Q3 2024 Akebia Therapeutics Inc Earnings Call
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Welcome to the third.
Third quarter 2024 financial results conference call.
Speaker Change: I would now like to hand, the conference over to your Speaker today, Mercedes Carrasco Senior director of Investor Relations. Please go ahead.
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Mercedes Carrasco: Thank you and welcome to <unk> third quarter 2024 financial results and business update conference call. Please note that our press release was issued earlier today Thursday November seven detailing our third quarter financial results and that release is available on the investors section of our website.
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Speaker Change: I would now like to hand the conference.
Speaker Change: Over to your speaker today, Mercedes Kraska Senior director of Investor Relations. Please go ahead.
Speaker Change: Your convenience a replay of today's call will also be available on our website. After we conclude joining me today, we have John Butler, Chief Executive Officer, Nik Grund, our Chief commercial officer, and Erik Ostrowski, Chief financial and business Officer.
Mercedes Kraska: Thank you and welcome to <unk> third quarter 2024 financial results and business update conference call. Please note that our press release was issued earlier today Thursday November seven detailing our third quarter financial results and that release is available on the investors section of our website.
Speaker Change: I'd like to remind everyone that this call includes forward looking statements. Each forward looking statement 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 results press release that we issued on November.
Mercedes Kraska: Convenience a replay of today's call will also be available on our website. After we conclude joining me today, we have John Butler, Chief Executive Officer, Nik Grund, our Chief commercial officer, and Erik What's Drosky, Chief financial and business Officer.
Speaker Change: Seven 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 CEO John Butler.
Mercedes Kraska: Like to remind everyone that this call includes forward looking statements. Each forward looking statement 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 results press release that we issued on November <unk>.
John Butler: Thanks, Mercedes and thanks, everyone for joining us today.
John Butler: The <unk> team has spent the past 15 years working to bring <unk> to patients. So I have to say I get excited every time I have the opportunity to give an update on the progress we're making in the homestretch of that journey.
Mercedes Kraska: Seven 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 CEO John Butler.
John Butler: We are building significant momentum as we prepare for U S market availability of FCO Gotta do staff expected in January of 'twenty five.
John Butler: Our teams work has yielded tremendous progress on each of our three launch initiatives.
John Butler: Thanks, Mercedes and thanks, everyone for joining us today.
John Butler: Do you keep the team has spent the past 15 years working to bring <unk> to patients. So I have to say I get excited every time I have the opportunity to give an update on the progress we're making in the homestretch of that journey.
John Butler: First at the prescriber level, we're driving demand second we're focused on contracting effectively with dialysis organizations to have meaningful and have meaningful progress to share.
John Butler: And third we've launched clinical initiatives to generate data that could demonstrate potential additional benefits of <unk> for patients.
John Butler: We are building significant momentum as we prepare for U S market availability of Vaxjo Gotta do staff expected in January of 'twenty five.
John Butler: I recently returned from the American Society of Nephrology or ASN kidney week as I mentioned previously I consider this our coming out party.
John Butler: Our teams work has yielded tremendous progress on each of our three launch initiatives.
John Butler: First at the prescriber level, we're driving demand second we're focused on contracting effectively with dialysis organizations to have meaningful and have meaningful progress to share.
John Butler: <unk> had a formidable presence focused on engagement across the kidney community building awareness and advocacy for Vaxjo.
John Butler: And third we've launched clinical initiatives to generate data that can demonstrate potential additional benefits of <unk> for patients.
John Butler: It was impossible to Miss us.
John Butler: Sure My takeaways.
John Butler: Over and over again I heard from Nephrologist that they are ready for a new choice and anemia management for their for their dialysis patients and they want to ensure their patients have access.
John Butler: I recently returned from the American Society of Nephrology or ASN kidney week as I mentioned previously I consider this our coming out party.
John Butler: Considering the traffic to our medical affairs Booth the interest in reviewing our existing clinical data and analyses on Vaxjo is at an all time high.
John Butler: <unk> had a formidable presence focused on engagement across the kidney community building awareness and advocacy for Vaxjo.
John Butler: We presented six posters on <unk> data and our authors and partners spent their time delving into the findings and responding physician questions.
John Butler: It was impossible to Miss us.
Speaker Change: Sure My takeaways.
Speaker Change: Over and over again I heard from Nephrologist that they are ready for a new choice and anemia management for their for their dialysis patients and they want to ensure their patients have access.
John Butler: And I'll, let Nick share more detail on prescriber demand in commercial efforts, but overall I'm extremely encouraged by the optimism that I felt amongst our team and within the broader kidney community from caregivers and investigators representatives from dialysis organizations and patient advocacy groups.
John Butler: Considering the traffic to our medical affairs Booth the interest in reviewing our existing clinical data and analyses on Vaxjo is at an all time high.
John Butler: We presented six posters on vascular data and our authors and partners spent their time delving into the findings and responding physician questions.
John Butler: <unk> is committed to the kidney community and we believe we have widespread support to make <unk> successful.
Speaker Change: Now, let nik share more detail on prescriber demand in commercial efforts, but overall I'm extremely encouraged by the optimism that I felt amongst our team and within the broader kidney community from caregivers and investigators representatives from dialysis organizations and patient advocacy groups.
John Butler: Now prior to ASN kidney week, we also shared important updates regarding reimbursement contracting and access.
John Butler: In October we secured TDAP, a reimbursement from CMS and we also received healthcare common procedure coding system or fixed fixed codes, which allows dialysis organizations to submit <unk> reimbursement in January of 'twenty five.
John Butler: <unk> is committed to the kidney community and we believe we have widespread support to make <unk> successful.
John Butler: Just to remind everyone CMS created TDAP, a reimbursement system to encourage the use of innovative products for patients on dialysis.
John Butler: Now prior to ASN kidney week, we also shared important updates regarding reimbursement contracting and access.
John Butler: TDAP a creates positive economics for dialysis organizations that makes vaxjo a desirable addition to their formularies.
John Butler: In October we secured a cheat app a reimbursement from CMS and we also received healthcare common procedure coding system or fixed fixed codes, which allows dialysis organizations to submit for biopsy of reimbursement in January of 'twenty five.
John Butler: While receiving <unk> Alfa reimbursement payment was our expectation we're pleased to have the assurance provided by this program as we engage in further contracting discussions.
