward and I guess is it fair to assume that the plan is to commercialize ivosidenib in your in-house, should it be approved in the future there?

Yeah, Michael. So our plans are – our plan is to make it available globally. You know, I think the plans for how we commercialize ex-U.S. are really going to dovetail with the ex-US regulatory strategy. So as that comes into sharper focus that will really drive how and when and what form that takes.

Great, thanks and great progress.

Thanks.

Thank you, Michael.

And I am not showing any further questions at this time. I would like to turn the call back over to our host.

Yes. Thank you very much. I'd like to thank obviously everybody who's participated on the call today and always a special thanks to all the patients and physicians and caregivers who participate in our clinical trials that makes all this exciting progress possible. So with that we'll end the call and thanks for participating.

Ladies and gentlemen, this concludes today's presentation. You may now disconnect. And have a wonderful day.