Q4 2019 Earnings Call
Ladies and gentlemen, thank you for standing by and welcome to that caveat fourth quarter and full year 2019 financial results and business highlights conference call.
Operator: Ladies and gentlemen, thank you for standing by, and welcome to the Akebia fourth quarter and full year 2019 Financial Results and Business Highlights conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please call 1-866-422-0111. Thank you. Please press star zero. I would now like to hand the conference to your host today, Kristen Shepard. Please go ahead, ma'am.
This time, all participants I know listen only mode.
So to speak of presentation, there will be a question and answer session.
Good question. During this session you want me to press Star one on your telephone.
Please be advised that today's conference is being recorded.
If you acquire any further assistance. Please press star Zero I would now like to have the conference yesterday Kristen Sheppard. Please go ahead.
Thank you and good morning, My name is Kristen Sheppard, Vice President Investor Relations with the caveat. Thank you for joining us to discuss it can be a fourth quarter and full year 2019 financial results in our recent business highlights.
Kristen Shepard: Thank you and good morning. My name is Kristen Shepherd, Vice President of Investor Relations with Akebia. Thank you for joining us to discuss Akebia's fourth quarter and full year 2019 financial results and recent business highlights. The press release containing the company's financial results for the fourth quarter and the full year was issued earlier this morning and is available on our Investor Relations website. For your convenience, an audio replay of today's call will also be available on our website shortly after we conclude today's webcast. Joining our call today are John Butler, President and Chief Executive Officer, and Jason Amello, Chief Financial Officer. Before we begin, I'd like to remind everyone that this conference call includes four forward-looking statements. Each foregoing statement contained in this call is subject to risks and uncertainties that could cause actual results to differ materially from those described in these statements.
The press release containing the Companys financial results for the fourth quarter in the full year was issued earlier. This morning and is available on our Investor Relations website.
For your convenience and audio replay of todays call will also be available on our website. Shortly after we conclude todays webcast.
Joining our call today, or John Butler, President and Chief Executive Officer, and Jason and Mellow Chief Financial Officer.
Before we begin I'd like to remind everyone that this conference call includes forward looking statements. Each forward looking statement contained in this call is subject to risks and uncertainties that could cause actual results could differ materially from those described in these statements.
Additional information regarding these factors is described in the risk factors and management's discussion and analysis sections of our most recent quarterly and annual reports filed with the FCC.
Kristen Shepard: Additional information regarding these factors is described in the Risk Factors and Management's Discussion and Analysis sections of our most recent quarterly and annual reports filed with the SEC. The forelooking statements on this call speak only as of the original date of this call, and we do not undertake any obligation to update or revise any of these statements. With that, I'd like to turn the call over to our CEO, John Butler.
The forward looking statements on this call speak only as of the original datasets called and we do not undertake any obligation to update or revise any of these statements.
With that I'd like turn call over to our CEO sound Butler John.
John P. Butler: Thanks, Kristen. Good morning, everyone, and thanks for joining us today. 2019 was a year of considerable progress for Akebia as we continue to advance our Global Phase III program for Beta-DoStat and position Akebia for the future. More specifically,
Thanks, Chris and good morning, everyone and thanks for joining us today.
2019 was Europe considerable progress for a TV yet as we continue to advance our global Phase three program forgot to do Scott and position to keep your for the future.
More specifically.
We made great strides executing on our global Phase three program for about a do stuff, having achieved full enrollment and protect and innovate so were 7400 patients.
John P. Butler: We are making great strides executing on our Global Phase III program for Vatidustat, having achieved full enrollment in Protect and Innovate with over 7,400 patients. In Japan, our collaboration partner Mitsubishi Tanabe submitted a JNDA for Vatidustat. If approved, this is expected to lead to the first launch of Vatadustat worldwide this year. We added key members to our senior team and bolstered our capabilities by successfully integrating a 140-person nephrology-focused commercial organization, and we executed on our financing strategy. Strengthening our balance sheet with a $100 million non-dilutive term loan.
In Japan, our collaboration partner Mitsubishi Tanabe submitted a J.M.D.A. for about a do stuff.
If approved this is expected to lead to the first launch about at least at worldwide. This year.
We added team members to our senior team and bolstered our capabilities by successfully integrating a 140 person nephrology focused commercial organization.
And we executed on our financing strategy strengthening our balance sheet with a 100 million dollar nondilutive term loan.
As a result to these achievements, we entered 2020 well position with significant opportunities to continue advancing our mission the better the life of each person impacted by kidney disease.
John P. Butler: As a result of these achievements, we entered 2020 well-positioned with significant opportunities to continue advancing our mission to better the life of each person impacted by kidney disease and build long-term value for our shareholders. With many significant milestones on the horizon, 2020 is already shaping up to be equally, if not more exciting, than 2019. We've developed what I think is an exciting path forward for Vatadustat. So, let me summarize the big picture at Akebia and what we're focused on in the coming months and throughout the year. Our highest priority remains the successful execution of our Global Phase III program for beta-DUSTAT, our investigational HIF-PHI being developed for the treatment of anemia due to CKD, which we believe is our largest value driver. To that end, I'm excited to say that the countdown to our data has begun.
Build long term value for our shareholders.
With many significant milestones on the horizon 2020 is already shaping up to be equally if not more exciting in 2019.
We've developed but I think is an exciting path forward forgot to do stuff.
So let me summarize the big picture to keep yet and what we're focused on in the coming months and throughout the year.
Our highest priority remains the successful execution of our global Phase three program for about a do stuff.
Instigations, if PHR being developed for the treatment of anemia due to CPG, which we believe is our largest value driver.
To that end I'm excited to say that the count onto our data has begun.
John P. Butler: In just a short time, next quarter in fact, Akebia plans to provide the first readout of our Global Phase III program for Beta-DoStats. We expect to report top-line data from INNOVATE, our studies in patients with anemia due to CKD on dialysis, in Q2. We expect to follow that with top-line data from PROTECT, our studies in non-dialysis patients with anemia due to CKD, in the middle of this year. It's incredibly exciting for all of us at Akebia to consider how close we are to the data readouts and to the potential introduction of Vatadustat into our nephrology-focused commercial engine, subject to regulatory approval. Akebia has an incredible opportunity to make a difference in the lives of patients with anemia due to CKD. An estimated 5.7 million people in the U.S. suffer from anemia due to CKD. Essentially, every organ in the body is affected by this disease, most notably the kidneys and heart.
Just a short time next quarter in fact, I keep your plans to provide the first read out of our global Phase three program for about a do stuff.
We expect to report topline data from innovate our studies in patients with anemia duty CKD on dialysis in Q2.
We expect to follow that with topline data from protect our studies and non dialysis patients with anemia due to CKD the middle of this year.
It's incredibly energizing to all of us to keep yet to consider how close we are to the data readout answer the potential introduction of data do stat into our nephrology focused commercial engine subject to regulatory approval.
I keep it has an incredible opportunity to make a difference in the lives of patients with anemia duty CKD.
An estimated 5.7 million people in the U.S. suffer from anemia due to CKD.
Virtually every organ and the body is affected by this disease, most notably the kidneys and heart.
There are limitations to the current standard of care in treating and managing this disease, including the risk of cardiovascular events.
