Q2 2026 argenx SE Earnings Call

Speaker #1: Good morning. My name is Leila, and I will be your conference operator today. I would like to welcome everyone to the call. At this time, all lines have been placed on mute to prevent any background noise.

Speaker #1: After the speaker's remarks, there will be a question-and-answer session. Thank you. I'd like to introduce Best El Jaco, Vice President of Corporate Affairs. You may now begin your call.

Speaker #2: Thank you. A press release was issued earlier today with our second quarter 2026 financial results and business update. This can be found on our website, along with the presentation for today's webcast.

Speaker #2: Before we begin, on slide 2, I'd like to remind you that forward-looking statements may be presented during this call. These may include statements about our future expectations, clinical developments, regulatory timelines, the potential success of our product candidates, financial projections, and upcoming milestones.

Speaker #2: Actual results may differ materially from those indicated by these statements. Our genics is not under any obligation to update statements regarding the future or to conform to those statements in relation to actual results, unless required by law.

Speaker #2: I'm joining on the call today by Karen Massey, Chief Executive Officer, Karl Gubitz, Chief Financial Officer, and Sandrine Thérèse Girard, Chief Commercialization Officer. Luke Troyan, Chief Medical Officer, will be available during the Q&A.

Speaker #2: I'll now turn the call over to Karen.

Speaker #3: Thank you, Beth. And welcome, everyone. I'll begin on slide 3. The team delivered one of our strongest quarters yet, marking our 18th consecutive quarter of growth.

Speaker #3: During the momentum, the value gap used to deliver for patients. The continued expansion of MG and CIDC markets and our ability to unlock new opportunities for growth, most recently with the zero-negative MG approval.

Speaker #3: The progress we're seeing across the business brings us closer to realizing Vision 2030, our roadmap for delivering near, medium, and long-term growth. Looking ahead, we have 2 registrational readouts before year-end, which support our goal of achieving 10 labeled indications.

Speaker #3: Together with our differentiated immunology pipeline, these programs position us to extend our growth well beyond 2030. Our success today creates the opportunity to reinvest in the best scientifically confined wherever we can find it, fueling the next phase of our genics growth.

Speaker #1: Continues to deliver professional. Continued expansion of both MG and CIDC markets, and our ability to unlock new opportunities for growth, most recently with the seronegative MG approval.

Speaker #1: What only my side—this is our entry point—it represents both a near-term label expansion opportunity and a foundation for long-term leadership. What continues to motivate us is the urgent patient need: in IM&M, patients can progress from their first symptoms to needing a wheelchair within a matter of months.

Speaker #3: Slide 4. VIVGA continues to change what is possible for patients with MG and CIDC. And we see strong growth across both indications and all regions.

Speaker #1: The progress we're seeing across the business brings us closer to realizing Vision 2030: our roadmap for delivering near, medium, and long-term growth. Looking ahead, we have 2 registrational readouts before year-end, which support our goal of achieving 10.

Speaker #3: We're reaching more patients than ever before, driven by our commitment to bring meaningful innovation to the treatment experience. Last year, we introduced our pre-filled syringe, expanding our prescriber base and supporting our goal to reach patients earlier in their treatment journey.

Speaker #1: We heard this at R&D days. And there are no approved treatments today. This sense of urgency to deliver for patients is what is driving our filing strategy.

Speaker #3: This year, we reached another important milestone with the approval of VIVGA for zero-negative GMG. VIVGA is now the first and only treatment approved across all serotypes of GMG, including for triple zero-negative patients who previously had no approved treatment option.

Speaker #1: Based on the benefit-risk of each subtype on its own, we saw a clear signal in both IM&M and DM in the Phase 2, and we're on track for a readout this quarter.

Speaker #1: Myositis is just the beginning. We believe a first-in-class launch in myositis can establish the foundation for broader leadership in rheumatology, ensuring data expected in the second half of 2027.

Speaker #3: This is transformational for patients and physicians, removing the need for testing. With ocular MG ahead, we are moving forward in our ambition to make VIVGA a treatment of choice across all MG patients.

Speaker #1: Slide 6. Imposter prove-out remains on track to become our second pipeline-in-a-product, with our first registrational readout in MMN expected later this year.

Speaker #3: Slide 5. We have 2 important readouts ahead that represent the next chapter of our growth strategy. Broadening our leadership in urology within Paso Prúbat and extending the impact of FCRN into new therapeutic areas, starting with rheumatology.

Speaker #1: MMN represents one of the clearest unmet needs in neurology. Imposter prove-out has the potential to offer a differentiated approach: supported by the efficacy, durability, and safety profile observed in the Phase 2 ARDA study.

Speaker #3: VIVGA has the potential to have a similar impact in rheumatology as it has had in neurology. Autoimmune myositis is our entry point. It represents both a near-term label expansion opportunity and the foundation for long-term leadership.

Speaker #3: What continues to motivate us is the urgent patient need. In IM&M, patients can progress from their first symptoms to needing a wheelchair within a matter of months.

Speaker #3: We heard this at R&D days. And there are no approved treatments today. This sense of urgency to deliver for patients is what is driving our filing strategy, based on the benefit risk of each subtype on its own.

Speaker #3: We saw a clear signal in both IM&M and DM in the phase 2, and we're on track for a readout this quarter. Myositis is just the beginning.

Speaker #3: We believe a first-in-class launch in myositis can establish the foundation for broader leadership in rheumatology, ensuring data expected in the second half of 2027.

Speaker #3: Slide 6. In Paso Prúbat remains on track to become our second pipelining of products, with our first registrational readout in MMN expected later this year.

Speaker #1: Slide 7. It's an incredibly exciting time to be building a company around scientific innovation. The pace of discovery is accelerating, and our job is to find the most promising science that can change outcomes for patients.

Speaker #3: MMN represents one of the clearest unmet needs in neurology. In Paso Prúbat has the potential to offer a differentiated approach: supported by the efficacy, durability, and safety profile observed in the phase 2 ARDA study.

Speaker #1: Our goal is to advance 5 late-stage molecules by 2030 to fuel long-term growth, and we are pursuing this through two pathways. We're extending our leadership in SCRM and we're broadening our immunology pipeline.

Speaker #3: We continue to see growing enthusiasm from the neurology community, particularly around the safety profile and the sustained improvements in grip strength observed in the open label extensions.

Speaker #1: We are already delivering against this strategy. Our future SCRM molecules are Genetics 213 and our Genetics 124, as well as our IgA sweeper, our Genetics 121, are progressing toward late-stage development.

Speaker #3: These are outcomes that matter in patients' daily lives. Our ambition extends well beyond MMN. The unique biology of C2 inhibition has the potential to benefit a broader range of patients, from our ongoing phase 3 programming CIDP to our combination study in MG.

Speaker #1: And our Genetics 118, Genetics 125, and TSP 101, now in Phase 1, each represent new pipelines in product opportunities. Together, these investments reflect a disciplined capital allocation strategy focusing on delivering durable growth over the long term.

Speaker #3: We are focused on unlocking the full potential of this mechanism for patients. Slide 7. It's an incredibly exciting time to be building a company around scientific innovation.

Speaker #1: And with that, I'll turn the call over to Carl.

Speaker #2: Thank you, Karen. Slide 8. I am pleased to present the second quarter 2026 financial results in this morning's press release. We continue to increase the number of patients that we treat, resulting in growing revenues.

Speaker #3: The pace of discovery is accelerating, and our job is to find the most promising science that can change outcomes for patients. Our goal is to advance 5 late-stage molecules by 2030 to fuel long-term growth.

Speaker #1: We continue to see growing enthusiasm from the neurology community, particular. Because the more range of patients from our ongoing phase 3 program in CIDP to our combination study in MG, we have focused on unlocking the full potential of this mechanism for patients.

Speaker #3: And we are pursuing this through 2 pathways. We're extending our leadership in FCRN, and we're broadening our immunology pipeline. We are already delivering against this strategy.

Speaker #2: Product net sales for the second quarter were $1.5 billion. Representing 60% year-over-year growth and 17% quarter over quarter growth. By region, product net sales were $1.3 billion in the US, $102 million in Japan, $136 million across the rest of the world, and $5 million related to product supply to XiLab in China.

Speaker #3: Our future FCRN molecules are genics 213 and our genics 124, as well as our IgA sweeper, our genics 121, are progressing towards late-stage development.

Speaker #3: And our genics 118, our genics 125, and TSP 101 now in phase 1, each represent new pipelining of product opportunities. Together, these investments reflect a discipline that capital allocation strategy focusing on delivering durable growth over the long term.

Speaker #2: Our US market grew by 15% quarter over quarter, with a gross-to-net and net pricing similar to prior quarters. In Japan, quarter over quarter net product sales growth is 55% or 35 million dollars.

Speaker #3: And with that, I'll turn the call over to Carl.

Speaker #2: Thank you, Karen. Slide 8. I am pleased to present the second quarter 2026 financial results in this morning's press release. We continue to increase the number of patients that we treat, resulting in growing revenues.

Speaker #2: Reported sales include a one-of-benefit of approximately 25 million dollars due to a change in our distribution model. Next slide, slide 9. Total operating expenses in the second quarter were $1 billion.

Speaker #2: Product net sales for the second quarter were $1.5 billion. Representing 60% year-over-year growth and 17% quarter-over-quarter growth. By region, product net sales were $1.3 billion in the US, $102 million in Japan, $136 million across the rest of the world, and $5 million related to product supply to XiLab in China.

Speaker #2: Representing an increase of 129 million dollars compared to have stepped up our combined R&D and SG&A investment to $903 million in the quarter. This increase is deliberate and reflects disciplined investment in multiple mid and late-stage clinical development programs and commercialization capabilities to support our growing multi-product portfolio.

Speaker #2: Our US market grew by 15% quarter-over-quarter, with a gross-to-net and net pricing similar to prior quarters. In Japan, quarter-over-quarter net product sales growth is 55% or 35 million dollars.

Speaker #2: Operating profit in the second quarter is $494 million. An increase of 146% year over year. Tax for the quarter is 11% of profit before tax.

Speaker #2: Reported sales include a one-of-benefit of approximately 25 million dollars due to a change in our distribution model. Next slide, slide 9. Total operating expenses in the second quarter were $1 billion.

Speaker #2: We ended the quarter with a cash balance of $5.2 billion. Including cash, cash equivalents, and current financial assets. An increase of more than $744 million from the beginning of the year.

Speaker #2: Representing an increase of $129 million compared to the first quarter. We have stepped up our combined R&D and SG&A investment to $903 million in the quarter.

Speaker #2: Our capital allocation priority continues to be building durable, long-term revenue growth. At the same time, we are well on track to deliver a financial profile that includes increasing operating margins, sustained earnings growth, and a significant cash generation I now turn the call over to Sandrine, who will provide details on the commercial front.

Speaker #2: This increase is deliberate, and reflects disciplined investment in multiple mid and late-stage clinical development programs and commercialization capabilities to support our growing multi-product portfolio.

Speaker #2: Operating profit in the second quarter is $494 million, an increase of $146% year-over-year. Tax for the quarter is 11% of profit before tax. We ended the quarter with a cash balance of $5.2 billion.

Speaker #1: Thank you, Carl. I'll begin on to set ArgenX support is our ability to translate the patient-first approach into execution across the entire treatment journey.

Speaker #1: From educating healthcare providers to supporting patients through ongoing care, we are focused on removing friction at every step. And this is an approach that continues to deliver results.

Speaker #2: Including cash, cash equivalents, and current financial assets. An increase of more than $744 million from the beginning of the year. Our capital allocation priority continues to be building durable, long-term revenue growth.

Speaker #1: More HCPs are choosing to prescribe Vivgart as their preferred biologic for MG and CIDP. More patients are requesting Vivgart, another result, getting on treatment treatment because Vivgart continues to make a meaningful difference in how they feel and lives.

