Akebia Therapeutics, Inc.
Q4 2017 Earnings Call Transcript

Published: 13 Mar 2018

[Operator:]

Good day, ladies and gentlemen, and welcome to Akebia's Fourth Quarter and Full-Year 2017 Financial Results Conference Call. [Operator Instructions] As a reminder, this call is being recorded. I would now like to introduce your host for today’s conference Mr. John Garabo, Director of Corporate Communications at Akebia. Your line is now open.

[John Garabo:]

Thank you, Skyler. Good afternoon, everyone. I’m John Garabo, Director of Corporate Communications. Thank you for joining us today to discuss Akebia's fourth quarter and full-year 2017 financial results. Today's call will be archived and a replay will be available after this call on our corporate website www.akebia.com. Before we begin, I’d like to remind everyone that this conference call includes forward-looking statements. Each forward-looking statement contained in the call is subject to risks and uncertainties that could cause actual results to differ materially from those described in these statements. Additional information regarding these factors appears under the heading 'Risk Factors' in our annual report on Form 10-K for the year ended December 31, 2017 and in our press release, issued earlier today, both of which are available on our corporate website. The forward-looking statements in this call speak only as of the original date of this call and we undertake no obligation to update or revise any of these statements. I'd like to now turn the call over to John Butler, Akebia’s President and Chief Executive Officer. John?

[John Butler:]

Thanks, John. Good afternoon everyone and thanks for joining us today to review our 2017 financial results and corporate progress. On today’s call, I’ll review our major accomplishments over the past year. Jason Amello, our Chief Financial Officer, will review then our financials. I'll close with our outlook for 2017 before opening the call for questions. Dr. Rita Jain, our Chief Medical Officer; Nikki Hadas, our General Counsel; and Michel Dahan, our Chief Business Officer will join us for Q&A. Given its mid-March and how focused we are on driving our business forward, it seems unusual to look back at 2017. But I believe our performance last year speaks to what this team can achieve this year and into the future. As you consider the level of execution we delivered in 2017, from the significant transactions we completed to the momentum of our clinical development program, you’ll see a team poised to continue to deliver as we drive the vadadustat development program forward and build a leading innovation driven renal company. You may recall, we announced a few weeks ago that we are targeting full enrolment for our Phase 3 INNO2VATE and PRO2TECT studies by the end of 2018 with topline results anticipated in 2019, subject to the accrual of MACE events followed by market launch anticipated in 2020, subject to regulatory approval. When I look ahead to the upcoming months of 2018, I see an exciting year for Akebia and for HIF-prolyl hydroxylase inhibitors. We are expecting important late stage data readouts from another company, which have the potential to validate HIF-PH inhibitors for the treatment of anemia due to chronic kidney disease. The timing of these data suggest that we have narrowed the timing gap between our program and theirs assuming we execute to our targeted timelines. We’re pleased with the progress we have made with our program and additionally we believe the straightforward approach we’ve taken to designing the PRO2TECT and INNO2VATE programs will ultimately be an advantage for Akebia. That being said, let me reiterate something you have heard me say before, that the size of the market opportunity and the significant need for innovation for this patient population provide a large opportunity for multiple products in this space. If we can deliver on the potential of HIF- PHI’s and bring an important new medicine to the patients we serve, that will be most meaningful. Turning back to our recent accomplishments

[Jason Amello:]

