Portola Pharmaceuticals (NASDAQ:PTLA) Q4 2016 Results Earnings Conference Call February 28, 2017 4:30 AM ET
Ana Kapor - IR and Corporate Communication
Bill Lis - CEO
Mardi Dier - CFO
John Curnutte - EVP Research & Development
Tao Fu - Chief Commercial and Business Officer
Cyrus Amoozegar - Morgan Stanley
Phil Nadeau - Cowen & Company
Yigal Nochomovitz - Citi Group
Jay Olson - Oppenheimer
Welcome to Portola Pharmaceuticals Conference Call. This call is being recorded. At the end of the Company's prepared remarks, we will open the call for questions and we’ll provide specific instructions.
I would now like to turn the call over to Ana Kapor, Investor Relations and Corporate Communication at Portola. Please go ahead.
Thank you and welcome to Portola's fourth quarter and year end 2016 financial results conference call. Joining me are Bill Lis, Chief Executive Officer; Dr. John Curnutte, Executive Vice President of Research and Development; Mardi Dier, Chief Financial Officer; and Tao Fu, Chief Commercial and Business Officer.
We issued a press release earlier today, a copy of which can be found at portola.com in the Investor Relations section.
Before we begin, I would like to remind you that various remarks that we make on this call contain forward looking statements, including statements regarding expected regulatory and clinical actions and developments of projected operating expenses. These statements are subject to risk, uncertainties and other factors that could cause actual results to differ materially from those expressed or implied in the statements themselves.
All forward looking statements made in this call are made based in the belief that Portola as of this date only. Future events or simply the passage of time may cause these beliefs to change. For more detailed description of the risks that impact these forward looking statements please refer to our most recent Quarterly Report on Form 10-Q and our Annual Report on Form 10-K. Please be aware you should not place undue reliance on the forward looking statements made today.
Finally this conference call is the property of Portola Pharmaceuticals and any recordings, duplication or rebroadcast without the express written consent of Portola is prohibited.
With that I will turn the call over to Bill Lis, CEO of Portola.
Thank you Ana, and good afternoon everybody, and thanks for joining us.
As many of you know 2017 is a pivotal year for Portola. We have the opportunity to gain approval for two products, Betrixaban, our investigational oral Factor Xa inhibitor, and Andexanet, our investigational Factor Xa inhibitor antidote. Both these products have the potential to significantly advance the field of thrombosis for the benefit of patients and to become standards of care for the indication, whether currently no approved therapies, Betrixaban and Andexanet are highly anticipated by the medical community currently based on the clinical data but also the significant unmet medical needs.
From a regulatory standpoint we continue to answer questions from the FDA and EMA as both evaluated these products for potential approval, we believe the evidence is clear demonstrating efficacy and safety for Betrixaban and Andexanet for the indications that we are pursuing but we also recognized regulatory risk that remains.
Betrixaban a product candidate with FDA fast track designation had its NDA accepted for priority review in December is given a PDUFA date of June 24, 2017 and as we recently announced the FDA informed us at the mid-cycle review that it does not plan to schedule an advisory committee meeting based on president for drug approval we see this as positive. The EMA validated our marketing authorization applications in December under a standard review, and we expect to receive a list of questions from the committee or CHMP in the upcoming months and to receive an opinion from CHMP towards the end of this year for approval.
For AndexXa, which has breakthrough therapy designation from the FDA, we continue to make progress in resolving the complete response letter related issues and planning for resubmission of the BLA in the second quarter 2017 and we expect FDA approval by the end of this year. The initial commercial supply of AndexXa will be with generation one manufacturing process that we discussed previously, approval for the generation two manufacturing process is expected about six months after the initial approval based on a supplemental application of DIS to date all Generation 2 process validation run at Lonza, our manufacturer has met our target and we are using these factors to build commercial inventory. We remain confident in the data we submitted for the approval in AndexXa and we continue to execute and also highlight regulatory risk.
