Q3 2025 argenx SE Earnings Call

Tim Van Hauwermeiren: Foreign.

Speaker #2: Good morning . My name is Rob and I will be your conference operator today . I would like to welcome everyone to the call .

Moderator: Good morning. My name is Rob 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. After the speaker's remarks, there will be a question and answer session. Thank you. I'd like to introduce Beth DelGiacco, Vice President, Corporate Communications and Investor Relations. You may begin your call.

Speaker #2: At this

Speaker #2: time , all lines have been placed on mute to prevent any background noise . After the speakers remarks , there will be a question and answer session .

Karen Massey: Thank you.

Beth DelGiacco: A press release was issued earlier today with our third quarter 2025 financial results and business update.

Karen Massey: This can be found on our website.

Beth DelGiacco: Along with the presentation for today's webcast. Before we begin on slide 2, I'd.

Karen Massey: like to remind you that forward looking.

Beth DelGiacco: 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. Actual results may differ materially from those indicated by these statements.

Speaker #3: Actual results may differ materially from those indicated by these statements. ArgenX is not under any obligation to update statements regarding the future or to conform those statements in relation to actual results unless required by law.

Karen Massey: argenx is not under any obligation to.

Beth DelGiacco: Update statements regarding the future.

Karen Massey: Conform those statements in relation to actual results unless required by law. I'm joined on the call today by.

Speaker #3: I'm joined on the call today by Tim Van Haren and Chief Executive Officer , Karl Gubitz Chief Financial Officer and Karen Massey Chief Operating Officer , Luke Troyan .

Beth DelGiacco: Van Hauwermeiren, Chief Executive Officer, Karl Gubitz, Chief Financial Officer, and Karen Massey, Chief Operating Officer.

Karen Massey: Luke Troyan, our Chief Medical Officer, will.

Speaker #3: Our Chief Medical officer will be available during Q&A . I'll now turn the call to Tim .

Beth DelGiacco: Be available during Q&A. I'll.

Karen Massey: Now turn the call to Tim.

Speaker #4: Thank you , Beth , and welcome everyone . I'll begin on slide number three at the start of the year , we set a bold growth agenda anchored in our long term roadmap for value creation .

Tim Van Hauwermeiren: Thank you, Beth, and welcome everyone. I'll begin on slide number three. At the start of the year, we set a bold growth agenda anchored in our long-term roadmap for value creation, Vision 2030. Today, VYVGART is delivering meaningful impact in two blockbuster indications with MG and CIDP. Our pre-filled syringe is now approved in most major markets, fueling new patient and prescriber adoption. We've also made significant pipeline progress and will enter 2026 with three phase 3 assets. At the same time, we are investing in our next wave of growth with four new molecules in phase 1 development by year-end and a vibrant immunology innovation program driving future opportunities. Slide 4. Today, I'm joining you from AANEM in San Francisco where we are engaging with the neurology community and sharing new data that reinforce our commitment to continuous innovation in rare neuromuscular diseases.

Speaker #4: Vision 2030 . Today , Vyvgart is delivering meaningful impact in two blockbuster indications with MG and Cidp . Our prefilled syringe is now approved in most major markets , fueling new patient and prescriber adoption .

Speaker #4: We've also made significant pipeline progress and will enter 2026 with three phase three assets . At the same time , we're investing in our next wave of growth with four new molecules in phase one development by year end and a vibrant immunology innovation program driving future opportunities .

Speaker #4: Slide four. Today, I'm joining you from A&M in San Francisco, where we're engaging with the neurology community and sharing new data that reinforces our commitment to continuous innovation in rare neuromuscular diseases.

Speaker #4: I would like to briefly highlight several key data sets presented . This week that underscore our leadership in GMG . Vyvgart has set a high bar in GMG , driving rapid , deep and sustained responses .

Tim Van Hauwermeiren: I would like to briefly highlight several key data sets presented this week that underscore our leadership in gMG. VYVGART has set a high bar in gMG, driving rapid, deep, and sustained responses. Our gold standard for patient impact is for patients to achieve minimum symptom expression, or MSE. New data from the ADAPT subcutaneous study show that up to 60% of patients reached MSE, with 83% maintaining it for at least eight weeks, highlighting the durability of VYVGART responses. We also know that steroid reduction is recognized as a critical outcome for both patients and prescribers. Building on earlier data showing meaningful steroid reductions with VYVGART at six months, we now see this sustained through 18 months with over 55% of VYVGART patients reducing steroids to below 5 milligrams per day.