Thank you, John and good afternoon everyone. The financial results for 2017 are indicative of our continued execution and optimization of our vadadustat development program, as well as the significant financial leverage we’ve obtained from our collaboration partners. Unqiue to the fourth quarter of 2017, the company actually reported a net profit rather than a net loss for the quarter. Specifically, net income for the fourth quarter was $12.3 million or $0.25 per diluted share, as compared to a net loss for the fourth quarter of 2016 of $37.9 million or $0.99 per share. It’s important to note that the net profit was due to revenue recognized in connection with our collaboration with Mitsubishi Tanabe or MTPC, which I will speak more about in a moment. When you look to the full-year of 2017, the company did report a net loss of $76.9 million or $1.77 per share, as compared to the net loss for the full-year of 2016 of $135.7 million or $3.60 [ph] per share. The significant decrease in the net loss from 2016 to 2017 is a result of having significant revenue recognized from our collaboration partners in 2017 offsetting increased R&D cost from having both the PRO2TECT and INNO2VATE programs enrolling concurrently for the full-year of 2017. When you look to the components of the P&L, on the revenue side, we are recognizing revenues from three collaboration arrangements. Our Otsuka U.S. agreement, our Otsuka international agreement, and our MTPC agreement. It’s important to point out that these collaborations are considered multiple element arrangements under the revenue recognition guidance. This generally means that non-contingent payments will be will be recognized over the life of the arrangement based on how activities under the arrangement are performed or delivered by Akebia versus when payments are actually received from the partner. With that said, collaboration revenue was $87.3 million for the fourth quarter of 2017, compared to $1.5 million for the fourth quarter of 2016, and $178 million for the full-year of 2017, compared to $1.5 million for 2016. The $1.5 million of collaboration revenue recognized in 2016 related only to the Otsuka U.S. agreement which was consummated in December 2016. Collaboration revenue recognized in 2017 related to revenue recognized under both the Otsuka U.S. agreement and the Otsuka International agreement, which was executed in April 2017, as well as revenue recognized during the fourth quarter of 2017 in connection with the MTPC agreement. With respect to the MTPC agreement you will recall that we had been differing $40 million of revenue since 2015 pending the satisfaction of two conditions. The enrolment of Japanese patients in a Phase 3 study, and our providing of clinical supply of vadadustat for MTPC. Both of those criteria were satisfied in Q4 2017 and accordingly we recognized $39.7 million of revenue in Q4, which consequently due to the amount resulted in Akebia reporting a net profit in Q4. Moving to research and development expenses, R&D expenses were $68.4 million for the fourth quarter of 2017, compared to $33.4 million for the fourth quarter of 2016. And $230.9 million for the full-year of 2017, compared to $115.8 million for the full-year of 2016. The increase is primarily attributable to an increase in external costs related to the continued advancement of PRO2TECT and INNO2VATE Phase 3 program, including ongoing enrolment of Phase 2 studies in Japan, and study commencement activities for FO2RWARD and TRILO2GY programs, both of which have been replaced with new study designs. R&D expenses were further increased by headcount, consulting, and facility related costs required to support our expanding R&D programs. We do expect R&D expenses to increase significantly for 2018 as we target the fully enrolled both PRO2TECT and INNO2VATE Phase 3 studies by the end of 2018, and as we advanced our activities around FO2RWARD and TRILO2GY. Despite this expected increase in R&D, it is important to keep in mind that a significant portion of the cost is reimbursed by our collaboration partners, which gets recorded as collaboration revenue as I mentioned earlier. General and administrative expenses were $7.6 million for the fourth quarter of 2017, compared to $6.1 million for the fourth quarter of 2016. That compares to $27 million for the full-year of 2017 versus $22.2 million for the full-year of 2016. The increase is primarily attributable to an increase in costs to support the company's R&D programs, again including headcount, consulting, compensation-related cost, as well as facility costs. We expect our G&A expenses to increase in future periods to support our continued research and development and as we prepare for commercialization of vadadustat. Turning to our capital position, we ended the year strong with our cash position of $317.8 million. The company also receives cost-share funding from its collaboration partners, generally on a prepaid quarterly basis. We expect our cash resources, including the prepaid quarterly committed cost-share funding from our collaborators to fund our current operating plan into the second quarter of 2019. And lastly, we ended the year with approximately 47.6 million shares outstanding or 52.5 million shares on a fully diluted basis, inclusive of outstanding options and RSUs. With that, I’ll turn it back to John.