In the EU for MAA, for AndexXa we validated this in August of 2016 and we expect an opinion from CHMP in December of 2017 with approval anticipated in the first quarter of 2018. To ensure that we have had sufficient funds to achieve the approval milestones for both of these products it goes through non-dilutive financing agreements with favorable terms recently, these agreements collectively are worth up to $200 million, they strengthen our balance sheet, provide us with cash runway into 2018 assuming success with our program.
I'm now going to briefly summarize the clinical data that we highlighted with the NDA to support the approval of Betrixaban and also the data in the upcoming BLA for resubmission of AndexXa also I will highlight at a high level, our commercialization strategy and then finally, I will provide a brief update on cerdulatinib which is currently in Phase 2 for the development in the treatment of blood cancers, I will start with Betrixaban.
So the evidence for basis of approval that we submitted in the NDA is based on the Phase 3 APEX trial and specifically the primary efficacy and safety outcomes in the total study population, population of 7513 patients and in the overall population for the combined 80 milligram and 40 milligram doses, 35 and 42 days of extended duration for Betrixaban compared to 10 days, standard duration lovanox followed by placebo demonstrated a 24% relative risk reduction in the composite efficacy endpoint of asymptomatic VTE , symptomatic VTE and VTE related debt with the P value of 0.006 demonstrate a 44% relative risk reduction symptomatic VTE alone, P value of 0.004 and a 41% relative risk reduction in stroke with the P value of 0.03. Importantly, these efficacy results are achieved without a significant increase in major bleeding with P value there of 0.55 and major bleeding with the primary safety endpoint in the trial.
Importantly grade or 30% relative risk reduction in the composite primary efficacy outcome favoring Betrixaban was seen in a population of 4,937 patients in the overall population. These were the patients stratified to the higher 80 milligram dose inside the P value of 0.002 also achieve then increasingly to bleeding.
Importantly we also highlighted in the NDA that the study's primary efficacy endpoint that is patients with the positive D-dimer sub population consisted of the 3870 patients narrowing this statistical significant to the P value of 0.054 through the according to the interpretation of the statistical analysis plan by Portola and CRO.
But the primary efficacy endpoint did achieve statistical significant in the D-dimer sub population cohort with the P value of 0.048 according to the interpretation of the statistical analysis plan by the independent academic groups involved in the conduct of the study. The academic group determined that one additional patient to an event in enoxaparin should be including in the primary efficacy analysis where Portola and its CRO include at this patient only in the secondary analysis.
I will remind you that the threshold for the formal analysis of the overall study population in addition to the D-dimer sub population was p-value 0.05. Finally additional pre-specified analysis to support this formal testing and the overall sub steady population that we argued in the NDA based on the following the D-dimer cohort by central lab patients stratify the 80 milligram dose and also the modified intension to treat analysis all of which achieved the p value of less than 0.005.
In addition to the initial APEX results that we published in New England Journal Medicine more recently we published additional supporting efficacy and safety results with betrixaban based in - published in prestigious journal such as Circulation and the American Heart Journal and we expect further publications of the results in the upcoming months.
So given the priority review and the PDUFA date at June, we'll be prepared to launch betrixaban if approved in August. Since early 2016 we've hired on an experienced team of people. These are strategic marketers, sales managers, managed market personnel and medical affair specialist. These are folks in term it's a labor foundation for successful launch not only at Betrixaban but also in AndexXa. We plan to contingently higher between now and those PDUFA date hospital sales team with extensive experience and a tremendous track record in the field of thrombosis and in the hospital setting. We expect to expand this team of AndexXa approved and as particular in adoption increases following at anticipated approval.
Our commercial strategy is pretty straight forward. It's really just intensive the leverage was an existing system based in the hospital for thrombosis, medical education programs, a utilized for the patient management for VTE prophylaxis and acute medically ill patients. This infrastructure includes academic practice guidelines, hospital mission and drug treatment protocol, hospital pay per forms measures and hospital discharge and pharmacy prescription management. If you take a look back at history all successfully commercialized anti-thrombotics that are initiated in the hospital at a mission and continue to discharge and leaves this model.