John Butler: Just to remind everyone CMS created cheetah offer reimbursement system to encourage the use of innovative products for patients on dialysis.
John Butler: Now that we have the hix fixed codes are key account managers can begin to educate dialysis organizations to ensure that these codes are known at each site to facilitate efficient vaxjo reimbursement.
John Butler: See the ABA creates positive economics for dialysis organizations that makes <unk> a desirable addition to their formularies.
John Butler: This quarter. We've also made progress on our effort to secure access to <unk> through commercial supply contracts with dialysis providers and group purchasing organizations.
John Butler: While receiving <unk> Alfa reimbursement payment whats our expectation we are pleased to have the assurance provided by this program as we engage in further contracting discussions.
Speaker Change: Nick will provide more details and speak to our goal of securing coverage for nearly 100% of patients on dialysis by the end of the year.
John Butler: Now that we have the hix fixed codes are key account managers can begin to educate dialysis organizations to ensure that these codes are known at each site to facilitate efficient vaxjo reimbursement.
John Butler: Finally, we're progressing on plans to generate new clinical data.
John Butler: In September we initiated our <unk> outcomes in center experience or voice trial in partnership with the U S renal care, which will use three times per week dosing of SCO and allow us to generate important data on key endpoints, such as mortality and hospitalization that can further educate the physician community and <unk>.
John Butler: This quarter. We've also made progress on our efforts to secure access to vaxjo through commercial supply contracts with dialysis providers and group purchasing organizations.
Speaker Change: Nick will provide more details and speak to our goal of securing coverage for nearly 100% of patients on dialysis by the end of the year.
Speaker Change: Port Vaxjo utilization.
John Butler: Finally, we're progressing on plans to generate new clinical data set.
John Butler: This study intends to enroll 2200 patients across the <unk> sites and we expect the first patient to be enrolled in the next few weeks.
John Butler: In September we initiated our <unk> outcomes in center experience or voice trial in partnership with U S. Renal care, which will use three times per week dosing of <unk> and allow us to generate important data on key endpoints, such as mortality and hospitalization that can further educate the physician community and some.
John Butler: Additionally, we are evaluating an issue initiating complementary trials at other dialysis organizations.
John Butler: The interest among those is also encouraging as it suggests they are eager to understand how vaxjo can improve care for their patients as they gain real world experience.
John Butler: Port Vaxjo utilization.
John Butler: This study intends to enroll 2200 patients across the <unk> sites and we expect the first patient to be enrolled in the next few weeks.
John Butler: We believe generating additional clinical data will help further our objective for <unk> to become the new oral standard of care for the treatment of anemia due to chronic kidney disease.
John Butler: Additionally, we are evaluating an issue initiating complementary trials and other dialysis organizations.
John Butler: We look forward to working closely with <unk> and other dialysis organizations to advance our understanding of additional potential benefits vaxjo treatment can bring to dialysis patients.
John Butler: The interest among those is also encouraging as it suggests they are eager to understand how <unk> can improve care for their patients as they gain real world experience.
John Butler: Now one final thought I'll share regarding ASN kidney week based on conversations we continue to have with Nephrologist.
John Butler: We believe generating additional clinical data will help further our objective for <unk> to become the new oral standard of care for the treatment of anemia due to chronic kidney disease.
John Butler: And that is.
John Butler: But the unmet need for anemia treatment for patients with <unk>, who are not on dialysis is more significant than ever and represents an additional multibillion dollar opportunity beyond the dialysis population.
John Butler: We look forward to working closely with U S. R C and other dialysis organizations to advance our understanding of additional potential benefits vaxjo treatment can bring to dialysis patients.
John Butler: That is a resounding message from physicians and at ASN, we reiterated our commitment to exploring a path for vaxjo label expansion into the non dialysis <unk> patient population.
John Butler: Now one final thought I'll share regarding ASN kidney week based on conversations we continue to have with Nephrologist.
John Butler: And that is.
John Butler: But the unmet need for anemia treatment for patients with <unk>, who are not on dialysis is more significant than ever and represents an additional multibillion dollar opportunity beyond the dialysis population.
John Butler: As we've said previously we expect to provide a more detailed update on this initiative by the end of the year.
Speaker Change: Now, let me turn it over to Nick to talk more about our commercial activities.
Nick: Thanks, John Good morning, folks, we continue to execute on our market readiness plans to foster and enable a strong market reception for <unk> upon market availability in fact, our sales team is focused nearly exclusively on vas here.
John Butler: That is a resounding message from physicians and at ASN, we reiterated our commitment to exploring a path for vaxjo label expansion into the non dialysis <unk> patient population.
Nick: Awareness and more importantly demand is building.
John Butler: As we've said previously we expect to provide a more detailed update on this initiative by the end of the year.
Nick: Building through our HCP education and patient identification efforts. We are also hard at work to complete commercial supply contracts facilitate processes at dialysis center business level and set up our distribution network the.
Speaker Change: Now, let me turn it over to Nick to talk more about our commercial activities.
Nick: Thanks, John Good morning, folks, we continue to execute on our market readiness plans to foster and enable a strong market reception for <unk> con market availability in fact, our sales team is focused nearly exclusively on vas here.
Nick: The significant commercial contracts that we have established for valves year to date, along with the Tampa <unk> codes. We recently received we believe will enable us to drive uptake within a significant percentage of the dialysis market immediately upon launch.
Speaker Change: Awareness and more importantly demand is building.
Speaker Change: Building through our HCP education and patient identification efforts. We are also hard at work to complete commercial supply contracts facilitate processes at dialysis center business level and set up our distribution network.
Nick: To recap our current commercial supply contracts include engagements with U S renal care dialysis organizations, serving 36000 patients.
Nick: One of the leading dialysis organizations in the U S serving more than 200000 patients and thousands of dialysis centers and most recently in engagement with renal purchasing group a specialty group purchasing organization that serves many of the independent and small dialysis organizations.
Speaker Change: Significant commercial contracts that we have established for <unk> year to date, along with the Tampa and ex picks codes. We recently received we believe will enable us to drive uptake within a significant percentage of the dialysis market immediately upon launch.
Nick: Through our contracts with Ddos and GPS approximately 60% of patients on dialysis have access to vas here.
Speaker Change: To recap our current commercial supply contracts include engagements with U S renal care dialysis organizations, serving 36000 patients.