[John Butler:]

Thanks Jason. Our goal is to build a leading innovation driven renal company and transform Akebia into a fully integrated commercial organization. Already 2018 is off to a strong start. We continue to drive progress for our global Phase 3 PRO2TECT and INNO2VATE programs. As I mentioned, we’re targeting full enrolment of these studies by the end of the year with topline results in 2019, subject to the accrual of MACE events, followed by a market launch in 2020 subject to regulatory approval. We’re moving ahead with our new FO2RWARD and TRILO2GY studies, which we enhanced in collaboration with Otsuka. Our investment in these study enhancements reflect our confidence in the program and desire to position vadadustat for commercial success. We are targeting the filing of IND submission for AKB-5169, a potential oral treatment for patients with inflammatory bowel disease for later this year. We continue to explore the potential of a vast range of HIF compounds, which we in-license from J&J innovation in the early 2017, and we continue to explore strategic business transactions to bring further value to Akebia. We advance our business from a position of financial strength with more than $300 million on our balance sheet and significant committed capital from our collaborators to come in over the course of the Phase 3 vadadustat development program. We also leverage the expertise and strong track record of our management team and the dedication and talent of all of our employees. And now, we’ll open the line for questions. Skyler?

[Operator:]

[Operator Instructions] Our first question comes from Chris Raymond with Piper Jaffray. Your line is now open.

[Chris Raymond:]

Thanks. Just on your competitors’ delay, I guess maybe, I know you probably don't want to spend too much time talking about this, but maybe just in relation to comparison with what you guys have going, so the delay as we read it was primarily based on the complexity, I think of their data analysis as multiple trials, multiple folks conducting these trials and it seems like your program is more sort of streamlined, not actually asking you to say definitively you won’t run into the same issue, but could you just sort of contrast your analysis versus roxadustat? And also we were kind of struck by their commentary that they would not have the pooled MACE analysis, and I know you just mentioned this John at the end of your comments, seems like you're still planning on having that, but just maybe talk about the significance of that and you mentioned also that your gap and timing has narrowed, just maybe talk about that a little bit if you don't mind. Thanks.

[John Butler:]

Thanks Chris. You know we're not going to obviously speculate on FibroGen's program, but I do think that the straightforward nature of our program is an advantage. I’ll ask Rita maybe to comment on that.

[Rita Jain:]

Thank you, John. Yes. With our program, we have taken an approach where we’ve decided to conduct two trials in the non-dialysis patient population, the PRO2TECT program, and two trials in the dialysis patient population, the INNO2VATE program. For all four of these studies, we have the same active control, darbepoetin alfa, and in addition to that, we’ve had similar endpoints across all four trials. Such that, we’ve designed the two Phase 2 studies, as studies that can be pooled to evaluate MACE data. The two Phase 3 studies in PRO2TECT and the two Phase 3 studies in Inno2vate. So, we do believe that the way the studies have been designed with the same active control, which is the standard of care in this space and then the ability to have similar endpoints and pool that data does allow this to be a fairly straightforward approach to looking at these data sets.

[John Butler:]

And so when we do read out PRO2TECT and INNO2VATE we will have the MACE data pooled across the studies when we report.

[Chris Raymond:]

Okay. And then, if I can ask a follow-up. So, knowing the INNO2VATE and PRO2TECT are your registration vehicles primarily, and I know you’ve guided to filing I think before the TRILO2GY trial reads out, can you just remind us the role that that trial serves?

[John Butler:]

Rita, do you want to talk about that?

[Rita Jain:]

Yes, hi. Thank you, John. As we mentioned, we have revised the design of the TRILO2GY trial, and we do plan to have a larger study than was initially planned, and within that trial we will include once-daily dosing and three times weekly dosing, as well as having data switching from a variety of ESA therapies at baseline. Now, this study will provide important information, but it is also important to note that our core registration program is based on INNO2VATE and PRO2TECT, and the data from those studies will provide for the registration. We also will have data from our Phase 2 U.S. study 011 in the dialysis population that looked at three times weekly dosing and also from our new Phase 2 FO2RWARD study, which is also going to include three times weekly dosing. So, right now, we’re not considering the TRILO2GY trial to be gating towards our initial filing. That said, we do think it will provide important information as John mentioned earlier to characterize and further differentiate vadadustat.

