Q4 2024 Akebia Therapeutics Inc Earnings Call
I'd like to remind everyone that this call includes forward looking statements. Each forward looking statements on this call is subject to risks and uncertainties that could cause actual results to differ materially from those described in these statements additional information describing these risks is included in the financial result press release that we issued on.
Speaker Change: March 13th as well as in the risk factors and management discussion and analysis section of our most recent annual and quarterly reports filed with the SEC with that I'd like to introduce our CEO John Butler.
John Butler: Thanks, Mercedes and thanks to everyone for joining us this morning.
Speaker Change: Well its march 13th which is world kidney day.
Speaker Change: As a company, whose mission is to better the lives of people impacted by kidney disease. This holds a special meeting.
Speaker Change: One of the enduring themes of world kidney data is driving innovation in the care of kidney disease.
Speaker Change: I am proud of the role of keep your plays and we will continue to play in delivering that innovation.
Speaker Change: As a matter of fact as you know we are just the early days of bringing an important new treatment to the care of patients on dialysis.
It is a pleasure to have the opportunity. This morning to discuss the excellent progress we've made and the launch of <unk>, our <unk> inhibitor for the treatment of anemia due to chronic kidney disease for patients on dialysis.
Speaker Change: We're in the earliest stage of our launch the data we will review today represents the first seven weeks of prescribing and of course, there's always some volatility at this stage.
Speaker Change: But even at this early stage, we're very excited about what we're seeing in the market.
Speaker Change: Now let me be clear, we do not plan to provide quarterly revenue guidance going forward.
Speaker Change: But we thought it was important to share early performance metrics, especially since we have only about two weeks left in the quarter.
Speaker Change: With that said I am very pleased to report that we expect 10% to $11 million and net product revenue for <unk> in the first quarter, a very strong start and well ahead of current analyst estimates.
Speaker Change: Our goal is to make Vaxjo standard of care for patients with anemia due to chronic kidney disease.
<unk> has two parts.
Our successful dialysis launch second and approval of <unk> for the non dialysis patient population.
Dress, both but let's drill down on the launch first.
Speaker Change: I outlined the three initiatives, we have to execute to work towards a successful launch and sustained growth.
Speaker Change: Great access through effective contracting drive demand at the prescriber level and generate data to identify potential additional benefits.
Speaker Change: When the first prescriptions were written for <unk> on January 13th we had commercial supply contracts in place with the dialysis providers, who care for nearly 100% of dialysis patients in the U S.
Speaker Change: Which we believe is a first for a drug with transitional drug add on payment adjustment or TDAP a reimbursement.
Speaker Change: Of course, having a contract in place with just the first step to broad access.
Speaker Change: We have also worked with the dialysis organizations.
Speaker Change: We have protocols in place and finalize other operational elements like distribution and ordering details.
Speaker Change: We've been successful working through this process and many dialysis organizations and these are the Dio is driving early prescribing.
Speaker Change: For some time, we've said, we expect our early use and adoption to come from the medium and small dialysis organizations, who care for about 150000 patients collectively.
This has been the case.
Speaker Change: And an appropriate area of focus but we're also pleased with the progress we're making across the broader market.
Speaker Change: Our access without corresponding prescriber demand does not get product to patients.
Speaker Change: You recall as we prepared for product introduction I spoke about the coiled spring strategy.
Speaker Change: Secure contracts and build prescriber demand to start transitioning patients onto vaxjo as quickly as possible upon availability.
Speaker Change: I believe that strategy is playing out.
Speaker Change: Excellent pull through to patient prescriptions, we've seen in the early launch metrics.
Nick: Nick will give you a sense of both prescribers and prescriptions through the end of February.
Nick: With the pieces for a successful launch in place and impressive early traction our team also focused on the third initiative.
Nick: Continuing to build evidence is what we believe ultimately allows the product to become standard of care.
Nick: The voice study in collaboration with U S. Renal care is an important effort to generate significant data potentially demonstrating additional benefits of vaxjo treatment.