John P. Butler: There are limitations to the current standard of care in treating and managing these conditions, including the risk of cardiovascular events. Our goal is to establish Vatidustat, upon regulatory approval, as a new oral standard of care to address important patient and prescriber needs with a differentiated safety profile compared with the current standard of care, ESA. We have a tremendous amount of confidence in our clinical development program and believe it's designed for clinical, regulatory, and commercial success. Very importantly, we expect clear data readouts for efficacy and safety. First, both Innovate and Protect are designed to assess non-inferiority for efficacy and cardiovascular safety for Vatidustat using an active control, DARPA, POET, and ALPHA, an injectable ESA, which is the current standard of care. Simply put, we believe that in order to change the standard of care, you need to compare it to the standard of care. We believe this will enable a straightforward collection and analysis of major adverse cardiovascular events, or MACE, across the relevant study and ultimately, a clear and understandable data readout on both efficacy and safety, setting us further apart from our competition. Now, let's go a little deeper into what differentiates Vatadustat.
Our goal is to establish about to do that upon regulatory approval as a new oral standard of care to address important patient and prescriber needs with a differentiated safety profile compared with the current standard of care Yesterdays.
We have a tremendous amount of confidence in our clinical development program and.
I believe it's designed for clinical regulatory and commercial success.
Very importantly, we expect cleared data read outs for efficacy and safety.
First both innovate and protect are designed to assess noninferiority for advocacy and cardiovascular safety for about a do start using an active control dobre potent alpha an injectable yesterday, which is the current standard of care.
Simply put we believe that in order to change the standard of care you need to compare to the standard of care.
We believe this will enable street Ford collection and analysis of major adverse cardiovascular events or mace across the relevant studies and ultimately a clear an understandable data readout on both efficacy and safety setting a further apart from our competition.
Going a little deeper into what differentiates us not to do stuff.
If successful. These studies, we expect that to do start to be the first drug <unk> of its class in the U.S. and you markets with clear data directly comparing this outcomes to the current standard of care in both dialysis and non dialysis patients.
John P. Butler: If successful in these studies, we expect Vatadustat to be the first drug of its class in the U.S. and EU markets with clear data directly comparing its outcomes to the current standard of care in both dialysis and non-dialysis. We believe these data will be highly informative for physicians, patients, and payers as they make important decisions about patient care and a key consideration when differentiating between HIF-PHIs in the class We have thoroughly and thoughtfully constructed a Global Phase III program, which was designed after extensive dialogue with the FDA and European regulators. We have a straightforward statistical analysis plan in place, and a prospectively defined and agreed-upon non-inferiority margin with the FDA and EMA. And we also agreed with the FDA on the key components of our statistical analysis.
We believe these data will be highly informative for physicians patients and payers as they make important decisions about patient care.
He consideration when differentiating between if ph eyes in the class.
We have thoroughly and thoughtfully constructed a global phase three program, which was designed after extensive dialogue with the FDA and European regulators.
We have a straightforward statistical analysis plan in place.
Prospectively defined and agreed to Noninferiority margin with the FDA anyway.
And we also agreed with the FDA on the key components of our statistical analysis plan.
All of which further increase our confidence in the success of our program.
John P. Butler: All of which further increases our confidence in the success of our program. So this is a very exciting program on multiple levels, and we believe all of this sets up an incredibly important period in the Akebia story this year. Expected top-line data readouts from our Global Phase III program for about a year. Consistent with the timelines we set forth over a year ago, we expect to report top-line data from Innovate next quarter, followed by top-line data from Protect in the middle of this As you would expect, as the time approaches, we'll move into a quiet period with respect to our communications with investors and analysts so that we can analyze the top-line data and prepare for release. We plan to submit additional data from these studies for presentation at future scientific venues and publication in peer-reviewed journals. And that's not all.
So this is a very exciting program on multiple levels and we believe all of this sets up an incredibly important period in the keep your story this year.
Expected topline data Readouts from our global Phase three program for about a do stuff.
Consistent with the timelines, we set forth over a year ago, we expect to report topline data from innovate next quarter, followed by topline data from protect the middle of this year.
As you would expect that's the time approaches will move into a quiet period with respect to our communications with investors and analysts. So that we can analyze the topline data and prepare for release.
We plan to submit additional data from these studies for presentation at future scientific venues and publication in peer reviewed journals.
And that's not all as I mentioned earlier, we've developed I think is an exciting passport forgot to do stuff.
John P. Butler: As I mentioned earlier, we've developed what I think is an exciting path forward for Vatidu staff. Recently, we announced an agreement with our partner in dialysis, V4 Pharma, to potentially access a Priority Review Voucher, or PRV, for the Vatidustad NDA with the FDA to expedite review. While there's more work to be done, we believe this path would meaningfully enhance the potential of bringing Vatidustad to patients as quickly as possible, subject to regulatory approval. Finally, we believe we are well-positioned for a very strong Vatidustat launch upon approval, with our partner Otsuka sharing in the launch costs and responsibilities, and a distribution agreement with V4Pharma that facilitates access to up to 60 percent of dialysis patients in the U.S., coupled with our existing nephrology-focused commercial organization.
Recently, we announced an agreement with our partner in dialysis before pharma to potentially access a priority review belcher or PRB for the data do set in D.A. with the FDA to expedite review.
Well, there's more work to be done we believe this path would meaningfully enhance the potential of brings out at least at the patients as quickly as possible subject to regulatory approval.
Finally, we believe we are well positioned for a very strong got to do start launch upon approval with our partner Otsuka sharing in the launch costs and responsibilities and a distribution agreement with before pharma that facilitates access up to 60% of the dialysis patients in the U.S., coupled with our existing nephrology focused commercial organs.
As Asia.
I'm very pleased with the strength of our partnerships and I'm encouraged by the confidence in a boozy hours in our partners continues to demonstrate in both about to do stat and to keep yet.
John P. Butler: I'm very pleased with the strength of our partnerships, and I'm encouraged by the confidence and enthusiasm our partners continue to demonstrate in both Vatadustat and Akebia. These partnerships continue to allow us to creatively and cost-effectively advance Vatadustat in ways that we believe have the potential to drive significant value for our investors. When you take all of these efforts, our depth of experience, the design of our clinical program, the potential to accelerate our NDA with a PRV, and our launch plans, you can see why we're so excited about this. I'll stop there and let Jason take you through the numbers.
These partnerships continue to allow us to creatively and cost effectively advanced about a do stat in ways that we believe have the potential to drive significant value for our investors.
When you take all of these efforts are depth of experience the design of our clinical program the potential to accelerate or in D.A. with the PRB and our launch plans.
You can see why we're so excited about the future.
I'll stop there and let Jason take you through the numbers.
Jason Amello: Thank you, John. And good morning.
Thank you John and good morning, as John mentioned, our highest priority is executing on our global phase three programs that attitudes that.
Jason Amello: As John mentioned, our highest priority is executing on our global phase three program for that to do step. We're also making significant progress to further developing our commercial strategies and capabilities to maximize the value of attitude stat, subject to approval. As we go through the financial results for the fourth quarter and the full year of 2019, it's important to keep in mind for comparison purposes that our merger with Carex Biopharmaceuticals closed on December 12, 2018, and as a result, 2018 only reflects 18 days of Carex operating results through December 31, 2018. So starting with revenue, total revenue was $69.6 million for the 4th quarter of 2019 compared to $59.9 million for the 4th quarter of 2018, and $335 million for the full year of 2019 compared to $207.7 million for the full year of 2018.
We're also making significant progress is further developing our commercial strategies and capabilities to maximize the value of that as you said subject to approval.
Let me go through the financial results for the fourth quarter in the full year 2019, it's important to keep in mind for comparison purposes that our merger with Keryx Biopharmaceuticals closed on December 12, 2018, and as a result 2018 only reflects heating days a cure operating results through December 31st 2018.