[Chris Raymond:]

Thanks.

[John Butler:]

Thanks Chris. Next question.

[Operator:]

Our next question comes from Bert Hazlett with BTIG. Robert. Your line is now open.

[Bert Hazlett:]

Thanks. Just thank you for the color on TRILO2GY and FO2RWARD. That’s helpful. John, you mentioned that you couldn't be happier with your partner Otsuka that is not necessarily always the case with partnerships, could you describe a little bit more as to what’s transpiring there with Otsuka that’s making you so effusive? I have got one or two more?

[John Butler:]

I feel that is effusive when it comes to partnerships. I have lived through a variety of partnerships not all of them are as collaborative as what we’ve seen from Otsuka across the board. But, I think Michel Dahan is obviously responsible for the deal and manages the alliance functions. So, I’ll ask him to comment.

[Michel Dahan:]

I'm very happy to. So, you know in the context of FO2RWARD and TRILO2GY let’s take this as an example. We started the discussion about how to maximize the potential of vadadustat globally, in the second half of last year. Shortly after we expanded our collaboration to include Europe and other international markets. And it was great to see the full, I mean full alignment with Otsuka on how to do that, how to maximize this opportunity above the commercial potential first and foremost. And frankly, you will see opportunities to optimize our program. I think the changes that we have announced to FO2RWARD and TRILO2GY reflect the strength of the alliance and here I mean joining our forces, right, and the high quality of the relationship, as well as frankly the high quality of Otsuka as the partner.

[John Butler:]

The thing I will add Bert is, having partnerships never makes drug development more streamlined or easier, but I will say the - not only Otsuka and who they are as a company, but also the way the agreement was constructed where we control development across the entire program and obviously consult closely with them, but you don't have some of the issues you have in a situation where there are multiple companies running multiple studies. So, we’re responsible for running all the studies consulting with them and just makes the process much more streamlined.

[Bert Hazlett:]

Okay. Thank you for that. Then just kind of a basic one with regard to numbers, 87 million revenue, roughly 40 million of that, I guess this is for Jason was booked due to deferred revenue that puts the collaboration revenue kind of continuing offs run rate at 47 million roughly for this quarter, and that versus 41 in the third quarter, as you think about R&D increasing, should we also think about that 41 versus 47, should that increase quarter-by-quarter going through 2018, is that what you're indicating?

[Jason Amello:]

Yes, the cost there is the component of how the revenue gets recognized. As the costs are increasing you will see a commensurate increase in revenue as well. The Mitsubishi revenue will come in again in Q1 and thereafter because we’re supplying them with product they will be fully furnished with their product for their Phase 3 trial by Q1. So, I think that revenue will kind of normalize and tail off, but the Otsuka revenue will continue, which will be commensurate with our R&D cost for the program.

[Bert Hazlett:]

Okay, terrific. And then just the IBD products, 5169, when is you always might actually be seeing data for that, is that a 2019 data read-out or more like 2020?

[Jason Amello:]

Well I think that I’ll probably hold off on answering that question at this point Bert. Let’s get to the timing of the IND, once we have that, you know at the same time obviously now we are working on what the design of Phase 1 would be. So, once we have both of those things we can give more clarity on timing of data.

[Bert Hazlett:]

Okay. Thanks. Congrats on all the progress.

[Jason Amello:]

Thanks Bert.

[Operator:]

Our next question comes from Difei Yang with Mizuho. Your line is now open.

[Difei Yang:]

Hi, good afternoon and thanks for taking my questions. Just a couple. The first one is on competitive. So, John could you share with us your top line view with regards to GSA's competitive product, as well as theirs? I know they both are behind you, but from product profile perspective how do you view them?