This include well known product such as Plavix and other anticoagulant agent and acute coronary syndrome rolled up in the setting of acute medically ill and other indications in the hospital and all factor inhibitors for the treatment of VTE and also for the prevention of VTE falling major hip surgery.
We developed betrixaban to address the significant unmet medical need of extended VTE prophylaxis and acute medical ill. Currently there is over $24 million acute medically ill patients that admitted to the hospital annually in G7 countries in the risk of VTE through represent an addressable market was up $3 to $4 billion as you consider a extended duration of about 35 to 42 days. The current standard of care for these patients is what we studied against in the APEX trial that injectable not preparing despite its wide spread use is estimated more than 1 million VTE events and 150,000 VTE related debts occurred annually in G7 countries. This is because there is no anti-coagulant including we are prepared for any other market Factor Xa inhibitor currently approved for extended duration in this indication.
I will now turn to AndexXa, our initial indication in the U.S. is expected to be for the reversal of apixaban and rivaroxaban treated patients who experience a severe bleed with bleeds such as intracranial bleeding or bleeding into major organs. Those approvals we plan to see expansion of the label to include other Factor Xa inhibitors such as betrixaban, edoxaban and enoxaparin and also for the setting of urgent surgery. This is a large and rapidly growing market, approximately 9 million patients who are currently on all Factor Xa inhibitors in G7 countries and the uptick of this class continues to increase, while Factor Xa inhibitors have many benefits of warfarin and enoxaparin, they are also associated with major bleeding based on Phase 3 trial data of approximately 1% to 3% of patients taking oral Factor Xa inhibitor who experience the major bleed and another 1% will acquire emergency surgery.
Importantly this is consistent with the 80,000 patients in the U.S. who were admitted to the hospital due to Factor Xa related bleeding during the year 2015 is estimated that this number has increased over 150,000 U.S. hospital admissions in the next decade. What's important to remember is that this bleeding has increased with associated increased risk of death, we looked at the results of randomized clinical trials, we find that 30 day mortality rate of patients with Factor Xa inhibitor related bleeding, this intracranial bleeding exceeds 40%. This would equate to an estimated 300 to 400 deaths per month due to ICH bleeding in the U.S. alone given that the number of patients taking Factor Xa inhibitors is higher in EU side countries, we expect similarly even higher numbers in the EU.
So in the absence of an FDA approved antidote what our physicians doing, some patients who require anticoagulation received off-label treatment in the four factor TCCs. We want to be clear. These agents have demonstrated effectiveness is reversing warfarin and are approved for this medication. But they are not approved to reverse back to 10 inhibitors importantly there is no strong biological rationale for the use with Factor X inhibitors. They have failed to demonstrate reversal of Factor Xa in addition to clinical trials and also no real controls label enabling clinical trials are being conducted with these agents. Therefore we believe there is a liability.
For AndexXa, we plan to use basically the same commercial strategy and infrastructure that we outlined with Betrixaban. We will implement kind of specific strategy to manage the limited Gen 1 supply that we have talked about over the last few years upon this approval but focus on getting the age indications with no severe bleeding. These are patients with intracranial hemorrhage bleeding into critical compartments or GIs that result in hemodynamic compromise, these patients have the highest mortality rate along with going to hospital phase and the highest treatment cost will target the top trauma centers and comprehensive stroke centers to start and then once we have an increase imply from our Generation 2 manufacturing process which comes Lonza, we expect significantly expand our hospital targeting not only in United States but outside of the United States as well.
As an update to the AndexXa ongoing ANNEXA-4 study, this is a study that's enrolling patients on Factor Xa inhibitors admitted to the hospital for major bleed, to date we have enrolled more than 170 patients at sites in five countries and ultimately towards the target of 350 patients. We have had three successful data safety monitoring committee reviews with the most recent one in December.