Speaker #2: At the same time, we are well on track to deliver a financial profile that includes increasing operating margins, sustained earnings growth, and a significant cash generation I now turn the call over to Sandrine, who will provide details on the commercial front.

Speaker #3: Thank you, Carl. I'll begin on slide 10. What continues to set our genics support is our ability to translate the patient-first approach into execution across the entire treatment journey.

Speaker #3: From educating healthcare providers to supporting patients through ongoing care, we are focused on removing friction at every step. And this is an approach that continues to deliver results.

Speaker #3: More HCPs are choosing to prescribe Vizgard as their preferred biologic for MG and CIDP. More patients are requesting Vizgard, another result, getting on treatment earlier.

Speaker #3: Patients are remaining on treatment because Vizgard continues to make a meaningful difference in how they feel and function in their daily lives. Today, we have patients who started in our very first quarter of launch and remain on therapy 18 quarters later.

Speaker #3: These strong fundamentals are reflected in our performance this quarter, and they continue to position us well for future growth. Slide 11. This quarter, we continue to see growth driven by both MG and CIDP across all regions, with new patient demand remaining at a consistently higher level.

Speaker #3: The prefilled syringe continues to be an important driver of this demand across both MG and CIDP. It's convenience and flexibility are supporting broader adoption of Vizgard, in the second quarter approximately 80% of prefilled syringe patients in the US have been new to Vizgard.

Speaker #1: Today, we have patients who started in our very first quarter of launch and remain on therapy 18 quarters later. These strong fundamentals are reflected in our performance this quarter and they continue to position us well for future growth.

Speaker #3: We also see increasing breadth and depth of prescriptions for Vizgard. Physician confidence in Vizgard is reflected in a repeat prescriber base of more than 5,000 neurologists and increasing use earlier in the treatment journey.

Speaker #1: Slide 11. This quarter, we continue to see growth driven by both MG and CIDP across all regions, with new patient demand remaining at a consistently higher level.

Speaker #3: While early into launch, we also saw a contribution to growth from our seronegative expansion in GMG. Vizgard is not the first and only biologic approved across all serotypes of generalized MG, significantly expanding our addressable market in MG by 11,000 patients.

Speaker #1: The prefilled syringe continues to be an important driver of this demand across both MG and CIDP. It's convenience and flexibility are supporting broader adoption of Vivgart, in the second quarter approximately 80% of prefilled syringe patients in the US have been new to Vivgart.

Speaker #3: Slide 12. Our recent approval across all serotypes of GMG, mask positive, triple seronegative, and LRP4 positive, strengthens Vizgard's leadership in MG and advances our goal of reaching the broadest patient population.

Speaker #1: We also see increasing breadth and depth of prescriptions for Vivgart. Physician confidence in Vivgart is reflected in a repeat prescriber base of more than 5,000 neurologists and increasing use earlier in the treatment journey.

Speaker #3: We are pleased with the early response to the label expansion, with extremely positive patient and HCP feedback. We have established relationships with more than 80% of seronegative MG treaters, and see the recent Vizgard label expansion having a halo effect on all GMG prescriptions.

Speaker #1: While early into launch, we also saw a contribution to growth from our seronegative expansion in GMG. Vivgart is not the first and only biologic approved across all serotypes of generalized MG, significantly expanding our addressable market in MG by 11,000 patients.

Speaker #3: Also driving increased uptake by prescribers in the serot positive population. On the payer side, we leverage the credibility and relationship we have built to secure policies, covering approximately 55% of US commercial life.

Speaker #1: Slide 12. Our recent approval across all serotypes of GMG, mask positive, triple seronegative, and LRP4 positive, strengthens Vivgart's leadership in MG and advances our goal of reaching the broadest patient population.

Speaker #3: All within 10 weeks since launch. Most plans are removing the serology testing requirement, making it simpler for physicians to prescribe Vizgard as the go-to option in MG.

Speaker #1: We are pleased with the early response to the label expansion, with extremely positive patient and HCP feedback. We have established relationships with more than 80% of seronegative MG treaters and see the recent Vivgart label expansion having a halo effect on all GMG prescriptions.

Speaker #3: There is also tremendous excitement and hope among patients, particularly triple seronegative patients with previously had no approved therapies available. One of these patients, Zach, shared: "I set up my computer and cried.

Speaker #3: Hope, this is finally real hope for the seronegative community." As we look ahead in MG, we see significant opportunity to reach patients earlier in the treatment journey and pending approval, expand into ocular MG.

Speaker #1: Also driving increased uptake by prescribers in the serot positive population. On the payer side, we leverage the credibility and relationship we have built to secure policies covering approximately 55% of US commercial life, all within 10 weeks since launch.

Speaker #3: These patients continue to face a meaningful burden of disease, underscoring the need for additional treatment options and reinforcing our commitment to serving community. Slide 13.

Speaker #1: Most plans are removing the serology testing requirement, making it simpler for physicians to prescribe Vyvgart as the go-to option in MG. There is also tremendous excitement and hope among patients, particularly triple seronegative patients, who previously had no approved therapies available.

Speaker #3: Let's move to the opportunity in CIDP. Within our initial 12,000 patient addressable population in the US, we are driving further adoption through physician education and continued evidence generation.

Speaker #1: One of these patients, Zach, shared: "I started my computer and cried. Hope, this is finally real hope for the seronegative community." As we look ahead in MG, we see significant opportunity to reach patients earlier in the treatment journey and pending approval, expand into popular MG.

Speaker #3: At the same time, we are laying out the groundwork to expand beyond this. Today, approximately 24,000 patients are being treated for CIDP in the US, and roughly half are considered well-managed on their current therapy.

Speaker #1: These patients continue to face a meaningful burden of disease, underscoring the need for additional treatment options and reinforcing our commitment to serving the full MG community.

Speaker #3: Yet, what we consistently hear is that many have learned to live around their disease. Often without realizing how much function they have lost. And this is exactly why generating data that shows meaningful functional improvement matters.

Speaker #1: Slide 13. Let's move to the opportunity in CIDP. Within our initial, 12,000-patient addressable population in the U.S., we are driving further adoption through physician education and continued evidence generation.

Speaker #3: Our grid strength results demonstrate the impact Vizgard can have on outcomes that are important in patients' daily lives and meaningful to the physicians treating them.

Speaker #3: Similarly, we have generated evidence that helps physicians navigate practical treatment decisions. Including transitioning appropriate patients from IVIG to Vizgard. We presented recently at PNS the results of a phase four switch study showing that 87% of patients on IVIG switched successfully to Vizgard.

Speaker #1: At the same time, we are laying out the groundwork to expand beyond this. Today, approximately 24,000 patients are being treated for CIDP in the US, and roughly half are considered well-managed on their current therapy.

Speaker #1: Yet, what we consistently hear is that many have learned to live around their disease. Often without realizing how much function they have lost. And this is exactly why generating data that shows meaningful functional improvement matters.

Speaker #3: Helping address the question, how do I switch from IVIG to Vizgard? Finally, we continue to explore the opportunity to reach patients earlier in their disease journey.

Speaker #3: We see significant potential among the large population of untreated patients, where our data suggests that treatment-naive patients may derive meaningful benefits from earlier treatment.

Speaker #1: Our grip-strength results demonstrate the impact Vivgart can have on outcomes that are important in patients' daily lives and meaningful to the physicians treating them.

Speaker #3: Slide 14. Looking ahead, we are preparing the organization for the next wave of growth. Review autoimmune myositis as a strategic entry point into rheumatology, with the potential for Vizgard to establish early leadership as the first FCRN.

Speaker #1: Similarly, we have generated evidence that helps physicians navigate practical treatment decisions. Including transitioning appropriate patients from IVIG to Vivgart. We presented recently at PNS the results of a phase four switch study showing that 87% of patients on IVIG switched successfully to Vivgart.

Speaker #3: We are augmenting our best-in-class launch playbook in MG and CIDP to be launch-ready for myositis. We are already engaging with 650 heroes treating autoimmune myositis, advancing disease state education, engaging patient communities, and getting ready to expand our field force footprint.

Speaker #1: Helping address the question, how do I switch from IVIG to Vivgart? Finally, we continue to explore the opportunity to reach patients earlier in their disease journey.

Speaker #1: We see significant potential among the large population of untreated patients, where our data suggests that treatment-naive patients may derive meaningful benefits from earlier treatment.

Speaker #3: With that, let me turn the call back to Karen for closing remarks.

Speaker #2: Thank you, Sandri. As you heard today, we continue to see strong momentum across the business, with significant opportunities ahead for Vizgard and a pipeline position to sustain growth well into the future.

Speaker #1: Slide 14. Looking ahead, we are preparing the organization for the next wave of growth. Review autoimmune myositis as a strategic entry point into rheumatology with the potential for Vivgart to establish early leadership as the first FCRN.

Speaker #2: And while there is much to be proud of in the first half of the year, there is even more ahead. We enter the second half of 2026 with multiple opportunities to advance innovation and further our mission of transforming the lives of people living with autoimmune disease.

Speaker #1: We are augmenting our best-in-class launch playbook in MG and CIDP to be launch-ready for myositis. We are already engaging with 650 heroes treating autoimmune myositis, advancing disease state education, engaging patient communities, and getting ready to expand our field force footprint.

Speaker #2: I want to thank our team, patients, and strategic partners for their continued commitment as we continue this commission together. And with that, operator, we'll open the call for questions.

Speaker #1: With that, let me turn the call back to Karen for closing remarks.

Speaker #2: Thank you, Sandri. As you said, today we continue to see strong momentum across the business, with significant opportunities ahead for Vyvgart and a pipeline positioned to sustain growth well into the future.

Speaker #1: We would like to ask a question. Please press star 5 on your telephone keypad. You may remove yourself at any time by pressing star 5 again.

Speaker #1: We would like to remind callers to please limit to one question. And we'll pause just a moment. Our first question will come from Miles Minter.

Speaker #2: And while there is much to be proud of in the first half of the year, there is even more ahead. We enter the second half of 2026 with multiple opportunities to advance innovation and further our mission of transforming the lives of people living with autoimmune disease.

Speaker #1: Your line is now open. Please go ahead.

Speaker #4: Thanks very much, and congrats on the call. I'm looking forward to the myositis data in the third quarter here as well. I'll keep it to one on the commercial business.

Speaker #2: I want to thank our team, patients, and strategic partners for their continued commitment as we continue this commission together. And with that, operator, we'll open the call for questions.

Speaker #4: You know, you've delivered quarter over quarter sort of mid-teens percentage growth, if you take out the first quarter seasonality. I just had a question on whether that sort of future growth trajectory might change with the launch in the seronegative population here.

Speaker #3: We would like to ask a question. Please press star 5 on your telephone keypad. You may remove yourself at any time by pressing star 5 again.

Speaker #4: And whether there's any sort of tailwinds that we should think about from the broader population now that, you know, most plants are not requiring the serology testing for that population.

Speaker #3: We would like to remind callers to please limit to one question. And we'll pause just a moment. Our first question will come from Miles Minter.

Speaker #4: Thanks very much.

Speaker #2: Yeah, thanks for the question, Miles. And I would agree with you. It is incredible. 18 quarters in that we're still delivering consistent growth quarter over quarter.

Speaker #3: Your line is now open. Please go ahead.

Speaker #4: Thanks very much, and congrats on the call. I'm looking forward to the myositis data in the third quarter here as well. I'll keep it to one on the commercial business.

Speaker #2: And what I would say related to the quarterly trends, you know, of course, every quarter has its own dynamics. And after Q1 seasonality, we generally see some rebound in Q2.

Speaker #4: You know, you've delivered quarter over quarter sort of mid-teens percentage growth, if you take out the first quarter seasonality. I just had a question on whether that sort of future growth trajectory might change with the launch in the seronegative population here.