[music].
So starting with revenue total revenue was 69.6 million for the fourth quarter of 2019 compared to 59.9 million for the fourth quarter 2018.
335 million to the full year 2019, compared to 207.7 million for the full year 2018.
Our collaboration agreements are both highly strategic an important elements of our financial strength and given that how collaboration and license revenue continues to be a significant source of revenue for us reflecting the value. We are creating as we continue to execute and advance our programs.
The majority of our collaboration revenue for both periods relates to our Super agreements.
Jason Amello: Our collaboration agreements are both highly strategic and important elements of our financial strength. Given that, our collaboration and licensed revenue continues to be a significant source of revenue for us, reflecting the value we are creating as we continue to execute and advance our program. The majority of our collaboration revenue for both periods relates to our ATSUKRA agreement. Historically, ATSUCA had funded 52.5% of our Phase 3 development costs at UTSCAT, and starting in Q2 2019, ATSUCA began funding 80% of these costs. Collaboration revenue was $40.6 million for the fourth quarter of 2019, compared to $53 million in the fourth quarter of 2018, and $223.9 million for the full year of 2019, compared to $200.9 million for the full year of 2018. The change in both periods is due to the timing in which VAT-induced debt development expenses are incurred and the associated revenue being recognized on a percentage of completion basis. Continued progress, and future collaboration revenue will also come in the form of additional milestones and royalties, which I'll discuss in a moment.
Historically have to get funded 52.5% of our phase three development cost is after you sat and starting in Q2 2019 typically get funding 80% of these costs collaboration revenue was 40.6 million for the fourth quarter 2019, compared to 53 million in the fourth quarter 2018 and 223.
Nine nine for the full year 2019, compared to 200.9 million for the full year of 2000 peachy.
The change in both periods due to the timing in which now did you stepped development expenses are incurred in the associated revenue being recognized on a percentage of completion basis.
But continued progress feature collaboration revenue will also come in the form of additional milestones and royalties so I'll discuss in a moment.
Net product revenue for the sales of Auryxia was 28.9 million for the fourth quarter of 2019, compared with 6.8 million for the 18 days of 2018, and a 111.1 million sort of full year 2019, compared to 6.8 million, but it's 18 days in two to 2018.
If you were to add the unaudited sales recorded by Keryx before the merger pro forma net revenue net product revenue from the seven auryxia for the full year 2018 would've been approximately 96 million.
Cost of goods sold associated with the manufacturer of Auryxia for 38.1 million for the fourth quarter 2019, which includes noncash charges related to the application of purchase accounting as a result since the merger Keryx.
Jason Amello: Net product revenue for the sales of Aritzia was $28.9 million for the 4th quarter of 2019 compared with $6.8 million for the 18 days of 2018, and $111.1 million for the full year of 2019 compared to $6.8 million for the 18 days of 2018. If you were to add the unaudited sales recorded by Carex before the merger, pro forma net product revenue from the sales of Rixia for the full year of 2018 would have been approximately $96 million. Cost of goods sold associated with the manufacture of Erixia was $38.1 million for the fourth quarter of 2019, which includes non-cast charges related to the application of purchase accounting as a result of the merger with Carrick, of $18.8 million to inventory step-up and $9.1 million to the immunization of intangible assets.
18.8 million to inventory step up and 9.1 million to the amortization of intangibles.
Cost of goods sold was was 145.3 million for the full year 2019, which includes noncash charges of 70.4 million to inventory step up and 36.4 million amortization of intangibles.
Well, we further down the piano R&D expenses were 80.4 million for the fourth quarter 2019, compared to 87.1 million for the fourth quarter of 2018, and 323 million for the full year 2019, compared to 291 $291 million or the full year 2018.
The change in both periods is largely attributable to a change in costs associated with our research and development programs, including protecting entity phase three studies as they advance towards read out this year.
It's important to keep in mind that 80% of our phase three costs are reimbursed by exercise, which gets recorded as collaboration revenue as I mentioned earlier.
Selling general and administrative expenses were 44.9 million for the fourth quarter of 2019 compared to 55.1 million for the fourth quarter of 2018, which included $41.7 million at merger related expenses in 2018.
Jason Amello: Cost of goods sold was $145.3 million for the full year 2019, which includes non-cash charges of $70.4 million for inventory step-up and $36.4 million for amortization of intent. Moving further down the P&L, R&D expenses were $80.4 million for the 4th quarter of 2019 compared to $87.1 million for the 4th quarter of 2018, and $323 million for the full year of 2019 compared to $291 million for the full year of 2018. The change in both periods is likely attributable to a change in costs associated with our research and development programs, including our Protect and Innovate Phase III studies as they advance towards readout this year. However, it is important to keep in mind that 80% of our Phase III costs are reimbursed by Otsuka, which gets recorded as collaboration revenue, as I mentioned earlier.
For the full year 2019, Sq name was $149.5 million compared to 87.1 million for the full year 2018, which included $49.5 million at merger related expenses in 2018.
Excluding the merger related expenses in 2018, the increase for both periods over 2018 is primarily attributable to having a full year of auryxia commercialization related costs in 2019 versus only 18 days in 2018.
As a result for the core going operating results, we reported a net loss of 94.5 million for the fourth quarter of 2019 compared to 60.1 million for the fourth quarter of 2018.
In 279.7 million for the full year 2019, compared to 143.6 million for the full year 2018.
Again, I point out that the net loss for the fourth quarter and the full year 2019 includes the impact of noncash charges to the goods sold up 27.9 million and $106.8 million respectively.
Related to the application of purchase accounting for the merger Keryx I mentioned earlier.
Looking ahead, assuming approval of added to set in Japan, we expect to receive a $15 million regulatory milestones.
Jason Amello: Selling general and administrative expenses were $44.9 million for the fourth quarter of 2019 compared to $55.1 million for the fourth quarter of 2018, which included $41.7 million of emerging related expenses in 2018. For the full year of 2019, SG&A was $149.5 million, compared to $87.1 million for the full year of 2018, which included $49.5 million of budget-related expenses in 2018. Excluding the merger-related expenses in 2018, the increase for both periods over 2018 is primarily attributable to having a full year of Erixia commercialization-related costs in 2019 versus only 18 days in 2018. As a result of the foregoing operating results, the company reported a net loss of $94.5 million for the fourth quarter of 2019, compared to $60.1 million for the fourth quarter of 2018, and $279.7 million for the full year of Again, I want to point out that the net loss for the fourth quarter in the...
And then from Mitsubishi cannot be this year.
Also as we move past our innovative protect read outs that are expected in Q2 in mid 2020, respectively. We expect both associated R&D expense expenses and revenues to decrease.
Separately I'm not that subject to the terms of our collaboration agreements with our strategic partners I keep you have to potentially received development and regulatory milestone payments from West Africa. Upon the approval of attributes that in the U.S. and in Europe.
Lastly, given the pending litigation in fundamental impact that CMS is noncoverage decision continues to have on our business, we're not providing guidance on auryxia revenue continued to be cautious in our planning pharmacy net product revenue for 2020.
We encourage you to do the same.
Over the longer term, we remain optimistic about auryxias growth prospects.
With respect to our capital position cash cash equivalents going available for sale Securities for 147.7 million at December 31st 2019.
We are pleased to have extended our cash runway Wellington 2021 through disciplined spending and the identification of operating efficiencies coupled with the receipt of a $15 million regulatory milestones and CPC, assuming approval of how to do sat in Japan.