We remain very confident in AndexXa based on the data published thus far including the robust Phase 3 data published for ANNEXA-4 in an interim study result published in the New England Journal of Medicine late last year. That interim analysis demonstrated that AndexXa rapidly substantially reversed anti-factor Xa activity. This is the anticoagulant mechanism for these drugs when administered with sustained reversal to 120 minutes through the infusion, it also showed that an estimated 80% of the bleeding patients achieved will be called excellent or good hemastatis, stoppage of bleeding over the 12 hour period following infusion.
In December, the New England Journal of Medicine published a letter to the editor on the ANNEXA-4 academic leaders updating a few data points one of them was the thrombotic event rates updating it from 18% in the 67 patients in the original paper to 12% in a subsequent analysis of 105 patients. What's important is this reflects a thrombotic event rate of 3% in the additional 38 patient that were rolled in that interim.
The rate of anticoagulation during that same interim period was 63% in the 38 patients compared to just 27% in the patients that were presented in the original New England Journal Medicine paper. We would like to remind you that is an ongoing study and that thrombotic event could continue to fluctuate.
One additional post marketing requirements that we previously mentioned is the usual care cohort. This is the study our cohort that will enable Factor Xa inhibitor patients we experience a major bleed that we are not on Andexanet. As I said previously AndexXa is unprecedented therefore we will continue to highlight the positive clinical data and also discuss regulatory and manufacturing risks.
Finally today I will turn to cerdulatinib. It's an exciting program. It's our oral dual Syk/JAK inhibitor and the development to treat relapsed in the track hematologic cancers and patients who have been treated with some of the most recent enabled therapies. We're continuing to enroll patients into our ongoing Phase 2 study. These are patients who are relapsed over factory at B-cell malignancies failed as I mentioned multiple therapies. We continue to see good clinical activity in the sponsors and expect to present initial study results at a meeting in the first half of 2017.
Finally in December we entered into an exclusive worldwide license agreement with Dermavant Sciences for the development in commercialization of cerdulatinib specifically in topical applications beyond oncology including moderate fear dermatologic indications we retained full rights to all non-topical formulations and indications.
And with that, I'll now turn the call over to Mardi Dier, our Chief Financial Officer.
Thank you, Bill.
For the fourth quarter of 2016 collaboration revenue earned under our collaboration and license agreements with BMS Pfizer, Bayer, J&J, Daiichi Sankyo and Dermavant Sciences with $13.7 million compared with $4.4 million of fourth quarter of 2015. Collaboration and license revenue for the year ended December 31, 2016 was $35.5 million compared to $12.1 million for the year ended December 31, 2016.
Total operating expenses for the fourth quarter of 2016 were $68.9 million compared with $70.7 million for the same period in 2015. Total operating expenses for the fourth quarter of 2016 included $7.9 million in stock based compensation expense compared with $6.8 million to the same period in 2015. The total operating expenses for the year ended December 31, 2016 were $305.1 million compared with $239.2 million for 2015.
Total operating expenses for the full year ended December 31, 2016 included $30.4 million in stock based compensation expense compared with $22.9 million for 2015. Research and development expenses for the fourth quarter of 2016 were $56 million compared with $59.8 million for the same period in 2015.
R&D expenses were $246.9 million for the year ended December 31, 2016 compared with $200.4 million for 2015. SG&A expenses for the fourth quarter in 2016 were $12.9 million compared with $10.9 million for the same period in 2015.
SG&A expenses for the year ended December 31, 2016 were $58.2 million compared with $38.9 million for 2015 as we increased headcount related cost commercial launch product activities and business development related cost and cost associated with professional and accounting fee.
For the fourth quarter of 2016 we reported the net loss of $53.8 million or net loss per share of $0.95 compared with a net loss of $66.1 million or net loss per share of a $1.23 for the same period in 2015. Shares used to compute net loss per share attributed to common stockholders were $56.5 million for the fourth quarter of 2016 compared to $53.6 million for the same period in 2015. Net loss for the year ended in 2016 was $269 million or net loss per share of $4.76 compared with the net loss of $226.5 million or net loss per share of $4.36 for the same period in 2015. Shared used to compute net loss per share attributable to common stockholders was $56.5 million for 2016 compared with $52 million for 2015.
