Q2 2024 Akebia Therapeutics Inc Earnings Call

August 8, 2024

Andrea: Thank you. Thank you for standing by. My name is Andrea and I will be your conference operator today. At this time, I would like to welcome everyone to the Akebia second quarter 2024 financial results.

Unknown Attendee: I will be your conference operator today.

Unknown Attendee: At this time, I would like to welcome everyone to the Akebia second quarter 2024 financial results. All lines have been placed in mute to prevent any background noise.

Unknown Attendee: After the speaker's remarks, there will be a question-and-answer session. If you would like to ask a question during this time, simply press par followed by the number one on your telephone keybed. If you would like to withdraw your question, press star one again.

Andrea: All lines have been placed in mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star followed by the number one on your telephone keypad.

Mercedes Carrasco: I would now like to turn the call over to Mercedes Carrasco, Senior Director in this relation. Thank you. Please go ahead.

Mercedes Carrasco: If you would like to withdraw your question, press star 1 again. I would now like to turn the call over to Mercedes Carrasco, Senior Director, Investor Relations. Thank you. Please go ahead.

Mercedes Carrasco: Thank you, and welcome to Akebia's second quarter 2024 financial results and business updates conference call.

Mercedes Carrasco: Thank you, and welcome to Akebia's 2nd Quarter 2024 Financial Results and Business Updates Conference Call.

Mercedes Carrasco: Please note that a press release was issued earlier today, Thursday, August 8th, detailing our first quarter financial and second quarter financial results, and that release is available on the investor section of our website. For your convenience, a replay of today's call will be available on our website after we conclude.

Speaker Change: Please note that a press release was issued earlier today, Thursday, August 8th, detailing our second quarter financial results, and that release is available on the investor section of our website.

Operator: For your convenience, a replay of today's call will be available on our website after we conclude. Joining me on today's call are John Butler, Chief Executive Officer; Nick Grund, Chief Commercial Officer; and Erik Ostrowski, Chief Financial and Business Officer.

Speaker Change: For your convenience, a replay of today's call will be available on our website after we conclude.

Mercedes Carrasco: Joining me for today's call, we have John Butler, Chief Executive Officer; Nick Gruns, Chief Commercial Officer; and Eric Ostrowski, Chief Financial and Business Officer. 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.

Speaker Change: Joining me for today's call, we have John Butler, Chief Executive Officer, Nick Grund, Chief Commercial Officer, and Erick Ostrowski, Chief Financial and Business Officer.

Operator: 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 August 8th, 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.

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.

Mercedes Carrasco: Additional information describing these risks is included in the financial results press release that we issued on August 8th, 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.

Speaker Change: Additional information describing these risks is included in the financial results press release that we issued on August 8th, as well in the risk factors and management discussion and analysis section of our most recent annual and quarterly reports filed with the SEC.

John Butler: With that, I'd like to introduce CEO John Butler. Thanks, Mercedes, and thanks everyone for joining us today. Since the Vassio FDA approval in late March, virtually the entire company has been diligently focused on its commercial launch. Now Nick's going to walk you through the details shortly, but the punchline is that in the four weeks since we spoke to you last, we've made significant progress on our key launch initiatives, which are first driving prescriber demand, second contracting effectively with dialysis organizations, and third advancing plans to generate clinical data that could demonstrate potential additional benefits of Vassio.

John Butler: Thanks, Mercedes, and thanks, everyone, for joining us today. Since Vastio received FDA approval in late March, virtually the entire company has been diligently focused on its commercial launch. Now Nick's going to walk you through the details shortly, but the punchline is that in the four weeks since we spoke to you last, we've made significant progress on our key launch initiatives, which are first, driving prescriber demand, second, contracting effectively with dialysis organizations, and third, advancing plans to generate clinical data that could demonstrate potential additional benefits of AFSEO. As recently announced, we filed our TDAPA application in June and are now about five months away from making VASEO available in the market.

Speaker Change: With that, I'd like to introduce CEO John Butler.

John Butler: Since Vastio received FDA approval in late March, virtually the entire company has been diligently focused on its commercial launch. Now Nick's going to walk you through the details shortly, but the punchline is that in the four weeks since we spoke to you last, we've made significant progress on our key launch initiatives, which are first, driving prescriber demand, second, contracting effectively with dialysis organizations, and third, advancing plans to generate clinical data that could demonstrate potential additional benefits of AFSEO.

John Butler: Thanks Mercedes and thanks everyone for joining us today.

John Butler: Since the Vastio FDA approval in late March, virtually the entire company has been diligently focused on its commercial launch. Now Nick's going to walk you through the details shortly, but the punchline is that in the four weeks since we spoke to you last, we've made significant progress on our key launch initiatives.

Nick Grund: which are first driving prescriber demand, second contracting effectively with dialysis organizations, and third advancing plans to generate clinical data that could demonstrate potential additional benefits of AFSEO.

John Butler: As recently announced, we filed our TDAP application in June, and are now about five months away from making Vassio available in the market. Our entire organization is incredibly energized by this upcoming event. We're encouraged by the strong reception for Vassio from the medical community. The excitement around Vassio was evident in two physician advisory boards we recently hosted. What's especially interesting is that these are physicians we haven't worked with in the past and are new to the Vassio story. The overwhelming response was that they're ready for a new choice in anemia management for dialysis patients. Our medical affairs team has been supporting dialysis organizations as they work to put Vassio clinical protocols in place ahead of TDAPA.

Nick Grund: As recently announced, we filed our TDAPA application in June and are now about five months away from making VASEO available in the market. Our entire organization is incredibly energized by this upcoming event.

John Butler: Our entire organization is incredibly energized by this upcoming event. We're encouraged by the strong reception for VAPSEO from the medical community. The excitement around BASIA was evident in two physician advisory boards we recently hosted. What's especially interesting is that these are physicians we haven't worked with in the past and are new to the VASEO story. The overwhelming response was that they are ready for a new choice in anemia management for dialysis patients

Nick Grund: We're encouraged by the strong reception for VAPSEO from the medical community.

Nick Grund: The excitement around BAFSA was evident in two physician advisory boards we recently hosted.

Nick Grund: What's especially interesting is that these are physicians we haven't worked with in the past and are new to the VASEO story. The overwhelming response was that they're ready for a new choice in anemia management for dialysis patients.

John Butler: Our medical affairs team has been supporting dialysis organizations as they work to put VASEO clinical protocols in place ahead of Tdapa. Today, we have a full complement of MSLs who are actively engaged in physician education, armed with a wealth of clinical data, including the Vatadustat Phase III New England Journal publications, as well as the additional data we've generated to support healthcare providers' understanding and utilization of the product. As we expand these discussions, physicians are very consistent in where they expect to use the product initially.

John Butler: Our medical affairs team has been supporting dialysis organizations as they work to put VASEO clinical protocols in place ahead of Tdapa. Today, we have a full complement of MSLs who are actively engaged in physician education, armed with a wealth of clinical data, including the Vatadustat Phase III New England Journal publications, as well as the additional data we've generated to support healthcare providers' understanding and utilization of the product. Similarly, our commercial team has also been making good progress.

Speaker Change: Our medical affairs team has been supporting dialysis organizations as they work to put VASEO clinical protocols in place ahead of Tdapa.

John Butler: Today, we have a full complement of MSLs who are actively engaged in physician education, armed with a wealth of clinical data, including the Vatadoostat Phase III New England Journal publications, as well as the additional data we've generated to support health care providers' understanding and utilization of the product. Similarly, our commercial team has also been making good progress. A field sales team is connecting with prescribers to drive awareness and demand. As we expand these discussions, physicians are very consistent in where they expect to use the product initially. The focus is on home patients as well as patients on the highest doses of the SAs.

Nick Grund: Today, we have a full complement of MSLs who are actively engaged in physician education, armed with a wealth of clinical data.

Nick Grund: including the Vatidustad Phase III New England Journal publications, as well as the additional data we've generated to support health care providers understanding and utilization of a product.

Nick Grund: Similarly, our commercial team has also been making good progress. Our field sales team is connecting with prescribers to drive awareness and demand.

John Butler: Our field sales team is connecting with prescribers to drive awareness and demand. As we expand these discussions, physicians are very consistent in where they expect to use the product initially, that is, patients at home as well as patients on the highest doses of ESA. These are the segments where physicians see the greatest unmet need, and they total more than 200,000 patients.

Nick Grund: As we expand these discussions, physicians are very consistent in where they expect to use the product initially. The focus is on home patients as well as patients on the highest doses of ESAs.

John Butler: These are the segments where physicians attribute the greatest unmet need, and they total more than 200,000 patients. We believe prescribers will expand utilization of ASEO beyond these patient groups after gaining experience with the product and seeing the benefits of ASEO for these initial patients. We're also very focused on the longer-term growth for ASEO. Generating new data to potentially expand the benefits of the product is critical. A key component of our strategy is to continue to generate this clinical data in collaboration with dialysis organizations. We're deeply engaged with DOs in study design, and believe these studies may meaningfully contribute to continue growth of ASEO post-TEDAPA in the dialysis population.

John Butler: These are the segments where physicians attribute the greatest unmet need, and they total more than 200,000 patients. They were deeply engaged with DOs in study design and believe these studies may meaningfully contribute to continued growth of VASEO post-TDAPA in the dialysis population. Once TDAPA ends in 2027, we'll have a price consistent with the ESAs, but we'll target the entire dialysis market, over 500,000 patients, and approximately Circling back to physician interest in Basio, an unsurprising additional point continues to come up, both in the advisory boards I mentioned earlier and in virtually every conversation we have with prescribers. Now, I turn it over to Nick to talk about our commercial progress.

Nick Grund: These are the segments where physicians attribute the greatest unmet need and they total more than 200,000 patients.

