Q2 2024 Kiniksa Pharmaceuticals International PLC Earnings Call

Good day and thank you for standing by.

Operator: and Executive Pharmaceuticals second quarter 2024 earnings conference call. At this time, all participants on this in the only mode. After this biggest presentation, there will be a question-and-answer session.

Operator: Pharmaceuticals 2nd Quarter 2024 Earnings Conference Call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press Star 1 while on your telephone. You will then hear an automatic message advising that your hand is raised. Please note that this conference is being recorded. I will now hand the conference over to your speaker host for today, Rachel Frank, Head of Investellations. Please go ahead.

Speaker Change: Welcome to Kiniksa Pharmaceuticals' 2nd Quarter 2024 Earnings Conference Call. At this time, all participants are on listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press Star 1 while on your telephone. You will then hear an automatic message advising your hand is raised.

Operator: Does a question during the session, you will need to press star one. Wanting a telephone, you will then hear an automatic message advising your hand is raised. Please note that this conference is being recorded.

Rachel Frank: I will now hand a conference over to speak to us today, Rachel Frank, Head of Investulations. Please go ahead.

Please note that this conference is being recorded. I will now hand the conference over to your speaker host for today, Rachel Frank, Head of Investor Relations. Please go ahead.

Rachel Frank: Thank you, operator.

Rachel Frank: Thank you, operator. Good morning, everyone.

Sanj Patel: Good morning, everyone. And thank you for joining Kiniksa's call to discuss our second quarter 2024 financial results in recent portfolio execution. Appress really highlighting these results can be found on our website under the Investors section.

Rachel Frank: Thank you, operator. Good morning, everyone. And thank you for joining Kiniksa's call to discuss our second quarter 2024 financial results in recent portfolio execution. A press release highlighting these results can be found on our website under the investors section.

Rachel Frank: And thank you for joining Kiniksa's call to discuss our second quarter 2024 financial results and recent portfolio execution. A press release highlighting these results can be found on our website under the Investors section. As for the agenda, our Chief Executive Officer, Sanj K. Patel, will start with an introduction. Next, Ross Moat, our Chief Commercial Officer, will provide an update on Arculas commercial execution. From there, Mark Ragosa, our Chief Financial Officer, will review our second quarter 2024 financial results.

Sanj Patel: As for the agenda, our chief executive officer, Sanj Patel, will start with an introduction. Next, Ross Moat, our Chief Commercial Officer, will provide an update on the Arclisk commercial execution. From there, Mark Rogosa, our Chief Financial Officer, will review our second quarter 2024 financial results.

Speaker Change: As per the agenda, our Chief Executive Officer, Sanj K. Patel, will start with an introduction.

Ross Moat: Next, Ross Moat, our Chief Commercial Officer, will provide an update on the Hercules commercial execution.

Mark Ragosa: From there, Mark Ragosa, our Chief Financial Officer, will review our second quarter 2024 financial results.

Rachel Frank: And finally, Sanj will return for closing remarks and to kick off the Q&A session, during which Eben Tessari, our Chief Operating Officer, and John Paolini, our Chief Medical Officer, will also be on the line. Before getting started, please know that we will be making forward-looking statements today that are subject to risks and uncertainties that may cause actual results to differ materially from these statements. A review of such statements and risk factors can be found on this slide, as well as under the caption, Risk Factors Contained in Our SEC Filings. These statements speak only as of the date of this presentation, and we undertake no obligation to update such statements, except as required by law. With that, I will turn it over to Thanh.

Rachel Frank: And finally, Saunzel returns for closing remarks and to kick off the Q&A session, for which Evan Tissari, our chief operating officer, and John Paulini, our chief medical officer, will also be on the line. Before getting started, please know that we will be making forward-looking statements today that are subject to risks and uncertainties that may cause actual results to differ materially from these statements. Or review such statements and risk factors can be found on this slide, as well as under the caption, "Risk factors" contained in our SEC filings. These statements speak only as of the date of this presentation, and we undertake no obligation to update such statements except as required by law.

Ross Moat: And finally, Sanj will return for closing remarks and to kick off the Q&A session for which Eben Tessari, our Chief Operating Officer, and John Paolini, our Chief Medical Officer, will also be on the line.

Ross Moat: Before getting started, please know that we will be making forward-looking statements today that are subject to risks and uncertainties that may cause actual results to differ materially from these statements.

Ross Moat: A review of such statements and risk factors can be found on this slide, as well as under the caption, Risk Factors Contained in Our SEC Filings. These statements speak only as of the date of this presentation, and we undertake no obligation to update such statements, except as required by law. With that, I will turn it over to Sanj.

Sanj Patel: With that, I will turn it over to Saunzel. Thanks, Rachel. And hello to everyone listening in. In the second quarter of the year, we've continued to execute and make significant progress across our portfolio. We've driven strong commercial performance and advanced our clinical stage asset, Abbey Probot, into a Phase 2v study in Schroger's disease. The full clinical development plan for this program is fully funded within our current operating plan. We've also maintained a strong financial position, and we expect to be cash flow positive on an annual basis. All of this positions us for continued success in the second half of the year and beyond.

Sanj K. Patel: Thanks, Rachel. And hello to everyone listening in. In the second quarter of the year, we continued to execute and make significant progress across our portfolio. We drove strong commercial performance and advanced our clinical stage asset, ABIPROBOT, into a Phase 2B study in Schroeger's. The full clinical development plan for this program is fully funded within our current operating plan. We've also maintained a strong financial position, and we expect to be cash flow positive on an annual basis.

Sanj: Thanks Rachel and hello to everyone listening in. In the second quarter of the year we've continued to execute and make significant progress across our portfolio.

Sanj: We've driven strong commercial performance and advanced our clinical stage asset, ABIPRUVAT, into a Phase IIb study in Sjogren's disease.

Speaker Change: The full clinical development plan for this program is fully funded within our current operating plan.

Speaker Change: We've also maintained a strong financial position and we expect to be cash flow positive on an annual basis.

Sanj K. Patel: All of this positions us for continued success in the second half of the year and beyond, starting on the commercial side since launching Arclist in recurrent pericarditis just over three years ago. Kiniksa has built an effective commercial operation, allowing us to reach an increasing number of recurrent pericarditis patients. We've introduced and advanced a fundamental shift in the treatment paradigm for this disease, and this has been pivotal in establishing Arclist as the standard of care for recurrent pericarditis.

Speaker Change: All of this positions us for continued success in the second half of the year and beyond.

Sanj Patel: Starting on the commercial side since launching Archaeist in recurrent pericarditis just over three years ago, Connector has built an effective commercial operation, allowing us to reach an increasing number of recurrent pericarditis patients. We've introduced and advanced a fundamental shift in treatment paradigm for this disease. And this has been pivotal in establishing Schroger Archaeist as the standard of care for recurrent pericarditis. We've also consistently driven Archaeist collaboration profitability. This allows us to invest in further commercialization. It also includes our recent Salesforce expansion, the American Heart Association initiative, and the Henwick Lungquist partnership that we announced last month.

Speaker Change: Starting on the commercial side, since launching Arclist in recurrent pericarditis just over 3 years ago,

Speaker Change: Kiniksa has built an effective commercial operation allowing us to reach an increasing number of recurrent pericarditis patients.

Speaker Change: We've introduced and advanced a fundamental shift in the treatment paradigm for this disease.

Speaker Change: And this has been pivotal in establishing Arclist as the standard of care for recurrent pericarditis.

Sanj K. Patel: We've also consistently driven Oculus collaboration profitability. This allows us to invest in further commercialization, which also includes our recent Salesforce expansion, the American Heart Association initiative, and the Henrik Lundqvist partnership that we announced last month. In the second quarter, Arcalist net product revenue grew to $103.4 million, which is 90% year-over-year growth. This growth was supported by continued strength across several key commercial drivers, including increasing prescriber adoption, High Physician and Patient Satisfaction, and over 90% payer approval of completed cases. The second quarter also benefited from higher compliance and lower gross net, both of which we do not expect to improve at the same rate going forward.