Any additional sales a common stock under our ATM facility with Cantor Fitzgerald.
The company received net proceeds of 73.5 million upon the sale of 10.7 million common shares at a weighted average price of $7.04 per share.
Jason Amello: 2019 includes the impact of non-cash charges to cost of goods sold of $27.9 million and $106.8 million, respectively, related to the application of purchase accounting for the merger with Carex that I mentioned earlier. Looking ahead, assuming approval of the attitude stat in Japan, we expect to receive a $15 million regulatory milestone payment from Mitsubishi Tanabe this year. Also, as we move past our Innovate and Protect readouts, which are expected in Q2 and mid-2020, respectively, we expect both associated R&D expenses and revenues to decrease. I'll note that, subject to the terms of our collaboration agreements with our strategic partners, Akebia could potentially receive development and regulatory milestone payments from Watsuka upon the approval of attitudes debt in the U.S. and in Europe. Lastly, given the pending litigation and fundamental impact that CMS's non-coverage decision continues to have on our business, we are not providing guidance on Erixia revenue and continue to be cautious in our planning for Erixia net We encourage you to do the same.
Were 16.8 million was received in Q4 2019, and 56.7 mine with received this quarter.
In line with good corporate governance, we expect to file a new ATM this quarter.
Lastly, we ended the year, what approximately 121.7 million shares outstanding.
With that I'll turn it back to be operator for questions.
Thank you as a reminder to ask a question you will need to press star one on your telephone.
I wish I had question first the pankey. Please standby we compile the candy roster. Our first question comes from Chris Raymond with Piper Sandler Your line is open.
Thanks, I'm just a couple of questions.
The priority review voucher I Wonder if you could just talk about your confidence I guess in in the regulatory package that makes you you know I guess sort of confident that.
You had an eight month review.
Just kinda comparing this to the decision by your competitor not to pursue that.
You know kind of just curious you know in terms of Ah.
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Signals feelings you get maybe from an FDA et cetera, obviously, you must have had some some degree of confidence to do this maybe talk about that little bit.
Operator: Over the longer term, we remain optimistic about Aritzia's growth prospects. With respect to our capital position, cash, cash equivalents, and available for sale securities were $147.7 million at December 31, 2019. We are pleased to have extended our cash runway well into 2021 through disciplined spending and the identification of operating efficiency, coupled with the receipt of a $15 million regulatory milestone from MCPC, assuming approval of attitude stat in Japan, and the additional sales of common stock under our ATM facility with Cantor Fitzgerald. The company received net proceeds of $73.5 million upon the sale of 10.7 million common shares at a weighted average price of $7.04 per share, of which $16.8 million was received in Q4 of 2019 and $56.7 million was received this quarter. In line with good corporate governance, we expect to file a new APM this quarter. Lastly, we ended the year with approximately 121.7 million shares. With that, I'll turn it back to the operator.
Yeah sure Chris Thanks, very much for the question I'm really just goes back to the program right I mean, the clarity of the data that we expect to get from our phase three programs for both innovate and protect.
No weve.
And saying this for.
For years now you know about our expectation around.
How are you will be able to analyze a interpret our data and by extension. How we expect the agency will be able to do that in an efficient manner as well and that gives us tremendous amount of confidence that.
Taking on a PRB and accelerating that.
That review I will pay grade dividends in the future.
Okay and then.
Just a a maybe a housekeeping issue we found on Clin trials Dot Gov. You guys. Just recently posted a phase one trial in healthy volunteers to assess a I think it's looking at the [noise].
You know effects of phosphate binders and the on the PK about a D. Stat can you maybe talk about the reasoning there and.
You know is that a up.
Gating factor at all on your and your package or is this more of a.
Chris Raymond: Thank you. As a reminder, to ask a question, you will need to press star 1 on your telephone. To withdraw your question, press the pound key. Please stand by while we compile the Q&A roster. Our first question comes from Chris Raymond with Piper Sandler. Your line is now open.
Marketing study if you will.
Yes, we decided to add a drug drug interaction studies with ER with phosphate binders.
You know we have done a number of did you guys in the past and made the decision with our partner that it made sense to do this it's no. These are pretty quick studies. This wont wont be a gating item in our filing at all.
John P. Butler: Hey, thanks. I just have a couple of questions. On the Priority Review Voucher, I wonder if you could just talk about your confidence, I guess, in the regulatory package that makes you, you know, again, sort of confident that in an eight-month review, just kind of comparing this to the decision by your competitor not to pursue that, you know, I'm kind of just curious, you know, in terms of, you know, signals, feelings you get maybe from FDA, et ceter Just maybe talk about that a little bit.
Cool thanks very much.
Thanks, Chris.
Thank you. Our next question comes from Eric Joseph with JP Morgan. Your line is now open.
Good morning, Thanks for taking the question.
Can you talk a little bit about where things stand in terms of I'm a bit as you said manufacturing and CMC.
Whether there are any.
Scale up sort of stability requirements that are required to move through kind of launch and.
I guess related to that to what extent.
John P. Butler: Sure, Chris. Thanks very much for the question. Really, this goes back to the program, right? The clarity of the data that we expect to get from our Phase 3 program for both innovate and protect. We've been saying this for years now about our expectations around how we will be able to analyze and interpret our data and, you know, by extension, how we expect the agency will be able to do that in an efficient manner as well. And that gives us a tremendous amount of confidence that taking on a PRV and accelerating that review will pay great dividends in the future. Okay, good.
You might have a asia or trying to exposure for you to do said many exactly thanks.
Thanks, Eric So what I'm. So yes, we're obviously, obviously hard at work on getting everything prepared for for filing our expectation for filing forgot to do status that we will have.
Multiple.
Hi, and drug product manufacturers as part of our initial label and all of the work that we need for registration is completed and obviously, we also have to have validation work done for a four jobs for Japan for PMTA, So that works obvious.
Actually is completed as well as that is well under review so.
You know, we feel very confident about where we are with that.
There, we don't think that there's any impact from China, we do have manufacturing.
John P. Butler: Just maybe a housekeeping issue, we found on ClinTrials.gov that you guys just recently posted a phase one trial in healthy volunteers to assess the effects of phosphate binders on the PK of the adidiv tag. Can you maybe talk about the reasoning there and is that a gating factor at all in your package, or is this more of a marketing study, if you will?
Second source in.
In China, but that validation work is ongoing now and we expect that.
There won't be any impact on on timing for review or approval.
It is obviously the corona virus, obviously that.
And constantly evolving situation and we will continue to monitor to that as well and frankly it at the end to them in the most important thing for US is patient safety and and we think about.
John P. Butler: Yeah, we decided to add drug-drug interaction studies with phosphate binders. We had done a number of DDIs in the past and made the decision with our partner that it made sense to do this. These are pretty quick studies. This won't be a gating item in our filing at all. Cool. Thanks very much.
You actually even that's that's really.
Where our primary thought is this is a very fragile population the dialysis population, who we deal with but but we haven't seen any impacts from it at this point, but we'll continue to monitor.
Got it that's very helpful. Thanks for taking my question I guess, maybe a follow up here.
John P. Butler: Thanks, Chris.
Eric Joseph: Operator Thank you. Our next question comes from Eric Joseph with J.P. Morgan. Your line is now open.
I just.
Is it.
There any way that you can kind of help guide.
John P. Butler: Good morning, thanks for taking the questions. Can you talk a little bit about where things stand in terms of beta use, manufacturing, and CMC, whether there are any scale-ups or stability requirements that are required to move through ahead of launch, and, related to that, to what extent you might have Asia or China exposure for beta-do-stat manufacturing. Thanks.