John Butler: We believe prescribers will expand utilization of FCO beyond these patient groups after gaining experience with the product and seeing the benefits of FCO for these initial patients. We're also very focused on the longer-term growth of Vapsia. Generating new data to potentially expand the benefits of a product is critical. A key component of our strategy is to continue to generate this clinical data in collaboration with dialysis organizations. We are deeply engaged with DOs in study design, and believe these studies may meaningfully contribute to continued growth of VASEO post-TDAPA in the dialysis population. We need to continue to generate important clinical data for VASEO to continue to move towards our goal of becoming a new standard of care. Think of it this way.

Nick Grund: We believe prescribers will expand utilization of FCO beyond these patient groups after gaining experience with the product and seeing the benefits of FCO for these initial patients.

Nick Grund: We're also very focused on the longer-term growth for Vafsio.

Nick Grund: Generating new data to potentially expand the benefits of the product is critical.

Nick Grund: A key component of our strategy is to continue to generate this clinical data in collaboration with dialysis organizations.

Nick Grund: We're deeply engaged with DOs in study design and believe these studies may meaningfully contribute to continued growth of VASEO post-TDAPA in the dialysis population.

John Butler: We need to continue to generate important clinical data for ASEO to continue to move towards our goal of becoming a new standard of care.

Nick Grund: We need to continue to generate important clinical data for Vafcio to continue to move towards our goal of becoming a new standard of care.

John Butler: Think of it this way. Today, we're targeting the TEDAPA patient population with a premium price. Once TEDAPA ends in 2027, we'll have a price consistent with the SAs, but we'll target the entire dialysis market of over 500,000 patients and approximately $1 billion today. New data, along with the positive experience over the TEDAPA period, will be central to meeting our goal.

John Butler: Today, we're targeting the Tdapa patient population with a premium price. Once Tdapa ends in 2027, we'll have a price consistent with the ESAs, but we'll target the entire dialysis market, over 500,000 patients, and approximately $1 billion today. New data, along with the positive experience over the TDAPA period, will be central to meeting our goal. The market for VASU and dialysis is significant. But let's also talk about potential expansion. Circling back to physician interest in VASEO, an unsurprising additional point continues to come up, both in the advisory boards I mentioned earlier and in virtually every conversation we have with prescribers.

Nick Grund: Think of it this way, today we're targeting the Tdapa patient population with a premium price.

Nick Grund: Once Tdapa ends in 2027, we'll have a price consistent with ESAs, but we'll target the entire dialysis market, over 500,000 patients, and approximately $1 billion today.

Nick Grund: New data, along with the positive experience over the TDAPA period, will be central to meeting our goal.

John Butler: The market for VASU and dialysis is significant, but let's also talk about potential expansion. Circling back to physician interest in VASU and unsurprising additional point continues to come up, both in the advisory boards I mentioned earlier and in virtually every conversation we have with prescribers. Physicians see a clear and obvious unmet need in the treatment of anemia in CKD patients, not on dialysis. We agree. Accordingly, we've prioritized VASU label expansion for non-dialysis CKD patients. As we said previously, we expect to provide a more detailed update on this initiative by the end of the year.

Nick Grund: The market for VASU and dialysis is significant, but let's also talk about potential expansion.

Nick Grund: Circling back to physician interest in VASEO, an unsurprising additional point continues to come up both in the advisory boards I mentioned earlier and in virtually every conversation we have with prescribers.

John Butler: Physicians see a clear and obvious unmet need for the treatment of anemia in CKD patients not on dialysis. We agree. Accordingly, we've prioritized VASEO label expansion for non-dialysis CKD patients. As we've said previously, we expect to provide a more detailed update on this initiative by the end of the year. Now, I'll turn it over to Nick to talk about our commercial progress.

Nick Grund: Physicians see a clear and obvious unmet need in the treatment of anemia in CKD patients not on dialysis.

Speaker Change: We agree. Accordingly, we've prioritized VASEO label expansion for non-dialysis CKD patients. As we've said previously, we expect to provide a more detailed update on this initiative by the end of the year.

Nick Gruns: Now, let me turn it over to Nick to talk about our commercial progress. Thanks, John, and thanks for those joining us on the call today. Our VASU launch activities continue to ramp and evolve, and we are making significant progress across all of our key initiatives targeting both the highly physician makers, as well as the doctors who are directly involved in patient care. The feedback we are getting on VASU has been positive, and doctors are enthusiastic about using the drug to help their dialysis patients, especially in patients who receive in-home dialysis, patients on high dose of the UCAs, or patients not achieving appropriate hemoglobin levels.

Nicholas Grund: Thanks, John, and thanks for those joining us on the call today. Our VAPSEO launch activities continue to ramp and evolve, and we are making significant progress across all of our key initiatives targeting both the high-level decision-makers as well as the doctors who are directly involved in patient care, feedback we are getting on Vasio has been positive, and doctors are enthusiastic about using the drug to help their dialysis patients, especially in patients who receive in-home dialysis, patients on high dose of EUCAs, or patients not achieving appropriate hemoglobin.

Nick Grund: Now, let me turn it over to Nick to talk about our commercial progress.

Nick Grund: Thanks, John , and thanks for those joining us on the call today. Our VAPSEO launch activities continue to ramp and evolve, and we are making significant progress across all of our key initiatives targeting both the high-level decision-makers as well as the doctors who are directly involved in patient care.

Nick Grund: The feedback we are getting on Vasio has been positive, and doctors are enthusiastic about using the drug to help their dialysis patients. We're also making strong advances on the contracting front, where we are discussing our entire product portfolio, which strengthens our dialogue with dialysis organizations. We have had contract conversations with dialysis organizations covering nearly 90% of patient lives, with many more to come. We're in the process of evaluating many new supply partners to minimize any disruption. The VASIO wholesale acquisition cost of approximately $15,500 per patient per year has been well received by our customers and stakeholders operating in the DDAP environment who want to use VASIO.

Nick Grund: The feedback we are getting on VASIO has been positive, and doctors are enthusiastic about using the drug to help their dialysis patients.

Nick Grund: especially in patients who receive in-home dialysis, patients on high dose of EUCAs, or patients not achieving appropriate hemoglobin levels.

Nick Gruns: We're also making strong advances on the contracting front, where we are discussing our entire product portfolio, which strengthens our dialogue with dialysis organizations. We have had contract conversations with dialysis organizations covering nearly 90% of patient lives, with many more to come. In the next several months, I can tell you that dialysis organizations are looking for part partners, partners who can help maximize the opportunity to incorporate innovative medications into their centers made possible by Tadapa and also navigate the changes that are necessary considering the high likelihood that phosphate binders will be added to the bundle. Akebia has been and will be that partner.

Nicholas Grund: We're also making strong advances on the contracting front, where we are discussing our entire product portfolio, which strengthens our dialogue with dialysis organizations. We have had contract conversations with dialysis organizations covering nearly 90% of patient lives, with many more to come in the next several months. I can tell you that dialysis organizations are looking for partners, partners who can help maximize the opportunity to incorporate innovative medications into their centers made possible by Tadapo and also navigate the changes that are necessary considering the high likelihood that phosphate binders will be added to the bundle. Akebia has been and will be that partner.

Nick Grund: We're also making strong advances on the contracting front, where we are discussing our entire product portfolio, which strengthens our dialogue with dialysis organizations. We have had contract conversations with dialysis organizations covering nearly 90% of patient lives, with many more to come.

Nick Grund: the next several months. I can tell you that dialysis organizations are looking for partners.

Nick Grund: Partners who can help maximize the opportunity to incorporate innovative medications into their centers made possible by Tadapa and also navigate the changes that are necessary considering the high likelihood that phosphate binders will be added to the bundle.

Nicholas Grund: Our national accounts team has been busy, and every day the pace is accelerating. We have also heard unanimously about the high degree of change associated with binders in the bundle. This change in reimbursement dynamics for phosphate binders could be associated with a change in distribution channels and, as a result, in the traditional inventory purchasing patterns for this category, including a, As such, dialysis organizations are reviewing their supply chain logistics to optimize their economics both ahead of and during the Tadapa period.

Nick Gruns: Our national accounts team has been busy, and every day the pace is accelerating. We have also heard uniformly about the high degree of change associated with binders in the bundle. This change in reimbursement dynamics for phosphate binders could be associated with a change in distribution channels. And as a result, in the traditional inventory purchasing patterns for this category, including Eriksia. As such, dialysis organizations are reviewing their supply chain logistics to optimize their economics, both ahead of and during the Tadapa period, where in the process of evaluating many new supply partners to minimize any disruption. That said, the change in distribution channel is not expected to impact overall demand for phosphate binders or Eriksia's market share.

Nick Grund: Akebia has been and will be that partner. Our national accounts team has been busy and every day the pace is accelerating.

Nick Grund: We have also heard uniformly about the high degree of change associated with binders in the bundle. This change in reimbursement dynamics for phosphate binders could be associated with a change in distribution channels.

Nick Grund: And as a result, in the traditional inventory purchasing patterns for this category, including Erixia.

Nick Grund: As such, dialysis organizations are reviewing their supply chain logistics to optimize their economics both ahead of and during the TADAPA period. We are in the process of evaluating many new supply partners to minimize any disruption.

Nicholas Grund: We're in the process of evaluating many new supply partners to minimize any disruption. That said, the change in distribution channel is not expected to impact overall demand for phosphate binders or Erixia market share, and we therefore anticipate similar revenue trends in 2024 as compared to last year, though the supply chain could see some fluctuation as these changes roll out. We have leveraged the ERICSEA contracting discussions to simultaneously engage in VAPSEA contracting. There is significant value for us as a company to have a portfolio of products promoted in the same space.

Nick Grund: That said, the change in distribution channel is not expected to impact overall demand for phosphate binders or Erixia market share, and we therefore anticipate similar revenue trends in 2024 as compared to last year, though the supply chain could see some fluctuation as these changes roll out.