Speaker Change: We've also consistently driven Oculus Collaboration profitability.

Speaker Change: This allows us to invest in further commercialization.

Speaker Change: It also includes our recent Salesforce expansion, the American Heart Association initiative and the Henrik Lundqvist Partnership that we announced last month.

Sanj Patel: In the second quarter, Archaeist Met Park revenue grew to 103.4 million dollars, which is 90% year-over-year growth. This growth was supported by continued strength across several key commercial drivers, including increasing prescriber adoption, high physician and patient satisfaction, and over 90% pay approval of completed cases. The second quarter also benefited from higher compliance and lower grossiness, both of which we do not expect to improve at the same rate going forward. With regard to prescribers, the total number since launch has increased from approximately 2,000 in Q1 to approximately 2,300 in Q2. Importantly, these prescribers are demonstrating a growing appreciation of the need to treat to the duration of underlying disease.

Speaker Change: In the second quarter, Arcalist Net Product Revenue grew to $103.4 million, which is 90% year-over-year growth.

Speaker Change: This growth was supported by continued strength across several key commercial drivers, including increasing prescriber adoption.

Speaker Change: high physician and patient satisfaction, and over 90% payer approval of completed cases.

Speaker Change: The second quarter also benefited from higher compliance and lower grossness, both of which we do not expect to improve at the same rate going forward.

Sanj K. Patel: With regard to prescribers, the total number since launch has increased from approximately 2,000 in Q1 to approximately 2,300 in Q2. Importantly, these prescribers are demonstrating a growing appreciation of the need to treat for the duration of the underlying disease. And that's reflected by the total average duration of therapy increasing from 23 months at the end of 2023 to approximately 26 months at the end of Q2. Additionally, at the end of the second quarter, approximately 11% of the 14,000 target population were actively on Alkalys treatment.

Speaker Change: With regard to prescribers, the total number since launch has increased from approximately 2000 in Q1 to approximately 2300 in Q2.

Speaker Change: Importantly, these prescribers are demonstrating a growing appreciation of the need to treat to the duration of underlying disease.

Sanj Patel: And that's reflected by the total average duration of therapy increasing from 23 months at the end of 2023 to approximately 26 months at the end of Q2. Additionally, at the end of the second quarter, approximately 11% of the 14,000 target population were actively on Archaeist treatment. As we look to grow this penetration number and ultimately help more patients, we continue to evolve our commercial efforts and initiatives. And we now expect 2024 full year Archaeist net sales to be between 4.5 and 4.15 million dollars, and Ross will cover in more detail this in a moment. Ultimately, it's our commercial execution that's helping to drive our strong financial position and our ability to drive further growth across the connector business.

Speaker Change: And that's reflected by the total average duration of therapy increasing from 23 months at the end of 2023 to approximately 26 months at the end of Q2.

Speaker Change: Additionally, at the end of the second quarter, approximately 11% of the 14,000 target population were actively on alkalis treatment.

Sanj K. Patel: As we look to grow this penetration number and ultimately help more patients, we continue to evolve our commercial efforts and initiatives, and we now expect 2024 full-year Arcolis net sales to be between four, five, and $415 million.

Speaker Change: As we look to grow this penetration number and ultimately help more patients, we continue to evolve our commercial efforts and initiatives.

Ross Moat: And we now expect 2024 full-year Arcalyst Net Sales to be between $45 and $415 million. And Ross will cover in more detail this in a moment.

Sanj K. Patel: And Ross will cover this in more detail in a moment. Ultimately, it's our commercial execution that's helping to drive our strong financial position and our ability to drive further growth across the Kiniksa business. With that in mind, and looking to our pipeline, we're really excited about the potential of Abiprobat to provide another growth opportunity for the company. We recently announced that we have started enrollment in the Phase 2b study of Abiprovar in Sjogren's disease.

Speaker Change: Ultimately, it's our commercial execution that's helping to drive our strong financial position and our ability to drive further growth across the Kiniksa business.

Sanj Patel: With that in mind, and looking to our pipeline, we're really excited about the potential of Abby Prubot to provide another growth opportunity for the company. We recently announced that we started an enrollment in the Phase 2B study of Abby Prubot's in Shroven disease. This is a debilitating chronic autoimmune disease that has no FDA-approved therapies. Based on the clear biological activity demonstrated by Abby Prubot's potential for convenient subcutaneous administration, and the external proof of concepts of the inhibition of the CD40 and CD154. We believe that Abby has the potential to provide meaningful benefit to patients.

Ross Moat: With that in mind, and looking to our pipeline, we're really excited about the potential of Abiprobat to provide another growth opportunity for the company.

Ross Moat: We recently announced that we started enrolment in the Phase 2b study of Abir Pruvats in Sjogren's disease. This is a debilitating chronic autoimmune disease that has no FDA approved therapies.

Sanj K. Patel: This is a debilitating chronic autoimmune disease that has no FDA-approved therapy based on the clear biological activity demonstrated by ABI approval, the potential for convenient subcutaneous administration, and the external proof of concept of the inhibition of the CD40 and CD154 interaction.

Ross Moat: Based on the clear biological activity demonstrated by Abhi Pruvath.

Ross Moat: potential for convenient subcutaneous administration and the external proof of concept of the inhibition of the CD40 and CD154 interaction.

Sanj K. Patel: We believe that ABI has the potential to provide meaningful benefit to patients. I do want to mention that today is World Children's Day. This is a day that's dedicated to raising awareness of this life-altering disease. We're very excited to be working closely with both the Sjogren's Foundation and Sjogren's Europe to help raise awareness. With that, I'll turn it over to Ross, who'll provide an update on how we plan to continue driving patient and physician adoption.

Ross Moat: We believe that AbbE has the potential to provide meaningful benefit to patients.

Sanj Patel: I do want to mention that today is World Shroven's Day. This is a day that's dedicated to raising awareness of this life-altering disease. We're very excited to be working closely with both the Shroven's Foundation and Shroven's Europe to help raise awareness.

Speaker Change: I do want to mention that today is World Children's Day. This is a day that's dedicated to raising awareness of this life-altering disease.

Speaker Change: We're very excited to be working closely with both the Sjogren's Foundation and Sjogren's Europe to help raise awareness.

Unknown Executive: Dennis.

Ross Moat: With that, I'll turn it over to Ross, who will provide an update on how we plan to continue driving patient and physician adoption. Ross, thank you, Falson. The Sanjnotive Q2 represented a solid quarter of growth, which was marked by strength across a number of key revenue drivers. As of the end of the second quarter, the number of active commercial patients reached approximately 11 percent into the 14,000 multiple recurrence target population, compared to around 9 percent as of the end of 2023. We're proud to be helping many recurrent pericarditis patients. We believe there is a massive opportunity ahead if we continue to execute our strategy to further build the recurrent pericarditis market.

Speaker Change: With that I'll turn it over to Ross who'll provide an update on how we plan to continue driving patient and physician adoption.

Ross Moat: Thank you, Sanj. As Sanj noted, Q2 represented a solid quarter of growth, which was marked by strength across a number of key revenue drivers. As of the end of the second quarter, the number of active commercial patients reached approximately 11% of the 14,000 multiple recurrence target population, compared to around 9% as of the end of 2020. We're proud to be helping many recurrent pericarditis patients. We believe there is a massive opportunity ahead if we continue to execute our strategy to further build recurrent pericarditis.

Speaker Change: Ross.

Ross Moat: Thank you, Sasha.

Ross Moat: As Sanj noted, Q2 represented a solid quarter of growth which was marked by strength across a number of key revenue drivers.

Ross Moat: As of the end of the second quarter, the number of active commercial patients reached approximately 11% into the 14,000 multiple recurrence target population, compared to around 9% as of the end of 2023.

Ross Moat: We are proud to be helping many recurrent pericarditis patients and we believe there is a massive opportunity ahead if we continue to execute our strategy to further build the recurrent pericarditis market.