Nick: Positive results from voice would potentially show a significant reduction in hospitalization versus the assays.
Nick: Data that we believe will be critical for physicians as they make anemia treatment decisions.
Nick: Dr Block the lead investigator began study enrollment at the beginning of December and as of last week. He has enrolled over half the total target of 2200 patients.
Nick: Finally to become standard of care for all patients with anemia due to <unk>, we need to be able to have the product approved for the non dialysis population.
Speaker Change: I was in the field with one of our key account managers, one day last month and every physician I spoke to proactively told me that they wanted to use the product for their <unk> patients.
Speaker Change: We plan to work to enable them to do that as quickly as possible.
Our latest communication from the FDA they offered the opportunity to meet with them to discuss the protocol for our planned phase III clinical trial Valor, which will study the use of <unk> in treating anemia in late stage <unk> patients who are not on dialysis.
Speaker Change: We believe taking the time for this meeting will be helpful to the success of the program in the long run.
Speaker Change: We expect to initiate the valor study in U S. Non dialysis patients in the second half of this year.
Speaker Change: We will continue to update you as appropriate as we get closer to initiating this important study.
Speaker Change: Treatment of non dialysis patients is clearly a significant significant potential opportunity for our key BS and for patients and it's a primary focus for our development organization.
Speaker Change: In parallel our commercial organization is completely focused on dialysis launch success now.
Speaker Change: Now, let me turn it over to Nick to give more details on the early days of our launch.
Thanks, John Good morning folks, let's start with the headlines for the vaccine are U S launch demand is extremely strong.
Speaker Change: We have seen the number of prescribers and prescriptions increasing throughout the quarter and we expect between 10 and $11 million <unk> net product revenue for Q1 2025.
Speaker Change: I am pleased with the early traction, especially considering the market dynamics, we have seen early in quarter one.
Speaker Change: With the transition of binders, and the bundle, including our own Auryxia no longer are a majority of patients filling prescriptions at retail pharmacies.
Speaker Change: Going forward. The large majority of prescriptions are going to be shipped directly to the patient's home to enable this change many of the dialysis organizations, let's now partner with a specialty pharmacy provider.
Thus far in quarter, one we are seeing prescription demand for all TDAP, a products, including Auryxia and Vaxjo outstrip capacity at specialty pharmacies in some cases with a backlog of four binders and vascular exceeding three weeks. However.
Speaker Change: However, because we are already have a robust distribution network, we were able to work with customers to find capacity.
Speaker Change: This backlog is starting to subside, but I believe that our customers and patients felt the negative impact now.
Speaker Change: Now, let's get into some of the underlying launch details and demand.
Speaker Change: Since approval, we've spent a lot of time discussing the importance of strategy focused on creating broad access and driving prescriber demand for vas yet.
Speaker Change: It is good to see that strategy translate into market activity.
Speaker Change: In terms of access we began shipping vascular on January nine we had contracts in place with dialysis organizations caring for nearly 100% of patients.
And I will reiterate that the need for deals to contract for phosphate binders, including Auryxia helped our team get to the table to contract for <unk> at the same time.
Speaker Change: To build demand since approval our key account managers have worked hard to educate prescribers on the unique attributes of <unk> and work with them to help identify patients that may benefit from <unk> therapy.
Speaker Change: <unk> these demand building discussions turn into action.
Speaker Change: I'd like to focus first on the physician reception now that vascular was available for prescribing as.
Speaker Change: As we expected home patients and those patients on higher doses of Esa is where some of the earliest patients prescribed <unk>.
Speaker Change: But we've also seen use more broadly within center patients. We believe prescribers will continue to expand utilization of <unk> in these patient groups after gaining experience with the product and seeing the benefits of <unk> for these initial patients.
Speaker Change: More broadly it is clear physicians are excited to have an alternative therapy to help manage anemia in <unk> patients the.
Speaker Change: The enthusiasm has been demonstrated not only through their interaction with our sales team, but is also tangible through our peer to peer programs to date since launch we've had over 70 peer to peer programs were key medical experts or <unk> educate their peers on vas here.