Speaker #2: But we expect the shape of the curve for the remainder of the year to look pretty consistent to what you've seen in prior years.

Speaker #2: We're off to a strong start. Of course, with seronegative. But you've had, we've had the same dynamic in prior years, with the launch of the PFS and that type of thing.

Speaker #4: Are there any sort of tailwinds that we should think about from the broader population now that, you know, most plans are not requiring serology testing for that population?

Speaker #2: So I would expect to look continue to look to grow and to look similar to prior years. Thanks for the question, Miles.

Speaker #4: Thanks very much.

Speaker #2: Yeah, thanks for the question, Miles. And I would agree with you. It is incredible. 18 quarters in that we're still delivering consistent growth quarter over quarter.

Speaker #1: Our next question will come from Derek Archila with Wells Fargo.

Speaker #2: And what I would say related to the quarterly trends you know, of course, every quarter has its own dynamics. And after Q1 seasonality, we generally see some rebound in Q2.

Speaker #5: Hey, good morning. And congrats on the quarter here. Excellent results. I just want to understand, so where do things stand with the ocular MG filing?

Speaker #5: And I guess, you know, maybe going to more tailwinds, but, you know, assuming approval, I guess, how do you think ocular could be a growth driver?

Speaker #2: But we expect the shape of the curve for the remainder of the year to look pretty consistent to what you've seen in prior years.

Speaker #5: And does that really materially change Vizgard's revenue trajectory? Thanks.

Speaker #2: We're off to a strong start. Of course, with seronegative. But you've had we've had the same dynamic in prior years, with the launch of the PFS and that type of thing.

Speaker #2: Yeah, thanks for the question. We're moving forward with urgency on ocular MG filing. I mean, there's a big patient unmet need. In ocular MG, of course, there's no advanced therapies approved in this patient population.

Speaker #2: So, I would expect to continue to look for growth and to see results similar to prior years. Thanks for the question, Miles.

Speaker #2: So we will be the first and only approved. Treatment in this population. So we're on track with the filing. We'll update you when we have a producer.

Speaker #3: Our next question will come from Derek Archila with Wells Fargo.

Speaker #5: Hey, good morning. And congrats on the quarter here. Excellent results. I just want to understand, so where do things stand with the ocular MG filing?

Speaker #2: Date. But maybe Sandri, you could comment a little bit on how you see the outlook if we do have an ocular approval.

Speaker #5: And I guess, you know, maybe going to more tailwinds, but, you know, assuming approval, I guess, how do you think ocular could be a growth driver?

Speaker #3: So thanks to Karen. And Derek for the question. So I see the ocular MG potential approval as another way to continue and to support a growth momentum.

Speaker #5: And does that really materially change Vivgart's revenue trajectory? Thanks.

Speaker #3: Over the last five years, we basically have had five launches when you think about that. So this would give us another launch to continue that growth momentum.

Speaker #2: Yeah, thanks for the question. We're moving forward with urgency on ocular MG filing. I mean, there's a big patient unmet need. In ocular MG, of course, there's no advanced therapies approved in this patient population.

Speaker #3: And we're well positioned because many of these patients are being treated by neurologists. And this is already a population of providers that we visit and that have experience with the drug.

Speaker #2: So we will be the first and only approved treatment in this population. So we're on track with the filing. We'll update you when we have a producer date.

Speaker #3: So I'm very confident that this will be another adding another leg to our growth for the long term.

Speaker #2: But maybe, Sandri, you could comment a little bit on how you see the outlook if we do have an ocular approval.

Speaker #1: Our next question will come from Tazina Maud with B of A.

Speaker #1: So thanks to Karen. And Derek for the question. So I see the ocular MG potential approval as another way to continue and to support a growth momentum.

Speaker #6: Hi, good morning. Thanks for taking my question. So Karen, and maybe Sandri, I wanted to get your thoughts about the competitive landscape. So you're right, you're 18 quarters in, and you've had commanding share.

Speaker #1: Over the last five years, we basically have had five launches when you think about that. So this would give us another launch to continue that growth momentum.

Speaker #6: But there continue to be new launches and upcoming launches. And some of the competitors that are talking about what advantages their products might have, include comments such as efficacy may not necessarily be, where it needs to be with FCRNs in general, and that patients might be dropping off therapy due to safety observations.

Speaker #1: And we're re well positioned because many of these patients are being treated by neurologists. And this is already a population of providers that we visit and that have experience with the drug.

Speaker #1: So, I'm very confident that this will add another leg to our growth for the long term.

Speaker #6: So can you maybe share with us your feedback from the field about what doctors' satisfaction is vis-à-vis their patient commentary on both efficacy? And can you talk to us about dropouts as a result of any safety concerns?

Speaker #3: Our next question will come from Tazina Maud with B of A.

Speaker #6: Hi, good morning. Thanks for taking my question. So, Karen, and maybe Sandri, I wanted to get your thoughts about the competitive landscape. So you're right.

Speaker #6: Thanks.

Speaker #2: Yeah, thank you, Tazina, for the question. Let me just comment broadly on competition, and then I'll hand it over to Sandri. But, you know, we've had this question a lot.

Speaker #6: You're 18 quarters in, and you've had commanding share. But there continue to be new launches and upcoming launches. And some of the competitors that are talking about what advantages their products might have include comments such as efficacy may not necessarily be, where it needs to be with FCRNs in general, and that patients might be dropping off therapy due to safety observations.

Speaker #2: I would say we launched in MG, and I like to say that our genics put MG on the map. And there has been a lot of competition that has followed us into the space.

Speaker #2: And throughout that, we've maintained our leadership in the market. And you can see, for example, four out of five physicians continue to say that they choose Vizgard before any other biologic.

Speaker #6: So can you maybe share with us your feedback from the field about what doctors' satisfaction is vis-à-vis their patient commentary on both efficacy? And can you talk to us about dropouts as a result of any safety concerns?

Speaker #2: But Sandri, maybe you want to comment on specifically the efficacy advantage and any other dynamics you see in the market.

Speaker #3: Yes. So Vizgard, I mean, like you said, Karen, is being seen and is being used today earlier than the others. You know, the others are used more in refactory populations.

Speaker #6: Thanks.

Speaker #2: Yeah, thank you, Tazina, for the question. Let me just comment broadly on competition, and then I'll hand it over to Sandri. But, you know, we've had this question a lot.

Speaker #3: And it's being used in earlier lines. And the reason is that the label supports it, and the data supports it. And when you look at the data, I wonder if anybody else can demonstrate an MSC that we have.

Speaker #2: I would say we launched in MG, and I like to say that ArgenX put MG on the map. And there has been a lot of competition that has followed us into that into the space.

Speaker #3: We have 60% of patients that have reached minimal symptom expression. And then that MSC is sustained over time. So I haven't seen until now other competitors being able to demonstrate MSC or even speak about MSC.

Speaker #2: And throughout that, we've maintained our leadership in the market. And you can see, for example, four out of five physicians continue to say that they choose Vivgart before any other biologic.

Speaker #3: And so that's really what stands out when you speak about the efficacy of Vizgard. And then if you combine that with its safety, over more than 25,000 patient years, I mean, this is a very strong combination of a safety and efficacy profile.

Speaker #2: But Sandri, maybe you want to comment on specifically the efficacy advantage and any other dynamics you see in the market.

Speaker #1: Yes. So Vivgart, I mean, like you said, Karen, is being seen and is being used today earlier than the others. You know, the others are used more in refractory populations.

Speaker #3: That puts us in a position to being used earlier lines. And that's why until now, we haven't really seen a meaningful impact on a growth trajectory.

Speaker #1: And it's been used in earlier lines. And the reason is that the label supports it, and the data supports it. And when you look at the data, I wonder if anybody else can demonstrate an MSC that we have.

Speaker #1: Our next question will come from Alex Thompson with Stifel.

Speaker #1: We have 60% of patients that have reached minimal symptom expression. And then that MSC is sustained over time. So I haven't seen until now other competitors being able to demonstrate MSC or even speak about MSC.

Speaker #4: Hey, great. Thanks for taking our question. You know, maybe for Karen, could you walk us through sort of what we should expect to see now at the top line for myositis in terms of both, you know, primary endpoint clinical data as well as, you know, the potential path to filing, particularly in DM?

Speaker #1: And so, that's really what stands out when you speak about the efficacy of Vyvgart. And then, if you combine that with its safety—over more than 25,000 patient-years—I mean, this is a very strong combination of a safety and efficacy profile.

Speaker #4: Thanks.

Speaker #2: Yeah, thanks, Alex. We're really looking forward to the readout in Q3. And we're on track. Just to set the stage, what we see as success for myositis is positive readout on the primary endpoint in one or more subsets.

Speaker #1: That puts us in a position to being used earlier lines. And that's why until now, we haven't really seen a meaningful impact on a growth trajectory.

Speaker #2: And that's the data that we'll share. So you'll remember from our myositis days, that we shared that we see both of these indications on their own, as potential blockbuster indications.

Speaker #3: Our next question will come from Alex Thompson with Saful.

Speaker #5: Hey, great. Thanks for taking our question. You know, maybe for Karen, could you walk us through sort of what we should expect to see now at the top line for myositis in terms of both, you know, primary endpoint clinical data as well as, you know, the potential path to filing particularly in DM?

Speaker #2: They both have significant unmet need. And they're both actually strategically important to us if we proceed with an approval. This will be important because it'll be the first in-class FCRN approval in rheumatology.

Speaker #2: So we'll be looking for positive data on the primary endpoint in one or more subset. But maybe Beth, you want to share a little bit more about what they can expect to see at top line results.

Speaker #5: Thanks.

Speaker #2: Yeah, thanks, Alex. We're really looking forward to the readout in Q3. And we're on track. Just to set the stage, what we see as success for myositis is positive readout on the primary endpoint in one or more subsets.

Speaker #6: Yeah, I mean, we're still working out the specific details of what the communication will look like. But what we know is that this is an important event with positive data for our genics.

Speaker #2: And that's the data that we'll share. So you'll remember from our myositis day, that we shared that we see both of these indications on their own, as potential blockbuster indications.

Speaker #6: It's our entry into rheumatology. And we'll want to capture that in our communication. And we'll also want to capture the primary endpoint analysis on in IMNM and in DM.

Speaker #6: So the details are still to come, but you can assume that those are the key topics of the communication.

Speaker #2: They both have significant unmet need. And they're both actually strategically important to us if we proceed with an approval. This will be important because it'll be the first-in-class FCRN approval in rheumatology.

Speaker #1: Our next question will come from Akash Tawari with Jefferies.

Speaker #2: So we'll be looking for positive data on the primary endpoint in one or more subsets. But maybe, Beth, you want to share a little bit more about what they can expect to see at top-line results.

Speaker #4: Hey, thanks so much. Can you give a little more color on your side plan for myositis? Based on your public comments, it seems like there is no alpha split.

Speaker #4: Basically, DM and INMN are now being run independently as two separate trials. Is that the correct read here? And then if the effect size in DM for your phase two trials was replicated in phase three, would the trial hit stat sig or not?

Speaker #6: Yeah, I mean we're still working out the specific details of what the communication will look like. But what we know is that this is an important event with positive data for ArgenX.

Speaker #6: It's our entry into rheumatology. And we'll want to capture that in our communication. And we'll also want to capture the primary endpoint analysis on in IMNM and in DM.

Speaker #4: And if not, what are some reasons that efficacy could improve from phase two to phase three? Thank you.

Speaker #2: Yeah, thanks for the questions, Akash. We have Luke here. So ask him to comment.

Speaker #6: So the details are still to come, but you can assume that those are the key topics of the communication.