Nick Gruns: And we therefore anticipate similar revenue trends in 2024, as compared to last year, though the supply chain could see some fluctuation as these changes roll out. We have leveraged Eriksia contracting discussion to simultaneously engage in Vatcio contracting. There is significant value to us as a company to have a portfolio of products promoted in the same space. And it allows for meaningful operational and potential financial benefits to be realized. The vatcio wholesale acquisition cost of approximately $15,500 per patient per year has been well received by our customers and stakeholders operating in the Tadapa environment who want to use vatcio.

Nick Grund: We have leveraged Erixia contracting discussion to simultaneously engage in Vatsio contracting. There is significant value to us as a company to have a portfolio of products promoted in the same space, and it allows for meaningful operational and potential financial benefits to be realized.

Nicholas Grund: And it allows for meaningful operational and potential financial benefits to be realized. The VASIO wholesale acquisition cost of approximately $15,500 per patient per year has been well received by our customers and stakeholders operating in the Dadaab environment who want to use VASIO. We expect our product supply contracts with dialysis organizations will include an off-invoice discount and a volume-based rebate.

Speaker Change: The Vafseo wholesale acquisition cost of approximately $15,500 per patient per year has been well-received by our customers and stakeholders operating in the TDAP environment who want to use Vafseo.

Nick Gruns: We expect our product supply contracts with dialysis organizations will include an often voiced discount and a volume-based rebate. We also continue to work towards having all contracts complete by January.

Nick Grund: We expect our product supply contracts with dialysis organizations will include an off-invoice discount and a volume-based rebate. We also continue to work towards having all contracts complete by January .

John Butler: We also continue to work towards having all contracts complete by January. Before I turn it back to John, I wanted to quickly note progress from our International Partner Committee. Vazio is now available in Germany and Austria, and Medici just recently launched in the Netherlands. It is still early days for the European launch, but we are encouraged by our partners' enthusiasm and execution in their launch.

Nick Gruns: Before I turn it back to John, I wanted to quickly know progress from our international partner, Medici. Vatcio is now available in Germany and Austria, and Medici just recently launched in the Netherlands. It is still early days for the European launch, but we are encouraged by our partners' enthusiasm and execution in their launch, John.

John Butler: Before I turn it back to John , I wanted to quickly note progress from our international partner, MIDDICI.

Speaker Change: Vazio is now available in Germany and Austria and Medici just recently launched in the Netherlands.

John Butler: It is still early days for the European launch, but we are encouraged by our partners' enthusiasm and execution in their launch. John ?

John Butler: Thanks, Nick. And now I'd like to introduce you to Erik Ostrowski, who joined Akebia in June as our Chief Financial Officer and Chief Business Officer. Erik has an impressive track record in corporate finance and financial team leadership. His skill set is highly complementary to our executive leadership team, and he's already adding value to the business. Erik, it's over to you to talk about our financial position. Thanks, John. I'm extremely pleased to have joined Akebia.

John Butler: Thanks, Nick. And now I'd like to introduce you to Erik Ostrowski, who joined Akebia in June as our Chief Financial Officer and Chief Business Officer.

John Butler: Thanks, Nick.

John Butler: And now I'd like to introduce you to Erica Strauski, who joined the KGB in June as our Chief Financial Officer and Chief Business Officer. Eric has an impressive track record in corporate finance and financial team leadership. His skill set is highly complimentary to our executive leadership team, and he's already adding value to the business.

John Butler: Thanks, Nick. And now I'd like to introduce you to Erik Ostrowski, who joined Akebia in June as our Chief Financial Officer and Chief Business Officer.

Speaker Change: Erik has an impressive track record in corporate finance and financial team leadership. His skill set is highly complementary to our executive leadership team and he's already adding value to the business.

Erik Ostrowski: Eric, over to you to talk about our financial position.

Erik Ostrowski: Thanks, John. I'm extremely pleased to have joined Akebia and firmly believe this is a transformational time for the company. Now, a month into the job, my conviction has strengthened.

Erik Ostrowski: Thanks, John.

Erik Ostrowski: Thanks, John. I'm extremely pleased to have joined Akebia and firmly believe this is a transformational time for the company. Now a month into the job, my conviction is strength. With the VASIO product launch and established revenue-generating business in Erixia and a promising HIF-based pipeline, I believe Akebia is well-positioned. And, importantly, I am happy to be working with a dedicated and hardworking team with such strong knowledge of and relationships in the renal. Now, let's review the quarterly financials.

Erik Ostrowski: I'm extremely pleased to have joined the KGB and firmly believe this is a transformational time for the company. Now a month into the job, my conviction is strengthened. With the Vatcio product launch and established revenue-generating business in Erixia and a promising kiss-based pipeline, I believe the KGB is well positioned for growth. And as importantly, I am happy to be working with a dedicated and hard-working team with such strong knowledge of and relationships in the retail space.

Speaker Change: Erik, over to you to talk about our financial position. Thanks, John . I'm extremely pleased to have joined Akebia and firmly believe this is a transformational time for the company.

Eric: Now a month into the job, my condition is strengthening.

Eric: With the VASIO product launch and established revenue-generating business in Erixia and a promising HIF-based pipeline, I believe Akebia is well-positioned for growth.

Speaker Change: And as importantly, I am happy to be working with a dedicated and hardworking team with such strong knowledge of and relationships in the renal space.

Erik Ostrowski: Now let's review the quarterly financials. Total revenue was $43.6 million in the second quarter of 2024. Of this amount, $41.2 million was derived from Erixia net product revenue, as compared to $42.2 million Erixia net product revenue during the second quarter of 2020. The remainder of our revenues during the quarter were derived from license, collaboration, and other revenues, which totaled $2.4 million. That's compared to $14.1 million in the second quarter of 2023. Of note, last year, second quarter, license and collaboration revenues included a one-time $10 million upfront payment related to our emergency license agreement. Keybia continues to carry a non-cash intangible hammerization charge of $9 million per quarter in COGS through the fourth quarter of 2024.

Erik Ostrowski: Total revenue was $43.6 million in the second quarter of 2020. Of this amount, $41.2 million was derived from Erixia Net Product Revenue as compared to $42.2 million of Erixia Net Product Revenue in the second quarter of 2023. The remainder of our revenues during the quarter were derived from license, collaboration, and other revenues, which totaled $2.4 million, as compared to $14.1 million in the second quarter of 2023. Of note, last year's second quarter license and collaboration revenues included a one-time $10 million upfront payment related to our MDC license.

Speaker Change: Now let's review the quarterly financials.

Eric: Total revenue was $43.6 million in the second quarter of 2024.

Eric: Of this amount, $41.2 million was derived from Erixia Net Product Revenue as compared to $42.2 million of Erixia Net Product Revenue during the second quarter of 2023.

Eric: The remainder of our revenues during the quarter were derived from license, collaborations, and other revenues, which totaled $2.4 million, as compared to $14.1 million in the second quarter of 2023.

Eric: Of note, last year's second quarter license and collaboration revenues included a one-time $10 million upfront payment related to our MDC license agreement.

Erik Ostrowski: Cogs of Goods sold $17 million in the second quarter of 2024 compared to $17.3 million in the second quarter of 2023. Akebia continues to carry a non-cash intangible amortization charge of $9 million per quarter in cogs through the fourth quarter of 2020. Research and development expenses were $7.6 million in the second quarter of 2024, compared to $20.2 million in the second quarter of 2023. This decrease was driven by the completion of certain clinical trial activities, a reduction in consulting expenses, and lower headcount-related costs.

Eric: Cogs of Goods sold with $17 million in the second quarter of 2024 compared to $17.3 million in the second quarter of 2023. Akebia continues to carry a non-cash intangible amortization charge of $9 million per quarter in cogs through the fourth quarter of 2024.

Erik Ostrowski: Research and development expenses were $7.6 million in the second quarter of 2024 compared to $20.2 million in the second quarter of 2023. This decrease was driven by the completion of certain clinical trial activities, a reduction in consulting expenses, and lower headcount related costs. Dulling general and administrative expenses were $26.9 million in the second quarter of 2024 compared to $27 million in the second quarter of 2023. And lastly, net loss was $8.6 million in the second quarter of 2024 compared to the net loss of $11.2 million in the second quarter of 2023. Cash and cash equivalence is a June 30, 2024, or $39.5 million.

Eric: Research and development expenses were $7.6 million in the second quarter of 2024, compared to $20.2 million in the second quarter of 2023. This decrease was driven by the completion of certain clinical trial activities, a reduction in consulting expenses, and lower headcount-related costs.

Eric: Selling General and Administrative expenses were $26.9 million in the second quarter of 2024 compared to $27 million in the second quarter of 2023.

Eric: And lastly, net loss was $8.6 million in the second quarter of 2024 compared to a net loss of $11.2 million in the second quarter of 2023.

Erik Ostrowski: Selling general and administrative expenses were $26.9 million in the second quarter of 2024 compared to $27 million in the second quarter of 2020. And lastly, the net loss was $8.6 million in the second quarter of 2024 compared to a net loss of $11.2 million in the second quarter of 2020. Cash and Cash Equivalents is June 30, 2024; we're $39.5 million. And I'm pleased to say we expect to have at least two years of cash runway. Our cash position continues to be supported by revenue from Erixia and careful expenses. And with that, we welcome questions.

Eric: Cash and cash equivalents as of June 30, 2024 were $39.5 million, and I'm pleased to say we expect to have at least two years of cash runway. Our cash position continues to be supported by revenue from Erixia and careful expense management.

Erik Ostrowski: And I'm pleased to say we expect to have at least two years of cash runway. Our cash position continues to be supported by revenue from Eriksia and careful expense management.

Unknown Attendee: And with that, we welcome questions. Thank you. We will now begin the question and answer session. If you have dialed in and would like to ask a question, please press tar one on your telephone keypad to raise your hand and join the queue. If you would like to withdraw your questions, simply press tar one again.