Speaker Change: While the number of programs is as impressive as the attendees level of interest and the engaged dialogue that reinforces the opportunity for vas yet.
Speaker Change: In these programs not only are we seeing strong HCP attendance, but we're also seeing broader tenants by the entire dialysis clinic care team, including prescribers anemia managers nurses and billing and coding personnel.
Speaker Change: This reinforces our premise that anemia management is an important component of carrying for <unk> patients on dialysis and that an alternative therapy to Esa is highly desired.
Speaker Change: Again, the interest is turning into action as physicians try biopsies for various patients.
Speaker Change: Early in our launch we want to gain breadth of prescribing.
Then as we move past the trial phase, we want to drive depth, resulting in greater volume of prescriptions, among our physician targets I'd like to share with you some insights and metrics are watching closely to monitor our launch progress.
As expected it is the small to mid sized dialysis organizations that are driving revenue.
Speaker Change: Through the end of February <unk> has been our largest customer.
Speaker Change: <unk> serves approximately 36000 patients across the U S. While you Src is certainly an early adopter other deals are also purchasing we.
Speaker Change: We are pleased to report that we have sales to three of the top four dialysis organizations.
Speaker Change: The larger organization that purchase still has work to do and operationalized, a protocol, which once implemented should enable broad prescribing.
Speaker Change: It appears they are willing to make the product available to patients in need on a medical exception basis now.
Speaker Change: In addition, we have a number of independent and small dialysis organizations purchasing biopsy out because of our robust distribution network and our direct contracts with dialysis organizations.
Speaker Change: We understand the product supply channel extremely well.
Speaker Change: This allows us to highlight that there are currently approximately three to four weeks of inventory in the channel.
Speaker Change: At the prescriber level from January 13th through the end of February over 500 physicians have prescribed <unk> with an average of approximately eight prescriptions each.
Speaker Change: Of course, there is various levels of prescribing from physicians ranging from those with only one prescription so those that have as high as 64 prescriptions since January 13th.
Speaker Change: These data tell me that our team has engaged with our highest priority prescribers and those prescribers are very willing to try vaxjo for their patients.
Speaker Change: <unk> of those physicians prescribing greater than 50% of them care for patients within other dialysis organizations. In addition to caring for patients at U S. R. C. Clinics. This gives us confidence that has the breadth of dialysis organizations that are fully operational expense, meaning protocols and other logistics are in place for the sale of <unk>.
Speaker Change: The physicians should be able to leverage their treatment experience across a number of organizations to drive depth of prescribing.
Speaker Change: Moving from physician demand and prescribing I wanted to spend a moment highlighting some early reimbursement trend.
Speaker Change: As we previously discussed we have been focused on access for Medicare fee for service patients as these patients have immediate reimbursement for <unk> drugs.
Speaker Change: We also indicated that we expect Medicare advantage coverage, where dialysis organizations have contracted with Medicare advantage plans for our <unk> our innovation payment.
Speaker Change: For instance in February alone, we have seen a greater than 15% of prescriptions have been written for payers other than Medicare fee for service.
Speaker Change: This is an encouraging sign that even early in March some Medicare advantage plans are already covering vas yet.
Speaker Change: We're extremely enthusiastic about the initial indications of demand for Vas here and look forward to updating all of you on our next call. Let me now turn it over to Eric.
Eric: Thanks, Nick.
Eric: John in his comments, we're very excited about our prospects in 2025 and are encouraged by what we've seen thus far with the launches.
Speaker Change: The U S.
Speaker Change: I will provide an overview of our fourth quarter and full year 2024 financial results as compared to the prior year.
Speaker Change: Total revenues, which are comprised of net product revenues as well as license collaboration and other revenues were $46 5 million $56 $2 million in the fourth quarters of 2024, and 2023, respectively and $162 million $194 $6 million in 2020 for 2023 years.
Of these amounts auryxia net product revenues of $44 4 million $53 2 million in the fourth quarters for 2023, respectively, and $182 $2 million $173 million in 2024 and 2023%.