Speaker #4: Our gold standard for patient impact is for patients to achieve minimum symptom expression or MSK. New data from the Adept Subcu study showed that up to 60% of patients reached MSK, with 83% maintaining it for at least highlighting the durability of Vyvgart responses.

Speaker #4: We also know that state of reduction is recognized as a critical outcome for both patients and prescribers . Building on earlier data showing meaningful reductions with Vyvgart at six months .

Speaker #4: We now see this sustained through 18 months with over 55% of Vyvgart patients reducing steroids to below five milligrams per day eight weeks , .

Speaker #4: We also presented data from the Adept Serum study , which met its primary endpoint , showing significant improvement in at week four compared to placebo .

Tim Van Hauwermeiren: We also presented data from the ADAPT SERUM study, which met its primary endpoint, showing significant improvement in MG-ADL at week four compared to placebo. Importantly, we observed increasingly pronounced and clinically meaningful improvements in both MG-ADL and QMG scores across subsequent treatment cycles in the overall population and across all patient subgroups. These positive results support our plan to file for a label expansion that includes all three seronegative subgroups: MuSK positive, LRP4 positive, and triple seronegative. This is a landmark moment in advancing our scientific understanding of MG, as the results indicate that pathogenic IgG autoantibodies drive disease regardless of antibody status. Additionally, we continue to showcase the strength of our ADHERE data in CIDP while introducing new HEOR insights that highlight a severe disease burden, long diagnostic journey, and the urgent need for innovation for these patients. Slide 5.

Speaker #4: Importantly , we observed increasingly pronounced and clinically meaningful improvements both mg-adl and Qmg scores across subsequent treatment cycles in the overall population . And across all patient subgroups .

Speaker #4: These positive results support our plan to file for label expansion that includes all three Seronegative subgroups . Musk positive Lrp4 positive and triple Seronegative .

Speaker #4: This is a landmark moment in advancing our scientific understanding of MG as the results indicate that pathogenic HG autoantibodies drive disease regardless of antibody status .

Speaker #4: Additionally , in we continue to showcase the strength of our adhere data in Cidp while Mg-adl introducing new , here insights that highlight the severe disease burden .

Speaker #4: Long diagnostic journey and the urgent need for innovation for these patients . Slide five . We now have three . First , in class molecules in phase three development Efgartigimod and Robert and ArgenX 109 , each representing a true pipeline in a product opportunity .

Tim Van Hauwermeiren: We now have three first-in-class molecules in phase 3 development: efgartigimod, empasiprubart, and ARGX-119, each representing a true pipeline-in-a-product opportunity. We continue to maximize the FcRn opportunity by advancing efgartigimod in severe IgG-mediated autoimmune diseases while building the future of this target with the next generation of molecules. As we grow our understanding of FcRn biology, we're building out our capabilities to address patient needs in therapeutic areas beyond neurology. We're also reinforcing our leadership in neurology with empasiprubart now in phase 3 development for MMN and CIDP with its selective approach blocking C2 at the intersection of the classical and lectin pathways, and empasiprubart is uniquely positioned to address a broad range of autoimmune diseases. Lastly, ARGX-119, our MuSK agonist, has now advanced to phase 3 in CMS.

Speaker #4: We continue to maximize the fcrn opportunity by advancing efgartigimod in severe IgG mediated autoimmune diseases . While building the future of this target with the next generation of molecules .

Speaker #4: As we grow , our understanding of fcrn biology , we're building out our capabilities to address patient needs in therapeutic areas beyond neurology .

Speaker #4: We're also reinforcing our leadership in neurology with Robert now in phase three development for MMN and Cidp , with its selective approach blocking C2 at the intersection of the classical and lectin pathways .

Speaker #4: And passive Robert is uniquely positioned to address a broad range of autoimmune diseases. Lastly, ArgenX 119, our Musk agonist, has now advanced to Phase 3 in CMS.

Speaker #4: It is designed to restore neuromuscular junction function , opening the door to indications like ALS and SMA , and underscoring our commitment to pioneering new biology in high unmet need .