Eric: And with that, we welcome questions.

Operator: Thank you. We will now begin the question and answer session. If you have dialed in and would like to ask a question, please press star 1 on your telephone keypad to raise your hand and join the queue. If you would like to withdraw your question, simply press star 1 again. If you are called upon to ask a question and are listening via loudspeaker on your device, please pick up your handset and ensure that your phone is not in mute when asking a question. Again, press star 1 to join the queue. And your first question comes from the line of Julian Harrison with BTIG. Thank you. Please go ahead.

Speaker Change: Thank you. We will now begin the question and answer session. If you have dialed in and would like to ask a question, please press star 1 in your telephone keypad to raise your hand and join the queue.

Unknown Attendee: If you are called upon to ask a question and are listening by a loud speaker on your device, please pick up your handset and ensure that your phone is not in between asking a question. Again, press tar one to join the queue.

Speaker Change: If you would like to withdraw your question, simply press star 1 again.

Eric: If you are called upon to ask a question and are listening via loudspeaker on your device, please pick up your handset and ensure that your phone is not in mute when asking a question.

Julian Harrison: And your first question comes from the line of Julian Harrison with BTIG. Thank you. Please go ahead. Thank you for taking my question, and congrats on all the progress.

Speaker Change: Again, press star 1 to join the queue. And your first question comes from the line of Julian Harrison with BTIG. Thank you. Please go ahead.

Julian Harrison: Thank you for taking my question and congratulations on all the progress. I'm sorry if I missed it, but I just want to confirm that it's still your expectation that you don't need to build out your sales force beyond what you already have for Rixia, and you probably don't need to manufacture additional API to meet initial demand for your Vafseo launch expected in January next year.

Julian Harrison: Thank you for taking my question and congrats on all the progress. I'm sorry if I missed it, but I just want to confirm that it's still your expectation that you don't need to build out your sales force beyond what you already have for a Rixia and you probably don't need to manufacture additional API to meet initial demand for your VAPSEO launch expected January next year.

John Butler: So Nick, do you want to talk about Salesforce?

John Butler: So if you want to talk about Sales Force.

Nicholas Grund: Salesforce. Absolutely. And so Julian, thanks for the question. Yeah, we've had a team in place for the entire year that's already been calling on dialysis organizations and providers. While there may be some small tweaking around the edges, I don't think there's going to be anything that I would regard as significant or material in how we approach the marketplace from a customer perspective.

Operator: Julian Harrison, Steven Burke, Unknown Attendee, Mercedes Carrasco, Ellen Snow, Erik Ostrowski, Nicholas Grund, Akebia Therapeutics Inc.

John Butler: Absolutely.

John Butler: And so, Julian, thanks for the question. Yeah, we've had a team in place for the entire year that's already been calling on dials, so organizations and providers. While there may be some small tweaking around the edges, I don't think there's going to be anything that I would regard as significant or material in how we approach the marketplace from a down perspective.

Speaker Change: so if you want to talk about salforce absolutely and so julian thanks for the question yet we've had an ent team in place for for the entire year that's always already been calling on dials organizations and providers

Speaker Change: while there may be some small tweaking around edudes i don't think there's going to be anything that i would regard to significant or material in how we approach the marketplace from a head count perspective

Nicholas Grund: I think the bigger change that we had was adding to the medical affairs group. We had slimmed down that group because medical affairs wasn't as impactful on Erixia, but they're incredibly important for protocol development for the dialysis providers. So we did expand that group. As I said, it's fully staffed now, and they're out there being very effective with physicians. And then your second question was about API. And, and, and, and that's correct. We have the product in place.

John Butler: I think the bigger change that we had was adding to the medical affairs group. You know, we had, we had skinny down that group because medical affairs wasn't as impactful on Eriksia, but they're incredibly important for protocol development for the dialysis providers. So we did expand that group. As I said, it's fully staffed now, and they're out there being very effective with physicians.

Speaker Change: i think the bigger

Speaker Change: change that we had was was adding to the medical affairs group, you know, we had

Speaker Change: We had skinnied down that group because medical affairs wasn't as impactful on Erixia.

Speaker Change: But, you know, they're incredibly important for protocol development for the dialysis providers, so we did expand that group. As I said, it's fully staffed now, and they're out there being very effective with physicians.

Erik Ostrowski: And then your second question was around API, and that's correct. We have product in place. Erik, maybe you want to talk to that? Yeah, we do. We have product in place. It's been discussed on prior calls. We do have some; it will be effectively zero-cost inventory because it was previously expensive to R&D. So, yeah, just to reiterate, we're well positioned from an inventory perspective for the launch. Yeah, our quality team did a great job of generating data to expand the dating for the product. So, you know, everything we have on the shelf will, that we had for two years ago, for the launch we were expecting, we can use now.

John Butler: And then your second question was around API. And, and, and that's correct; we have a product in place. Now, Erik, maybe you want to

Speaker Change: And then your second question was around API, and that's correct, we have product in place.

Unknown Speaker: Can I talk to that? Yeah, no, we do not. We have projects in place, as has been discussed on prior calls. We do have some, and it will be effectively zero cost inventory because it was previously expensed to R&D. So yeah, just to reiterate, we're well-positioned from an inventory perspective. Yeah, our quality team did a great job of generating data to expand the data collection for the product. So, you know, everything we have on the shelf that we had for two years ago for the launch we were expecting, we can use now.

Speaker Change: Now, Erik, maybe you want to...

Erik: Can I talk to that? Yeah. No, we do. We have projects in place. As has been discussed on prior calls, we do have some, you know, we'll be effectively zero cost inventory because it was previously expensed to R&D.

Speaker Change: so yeah just to reiterate or well positioned from an inventory perspectives

Erik Ostrowski: Yeah, we're

Speaker Change: from the watch.

Speaker Change: Yeah, our quality team did a great job of generating data to expand the dating.

Speaker Change: for the product, so everything we have on the shelf that we had for two years ago for the launch we were expecting.

Unknown Speaker: And it's a great place to be, just from the perspective that you don't have significant cash outlay for manufacturing. But, of course, you do like to manufacture some product and keep your CDMOs current on the process. But it is it is helpful from a cash perspective.

Erik Ostrowski: And it's a great place. I mean, just from the perspective that you don't have significant cash outlay for manufacturing. But of course, you do like to manufacture some product and keep your CDMO's current on the process. But it is helpful from a, from a cash perspective.

Speaker Change: we can use now. And it's a great place to be, just from the perspective that...

Speaker Change: You don't have a significant cash outlay.

Speaker Change: ahhh

Speaker Change: for manufacturing. But of course, you do like to manufacture some product and keep your CDMOs current on the process.

unknown: But it is it is helpful from a cash perspective.

Speaker Change: But it is, it is helpful from a, from a cash perspective.

Unknown Attendee: Okay, great. Thank you.

Julian Harrison: Okay, great. Thank you. And then one more, if I may. It's great to hear that you're already engaging dialysis providers representing, I think you said, 90% of the addressable market already. I'm wondering how much of that you expect to be enabled through your recently updated relationship with CSLV4.

Julian Harrison: And then one more, if I may. It's great to hear that you're engaging dialysis providers representing, I think you said, 90% of the addressable market already. I'm wondering how much of that you expect to be enabled through your recently updated relationship with CSLV4? Yeah, no, it's a great question. It's frankly, we were already engaging with them around Erixia. If you remember, some of the catalysts for Erixia was the proposed rule that came out around binders in the bundle. That helped dialysis organizations really understand that it was coming, which was a catalyst for their urgency to meet with us earlier in the year.

Speaker Change: Okay, great. Thank you. And then one more, if I may. It's great to hear that you're already engaging dialysis providers representing, I think you said, 90% of the addressable market already. I'm wondering how much of that you expect to be enabled through your recently updated relationship with CSLV for?

unknown: Yeah, no, it's a great question. Frankly, we were already engaging with them around Erixia. If you remember, some of the catalysts for Erixia were the proposed rule that came out around binders in the bundle. That helped dialysis organizations really understand that it was coming, which was a catalyst for their urgency to meet with us earlier in the year. And really, the 90% is since the V4 announcement; we've met with

John Butler: Yeah, no, it's a great question. Frankly, we were already engaging with them around Erixia. If you remember, some of the catalysts for Erixia were the proposed rule that came out around binders in the bundle. That helped dialysis organizations really understand that it was coming, which was a catalyst for their urgency to meet with us earlier in the year. And really, the 90% is since the V4 announcement, we've met with providers representing 90%, approximately 90% of the patients. So the V4 catalyst is additional reasons for them to want to get us back in the room in order to discuss contracting and the process.

Speaker Change: yeah no it's the great question is it's frankly we were already engaging with them around a rx ia if you remember some of the catalyst for rixia was the proposed rule that came out around binders in the bundle that help dialesis organizations really understand that it was coming which which was a catyst for their urgency to meet with us earlier in the year and really the ninety percent is sincese the v for announcement we've met with

John Butler: And really, the 90% is since the V4 announcement. We've met with providers representing approximately 90% of the patients. So the V4 catalyst becomes additional reasons for them to want to get us back in the room in order to discuss contracting and the process. I mean, Nick talked about us becoming a partner. I think we've considered ourselves a partner for some time.

Speaker Change: providers representing 90%, approximately 90% of the patients. So the V4 catalyst becomes additional reasons for them to want to get us back in the room in order to discuss contracting and the process.

John Butler: I mean, Nick talked about us becoming a partner, you know, I think we've considered ourselves a partner for some time, but when you have to contract directly with the dialysis providers, and now we're doing that on two products, and particularly with phosphate binders, where there's going to be a lot of work for them to incorporate those into the, you know, as you said, they're now purchasing the phosphate And, you know, they really want to work with companies as closely as possible on, you know, a lot of operational aspects, not just contractual aspects. And that's one of those reasons why it's so powerful to have both products that we're talking to them about; it just increases the partnership between Akebia and dialysis providers in some really core areas.