Speaker #5: Yeah, and thanks, Akash. So you are correct, huh? So the way we now approach the analysis of the phase three, is that we will independently analyze the subsets.

Speaker #3: Our next question will come from Akash Tawari with Jefferies.

Speaker #5: So each has their own chance to win. As you also know from the research data, of course, the enrollment differed between subsets. So that will affect the intrinsic power.

Speaker #5: Hey, thanks so much. Can you give a little more color on your side plan for myositis? Based on your public comments, it seems like there is no alpha split.

Speaker #5: Basically, DM and INMN are now being run independently as two separate trials. Is that the correct read here? And then if the effect size in DM for your phase two trials was replicated in phase three, would the trial hit stat sig or not?

Speaker #5: Nevertheless, the analysis plans are completely in parallel. With respect to your question on effect size if we see effect size in phase three, in DM, that what we have observed in phase two, you could make the assumption that because it's twice as long and twice as big, that that would increase the chance for a statistics difference, which is certainly true, but not a guarantee.

Speaker #5: And if not, what are some reasons that efficacy could improve from phase two to phase three? Thank you.

Speaker #2: Yeah, thanks for the questions, Akash. We have Luke here. So ask him to comment.

Speaker #4: Yeah, and thanks, Akash. So you are correct, huh? So the way we now approach the analysis of the Phase 3 is that we will independently analyze the subsets.

Speaker #5: We just will have to turn the data cards. See what we have, and then determine our path forward. But whether stat sig or stat negative, we are working on a plan forward in DM.

Speaker #4: So each has their own chance to win. As you also know from the research data, of course, the enrollment differed between subsets, so that will affect the intrinsic power.

Speaker #1: Our next question will come from Rajan Sharma with Goldman Sachs.

Speaker #4: Nevertheless, the analysis plans are completely in parallel. With respect to your question on effect size, if we see effect size in phase three, in DM, that what we have observed in phase two, you could make the assumption that because it's twice as long and twice as big, that that would increase the chance for a statistics difference, which is certainly true, but not a guarantee.

Speaker #4: Hi, thanks for taking my question. I've actually got one on empathy pre-run. Could you just provide a little more color on the DGF update, please?

Speaker #4: So it seems like you're progressing development, but not in DGF itself. So can you maybe help us understand what the forward path is here in terms of indications?

Speaker #4: And when you may be in a position to move through a pivotal trial and what it was that you saw in the 52-week data that gives you confidence to move forward?

Speaker #4: We just will have to turn the data card, see what we have, and then determine our path forward. But whether stat sig or stat negative, we are working on a plan forward in DM.

Speaker #4: And I'm just wondering if there's any additional reassurance into MMN based on what you've seen in the DGF trial. Thank you.

Speaker #2: Yeah, happy to have Luke comment on this. Just a reminder, this is a phase two proof of concept study. And what we wanted to do was use it to explore and learn about the use of empath in the transplant setting broadly.

Speaker #3: Our next question will come from Rajan Sharma with Goldman Sachs.

Speaker #5: Hi, thanks for taking my question. I've actually got one on empathy pre-run. Could you just provide a little more color on the DGF update, please?

Speaker #2: With a focus on DGF in the particular study. But Luke, maybe you can talk about what we saw in the path forward.

Speaker #5: Yeah, thanks. Thanks, Karen. Thanks for the question. So as already said, this was a relatively small trial. Basically, evaluating a hypothesis whether we could influence the reperfusion injury with this mechanism.

Speaker #5: So it seems like you're progressing development, but not in DGF itself. So can you maybe help us understand what the forward path is here in terms of indications?

Speaker #5: And when you may be in a position to move to a pivotal trial? And what it was that you saw in the 52-week data that gives you confidence to move forward?

Speaker #5: And the transplant situation lends itself to this. And we had chosen as a target DGF, which is a relatively short-term goal. So when we saw the data at 24 weeks, we found an intriguing signal, which made us decide, let's continue the exploration of the study.

Speaker #5: And I'm just wondering if there's any additional reassurance into MMN based on what you've seen in the DGF trial. Thank you.

Speaker #2: Yeah, happy to have Luke comment on this. Just a reminder, this was a phase two proof of concept study. And what we wanted to do was use it to explore and learn about the use of empath in the transplant setting broadly with a focus on DGF in the particular study.

Speaker #5: After 52 weeks, which more or less confirmed that there is something in the renal parameters here that is affected. Which gives us an interesting perspective on exploring the transplant.

Speaker #2: But Luke, maybe you can talk about what we saw in the path forward.

Speaker #4: Yeah, thanks. Thanks, Karen. Thanks for the question. So, as already said, this was a relatively small trial, basically evaluating a hypothesis of whether we could influence reperfusion injury with this mechanism.

Speaker #5: However, it does not support DGF, which, as I said, is a short-term readout. To be continued as an indication.

Speaker #2: And maybe just to comment on the second part of your question, around MMN read-through, I don't think I would take any read-through for MMN other than we did see some effect of the drug.

Speaker #4: And the transplant situation lends itself to this. And we had chosen as a target DGF, which is a relatively short-term goal. So when we saw the data at 24 weeks, we found an intriguing signal which made us decide, let's continue the exploration of the study up to 52 weeks, which more or less confirmed that there is something in the renal parameters here that is affected.

Speaker #2: But in particular for MMN, with the readout in Q4, I think the most important data point to look at there was our positive phase two study.

Speaker #2: Where on the endpoint of grip strength in the both in the initial phase part A, as well as the open label extension, we saw positive results.

Speaker #2: Thanks for the question.

Speaker #1: Our next question will come from Yateen Sinaja with Guggenheim.

Speaker #4: Which gives us an interesting perspective on exploring the transplant. However, it does not support DGF, which, as I said, is a short-term readout. To be continued as an indication.

Speaker #4: Hey guys, thank you for taking my question. Again, excellent results. Congrats again. So quick one on the pipeline, specifically on ARGX121. The IGN program.

Speaker #2: And maybe just to comment on the second part of your question, around MMN read-through, I don't think I would take any read-through for MMN other than we did see some effect of the drug.

Speaker #4: Could you maybe talk about a little bit about the profile that you have seen in phase one that is enabling you to move into phase two?

Speaker #2: But in particular for MMN, with the readout in Q4, I think the most important data point to look at there was our positive phase 2 study, where on the endpoint of grip strength, both in the initial phase, part A, as well as the open-label extension, we saw positive results.

Speaker #4: What level of IGA reduction you saw? How should we think about frequency? All of that. Thank you.

Speaker #2: Yeah, thanks for the question about our genics 121. We're really excited about 121 and broadening our pipeline. With the IGA sweeper. And we had shared data specifically from phase one and with the profile.

Speaker #2: Thanks for the question.

Speaker #3: Our next question will come from Yateen Sineja with Guggenheim.

Speaker #5: Hey guys, thank you for taking my question. Again, excellent results. So congrats again. So quick one on the pipeline. Specifically on ARGX 121, the IGN program, could you maybe talk about a little bit about the profile that you have seen in phase one that is enabling you to move into phase two?

Speaker #2: Showed that our genics 121 reduces IGA by about 90% within a matter of days. And that reduction is maintained all the way out till day 28 with one single dose.

Speaker #2: So very impressive data. And we're moving very quickly with urgency into IGAN. And perhaps, Luke, you could share your thoughts on the IGAN program since the development program.

Speaker #5: What level of IgA reduction did you see? How should we think about frequency? All of that. Thank you.

Speaker #5: Well, with such a signaling phase one, we are already excited to keep this really moving fast. When we showed those data, the key opinion leaders, they were also very enthusiastic.

Speaker #2: Yeah, thanks for the question about ArgenX 121. We're really excited about 121 and broadening our pipeline. With the IgA sweeper. And we had shared data specifically from phase one and with the profile that showed that ArgenX 121 reduces IgA by about 90% within a matter of days.

Speaker #5: And this speed and depth really puts it aside from. As we all know, IGAN has quite some efforts going on. But our signature of the drug here really sets us apart.

Speaker #5: And it's really offering us great hopes for the phase two and the phase three. That we can bring a meaningful drug to patients.

Speaker #2: And that reduction is maintained all the way out till day 28 with one single dose. So very impressive data. And we're moving very quickly with urgency into IGAN.

Speaker #1: Our next question will come from Yaron Werber with Callan.

Speaker #2: And perhaps, Luke, you could share your thoughts on the IgAN program, clinical development program.

Speaker #4: Great. Thanks so much. Congrats on a really nice quarter. Just a question for you on MMN. And thanks for putting that. Slide into the deck that shows the grip strength change from baseline.

Speaker #4: Well, with such a signaling phase one, we are all pretty excited to keep this really moving fast. When we showed those data, the key opinion leaders, they were also very enthusiastic.

Speaker #4: What we hear from clinicians is that 8 points clinically meaningful. And I believe the primary is not inferiority. And then you have superiority. Can you maybe just talk about that phase three trial design maybe a little bit of the powering or whatever you can share as to how do you what do you expect from baseline?

Speaker #4: And this speed and depth really puts it aside from, as we all know, IGAN, has quite some efforts going on. But our signature of the drug here really sets us apart.

Speaker #4: And it's really offering us great hopes for the phase two and the phase three, that we can bring a meaningful drug to patients.

Speaker #4: Thank you.

Speaker #2: Yeah, maybe Luke has a positive view to talk about the study design?

Speaker #5: Yeah. And Zane, thanks for the question. Because it allows us to talk through what are we really trying to achieve at our genics. So with the phase two data, as you remember, we had like an 81% reduction in the need for rescue with IVIG based for those that received empathy pre-bard.

Speaker #3: Our next question will come from Yaron Werber with Callan.

Speaker #5: Great. Thanks so much. Congrats on that really nice quarter. Just a question for you on MMN. And thanks for putting that slide into the deck that shows the grip strength change from baseline.

Speaker #5: This to the points where we said if every rescue we need to take forward as on IVIG, we might as well do IVIG head-to-head, which would also provide the most meaningful data for prescribers.

Speaker #5: What we hear from clinicians is that 8 points clinically meaningful. And I believe the primary is not inferiority. And then you have superiority. Can you maybe just talk about that phase three trial design, maybe a little bit of the powering or whatever you can share as to how do you what do you expect from baseline?

Speaker #5: So we designed this trial where after stabilization on IVIG, an optimizing that we initiate either a continuation of the IVIG regimen or a switch to.

Speaker #5: Thank you.

Speaker #2: Yeah, maybe Luke has a positive view to talk about the study design?

Speaker #4: Yeah. And as any thanks for the question, because it allows us to talk through what are we really trying to achieve at ArgenX. So with the phase two data, as you remember, we had like an 81% reduction in the need for rescue with IVIG based for those that received empathy pre-bard.

Speaker #5: Empathy pre-bard. The endpoint here is indeed grip strength, which we picked in conversation with actually the agencies. Because there were quite meaningful data available, which allowed us to define a non-inferiority margin.

Speaker #4: This to the point where we said, if every rescue we need to take forward as on IVIG, we might as well do IVIG head to head, which would also provide the most meaningful data for prescribers.

Speaker #5: And the non-inferiority margin is set, I think, pretty relevantly. But we also have the opportunity to go to superiority. And I think based on the phase two data, and what we learned on IVIG, that there is, in my opinion, a great chance that we could show that.

Speaker #4: So we designed this trial where, after stabilization on IVIG and optimizing that, we initiate either a continuation of the IVIG regimen or a switch to empasiprepbard.

Speaker #5: But the non-inferiority at least gives us the ability to at least provide that information.

Speaker #4: The endpoint here is indeed grip strength, which we fixed in conversation with, actually, the agencies. Because there were quite meaningful data available, which allowed us to define a non-inferiority margin.

Speaker #2: Yeah. Thanks, Luke. And just to. To wrap up, what I would say is what we see as success is a positive readout on the primary endpoint, non-inferiority.