Tim Van Hauwermeiren: It is designed to restore neuromuscular junction function, opening the door to indications like ALS and SMA and underscoring our commitment to pioneering new biology in high unmet need indications. Pipeline and the product molecules are designed with built-in optionality, giving us the flexibility to prioritize indications and allocate resources to programs where we can deliver the greatest patient impact. In line with this strategy, we've made three disciplined development decisions. First, we stopped development of empasiprubart in dermatomyositis due to operational challenges with study enrollment. That said, DM remains an area of commitment for us. This is a population that has seen little innovation, an unmet need further validated by the strong pace of DM enrollment in our ALKIVIA study with efgartigimod. Second, we decided not to advance efgartigimod into a registration study in lupus nephritis based on the results of the phase 2 data.

Speaker #4: Indications pipeline and product molecules are designed with built-in optionality, giving us the flexibility to prioritize indications and allocate resources to programs where we can deliver the greatest patient impact in line with the strategy. We’ve made three disciplined development decisions.

Speaker #4: First , we stopped development of Robert in dermatomyositis due to operational challenges with study enrollment . That said , DM remains an area of commitment for us .

Speaker #4: This is a population that has seen little innovation , an unmet need . Further validated by the strong pace of enrollment in our study with Efgartigimod .

Speaker #4: Second, we decided not to advance Vyvgart into a registrational study in lupus nephritis based on the results of the Phase 2 data.

Speaker #4: Efgartigimod was well tolerated and safety in line with established profile . Third , we are rolling out our next efgartigimod indication , which is grave's disease .

Tim Van Hauwermeiren: Efgartigimod was well tolerated and safety in line with established profile. Third, we are rolling out our next efgartigimod indication, which is Graves disease. This expands our reach into thyroid-driven autoimmunity and allows us to move directly into phase 3 in a disease where there is a high need for a new treatment option. We expect to initiate the registration studies early next year. These are well-informed decisions to ensure we focus our time and capital on indications where we can deliver the most value. We're also thinking in terms of long-term growth horizons for our core assets, which means that even though we are moving forward in certain indications today, we are a data-based company and will be ready to revisit our decisions as new evidence emerges. Slide 6, the progress we've made positions us for five registration readouts next year.

Speaker #4: This expands our reach into thyroid driven autoimmunity and allows us to move directly into phase three . In a disease where there is a high need for a new treatment option .

Speaker #4: We expect to initiate the registration studies early next year . These are well informed decisions to ensure we focus our time and capital on indications where we can deliver the most value .

Speaker #4: We also thinking in terms of long term growth horizons for our core assets , which means that even though we aren't moving forward in certain indications today , we are a data based company and will be ready to revisit our decisions as new evidence emerges .

Speaker #4: Slide six . The progress we've made positions us for . Five registrational readouts next year . Each reflects our disciplined approach to indication selection , a clear biology rationale .

Tim Van Hauwermeiren: Each reflects our disciplined approach to indication selection, a clear biology rationale, trial designs anchored in robust clinical endpoints, and strong commercial potential to address an unmet patient need. Ocular MG will be the first of these in 2026. We have established a strong biologic rationale supported by encouraging ocular domain data from the ADEPT study and real-world case reports. The Ocular study will assess the MGII ocular score, and if successful, could expand our label to include MGFA class I patients. Myositis and Thyroid eye disease (TED) studies extend our reach into rheumatology and endocrinology. With myositis, the Phase 2 portion of the registrational Alkavia study demonstrated meaningful improvement in muscle strength and physical function using TIS, which we will evaluate over 52 weeks in the Phase 3. In TED, where stimulating TSHR autoantibodies drive disease, we leveraged peer data to advance directly into Phase 3.

Speaker #4: Trial designs anchored in robust clinical endpoints and strong commercial potential to address an unmet patient need . Achr-mg will be the first of these in 2026 .

Speaker #4: We have established a strong biologic rationale , supported by encouraging Auckland Domain data from the Adapt study and real world case reports . The ocular study will assess the ocular score and if successful , could expand our label to include Mgfa class one patients .

Speaker #4: Myositis and Ted studies extend our reach into rheumatology and endocrinology with myositis , the phase two portion of the Registrational study demonstrated meaningful improvement in muscle strength and physical function .