[John Butler:]

Yes. So, yes GSK is, we believe still behind us in development. I think recently you’ve seen that they’ve made some investments in new studies et cetera in the program, and I think that’s really a reflection of the market opportunity here. Even though if timelines continue as they are today, they would be third to the market. And they see a significant opportunity that minds reputation of their willingness to continue to invest in the program. I think we will wait and see Phase 3 data and compare at that point-in-time. As we understand the bare compound, they are still not - the last we heard they were looking for a partner ex or in the U.S. and were not moving forward the development, I haven't seen anything that leads me to believe a change has happened there, or a deal has been signed. We do expect and we understand that they are moving forward with development in Japan, whereas I mentioned before you do not need the large MAZE data and then very little has been published about the bear compound. So, it’s hard to even speak much about their characteristics.

[Difei Yang:]

Thank you. Very helpful. And then my next question is on bio similar. So, we know there are a couple of bio similar versions of ESA’s are being reviewed by the FDA, so how do you see the market dynamics will change has those biosimilars are being approved, I believe would be ahead of the HIF-PH launches?

[John Butler:]

Well, I think we’re at the point now, where - I don’t know, I’ve been here since 2013 and we have been expecting biosimilar approval any time, right, and so we’re in 2018 and we still haven't seen one yet in the U.S. certainly. So, who knows, but fundamentally remember the safety concerns of the current ESA’s will be the safety concerns of the biosimilar ESA’s. And the differentiated product profile that we’re developing and hope to show in Phase 3, I think will carry over to all of the ESA’s in the market. We call that the dialysis market is a bundled reimbursement market. So, it’s contract based and we think that the transaction we completed last year with Vifor is absolutely critical and important strategic for us that allows us access to those 40% of patients that for Fresenius treats assuming the Phase 3 data supports regulatory approval of course, and as you think about the market that we’ve always been most excited about, maybe is the non-dialysis market and remember there is well over 1 million patients in the U.S. who are anemic, who have chronic kidney disease, and for a market like that, a once a day oral offering will always be favored by physicians and patients certainly versus an injectable product. So, we like our competitive positioning against both the current ESA’s and potentially biosimilars.

[Difei Yang:]

Thank you for sharing your thoughts. Very helpful.

[John Butler:]

Thanks, Difei.

[Operator:]

Our next question comes from Kennen Mackay with RBC Capital Markets. Your line is now open.

[Kennen Mackay:]

Hi, thanks for taking the question. John, wondering maybe if you can comment on sort of where you are getting the conviction that the Phase 3 trial, especially with the MAZE could be complete next year, is that from the events that have come in here or sort of anticipating events from patients who will be enrolled in the latter half of the year? And then secondly on that enrolment wanted to get a sense of whether that timing by year end was counting more on site expansion or enrolment at currently open sites to meet that deadline? And then one final question, just housekeeping, I think some times in the past you had mentioned the SMB meeting taken place and suggesting continuation of the trial [indiscernible] safety profile or balance safety profile, just wanted to check if that meeting had occurred this quarter and how they positive go forward signal? Thank you very much.

[John Butler:]

All right Kennen, I didn't write those down. Hopefully - there is a lot of questions there. I will start with the last. We haven't had the SMB meeting since the one we reported last, I can't remember exactly what quarter that was, but as I said before, by their charter they have to be twice a year, we expect that they will probably meet more frequently as there is more data for them to review, but we haven't had one in the time since the last report. So, you asked about enrolment and kind of timing et cetera, whenever you look at and kind of project to when data will read out, you’re looking at your enrollment and your expected event rate. That’s - it is kind of those two things that will drive the timing of seeing events and so seeing data and that’s what we're looking at kind offer a range of rates - event rates etcetera and again that is why we always kind of characterize it as we are expecting data in 19 subjects to those events. I mean those will come in and obviously that accelerates as you have more time and more patients on the trial. While we are still adding sites, I think the dramatic majority of sites are on really you agree and that’s where we expect to get enrolment from. I think we have, I don't know if there are any other countries we are adding at this point. I think we are, [indiscernible].

[Rita Jain:]

No, I think, John you’re correct. We have largely activated the majority of sites and countries that we plan to, and so we’re now focused on a number of strategies to continue to accelerate enrolment within those countries and sites, and so that’s what we’re watching, as well as the MAZE data as that comes in.

[Kennen Mackay:]

Got it. Thanks John and thanks Rita.