Speaker #2: And obviously, upside would be superiority. But when we speak to KOLs, and prescribers, we certainly hear excitement about the fact that we have a head-to-head versus IVIG.

Speaker #4: And the non-inferiority margin is set, I think, pretty relevantly. But we also have the opportunity to go to superiority. And I think based on the phase two data, and what we learned on IVIG, that there is, in my opinion, a great chance that we could show that.

Speaker #2: And certainly with our experience in CIDP, we have some experience competing in that space as well. So I think we're set up for success, assuming a positive readout towards the end of the year with MMN.

Speaker #1: Our next question will come from Danielle Brill with Truist.

Speaker #4: But the non-inferiority at least gives us the ability to at least provide that information.

Speaker #4: Hey guys, this is Alex on for Danielle. Thanks for the question. And congrats on the quarter. Just a question on CIDP as it pertains to the current commercial dynamics, as well as the ongoing EMPA trials.

Speaker #2: Yeah. Thanks, Luke. And just to wrap it up, what I would say is what we see is success is a positive readout on the primary endpoint, non-inferiority.

Speaker #4: As far as it relates to the commercial read through the CIDP launch, in the regions where VivGuard is available, who are the types of patients who are enrolling in the EMPA CIDP trials instead of trialing VivGuard?

Speaker #2: And obviously, upside would be superiority. But when we speak to KOLs and prescribers, we certainly hear excitement about the fact that we have a head-to-head versus IVIG.

Speaker #4: Thanks.

Speaker #2: Hi, yeah. For me to start, just to lay out our strategy, with CIDP, so we see that CIDP is a heterogeneous disease. And there is significant unmet need.

Speaker #2: And certainly with our experience in CIDP, we have some experience competing in that space as well. So I think we're set up for success, assuming a positive readout towards the end of the year with MMN.

Speaker #2: Until VivGuard launched, there hadn't been innovation in the space for 30 years. And we've seen the strong uptake of VivGuard in CIDP. What we know is with the disease heterogeneity, that there is also IGMs driving the disease.

Speaker #3: Our next question will come from Danielle Brill with Truist.

Speaker #5: Hey guys, this is Alex on for Danielle. Thanks for the question. And congrats on the quarter. Just a question on CIDP as it pertains to the current commercial dynamics, as well as the ongoing EMPA trials.

Speaker #2: And so that's why we have the study with empathy pre-bard, where we think we have strong biology. Rationale. So our hypothesis is that there are some patients that we have a 70% response rate with VivGuard.

Speaker #5: As far as it relates to the commercial read through the CIDP launch, in the regions where Vivgard is available, who are the types of patients who are enrolling in the EMPA CIDP trials instead of trialing Vivgard?

Speaker #2: So those patients that don't respond to VivGuard might have more IGM-driven disease. And so we think that there's an opportunity for empathy pre-bard in those patients.

Speaker #5: Thanks.

Speaker #2: Hi, yeah. So maybe to start, just to lay out our strategy with CIDP. We see that CIDP is a heterogeneous disease, and there is significant unmet need.

Speaker #2: There also might be patients where they have sort of multiple drivers of the disease. And so an overlap that might be between eligible for both VivGuard and empathy pre-bard.

Speaker #2: Until Vyvgart launched, there hadn't been innovation in the space for 30 years. And we've seen the strong uptake of Vyvgart in CIDP. What we know is, with the disease heterogeneity, that there are also IgMs driving the disease.

Speaker #2: So our strategy here is to study empathy pre-bard and we're enrolling empathy pre-bard in a broad patient population so we can understand what empathy the impact empathy pre-bard on the disease.

Speaker #2: And then once we have the data readout, we can analyze that data as well as the VivGuard data, and really understand what is driving the best outcome for patients and move forward with a commercial strategy from there.

Speaker #2: And so that's why we have the study with empathy pre-bard, where we think we have strong biology rationale. So our hypothesis is that there are some patients that we have a 70% response rate with Vivgard.

Speaker #2: Thanks for the question.

Speaker #2: So those patients that don't respond to Vivgard might have more IGM-driven disease. And so we think that there's an opportunity for empathy pre-bard in those patients.

Speaker #1: Our next question will come from Thomas Smith with Lyrinc Partners.

Speaker #4: guys, good morning. Thanks for taking our questions. And let me add my congrats on the really strong quarter here. On the pipeline, could you just provide some updated thoughts on how you're thinking about advancement between your next-gen FCR in Canada 213 and 124?

Speaker #2: There also might be patients where they have sort of multiple drivers of the disease. And so an overlap that might be between eligible for both Vivgard and empathy pre-bard.

Speaker #2: So our strategy here is to study empathy pre-bard and we're enrolling empathy pre-bard in a broad patient population so we can understand what empathy the impact of empathy pre-bard on the disease.

Speaker #4: Any additional color on the target profile, you're aiming for 124 with respect to IGG lowering or dosing interval or other potential differentiation? And how do you think about indication selection between lifecycle management and potential expansion opportunities across those candidates?

Speaker #2: And then once we have the data readout, we can analyze that data as well as the Vivgard data, and really understand what is driving the best outcome for patients and move forward with a commercial strategy from there.

Speaker #4: Thanks so much.

Speaker #2: Yeah, thanks for the question. Our goal with FCRN is to maintain our leadership and even advance our leadership for decades to come. And we have a few pieces or.

Speaker #2: Thanks for the question.

Speaker #3: Our next question will come from Thomas Smith with Lyrinc Partners.

Speaker #2: For that strategy. Next-generation molecules, 213 and 124 that you refer to, 213 is we call it phase three ready. And 124, we're in the in phase one at the moment.

Speaker #5: Hey guys, good morning. Thanks for taking our questions. And let me add my congrats on the really strong quarter here. On the pipeline, could you just provide some updated thoughts on how you're thinking about advancement between your next-gen FCR in Canada 213 and 124?

Speaker #2: And by the end of the year, we'll be in a position to move it into late-stage clinical development. So at the moment, we're working with our teams, based on that data, to assess the two molecules, plus our Genics 213.

Speaker #5: Any additional color on the target profile, you're aiming for 124 with respect to IGG lowering or dosing interval or other potential differentiation? And how do you think about indication selection between lifecycle management and potential expansion opportunities across those candidates?

Speaker #2: We know has a Q4 weekly dosing schedule. Our Genics 124, we're further categorizing the advantages that it will bring over VivGuard at the moment.

Speaker #2: And then we'll be in a position where we can lay out what the strategy is for the full portfolio between VivGuard, 213, and 124.

Speaker #5: Thanks so much.

Speaker #2: Yeah, thanks for the question. Our goal with FCRN is to maintain our leadership and even advance our leadership for decades to come. And we have a few pieces or parts to that strategy.

Speaker #2: The other component of our strategy that's really exciting is that we are in development of an oral FCRN. And that program also moves forward with quickly at the moment.

Speaker #2: Next-generation molecules, 213 and 124 that you refer to, 213 is we call it phase three ready. And 124, we're in the in phase one at the moment.

Speaker #2: Thanks for the question.

Speaker #1: Our next question will come from Sean Lomond with Morgan Stanley.

Speaker #2: And by the end of the year, we'll be in a position to move it into late-stage clinical development. So, at the moment, we're working with our teams, based on that data, to assess the two molecules.

Speaker #4: Good morning, Karen and team. Hope everyone's well. Karen, just going back to the seronegative GMG impact, what's specific early prescribing trends of most exceeded your expectations?

Speaker #2: Of course, ArgenX 213, we know, has a Q4 weekly dosing schedule. ArgenX 124, we're further categorizing the advantages that it will bring over Vivgard at the moment.

Speaker #4: And how should investors think about the revenue contribution from seronegative patients over the next 12 to 24 months?

Speaker #2: Yeah, thanks for the question. And I'll hand it over to Sandrine in a moment. But I'd be remiss if I didn't just say, first of all, that I'm really proud to see seronegative launch.

Speaker #2: And then we'll be in a position where we can lay out what the strategy is for the full portfolio between Vivgard, 213, and 124.

Speaker #2: It really is the. Genics playbook in action. We made a commitment to this patient population many years ago when we launched VivGuard. That we would bring this innovation to seronegative patients.

Speaker #2: The other component of our strategy that’s really exciting is that we are in development of an oral FcRn. And that program is also moving forward quickly at the moment.

Speaker #2: And to see that happening in the market and being so positively responded to is really exciting. But Sandrine, maybe you could comment a little bit more on the dynamics you're seeing with the launch.

Speaker #2: Thanks for the question.

Speaker #3: Our next question will come from Sean Lomond with Morgan Stanley.

Speaker #5: Good morning, Karen and team. Hope everyone's well. Karen, just going back to the seronegative gMG impact, what specific early prescribing trends have most exceeded your expectations?

Speaker #3: Thank you, Karen. And thank you for asking a question on seronegative. Because for me, this is a big event in the second quarter. So it's great to have someone asking that question.

Speaker #3: So I spent time in the field over the last few weeks to listen directly and hear the feedback from prescribers, but also from patients.

Speaker #5: And how should investors think about the revenue contribution from seronegative patients over the next 12 to 24 months?

Speaker #3: And although we are only 10 weeks in, so it's still very early, the feedback is overwhelmingly positive. I mean, you saw the quote I had in the presentation from the patients.

Speaker #2: Yeah, thanks for the question. And I'll hand it over to Sandrine in a moment. But I'd be remiss if I didn't just say, first of see seronegative launch.

Speaker #3: Many were actually waiting for a solution because they had been excluded from clinical trials, especially the triple seronegatives patients. And they were really waiting for an option.

Speaker #2: It really is the ArgenX playbook in action. We made a commitment to this patient population many years ago when we launched Vivgard. That we would bring this innovation to seronegative patients.

Speaker #3: And so a lot of hope, a lot of enthusiasm for the patient side. Some of them were calling their physicians to make sure that they were at access to the product as soon as possible.

Speaker #2: And to see that happening in the market and being so positively responded to is really exciting. But Sandrine, maybe you could comment a little bit more on the dynamics you're seeing with the launch.

Speaker #3: On the provider side, what is interesting is that when they consider no that the fact that we add seronegatives to the label is that we now have a full, fully loaded GMG label.

Speaker #4: Thank you, Karen. And thank you for asking a question on seronegative. Because for me, this is a big event in the second quarter. So it's great to have someone asking that question.

Speaker #4: So I spent time in the field over the last few weeks to listen directly and hear the feedback from prescribers, but also from patients.

Speaker #3: And that adds simplicity in decision-making, streamlining decision-making. They quote, "I consider no VivGuard as the go-to option for all my GMGs." And so one of the things we have observed over the first few weeks is that it has really a strong halo effect beyond the seronegative patients onto the positive serotype patients.

Speaker #4: And although we are only 10 weeks in, so it's still very early, the feedback is overwhelmingly positive. I mean, you saw the quote I had in the presentation from the patients.

Speaker #4: Many were actually waiting for solutions because they had been excluded from clinical trials, especially the triple-seronegative patients. And they were really waiting for an option.

Speaker #3: And that was something that we were expecting. But it's great to see confirmed. What we are also very, very happy about is that the payers have been approving quite quickly.

Speaker #4: And so, a lot of hope, a lot of enthusiasm on the patient side. Some of them were calling their physicians to make sure that they had access to the product as soon as possible.

Speaker #3: And endorsing their policy VivGuard in seronegative, where we have roughly 5% of the covered lives yet already, less than three months after launch. And I had said that it would take three to six months to get to roughly 90%.

Speaker #4: On the provider side, what is interesting is that when you look at what the provider are saying is that they consider now that the fact that we add seronegative to the label is that we now have a full, fully loaded GMG label.