For fiscal year 2017, assuming success with our programs we expected total GAAP operating expenses to be between $323 million and $344 million. For the fiscal year of 2017, we expect total pro forma operating expenses to be between $290 million and $310 million excluding stock-based compensation. These expenses will be primarily from manufacturing in both Andexanet and Betrixaban, support of ongoing clinical trials in preparation and execution for the commercial launches of both Betrixaban and AndexXa.
As of December 31, 2016 cash, cash equivalents and investments totaled $318.8 million compared to cash, cash equivalents and investments of $460.2 million as of December 31, 2015. We recently strengthened our balance sheet with two non-diluted transactions and now have runway well into 2018 assuming success with our programs. We're excited about the year ahead with the series of important milestones over this next several months that we consider to be value driving opportunities.
For Betrixaban, we anticipate FDA approval and launch in the U.S. in the second half of 2017 and an opinion from the CHMP in the fourth quarter of 2017. For AndexXa, we plan to resubmit our BLA in the second quarter of 2017 and potentially gain approval in the U.S. before year end in the U.S. In the EU we expect an opinion from the CHMP towards the end of 2017.
So I want to thank you for your ongoing interest in Portola. We will continue to update you on our progress and look forward to seeing some of you next month at the Cowen Conference and the Oppenheimer Conference and as a reminder, if you are planning to attend ACC, the ACC Meeting in Washington DC in a couple of weeks please join us at our Investor and Analyst Reception with our KOLs for members of our APACs executive committee on Friday, March 17 at 4 PM.
That concludes our comments and we'll now turn this over for Q&A. Operator?
[Operator Instructions] Our first question comes from the line of Matthew Harrison of Morgan Stanley. Your line is now open.
Hi yes, this is Cyrus on for Matt. Question about your guidance, can you give us some more color there, how much is related to the commercial ramp for Betrixaban and Andexanet versus R&D and can you help us understand what might the levers are behind these?
Yes hi, this is Mardi. Well we don't give specifics on the numbers but what we said in the past and what will continue to be true is that the main driver for R&D and actually for our operating expenses will be manufacturing in 2017 as same with 2016 because without - will be manufacturing both Betrixaban and Andexanet both Gen 1 and Gen 2 and before the products are approved, those dollars went through R&D.
And then as a reminder for selling costs, these are both hospital based programs. So in launching in the U.S. in particular we'll hire a number of sales personnel at the launch time in the August timeframe - by the August timeframe for Betrixaban and that will continue to ramp through the year and then with Andexanet sales force we will add more in 2018 and what we have said in the past with respect to U.S. hospital sales force is that in total we'll reach 125 to 150 sales reps. But that will occur over a bit of time.
Yes I think again, that the overwhelming majority is in manufacturing and the overwhelming majority in that is for Andexanet.
Got it. Thank you.
Thank you. Our next question comes from the line of Phil Nadeau of Cowen & Company. Your line is now open.
Good afternoon. Thanks for taking my questions and congratulations on the progress. Just first on AndexXa. What you have to do between hear and refilling, what are kind of the critical steps that still needs to be completed.
Yes, so we haven't given - we're not given is in full detail set but there pretty consistent with what we've outlined previously additional analytics around the product Generation 1 and we're just slowly moving through each one of those activities and deliverables.
Okay. So you feel very confident that Q2s still the right time for the filing.
Yes, we do. From what we know today Phil is one by one we're just checking them off and moving through them. So there were a number of them and we're working through them at this time.
Okay, great. And second on Betrixaban, can you give us some sort of qualitative sense of how some - interacting with the FDMS filing and I guess what we can as of outsiders will hear next in term of that review. Is there any other milestone that we'll hear or is it really just to PDUFA date next.
Yes, that's a difficult priority review. The first we understand the question itself is a long time - maybe not so much we can now with PDUFA date. So we haven’t provided a lot of specific so it is a pretty traditional review process and we just got through the mid-cycle review. So there is a lot of activity as far as question that and responses given, we expect a lifecycle review in Q2 so we expect some more activity while we including some label discussion but that's probably as much you would say.