Nick: The dialysis organizations and group purchasing organizations have been active participants in the contracting process and it's clear that leaders within the organizations share our commitment to delivering innovative treatments to people living with kidney disease.
Speaker Change: One of the leading dialysis organizations in the U S serving more than 200000 patients and thousands of dialysis centers and most recently in engagement with renal purchasing group a specialty group purchasing organization that serves many of the independent and small dialysis organizations.
Nick: We previously announced the vascular WAC of approximately $15500 per year.
Speaker Change: Through our contracts with Ddos and GPS approximately 60% of patients on dialysis have access to the us here.
Nick: Our commercial supply contracts are coming together as we expected and included an off invoice discount and volume based rebates.
Speaker Change: The dialysis organizations and group purchasing organizations have been active participants in the contracting process and it's clear that leaders within the organizations share our commitment to delivering innovative treatments to people living with kidney disease.
Nick: Through the volume based rebates as vascular use increases the price will decline.
Nick: From an <unk> perspective, this is a dynamic we welcome.
Nick: That implies that if the price decreases the utilization and market share <unk> is growing.
Speaker Change: We previously announced the vascular WAC of approximately $15500 per year.
Nick: In addition, within the contracts deals are assured of predictability of price post to therefore, when we expect the price of <unk> to be essentially in line with the price of BSA.
Speaker Change: Our commercial supply contracts are coming together as we expected and included an off invoice discounts and volume based rebates.
Nick: This pricing strategy and our commitment to access we believe will enable us to have a strong launch.
Speaker Change: Through the volume based rebates as vascular use increases the price will decline.
Speaker Change: From an <unk> perspective, this is a dynamic we welcome.
Nick: We expect to generate revenue within the first two years of market availability by targeting late step eligible patient population and other populations where access is enabled.
Speaker Change: That implies that if the price decreases the utilization and market share <unk> is growing.
Speaker Change: In addition, within the contracts deals are assured of predictability of price posted alpha when we expect the price of <unk> to be essentially in line with the price of BSS.
Nick: While we expect a price decrease posted up in 2027 again, we expect it will be offset by a potential volume increase as we will then be targeting the entire dialysis patient population not just those who were previously eligible for <unk>.
Speaker Change: This pricing strategy and our commitment to access we believe will enable us to have a strong launch.
Nick: The anemia management market in dialysis alone today is approximately $1 billion in just the U S.
Speaker Change: We expect to generate revenue within the first few years of market availability by targeting late step eligible patient population and other populations where access has enabled.
Nick: Our intent is to enable broad access to vasco from dialysis organizations with the goal of having agreements in place with dialysis organizations covering nearly 100% of dialysis patients.
Speaker Change: While we expect a price decrease posted up in 2027 again, we expect it will be offset by a potential volume increase as we will then be targeting the entire dialysis patient population not just those who were previously eligible for <unk>.
Nick: We continue to work on additional commercial supply contracts and with over 25% of patients not getting to goal. We believe there is compelling need to have an alternative therapy available.
Speaker Change: The anemia management market in dialysis alone today is approximately $1 billion in just the U S.
Nick: I will note that having <unk> in place along with Auryxia as upcoming to that but for the phosphate binder class.
Speaker Change: Our intent is to enable broad access to vasco from dialysis organizations with the goal of having agreements in place with dialysis organizations covering nearly 100% of dialysis patients.
Nick: They are both additional levers that we can pull as we pursue additional commercial supply contracts.
Nick: Dialysis organizations are preparing for this distribution change and as such there are advantages of contracting across the <unk> portfolio of products as demonstrated by.
Speaker Change: We continue to work on additional commercial supply contracts and with over 25% of patients not getting to goal. We believe there is compelling need to have an alternative therapy available.
Nick: 100% of our contracts to date include both products.
Speaker Change: I will note that having <unk> in place along with Auryxia as upcoming to that but for the phosphate binder class.
Nick: We will continue to approach our commercial supply contract discussions accordingly.
Nick: So contracting provides the access reimbursement ensures the coverage, but its the caregivers who will determine what patients are appropriate for <unk> and importantly, the prescriptions for <unk>.
Speaker Change: They are both additional levers that we can pull as we pursue additional commercial supply contracts.
Speaker Change: Dialysis organizations are preparing for this distribution change and as such there are advantages of contracting across the <unk> portfolio of products as demonstrated by.
Nick: To that end our team has also been making good progress connecting with prescribers to drive awareness and demand.
Speaker Change: 100% of our contracts to date enclitic golf products.
Nick: As a result, we have seen significant increases in awareness and importantly, 92% of physicians surveyed intended to use the product with a robust 27% of physicians intending to use the product within the first three months of launch.
Speaker Change: We will continue to approach our commercial supply contract discussions accordingly.
Speaker Change: So contracting provides the access reimbursement ensures the coverage, but its the caregivers who will determine what patients are appropriate for <unk> and importantly write the prescriptions for <unk>.
Nick: With our field sales team now devoting nearly 100% of their time diverse yet we expect these measures to continue to grow.
Speaker Change: To that end our team has also been making good progress connecting with prescribers to drive awareness and demand.
Nick: Nephrologist are very consistent and where they expect to use the product initially.
Nick: The focus is on our home patients as well as patients on the highest doses of Esa.
Speaker Change: As a result, we have seen significant increases in awareness and importantly, 92% of physicians surveyed intended to use the product with a robust 27% of physicians intending to use the product within the first three months of launch.
Nick: These are segments, where physicians attribute the greatest unmet need and they totaled more than 200000 patients.
Nick: We believe prescribers will expand utilization of Fas beyond these patient groups after gaining experience with the product and seeing the benefits of <unk> for these initial patients.
Speaker Change: With our field sales team now devoting nearly 100% of their time diverse yet we expect these measures to continue to grow.
Speaker Change: Nephrologist are very consistent and where they expect to use the product initially.
Speaker Change: The only additional insight to John's comments on ASN is regarding the high level of engagement.
Speaker Change: The focus is on our home patients as well as patients on the highest doses of Esa.
Nick: Whether it was in the booth and meetings with metal medical experts and business personnel are in broader product theater type presentation, the thoughtfulness excitement and quality demonstrated by the <unk> team allow for meaningful dialogue that progressed our goals.