Speaker Change: I mean Nick talked about us becoming a partner, you know, I think we've considered ourselves a partner for some time, but when you have to contract directly with the dialysis providers.

John Butler: But when you, you have to contract directly with the dialysis providers. And now we're doing that on two products. And particularly with phosphate binders, where this will be a lot of work for them to incorporate those into the, as you said, they are now purchasing the phosphate binder, managing that with their patients a lot of work in that. And they really want to work with companies as closely as possible on operational aspects, not just contractual aspects. And that's where it's one of those reasons why it's so proud to have both products that we're talking to them about.

Nick Grund: And now we're doing that on two products, and particularly with phosphate binders, where there's going to be a lot of work for them to incorporate those into the, you know,

Speaker Change: As you said, they're now purchasing the phosphate binder, managing that with their patients. A lot of work in that. And they really want to work with companies as closely as possible on

Speaker Change: You know, a lot of operational aspects, not just contractual aspects.

Speaker Change: That's one of those reasons why it's so powerful to have both products that we're talking to them about. It just increases the partnership between Akebia and dialysis providers on some really core areas of their business.

John Butler: It just increases the partnership between a kebia and dialysis providers on some really core areas of their business. The only thing I'll probably add to that is, you know, our history in dialysis allows those conversations to be won with a knowledge of their operational concerns, right? If you do, if you walk into these conversations without the knowledge of how they think about their business and what's important to them, it does become a conversation that can appear very one-sided and, you know, out for a kebia only. And in a partnership, if they don't have an opportunity to be able to use the products successfully, then it's really not a partnership.

John Butler: The only thing I'd probably add to that is, you know, our history in dialysis allows those conversations to be ones with a knowledge of their operational concerns, right? If you walk into these conversations without the knowledge of how they think about their business and what's important to them, it does become a conversation that can appear very one-sided and, you know, out for Akebia only. And in a partnership, if they don't have an opportunity to be able to use the product successfully, then it's really not a partnership.

unknown: The only thing I'd probably add to that is, you know, our history in dialysis allows those conversations to be ones with a knowledge of their operational concerns, right? If you don't, if you walk into these conversations without the knowledge of how they think about their business and what's important to them, it does become a conversation that can appear very one-sided and, you know, out for Akebia only. And in a partnership, if they don't have an opportunity to be able to use the product successfully, then it's really not a partnership.

Speaker Change: The only thing I'll probably add to that is, you know, our history in dialysis allows those conversations to be one with a knowledge of their operational concerns.

Speaker Change: allright if you donknow if you walk into these conversations without the knowledge of how they think about their business and what's important to them it doesn become a conversation that can appear very one sided and out for keb only and in a partnership

Speaker Change: If they don't have an opportunity to be able to use the product successfully, then it's really not a partnership, and so creating that environment is really important. Yeah, and we've been saying for years how important knowing the dialysis business is.

John Butler: And so creating that environment is really important. And we've been saying for years how important knowing the dialysis business is. And I think Erik, you know, here for a month, is learning how different and complicated dialysis can be. And, you know, that is a real competitive advantage for us. Thanks for the questions, Julian.

John Butler: And so creating that environment is really important. Yeah, and we've been saying for years how important knowing the dialysis business is. And, I mean, I think Erik, you know, here for a month is learning how different and complicated dialysis can be. And, you know, that is a real competitive advantage for us.

John Butler: And so creating that environment is really important.

John Butler: And we've been saying for years how important knowing the dialysis business is, and meaning Eric, you know, here for a month is learning how different and complicated dialysis can be. And, you know, that is a real competitive advantage for us. Thanks for the questions, Julian.

Erik: I mean, I think Erik, you know, here for a month is learning how different and complicated dialysis can be. And, you know, that is a real competitive advantage for us.

Speaker Change: Thanks for the questions, Julian.

Unknown Attendee: Thank you.

Ed Arce: Thank you. And your next question comes from the line of Ed Arce with HC Wainwright. Thank you. Please go ahead.

Ed RC: And your next question comes from the line of ad RC with H.E. Winwright.

Speaker Change: Thank you. And your next question comes from the line of Ed Arce with HC Wainwright. Thank you. Please go ahead.

Ed RC: Thank you. Please go ahead. Hi, good morning. Thanks for taking my questions, and congrats on the progress towards the launch next year. A couple of questions for me first on the whack price that you announced. I'm wondering if you could give a little details around some of the criteria as you thought through working to optimize the price not only for but afterwards and you know what sort of key aspects came into that thought process. Secondly, with Medici, wondering if you can disclose what proportion of the collaborative sales this quarter came from Germany. I think it was Germany and Australia which launched in June. If there were any, and if there's any other further countries that you expect to come online between now and the end of the year.

Ed Arce: Hi, good morning. Thanks for taking my questions. Congratulations on the progress towards the launch next year. A couple of questions for me, first on the WAC price that you announced. I'm wondering if you could give a little details around some of the criteria as you thought through working to optimize the price, not only for Tadapa, but afterwards, and, you know, what sort of key aspects came into that thought process. Secondly... Arce, with Medici, I'm wondering if you can disclose what proportion of the collaborative sales this quarter came from Germany. I think it was Germany and Australia, which launched in June, if there were any, and if there's any other further countries that you expect to come online between now and the end of the year.

unknown: Hi, good morning. Thanks for taking my questions.

Ed Arce: Hi, good morning. Thanks for taking my questions.

Ed Arce: Congrats on the progress towards the launch next year.

Ed Arce: A couple questions for me, first on the WAC price that you announced. I'm wondering if...

Speaker Change: You could give a little details around some of the.

Speaker Change: criteria as you thought through working to optimize the price

Speaker Change: not only for to dap up but afterwards and what sort of key aspects came into that thought process

Speaker Change: Secondly,

Speaker Change: With Medici, I'm wondering if you can disclose what proportion of the collaborative sales this quarter came from Germany. I think was

Speaker Change: Germany and Australia, which launched in June , if there were any. And if there's any other further countries that you expect to come online between now and the end of the year. Thanks so much.

Ed RC: Thanks so much.

Erik Ostrowski: So I'll, oh Erik, do you want to just handle it for a second?

Erik Ostrowski: So I don't know, Erik, do you want to just handle a second one? Yeah, I mean that's a quick one. Yeah, so no revenues from Medici in this quarter, as you pointed out. That was, you know, a G-Mod. So yeah, they just they just started. So you know, we look forward to seeing that progress. I don't know if we have, like, do you know any other countries that are expecting to? I know there's, there's other ones, just one. I don't know, just one. There are others for some of the other in order countries will be in the balance of the year.

Erik Ostrowski: Yeah, I mean, that's a quick one. Yeah. So no revenues from D.C. in this quarter. As you pointed out, that was, you know, a

Speaker Change: So I'll, oh, Erik, do you want to just handle a second? Yeah, I mean, that's a quick one. Yeah, so no revenues from the D.C. in this quarter. As you pointed out, that was, you know, a June .

Unknown Speaker: They have just started. So, you know, we look forward to seeing that progress. I don't know if we have Do you know any other countries you're expecting to? I know there are other ones just went just went there, others for some of the other Nordic countries will be in the balance of the year. Yeah, I mean, the larger countries are where they have to do the price negotiation, which, you know, I think we'll start to see them come online next year. But the smaller countries like the Netherlands and now the Nordic countries will come on sooner. Nick, you want to walk through the thoughts around WAC pricing? Yeah, and so on.

Speaker Change: March.

Speaker Change: Yeah, they just, they just started. So, you know, we look forward to seeing that progress. I don't know if we have...

Speaker Change: Nick, do you know any other countries you're expecting to... I know there's other ones just went. There are others for... Some of the other Nordic countries will be in the balance of the year.

Nick Gruns: Yeah, I mean, you know the larger countries is where they have to do the price negotiation, which you know I think we'll start to see them come online next year. But the smaller countries like Netherlands and now that the Nordic countries will come on sooner.

Nick Grund: Yeah, I mean, you know, the larger countries is where they have to do the price negotiation, which, you know, I think we'll start to see them come online next year.

unknown: But the smaller countries like the Netherlands and now the Nordic countries will come on board sooner.

Nick Grund: But the smaller countries like Netherlands and now the Nordic countries will come on sooner.

Nick Gruns: Nick, you want to walk through the thoughts around whack pricing? Yeah, and so really whack pricing, a couple of the different things is when we thought about it is one what price would allow for a dialysis organizations to be successful during the TAPA period. And so, how do you set up your contract? What is the whack price? Is your reimbursement for the first several quarters of TAPA and allowing TAPA, which really supports innovative products, being utilized that whack price? And then how do we make it a price that makes our dialysis organizations and a key be successful? Was a consideration to how do we make sure we manage that price over the TAPA period so that post TAPA, when we talk about ESA-like pricing, we can manage ESA-like pricing to make the products sustainable post TAPA.

Nicholas Grund: Yeah, and so really, WAC pricing, a couple different things when we thought about it. One, what price would allow dialysis organizations to be successful during the TADAPA period? And so how do you set up your contract?

Nick Grund: And so really, WAC pricing, a couple of different things when we think about it is one, two, how do we make sure we manage that price over the TADAPA period? So that, post-TADAPA, when we talk about ESA-like pricing, we can manage ESA-like pricing to make the product sustainable post-TADAPA. Remember, it's a billion-dollar market today at ESA pricing, and therefore, creating that predictability post-TADAPA that the dialysis organizations wanted is critically important.

Nick Grund: Nick, you want to walk through the thoughts around WAC pricing? Yeah, and so really, WAC pricing, a couple different things is when we thought about it is, one,

Nick Grund: What price would allow for dialysis organizations to be successful during the TADAPA period?