Speaker #3: And we are well on track to get there. And so what is also very important is not just the quantity of coverage, but also the quality.

Speaker #4: And that adds simplicity in decision-making. Streamlining decision-making. They quote, "I consider now Vivgard as the go-to option for all my GMGs." And so one of the things we have observed over the first few weeks is that it has really a strong halo effect beyond the seronegative patients onto the positive serotype patients.

Speaker #3: And seeing that the majority of the plants are removing the testing requirements for the serotype is also making the life of the providers easy.

Speaker #3: So if I would summarize, it's all about leadership in MG with that approval, but also simplicity of decision-making for the providers. So great feedback.

Speaker #4: And that was something that we were expecting. But it's great to see it confirmed. What we are also very, very happy about is that the payers have been approving quite quickly.

Speaker #4: Thank you.

Speaker #1: Our next question will come from Samantha Semenko with Citi.

Speaker #5: Hi, good morning. And thanks very much for taking the question. Just one on CIDP for me. You outlined in your slides market expansion opportunity.

Speaker #4: And endorsing their policy Vivgard and seronegative, where we have roughly 55% of the covered lives yet, already. Less than three months after launch. And I had said that it would take three to six months to get to roughly 90%.

Speaker #5: I'm wondering what you're seeing in the data about treatment naive patients, utilizing VivGuard as a first line. Are you seeing a shift towards these patients being treated more frequently?

Speaker #4: And we are well on track to get there. And so what is also very important is not just the quantity of coverage, but also the quality.

Speaker #5: And if so, how should we think about the progression of the launch and that segment going forward? Thanks very much.

Speaker #4: And seeing that the majority of the plants are removing the testing requirement for the serotype is also making the life of the providers easy.

Speaker #2: Yeah, thanks for the CIDP question. Sandrine, maybe you can comment?

Speaker #4: So if I would summarize, it's all about leadership in MG with that approval, but also simplicity of decision-making for the providers. So great feedback.

Speaker #3: Yeah. So it's indeed a very big opportunity for us to really make sure that VivGuard is used as early as possible. Because still the majority of the patients start with IVIG when they start their treatment for CIDP.

Speaker #5: Thank you.

Speaker #3: Our next question will come from Samantha Semenko with Citi.

Speaker #3: So we publish data. And we are generating more and more evidence to show that if you are prescribing VivGuard for treatment naive patients, actually you see clinical benefits.

Speaker #6: Hi, good morning. And thanks very much for taking the question. Just one on CIDP for me. You outlined in your slides market expansion opportunity.

Speaker #3: And we presented a study at AAN where we show that 87.5% of the patients that were treatment naive benefited from a clinical response. And we are using data to encourage physicians to try VivGuard in these earlier line patients.

Speaker #6: I'm wondering what you're seeing in the data about treatment naive patient utilizing Vivgard as a first line. Are you seeing a shift towards these patients being treated more frequently?

Speaker #6: And if so, how should we think about the progression of the launch in that segment going forward? Thanks very much.

Speaker #3: And they are seeing good results. Now it's taking time. It's taking time because you have to change entrenched habits. And you have also to make sure that payers are supporting that.

Speaker #2: Yeah, thanks for the CIDP question. Sandrine, maybe you can comment?

Speaker #4: Yeah, so it's indeed a very big opportunity for us to really make sure that Vyvgart is used as early as possible, because still the majority of patients start with IVIG when they begin treatment for CIDP.

Speaker #3: Because still the majority of them, I require some kind of experience with IVIG. So that's why we are working on. But you see more and more traction in these treatment naive populations as well as in the patients that are seen as well managed but need some more functional improvement.

Speaker #4: So we publish data, and we are generating more and more evidence to show that if you are prescribing Vyvgart for treatment-naive patients, you actually see clinical benefits.

Speaker #1: Our next question will come from Gavin Clark-Gartner with Evercore ISI.

Speaker #4: And we presented a study at AAN where we showed that 87.5% of the patients who were treatment-naive benefited from a clinical response. And we are using data to encourage physicians to try Vyvgart in these earlier-line patients.

Speaker #4: Hey, thanks for taking the question. Just following the recent early provider update, are you considering any changes to your CIDP development plans for EMPA?

Speaker #4: And I guess on this point, did this outcome change what you think the likelihood of EMPA meeting superiority versus IVIG is in either CIDP or MMN?

Speaker #4: And they are seeing good results. Now it's taking time. It's taking time because you have to change entrenched habits. And you have also to make sure that payers are supporting that.

Speaker #4: Thank you.

Speaker #2: Yeah, thanks for the question, Gavin. As a reminder, before I hand it over to Luke, our clinical development program, the CIDP for imposter provide, has two studies.

Speaker #4: Because still the majority of them are requiring some kind of experience with IVIG. So that's why we are working on. But you see more and more traction in these treatment naive populations as well as in the patients that are seen as well managed but need some more functional improvement.

Speaker #2: One is head-to-head versus IVIG. And the other is a placebo-controlled study. And so I think it's around the placebo-controlled study that you're particularly asking for, but also maybe some comments, Luke, on your confidence in the IVIG study as well.

Speaker #3: Our next question will come from Gavin Clark-Gartner with Evercore ISI.

Speaker #6: Yeah, and what is important to realize for CIDP and we use the term already is a heterogeneous disease also. And therefore, your selection of patients matters.

Speaker #5: Hey, thanks for taking the question. Just following the recent early provider update, are you considering any changes to your CIDP development plans for EMPA?

Speaker #6: We took particular care in that here study to install, for example, that clinical education committee, which now has become the standard. What we continue to exclude possible CIDP patients, for example, is one of the differences.

Speaker #5: And I guess on this point, did this outcome change what you think the likelihood of EMPA meeting superiority versus IVIG is in either CIDP or MMN?

Speaker #5: Thank you.

Speaker #6: And then if you then on top of that, go with very refractory patients, you may come in a situation where the disease has burned out more or less.

Speaker #2: Yeah, thanks for the question, Gavin. As a reminder, before I hand it over to Luke, our clinical development program, the CIDP for impulsive provide, has two studies.

Speaker #2: One is the head-to-head versus IVIG. And the other is a placebo-controlled study. And so I think it's around the placebo-controlled study that you're particularly asking for, but also maybe some comments moved on your confidence in the IVIG study as well.

Speaker #6: And then what's your ability to change? We, of course, want to learn. And we will be looking more closely at this data and evaluate is there anything we need to do to optimize our studies.

Speaker #6: But we are continuing with our plans to continue both.

Speaker #7: Yeah, and what is important to realize for CIDP and we use the term already is a heterogeneous disease also. And therefore, your selection of patients matters.

Speaker #2: Yeah, and maybe just one more comment on that. That it's made me reflect on is that it's very clear from this that it's not easy to run successful clinical trials in CIDP and one advantage that we have is that we do have the VivGuard experience.

Speaker #7: We took particular care in that Her study to install, for example, that Clinical Education Committee, which now has become the standard. What we continue to do is exclude possible CIDP patients, for example, which is one of the differences.

Speaker #2: And we've been able to demonstrate that ability. So that gives me additional confidence as well.

Speaker #1: Our next question will come from Sophia Graff with JPMorgan.

Speaker #7: And then if you then on top of that, go with very refractory patients, you may come in a situation where the disease has burned out more or less.

Speaker #5: Good afternoon. Thanks for taking my question. One on the upcoming myositis trial. You've commented that you currently no longer see a path forward for polymyositis patients.

Speaker #7: And then what's your ability to change? We, of course, want to learn. And we will be looking more closely at this data and evaluate is there anything we need to do to optimize our studies.

Speaker #5: But given the strong evidence that ACES is autoantibody-driven, would there be scope to run an ACES-specific trial in future? Or is this population still a bit too small to target?

Speaker #7: But we are continuing with our plans to continue both.

Speaker #2: Yeah, and maybe just one more comment on that that it's made me reflect on is that it's very clear from this that it's not easy to run successful clinical trials in CIDP and one advantage that we have is that we do have the Vivgard experience.

Speaker #6: Yeah, thank you for that question. We are, of course, want to reach as many patients as we can. Just from a technical point of view in this trial, with the enrollment numbers, we just can't get there.

Speaker #6: But we will learn. And so ACES is not just confined to PM and polymyositis. Itself is heterogeneous and has been a bit kind of being more and more allocated to the other subsets as we get to know more.

Speaker #2: And we've been able to demonstrate that ability. So that gives me additional confidence as well.

Speaker #3: Our next question will come from Sophia Graff with JPMorgan.

Speaker #6: So we will definitely look at the data as they come. And determine a plan forward for ACES.

Speaker #6: Good afternoon. Thanks for taking my question. One on the upcoming myositis trial. You've commented that you currently no longer see a path forward for polymyositis patients.

Speaker #5: Thank you.

Speaker #1: Our next question will come from Victor Flock with BNPP.

Speaker #6: But given the strong evidence that ACES is autoantibody-driven, would there be scope to run an ACES-specific trial in future? Or is this population still a bit too small to target?

Speaker #4: Hey, thanks so much for taking our question. So maybe just one on the PFS. So I've noticed in your slide that the proportion of PFS patients new to VivGuard actually increased to 80% from 68% in Q1, which is quite impressive.

Speaker #7: Yeah, thank you for that question. We, of course, want to reach as many patients as we can. Just from a technical point of view in this trial, with the enrollment numbers, we just can't get there.

Speaker #4: So I was just wondering, whether it makes you incrementally more bullish about the autoinjector opportunity. And whether there is any chance you can share more details on the remaining development milestone for the autoinjector and the expected launch timing.

Speaker #7: But we will learn. And so ACES is not just confined to PM and polymyositis. Itself, it's heterogeneous and has been, kind of, being more and more allocated to the other subsets as we get to know more.

Speaker #4: Thank you very much.

Speaker #2: Yeah, so thanks for the question on PFS. I'll hand it over to Sandrine in a moment. But just to confirm, autoinjector is on target or on schedule for 2027 launch.

Speaker #7: So, we will definitely look at the data as they come and determine a plan forward for ACES.

Speaker #6: Thank you.

Speaker #2: But maybe some of the dynamics you're seeing with prefilled syringe in the market, Sandrine?

Speaker #3: Our next question will come from Victor Flock with BNPP.

Speaker #3: Yeah, so thank you for your question, Victor. So indeed, I wrote on the slide 80% of the patients that are on PFS in the second quarter in the US are new to VivGuard.

Speaker #5: Hey, thanks so much for taking our question. So maybe just one on the PFS. I've noticed in your slide that the proportion of PFS patients new to Vyvgart actually increased to 80% from 68% in Q1, which is quite impressive.

Speaker #3: So it's true expansion for us. And you compare to last time where we said 68%. Last time, 68% was launch to date. So these were the patients since the launch.

Speaker #3: This time, we should actually just focus to. If you look at launch to date, to compare apples with apples, we would be at 70%.

Speaker #5: So I was just wondering whether it makes you incrementally more bullish about the autoinjector opportunity, and whether there is any chance you can share more details on the remaining development milestone for the autoinjector and the expected launch timing?

Speaker #3: So it's a slight increase, but it's not 80%. 80% is really the last quarter and it shows that actually more and more of the patients that start on VivGuard actually are truly new and start on PFS, sorry, are new to VivGuard.

Speaker #5: Thank you very much.

Speaker #2: Yeah, so thanks for the question on PFS. I'll hand it over to Sandrine in a moment. But just to confirm, autoinjector is on target or on schedule.

Speaker #3: So thank you for the question.

Speaker #1: Our next question will come from Andy Chen with Wolf.

Speaker #2: For 2027 launch. But maybe some of the dynamics you're seeing with prefilled syringe in the market, Sandrine?

Speaker #4: Hi, thank you for taking my question. This is Jason taking it for Andy. I just wanted to ask a question in terms of seronegative approval and what its effect on this quarter's earnings had.