Speaker #4: Using this , which we will evaluate over 52 weeks in the phase three . In Ted , where stimulated Tshr autoantibodies drive disease .

Speaker #4: We leveraged peer data to advance directly into phase three across both indications . We see a clear opportunity for Vyvgart to deliver differentiated efficacy and safety .

Tim Van Hauwermeiren: Across both indications, we see a clear opportunity for VYVGART to deliver differentiated efficacy and safety. MMN will be our first registration readout for empasiprubart. With IVIG as the only available therapy today, there is a significant opportunity to disrupt this market with a novel treatment. In consultation with regulatory agencies, we've changed the primary endpoint to grip strength, which should capture meaningful functional improvement for patients. Lastly, in ITP, which is already approved in Japan, we designed an efficient confirmatory trial to enable regulatory submission in the U.S. and Europe. Translational data continue to show that efgartigimod reduces platelet destruction and supports platelet production and maturation. Slide 7, as part of Vision 2030 and in support of our ambitious goals, we're making investments across our business to ensure long-term sustainable growth.

Speaker #4: Will be our first registrational readout for Robert with IVIg as the only available therapy today . There is a significant opportunity to disrupt this market with a novel treatment in consultation with regulatory agencies .

Speaker #4: We've changed the primary endpoint to grip strength , which should capture meaningful , functional improvement for patients . Lastly , in ITP , which is already approved in Japan , we designed an efficient confirmatory trial to enable regulatory submission in the US and EU .

Speaker #4: Translational data continue to show that Efgartigimod reduces platelet destruction and supports splitted production and maturation . Slide seven . As part of vision 2030 and in support of our ambitious goals , we are making investments across our business to ensure long term sustainable growth with actively scaling our operations in the US , including an expanded collaboration with Fujifilm through a new manufacturing facility in North Carolina .

Tim Van Hauwermeiren: We're actively scaling our operations in the U.S., including an expanded collaboration with Fujifilm through a new manufacturing facility in North Carolina. This move strengthens our global supply chain and supports our manufactured in a region for the region strategy, ensuring we can meet growing demand for VYVGART and future pipeline therapies. At the same time, we are investing our pipeline innovation engineering, doubling down on our pursuit of novel biology. Because this playbook is working, we remain on track to have four new pipeline assets in Phase 1 by year end, with more expected to advance from our 20 active IIP programs, each representing a potential breakthrough in immunology. With that, I will now turn the call over to Karl.

Speaker #4: This move strengthens our global supply chain and supports our manufactured in a region for the region strategy , ensuring we can meet growing demand for Vyvgart and future pipeline therapies .

Speaker #4: At the same time , we are investing our pipeline innovation engine , doubling down on our pursuit of novel biology because this playbook is working .

Speaker #4: We remain on track to have four new pipeline assets in phase one by year end , with more expected to advance from our 20 active IIP programs each representing a potential breakthrough in immunology .

Speaker #4: With that , I will now turn the call over to Carl . Thank you . Tim . Slide eight .

Karl Gubitz: Thank you, Tim. Slide 8, the third quarter 2025 financial results are detailed in this morning's press release. We are proud to report an outstanding quarter reflecting exceptional execution and sustained momentum in our business. In the third quarter, we reported total product net sales of $1.13 billion, marking a historic milestone for argenx as we surpassed for the first time $1 billion in VYVGART sales. In a single quarter, we achieved growth of 19% or $178 million in product net sales when comparing to the previous quarter of this year and 96% or $554 million in growth when comparing Q3 on a year-over-year basis. If you look at the breakdown by region, product net sales were $964 million in the U.S., $60 million in Japan, $94 million across our rest of the world markets, including our partner markets, and $9 million for product supply to XYLAB in China.

Speaker #5: The third quarter 2020 financial results are detailed in this morning's press release . We are proud to report an outstanding quarter reflecting exceptional execution and sustained momentum in our business .

Speaker #5: In the third quarter . We reported total product net sales of $1.13 billion , marking a historic milestone for ArgenX . As we surpassed for the first time $1 billion in Vyvgart sales in a single quarter .

Speaker #5: We achieved growth of 19%, or $178 million in product net sales. When comparing to the previous quarter of this year, we saw a 96% increase, amounting to $554 million in growth.