Nicholas Grund: What is the WAC price, which is your reimbursement for the first several quarters of TADAPA and allowing TADAPA, which really supports innovative products being utilized, that WAC price, and how do we make it a price that makes our dialysis organizations and Akebia successful was a consideration. Two, how do we make sure we manage that price over the TADAPA period? So that, post-TADAPA, when we talk about ESA-like pricing, we can manage ESA-like pricing to make the product sustainable post-TADAPA.

Nick Grund: And so how do you set up your contract? What is the WAC price? Is your reimbursement for the first several quarters of TADAPA and allowing TADAPA, which really supports innovative products being utilized,

Nick Grund: that WAC price and how do we make it a price that makes our dialysis organizations and Akebia successful was a consideration.

Unknown Attendee: I will be your conference operator today.

Unknown Attendee: At this time, I would like to welcome everyone to the Akebia Second Quarter 2024 Financial Results. All lines have been placed in mute to prevent any background noise.

Nick Grund: Two, how do we make sure we manage that price over the TADAPA period, so that post-TADAPA, when we talk about ESA-like pricing, we can manage ESA-like pricing to make the product sustainable post-TADAPA. Remember, it's a billion-dollar market today at ESA pricing.

Nicholas Grund: Remember, it's a billion-dollar market today at ESA pricing, and therefore, creating that predictability post-TADAPA that the dialysis organizations wanted is critically important. And then, lastly, but importantly, the non-dialysis population. Less than 25% of patients today in the non-dialysis space are on an anemia management product or being treated for their anemia. And when they enter into dialysis, the outcomes associated with folks that have been treated versus those who have not are enormous. And so the value of having a product like Vatsio in the non-dialysis space is very, very high. And therefore, making sure we're pricing for that dynamic and that innovative value in that subset of the population is important as well.

Nick Gruns: Remember, it's a billion-dollar market today at ESA pricing, and therefore creating that predictability post TAPA that the dialysis organizations wanted is critically important. And then lastly, but importantly, the non-dialysis population, less than 25% of patients today in the non-dialysis space, are on an enenium management product or being treated for their enenium, and when they enter into dialysis, the outcomes associated with folks that have been treated versus those not is enormous. And so the value of having a product like VASIO in the non-dialysis space is very, very high, and therefore, making sure we're pricing for that dynamic and that innovative value in that subset of population is important.

Unknown Attendee: After the speakers remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press par followed by the number one in your telephone keybed. If you would like to withdraw your question, press star one again.

Nick Grund: And therefore, creating that predictability post-TADAPA that the dialysis organizations wanted is critically important.

Mercedes Carrasco: I would now like to turn the call over to Mercedes Carrasco, Senior Director in this relation. Thank you, please go ahead. Thank you, and welcome to Akebia's Second Quarter 2024 Financial Results and Business Updates Conference call.

Nick Grund: And then lastly, but importantly, the non-dialysis population.

Nick Grund: Less than 25% of patients today in the non-dialysis space are on an anemia management product or are being treated for their anemia. And when they enter into dialysis, the outcomes associated with folks that have been treated versus those not is enormous.

Mercedes Carrasco: Please note that a press release was issued earlier today, Thursday, August 8th, detailing our first quarter financial, second quarter financial results, and that release is available on the investor section of our website. For your convenience, a replay of today's call will be available on our website after we conclude.

Nick Grund: And so the value of having a product like VASIO in the non-dialysis space is very, very high. And therefore, making sure we're pricing for that dynamic and that innovative value in that subset of population is important as well.

John Butler: as well. Yeah, I, that last point is, you know, just can't be emphasized. And often, frankly, I mean, I, I, I think it really was a challenge balancing what's right for the dialysis market today versus, you know, what's possible and the benefit we would bring to the non-dialysis patient population. I, I, I hope we've struck the balance here. And, you know, particularly as Nick pointed out, that whack reimbursement for the first few quarters of T-DAPA is critical because there's some real operational costs for the dialysis providers to, to add a new product to, to protocols and plays, storage, etc.

unknown: Yeah, that last point is, you know, just can't be emphasized enough, and Frankly, I think it really was a challenge balancing what's right for the dialysis market today versus what's possible and the benefit we would bring to the non-dialysis patient population. And I hope we've struck the balance here, you know, particularly as Nick pointed out, that WAC reimbursement for the first few quarters of Tdap is critical because there are some real operational costs for the dialysis providers to add a new product, to put protocols in place, storage, et cetera, and, you know, they have to see the business rationale for them to do that. You know,

John Butler: Yeah, that last point is, you know, just can't be emphasized enough, and Frankly, I think it really was a challenge balancing what's right for the dialysis market today versus what's possible and the benefit we would bring to the non-dialysis patient population. And I hope we've struck the balance here, you know, particularly as Nick pointed out, that WAC reimbursement for the first few quarters of Tdap is critical because there are some real operational costs for the dialysis providers to add a new product, to put protocols in place, storage, etc., and, you know, they have to see the business rationale for them to do that.

Speaker Change: Yeah, I that last point is you just can't be emphasized enough and frankly, I mean, I I think it really was a challenge balancing

unknown: Very helpful. Thanks so much.

Mercedes Carrasco: Joining me for today's call, we have John Butler, Chief Executive Officer, Nick Gruns, Chief Commercial Officer, and Eric Ostrowski, Chief Financial and Business Officer. 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.

Speaker Change: what's right for the dialysis market today versus, you know, what's possible and the benefit we would bring to the non-dialysis patient population. I hope we've struck the balance here.

Nick Grund: You know, particularly, as Nick pointed out, that WAC reimbursement for the first few quarters

Nick Grund: of Tdap is critical because there's some real operational costs for the dialysis providers to add a new product to put protocols in place, storage, etc. And, you know, they have to see the business rationale for them to do that. And, you know,

Mercedes Carrasco: Additional information describing these risks is included in the financial results press release that we issued on August 8th, as well in the risk effectors and management discussion and analysis section of our most recent annual and quarterly reports filed with the SEC.

John Butler: And, you know, they have to see the business rationale for them to do that. And, you know, yet, and we, you also want to be very cognizant of the optics around, you know, kind of how pricing is viewed. So, you know, it's quite the balance we had to strike. We did a lot of, and had a lot of conversations, folks, before making that decision. And, and, you know, as Nick pointed out, and his remarks, I think it, I think we did hit the right balance for the dialysis population. Folks are reacting quite well. And they're very willing to contract and put the product as part of their formula.

John Butler: You know, Yet, you also want to be very cognizant of the optics around, you know, kind of how pricing is viewed. So, you know, it's quite the balance we had to strike. We did a lot of and had a lot of conversations with folks before making that decision. And, you know, as Nick pointed out in his remarks, I think we did hit the right balance for the dialysis population. People are reacting quite well and are very willing to, to contract and put the product as part of their formulary. The only additional

Speaker Change: Yet, you also want to be very cognizant of the optics around.

John Butler: With that, I'd like to introduce CEO John Butler. Thanks Mercedes, and thanks everyone for joining us today. Since the Vassio FDA approval in late March, virtually the entire company has been diligently focused on its commercial launch. Now Nick's going to walk you through the details shortly, but the punchline is that in the four weeks since we spoke to you last, we've made significant progress on our key launch initiatives, which are first driving prescriber demand, second contracting effectively with dialysis organizations, and third advancing plans to generate clinical data that could demonstrate potential additional benefits of Vassio.

Speaker Change: kind of how pricing is viewed. So, you know, it's quite the balance we had to strike. We did a lot of and had a lot of conversations with folks before making that decision. And, you know, as Nick pointed out in his

Nick Grund: his remarks, I think we did hit the right

Nick Grund: balance for the for the dialysis population. Folks are reacting.

Speaker Change: quite well and are very willing to to contract and put the product as part of their formula. The only additional context I'll add, Ed, is I've been with a lot of customers over the last month and

John Butler: The only additional context I'll add is I've been with a lot of customers over the last month. And, as you go through the whack price and how to understand that, how to operationalize it, what it means in the context of the contract structure that we've talked about, an off-invoice discount and volume-based rebates, which we've talked about again, as volume goes up, their price goes down, which means their economics improve. Uh, they've looked at and said, huh, that makes a lot of sense, right? And that's what you really want your, from your customers is that, that makes a lot of sense, that reinforcement that, you've done the right thing for them, which is important.

Nicholas Grund: The only additional context I'll add, Ed, is I've been with a lot of customers over the last month. And as you go through the WAC price and how to understand that, how to operationalize it, what it means in the context of the contract structure that we've talked about, an off-invoice discount and volume-based rebates, which we've talked about, again, as volume goes up, their price goes down, which means their They looked at it and said, huh, that makes a lot of sense, right? And that's what you really want from your customers, that it makes a lot of sense, that reinforcement that you've done the right thing for them, which is important.

Ed Arce: As you go through the WAC price and how to understand that, how to operationalize it, what it means in the context of the contract structure that we've talked about, an off-invoice discount and volume-based rebates.

Ed Arce: which we've talked about again as a as volume goes up their price goes down which means their economics improve

Speaker Change: they've looked at and said, huh, that makes a lot of sense, right? And that's what you really want from your customers is that that makes a lot of sense, that reinforcement that you've done the right thing for them, which is important.

John Butler: And, and it, it, it really creates an environment where physicians can try to actually, right? I mean, you know, as he said, you can have a great contract in place, but if you don't have physician demand, you know, they're not going to force that; that our sales force is driving that demand. And, and we know that if physicians have access and are able to use it, which we create through the contracting, that physicians will like using the product, they'll see the benefits of using the product, and they'll expand their use of the product. And that's what positions as well; even though post-Tedapha, we're going to have to take this price cut, if you will.

John Butler: The overwhelming response was that they're ready for a new choice in anemia management for dialysis patients. Our medical affairs team has been supporting dialysis organizations as they work to put Vassio clinical protocols in place ahead of TDAPA. Today, we have a full complement of MSLs who are actively engaged in physician education, armed with a wealth of clinical data, including the Vatadoostat Phase III New England Journal publications, as well as the additional data we've generated to support health care providers understanding and utilization of the product.