[John Butler:]

Thanks, Kennen.

[Operator:]

Your next question comes from Jonathan Aschoff with National Securities. Your line is now open.

[Jonathan Aschoff:]

Hi guys, thanks for taking the question, the last question you talked about two-thirds of my question, so I guess the last third, was given now the enrolment case that you’re thinking of and sort of the 2019 year for data that is kind of depending on the pace of MACE, my I guess the only left to my question is, do you think the 2020 commercialization might be on the aggressive side?

[John Butler:]

Again, I mean this will, we will all see together. This is our expectation based on what we're seeing today. We will move, as quickly as possible to submit a high-quality regulatory filing from that time we see our data and move as quickly as possible into the commercial settings. So, we're not going to launch about, I mean we're going to work hard to move as quickly as we can, but as we get closer to understanding exactly when data will come out, we engage in our regulatory meetings, we will understand the timing better and we will update, but I think we will we feel very comfortable with the guidance we have given at this point.

[Jonathan Aschoff:]

Okay. Thank you, guys.

[John Butler:]

Thanks Jonathan.

[Operator:]

Your next question comes from Ed Arce with H.C. Wainwright & Company. Your line is now open.

[Ed Arce:]

Hi guys thanks for taking my questions, appreciated. A lot of them have already been asked, but I just want to go back to your two ongoing, well one of the two ongoing planned studies anyway of FO2RWARD and TRILO2GY and I know TRILO2GY is due to start later this year, but with FO2RWARD in particular being that that would be rolled into the NDA package, I was just wondering if you could give us a little more detail and perspectives John perhaps on how you think about that adding to the speed of your commercial momentum and how that would differentiate the drug in new environment of really three closely timed competitors? And then I have a follow-up. Thanks.

[John Butler:]

Okay. Rita, maybe you want to start with that one.

[Rita Jain:]

Yes, certainly. So, I think as we mentioned earlier, we’ve enhanced the design of our Phase 2 study FO2RWARD and with the new protocol we have decided to enroll a larger sample size with a broader patient population though that still includes the ESA hyporesponder group. And within the study, we will be looking both at once-daily and three times weekly dosing, as well as obtaining data to inform ESA switching protocol. So, in all this data set will provide a range of information that can support our registration package and then as you know in innovate trials, in 2016 we are looking at new onset dialysis and then in 2017 we’re looking at established dialysis subjects whether hemodialysis or perennial dialysis and then within that trial we do allow ESA hyporesponders to be enrolled. So, I think we’re trying to have a totality of data that could inform the dialysis, as well as the non-dialysis population and we think the FO2RWARD trial will add to that data set. And I’ll turn it over to Michel.

[John Butler:]

And Michel maybe you want to comment on the commercial implication?

[Michel Dahan:]

Happy to. We have with those two studies an opportunity to really only characterize and differentiate vadadustat. Let me mention three salient points. First TIW, I mean we talked about the importance of having proved those inflexibility and that’s what we are targeting. So, we will have that as part of FO2RWARD and data will be included in our DA. But then also BSA switching data from all types of ESA’s that are being used today, including [indiscernible] and RNS. And then obviously the hyporesponder patient population. A population that has - where we see very important unmet need, and while it is a small patient population, you're talking about 10% to 15% of patients. It actually represents an important cost driver because of the unmet need and because they drive maybe 40% of the use of ESAs in the dialysis market. And so, we will data in all of those important, well in that patient population and to support the full profile of vadadustat by the time we launch.

[John Butler:]

Thanks Michelle. And Ed, you had a follow-up?

[Ed Arce:]

Yes. Thank you. Thank you both that was very helpful. The only other question was and I know Jason, you touched upon this briefly, but if you could share any sort of P&L guidance for us in 2018, particularly after the pump in the revenue from the MTPC collaboration?