Speaker Change: These decreases were primarily driven by a reduction in volume, partially offset by price increases and execution of our contracting strategy. The third party payers as a reminder, in late March 2025, Ah repeat wilderness Ips.
Speaker Change: License collaboration and other revenues of $2 1 million $3 million in the fourth quarter of 2024, and 2023, respectively and $8 million in 2024 compared to $24 $3 million. In 2023 included a one time $10 million license agreement.
Speaker Change: 19.
Speaker Change: Cost of goods sold was $20 4 million $18 $7 million in the fourth quarter of 2024, and 2023, respectively, and $63 2 million $74 $1 million of 'twenty 'twenty four 'twenty transfer perspective.
Speaker Change: And our full year 2024, and during the fourth quarter of 2023, we realized a $12 $3 million benefit $4 3 million.
Speaker Change: Fifth respectively due to our ability to sell inventory previously written down as excess inventory and.
Speaker Change: In addition, the decrease in cost in both period over period comparisons reflects lower auryxia sales volumes in 2024 as compared to 2023.
Speaker Change: R&D expenses were $11 8 million $9 $9 million in the fourth quarters of 2020 for 2023, respectively and $37 $7 million.
Speaker Change: $3 1 million in 2024 and 2020.
Speaker Change: The quarterly increase was driven by expense related to the amendment of our license agreement with <unk>.
Speaker Change: The decrease was driven by the completion of activities related to certain clinical trials lower head count related costs and decreased professional services would be helpful.
Speaker Change: SG&A expenses were $27 $7 million $25 $4 million in the fourth quarters of 2024, and 2023, respectively, and $106 $5 million and $100 $2 million in 2024, and 2023 year stack.
Speaker Change: These increases were driven by costs incurred in connection with preparatory activities related to <unk>.
Launch now.
Speaker Change: Net loss was $22 8 million in the fourth quarter of 2024 compared to net income of <unk> 6 million in the fourth quarter of 2023.
Speaker Change: Lots of $69 4 million compared.
Speaker Change: Compared to $51 9 million.
Speaker Change: The increases in net loss were impacted by lower period over period revenues as well as by noncash interest expense compared to 2024 related to the settlement royalty liability in connection with the July 2024, deepwater termination settlement agreement, which was $4 $9 million in the fourth quarter for $9 3 million for the full year.
Speaker Change: Sure.
Speaker Change: Cash and cash equivalents as of December 31, 2024 were $51 9 million compared to $42 5 million.
Speaker Change: December 31.
Speaker Change: Great.
Speaker Change: We expect this cash and cash from operations will be sufficient to fund our current operating plan, including planned pipeline advancement for at least two years.
Speaker Change: Post year end, we further strengthened our financial position by raising $18 $4 million of net proceeds from sales under our ATM facility, including the sale of shares to top tier healthcare specialists investors, which we believe has helped increase institutional sponsorship of the GDS stock.
Speaker Change: In addition on February three 2025, we elected to draw down on truck seat black.
Speaker Change: Blackrock credit agreement, resulting in net proceeds of $9 3 million tonnes.
Speaker Change: With that we welcome questions.
Speaker Change: Thank you if you'd like to ask a question. Please press star one one.
Speaker Change: If your question has been answered and you'd like to remove yourself from the queue. Please press star one again.
Speaker Change: Our first question comes from Allison <unk> with Piper Sandler Your line is open.
Speaker Change: Okay.
Speaker Change: Morning, guys. Thanks for taking the questions just a couple from me.
Speaker Change: First I think you touched on this in the prepared remarks, but does that Q1 zero revenue include any stocking or inventory build.
Speaker Change: Second just what are you seeing in terms of dose frequency, particularly for those.
Speaker Change: Dialysis patients daily weekly.
Speaker Change: And third and last can you just talk about how protocols nation is gating uptake at large scale dialysis <unk> and just how long until you think you see uptake at those ldls. Thanks.
Speaker Change: Great. Thanks Ali.
Speaker Change: So first was Q1 revenue and stocking yes, I mean this is obviously you have your first quarter is.