John Butler: It really creates an environment where physicians can try vapor therapy here, right? I mean, you know, as he said, you can have a great contract in place, but if you don't have physician demand, they're not going to force that.

Ed Arce: And any.

Ed Arce: It really creates an environment where

Speaker Change: Physicians can tribapse it, right? I mean, you know, as I said, you can have a great contract in place, but if you don't have physician demand, you know, they're not going to force that. Our sales force is driving that demand.

John Butler: Our sales force is driving that demand, and we know that if physicians have access and are able to use it, which we create through the contracting, that physicians will like using the product, they'll see the benefits of using the product, and they'll expand their use of the product. And that's what positions us as well, even though, post-Tdapa, we're going to have to take this price cut, if you will.

Speaker Change: And we know that if physicians have access and are able to use it, which we create through the contracting, that physicians will

Speaker Change: like using the product, they'll see the benefits of using the product, and they'll expand their use of the product. And that's what positions as well, even though post-TDAPA, we're going to have to take this

John Butler: Similarly, our commercial team has also been making good progress. A field sales team is connecting with prescribers to drive awareness and demand. As we expand these discussions, physicians are very consistent in where they expect to use the product initially. The focus is on home patients as well as patients on the highest doses of the SAs. These are the segments where physicians attribute the greatest unmet need, and they total more than 200,000 patients.

John Butler: And, you know, we're now going to be targeting the entire dialysis market, and people will be open to that. And that's a billion-dollar market today. So, that's a, you know, a significant opportunity.

John Butler: You know, we're now going to be targeting the entire dialysis market, and people will be open to that. And that's a billion-dollar market today. So that's a significant opportunity, and then hopefully, as shortly as possible thereafter, we will introduce the product into the non-dialysis market with a label that says non-dialysis. And then you'll start to have patients starting dialysis on Vapsio. So this is how you become the standard of care. It's a process. The first step in dialysis is you've got to have that contract in place that allows physicians to access the product. And that WAC pricing decision was very, very central to that, to making that possible. Very helpful.

Ed Arce: Very helpful. Thanks so much.

Speaker Change: price cut, if you will, you know, we're now going to be targeting the entire dialysis market and people will be open to that. And that's a billion dollar market today. So that's a significant opportunity. And then hopefully as shortly as possible thereafter.

John Butler: And then hopefully, as shortly as possible, thereafter, we introduced the product into the non-dialysis market, with a label and non-dialysis. And, and, you know, then you'll start to have patients starting dialysis on that field. So, it, this is how you become standard of care. It's, it's a process. First step in dialysis is you've got to have that, that contract input in place that allows physicians to access the product, and that whack pricing decision was very, very central to that, to making that possible. Very helpful.

Speaker Change: We introduced the product into the non-dialysis market with a label in non-dialysis and and you know Then you'll start to have patients starting dialysis

Speaker Change: on VASEO. So this is how you become standard of care. It's a process.

John Butler: We believe prescribers will expand utilization of ASEO beyond these patient groups after gaining experience with the product and seeing the benefits of ASEO for these initial patients. We're also very focused on the longer-term growth for ASEO. Generating new data to potentially expand the benefits of the product is critical. A key component of our strategy is to continue to generate this clinical data in collaboration with dialysis organizations. We're deeply engaged with DOs in study design, and believe these studies may meaningfully contribute to continue growth of ASEO post-TEDAPA in the dialysis population. We need to continue to generate important clinical data for ASEO to continue to move towards our goal of becoming a new standard of care.

unknown: First step in dialysis is you've got to have that contract in place that allows physicians to access the product. And that WAC pricing decision was very, very central to that, to making that possible.

Unknown Attendee: Thanks so much. Thanks, Ed.

Speaker Change: Very helpful. Thank you so much.

Unknown Attendee: Thank you. There are no questions.

Operator: Thank you. There are no questions. I will now turn the conference back over to John Butler, CEO, for closing remarks.

Ed Arce: Thanks, Ed.

John Butler: I will now turn the conference back over to John Butler's CEO for closing remarks. Thanks, Andrea. We remain extremely energized by our contracting process and the upcoming Vasio market availability, which is not only a few months away. We're on target with all of our internal timelines and believe we will have all the pieces in place for a successful launch.

Ed Arce: Thank you. There are no questions. I will now turn the conference back over to John Butler, CEO , for closing remarks.

John Butler: Thanks, Andrea. We remain extremely energized.

Nick Grund: Thanks, Andrea. We remain extremely energized by our contracting process and the upcoming Vapsio market availability, which is now only a few months away. I really look forward to seeing many of you at the Fall Investor Conferences and, hopefully, at ASN Kidney Week in October.

Nick Grund: Thanks Andrea. We remain extremely energized by our contracting process and the upcoming Vapsio market availability, which is now only a few months away. We're on target with all of our internal timelines and believe we will have all the pieces in place for a successful launch.

John Butler: I really look forward to seeing many of you at the fall investor conferences and hopefully at the ASN Kidney Week in October. Thanks everyone. Enjoy the rest of your summer.

Nick Grund: I really look forward to seeing many of you at the Fall Investor Conferences and hopefully at the ASN Kidney Week in October . Thanks, everyone. Enjoy the rest of your summer.

John Butler: Think of it this way. Today, we're targeting the TEDAPA patient population with a premium price. Once TEDAPA ends in 2027, we'll have a price consistent with the SAs, but we'll target the entire dialysis market over 500,000 patients and approximately $1 billion today. New data, along with the positive experience over the TEDAPA period, will be central to meeting our goal.

Unknown Attendee: Thank you, ladies and gentlemen; that concludes today's call. Thank you all for joining. You know, disconnect.

Speaker Change: Thank you, ladies and gentlemen, that concludes today's call. Thank you all for joining. You may now disconnect.

Nick Gruns: Now, let me turn it over to Nick to talk about our commercial progress. Thanks, John, and thanks for those joining us on the call today. Our VASU launch activities continue to ramp and evolve, and we are making significant progress across all of our key initiatives targeting both the highly physician makers, as well as the doctors who are directly involved in patient care. The feedback we are getting on VASU has been positive, and doctors are enthusiastic about using the drug to help their dialysis patients, especially in patients who receive in-home dialysis patients on high dose of the UCAs, or patients not achieving appropriate hemoglobin levels.

Nick Gruns: We're also making strong advances on the contracting front, where we are discussing our entire product portfolio, which strengthens our dialogue with dialysis organizations. We have had contract conversations with dialysis organizations covering nearly 90% of patient lives with many more to come. In the next several months, I can tell you that dialysis organizations are looking for part Partners, partners who can help maximize the opportunity to incorporate innovative medications into their centers made possible by Tadapa and also navigate the changes that are necessary considering the high likelihood that phosphate binders will be added to the bundle.

Nick Gruns: Akebia has been and will be that partner. Our national accounts team has been busy and every day the pace is accelerating. We have also heard uniformly about the high degree of change associated with binders in the bundle. This change in reimbursement dynamics for phosphate binders could be associated with a change in distribution channels. And as a result, in the traditional inventory purchasing patterns for this category, including Eriksia. As such, dialysis organizations are reviewing their supply chain logistics to optimize their economics, both ahead of and during the Tadapa period where in the process of evaluating many new supply partners to minimize any disruption.

Nick Gruns: That said, the change in distribution channel is not expected to impact overall demand for phosphate binders or Eriksia market share. And we therefore anticipate similar revenue trends in 2024, as compared to last year, though the supply chain could see some fluctuation as these changes roll out. We have leveraged Eriksia contracting discussion to simultaneously engage in vatcio contracting. There is significant value to us as a company to have a portfolio of products promoted in the same space.

Nick Gruns: And it allows for meaningful operational and potential financial benefits to be realized. The vatcio wholesale acquisition cost of approximately $15,500 per patient per year has been well received by our customers and stakeholders operating in the Tadapa environment who want to use vatcio. We expect our product supply contracts with dialysis organizations will include an often voiced discount and a volume-based rebate.

Nick Gruns: We also continue to work towards having all contracts complete by January.

Nick Gruns: Before I turn it back to John, I wanted to quickly know progress from our international partner, Medici. Vatcio is now available in Germany and Austria and Medici just recently launched in the Netherlands.

Nick Gruns: It is still early days for the European launch, but we are encouraged by our partners' enthusiasm and execution in their launch, John.

John Butler: Thanks, Nick.

Erik Ostrowski: Eric, over to you to talk about our financial position. Thanks, John.

Erik Ostrowski: I'm extremely pleased to have joined the KGB and firmly believe this is a transformational time for the company. Now a month into the job, my conviction is strengthened. With the vatcio product launch and established revenue-generating business in Erixia and a promising kiss-based pipeline, I believe the KGB is well positioned for growth. And as importantly, I am happy to be working with a dedicated and hard-working team with such strong knowledge of and relationships in the retail space.

Erik Ostrowski: Of note, last year, second quarter, license and collaboration revenues included a one-time 10 million dollar upfront payment related to our emergency license agreement. Keybia continues to carry a non-cash intangible hammerization charge of $9 million per quarter in cogs through the fourth quarter of 2024. Research and development expenses were $7.6 million in the second quarter of 2024 compared to $20.2 million in the second quarter of 2023. This decrease was driven by the completion of certain clinical trial activities, a reduction in consulting expenses and lower headcount related costs.

Erik Ostrowski: Dulling general and administrative expenses were $26.9 million in the second quarter of 2024 compared to $27 million in the second quarter of 2023. And lastly, net loss was $8.6 million in the second quarter of 2024 compared to the net loss of $11.2 million in the second quarter of 2023. Cash and cash equivalence is a June 30, 2024, or $39.5 million. And I'm pleased to say we expect to have at least two years of cash runway. Our cash position continues to be supported by revenue from Eriksia and careful expense management.