Speaker #4: Yeah, so thank you for your question, Victor. So indeed, I wrote on the slide 80% of the patients that are on PFS in the second quarter in the US are new to Vivgard.

Speaker #4: And also, I wanted to ask in terms of the launch curve of seronegative and ocular, would they be similar? Or what might there be in terms of subtle differences?

Speaker #4: So it's true expansion for us. And if you compare to last time, where we said 68%—last time, 68% was launched to date. So these were the patients since the launch.

Speaker #4: This time, we should actually just focus too. If you look at launch today, to compare apples with apples, we would be at 70%. So it's a slight increase, but it's not 80%.

Speaker #4: And anything to think about when we're looking at the uptake of ocular? Thank you.

Speaker #2: Yeah, thanks for the question. Kyle, maybe you can comment on the dynamics of the quarter.

Speaker #4: 80% is really the last quarter and it shows that actually more and more of the patients that start on Vivgard actually are truly new and start on PFS, sorry, are new to Vivgard.

Speaker #7: Thank you, Kat. And thank you, Jason, for the question. Yeah, Sandrine already mentioned in the prepared remarks, the quarter was driven by strong fundamentals and PFS was the key driver of growth.

Speaker #4: So thank you for the question.

Speaker #7: However, seronegative, of course, is also a contributor. In particular, the seronegative the triple negative patients, where we see the huge unmet need. And also the halo effect, the seronegative had on the broader GMG market.

Speaker #3: Our next question will come from Andy Chen with Wolf.

Speaker #5: Hi, thank you for taking my question. This is Jason taking it for Andy. I just wanted to ask a question in terms of seronegative approval and what its effect on this quarter's earnings had.

Speaker #5: And also, I wanted to ask, in terms of the launch curve of seronegative and ocular, would they be similar, or what might there be in terms of subtle differences?

Speaker #7: So I think what and of course, we expect that to also flow into Q3. In terms of ocular, I think as we always said, you need continued innovation to maintain the growth.

Speaker #5: And anything to think about when we're looking at the uptake of ocular? Thank you.

Speaker #7: And regular new launches, of course, is what we need. And I think we are very excited, but we're going to continue to deliver that for patients.

Speaker #2: Yeah, thanks for the question. Kyle, maybe you can comment on the dynamics of the quarter.

Speaker #8: Thank you, Karen. And thank you, Jason, for the question. Yeah, Sandrine already mentioned in the prepared remarks, the quarter was driven by strong fundamentals and PFS was the key driver of growth.

Speaker #7: Thank you for the question.

Speaker #1: Your next question will come from Luca Issi with RBC Capital Markets.

Speaker #2: Oh, great. Thanks

Speaker #8: However, seronegative, of course, is also a contributor. In particular, the seronegative the triple negative patients, where we see the huge unmet need. And also the halo effect, the seronegative had on the broader GMG market.

Speaker #6: so much for taking the question. And congrats on another great quarter. Maybe Luke, just want to circle back on a prior question to myositis.

Speaker #6: You mentioned that IM&M and DM are independent analysis to each of them as its own chance to fit the stats. But the FDA still asks you to.

Speaker #6: How far between the two trials, given that this was originally structured as an all-comma trial that enrolled both populations together? Or are each trial at this point completely independent from one another under absolutely no crosstalk between the two trials?

Speaker #8: So I think what—and of course, we expect that to also flow into Q3. In terms of ocular, I think as we always said, you need continued innovation to maintain the growth.

Speaker #6: I guess the other way to ask the question, are these trials successful if the p-value is below 0.05? Or do you need to hit p-value below 0.025?

Speaker #8: And regular new launches, of course, is what we need. And I think we are very excited, but we're going to continue to deliver that for patients.

Speaker #6: Because again, you're splitting the alpha between the two trials. Any comment there, much appreciated. Thank you. Yeah, so I want to stay consistent with how we answer that at the R&D day, which is we are not going to comment on a specific alpha value.

Speaker #8: Thank you for the question.

Speaker #3: Your next question will come from Luca Issi with RBC Capital Markets.

Speaker #9: Oh, great. Thanks so much for taking the question. And congrats on another great quarter. Maybe Luke, just want to circle back on a prior question.

Speaker #6: Because even in these rare diseases, even with alphas, that are in between 0.05 and 0.1 even, you can have a conversation. It's not that we go in there, but I'm just saying we're not going to disclose the actual alpha value.

Speaker #9: So myositis—you mentioned that IMNM and DM are independent analyses, each of them with its own chance to fit the stats. But did the FDA still ask you to split the alpha between the two trials, given that this was originally structured as an all-comer trial that enrolled both populations together?

Speaker #6: And yeah, the data cart is to be turned soon.

Speaker #9: Or are each trial at this point completely independent from one another and there's absolutely no crosstalk between the two trials? I guess the other way to ask the question, are these trials successful if the p-value is below 0.05?

Speaker #2: Yeah, and maybe just to give you some additional insight and color on the strategy and the filing strategy. So as Luke shared earlier, the analysis plan is independent of each other.

Speaker #9: Or do you need to hit p-value below 0.025? Because again, you're splitting the alpha between the two trials. Any comment there, much appreciated. Thank you.

Speaker #2: So IM&M and then DM separately. So they are two separate analysis plans. And our filing path or our filing strategy and path forward is in IM&M, recall that there are no approved treatments in IM&M.

Speaker #7: Yeah, so I want to stay consistent with how we answered that at the R&D Day, which is that we're not going to comment on a specific alpha value.

Speaker #2: And so we have breakthrough designation. With the FDA, and have had significant and have had those communications based on that with the FDA. In DM, what we'll be looking for, of course, is statistical significance.

Speaker #7: Because even in these rare diseases, even with alphas, that are in between 0.05 and 0.1 even, you can have a conversation. It's not that we go in there, but I'm just saying we're not going to disclose the actual alpha value.

Speaker #2: And once we have that data, we'll be able to continue discussions with the FDA on what the path forward is there. But what I want to come back to is that with this myositis study, what we've given ourselves the opportunity to do is have two opportunities for label expansion.

Speaker #7: And yeah, the data cart is to be turned soon.

Speaker #2: Yeah, and maybe just to give you some additional insight and color on the strategy and the filing strategy. So, as Luke shared earlier, the analysis plans are independent of each other.

Speaker #2: Both or each of them individually as blockbuster in potential blockbuster indications. IM&M and DM. So we're on track for Q3. We'll turn the data card, and we'll determine the path forward from there.

Speaker #2: So IM&M and then DM separately. So they are two separate analysis plans. And our filing path, or our filing strategy and path forward, is in IM&M. Recall that there are no approved treatments in IM&M.

Speaker #6: Got it. Thanks so much.

Speaker #1: Our next question will come from Sebastian Vendersot with Kempen.

Speaker #4: Hi, guys. Congrats on the excellent quarter. And thanks for taking the question. Can you maybe share your latest thinking on your ambitions regarding business development M&A?

Speaker #2: And so we have breakthrough designation. With the FDA, and have had significant and have had those communications based on that with the FDA. In DM, what we'll be looking for, of course, is statistical significance.

Speaker #4: What should or should we not expect in this aspect for the next 12 to 24 months? And can you maybe describe the profile of assets that you'll be looking forward to add to your pipeline?

Speaker #2: And once we have that data, we'll be able to continue discussions with the FDA on what the path forward is there. But what I want to come back to is that with this myositis study, what we've given ourselves the opportunity to do is have two opportunities for label expansion.

Speaker #4: Thank you.

Speaker #2: Yeah, thanks for the question. So our overall capital allocation strategy is very much focused on delivering growth, growth in the short, mid, and long term.

Speaker #2: Both, or each of them individually, as blockbuster in potential blockbuster indications—IM&M and DM. So we're on track for Q3; we'll turn the data card and we'll determine the path forward from there.

Speaker #2: And in line with that, our capital allocation strategy focuses on, number one, fueling VivGuard growth. Number two, funding and accelerating our internal pipeline that includes our FCRN assets that I was talking about earlier, but also beyond FCRN.

Speaker #9: Got it. Thanks so much.

Speaker #3: Our next question will come from Sebastian Vandersoot with Kempen.

Speaker #5: Hi, guys. Congrats on the excellent quarter. And thanks for taking the question. Can you maybe share your latest thinking on your ambitions regarding business development M&A?

Speaker #2: And then, of course, with the strength of our balance sheet, we also have the opportunity to look at business development. Now, looking at business development opportunities in order to identify potential new assets, is not a new strategy for us.

Speaker #5: What should or should we not expect in this aspect for the next 12 to 24 months? And can you maybe describe the profile of assets that you will be looking for to add to your pipeline?

Speaker #2: Always, the approach that our Genics has taken has been to partner to look for novel biology, new mechanisms of action, where there's significant unmet patient needs.

Speaker #5: Thank you.

Speaker #2: Yeah, thanks for the question. So our overall capital allocation strategy is very much focused on delivering growth, growth in the short, mid, and long term.

Speaker #2: And in the past, we always we partnered with academic institutions in order to identify that biology and build those molecules. With the strength of our balance sheet, and our continued profitability, we can now widen the lens and also look at biotech companies that are pursuing but we use the same bar for those business development opportunities as we do for our internal pipeline.

Speaker #2: And in line with that, our capital allocation strategy focuses on, number one, fueling Vyvgart growth. Number two, funding and accelerating our internal pipeline. That includes our FDRN assets that I was talking about earlier, but also beyond FDRN.

Speaker #2: And then, of course, with the strength of our balance sheet, we also have the opportunity to look at business development. Now, looking at business development opportunities in order to identify potential new assets, is not a new strategy for us.

Speaker #2: And that bar is that it has to be novel biology, and it has to be in areas where there is significant unmet patient need.

Speaker #2: So we're holding that we hold the bar high, but I can tell you when we find those opportunities where we can have an impact for patients, we will leverage the flexibility of the balance sheet to be able to go after them and continue to build our pipeline.

Speaker #2: In all ways, the approach that ArgenX has taken has been to partner to look for novel biology, new mechanisms of action, where there's significant unmet patient needs.

Speaker #2: Thanks for the question.

Speaker #1: Our next question will come from Douglas Thao with HC Wainwright.

Speaker #2: And in the past, we always partnered with academic institutions in order to identify that biology and build those molecules. With the strength of our balance sheet and our continued profitability, we can now widen the lens and also look at biotech companies that are pursuing—but we use the same bar for those business development opportunities as we do for our internal pipeline.

Speaker #4: Hi, good morning. Thanks for taking the questions. Just I'm curious in terms of the CIDP opportunity and the slide, were you indicate the number of patients who are diagnosed but not treated?

Speaker #4: And I'm just curious if your sense is, is those patients aren't being treated just given the sort of tolerability issues related to IVIG? And is VivGuard sort of sort of tolerability becoming attractive sort of attribute that you are going to sort of try to sell to clinicians in terms of bringing those patients back into treatment?

Speaker #2: And that bar is that it has to be novel biology, and it has to be in areas where there is significant unmet patient need.

Speaker #2: So, we're holding that—we hold the bar high. But I can tell you, when we find those opportunities where we can have an impact for patients, we will leverage the flexibility of the balance sheet to be able to go after them and continue to build our pipeline.

Speaker #2: Yeah, thanks for the question, Douglas. And I think what you can see from that slide that I find exciting is that it's clear we're just at the beginning of the growth curve.

Speaker #2: Thanks for the question.

Speaker #2: For CIDP, and there's a lot of opportunity for continued growth. But maybe, Sandrine, you can share what you're seeing in the market around those patients.

Speaker #3: Our next question will come from Douglas Thao with HC Wainwright.