Speaker Change: When they do need.
Speaker Change: To put inventory in Nic referenced that we expect them to stay in that 2% to four week range.
Speaker Change: Inventory and remember this has been a retail products, so youre not putting it into the wholesaler and the retailer there is kind of one stop to the desk specialty distributor and it goes from there. So we have a very very good handle on.
Speaker Change: On that but in that revenue guidance, there will be a little bit of.
Speaker Change: Of inventories.
Speaker Change: And that's part of it.
Speaker Change: So on the dose frequency side.
Speaker Change: This is I mean, it's almost all QD.
Speaker Change: Today I mean, there are some that are are starting their protocols. Some smaller centers that are starting to protocols.
Speaker Change: With TRW dosing.
Speaker Change: <unk>.
Speaker Change: Certainly U S. Renal for instance, it's a QD.
Speaker Change: Dose protocol.
Speaker Change: In place of anything on that.
Speaker Change: Thanks.
Speaker Change: No I think at all.
Speaker Change: And the protocol is Asian, so as we said I mean this is this is.
Speaker Change: What what takes you to get the contract in place then you have got to get a protocol in place and beyond the protocol you have got to get all of the operational details, but one of the ways I have been describing it is that kind of the distance between the person who signs the contract and the person writes a prescription that the assure that distance the faster they can move.
Speaker Change: And that is clearly the case.
Speaker Change: It is.
Speaker Change: So.
Speaker Change: Think about it.
Speaker Change: One of the <unk>, who has ordered product.
Speaker Change: While they have a protocol written getting it operationalized into their myriad of systems et.
Speaker Change: Et cetera.
Speaker Change: Is simply taking longer than.
Speaker Change: Then, we like and it's hard to say exactly.
Speaker Change: How quickly they'll have it up and running I mean I think the.
Speaker Change: There is.
Speaker Change: There is an understanding of the value of having the product available there.
Speaker Change: A desire from the physicians to write it and then Theres all the bureaucracy that goes in between that gets it up and running.
Speaker Change: You've talked about kind of the first half of the year really being driven by the small and medium providers I mean, it was 150000 patients there and we feel.
That can make most of the year, but I think as we get into the second half of the year, we want to see.
Speaker Change: More movement at the at the larger providers and we expect we will based on the conversations we've had at least with the certainly with the one.
The fact that they are allowing the product for patients. So that identified are prescribers identify as high need.
Speaker Change: It is great right I mean, it's a start it gets people experience with the drug.
Speaker Change: No they want to make the product available, but just make that available outside of there.
Speaker Change: Systems that they have to have in place.
Speaker Change: To make this.
Speaker Change: Got it.
Speaker Change: Available broadly at the.
Speaker Change: At the deal.
Speaker Change: Excellent. Thank you.
Speaker Change: Thanks Alan.
Speaker Change: Our next question comes from Julian Harrison with BTG. Your line is open.
Julian Harrison: Hi, Good morning. Thank you for taking my questions first Nick I think you mentioned in your prepared remarks that recent backlog and their brakes here I'm. Just wondering if you could expand a little bit more on that has demand for auryxia now with T type of online maybe exceeded initial expectations and my understanding you correctly there.
Yes, Julien it's a great question I just want to be really clear the backlog was for all phosphate binders and <unk> not just the <unk>.
Speaker Change: And it's really when a lot of the prescriptions are being filled at the retail pharmacy. There was enough stocking in inventory patients will go to the 10000 or so retail pharmacies in the U S to pick up their prescription on January one all of those moved into specialty pharmacy for the most part.
Speaker Change: And the specialty pharmacy providers, frankly didn't have the capacity and so if you think about the intake process a prescription for a patient.
That prescription has to be loaded into a specialty pharmacy system, they've got a check insurance they've got to do all of that verification that goes around with a prescription and in some cases. They got 20000 prescriptions in the first 15 days of the month.
Speaker Change: And so that inflow of heavy effort level prescriptions caused the backlog across the board.