Ross Moat: A key component of continuing to build the market is disease awareness, which ultimately impacts all of the other underlying commercial growth drivers. As a rare chronic flaring disease, recurrent pericarditis is often misdiagnosed and under-treated due to a lack of access to expert care. In a Harris-Paul survey, 96 percent of patients reported that they were incorrectly diagnosed with other conditions prior to their recurrent pericarditis diagnosis. In fact, they had an average of 2.7 misdiagnoses before their recurrent pericarditis diagnosis. Additionally, once a diagnosis is reached, our aim is to evolve the physician's mindsets to recognize interleukin one alpha and beta as the underlying driver of the disease and to be proactive in moving away from continued systemic treatments and utilize arclest.

Ross Moat: A key component of continuing to build the market is disease awareness, which ultimately impacts all of the other underlying commercial growth drivers. As a rare chronic flaring disease, recurrent pericarditis is often misdiagnosed and undertreated due to a lack of access to expert care. In a Harris Poll survey, 96% of patients reported that they were incorrectly diagnosed with other conditions prior to their recurrent pericarditis diagnosis. In fact, they had an average of 2.7 misdiagnoses before their recurrent pericarditis diagnosis.

Ross Moat: A key component of continuing to build the market is disease awareness, which ultimately impacts all of the other underlying commercial growth drivers.

Ross Moat: Additionally, once the diagnosis is reached, our aim is to change physicians' mindsets to recognize interleukin-1, alpha, and beta as the underlying driver of the disease and to be proactive in moving away from continued systemic treatment and utilize our This includes evolving digital marketing materials and expanding our field force to approximately 85 representatives with the goal of achieving greater reach and frequency of engagements with healthcare providers.

Ross Moat: As a rare chronic flaring disease, recurrent pericarditis is often misdiagnosed and undertreated due to a lack of access to expert care.

Ross Moat: In a Harris Poll survey, 96% of patients reported that they were incorrectly diagnosed with other conditions prior to their recurrent pericarditis diagnosis.

Ross Moat: In fact, they had an average of 2.7 misdiagnoses before their recurrent pericarditis diagnosis.

Ross Moat: Additionally, once the diagnosis is reached, our aim is to evolve the physician's mindset

Speaker Change: to recognize interleukin-1, alpha and beta as the underlying driver of the disease and to be proactive in moving away from continued systemic treatment and utilize ARCLIS.

Ross Moat: Based on our learning since launch, we've made a number of investments focused on improving the awareness and understanding of the disease. This includes evolving digital marketing materials and expanding our field force through approximately 85 representatives, with the goal of achieving greater reach and frequency of engagements with health care professionals. Additionally, we recently announced two exciting initiatives. Firstly, we're sponsoring the American Heart Association's Addressing Recurrent Pericarditis Initiative, which is a multifaceted national effort to improve quality of care for recurrent pericarditis patients through building centers of excellence and disseminating best practices for the diagnosis and management of the disease.

Speaker Change: Based on our learning since launch, we've made a number of investments focused on improving the awareness and understanding of the disease.

Speaker Change: This includes evolving digital marketing materials and expanding our field force to approximately 85 representatives with the goal of achieving greater reach and frequency of engagements with healthcare professionals.

Ross Moat: Additionally, we recently announced two exciting initiatives. Firstly, we're sponsoring the American Heart Association's Addressing Recurrent Pericarditis, which is a multifaceted national effort to improve the quality of care for recurrent pericarditis patients through building centers of excellence and disseminating best practices for the diagnosis and management of the disease. Under this initiative, the AHA has identified 15 champion sites that will establish a learning collaborative to improve referral pathways, identify gaps, and develop solutions that can be shared with regional healthcare practices across the UK.

Speaker Change: Additionally, we recently announced two exciting initiatives.

Speaker Change: Firstly, we're sponsoring the American Heart Association's Addressing Recurrent Pericarditis Initiative.

Speaker Change: which is a multi-faceted national effort to improve quality of care for recurrent pericarditis patients through building centres of excellence and disseminating best practices for the diagnosis and management of the disease.

Ross Moat: Under this initiative, the AHA has identified 15 champion sites that will establish a learning collaborative to improve referral pathways, identify gaps, and develop solutions that can be shared with regional healthcare practices across the country. In addition to creating a scalable national model of care, this initiative will also develop educational materials and digital media for both patients and physician audiences. Finally, we also recently announced a partnership with Henrik Linquist, National Hockey League Hall of Famer and former goalie of the New York Rangers, to raise awareness of the realities of suffering from recurrent pericarditis and the importance of proactive early treatment to prevent future floods.

Speaker Change: Under this initiative, the AHA has identified 15 champion sites that will establish a learning collaborative to improve referral pathways, identify gaps, and develop solutions that can be shared with regional healthcare practices across the country.

Ross Moat: In addition to creating a scalable national model of care, this initiative will also develop educational materials and digital media for both patients and physician audiences. Finally, we recently announced a partnership with Henrik Lindquist, a National Hockey League Hall of Famer and former goalie of the New York Rangers, to raise awareness of the realities of suffering from recurrent pericarditis and the importance of proactive early treatment to prevent future flare-ups. We look forward to providing more details when the awareness campaign formally kicks off in September.

Speaker Change: In addition to creating a scalable national model of care, this initiative will also develop educational materials and digital media for both patients and physician audiences.

Speaker Change: Finally, we also recently announced a partnership with Henrik Lundqvist.

Henrik Lundqvist: National Hockey League Hall of Famer and former goalie of the New York Rangers to raise awareness of the realities of suffering from recurrent pericarditis and the importance of proactive early treatment to prevent future flares.

Ross Moat: We look forward to providing more details when the awareness campaign formally kicks off in September. In Q2, we saw a growth of around 300 new prescribers versus the prior quarter. This takes the total prescriber base to more than 2,300 since launch and demonstrates solid growth in the breadth of prescribing. Additionally, the depth of prescribing is growing. With the number of repeat prescribers now reaching around 550. Looking year over year, we're seeing an acceleration in the step-up of both prescribers and repeat prescribers, which bodes well for the future as physicians continue to share their positive prescribing experiences and patients report the magnitude of effects from being treated with Arclist.

Henrik Lundqvist: We look forward to providing more details when the awareness campaign formally kicks off in September .

Ross Moat: In Q2, we saw a growth of around 300 new prescribers versus the prior period. This takes the total prescriber base to more than 2,300 since launch and demonstrates solid growth in the breadth of prescribers. Additionally, the depth of prescribing is growing, with the number of repeat prescribers now reaching around 550. Looking year over year, we're seeing an acceleration in the step-up of both prescribers and repeat prescribers, which bodes well for the future as physicians continue to share their positive prescribing experiences, and patients report the magnitude of effects from being treated with ART.

Speaker Change: In Q2, we saw a growth of around 300 new prescribers versus the prior quarter.

Speaker Change: This takes the total prescriber base to more than 2,300 since launch and demonstrates solid growth in the breadth of prescribing.

Speaker Change: Additionally, the depth of prescribing is growing, with the number of repeat prescribers now reaching around 550.

Speaker Change: Looking year over year, we're seeing an acceleration in the step-up of both prescribers and repeat prescribers, which bodes well for the future as physicians continue to share their positive prescribing experiences and patients report the magnitude of effects from being treated with ARCLIS.

Ross Moat: Furthermore, with the growth in repeat prescribers over time, there's starting to account for a meaningful size of the new patients starting Arclist. Year to date, repeat prescribers accounted for greater than 40% of all new enrollments over the same time period. And we're still nascent in the overall recurrent pericarditis market's opportunity for Arclist. One measure to demonstrate this is that our recently increased sales falls are targeting around 11,000 prescribers, covering approximately 85% of the recurrent pericarditis patients nationally. Clearly, with around 2,300 prescribers launched to date and considering some of those doctors are not within our target base, we're only just getting going, and we have a huge opportunity to further expand both the breadth and the depth of the prescriber base.