But to anticipating a data within second quarter from from innovate.
Your opening comments to me to remark about kind of moving into a quiet period does that reflect sort of visibility that you're seeing on then accrual.
John P. Butler: Thanks, Eric. So, yes, we're obviously hard at work on getting, you know, everything prepared for filing. Our expectation for filing for VataDoStat is that we will have multiple API and drug product manufacturers as part of our initial label, and all of the work that we need for registration is completed. And, you know, obviously, we also have to have validation work done for Japan, for the PMDA. So, that work, obviously, is completed, as well, and it's well under review. So, you know, we feel very confident about where we are with that second source in China, but that validation work is ongoing now, and we expect that there won't be any impact on timing for review or approval. This is obviously, the coronavirus is obviously a constantly evolving situation, and you know, we will continue to monitor that as well. And frankly, at the end of the day, I mean, the most important thing for us is patient safety. And, you know, when we think about the US even, you know, that's really where our primary thought is. This is a very fragile population, the dialysis population we deal with. But we haven't seen any impacts from it at this point, but we'll continue to monitor it.
Right now and I guess is there a way to sort of narrow down one with them second quarter results dissipate topline data.
Thanks, Eric So so second quarter has been our our guidance for I think over a year now and that's where we are maintaining and guidance.
It really was innovate this is no longer about.
Hi. This study actually is it about a accrual of mace events and we are very confident that we have achieved or or or about to achieve the number of target number of mace events. So it's really about you know the time too.
Clean the date or lock the database analyze et cetera. So.
You know and obviously that can take a differential amounts of time. So I think sticking with second quarter. Just is very comfortable for us to know what we have the time to do this right.
Got it okay, that's taking the questions.
Thank you.
Thank you. Our next question comes from Difei Yang with Mizuho. Your line is now open.
Hi, Good morning, Thanks for taking my question just a quick one with regard to the evolving Colvin 19 situation that.
From risk management perspective that anyway, my change the timeline.
Readout on topline lead out just because of the potential disruption at different hospitals et cetera et cetera.
John P. Butler: Got it. That's very helpful. Thanks for taking the question. I guess maybe there will be a follow up here. Is there any way that you can kind of help guide us to anticipating data within the second quarter from Innovate? I know in your opening comments, you made a remark about kind of moving into a quiet period. Does that reflect sort of the visibility that you're seeing on event accrual right now? And I guess is there a way to sort of narrow down when within the second quarter we can anticipate top-line data? Thanks.
Yeah no. Thanks for that question Difei. So right now, we don't anticipate or see any significant impact that cobiz 19 might have on the read out.
And I say said in answer to Eric's question I mean, this is really about.
John P. Butler: Thanks Eric. So second quarter has been our guidance for, I think, over a year now, and you know that's where we are maintaining our guidance. It really is with Innovate, this is no longer about, by this study actually, accruing MACE events, and we are, you know, very confident that we have achieved or you know are about to achieve the number of target MACE events. So it's really about the time to... clean the data, lock the database, analyze, et cetera. So, you know, and obviously, that can take, you know, different amounts of time. So, you know, I think sticking with the second quarter just is very comfortable for us to know we have the time to do this right.
What's best for the patients and making sure that that that remains our our focus.
It's.
Yeah again, we don't anticipate any any change, but it's such an evolving situation that you know we're constantly.
You know kind of evolving with it.
But you know at them now.
We feel confident.
Okay. Thank you. Thank you now a more of a technical question relative to NBP setting.
For a better do stat I think in the past, we talked about how yes AB.
John P. Butler: Got it. Thanks for taking the question.
And.
Defy Young: Thank you. Thank you. Our next question comes from Defy Young with Mizzouho. Your line is now open.
And and being tested I'm no. We are just wondering from the topline.
John P. Butler: Hi, good morning, and thanks for taking my question. Just a quick one with regard to the evolving COVID-19 situation. Would that, from a risk management perspective, in any way change the timeline for readout, on top-line readout, just because of the potential disruptions at different hospitals, et cetera, et cetera?
<unk> perspective, what we [noise].
The potential benefits with regards to delaying the progress from states three two states war and so Uh huh.
Or should we just be is backing.
John P. Butler: Yeah, no, thanks for that question, Defe. So right now, we don't anticipate or see any significant impact that COVID-19 might have on the readout, but as I said in answer to Eric's question, I mean, this is really about what's best for the patients and, you know, making sure that that remains our focus. You know, it. Again, we don't anticipate any, any change, but it's such an evolving situation that, you know, we're constantly, you know, kind of evolving with it. But, you know, as of now, we feel confident.
He very topline results you fairly Iraqi.
Thank you did say again for that question gives us the opportunity to make sure we clarify what to expect in topline read out.
Fine read out it's just that its topline. So if you recall for for innovate and then you'll see the same for protect you have a primary efficacy endpoint for each of the two studies.
You know the incident patient population and the conversion population.
In innovate and you'll see a topline.
Primary efficacy endpoint read out for each of those and of course, you combine the mace events and have one topline safety read out and Nash primary endpoint and not what you will see and topline data along with it kind of general safety I mean, if you look at docket, our old press releases from data that we presented you'll get a sense of.
John P. Butler: We are just wondering, from the top line readout perspective, would we see any potential benefits with regard to delaying the progression from stage 3 to stage 4 and so on, or should we just be expecting really very top line results on non-inferiority?
The completeness with which we which we present data, but it will be topline so things like progression et cetera that we will be saving for a future scientific meeting and publication.
John P. Butler: Thank you again for that question. It gives us the opportunity to make sure we clarify what to expect in the top-line readout. A top-line readout is just that. It's the top line. So if you recall for Innovate, and then you'll see the same for Protect, you have a primary efficacy endpoint for each of the two studies, the incident patient population and the conversion population in Innovate, a primary efficacy endpoint readout for each of those. And, of course, you combine the MACE events and have one top-line safety readout, and that's the primary endpoint, and that's I mean, if you look back at our old press releases on data that we've presented, you'll get a sense of the completeness with which we present data, but it will be top-line. So things like progression, et cetera, that we will be saving for a future scientific meeting and publication.
Thank you John.
Well the clarification.
Thank you defect.
Thank you next question comes from Chad Messer Needham Your line is open.
Hello around that this would get along for Chad.
Just a question about.
In previous presentations, you guys discussed new CMS real about a transitional drug add on payment adjust or.
Could you provide additional detail how.
How this would improve your market access.
<unk>.
Thanks for the question and so she dapa transitional their drug add on payment adjustment is a rule that was published by CMS late last year and it will according to the final rule. It will apply to any new drug that is introduced for the dialysis population of course data do stat.
John P. Butler: Thank you, John, for the clarification.
I would be included in that and what that allows for dialysis is for payment for the drug on an ASP basis outside of the bundle for two years. So this is obviously really meant to encourage innovation for dialysis patients and its create incredibly helpful for driving up.
John P. Butler: Thank you, Deepak.
Guillaume: Thank you. Our next question comes from Chad Messer with Needham. Your line is now open.
John P. Butler: Hello, Rhonda. This is Guillaume for Chad. Just a question about the new CMS rule about a transitional drug add-on payment adjuster. Could you provide additional detail on how this would improve your market access? Thank you.
Taken adoption at the dialysis centers.
So we do expect that.