Speaker Change: As a reaction what we have done is with a broad distribution network. We said, let's move our customers around in some way shape or form to be able to help them get to the capacity and therefore fill the prescriptions and so while we'll call. It in that month of January maybe early February we're in this kind of 20% to 24 day backlog that's subsided substantially.
Speaker Change: Really for our products over the course of the quarter and then we think that it's down in this kind of five day range today.
Speaker Change: But it didn't impact all folks who have a today offer product in quarter one.
Speaker Change: And then it's important to point out that we're focused on those small and medium sized providers today and it was really the smaller providers, who kind of kept waiting and hoping that that legislation was going to pass to keep the binders out of the bundle. So they just werent operationally ready.
Speaker Change: We were we're trying to push them to be and so I do think they appreciate the help that we're giving them now and only kind of increases are standing with them, but again.
The demand is there.
Speaker Change: And youre seeing the demand.
You work through operational issues, and I think it bodes well for the growth of the product.
Speaker Change: Okay got it. Thank you that makes a lot of sense and then I'm wondering if you could just talk a little bit more about the timing of your next regulatory interactions for initiating the valor study at back half of this year and I'm. Just wondering are you really just seeking alignment on study design at this point are there any other open questions.
Speaker Change: No I think it's really it is really about about study design and we look at.
Speaker Change: The communication that we've gotten from them.
Speaker Change: Is it kind of in a quite a positive light.
Speaker Change: Sure.
Speaker Change: As I've said before I mean, they communicated that they see a significant unmet need for an oral therapy to treat patients with non die out non dialysis patients in EMEA right.
Speaker Change: <unk>.
Speaker Change: A significant change from where they were 10 years ago.
Speaker Change: And with that the opportunity to go and meet with them and talk about.
Speaker Change: We want to get started as quickly as we can there is no question about it but its not when you start it's when you're finished.
Speaker Change: And the idea that we have.
Speaker Change: Have this conversation.
Speaker Change: Find opportunities to us to actually speed.
Speaker Change: The program.
Speaker Change: The program up from where we are.
Speaker Change: Just too good to pass up so.
Speaker Change: <unk> win that we expect that will be a type C meeting.
Speaker Change: When we meet with them and we haven't sent that meeting request and now we're kind of working through that.
Speaker Change: What you have to.
Speaker Change: To send that and so we'll we'll give an update when we and when we know more as appropriate but obviously, we're looking to do all of this as quickly as we can but again speed but.
Speaker Change: Really want to take advantage of the opportunity they have given us here.
Speaker Change: Excellent. Thank you.
Julian Harrison: Thanks Julien.
Speaker Change: Thank you as a reminder, if you'd like to ask a question. Please press star one one.
Speaker Change: Our next question comes from Ed Arce with HC Wainwright and company. Your line is open.
Ed Arce: Hey, good morning, guys. Congrats on the first couple of months of your launch thanks for taking my questions.
Speaker Change: Firstly.
Speaker Change: Yes, I joined a couple of minutes late so I just wanted to.
Speaker Change: Let's see if I could.
Have you go through quickly.
Speaker Change: The launch metrics that you plan to disclose on a quarterly basis, and then I have a couple of follow ups.
Speaker Change: So let's talk about what.
Speaker Change: I'll, let Nick kind of go through again, what we what we provided and I think that that idea of prescribers in average prescriptions.
Speaker Change: It's something that will be really helpful. In your.
Speaker Change: Following the progress we're making so Nick you want to review that again, yes. So what we had talked about was over 500 physicians prescribing through the end of February with an average prescription level at about eight prescriptions per prescriber.
Speaker Change: And there is a broad range and so we have a number of physicians that are still prescribing just one prescription and.
And we also have prescribers that are prescribing is highest 64 prescriptions and so we're seeing good breadth of prescribing.
And some depth early on I think we need to continue to drive that we've seen acceleration of prescribers and prescriptions throughout the quarter.
Speaker Change: So we're in that kind of arrow pointing to the upper right, which is awesome.