Ross Moat: Furthermore, with the growth in repeat prescribers over time, they're starting to account for a meaningful proportion of the new patients starting out. Year-to-date repeat prescribers accounted for greater than 40% of all new enrollments over the same time, and we're still nascent in the overall recurrent pericarditis market. One measure for our one measure to demonstrate is that our recently increased sales force is targeting around 11,000 prescribers, covering approximately 85% of the recurrent pericarditis patients.

Speaker Change: Furthermore, with the growth in repeat prescribers over time, they're starting to account for a meaningful size of the new patients starting after this.

Speaker Change: Year to date, repeat prescribers accounted for greater than 40% of all new enrollments over the same time period.

Speaker Change: And we're still nascent in the overall recurrent pericarditis market opportunity for Arclis.

Speaker Change: One measure to demonstrate this.

Speaker Change: is that our recently increased sales force are targeting around 11,000 prescribers, covering approximately 85% of the recurrent pericarditis patients nationally.

Ross Moat: Clearly, with around 2,300 prescribers launched to date and considering some of those doctors are not within our target, we're only just getting going, and we have a huge opportunity to further expand both the breadth and the depth of the prescribing. Turning to the next slide, our market research is also pointing to the opportunity ahead. When interviewing healthcare professionals, both current prescribers and those who haven't previously prescribed alkalis, both overwhelmingly expect prescribing of alkalis, with zero expected. In addition, and unsurprisingly, given the positive experiences they're having, rheumatologists and cardiologists are considering the use of alkalis in patients earlier in their disease course than they were compared to a year ago.

Speaker Change: Clearly, with around 2,300 prescribers launched to date, and considering some of those doctors are not within our target base, we're only just getting going, and we have a huge opportunity to further expand both the breadth and the depth of the prescriber base.

Ross Moat: Turning to the next slide, our market research is also pointing to the opportunity ahead. When interviewing healthcare professionals, both current prescribers and those who haven't previously prescribed Arclist, both overwhelmingly expect prescriber of Arclist to grow with zero expect in a decrease. In addition, and unsurprisingly, given the positive experiences they're having, rheumatologists and cardiologists are considering the use of Arclist in patients earlier in their disease course than they were compared to a year ago. More broadly, this tells us that we're succeeding in our efforts to evolve physician's mindsets to appreciate that recurrent pericarditis is a serious and debilitating disease that requires a proactive treatment with an interleukin one approach.

Speaker Change: Turning to the next slide, our market research is also pointing to the opportunity ahead. When interviewing healthcare professionals, both current prescribers and those who haven't previously prescribed Arcanist, both overwhelmingly expect prescribing of Arcanist to grow.

Speaker Change: with zero expecting a decrease.

Speaker Change: In addition, and unsurprisingly, given the positive experiences they're having, rheumatologists and cardiologists are considering the use of alkalis in patients earlier in their disease course than they were compared to a year ago.

Ross Moat: More broadly, this tells us that we're succeeding in our efforts to change physicians' mindsets to appreciate that recurrent pericarditis is a serious and debilitating disease that requires proactive treatment with an interleukin-1 approach. This underscores that we're starting to establish a new standard of care for recurrent pericarditis. As mentioned earlier, Q2 was a particularly strong quarter, mainly driven by an increased number of patients on therapy due to an acceleration of patient starts and longer duration. A portion of the growth was also due to metrics that improved in Q2 compared to Q1, where we don't anticipate the same magnitude of growth in subsequent quarters. For example, Additionally, year-to-date gross net decreased from 13.5% at the end of Q1 to 10.8% at the end of Q2 due to better-than-expected copay utilization, with more patients reaching their out-of-pocket maximums earlier than forecast.

Speaker Change: More broadly, this tells us that we're succeeding in our efforts to evolve physicians' mindsets to appreciate that recurrent pericarditis is a serious and debilitating disease that requires a proactive treatment with an interleukin-1 approach.

Ross Moat: This underscores that we're starting to establish a new standard of care for recurrent pericarditis with Arclist. Downs mentioned earlier, the Q2 was a particularly strong quarter, mainly driven by an increased number of patients on therapy due to an acceleration of patient starts and longer durations of therapy. A portion of the growth was also due to metrics that improved in Q2 compared to Q1, where we don't anticipate the same magnitude of growth in subsequent quarters. For example, higher compliance rates result in from Q1 parent-clan changes and a new compliance and adherence program that we launched to support patients even further on their journey on.

Speaker Change: This underscores that we're starting to establish a new standard of care for recurrent pericarditis with Arclisk.

Speaker Change: As mentioned earlier, the Q2 was a particularly strong quarter, mainly driven by an increased number of patients on therapy due to an acceleration of patient starts and longer durations of therapy.

Speaker Change: A portion of the growth was also due to metrics that improved in Q2 compared to Q1, where we don't anticipate the same magnitude of growth in subsequent quarters.

Speaker Change: For example, higher compliance rates resulting from Q1 payer plan changes and a new compliance and adherence programme that we launched to support patients even further on their journey on Arclisk.

Ross Moat: Marklist. Additionally, near-to-date grossed and at decreased from 13.5% at the end of Q1 to 10.8% at the end of Q2 due to better than expected copay utilization, with more patients reaching the outer pocket maximums earlier than forecast. As a result of the strong Q2 performance, we are $470 million to $90 million to $405 million to $415 million.

Speaker Change: Additionally, year-to-date gross net decreased from 13.5% at the end of Q1

Speaker Change: to 10.8% at the end of Q2 due to better than expected co-pay utilisation, with more patients reaching their out-of-pocket maximums earlier than forecast.

Mark Ragosa: As a result of the strong Q2 performance, we are delighted to increase the net revenue guidance for 2024 from $370 million to $390 million to $405 million to $415 million. I'll now turn it over to Mark to discuss the second quarter 2024 financial results. Mark

Speaker Change: As a result of the strong Q2 performance, we are delighted to increase the Net Revenue Guidance for 2024 from $370 million to $390 million to $405 million to $415 million.

Mark Ragosa: I now turn over to Mark to discuss the second quarter of 2024 financial results.

Speaker Change: I'll now turn it over to Mark to discuss the second quarter 2024 financial results. Mark.

Mark Ragosa: Mark. That's a detailed second quarter of 2024 financial results can be found in a press release we issued earlier today. There are several items on the slide that I'd like to call your attention to this morning. First total revenue in the second quarter of 2024 was $108.6 million, including Arcliffe's net product revenue of $103.4 million, representing 90% year-over-year growth, and collaboration revenue of $5.2 million, representing the recognition of milestones earned under the economic license agreement for Fixerola Mab, including a $5 million developed in milestone received this quarter related to a third indication. Second, Arcliffe's collaboration operating profit in the second quarter grew 114% year-over-year to $59.9 million in growth collaboration expenses to $30 million.

Mark Ragosa: A detailed second quarter 2024 financial results can be found in the press release we issued earlier today. There are several items on this slide that I'd like to call your attention to this morning.

Mark Ragosa: Thanks Ross. Detailed second quarter 2024 financial results can be found in the press release we issued earlier today.

Mark Ragosa: There are several items on this slide that I'd like to call your attention to this morning.

Sanj K. Patel: First, total revenue in the second quarter of 2024 was $108.6 million, including ArclisNet product revenue of $103.4 million, representing 90% year-over-year growth, and collaboration revenue of $5.2 million, representing the recognition of milestones earned under the Genentech License Agreement for Vixorilumab, including a $5 million development milestone received this quarter related to a third indication. Second, Arkela's collaboration operating profit in the second quarter grew 114% year-over-year to $59.9 million and drove collaboration expenses to $30 million.

Mark Ragosa: First, total revenue in the second quarter of 2024 was $108.6 million.

Speaker Change: Including Arklis Net Product Revenue of $103.4 million, representing 90% year-over-year growth, and Collaboration Revenue of $5.2 million.

Speaker Change: representing the recognition of milestones earned under the genetic license agreement for Vixorilumab including a five million development milestone received this quarter related to a third indication.