Speaker Change: These are segments, where physicians attribute the greatest unmet need and they total more than 200000 patients.
Speaker Change: We believe prescribers will expand utilization of <unk> beyond these patient groups after gaining experience with the product and seeing the benefits of <unk> for.
Nick: I got to say Theres, nothing more reassuring to a commercial person walking into a tradeshow and seeing attendees a couple deep waiting to engage with our people and our content.
Speaker Change: These initial patients.
Speaker Change: The only additional insight to John's comments on ASN is regarding the high level of engagement.
Nick: Overall, we are pleased with our progress in shaping the environment for <unk> and are looking forward to putting revenue numbers on the board in quarter one.
Speaker Change: It was in the booth and meetings with metal medical experts and business personnel are in broader product theater type presentation, the thoughtfulness excitement and quality demonstrated by the <unk> team allowed for meaningful dialogue that progressed our goals.
Eric: Let me now turn it over to Eric.
Eric: Thanks, Nick.
Eric: As John and <unk> have expressed the team has been working incredibly diligently across a number of initiatives and excitement is building both internally and externally for availability of <unk> in the U S. I'll now provide an overview of our third quarter financial results.
Speaker Change: And I got to say Theres, nothing more reassuring to a commercial person walking into our trade show and seeing attendees a couple deep waiting to engage with our people and our content.
Speaker Change: Overall, we are pleased with our progress in shaping the environment from last year and are looking forward to putting revenue numbers on the board in quarter one.
Eric: Total revenue was $37 4 million in the third quarter of 2024 compared to $42 million in the third quarter of 2023. This consisted of $35 $6 million of Auryxia net product revenue as compared to $40 $1 million of Auryxia net product revenue during the third quarter 2003.
Eric: Now I'll turn it over to Eric.
Eric: Thanks, Nick.
Eric: Johnny Jacobs Express the team has been working incredibly diligently across a number of initiatives and excitement is building both internally and externally for availability of <unk> in the U S. I'll now provide an overview of our third quarter financial results.
Eric: Decrease was primarily due to a reduction in volume, partially offset by price increases and execution of our contracting strategy with third party Payors looking forward. Despite the fact that we believe overall market demand for Auryxia and other phosphate binders has been steady throughout this year, we expect <unk> net product revenue in the fourth quarter of 2024 will be.
Eric: Total revenue was $37 4 million in the third quarter of 2024 compared to $42 million in the third quarter of 2023.
Eric: It consisted of $35 $6 million of Auryxia net product revenue as compared to $40 $1 million of Auryxia net product revenue during the third quarter. Three the decrease was primarily due to a reduction in volume, partially offset by price increases and execution of our contracting strategy with third party Payors looking forward. Despite the fact.
Eric: Around the level of our net product revenue from Q2 of this year, which is lower than the fourth quarter of 2023.
Eric: This is being driven by the anticipated disruption to the supply chain for the phosphate binder class in late 2024 ahead of 2025 could offer reimbursement for this category.
Eric: More specifically, we expect distribution will largely shift away from wholesalers to dialysis organizations, which will in turn decrease wholesaler inventory stocking.
Eric: We believe overall market demand for Auryxia and other phosphate binders has been steady throughout this year, we expect <unk> net product revenue in the fourth quarter of 2024 will be around the level of our net product revenue for Q2 of this year, which is lower than the fourth quarter of 2023. This.
Eric: License collaboration and other revenue was steady at $1 8 million in the third quarter of 2024 as compared to $1 9 million in the third quarter of 2023.
Eric: This is being driven by the anticipated disruption to the supply chain for the dry phosphate binder class in late 2024 ahead of 2025% of that reimbursement for this category.
Eric: Cost of goods sold was $14 $2 million in the third quarter of 2024 compared to $18 million third quarter of 2023. The decrease was driven by a $3 $7 million benefit due to our ability to commercially sell inventory previously written down as excess inventory.
Eric: More specifically, we expect distribution to largely shift away from wholesalers to dialysis organizations, which will in turn decrease wholesaler inventory stocking.
Eric: License collaboration and other revenue was steady at $1 8 million in the third quarter of 2024 as compared to $1 9 million in the third quarter of 2023.
Eric: Research and development expense decreased to $8 $5 million in the third quarter, four as compared to $13 3 million in the third quarter.
Eric: <unk>, which was driven by the completion of activities related to certain clinical trials lower head count related costs and decreased professional service and consulting expense.
Eric: Cost of goods sold was $14 $2 million in the third quarter of 2024 compared to $18 million third quarter of 2023. The decrease was driven by a $3 $7 million benefit due to our ability to commercially sell inventory previously written down as excess inventory.
Eric: SG&A expense was $26 5 million in the third quarter of 2024, an increase from $22 $7 million in the third quarter of 2023. This increase was driven by costs incurred in connection with prelaunch activities related to <unk> product availability in the U S.
Eric: Research and development expense decreased to $8 $5 million in the third quarter, four as compared to $13 $3 million in the third quarter.
Eric: 2023, which was driven by the completion of activities related to certain clinical trials lower head count related costs and decreased professional service and consulting expense.
Eric: And lastly, net loss was $20 million in the third quarter of 2024 compared to a net loss of $14 $5 million in the third quarter of 2023. The increase in net loss included $4 4 million and noncash interest expense related to the settlement royalty liability in connection with the deepwater termination.
Eric: SG&A expense was $26 5 million in the third quarter of 2024, an increase from $22 $7 million in the third quarter of 2023. This increase was driven by costs incurred in connection with prelaunch activities related to the <unk> product availability in the U S.
Eric: We ended the quarter with $34 million in cash and cash equivalents and consistent with prior guidance have at least two years of cash runway.
Eric: And lastly, net loss was $20 million in the third quarter 2024, compared to a net loss of $14 5 million.
Eric: Q3, we raised $9 $7 million in net proceeds from our ATM facility, bringing pro forma end of Q3 cash to $43 $7 million.
Eric: With an established sales force and supply of <unk> inventory in hand.
Eric: Pleased to say, we stand well positioned from a financial point of view for <unk> U S product availability.
Eric: And with that we welcome questions.
Speaker Change: As a reminder to ask a question. Please press star one on your telephone and wait for your name to be announced.
Speaker Change: To withdraw your question. Please press star one again please.