John P. Butler: Thanks for the question. PDAPA, Transitional Drug Add-on Payment Adjustment, is a rule that was published by CMS late last year, and it will, according to the final rule, apply to any new drug that is introduced for the dialysis population. Of course, DATADUCE would be included in that, and what that allows for dialysis is payment for the drug on an ASP basis outside of the bundle for two years. So, you know, this is obviously really meant to encourage innovation for dialysis patients, and it's incredibly helpful for driving uptake and adoption at the dialysis centers. So we do expect that we'll be able to access that for DATADUCE. You know, this is when you pair PDAPA with our relationship with V4, which, again, I mean, we put in place to drive revenue quickly because of the relationship that they have with Fresenius Medical Care, plus another 20% of small and medium-sized dialysis providers. When you pair those two, we think that is an incredible opportunity for DATADUCE to accelerate its launch revenue.
That will be able to access that for about a do stat.
This is when you when you pay or two dapa without relationship, but before a which again I mean, we put in place to drive revenue quickly because of the relationship that they have with Fresenius medical care plus.
Another 20% of small medium sized dialysis providers. When you pair those two we think that is a an incredible opportunity for better do start to accelerate its launch revenue.
Just to make sure that in my understanding is correct. So for the first two years patients I'm using the rule.
CMS.
It would be getting drug at cost.
So the the way it works is that dialysis providers will purchase spend of two stat.
And then I want to calculated A.S.P. basis, the same way it's done for other.
Kind of part be covered drugs.
They would be reimbursed for that drug.
At a is at an ASP plus zero level right now normally essays today, our end the bundle and so the whatever price they pay that's incorporated into the into the bundle they will still be getting that full bundled payment, but be able to get there. He say, Matt that to do start in this case outside of the bundle.
John P. Butler: Just to make sure my understanding is correct, for the first two years, patients using the rule of CMS would be getting drugs at cost.
Now all of this of course, there's details around exactly how this will work there hasn't been a drug yet incorporated into this outside of.
John P. Butler: So the way it works is that dialysis providers will purchase metadustat. And then, you know, on a calculated ASP basis, the same way it's done for other, you know, kind of Part B covered drugs, they would be reimbursed for that drug at an ASP plus zero level, right? Now, normally, ESAs today are in the bundle. And so whatever price they pay, that's incorporated into the bundle. They will still be getting that full bundle payment but will be able to get their ESA med, Vatadu stat, in this case, outside of the bundle. Now, in all of this, of course, there are details around exactly how this will work. There hasn't been a drug yet incorporated into this outside of Parsovib and Senecalcet. So some of this detail still remains to be worked out by CMS. But if you think about it, you know, the opportunity to be paid for your drug for anemia,
The.
Parts of Evensen accounts that so.
Some of this detailed still remains to be a to be worked out by CMS, but if you think about it you know the opportunity to be paid for your your drug for yes for Rem anemia outside of the bundle creates a great economic incentive for the dialysis providers and.
Obviously, a great opportunity for patients to benefit from the drugs.
That makes sense. Thank you so much further clarification.
Thank you. Our next question comes from David Lebowitz with Morgan Stanley. Your line is nothing.
Thank you for taking my question would you be able to I guess run us through for the two phase three trials.
What.
Based on the number of patients in the studies.
What.
How many events need to take place I guess in each arm I guess for for it to actually meet Noninferiority.
John P. Butler: and obviously a great opportunity for patients to benefit from the drug.
John P. Butler: That makes sense. Thank you so much for the clarification.
David Lebowitz: Thank you. Our next question comes from David Lebowitz of Morgan Stanley. Your line is now open.
And the is there on the May side of things is superiority something even be really being considered.
David Lebowitz: Thank you for taking my question. Would you be able to, I guess, run us through, um, for the two phase three trials? What... Based on the number of patients in the studies, how many events need to take place in each arm, I guess, for it to actually meet non-inferiority? And is there, on the MACE side of things, is superiority something even really being considered?
[noise]. Thanks for the questions David So we've not disclosed the number of events that were targeting and obviously all of the modeling. We've done is looking at a hazard ratio of one I mean a.
Kind of pure Noninferiority measure and and that's what we're looking for that's what our expectations are.
Is that we will see noninferiority between the.
John P. Butler: Thanks for the questions, David. So we've not disclosed the number of events that we're targeting. You know, obviously, all of the modeling we've done is looking at a hazard ratio of one. I mean, a kind of pure non-inferiority.
Between the two treatments and.
You know the great thing is when you look at what physicians are expecting what they're looking for a when it comes to choosing a new drugs to add to treat anemia versus what they've been using four years.
John P. Butler: And that's what we're looking for. That's what our expectations are, that we will see non-inferiority between the two treatments. And, you know, the great thing is when you look at what physicians are expecting, what they're looking for when it comes to choosing a new drug to treat anemia versus what they've been using for years, Vatidustat is really the ideal product to compete there and differentiate from the ESAs, and it's not about superiority in MACE. It's mostly about maintaining EPO in the physiologic range. And that is, when you look at the EPO data that we've already published, you can see that that is what VataduSat accomplishes, and it positions well not only versus the ESAs but versus other HIFs that are in development in the class as well.
Got it do stat is.
Really the ideal products to compete there and differentiate from from the safe and it's not about superiority on makes its mostly about maintaining depot when the physiologic range and that is when you look at the eco data that we've already published you can see that that is what to do set a comp.
Wishes and it positions well not only versus the assays, but worth versus other if that are in development in the class as well then when you add that to the fact that we increased hemoglobins on a slow and steady pace versus fast and furious would you see with other products.
And we minimalize minimize hemoglobin cycling and importantly excursions. These are all the areas that physicians want to see these are all things we've demonstrated in prior studies already including most recently in our phase three data out of Japan. So when we think we're incredibly well positioned from a commercial perspective.
John P. Butler: Then when you add that we increase hemoglobin at a slow and steady pace versus Fast and Furious, which you see with other products, and we minimize hemoglobin cycling and, importantly, excursions, these are all areas that physicians want to see. These are all things we've demonstrated in prior studies already, including most recently in our phase 3 data out of Japan. So we think we're incredibly well-positioned from a commercial perspective, and non-inferiority is what we're expecting from the MACE trial.
Noninterest already is what we're expecting from the from the makes trial.
Thank you for taking my question.
Thank you and next question comes from at odds with H.C. Wainwright. Your line is now open.
Hi, everyone. Thanks for taking my questions.
And congrats on the recent PRB agreement.
So just a couple of questions for me just sort of on a modeling basis here given that those who can now for a better part of a three quarters has been paying the the higher 80% reimbursement and recorded as collaboration revenue I wanted.
David Lebowitz: Thank you for taking my question.
Antonio Eduardo Arce: Thank you. Our next question comes from Ed Arce with H.C. Wainwright. Your line is now open.
Jason Amello: Hi everyone, thanks for taking my questions and congratulations on the recent PRV agreement. So just a couple of questions for me, just sort of on a modeling basis here, given that Osuka now for the better part of three quarters has been paying the higher 80% reimbursement and recorded as collaboration revenue. I wanted to see if you could remind us how that will ultimately impact your future, you know, profit sharing as that has to be sort of backed into that number, and then I have a follow-up.
To see if you could remind us how that will ultimately.
The impact your future profit sharing as that has to be sort of from.
Backed into ultimately that number.
Okay sure.
Sure as Jay said, yes, so as as R&D expenses start to decline the collaboration revenue, obviously as a percentage of that well start to decline. We're constantly evaluating you know the post post data post approval.