Speaker Change: Second, Arklis Collaboration operating profit in the second quarter grew 114% year-over-year to $59.9 million and drove collaboration expenses to $30 million.

Mark Ragosa: Third, higher cost of goods sold in collaboration expenses, both of which are largely driven by Arcliffe's revenue growth, as well as investment related to Arcliffe's commercialization through a year-over-year operating expense growth in the second quarter. Fourth, net loss in the second quarter was $3.9 million compared to net income of $59 million in the second quarter of last year when we recognize a non-cash tax benefit related to the treatment of our deferred tax assets. And lastly, net cash flow in the second quarter was $5.2 million, bringing our end-of-period cash balance to $218.8 million. We continue to expect our cash reserves, as well as strong commercial execution and financial discipline, to support our current operating plan, and we expect to remain cash flow-positive on an annual basis.

Sanj K. Patel: Third, higher cost of goods sold and collaboration expenses, both of which are largely driven by ARCLIS revenue growth, as well as investment related to ARCLIS commercialization through year-over-year operating expense growth in the second quarter. Fourth, our net loss in the second quarter was $3.9 million compared to net income of $15 million in the second quarter of last year when we recognized a non-cash tax benefit related to the treatment of our deferred tax assets.

Speaker Change: Third, higher cost of goods sold in collaboration expenses, both of which are largely driven by ARCLIS revenue growth, as well as investment related to ARCLIS commercialization through year-over-year operating expense growth in the second quarter.

Speaker Change: Fourth, net loss in the second quarter was $3.9 million compared to net income of $15 million in the second quarter of last year when we recognized a non-cash tax benefit related to the treatment of our deferred tax assets.

Sanj K. Patel: And lastly, net cash flow in the second quarter was $5.2 million, bringing our end-of-period cash balance to $218.8 million. We continue to expect our cash reserves, as well as strong commercial execution and financial discipline, to support our current operating plan, and we expect to remain cash flow positive on an annual basis. With that, I'll turn the call back to Sanj for closing remarks.

Speaker Change: And lastly, net cash flow in the second quarter was $5.2 million, bringing our end-of-period cash balance to $218.8 million.

Speaker Change: We continue to expect our cash reserves, as well as strong commercial execution and financial discipline to support our current operating plan, and we expect to remain cash flow positive on an annual basis.

Sanj Patel: With that, I'll turn the call back to Alexander for closing remarks. Thanks, Mark. As you've heard, we're focused on accelerating Tenix's growth through our commercial execution with Arcliffe and by advancing our pipeline. Importantly, we expect to remain cash flow-positive on an annual basis while continuing to invest in value-creating opportunities.

Sanj K. Patel: Thanks Mark. As you've heard, we're focused on accelerating Kiniksa's growth through our commercial execution with our partners and by advancing our pipeline. Importantly, we expect to remain cashflow positive on an annual basis while continuing to invest in value-creating opportunities. I am jolly excited about the strides we're making to provide life-changing medicines for patients and to build sustainable value. With that, I'll now turn the call back to the operator for questions. Operator, and Liisa Hammond.

Speaker Change: With that, I'll turn the call back to Sanj for closing remarks.

Sanj: Thanks Mark. As you've heard, we're focused on accelerating Kiniksa's growth through our commercial execution with Arclist and by advancing our pipeline.

Sanj: Importantly, we expect to remain cashflow positive on an annual basis while continuing to invest in value-creating opportunities.

Sanj Patel: I am jolly excited about the strides we're making to provide live-changing medicines for patients and building sustainable value.

Speaker Change: I am jolly excited about the strides we're making to provide life-changing medicines for patients and to building sustainable value.

Operator: With that, I'll now turn the call back to the operator for questions. Operator? Finally, Liisa and John, and as a question, you will need to press star 11 on your telephone and wait for your name to be announced. To withdraw your question, simply press Star 11 again.

Speaker Change: With that, I'll now turn the call back to the operator for questions. Operator?

Operator: Finally, ladies and gentlemen, to ask a question, you will need to press star 1 1 on your telephone and wait for your name to be announced. To withdraw your question, simply press star 1 1 again. Please stand by while we compile the county roster. Now, the first question comes from the line of Anupam Rama with J.P. Morgan. Your line is open.

Speaker Change: Finally, ladies and gentlemen, to ask a question, you will need to press star 1 1 on your telephone and wait for your name to be announced. To withdraw your question, simply press star 1 1 again. Please stand by while we compile the county roster.

Operator: Please then, bye. We'll be compiled again, er, raster.

Anupam Rama: Now, first question coming from the line of Anupam Rama with JP Morgan, Neil and his open. Hey guys, congrats on the quarter. Just a quick one for me, as you're thinking about arthlyst treatment duration now over two years, where would you say, physician and pair understanding about arthlyst being more of a chronic therapy versus a product. Use for sort of a defined treatment duration is currently. Thanks so much.

Speaker Change: Now, first question coming from the line of Anupam Rama with J.P. Morgan. Your line is open.

Sanj K. Patel: Hey guys, congrats on the quarter. Just a quick one from me. As you're thinking about ARTLIS treatment duration now being over two years, where would you say physician and payer understanding about ARTLIS being more of a chronic therapy versus a product used for sort of a defined treatment duration is currently? Thanks so much.

Anupam Rama: Hey guys, congrats on the quarter. Just a quick one from me. As you're thinking about Arclis treatment duration now over two years, where would you say physician and payer understanding about Arclis being more of a chronic therapy versus a product

Speaker Change: used for sort of a defined treatment duration as currently. Thanks so much.

Sanj Patel: Thanks Anupam, this is Sanj, and I'm sure I'll hand it over to either Ross or John, but you know, certainly we see the current recorditis as a chronic flaring disease, and certainly our education to both pairs, physicians, prescribes, is very much along that line. I think there's a growing understanding that this is definitely a chronic disease, and you've seen the duration increase since the launch just over three years ago.

Sanj K. Patel: Thanks, Anupam. This is Sanj, and I'm sure I'll hand it over to either Ross or John.

Ross Moat: But, you know, certainly, we see recurrent pericarditis as a chronic flaring disease, and certainly, our education of both payers, physicians, and prescribers has been very much along that line. I think there is a growing understanding that this is definitely a chronic disease. And you've seen the duration, you know, increase since the launch just over three years ago. But I'll maybe hand over to Ross, who's obviously in close contact with the payer community via his payer group. Thanks, Sanj. Hi Anupam.

Sanj: Thanks Anupam, this is Sanj and I'm sure I'll hand it over to either Ross or John but you know certainly we see recurrent pepiditis as a chronic flaring disease and certainly our education to both

Speaker Change: payers, physicians, prescribers have been very much along that line. I think there is a growing understanding that this is

Ross Moat: is definitely a chronic disease and you've seen the duration increase since the launch just over three years ago. But I'll maybe hand over to Ross who's obviously in close contact with the payer community via his payer group.

Ross Moat: But I'll maybe hand over to Ross, who's obviously in close contact with the pair of community, via his pair group. Thanks, Anupam. Thank you for the question. So I think you're absolutely right. I think we are starting to see, you know, somewhat on the shift, and that's been evolving since the time of launch. As Sanj, I'll write most recently, changing from a total average duration of around 23 months to now around 26 months. We're really focusing on making sure people understand the natural history of the disease, which is a medium around three years of disease and around a third of the patients are still suffering from the disease at five years out.

Ross Moat: Thank you for the question. I think you're absolutely right. I think we are starting to see, you know, somewhat of a shift. And that's been evolving since the time of launch, as Sanj outlined, most recently changing from a total average duration of around 23 months to now around 26 months. We're really focusing on making sure people understand the natural history of the disease, which is a median of around three years of disease, and around a third of the patients are still suffering from the disease at five years out.

Ross Moat: Thanks Sanj. Hi Anupam, thank you for the question. So I think you're absolutely right, I think we are starting to see, you know, somewhat of a shift and that's been evolving since the time of launch as Sanj outlined, most recently changing from a total average duration of around 23 months to now around 26 months.