Speaker Change: Please standby, while we compile the Q&A roster.
Speaker Change: Our first question comes from Allison <unk> with Piper Sandler Your line is open.
Speaker Change: Hey, good morning, guys and thanks for taking the questions.
Speaker Change: Just a couple from me.
Speaker Change: Just on the potential for <unk>.
Speaker Change: Label expansion into non <unk>.
Speaker Change: Non dialysis could you sort of frame.
Speaker Change: Kind of what kind of.
Speaker Change: On the regulatory interactions.
Speaker Change: It can be expecting.
Speaker Change: And just kind of what are the potential range of outcomes from those areas.
Speaker Change: On regulatory interactions and the terms of that in terms of defining a path to non dialysis pretty well.
Speaker Change: And then I think you've covered this in the prepared remarks, but.
Speaker Change: A little bit, but it seems like <unk> did have a really big presence at ASN, just hoping you could characterize the kind of feedback you've been getting from docs on that are there any themes that stand out.
Speaker Change: That you'd like to call out.
Speaker Change: Thank you.
Speaker Change: Great. Thanks Ali So the first question on NPD label expansion so.
Speaker Change: As we've said, we expect to engage with FDA this year.
Speaker Change: It's kind of hard to say, what the outcome will be of that until we have the engagement and.
Speaker Change: Hoping you could characterize the kind of feedback you've been getting from docs on that are there any themes that stand out.
Speaker Change: So.
Speaker Change: But our expectation is and what we want is we know we have to do clinical work to get an NDA.
Eric: That you'd like to call out.
Speaker Change: Great. Thanks Ali So the first question on MTBE label expansion so.
Speaker Change: <unk>, that's that was clear in the in the CRM as we've said before they were open to and said in the CRM I'll come back and discuss.
Speaker Change: As we've said, we expect to engage with FDA this year.
Speaker Change: Patient group that that makes sense for where the benefit risk is positive right. So we believe we've outlined that and are looking to engage with them on that conversation around what a protocol would look like what a study would look like to get there you know as well as I.
Speaker Change: It's kind of hard to say, what the outcome will be of that until we have the engagement.
Eric: And.
Eric: So.
Speaker Change: But our expectation is and what we want is we know we have to do clinical work to get an NDA.
Eric: Label, that's that was clear in the in the CRM.
Speaker Change: It's not like the FDA is going to say.
Eric: As we've said before they were open to and said in the Sierra I'll come back and discuss.
Speaker Change: Yes, that's great do that and Youll get approved by the Middle everything will always be a review issue, but you want to know that you have alignment that you were delivering.
Eric: Your patient group that that makes sense for where the benefit risk is positive right. So we believe we've outlined that and are looking to engage with them on that conversation on what a protocol would look like what a study would look like to get there you know as well as I.
Speaker Change: Protocol of study.
Speaker Change: They will view positively and that's that's our hope and that's what we hope to be able to to.
Speaker Change: To describe to folks that we have a clinical path that makes sense for us that we can do.
Eric: It's not like the FDA is going to say.
Speaker Change: For a reasonable amount of money in a reasonable amount of time.
Eric: Yes, that's great do that and you'll get approved right in middle everything will always be a review issue, but you want to know that you have alignment that you were delivering.
Speaker Change: That will deliver to FDA the data that they need.
Speaker Change: <unk>.
Speaker Change: To approve the product for non dialysis again, they recognize that there is a.
Eric: Protocol of study.
Speaker Change: The high unmet need.
Eric: That they will view positively and that's that's our hope and that's what we hope to be able to to.
Speaker Change: <unk> sort of leaking into your second question and every every patient group that I spoke to at ASN, and we spoke to the mall and.
Eric: To describe to folks that we have a clinical path that makes sense for us that we can do.
Speaker Change: Individually.
Eric: For a reasonable amount of money in a reasonable amount of time.
Speaker Change: You talked about the non dialysis opportunity, so I'd expect them to engage with the FDA as well.
Eric: That will deliver to FDA the data that they need.
Speaker Change: But it will be a little bit of when we get the feedback we'll know exactly we'll be able to share with you, but we do expect it will be.
Eric: <unk>.
Eric: To approve the product for non dialysis again, I mean, they recognize that there is.
Eric: A high unmet need.
Eric: And sort of leaking into your second question.
Speaker Change: Give some clarity about kind of how we'll move forward and it's never just one interaction like that first interaction.
Eric: Every patient group that I spoke to at ASN, and we spoke to the mall.
Speaker Change: You're a path and then you continue to interact with them to make sure youre delivering them, what they need to facilitate the.
Eric: Individually.
Eric: They talked about the non dialysis opportunity, so I'd expect them to engage with the FDA as well.
Speaker Change: The approval.
Eric: But it will be a little bit of.
Speaker Change: And the second question I'll start and I'll pass it to Nick.
Eric: When we get the feedback we'll know exactly we'll be able to share with you, but we do expect it will be.
Speaker Change: But we had.
Speaker Change: So many interactions.
Eric: <unk>.
Speaker Change: Over the course of the week.
Eric: Give some clarity about how kind of how we will move forward and it's never just one interaction like that first interaction gives you a path and then you continue to interact with them to make sure youre delivering them what they need.
Speaker Change: One of the things that we.
Speaker Change: Tried to make come through in the script was just the optimism from folks who've been working with us for years to make this product available and we are routes are so deep in this community.
Eric: To facilitate the.
Eric: The approval.
Speaker Change: And so many folks have worked hard to to help us bring <unk> to this point I think everyone was.
Speaker Change: Excited for us and for themselves that they have this opportunity to.
Speaker Change: To make the product available for sure that doesn't mean no. One has written a prescription yet right I mean, we still have to execute.
Speaker Change: Absolutely, but I.
Speaker Change: I think it starts with that that level of positivity, whether it was the <unk> who've been part of our steering committee or the patient groups that I referenced.
Speaker Change: Investigators who.
Speaker Change: Came up to me that the reception that we had.
Speaker Change: On the Wednesday night and.
Speaker Change: When we talked about our commitment to NPD. They came up and talked about wanting to be part of that study, but there's they've been part of studies we've done in the past.
Speaker Change: Really feel feel strongly about the drug I mean, all of those just puts us in a really positive spot and it really differentiated spot versus other.