[Jason Amello:]

Sure. Ed, as you know, we don't really give financial guidance on our financial results, but to guide you qualitatively, as I mentioned in the discussion, R&D is going to continue to increase because we're really targeting to have enrolment by the end of this year. And if you look at the increase from last year to this year it is rather significant, which was reflecting that check and trial coming on for where INNO2VATE was started in August 2016, and you see that significant ramp in 2017. Now, we have both of those trials running simultaneously for a full-year and trying to ramp up the enrolment by the end of this year. So, you should expect a significant ramp there, not exactly a mirror image of last year, but it would still be a rather significant ramp.

[Ed Arce:]

And maybe just to reiterate the revenue side? The MTPC [indiscernible].

[Jason Amello:]

Correct. And as I mentioned on the previous question I was asked; the cost is an element of how the revenue gets a recognized. So, if cost go up, revenue goes up. Mitsubishi is under a different arrangement then Otsuka where we are actually supplying them product and they're running their own Phase 3. So, they are funding their Phase 3 program, we’re supplying them product. So that becomes our responsibility under that agreement and that’s a much more-shorter period than the long trials that we’re running with Otsuka. So, as I mentioned in Q1 of 2018, our responsibility relative to Mitsubishi will be pretty much satisfied because we would have satisfied their product supply requirement by Q1. So, you will see the balance of any revenue that we recognized in Mitsubishi absent milestones that come in at later dates will be satisfied in Q1.

[Ed Arce:]

Okay great. Thanks. That confirms what I had from before. Appreciate it.

[Jason Amello:]

Great.

[John Butler:]

Thanks, Ed.

[Operator:]

And our next question comes from Jeff Hung with UBS. Your line is now open.

[Jeff Hung:]

Thanks for taking the question. Can you talk a little bit about why Mitsubishi Tanabe’s Phase 3 does not include the MACE endpoint [indiscernible]?

[John Butler:]

So, Jeff you were breaking up a little bit, but I think you asked why the Mitsubishi Tanabe program doesn't require a MACE endpoint and - thanks, great. So, the PMDA, Japanese regulators don't require MACE data for registration in Japan. And if you recall, when we were deciding between kind of a local program, which Mitsubishi would run, and a global program having to participate in the MACE program we really chose the local program because they could move more quickly. Yet, they recognize, our partner recognizes that having access to the MACE data could be quite important commercially and that is why we put the agreement in place where they can access that data for a payment, but of course none of the, again PMDA doesn't require the MACE data, they have - the Mitsubishi Tanabe now has all four of their trials up and running and they will, you know again they are seeing - 2019 they have been doing a fantastic job of driving those studies, the timing of those studies, and so we are expecting really to see that data in the first half of next year.

[Jeff Hung:]

Great. And then can you provide us what drove the recent changes to FO2RWARD and TRILO2GY, like was this driven by specific data or by regulators or was there something you wanted to see that you saw you wouldn't have seen in the previous design?

[John Butler:]

Yes, it really was driven by, Michel kind of referenced to it before. I mean to a large extent it was, the collaboration with Otsuka, really - we signed the European part of the agreement in April or so of last year. So, it’s really the second half of last year that it was, that was really up and running and frankly our kind of focus has been very U.S. centric and having a much more global view of our need from a commercial standpoint and looking to optimize - the commercial possibilities for the product really drove - significantly drove the changes, where we could look, have a much more holistic view of the dialysis population understand, have much more data, more publication opportunities, more to help with building value [indiscernible] et cetera outside of the US. It really was looking to optimize for the commercial opportunity here. Anything to add on that Rita or Michel.

[Michel Dahan:]

No, I think, that’s right. We’ve included endpoints for example [indiscernible].

[John Butler:]

Yeah, multiple secondary endpoint in order to support value dose globally. You mean things that you do with your partners when you have a global view on how to maximize the opportunity in all key markets.

[Jeff Hung:]

Great. Thank you.

[Operator:]

[Operator Instructions] And I'm showing no further questions.

[John Butler:]

Great. Thanks Skyler. Thanks everyone for joining us today. Have a great evening. We look forward to updating you further during the year. Thank you.

[Operator:]

Ladies and gentlemen, thank you for your participation in today's conference. This does conclude the program, you may now disconnect. Everyone, have a great day.