Ross Moat: We're really focusing on making sure people understand the natural history of the disease which is a medium to go down three years.

Ross Moat: of disease and around a third of the patients are still suffering from the disease at five years.

Ross Moat: So we're really trying to utilize that. That backdrop is the way of treating for for office. And I think we're starting to see the free itself that people really understanding it and treating to the natural history. Our clinical experience also mirrors some of that as well, where we have a medium of two years' treatment duration, a maximum of three years' treatment duration under the long-term extension. We obviously have a residence registry ongoing as well to help collect that more long-term longitudinal information from patients. So I guess I can say we're starting to see it continue to evolve.

Ross Moat: So we're really trying to utilize that backdrop as the way of treating our case. And I think we're starting to see the fruits of that, of people really understanding it and treating it to the natural history. Our clinical experience also mirrors some of that as well, where we have a median of two years of treatment duration, and a maximum of three years of treatment duration under the long-term extension. We obviously have a resonance registry ongoing as well to help collect that more long-term longitudinal information from patients.

Ross Moat: out so we're really trying to utilize that that backdrop as the way of treating for for our case and I think we're starting to see

Ross Moat: see the fruits of that, people really understanding it and treating to the natural history. Our clinical experience also mirrors some of that as well where we have a median of two years treatment duration, a maximum of three years treatment duration under the long-term extension. We obviously have a resonance registry ongoing as well to help collect that more long-term longitudinal information from patients. So I guess I can say that we're starting to see it continue to evolve and we'll see whether that continues along the trajectory for the future or not. But it's obviously a key focus for us and to make sure the patients are treated appropriately throughout the course of the disease that they're suffering from rather than stopping too early, which we do see and then patients go and restart back on our list.

Ross Moat: So I guess I can say that we're starting to see it continue to evolve, and we'll see whether that continues along the trajectory for the future or not. But it's obviously a key focus for us and to make sure the patients are treated appropriately throughout the course of the disease that they're suffering from rather than stopping too early, which we do see, and then patients go and restart back on our list if symptomology comes back.

Ross Moat: And we'll see whether that continues along the trajectory for the future or not. But it's obviously a key focus for us and to make sure the patients are treated appropriately throughout the course of the disease that they're suffering from, rather than stopping too early, which we do see. And then patients go and restart back on our list. If symptomology comes back on the pile side, generally we see power approved force for 12 months duration and then an attestation from the position that the patient needs to continue on therapy and is seeing good experience on therapy.

Ross Moat: On the payer side, generally, we see payer approvals for 12 months duration, and then an attestation from the physician that the patient needs to continue on therapy and is seeing good experience with therapy to just roll over and continue for the next year. So obviously, we've had many, many patients go through that re-approval process.

Ross Moat: Econtomology Comments back.

Speaker Change: On the payer side, generally we see payer approvals for 12 months duration and then an attestation from the physician that the patient needs to continue on therapy and is seeing good experience on therapy to just roll over and continue for the next year. So obviously we've had many, many patients go through that re-approval process now as well.

Anupam Rama: So just roll over and continue for the next year. So obviously we've had many, many patients go through that. So we approve of process and how as well. Thanks so much for taking the question, and congrats again.

Unknown Attendee: Thanks so much for taking the question and congratulations again.

Speaker Change: Thanks so much for taking the question and congrats again.

Unknown Executive: Thank you.

Operator: Thank you. And our next question comes from the line of Paul Choi with Goldman Sachs. You'll let us open, then?

Khalil: And our next question coming from Delina Paul Choi with Goldman Sachs. You're on this open. Hi everyone, congrats on my quarter. This is Khalil calling in for Paul. Thank you so much for taking our questions. I guess a couple of quick ones from us.

Speaker Change: Thank you. And our next question coming from the line of Paul Choi with Goldman Sachs, you'll let us open.

Unknown Attendee: Hi everyone, congrats on the quarter. This is Khalil calling in for Paul.

Khalil: Hi everyone, congrats on the quarter. This is Khalil calling in for Paul. Thank you so much for taking our questions. I guess a couple quick ones from us. One, you talked about the GTN decline, decreasing this quarter. We're just wondering if you had any kind of color on what the steady state should be going forward and what how we should think about that. And then secondly, we're wondering if you had any color on the cadence of enrollment in the IV-Provide trial. Thank you so much.

Khalil: When you talk about the GTN decline, decreasing this quarter, we're just wondering if you had any kind of color on what the steady state should be going forward and how we should think about that. And then secondly, we're wondering if had any color on the cadence of enrollment in the approved trial. Thank you so much.

Ross Moat: Maybe Ross, why don't you start on the manner of John? Yeah, sure. I'll take the question as part to begin with. Maybe just to orient you to a point of reference, which is through 2023, where we saw the four-year gross than that of 9.8% throughout the entire year. But at the end of Q1, the year-to-date gross than it was 13.5%, and as we mentioned on the prepared remarks of the end of Q2, that was reduced quite substantially to 10.8% as the year-to-date number at the end of Q2. So, you know, many of those coming from the copay dynamics in Q1.

Ross Moat: Maybe Ross, why don't you start and we'll hand it over to John? Yeah, sure. I'll take the gross net part to begin with. So maybe just to orientate you to a point of reference, which is through 2023, where we saw a full year gross net of 9.8% throughout the entire year. At the end of Q1, the year-to-date gross net was 13.5%, and as we mentioned in the prepared remarks at the end of Q2, that was reduced quite substantially to 10.8%.

Unknown Attendee: Thank you so much for taking our questions. I guess a couple quick ones from us. One, you talked about the GTN decline and decreased this quarter. We're just wondering if you had any kind of color on what the steady state should be going forward and how we should think about that. And secondly, we're wondering if you have any color on the cadence of enrollment in the adequate trial. Thank you so much. Maybe Ross, why don't you start?

Speaker Change: Maybe Ross, why don't you start and then I'll listen to John.

Ross Moat: Yeah, sure. I'll take the gross net part to begin with. So maybe just to orientate you to a point of reference, which is through 2023, where we saw the full year gross net of 9.8%.

Speaker Change: throughout the entire year. At the end of Q1, the year-to-date growth scenario was 13.5%. And as we mentioned on the prepared remarks at the end of Q2, that was reduced quite

Ross Moat: As the year-to-date number at the end of Q2. So, you know, much of that is coming from the co-pay dynamics. In Q1, obviously, there were a lot of industry headwinds associated with payer plan changes and co-pays. We saw that reverse quite substantially through Q2, which kind of accounted for a meaningful amount of the growth that I think was important. But obviously, we have not provided a forward look into what we expect the full year of 2024 to be from a gross net perspective.

Speaker Change: substantially to 10.8 as the year-to-date number at the end of Q2. So, you know, many of that is coming from the copay dynamics in Q1. Obviously, there's a lot of industry headwinds associated with payer plan changes and copays. We saw that reverse quite substantially through Q2, which kind of accounted for a meaningful amount of the growth that I think was important. But obviously, we have not provided a forward look into what we expect the full year of 2024 to be from a gross net perspective.

Ross Moat: I've seen there's a lot of industry headwinds associated with pay or plan changes and copays. We saw that reverse quite substantially through Q2, which kind of accounted for meaningful amounts of the growth.

John Paolini: I think it was, what was important, but obviously we've not provided forward, you know, a concern what we expect the full year of 2024 to be from a gross net perspective. And then we've got it in your second question.

John F. Paolini: And then with regard to your second question, this is John Paolini, the Chief Medical Officer, regarding your question about the Phase 2B study for epiPruvart. Yes, we were pleased to announce in the earlier part of July that we had initiated enrollment in the Phase 2B Sherven's trial. And today, of course, being International Sherven's Day, we really pause to reflect upon the importance of this debilitating disease and Kiniksa's contribution to trying to grow the science in this space with the development program for epiPruvart. And so, as was mentioned by Sanj, your enrollment has initiated, and at this point, you know, further updates could be provided through the usual mechanisms, ClinicalTrials.gov.