Speaker Change: His products that have launched without that kind of commitment and excitement and I know Nick had a lot of interactions as well so I'll pass it to him.
Speaker Change: It's great question is.
Speaker Change: Takeaways are really three.
Speaker Change: Early in the year, while people were interested in Vaxjo. The urgency was much less than you see now now it's up when can I get it is it contracted do I have access what is the distribution look like very specific granular questions that mean, they are on the verge of implementing something within their centers.
Speaker Change: Second.
Speaker Change: John mentioned in his prepared remarks.
Speaker Change: Level of clinical questions, we're getting now arc.
Speaker Change: So much of Hey, what do you think I should use it and it's what's the dose how do I start off when do I stopped the prior therapy very specific that indicate a desire to write the prescription for patients in need.
Speaker Change: And lastly.
Speaker Change: Many of the physicians that I talked to were really highlighting the need for an alternative therapy.
Speaker Change: They look at that at us as potentially a standard of care, but theyre also second to that realizing the shortcomings of their current Esa therapies.
Speaker Change: And so that need is really.
Speaker Change: <unk> brought forward in that not only is there a patient need there is also a product mix.
Speaker Change: So those are my three takeaways.
Speaker Change: Honestly I mean, sometimes you have physicians, who were naming numbers right.
Speaker Change: We've all been associated with nephrology launches before right I mean, the bill they will named numbers, but it still takes them a long time to do things and that's why it's been so nice to have this time pre product availability to kind of wade through some of that inactivity.
Speaker Change: Inactivity and get to the place where Nick just described that.
Speaker Change: Is that help alley.
Speaker Change: Yeah that helps a lot thanks guys.
Speaker Change: Thank you.
Speaker Change: Thank you. Our next question comes from Ed Arce with H C. Wainwright Your line is open.
Eric: They will need members, but it still takes them a long time to do things and we that's why it's been so nice to have this time pre product availability to kind of wade through some of that.
Speaker Change: Hi, guys good morning.
Speaker Change: And can.
Speaker Change: Congrats on all the.
Speaker Change: And all the good work.
Eric: Inactivity and get to the place where Nick just described that helped Ali.
Speaker Change: San Diego recently.
Speaker Change: Couple of questions for me and then maybe a follow up firstly.
Ali: Yeah that helps a lot thanks guys.
Speaker Change: You mentioned on your release that you are now at approximately 60% of the dialysis centers, which supply contracts from wondering if.
Ali: Thank you.
Speaker Change: Thank you. Our next question comes from Ed Arce with H C. Wainwright Your line is open.
Speaker Change: If you had a certain goal in mind.
Ed Arce: Hi, guys good morning.
Eric: Yes.
Speaker Change: By launch date in January.
Eric: Congrats on all the.
Eric: And all the good work.
Speaker Change: And how much further you think.
Eric: San Diego recently a couple.
Speaker Change: You can get by them.
Speaker Change: Couple of questions from me and then maybe a follow up firstly.
Speaker Change: And then secondly around the voice trial.
Eric: You mentioned on your release that you are now at approximately 60% of the dialysis centers with supply contracts from wondering if.
Speaker Change: You said, you're looking to start enrollment here in a few weeks.
Speaker Change: Wondering if you could discuss sort of the timeline of that trial and as you get data how that could impact.
Eric: If you had a certain goal in mind.
Eric: By launch date in January.
Speaker Change: Actual prescribing and administration.
Eric: And how much further you think.
Eric: You can get by then.
Speaker Change: Of the drug once launched thank you.
Eric: And then secondly around the voice trial.
Speaker Change: Yeah.
Speaker Change: Thanks, guys. So I'm going to do the second one first and then I'm going to hand, it to Nick to talk about the.
Speaker Change: You said, you're looking to start enrollment here in a few weeks.
Speaker Change: The dialysis centers. So so the voice trial again, which is a collaborative research study with U S renal care and Geoff block.
Speaker Change: Wondering if you could discuss sort of the timeline of that trial and as you get data how that could impact.
Speaker Change: Is the lead investigator on that and we've worked with Jeff I've worked with Jac for 20 something years. He has an amazing trial list.
Speaker Change: Actual prescribing and administration.
Speaker Change: The drug once launched thank you.
Speaker Change: He gets studies enrolled incredibly efficiently and I couldnt be happier that he was.
Eric: Okay.
Speaker Change: Thanks, guys. So I'm going to do the second one first and then I'm going to hand, it to Nick to talk about the.
Speaker Change: Very very excited about about working on this trial with as I've seen some of the material as he has put together to help with enrollment.
Nick: The dialysis centers. So so the voice trial again, which is a collaborative research study with U S renal care and Geoff block.
Speaker Change: You bet.
Speaker Change: Is the lead investigator on that and we've worked with Jeff I've worked with Jac for 'twenty.
Speaker Change: Is it really runs a professional organization but.
Speaker Change: So I guess.
Speaker Change: As I said, we expect to see the first.
Speaker Change: In years, he has an amazing trial list.
Speaker Change: Patient enrolled within the next few weeks.
Speaker Change: He gets studies enrolled incredibly efficiently and I couldnt be happier that he was.
Speaker Change: We hope that this is a quick enrollment I mean, its very broad inclusion criteria.
Speaker Change: Very very excited about about working on this trial with as I've seen some of the material that he has put together to help with enrollment.
Speaker Change: And as patients on dialysis very few exclusions for that.
Speaker Change: The goal is.
Speaker Change: Okay.
Speaker Change: We haven't talked about when we expect it to be.
Speaker Change: It really runs a professional organization, but so I guess.
Speaker Change: Fully enrolled.
Speaker Change: As I said, we expect to see the first.
Speaker Change: Or completed but it is it is an outcome study right. So there is a.
Speaker Change: <unk> patient enrolled within the next few weeks.
Speaker Change: An amount of follow up after the last patient enrolls that everyone.
Speaker Change: We hope that this is a quick enrollment I mean, its very broad inclusion criteria.
Speaker Change: Every patient in this study will have at least.
Speaker Change: And as patients on dialysis very few exclusions for that.
Speaker Change: A set amount of follow up so with the goal as we think about study is it's using three times weekly dosing right. So.
Speaker Change: The goal is.
Speaker Change: Haven't talked about when we expect it to be.
Speaker Change: That gives you src a significant amount of experience.
Speaker Change: Fully enrolled.