Speaker #5: Hi, good morning. Thanks for taking the questions. Just I'm curious, in terms of the CIDP opportunity and the slide, were you indicate the number of patients who are diagnosed but not treated?

Speaker #5: Yes, thank you, Karen. So in the CIDP, lots of opportunities for further growth within the addressable market we started with at launch, but also way beyond that.

Speaker #5: And so what I noticed when I discussed CIDP with patients, but most importantly with providers, is that it's a disease which is not well understood.

Speaker #5: And I'm just curious if your sense is, is those patients aren't being treated just given the sort of tolerability issues related to IVIG? And is Vivgard sort of sort of tolerability becoming attractive sort of attribute that you are going to sort of try to sell to clinicians in terms of bringing those patients back into treatment?

Speaker #5: And when there is not really a true dialogue between the patients and the providers, we're actually the unmet need is underestimated. And even when a patient is being treated and is thought as being well managed, actually, this is not the case, because there is not this true dialogue.

Speaker #5: And I often use example like you would ask somebody, are you doing OK? Can you brush your hair in the morning? And the person say, yes, I can.

Speaker #2: Yeah, thanks for the question, Douglas. And I think what you can see from that slide that I find exciting is that it's clear we're just at the beginning of the growth curve for CIDP.

Speaker #5: And then when you ask all them to do that, they say, I'm lying on my bed to brush my hair, which shows that there is really a muscle weakness there, and that we must show to this patient.

Speaker #2: And there's a lot of opportunity for continued growth. But maybe, Sandrine, you can share what you're seeing in the market around those patients.

Speaker #5: And this provider that you can make a difference by putting them on treatment like VivGuard. And this is the same happening for patients who are not on treatment.

Speaker #4: Yes, thank you, Karen. So, in the CIDP, there are lots of opportunities for further growth within the addressable market in the startup we have launched, but also well beyond that.

Speaker #5: And that have been diagnosed because they kind of underestimate the level of functional how they function every day. They have accommodated their life they have moved from a house to an apartment.

Speaker #4: And so what I noticed when I discussed CIDP with patients, but most importantly with providers, is that it's a disease which is not well understood.

Speaker #4: And when there is not really a true dialogue between the patients and the providers, we're actually the unmet need is underestimated. And even when a patient is being treated and is thought as being well managed, actually this is not the case because there is not this true dialogue.

Speaker #5: They don't drive anymore. They have just lowered the bar of what their life should look like, what the quality of life should look like, and what we're trying to do is generate data to show that you can get your life back if you really take that seriously.

Speaker #4: And I often use example like you would ask somebody, are you doing okay? Can you brush your hair in the morning? And the person say, yes, I can.

Speaker #5: This takes time. This takes a lot of data generation, and it takes also patients to go and have the discussion with their providers. So that's what we are trying to do.

Speaker #4: And then when you ask all them to do that, they say, I'm lying on my bed. To brush my hair, which shows that there is really a muscle weakness there, and that we must show to this patient and this provider that you can make a difference by putting them on treatment like Vivgard.

Speaker #1: Our next question will come from Casey Ding with Redburn.

Speaker #4: Hi, thanks for taking my question. Can I just ask a quick follow-up question on the BD? Are you interested in the assets within the same therapy areas that could further strengthen your existing portfolio?

Speaker #4: And this is the same happening for patients who are not on treatment. And that have been diagnosed because they kind of underestimate the level of functional or they function every day.

Speaker #4: Or are you looking for complementary assets that could broaden your portfolio? Thank you so much.

Speaker #4: They have accommodated their life. They have moved from a house to an apartment. They don't drive anymore. They have just lowered the bar of what their life should look like, what the quality of life should look like. What we're trying to do is generate data to show that you can get your life back if you really take that seriously.

Speaker #2: Yeah, thanks for the question. So when we build our pipeline, whether it's with internal assets, or through business development, we're focused on immunology assets.

Speaker #2: But we are focused on diversifying our pipeline beyond FCRN. And so you can see that within our internal pipeline, of course, we have empath approvals.

Speaker #4: This takes time. This takes a lot of data generation, and it takes also patients to go and have the discussion with their providers. So that's what we are trying to do.

Speaker #2: We have our Genics 121. We also have molecules in earlier stage development that are very exciting. When we look at internal and external molecules, we set the bar as what we're looking for is novel biology and we need to have clarity and on how we can de-risk that novel biology, to move into patients.

Speaker #3: Our next question will come from Casey Ding with Redburn.

Speaker #5: Hi, thanks for taking my question. Can I just ask a quick follow-up question on the BD? Are you interested in the assets within the same therapy areas that could further strengthen your existing portfolio?

Speaker #2: And we keep the bar high on that, as well as these areas of high unmet patient need, where we could bring the first-in-class or the best-in-class assets forward for patients.

Speaker #5: Or are you looking for complementary assets that could broaden your portfolio? Thank you so much.

Speaker #2: Yeah, thanks for the question. So, when we build our pipeline—whether it's with internal assets or through business development—we're focused on immunology assets.

Speaker #2: And so that's the strategy that we have for both our internal pipeline as well as business development.

Speaker #1: Our next question will come from Jeanne Deng with UBS.

Speaker #2: But we are focused on diversifying our pipeline beyond FCRN. And so you can see that within our internal pipeline, of course, we have empath approvals.

Speaker #6: Hi, thank you for taking my question. One DM, please. So just wondering, there are some studies or evidence kind of suggesting DM is more sort of interferon-1-driven disease and the role of autoantibodies is not as clear as that.

Speaker #2: We have ArgenX 121. We also have molecules in earlier stage development that are very exciting. When we look at internal and external molecules, we set the bar as what we're looking for is novel biology.

Speaker #6: IMNM. So just wondering, for your DM study, but I think on the other hand, especially in DM, some autoantibodies have very strong predictive power to prognosis and symptoms, et cetera, et cetera.

Speaker #2: And we need to have clarity and on how we can de-risk that novel biology, to move into patients. And we keep the bar high on that, as well as these areas of high unmet patient need, where we could be bringing the first-in-class or the best-in-class assets forward for patients.

Speaker #6: So just wondering, do you see some several subtypes of DM that potentially have better response? And are you enriching those for the study? Thank you.

Speaker #2: And so that's the strategy that we have for both our internal pipeline as well as business development.

Speaker #2: Yeah, thanks for the question. Maybe I can just start by sharing at a high level what we shared at our D day, which is we see a clear biology rationale for both IMNM and DM.

Speaker #3: Our next question will come from Jeanne Deng with UBS.

Speaker #6: Hi, thank you for taking my question. One DM, please. So just wondering, there's some studies or evidence kind of suggesting DM is more sort of interferon-1-driven disease, and the role of autoantibodies is not as clear as that.

Speaker #2: They are both autoantibody-driven diseases. But maybe Luz, you can provide a little more detail.

Speaker #3: Yeah, thanks. Again, the theme of these diseases are not driven by just one mechanism. Which is why we thought that multiple modes of action are moving forward.

Speaker #6: I am an M. So just wondering, for your DM study, but I think on the other hand, especially in DM, some autoantibodies have very strong predictive power to prognosis and symptoms, et cetera, et cetera.

Speaker #3: The anti-molecule clearly is more in the interferon-1 pathway, as you indicate. Which we feel is clearly a demonstrated driver, mostly in skin pathophysiology, but some in the muscle.

Speaker #6: So just wondering, do you see some several subtypes of DM that potentially have better response? And are you enriching those for the study? Thank you.

Speaker #3: We feel that given the demonstrated level of autoantibodies present in these diseases and their targets, that addressing primarily the autoantibodies has a role to play.

Speaker #2: Yeah, thanks for the question. Maybe I can just start by sharing at a high level what we shared at our D day, which is we see a clear biology rationale for both IM and M and DM.

Speaker #3: And in that sense of phase two, subset data demonstrate that there was a signal in DM. Which could not be driven by interferon-1. So yeah, there's place for more than one approach here.

Speaker #2: They are both autoantibody-driven diseases. But maybe Luz, you can provide a little more detail.

Speaker #2: Yes. And that was what I was going to just close out with. I think that's important, Luke. I mean, there's been really very limited innovation in the myositis space for many, many years.

Speaker #7: Yeah, thanks. Again, the theme of these diseases are not driven by just one mechanism. Which is why we thought that multiple multifunctional moving forward.

Speaker #7: The anti-molecule clearly is more in the interferon-1 pathway, as you indicate. Which we feel is clearly a demonstrated driver, mostly in skin pathophysiology, but some in the muscle.

Speaker #2: And so I think if you take if you zoom out, there is room for more than one mechanism of action in DM. And in particular, what I think is going to be important is to look at the muscle involvement and the impact of these mechanisms of action on the muscle.

Speaker #7: We feel that, given the demonstrated level of our antibodies present in these diseases and their targets, addressing primarily the autoantibodies has a role to play.

Speaker #2: Because that is the defining feature of this disease. And that's something that we'll be looking for in our phase three readouts. Thanks for the question.

Speaker #7: And in that sense, the phase two subset data demonstrated that there was a signal in the end, which could not be driven by interferon-1.

Speaker #1: And our final question will come from Niall Alexander with Deutsche Bank.

Speaker #4: Hi, good afternoon. Niall Alexander from Deutsche Bank. Thanks for taking my questions. So just one and we've got pricing and channel mix. It'd be helpful seeing if you can provide the actual realized list price per average subcutaneous patient at present.

Speaker #7: So yeah, there's place for more than one approach here.

Speaker #2: Yes. And that was what I was going to just close out with. I think that's important, Luke. I mean, there's been really very limited innovation in the myositis space for many, many years.

Speaker #4: Any color you can give on gross to net pricing and discount. And in addition, it'd be great to get a sense of the channel split for VivGuard sales right now.

Speaker #2: And so I think if you zoom out, there is room for more than one mechanism of action in DM. And in particular, what I think is going to be important is to look at the muscle involvement and the impact of these mechanisms of action on the muscle.

Speaker #4: Thank you.

Speaker #3: Thank you. Yeah, of course. I mean, the list price is in the US is public information, and we can I mean, you can also reach out to us if you need help with that.

Speaker #2: Because that is the defining feature of this disease. And that's something that we'll be looking for in our phase three readout. Thanks for the question.

Speaker #3: I think what is important is that the gross to net and the net price per patient continue to be stable. It's the same in Q2 as it was in prior quarters.

Speaker #3: And our final question will come from Niall Alexander with Deutsche Bank.

Speaker #3: Over time, you'll see a slight increase in gross to net quarter over quarter. And that is because TFS, trifosferins for self-injection, do have a slightly higher gross to net than the other presentations.

Speaker #5: Hi, good afternoon. Niall Alexander from Deutsche Bank. Thanks for taking my questions. So, just one, and we've got pricing and channel mix. It'd be helpful seeing if you can provide the actual realized list price per average subcutaneous patient at present.

Speaker #3: But that, of course, is offset by higher adherence. So I think what we can say is that the net prices per patient continues to be stable.

Speaker #5: Any color you can give on gross to net pricing and discount? And in addition, it'd be great to get a sense of the channel split for Vyvgart sales right now.

Speaker #3: And the business is and there's nothing really new to say. So thank you for the question.

Speaker #5: Thank you.

Speaker #7: Thank you. Yeah, of course. I mean, the list price is in the US is public information, and we can I mean, you can also reach out to us if you need help with that.

Speaker #7: I think what is important is that the gross-to-net and the net price per patient have continued to be stable. It's the same in Q2 as it was in prior quarters.

Speaker #7: Over time, you'll see a slight increase in gross-to-net quarter over quarter. And that is because self-injection does have a slightly higher gross-to-net than the other presentations.

Speaker #7: But that, of course, is offset by higher adherence. So I think what we can say is that the net prices per patient continues to be stable.

Speaker #7: And the business is and there's nothing really new to say. So thank you for the question.