Speaker Change: And with regard to your site.

John Paolini: This is John Palini for the two medical officers regarding your question for the Phase 2D study for Epiprovibe. Yes, now we were pleased to announce that the earlier part of July that we had initiated enrollment in the phase 2D. We're going to be sure that it's trial. And today, of course, being in a national share this day, we really pause to reflect upon the importance of this, you know, debilitating disease and your context is contribution to trying to grow the science in this space with the development program and have you prove right. And so, as was mentioned by Sam, your enrollment has initiated, and at this point, you know, further updates could be provided.

John F. Paolini: With regard to your second question, this is John Paolini for the Chief Medical Officer regarding your question for the Phase 2B study for epiPruvart.

Unknown Attendee: Got it. Thank you so much and congrats again.

John F. Paolini: Yes, we were pleased to announce in the earlier part of July that we had initiated enrollment.

John F. Paolini: in the face to be Shervin's trial.

Speaker Change: And today, of course, being International Children's Day, we really pause to reflect upon the importance of this, you know, debilitating disease.

Speaker Change: and Kiniksa's contribution to trying to grow the science in this space with the development program at I.V. Pruvart. And so, as was mentioned by Sanj, enrollment has initiated, and at this point, further updates could be provided through the usual mechanisms, clinicaltrials.gov.

Khalil: You see the usual mechanisms. Clinical trial stock up. Got it. Thank you so much, and congrats again. Thank you.

Speaker Change: Got it. Thank you so much and congrats again.

Eva Fortea: And our next question coming from the line up in a portrait of Redoho with Bells Fargo. You'll let us open. Hi guys, congrats on the quarter, and thanks for taking our questions. A few from us. Go first on our colors. You mentioned 11% of patients with multiple recurrences were on our treatment. So for this 11%, can you provide a bit more color and how this is between patients on second and the recurrence and beyond. And also does this include patients on first recurrence or how should we be thinking about, you know, this patients and how much outside can we expect for the remaining of the year.

Speaker Change: Thank you.

Operator: And our next question coming from the lineup, Eva Portea Verdejo with Wells Fargo. Your line is open.

Speaker Change: Thank you.

Speaker Change: Operator And our next question coming from the line up, Evaporte Verdejo with Wells Fargo, your line is open.

Unknown Attendee: Hi guys, congratulations on the quarter and thanks for taking our questions. A few from us. First, on Alkalyst, you mentioned 11% of patients with multiple recurrences were on Alkalyst treatment. So, for this 11%, can you provide a bit more color on how this is split between patients on 2nd and 3rd recurrence and beyond? And also, does this include patients on 1st recurrence? How should we be thinking about this patient, and how much upside can we expect for the remaining of the year? And on Aviprobar? What should we think about the cadence of new trials in immune indicators?

Evaporte Verdejo: Hi guys, congrats on the quarter and thanks for taking our questions.

Evaporte Verdejo: A few from us, so first on alkalis, you mentioned 11% of patients with multiple recurrences were on alkalis treatment. So, for this 11%, can you provide a bit more color on how this is split between patients on second and third recurrence and beyond?

Speaker Change: And also, does this include patients on first recurrence, or how should we be thinking about, you know, this patient and how much upside can we expect?

Ross Moat: And on as we provide, how should we think about the kids of new trial and indication.

Speaker Change: For the remaining of the year and on every pro bar, how should we think about the cadence of new trials in new indications?

Ross Moat: Hi there, this is Ross. So, thanks very much for the question. I found it a little bit difficult to hear the second part, but if I don't answer it correctly, please just let me know, and I'll have another go. But regarding the 11% penetration into the 14,000 multiple recurrent patients, that's obviously the patient group that has suffered from two or more recurrences, and the 11% is a moment in time; how many active commercial patients we have on Arclisk within that price range, that multiple recurrence number.

Ross Moat: Hi there. This is Ross. So thanks very much for the question. I finally literally did go to his the second part, but if I don't answer it correctly, please just let me know, and I have another, another guy. But regarding the 11% penetration into the 14,000 multiple recurrent patients, that's obviously the patient group that have suffered for two or more recurrences, and the 11% is a moment in time. How many active commercial patients we have on our list within that price? Let's back to that. and a multiple recurrence number. So, out of all the patients that are on Arclist, the vast majority are on two or more recurrences, but we certainly have some patients that are just on their first recurrence earlier in the disease as well.

Speaker Change: Hi there, this is Ross. Thanks very much for the question. I found it a little bit difficult to hear the second part, but if I don't answer it correctly, please just let me know and I'll have another go. Regarding the 11% penetration into the 14,000 multiple recurrent patients, that's obviously the patient group that have suffered for two or more recurrences, and the 11% is a moment.

Speaker Change: in time how many active commercial patients we have on on our list within that that that price that

Ross Moat: So out of all the patients that are on Arclisk, the vast majority are on two or more recurrences, but we certainly have some patients that are just on their first recurrence earlier in the disease as well. And as a reminder, we do have a very broad label that completely allows for that, for physicians to utilize it on the first recurrence. And the graph that I shared in the prepared remarks as well shows physicians' future intent when they consider prescribing Arclisk.

Speaker Change: multiple recurrence number. So out of all the patients that are on Arclis, the vast majority are on two or more recurrences, but we certainly have some patients that are just on their first recurrence earlier in the disease as well. And as a reminder, we do have a very broad label that completely allows for that for physicians to utilize it on the first recurrence. And the graph that I shared in the prepared remarks as well also shows physicians' future intent of when they consider prescribing Arclis. And you can see that growing as an intent to consider it within the first recurrence and obviously going up within each recurrence that patients suffer from. So I think we're making good progress with that regard, and hopefully that helps to answer your question.

Ross Moat: As a reminder, we do have a very broad label that completely allows for that for physicians to utilize it on the first recurrence, and the graph that I shared in the prepared remarks as well also shows physicians' future intent of when they consider prescribing that in Arclist. You can see that growing as an intent to consider it within the first recurrence and obviously going up within each recurrence that the patients suffer from. So I think we're making good progress with that regard, and hopefully that helps to answer your question.

Ross Moat: And you can see that growing as an intent to consider it within the first recurrence, and obviously going up within each subsequent recurrence that the patients suffer from. So I think we're making good progress with that regard, and hopefully that helps to answer your question. Eva, could you repeat the second half of your question? It was very difficult to hear.

Ross Moat: Eva, did you repeat the second half of your question? It was very difficult to hear. We heard Abby Prubar and Cadence, but was it the phase to be Schrödinger's trial or was it the potential new indication you're asking about? Yeah, potential new indications basically, how should we think about the cadence of the new indications for Abby Prubar? Yeah, I mean obviously we're looking very, very closely at the applicability for Abby Prubar. We're very excited about the mechanism. There has been proof of concept in a number of different areas, as you probably understand. And so obviously Schrodinger's is the first one that we've started with the phase to be, but often said it isn't sort of mutually exclusive as it were that we would have to wait for that readout.

Ross Moat: We heard about Abhi Prabhat and Cadence, but was it the Phase 2b Sjogren's trial or was it the potential new indications you were asking about? Yeah, potential new indications, basically how should we think about Cadence and the new indications for Abipobar. Yeah, I mean, obviously, we're looking very, very closely at the applicability of ibuprofen. We're very excited about the mechanism. There has been proof of concept in a number of different areas, as you probably understand. And so obviously, Sjogres is the first one that we've started with Phase IIb.

Eva: Eva, could you repeat the second half of your question? It was very difficult to hear. We heard Abhi Prabhat and Cadence, but was it the Phase 2b Sjogren's trial or was it the potential new indications you were asking about? Yeah, potential new indications. Basically, how should we think about the Cadence?

Eva: All the new indications for Abipobar.