Speaker #5: When comparing three Q on a year over year basis . If you look at the breakdown by region , product , net sales were $964 million in the US , $60 million in Japan , $94 million across our rest of world markets , including our partner markets , and $9 million for product supply to XAI Lab in China .

Speaker #5: The product net sales in the US , specifically grew by 20% quarter over quarter , reflecting the impact of our investments in the face launch earlier this year .

Karl Gubitz: The product net sales in the U.S. specifically grew by 20% quarter over quarter, reflecting the impact of our investments in the PFS launch earlier this year. PFS is now firmly established as a growth driver in our markets, supporting our continued momentum in gMG and CIDP. The growth to net adjustments in Q3 and the net pricing in the U.S. are in line with the prior quarter. Next slide. Total operating expenses in the third quarter are $805 million, representing a 5% increase compared to the second quarter. Our R&D expenses increased by 9% or $28 million and our SG&A expenses by 4% or $11 million. Building on our solid revenue performance, we continue to invest in our growth opportunities. Therefore, expect our expenses to continue to grow in the single digits for the rest of the year.

Speaker #5: BFS is now firmly established as a growth driver in our markets , supporting our continued momentum in GMG and Cidp across the net .

Speaker #5: Adjustments in Q3 and the net pricing in the US are in line with the prior quarter . Next slide . Total operating expenses in the third quarter are $805 million , representing a 5% increase compared to the second quarter .

Speaker #5: Our R&D expenses increased by 9% , or $28 million , and our expenses by 4% , or $11 million . Building on our solid revenue performance .

Speaker #5: We continue to invest in our growth opportunities . Therefore , expect our expenses to continue to grow in the single digits for the rest of the year .

Speaker #5: This will result in our combined R&D and G&A expenses to land just north of $2.5 billion at between 2.6 billion and $2.7 billion .

Karl Gubitz: This will result in our combined R&D and SG&A expenses to land just north of $2.5 billion at between $2.6 billion and $2.7 billion. Cost of sales for the quarter is $109 million. Our year-to-date gross margin remains consistent at 11%. Our operating profit for the quarter is $346 million and the quarterly financial income is $43 million, which results in profit before tax of $386 million. The year-to-date effective tax rate is 13%. After tax, the profit for the quarter is $344 million and $759 million on a year-to-date basis. Our cash balance at the end of the quarter, represented by cash, cash equivalents, and current financial assets, is $4.3 billion, which represents a nearly $1 billion increase in cash since the beginning of the year. I will now turn the call over to Karen, who will provide details on the commercial front.

Speaker #5: Cost of sales for the quarter is $109 million , our year to date gross margin remains consistent at 11% . Our operating profit for the quarter is $346 million , and the quarterly financial income is $43 million , which results in profit before tax of $386 million for year to date , effective tax rate is 13% after tax .

Speaker #5: The profit for the quarter is $344 million and $759 million on a year . To date basis . Our cash balance at the end of the quarter , represented by cash , cash equivalents and current financial assets , is $4.3 billion , which represents a nearly $1 billion increase in cash since the beginning of the year .

Speaker #5: I will now turn the call over to Karen , who will provide details on the commercial front .

Speaker #6: Thanks , Carl . Let's go to slide ten . As we close the year , it's inspiring to reflect on how far we've come since Vyvgart first approval four years ago , reaching more than 15,000 patients globally across three indications and three product presentations .

Karen Massey: Thanks, Kyle. Let's go to slide 10. As we close the year, it's inspiring to reflect on how far we've come since VYVGART's first approval four years ago, reaching more than 15,000 patients globally across three indications and three product presentations. We're transforming patient outcomes, redefining what patients can demand from their treatments, and pioneering an entirely new class of medicine. With our first-in-class FcRn blocker, this quarter is a continuation of delivering that transformative impact. Today, I'm excited to share how our commercial strategy continues to turn innovation into access and impact for patients, and how we plan to sustain our growth momentum into 2026. Slide 11. Once again, the team has delivered an outstanding quarter, reflecting growth in all indications across all markets. The pre-filled syringe is performing exactly as expected, driving increased VYVGART demand among patients and prescribers who embrace a more flexible treatment option.

Speaker #6: We're transforming patient outcomes , redefining what patients can demand from their treatments , and pioneering an entirely new class of medicine with our first in class fcrn blocker .