Speaker Change: Or completed but it is it is an outcome study right. So there is a.
Speaker Change: Using that dosing regimen makes the investigators comp comfortable with that.
Speaker Change: The amount of follow up after the last patient enrolls that everyone.
Speaker Change: And we think that will impact how they think about protocols at <unk> and probably beyond USA C. When others see that.
Speaker Change: Every patient in this study we will have at least.
Speaker Change: A set amount of follow up so.
Speaker Change: This very significant dialysis providers.
Speaker Change: With the goal as we think about study is.
Speaker Change: Is using that dosing regimen successfully so we think that will have a very important near term impact, but the reason that we're doing the study is to generate this data.
Speaker Change: It's using three times weekly dosing right. So.
Speaker Change: That gives you src significant amount of experience.
Speaker Change: Using that dosing regimen makes the investigators confident comfortable with that.
Speaker Change: That we believe will show a benefit and think about it we've got two years of TDAP a reimbursement at the end of those two years.
Speaker Change: And we think that will impact how they think about protocols at U S RC and probably beyond Usmc when others see that.
Speaker Change: We have to lower the price of <unk>, but now we get to efficiently entire pond, if you will right and the entire dialysis population will be available to us.
Speaker Change: This very significant dialysis providers.
Speaker Change: Is using that dosing regimen successfully so we think that will have a very important near term impact, but the reason that we're doing the study.
Speaker Change: The way, we think about it as physicians get experience using it in those patients where theres a TDAP a benefit they like the product.
Speaker Change: Is to generate this data.
Speaker Change: That we believe will show a benefit and think about it we've got two years of TDAP a reimbursement at the end of those two years.
Speaker Change: They see how well it works for patients then you generate additional positive data.
Speaker Change: And that allows that next step of becoming standard of care really really penetrating that market quite significantly in the third step is you have non dialysis approval and then when patients arrive on dialysis. They arrive on on <unk>, So getting data from voice as soon as possible after.
Speaker Change: We have to lower the price.
Speaker Change: <unk>, but now we get to efficiently entire pond, if you will right I mean, the entire dialysis population will be available to us we the way we think about it as physicians get experience using it in those patients where theres a TDAP a benefit they like the product.
Speaker Change: They see how well it works for patients then you generate additional positive data and that allows that next step of becoming standard of care really really penetrating that market quite significantly in the third step is you have non dialysis approval and then when patients arrive on dialysis they arrive on.
Speaker Change: The TDAP.
Speaker Change: Period ends or before again, it really depends on how quickly we enroll but this isn't a study that's supposed to last five or six years. So this is one that we expect will move quite quickly.
Speaker Change: And.
Speaker Change: The dialysis.
Speaker Change: Contracting mix, yes.
Speaker Change: <unk>.
Speaker Change: As he said add worried about 60% now our goal this might sound like it's lacking humility our goal is to hit 100%.
Speaker Change: Getting data from voice as soon as possible.
Speaker Change: After the TDAP.
Speaker Change: But it's based on really three important things one there is a reimbursement mechanism in place from CMS a few data that supports the use of innovative drugs during the two year period.
Speaker Change: Period ends or before again, it really depends on how quickly we enroll but this isn't a study that's supposed to last five or six years. So this is one that we expect will move quite quickly.
Speaker Change: Second our pricing strategy, we've created a pricing strategy that should allow for the deals to have good economics during the <unk> period around our product and importantly, we've created predictability posted app through matching.
Speaker Change: And.
Speaker Change: The dialysis set contra.
Speaker Change: Contracting next as he said add worried about 60% now our goal this might sound like it's lacking humility our goal is to hit 100%.
Speaker Change: Our being very similar to Esa pricing and then lastly, none of those things really matter unless there is a clinical need there is a clinical need over 25% of patients still are not getting to goal on today's quote unquote standard of care and we believe that fast it gives those patients an opportunity to get scale.
Speaker Change: So a 100% is absolutely our goal remember there are two providers, one of whom we have under contract already represent about 70%.
Speaker Change: And so you know where a lot of our efforts are focused.
Speaker Change: And just one quick follow up to clarify on the voice study.
Eric: unless there's a clinical need, there is a clinical need. Over 25% of patients still are not getting to go on today's quote unquote standard of care. And we believe that VASEO gives those patients an opportunity to get to go.
Speaker Change: We have recall, we have the focus study, which we expect to be published any day has been accepted for publication.
Speaker Change: We expect that to be online any day now.
Eric: So 100% is absolutely our goal. Remember, you know, there are two providers, one of whom we have under contract already, who represent, you know, about 70%. So you know where a lot of our efforts are focused. And just to, one quick follow-up to clarify on the voice study.
Speaker Change: We think that that work is sufficient to go to the FDA and have the TRW dosing added to our label.
Speaker Change: Recall, we have made the strategic decision to focus on <unk> first.
Speaker Change: And then go do talk to them about TRW. After as we will have the focus publication in dialysis providers will be getting that experience.
Eric: Recall, we have the FOCUS study, which we expect to be published any day. It's been accepted for publication. We expect it to be online any day now.
Speaker Change: But we don't we don't think we need the voice study for.
Speaker Change: For FDA approval, we really think about that as a way to.
Speaker Change: Generate more data to help expand.
Speaker Change: Access to the product post <unk>.
Speaker Change: Yes.
Speaker Change: Alright, great.
Speaker Change: And then just one follow up.
Speaker Change: I noticed you made the point that right now 100% of the contracts that you.
Speaker Change: You've signed with the deals.
Speaker Change: Include both <unk> and Auryxia.
Speaker Change: And as we.
Speaker Change: Look two generics of Auryxia are coming in pretty soon I'm wondering if you can discuss.
Speaker Change: The efforts.
Speaker Change: <unk> mentioned previously around.
Speaker Change: Maintaining.
Speaker Change: Those revenue levels.
Speaker Change: <unk> is close to us what they are now as possible.
Speaker Change: Yes.
Speaker Change: <unk>.
Speaker Change: Auryxia has been such an important part of.
Speaker Change: The past year for us.
Speaker Change: Nick kind of referenced it.
Speaker Change: Dialysis providers allowed us in.
Speaker Change: Can you talk about contract Vaxjo, because they needed to get contracts for for Auryxia are put in place and it really has enabled a lot of these contracting discussions and has been incredibly important for us.