Jason Amello: Sure, Ed, it's Jason. Yeah, so as R&D expenses start to decline, the collaboration revenue obviously has a percentage of that. We're constantly evaluating the post-data, post-approval costs that we'll have and other studies that we'll be doing relative to that, so that'll constantly be changing based on forecasts and so forth, but in the near term, as you see, the trial is coming to an end, and R&D is coming to an end.
Cost they will have another study that will be doing relative to that to do stat. So that will constantly be modulating based on forecast and so forth, but in the near term as you see trial coming to an end in R&D going down you'll see a downtick in the collaboration revenue as well.
But remember the.
When you look at that difference between the 51% and the 80% and that is revenue they will be able to to claw back through milestones and royalty.
Jason Amello: But remember, when you look at that difference between...
Jason Amello: Unknown Attendee, David Spellman, Wing Yip, Antonio Arce, Allison Bratzel, Julian Harrison, Steven Burke, Unknown Attendee, Mercedes Carrasco, Ellen Snow, Nicholas Grund, Akebia Therapeutics Inc. in the future, but we also created in the contract that they can't take down any more than 50% of any payment in a year. So, you know, it moderates the timing over which they'll get that payment back.
[music].
In the future, but we also created in the contract that they can't.
Take down any more than 50% of any payment in the year. So it moderates a timing.
Over which they'll get that payment back.
Okay all right.
And.
Just just another follow up.
You mentioned, the 15 million milestone.
Antonio Eduardo Arce: Okay, all right. Great.
Jason Amello: Just another follow-up. You mentioned the $15 million milestone that you expect later this year upon approval in Japan. Are there any other external milestones or payments between now and sort of the end of your runway?
It's a you expect later this year upon approval in Japan are there any other external milestones or payments.
Between now and and sort of.
Jason Amello: Yeah, so obviously, through the partnerships with Otsuka in both the U.S. and Europe, there are development and regulatory milestones that get paid upon approval. So that will depend on the timing of the data, the quality of the data, and so forth. So those are sizable milestones that will happen upon approval. With V4, assuming that Adustat is in the bundle, through the V4 arrangement, there's a $25 million milestone with that as well.
You were at the end of your run rate that you might expect.
Yes, so we have obviously so the partnerships with OXXO got.
About U.S. and Europe, there are a development and regulatory milestones that get paid upon approval.
So don't depend on the timing of the data that the quality of the data in southwest. So those are sizable milestones I will happen upon approval with before assuming that bad news that isn't the bundle or through the before arrangement that $25 million milestone with that as well.
Great. Thanks again.
Jason Amello: Great, thanks again.
Bert Haslett: Thank you. Our next question comes from Bert Haslett with BTIG. Your line is now open.
Thank you I next question comes from Bert Hazlett with BTI G. Your line is open.
Jason Amello: Thanks. Yeah, just a point of clarification on what Ed just asked. The milestones are due on the timing and the quality of the data. Could you just go into that quality part a little bit more? Have a great day.
Thanks, just a point of clarification, what I'd just ask the milestones are due on the timing and the quality of the data could you just go into that quality part a little bit more.
Yes.
Jason Amello: There are different criteria that result in different milestones. So it depends on what the label says. It depends on where we fall from a competitive position standpoint, things like that. It's more around not just, okay, you have approval, but what type of approval it is. And the milestones are different based on each of those types of outcomes.
There's there's different.
Criteria that we'd be dolphin different milestone so it depends on what the label says.
It depends on where we fall from a competitive position standpoint.
Things like that so it's more around not just okay. You have approval by what type of approval is it and did the milestones are different based on each of those types of outcomes.
Jason Amello: Can you go in a little bit more on the degree of difference between the milestones, depending upon what they are?
Can you go in a little bit more into the degree of difference of the milestone depending upon what they are.
Jason Amello: No, we haven't disclosed that yet. We have to see the data before we will disclose anything like that.
No we haven't disclosed that yet if we have to see the data before we will disclose anything like that.
Okay, well just on the data then.
John P. Butler: Okay, um, well, just on the data, then, in terms of you're preparing for similar results for your company, you've got a sequential readout, innovate, and then protect. What should we be thinking, you know, we're going to get the top line data with innovate? How should we be thinking? And how should we investors be considering how innovation can inform and protect results? I know it's gonna be complicated. I know, there's a lot of moving parts. But just in general terms, if you could frame that for us, that would be helpful.
In terms of you preparing for several results for your company.
Got a sequential read out innovate and then protein product how should we be thinking if we're going to get the topline data with innovate how should we be thinking and how should we investors be considering how innovate can inform protect results I know, it's going to be complicated I know, there's a lot of moving parts, but just in general terms would be.
Could frame that for us that would be helpful.
[noise] I'm sure birth. Thanks for the question I you know obviously.
John P. Butler: Sure, Bert. Thanks for the question. Every data point informs the next, right? You know, this is MACE data on a fragile population in Innovate, and, you know, so seeing positive results there, I think, will be informative, certainly for me, as to what we'll see in Protect. Just like, you know, seeing competitive data, MACE data, I think, is as complicated as the analysis there was, and I think it informs us and, you know, reduces our risk. Our Japanese Phase III data, on the efficacy side, informs, you know, the Innovate data, and I think the Innovate data will, I think, certainly inform Protect, as well. But it's different patient populations, so they're always, you know, still at risk until you see the data readout, but I certainly will be more encouraged about what PROTECT can show when I see positive innovative data.
Every every data point informs the next right.
This is makes data in a fragile population and innovate and then you know so seeing positive results. There I think are will be informative I certainly will for me as to what we'll see in protect and just like seeing competitive data may state or.
I think it was as complicated as the yes. The analysis there was I think.
Informs us and reduces our risk our Japanese phase three data.
On the efficacy side informs you know that the innovate data and I think the innovate data will will I think certainly inform protect as well, but it's different patient populations. So there and there are always.
Still has do you still have risk until you see the data read out, but I I certainly will be.
More encouraged about what protects can show when I see positive in it may data.
Okay. Thank you just a couple of quick ones I know that you and said this before how long would you expect in the in the case a positive data how long would it take you to file the NDA in the U.S. and the you and then just regard with the ATM.
John P. Butler: Okay, thank you. Just a couple of quick ones.
John P. Butler: I know that you have said this before, but how long would you expect in the case of positive data? How long would it take you to file the NDA in the US and the EU? And then just deal with the ATM? I think you said 56.7 this quarter, and could you give us the shares outstanding again that are currently out? Thanks.
Hey, I think you said 56.7 this quarter and could you give us the shares outstanding again that are currently out thanks.
Yeah, So I'm on the ATM or it was 17 million raising Q4 and 57 million.
Jason Amello: Yes, on the ATM, $17 million was raised in Q4 and $57 million this quarter in Q1. And the total outstanding shares currently, inclusive of all of that, is $121.7 million.
This quarter in Q1.
And the total outstanding shares currently inclusive of all of that is 121.7 million.
That's ended the year could that that would you ended the year. So you had 57 million to that.
Jason Amello: ..
Jason Amello: That was the end of the year. So you add $57 million to that, the $10.7 million in shares that were raised, total. I can tell you how much it was in 19. Thank you for your time.
The 10.7 million shares that was raised.
Total.
I can tell you how much was a 19.
[laughter] Ishares risk.
So Jason getting that updated number for you.
John P. Butler: So Jason's getting that updated number for you. Bert, I'm sorry, what was the second one?
Oh I'm sorry, the second question again.