Speaker Change: Yeah, I mean, obviously, we're looking very, very closely at the applicability for

Speaker Change: Abhi Prabhat. We're very excited about the mechanism. There has been proof of concept in a number of different areas, as you probably understand, and so obviously shoulders is the first one that we've

Speaker Change: started with the Phase 2b. We've often said it isn't sort of mutually exclusive, as it were.

Ross Moat: We've often said it isn't sort of mutually exclusive, as it were, that we would have to wait for that readout. You know, we have had the proof of concept from the rheumatoid arthritis trial. We're very pleased with that, particularly the RF factor data and the PD marker data. But time will tell. We'll have to obviously, at this point, not disclosed what other indications we're considering or when we'll announce them. But we're certainly going to look very carefully and work very hard at thinking about what the next steps are in that program.

Ross Moat: We've had to prove the concept from the rheumatoid arthritis trial. We're very pleased with that, particularly the RF factor data and the PD market data. But time will tell. Well, that's obviously with this point, we've not disclosed what other indications we're considering or when we'll announce them, but we're certainly going to look very carefully and work very hard about thinking about what the next steps are in that program.

Speaker Change: that we would have to wait for that readout, you know, we've had the proof of concept from the rheumatoid arthritis trial, we're very pleased with that, particularly the RF.

Speaker Change: and the PdMarker data. But time will tell. We'll have to, obviously, at this point we've not disclosed what other indications we're considering or when we'll announce them, but we're certainly going to look very carefully and work very hard about thinking about what the next steps are in that program.

Eva Fortea: Okay, thanks. Thank you, Eva.

Speaker Change: Okay, thanks.

Lisa Bangle: Thank you. And I want to ask a question coming from the line of Lisa Bangle with Evercries. Are you on the open?

Eva: Thank you, Eva.

Operator: And our next question comes from the line of Liisa Bayko with Evercrise. Your line is open.

Eva: Thank you.

Speaker Change: And our next question coming from the lineup, Liisa Bayko with Evercrise, your line is open.

Unknown Attendee: Hi there, thanks for taking my questions. Congratulations on a strong quarter and the trajectory of RwandaSEP. I have a question for you, just on whether there were any inventory changes or just, I'm trying to reconcile, you know, kind of ending the quarter with 11. David Tessari, Mark Ragosa, Rachel Frank, Ross Moat, Alexander Hammond, Paul Choi, Kiniksa Pharmaceuticals Ltd. So, any inventory changes or other things that could have sort of given a sort of temporary boost to sales for this quarter?

Mark Ragosa: Hi there. Thanks for seeing my question. Congratulations for the strong border and the trajectory of a lot of stuff. I have a question for you. Was there any inventory changes or I'm trying to reconcile, you know, kind of ending the quarter of 11% of patients on therapy and then, you know, just kind of how it flows. I know you had a growth in that for a little bit different for this year. So any inventory changes are other things that could have given a sort of temporary boost itself to the quarter. And then also, what is most in that for the next two quarters and to be able to be or overall for the year?

Liisa Ann Bayko: Hi there, thanks for taking my questions. Congratulations on a strong quarter and the trajectory of RwandaSep. I have a question for you just on, was there any inventory changes or just, I'm trying to reconcile, you know, kind of ending the quarter of 2011.

Liisa Ann Bayko: percent of patients on therapy, and then, you know, just kind of how it flows. I know you had your growth in that for a little bit different for this year. So, so any inventory changes or other things that could have sort of given a sort of temporary boost of sales for this quarter? And then also, what is growth in that for the for the next two quarters, anticipated to be, or overall for the year? Thanks.

Mark Ragosa: Yeah, I mean, I can make some comments and show Russell jump in. I mean, there's nothing of repute as far as inventory changes. Ross had made some comments in regards to some of the one-time growth of a scene. We certainly haven't commented to our overall overall guidance for grossing that, but by all means, look at our thank you. You'll see some, you know, previous disclosures, and then suddenly you'll see them from this current 10 queue, but nothing to report and nothing something unusual on the, on the inventory side.

Unknown Executive: Yeah, I mean, I can make some comments. I'm sure Ross will jump in, too. I mean, there's nothing of repute as far as industry changes are concerned. Ross had made some comments in regards to some of the one-time growth that we've seen. We certainly haven't commented on our overall guidance for gross net, but by all means, look at our 10Q. You'll see some previous disclosures, and then suddenly you'll see them from this current 10Q, but nothing to report, and certainly nothing unusual in the inventory.

Liisa Ann Bayko: Yeah, I mean, I can make some comments. I'm sure Ross will jump in. I mean, there's nothing of repute.

Liisa Ann Bayko: As far as industry changes, Ross has made some comments in regards to some of the one-time growth that we've seen. We certainly haven't commented to our overall guidance for growth to net, but by all means look at our Thank You and you'll see some

Liisa Ann Bayko: some, you know, previous disclosures and suddenly you'll see them from this current 10Q. But nothing to report and nothing certainly unusual on the inventory's side.

Unknown Executive: Okay, maybe it's just time to go add to something. Okay, so there's no inventory changes or anything like that. I mean, you might expect it if you're selling more. There are no major untoward inventory changes.

Mark Ragosa: Okay, maybe it's just planning to add to something. Okay, so there's no inventory changes, or I don't like that. I mean, you might expect that if you're selling more. There's no major, there's no major untoward in British changes.

Speaker Change: Okay, maybe it's just timing of the ads or something.

Speaker Change: Okay, so there's no inventory changes or anything like that.

Speaker Change: I mean, you might expect that if you're selling more. There's no major, there's no major untoward in bridging changes.

Lisa Bangle: All right, thanks.

Unknown Executive: Wait, I'm like you're writing, writing the Jetsons car, Lisa, so it's been a noise coming through, but thank you for the question. Oh, sorry. Okay.

Speaker Change: Alright, thanks.

Unknown Executive: Sounds like you're driving in a Jetsons car, Liisa, so there's a bit of a noise coming through, but thank you for the question. Oh, sorry. Okay, bye.

Speaker Change: Right

Speaker Change: Sounds like you're driving in a Jetsons car, Liisa, so there's a bit of a noise coming through, but thank you for the question.

Unknown Executive: Thank you.

Lisa Bangle: Oh, sorry. Okay, bye.

Lisa Bangle: Thank you.

Operator: And I'm showing no further questions in the queue at this time.

Operator: I am showing no further questions in the queue at this time. I will now turn the call back over to Mr. Sanj Patel, Chief Executive Officer, for any closing remarks.

Lisa Bangle: Thank you.

Sanj Patel: I will now turn the call back over to Mr. Sunch Patel, Chief Executive Officer, for any closing remarks. No, thank you very much. Obviously, we're very pleased with the performance today, so we continue to execute both commercially and from the portfolio side. Preacher, so we're dialing in, and we look forward to providing you this one updates in the future. So thank you very much.

Speaker Change: I am showing no further questions in the queue at this time. I will now turn the call back over to Mr. Sanj Patel, Chief Executive Officer, for any closing remarks.

Sanj K. Patel: No, thank you very much. Obviously, we're very pleased with the performance to date. We continue to execute both commercially and from the portfolio side. Appreciate everybody dialing in, and we look forward to providing additional updates in the future. So, thank you very much.

Sanj K. Patel: No, thank you very much. Obviously, we're very pleased with the performance to date. We continue to execute both commercially and from the portfolio side. Appreciate everybody dialing in and we look forward to providing additional updates in the future. So thank you very much.

Operator: Please, I'm Joel Mandela from the conference for today. Thank you for your participation, and you may now disconnect. Thank you. Thank you very much.

Operator: Ladies and gentlemen, that does conclude our conference for today. Thank you for your participation, and you may now disconnect.

Speaker Change: Ladies and gentlemen, that does conclude our conference for today. Thank you for your participation and you may now disconnect.

Q2 2024 Kiniksa Pharmaceuticals International PLC Earnings Call

Demo

Kiniksa Pharmaceuticals

Earnings

Q2 2024 Kiniksa Pharmaceuticals International PLC Earnings Call

KNSA

Tuesday, July 23rd, 2024 at 12:30 PM

Transcript

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