Speaker Change: But there is still work to do and there is still a lot of opportunity out there and we're going to capitalize that in the coming months and quarters I think when you see someone writing one or two prescriptions thats trial.
Speaker Change: And even eight on average is really encouraging.
Speaker Change: It's a matter of fact, one of the most recent launches and dialysis was.
Speaker Change: Which I think is considered a pretty successful launch is exposed and different different markets with both in dialysis might be interesting to see what their kind of first seven seven weeks or so of results were yes, and John said it well is as we looked around for comparator is look let's be honest there hasnt been a lot of successes recently in dialysis, but.
Speaker Change: <unk> is one that kind of stands out.
Speaker Change: Comparatively if you look at their first seven or eight weeks of their launch.
Speaker Change: There are number of prescribers is about half of what we have for prescribers.
And so as you look at kind of trajectory.
Speaker Change: It looks like comparatively we're off to a faster start in terms of driving that trial broadly among prescribers.
Speaker Change: Okay, Great and then just as you think about.
Speaker Change: Just as I'm thinking about the.
Speaker Change: The progression throughout this year as you transition from as you said, mostly to small and medium deals for now and then.
Speaker Change: The larger <unk>.
The second half of the year just wondering.
On gross to net what is that looking like right now in the early initial months and where would you expect it to be steady state and also the split between commercial and Medicare.
What is that looking right now and then ultimately where would you see it.
Speaker Change: Settling out steady state.
Speaker Change: You want to talk about the.
Speaker Change: The commercial to Medicare piece, Yes, certainly we're seeing good uptake in Medicare advantage plans. If you would call Ed that we had really two major portions Medicare and Medicare advantage patients represent a vast majority about 80% of the total patients are in that bucket and it's split about half and half between <unk>.
Speaker Change: Call typical Medicare fee for service and patients that are Medicare advantage Medicare fee for service, we have immediate reimbursement and then the dealers will have written immediate reimbursement for the patients that they put on Vaxjo Medicare advantage the deals would need to contract with Medicare advantage plans to be able to make sure they get eight to damper like or an innovation payment.
Speaker Change: <unk> with new products.
Speaker Change: And so we are seeing obviously immediate reimbursement upon the fee for service side on the mechanic Medicare advantage side, we're actually really encouraged at about 15% of all the prescriptions, we've seen our for our Medicare advantage patients, which means the deals have been successful.
Speaker Change: Some extent in contracting with those Medicare advantage plans, and so that bodes well for us.
Speaker Change: Additional addressable population is that can get access to <unk> as we move forward.
Speaker Change: When we think about the commercial plan the commercial folks that are actually a really small percentage, we have seen selective commercial reimbursement, but the commercial patients are such a smaller portion of the overall.
Dialysis population when compared to Medicare advantage and Medicare I think if you focus on that that 80% to 85% of the population that's Medicare and as we've talked in the past. We've always told you look to be most conservative just focus on patients who have teed up.
Speaker Change: Fee for service teed up a payment which is half of your Medicare population.
Speaker Change: We're really encouraged by the fact that in the first couple of months, we're seeing 15% of prescriptions come through outside or beyond.
Speaker Change: Our fee for service.
Speaker Change: That's a really good leading indicator we've always believed that you would get more remember the Ma.
<unk> contracts are not ours, the dialysis providers. So the fact that theyre getting access and again using the smaller providers, we think the larger providers have even better access.
Speaker Change: Really does bode well for kind of that the total addressable market for the population ultimately.
Speaker Change: And the other question you asked was about gross to net so we're not providing gross to net.
Speaker Change: On the call.
Speaker Change: A couple of things just to help.
Speaker Change: Get you there.
Speaker Change: The average <unk>.
Virtually all of the prescriptions written were kind of for that starting dose, which is 300 milligrams and thats a bottle right. So that's 278 bucks per bottle as the WAC.
For that.
The reason, we're really cautious about providing most of the discounts then comes from our contracts, we talked about our contracts, having a small off invoice discount and then.
Speaker Change: A volume based discount and that as their volumes grow that discount will grow as well and over time, our gross to net will.