For the first time into India and in the U.S. and the Eagle Yeah, well you know.
John P. Butler: are the first.
John P. Butler: We are going to move as quickly as possible, and I think that's the safest way to say it. You know, we will have NVA, we'll be working on that, and then it's about when we'll get Protect and how quickly we can pull all of that together into a filing. I mean, we are going to be moving extremely quickly. You know, my expectation, you know, we're looking to file them as close to simultaneously as possible. My expectation is that the NDA will come first, but, you know, we're, obviously, there's a tremendous amount of overlap between the packages. So, you know, we'll be working with Otsuka on that, and we have a very robust plan, but it is. We won't let any grass grow under our feet.
We're going to move as quickly as possible and I think that's the safest way to say, we will have innovate we'll be working on that and then it's about when we'll get protect a and how quickly we can pull all of that together into a filing I mean, we are going to be moving.
Extremely quickly my expectation you know, we're looking to file them as close as simultaneously as possible. My expectation is that the FDA will come first but we're obviously, there's a tremendous amount of overlap between the the packages. So.
Where we'll be working with otsuka on.
On that and we have a a very robust plants, but it is HM.
We won't but any grasher under our feet [noise].
John P. Butler: Okay, we'll look forward to the data. Thank you very much for taking the time to answer the question.
[laughter] okay.
I will afford them Dave. Thank you very much for taking the question, but just to give you the share count. So if you asked the extra number of shares that were sold in Q1 that'll bring me a the new share count 229.79.
Jason Amello: Just to give you the share count; if you add the extra number of shares that were sold in Q1, that will bring the new share count to $129.7 million.
Okay. Thank you okay.
Bert Haslett: Okay, thank you.
Thanks, Jay. Thanks. Thank you. That's reminder to ask a question you will need to press star one on your telephone.
Kenan MacKay: As a reminder, to ask a question, you will need to press Star 1 on your telephone. Our next question comes from Kenan MacKay with RBC Capital Markets. Your line is now open.
Next question comes from Kennen Mackay with RBC capital markets. Your line is now open.
Hi, Thanks for taking my question I had two questions one on statistical analysis its be Oh.
Kenan MacKay: Hi, thanks for taking the question. I've had two questions, one on statistical analysis. I was just hoping you could describe how a superiority analysis would be run. So is the non-inferiority and then superiority analysis hierarchical, even if we're not sort of expecting superiority? And can you just remind us of the definition of non-inferiority? [inaudible]
I was just hoping if you could describe how a superior already analysis would be run so it's been noninferiority and then superiority analysis.
<unk> coal, even if we're not sort of expecting the superiority and.
You just remind it's a bit definition is non inferiority.
That's how the analysis could be conducted.
John P. Butler: Yeah, so, so, answering from the perspective of not being a statistician. But the, you know, a superiority analysis is the same analysis as a non-inferiority analysis. Important, you know, again, I want to make sure that the main point that everyone takes away is that it's a non-inferiority study. That's the outcome we're expecting.
Yes, so when so you know answering from the perspective of not being a statisticians and but the superiority analysis is is the same analysis has a noninferiority analysis and important again I want to make sure that the main point that everyone takes away is that this a noninferiority study that's the outcome where expect.
And you know if you are superior simply if you the lower bound of your 95% confidence interval doesn't cross won and again, that's not our expectation for the study, but that's that's kind of the definition of it.
John P. Butler: And you know, if you're superior, simply because the lower bound of your 95% confidence interval doesn't cross one. And again, that's not our expectation for the study, but that's, that's kind of the definition of it. You know, I don't believe it should be considered a hierarchical analysis because it's the same analysis.
I don't believe it's considered a hierarchical analysis because it's the same analysis.
Okay. Okay. Thanks, Darren and then maybe on hemoglobin and a differentiation versus the mace endpoint. There. So we know Ns hemoglobin goals and protocol. So those are those are set but can you remind us the protocol for.
Kenan MacKay: Okay. Thanks, John.
John P. Butler: And then maybe on hemoglobin and differentiation versus the MACE endpoint there. So we know, Erin asked, hemoglobin goals and protocols are set, but can you remind us the protocol for the data set hemoglobin levels? Is it possible to even get superiority on hemoglobin given that you're treating to a set goal there?
The data stash hemoglobin levels is it possible to even get superiority and hemoglobin given that the turn it into a set Goldman.
John P. Butler: Yeah, I would.
Yeah I would be.
John P. Butler: Yeah, I would be very, very surprised to see that. And I think, you know, when you see that with a competitor, most physicians kind of discount it, calling it superiority because, you know, with an ESA, if I want to hire hemoglobin, I give them more, right? So that's not the, that's not at all the goal.
Very very surprised to see that and I think you know when you've seen that with a competitor. Most physicians you kind of discount calling it superiority because you know with a with any I say, if I want a higher hemoglobin I give more right. So that's not the that's not at all the goal.
You know what with with both got to do Sad and Aaron asked.
John P. Butler: You know, with both Batadustat and Aranesp, in our studies, physicians are treating to the same range. In the U.S., they're treating to maintain hemoglobin within the range of 10 to 11. And outside of the U.S., they're treating to maintain it within a range of 10 to 12 for both products.
In our studies physicians are treating to the same range in the U.S. to treating too.
To maintain the hemoglobin within the range of 10 to 11.
And outside of the U.S.
Maintain it within a range of 10 to 12 for both products.
John P. Butler: So, you know, and again, when you look at what differentiates Batadustat, it's this idea that you have this slow, steady increase in hemoglobin, and you avoid cycling and excursions. You know, if you think about an analysis for, you know, your primary endpoint is the average hemoglobin between weeks 24 and 36. And you don't get penalized for having hemoglobin that's too high. You know, that's an excursion beyond where you where you expect it to be. So, you know, I think with all of that, just expecting to see non-inferiority for hemoglobin will be perfect, it will be just what we want to show in this study, just like we showed it in Japan or with our partner Mitsubishi. Thank you.
So you you again when you look at what differentiates about a do stat is this idea that you have the slow steady increase in hemoglobin and you avoid cycling and excursions. You know you think about an analysis for.
Your primary endpoint as the average hemoglobin between we 24 36, and you don't get penalized for having hemoglobin, that's too high and that's an excursion beyond where you where do you expect it to be so.
You know I think.
With all of that you just expecting to see Noninferiority for hemoglobin is well we'll be perfect. It will be just what we want to show in the study just like we showed it in the Japanese study.
Our partner in specialty.
Kenan MacKay: Very helpful. Thank you very much.
Very helpful. Thank you very much.
Kenan MacKay: Thanks guys.
Hi, Scott.
John P. Butler: Thank you. I'm not showing any further questions at this time. I would now like to turn the call back over to John Butler, CEO, for closing remarks.
Thank you I'm not showing any further questions at this time I'd now like to turn the call back over to John Butler CEO for closing remarks.
John P. Butler: Thanks very much, Joelle, and thanks everyone for joining us today. I hope you'll agree that we have an incredibly exciting time coming up in the very near term, and we look forward to keeping you updated on the progress and speaking to you next quarter about the results of our Innovate Phase 3 program. Thanks very much, and have a great day.
Thanks, very much do well and thanks, everyone for joining us today I I hope you'll agree that we have an incredibly exciting time coming up in the very near term and we look forward to keeping you updated on the progress and speaking to you next quarter about the results of.
Our innovate a phase three program. Thanks, very much have a great day.
Operator: Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.
Ladies and gentlemen, this concludes today's conference call. Thank you for participating you may now disconnect.
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