Unknown Attendee: And with that, we welcome questions. Thank you.

Unknown Attendee: We will now begin the question and answer session. If you have dialed in and would like to ask a question, please press tar one in your telephone keypad to raise your hand and join the queue. If you would like to withdraw your questions, simply press tar one again. If you are called upon to ask a question and are listening by a loud speaker on your device, please pick up your handset and ensure that your phone is not in between asking a question. Again, press tar one to join the queue.

Julian Harrison: And your first question comes from the line of Julian Harrison with BTIG. Thank you, please go ahead. Thank you for taking my question and congrats on all the progress.

John Butler: I'm sorry if I missed it, but just want to confirm that it's still your expectation that you don't need to build out your sales force beyond what you already have for Eriksia. And you probably don't need to manufacture additional API to meet initial demand for your VACO launch expected January next year. So if you want to talk about sales force. Absolutely. And so Julian, thanks for the question. Yeah, we've had a team in place for the entire year that's already been calling on dials, so organizations and providers.

John Butler: While there may be some small tweaking around the edges, I don't think there's going to be anything that I would regard as significant or material in how we approach the marketplace from a down perspective. I think the bigger change that we had was adding to the medical affairs group. You know, we had, we had skinny down that group because medical affairs wasn't as impactful on Eriksia, but they're incredibly important for protocol development for the dialysis providers.

John Butler: So we did expand that group. As I said, it's fully staffed now, and they're out there being very effective with physicians, and then your second question was around API, and that's correct. We have product in place. Erik, maybe you want to talk to that? Yeah, we do. We have product in place. It's been discussed on prior calls. We do have some, it will be effectively zero cost inventory, because it was previously expensive to R&D.

John Butler: So yeah, just to reiterate, we're well positioned from an inventory perspective for the launch. Yeah, our quality team did a great job of generating data to expand the dating for the product. So, you know, everything we have on the shelf will, that we had for two years ago, for the launch we were expecting, we can use now. And it's great place. I mean, just from the perspective that you don't have significant cash outlay for manufacturing. But of course, you do like to manufacture some product and keep your, your CDMO's current on the process. But it is helpful from a, from a cash perspective.

Unknown Attendee: Okay, great.

Unknown Attendee: Thank you.

Unknown Attendee: And then one more if I may, it's great to hear that you're engaging dialysis providers representing, I think you said 90% of the addressable market already.

John Butler: I'm wondering how much of that you expect to be enabled through your recently updated relationship with CSLV4? Yeah, no, it's a great question. It's frankly, we were already engaging with them around Erixia. If you remember, some of the catalysts for Erixia was the proposed rule that came out around binders in the bundle. That helped dialysis organizations really understand that it was coming, which was a catalyst for their urgency to meet with us earlier in the year.

John Butler: And really, the 90% is since the V4 announcement we've met with providers representing 90% approximately 90% of the patients. So the V4 catalyst becomes additional reasons for them to want to get us back in the room in order to discuss contracting and the process. I mean, Nick talked about us becoming a partner. I think we've considered ourselves a partner for some time. But when you, you have to contract directly with the dialysis providers.

John Butler: And now we're doing that on two products. And particularly with phosphate binders, where this will be a lot of work for them to incorporate those into the, as you said, they are now purchasing the phosphate binder, managing that with their patients a lot of work in that. And they really want to work with companies as closely as possible on operational aspects, not just contractual aspects. And that's where it's one of those reasons why it's so proud to have both products that we're talking to them about.

John Butler: It just increases the, the partnership between a kebia and dialysis providers on some really core areas of their business. The only thing I'll probably add to that is, you know, our history in dialysis allows those conversations to be won with a knowledge of their operational concerns, right? If you do, if you walk into these conversations without the knowledge of how they think about their business and what's important to them, it does become a conversation that can appear very one-sided and, you know, out for a kebia only.

John Butler: And in a partnership, if they don't have an opportunity to be able to use the products successfully, then it's really not a partnership. And so creating that environment is really important. And we've been saying for years how important knowing the dialysis business is and meaning Eric, you know, here for a month is learning how different and complicated dialysis can be. And, you know, that is a real competitive advantage for us. Thanks for the questions, Julian.

Unknown Attendee: Thank you.

Ed RC: And your next question comes from the line of ad RC with H.E. Winwright. Thank you. Please go ahead. Hi, good morning. Thanks for taking my questions and congrats on the progress towards the launch next year. A couple of questions for me first on the whack price that you announced. I'm wondering if you could give a little details around some of the criteria as you thought through working to optimize the price not only for but afterwards and you know what sort of key aspects came into that thought process.

Ed RC: Secondly, with Medici, wondering if you can disclose what proportion of the collaborative sales this quarter came from Germany. I think was Germany and Australia which launched in June if there were any and if there's any other further countries that you expect to come online between now and the end of the year. Thanks so much. So I don't know, Erik, do you want to just handle a second one? Yeah, I mean that's a quick one.

Ed RC: Yeah, so no revenues from Medici in this quarter as you pointed out, that was you know a G-Mod. So yeah, they just they just started. So you know, we look forward to seeing that progress. I don't know if we have like do you know any any other countries that are expecting to I know there's there's other ones just one. I don't know, just one. There are others for some of the other in order countries will be in the balance of the year.

Ed RC: Yeah, I mean, you know the larger countries is where they have to do the price negotiation which you know I think we'll start to see them come online next year. But the smaller countries like Netherlands and now that the Nordic countries will come on sooner.

Nick Gruns: Nick, you want to walk through the thoughts around whack pricing? Yeah, and so really whack pricing, a couple of the different things is when we thought about it is one what price would allow for a dialysis organizations to be successful during the TAPA period. And so how do you set up your contract? What is the whack price? Is your reimbursement for the first several quarters of TAPA and allowing TAPA which really supports innovative products being utilized that whack price and then how do we make it a price that makes our dialysis organizations and a key be successful was a consideration to how do we make sure we manage that price over the TAPA period so that post TAPA when we talk about ESA like pricing, we can manage ESA like pricing to make the products sustainable post TAPA.

Nick Gruns: Remember, it's a billion dollar market today at ESA pricing and therefore creating that predictability post TAPA that the dialysis organizations wanted is critically important. And then lastly, but importantly the non dialysis population less than 25% of patients today in the non dialysis space are on an enenium management product or being treated for their enenium and when they enter into dialysis the outcomes associated with folks that have been treated versus those not is enormous.

Nick Gruns: And so the value of having a product like VASIO in the non dialysis space is very very high and therefore are making sure we're pricing for that dynamic and that innovative value in that subset of population is important, as well. Yeah, I, that last point is, you know, just can't be emphasized. And often frankly, I mean, I, I, I think it really was a challenge balancing what's right for the dialysis market today versus, you know, what's possible and the benefit we would bring to the non-dialysis patient population.

Nick Gruns: I, I, I hope we've struck the balance here. And, you know, particularly as Nick pointed out, that whack reimbursement for the first few quarters of T-DAPA is critical because there's some real operational costs for the dialysis providers to, to add a new product to, to protocols and plays, storage, etc. And, you know, they have to see the business rationale for them to do that. And, you know, yet, and we, you also want to be very cognizant of, of the optics around, you know, kind of how pricing is, is viewed.

Nick Gruns: So, you know, it's, it's quite the balance we had to strike. We did a lot of, and had a lot of conversations, folks, before making that decision. And, and, you know, as Nick pointed out, and his, his remarks, I think it, I think we did hit the right balance for the, for the dialysis population. Folks are reacting quite well. And they're very willing to, to contract and, and put the product as part of their formula.

John Butler: The only additional context I'll add is I've been with a lot of customers over the last month. And, as you go through the whack price and, and how to, to, to understand that, how to operationalize it, what it means in the context of the contract structure that we've talked about, an off invoice discount and volume-based rebates, which we've talked about again, as volume goes up, their price goes down, which means their economics improve.

John Butler: Uh, they've looked at and said, huh, that makes a lot of sense, right? And that's what you really want your, from your customers is that, that makes a lot of sense, that reinforcement that, you've done the right thing for them, which is important. And, and it, it, it really creates an environment where physicians can try to actually, right? I mean, you know, as he said, you can have a great contract in place, but if you don't have physician demand, you know, they're not going to force that, that our sales force is driving that demand.

John Butler: And, and we know that if physicians have access and are able to use it, which we create through the contracting, that physicians will like using the product, they'll see the benefits of using the product, and they'll expand their use of the product. And that's what positions as well, even though post-Tedapha, we're going to have to take this price cut, if you will. And, you know, we're now going to be targeting the entire dialysis market, and people will be open to that.

John Butler: And that's a billion dollar market today. So, that's a, you know, a significant opportunity. And then hopefully, as shortly as possible, thereafter, we introduced the product into the non dialysis market, with a label and non dialysis. And, and, you know, then you'll start to have patients starting dialysis on that field. So, it, this is how you become standard of care. It's, it's a process. First step in dialysis is you've got to have that, that contract input in place that allows physicians to access the product, and that whack pricing decision was very, very central to that, to making that possible. Very helpful. Thanks so much. Thanks, Ed. Thank you.

Unknown Attendee: There are no questions.

John Butler: I will now turn the conference back over to John Butler's CEO for closing remarks. Thanks Andrea. We remain extremely energized by our contracting process and the upcoming Vasio market availability, which is not only a few months away. We're on target with all of our internal timelines and believe we will have all the pieces in place for a successful launch. I really look forward to seeing many of you at the fall investor conferences and hopefully at the ASN Kidney Week in October. Thanks everyone.

Unknown Attendee: Enjoy the rest of your summer.

Unknown Attendee: Thank you, ladies and gentlemen, that concludes today's call. Thank you all for joining. You know, disconnect.

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