Okay. And on the mid cycle review when you announced those…
Nadeau I need to make one more comment. Anything that is material positive or negative between now and then we will communicate.
Okay, that's helpful. And then just on the mid cycle review, there has been some controversy among investors for how they interrupt the title of your press release where you said no issues there needed a panel. How should we interrupt that, is it - that there is no major issues that the FDA product at the mid-cycle review or is it more specifically simply no major issues that required the panel, I think as I said there is a lot of debate among investors. And I have one question.
So we understand the given complexity of the results. So we understand that the people are going to see on both sides. I think we just tend not to comment. As we said, we see it as positive and honestly there is a positive that we don’t have an headcount and they transacted it. You have a prior review and you don’t have an headcount that’s about the highest probability of gaining approval and if you have a prior review within headcount it's probably too little less, so it will take it as a positive.
I don’t want to speak on behalf of the agency but we understand why people would be on either side of and you probably just no need to comment anything further again we will go back if we thought something that’s material in the mid cycle review that was negative we would say that.
So we just reset from the day one, when we said top line results that were confident right we just keep checking boxes off and gaining a little bit more confident each day and this is just another mid cycle reviews another box we checked we hope to is approved. And I think that’s the best way to characterize if you’re understanding people why you all asking the questions.
Great, that's fair enough. Thanks for taking my questions and congratulations.
Thank you. Our next question comes from the line of Yigal Nochomovitz of Citi Group. Your line is now open.
Hi, thanks for taking the questions. Bill can you comment on whether the FDA is going to require another instruction of the CMC Biologics facility in Bothell, Washington either before you resubmit the BLA or after? Thanks.
That's a good question. John maybe you want to give an answer to that to the extent you can?
Yes it is a good question, I would say at this point we have no indication that another inspection will take place as we share the feedback from the agency following April inspection what was incorporated into the complete response letter and as Bill said a little bit earlier, we have the complete risk of all the elements of the complete response letter, we met with the agency to discuss these and our plans and we are working through all of them.
So based on what we know right now what we know is that we will be addressing issues raised from the first inspection as part of the CRO response then we have no indication of another inspection.
Okay, thanks. And can you provide any other additional updates on the thrombotic events rate post the December update that you gave in ANNEXA-4 or is that the most recent?
That's what we have for now and again lot of the executive committee events AndexXa, ANNEXA-4 plans to give an additional update, I would say it's probably likely before the end of the trial but we can't give an indication when.
Okay. And can you comment at this point on the split between the intracranial hemorrhage bleed in ANNEXA-4 versus peripheral i.e. GI bleeds?
Well John I think let me answer and then John you can comment. I think in the New England Journal Publication we broke out, we split it out and to my knowledge John what we say remains consistent with that for...
I didn't quite catch up a portion of your question regarding in terms of the intracranial sub-types is that what you are asking about?
No sorry, I just was asking what's the mix on present intracranial hemorrhage that you enrolled in ANNEXA-4 versus GI or peripheral?
So as we have said previously one of the things that the FDA has communicated with this particular interest in the intracranial given the very significant unmet medical need there and so we have been enriching what not made publicly, what the current blend is there are substantial number of intracranial hemorrhages in the doses, I think if you look at the published paper that was online end of August that we presented at ESC and we have had further enrichments since that time. So it is heavily rich I believe but it heavily focused on intracranial as we and the agency view that as a very important subtype for bleeding.
Okay, great. And then I guess I had a little commercial question on ANNEXA, I know you guys have said before that initially you are going to target 200 to 300 hospitals, have you talked about or can you discuss how many hospitals you are going to target at peak once you are fully enrolled principally launched with Lonza batch 2 so obviously that will be helpful to the calculations on long-term market segments?
I think - the thing now is the initial launch of Betrixaban for that we will plan somewhere between 500 and 1000 to start and then that usually expand somewhere around 12 or 1,500 and covers an overwhelming majority of the targets. And so you can see over a long period of time that that would be the same trajectory that with Andexanet as well. We would start lower than 500 and it will probably take longer to ramp to the 1200 to 1500 but certainly it would be somewhat consistent and again assuming success with Betrixaban it would be the same sales team.