Speaker Change: Will decline so.
Speaker Change: You can interpret that as a bit higher now even as different providers come in you might see some fluctuation in that.
Speaker Change: The other thing too to remember these prescriptions are being written for that starting dose we know from our clinical studies that the average dose that patients have to take was about 400 milligrams a day, so about a third higher than.
Speaker Change: And then what Youre seeing in the prescriptions today, so as we move forward you're going to see this discount for the rebates, but I think youll also see some offsetting growth in the size of a prescription.
Speaker Change: In the dose.
Speaker Change: I know that doesn't give you everything you need but it's.
Speaker Change: Hopefully it helps a bit.
Yes, no that's great John I appreciate it.
Speaker Change: The detail there and then.
Speaker Change: Just one more if I may on valor I know you're seeking.
Speaker Change: Seeking.
Speaker Change: To get prepared for this meeting and the opportunity there to seek alignment.
Speaker Change: <unk>.
Speaker Change: What.
Speaker Change: What portions of the study design that you are seeking.
Speaker Change: Can you share with us today and.
Speaker Change: And do you think.
Speaker Change: The cost of that study is embedded within your current run rate.
Speaker Change: Great questions Ted So the last question is definitely yes.
Speaker Change: The cost is embedded in our runway.
Our discussion it is part of our base operating plan.
Speaker Change: And again, we expect to be able to run this trial more efficiently given there aren't two other products out there trying to enroll studies, we have a commercial product, albeit for dialysis. So there is a higher level of comfort, we're focusing on nephrologist versus kind of a lot of primary care and the initial.
Speaker Change: Protect study so we really think we can do this in an efficient.
Speaker Change: From a financial perspective, and a quick way we've talked about before is we're looking to do this.
Speaker Change: With a standard of care.
Speaker Change: Comparator and kind of discussing with the agency.
Speaker Change: How we will analyze that data and how you kind of will look at that I think again getting that agreement and or at least kind of having that discussion upfront.
Speaker Change: We will definitely be helpful. As they are reviewing the drug later on.
Speaker Change: So I think it's a lot about about that.
Speaker Change: The analysis plan.
Speaker Change: And using.
Speaker Change: A.
Speaker Change: Standard of care comparator, because remember the U S data from protect which had over 700 patients.
Speaker Change: Demonstrated that there wasn't an increase makes risk that had a DARPA poet and control right. If this has got.
Speaker Change: With different control understanding how we're going to do that analysis, and how theyre going to.
Speaker Change: Analyze the data.
Speaker Change: And doing that upfront I think we can make.
The tweaks to the protocol that would be helpful for them.
Speaker Change: We can do that now it obviously has a lot more efficient than if we if we have to do it down the line. If we waited a year before we talk to them about the SAP. So.
Speaker Change: And I think all of that and I don't know.
Speaker Change: Encouraged by the fact that they are and they really do seem to to want to help see us succeed we have to execute the trial, but.
Speaker Change: But we are.
Speaker Change: We're encouraged at this point with their engagement.
Speaker Change: Yes, that's great.
Speaker Change: Helpful. Thank you so much and congrats again on the initial launch here.
Speaker Change: Thank you Ed I appreciate it.
Speaker Change: Thank you I'm showing no further questions at this time I'd like to turn the call back over to John Butler for any closing remarks.
John Butler: Michelle Thank you so much and thank you all for the questions and for your time. This morning, our vascular launch is going extremely well, we're committed and focused on the work to make vascular standard of care for treating anemia due to <unk> in kidney months and throughout the year, it's our patients and our purpose that motivate us to continue our pursuit.
John Butler: We look forward to updating you on our progress in May on our Q1 call.
John Butler: And seeing many of you during investor meetings later in the year.
John Butler: Thanks, everyone and have a good day.
John Butler: Thank you for your participation. This does conclude the program you may now disconnect.
John Butler: Okay.
John Butler: Goodbye.
John Butler: Okay.
John Butler: Okay.
John Butler: Sure.
John Butler: Okay.
John Butler: Okay.
John Butler: Yes.