Speaker Change: We are.
Speaker Change: Again, we have those <unk> contracts in place we know that.
Speaker Change: That providers are looking at that.
Speaker Change: Additionally, the binders to the bundle and thinking about that process that happened with cinacalcet in parts of the bib and using those branded products for two years so that.
Speaker Change: They have.
Speaker Change: There is a larger number added to the bundle at the end of.
Speaker Change: Of that two year process.
Speaker Change: We do not know exactly what's going to happen with that.
Speaker Change: And the filers for <unk>.
Speaker Change: For Auryxia right I mean, there is there were six Anda filers Theres no and as that had been conditionally approved at this point in time. So we don't know who is going to.
Speaker Change: Introduce products at the end of at the end of March if anyone of course, you've got your your first filer generally an authorized generic so it'll be limited competition for most of 2025.
Speaker Change: That allows us to.
Speaker Change: To maintain stronger access for Auryxia on a branded basis all of those pieces put together.
Speaker Change: 425, we're very conservative as we think about 'twenty six even towards the end of 'twenty five.
Speaker Change: Call it the fourth quarter of 'twenty, five, but before that we think theres great opportunity in the way we've built our our contracts we are able to maintain revenue.
Speaker Change: Even if at a lower price if we choose to and that is that's important.
Speaker Change: Because there is power in that.
Speaker Change: And that portfolio and Nick I know if he has anything to add there.
Speaker Change: Thank you Ed at all I mean again, it's the predictability that being with.
Speaker Change: The branded manufacturer that we can provide and having that opportunity too.
Speaker Change: Reduce our pricing if need be to due to generic competition. It allows them not to have to expand the operational cost to switch and enter a generic formulation into their protocol and generics come and go into the marketplace over time.
Speaker Change: I think it provides.
Speaker Change: It goes with a bit of peace of mind that we have the ability to be there throughout the generic <unk>.
Speaker Change: Process, if you will and where there is a partner for the dialysis providers with Auryxia again, I mean, auryxia long term, we know that the growth of <unk>.
Speaker Change: <unk> and the value, we're driving is being driven by Vaxjo right long term I mean this is.
Speaker Change: No.
Speaker Change: I hate to say this way, but I think of Auryxia as a tool to enable that <unk> growth right. I mean, it is it is something to <unk>.
Speaker Change: Great product a product they want on formulary, they want to be able to use they needed to.
Speaker Change: Contracts in place.
Speaker Change: And and we're there to support them through that and we believe that will help them.
Speaker Change: To make a decision to incorporate <unk> as well so it's a very important part of our commercial thinking but not part of our strategic growth story longer term.
Speaker Change: Got it.
Speaker Change: Thanks, so much.
Speaker Change: Thanks, Ed.
Speaker Change: Thank you. Our next question comes from Julian Harrison with <unk>. Your line is open.
Speaker Change: Hi, good morning, Congrats on all the momentum and thank you for taking my questions.
Speaker Change: Great to see the progress on the contracting front for <unk> I'm wondering if you're able to share approximately what percent of the home dialysis segment is contracted at this time is at approximately 60% higher or lower than that and then also for your earlier stage programs like acute kidney injury are you, giving any guidance now.
Speaker Change: Or how soon you plan to be in the clinic for those efforts. If you could talk about the remaining steps to first scientists that'd be helpful as well.
Speaker Change: Nick the home.
Speaker Change: Yes, so the percent Tom NH dialysis organization changes a little bit.
Speaker Change: Both the home as well as the incentive population are included in all of our contracts so none of our contracts.
Speaker Change: Ultimately it will come down to as we suggested writing the protocols, but the two populations that come to mind. When we talk to physicians is certainly the home slash PD population and the high dose Esa and so in reality, there's probably very little difference between the percentage, 60% approximately that we have on the overall.
Speaker Change: And how that splits up between home and in center.
Speaker Change: Thanks for that so.
Speaker Change: Julien Thanks, so much for the question on our early programs I know that.
Speaker Change: Everyone's focus is on the <unk> launch and it's our focus as well right. We know we need to do that.
Speaker Change: That incredibly well.
Speaker Change: But at the same time, we're really excited about.
Speaker Change: About our early stage programs and we're really thinking a lot about kind of the future growth of the company and what will fuel our growth in the future and so it can be 900, <unk>, which is the Hai program that you referenced.
Speaker Change: In.
Speaker Change: Pre IMD.
Speaker Change: Development now.
Speaker Change: In doing Tox work et cetera, and our goal is to have it in the clinic before the end of next year as we've said before we seem to be on track for that it's an early stage program. So.
Speaker Change: You always have to kind of hold on tight.
Speaker Change: We're quite excited about that.
Speaker Change: And then of course 100, 108 hour program in retinopathy of Prematurity, which.
Speaker Change: I am equally if not more excited about.
Speaker Change: Is behind 900, I know, but we are.
Speaker Change: We're moving that product forward doing CMC work.
Speaker Change: Et cetera.
Speaker Change: We had an advisory.
Speaker Change: Board meeting on one don't want to wait on retinopathy of prematurity.
Speaker Change: Four months ago, I guess now.
Speaker Change: And.
Speaker Change: Remember texting.
Speaker Change: Steve Burke, our CFO during the meeting just talking about how we have to move faster.
Speaker Change: These folks were just so excited about the opportunity that product could could have an.
Speaker Change: In that population of neonates so.
Speaker Change: We're really excited about moving that one forward, but that one clearly is not going to be in the clinic next year.
Speaker Change: But hopefully.
Speaker Change: Soon after 909 hours as we can move it but I appreciate that question.
Speaker Change: Thank you. This concludes our question and answer session.
Speaker Change: Now I'd like to turn it back to John Butler CEO for closing remarks.
John Butler: Thanks, operator and.
John Butler: In summary, our contracting is going extremely well and we're very well positioned for a running start when value is available in January.
Speaker Change: The near and long term commercial success of FCO hinges on our ability to execute on these initiatives. We discussed today I am pleased to say we've been hitting on every internal metric.
Speaker Change: We look forward to seeing many of you during our investor meetings later this year and then in San Francisco in January we look forward to updating you on our progress then thanks, everyone have a great day.
Speaker Change: This concludes today's conference call. Thank you for participating you may now disconnect.