Got it, all right. Thank you.
Thank you. Our next question comes from the line of Jay Olson of Oppenheimer. Your line is now open.
Hi guys, congrats on the progress and thanks for taking my questions. I'm curious about the agreement with HealthCare Royalty Partners, can you describe how that deal came about and what sort of due-diligence was done by HealthCare Royalty Partners including the type of data they may have had access to during their due-diligence process?
Yes hi Jay, it's Mardi. We had a nice long relationship with HealthCare Royalty Partners, and the deal came about even from last year when we had communicated that we were looking for non-dilutive non-equity dilutive ways to bring capital into the company and we are able to close two of those deals, one was our partner BMS and Pfizer brining in $50 million of the company and then subsequent to that, the Healthcare Royalty deal was $50 million in upfront, and then $100 million upon approval on the AndexXa.
We have been talking to healthcare royalty partners for better part of 2016 in fact and of course were the CRO and we had to look at the deal actually a slightly different way but I think it came up positively. Let's just say that, they are a very - a team with deep expertise and they had access to whatever they needed to review to get comfortable with consummating this deal. So that varies to due diligence process.
Great, thank you, that’s very helpful. And then I guess separately it looks like there is a number of interesting abstract titles posted on the ACC website. Could you may be highlight a few key things that we should be paying particular attention to.
That's for us and for others or just us Jay?
Well Friday for sure there is a special session in thrombosis and there will be a presentation on Andexanet and APEX by people who are on the executive committees of our program so that will be important and that's why we are kind of - food and drinks immediately after and then I think what would also [indiscernible] had a few extracts on Betrixaban accepted and they are on the..
We'll find that date, we’ll make sure we give you a specific - there are few more abstracts that we can - that will put press release out to make sure everybody knows.
Let's say here is one expanded duration. Okay, this is the short duration that the hospital period and the longer duration period for Betrixaban and for Andexanet.
Okay, great. Thank you very much.
We'll send something else, our commercial team.
Yes, we’ll send something else.
Send something else.
[Operator Instructions] Our next question comes from the line of [indiscernible] WM Blair. Your line is now open.
Hi, thanks for my call. Couple on AndexXa, first of all have you given any update on the Day 120 questions from the EMA? Have those been responded to and do they include anything in there about analytic method validation for CMC.
John do you want to...
Sure, I think.
I don’t think we said anything specifically about the Day 120 questions early given out any. Nor do we find things but maybe we can get high level comments.
Yes, two high level comments typically the Day 120 comments are fairly similar to the Day 80 comments and I think we've talked about the Day 80 comments and generally there are very similar not a little bit more strength and focused and that was a our experience with the AndexXa what the EMA was would be can growth and with that general experience.
And with regard to the kinds of questions that are in there, I think what we said in and again I’ve gone through all of these there is really nothing new in the EMA comments that we have not already talked to the FDA about. So again very fortunately for us there is no real new ground that's been broken by the EMA some of the issues that the FDA had themselves raise was not reflected in there.
So, in terms of a [indiscernible] and the EMA issues, really would represent a subset within the broader set of comments and concerns that the FDA has raised. So no big surprises and very much things that we have and are already working on.
Sure, thanks John. And then Bill if you can just clarify what exactly you said regarding that usual care cohort for ANNEXA-4. I couldn't quite get that some of your planning on to launch or if you still on discussions with the FDA on that?
Yes, good question. We are still in discussions with almost this is a post marketing commitments one that probably that we expect to go up even much further from a timeline standpoint then the ANNEXA-4 study. And so we continue to kind of tweak and immense the initial - the original protocol and our expectations which will come through file agreement with the FDA and some other details and likely initiate this year sometime.
Okay, great. Thanks for taking my questions.
[Operator Instructions] And that does conclude today's program. You may all disconnect. Everyone have a great day.
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