Speaker #6: This quarter is a continuation of delivering that transformative impact . Today , I'm excited to share how our commercial strategy continues to turn innovation into access and impact for patients , and how we plan to sustain our growth momentum into 2026 .

Speaker #6: Slide 11 . Once again , the team has delivered an outstanding quarter reflecting growth in all indications across all markets . The prefilled syringe is performing exactly as expected .

Speaker #6: Driving increased Vyvgart demand among patients and prescribers who embrace a more flexible treatment option . More than half of patients starting on FS are new to Vyvgart , with the rest switching from vial or IV .

Karen Massey: More than half of patients starting on PFS are new to VYVGART, with the rest switching from Hytrulo vial or IV. Since the launch of PFS for self-injection, over 260 prescribers have written their first ever VYVGART prescription, expanding our prescriber base and setting the stage for continued patient growth. We've also strengthened payer access, securing additional policies to enable more patients to initiate treatment. Growth outside the U.S. is strong, with the PFS approved in most major markets. I'm excited to now share how we're executing on our strategy to strengthen our MG leadership and build the momentum to establish an equally strong foothold in the CIDP treatment landscape. Slide 12.

Speaker #6: Since the launch of FS for Self-injection , over 260 prescribers have written their first ever Vyvgart prescription , expanding our prescriber base and setting the stage for continued patient growth .

Speaker #6: We've also strengthened payor access , securing additional policies to enable more patients to initiate treatment growth outside the US is strong , with the FS approved in most major markets .

Speaker #6: I'm excited to now share how we're executing on our strategy to strengthen our leadership and build the momentum to establish an equally strong foothold in the cidp treatment landscape .

Speaker #6: Slide 12 . In milligrams , we have consistently delivered new patient growth for 15 quarters while executing on our strategy to unlock the full 60,000 patient opportunity , advancing two label expansion studies in Sierra negative and ocular milligrams , and driving earlier adoption of Vyvgart to expand the biologics market by an additional 25,000 patients .

Karen Massey: In MG, we have consistently delivered new patient growth for 15 quarters while executing on our strategy to unlock the full 60,000 patient opportunity, advancing two label expansion studies in seronegative and ocular MG, and driving earlier adoption of VYVGART to expand the biologics market by an additional 25,000 patients. Today, we're the number one prescribed and fastest growing biologic in MG. Where we see the biggest opportunity to maintain this leadership is to reach patients earlier in the treatment paradigm. We're already seeing this shift take place, with the percentage of patients coming from oral therapies increasing year over year. Now at 70%, the PFS is fueling this momentum, opening doors to new segments of younger, more active patients, and our strong safety and efficacy remain the foundation of physician confidence, driving earlier prescribing decisions.

Speaker #6: Today , we're the number one prescribed and fastest growing biologic in milligrams , where we see the biggest opportunity to maintain this leadership is to reach patients earlier in the treatment paradigm .

Speaker #6: We're already seeing this shift take place with the percentage of patients coming from oral therapies increasing year over year . Now , at 70% .

Speaker #6: The FS is fueling this momentum . Opening doors to new segments of younger , more active patients . And our strong safety and efficacy remain the foundation of physician confidence , driving earlier prescribing decisions .

Speaker #6: As Tim highlighted , we're excited to be moving closer to potentially expanding our label to include Seronegative GMG patients following positive top line results .

Karen Massey: As Tim highlighted, we're excited to be moving closer to potentially expanding our label to include seronegative MG patients following positive top line results. The unmet need here is significant, especially for triple CRO negative patients who experience diagnostic challenges and currently have no approved therapies. Ocular MG is next. Patients often struggle with symptoms that make everyday activities like working or driving nearly impossible. Many are heavily reliant on steroids in the absence of treatment options. These programs reflect our commitment to address underserved populations and redefine care in MG, setting a higher bar for what patients can expect from treatment. Slide 13 In CIDP, we continue to deliver innovation that translates into patient impact. We're seeing consistent growth in both patient starts and prescriber engagement, driven by physician trust in the safety profile of VYVGART Hytrulo and its ability to deliver meaningful functional improvement.

Speaker #6: The unmet need here is significant , especially for Seronegative patients who experience diagnostic challenges and currently have no approved therapies . Ocular MG is next .

Speaker #6: Patients often struggle with symptoms that make everyday activities like working or driving nearly impossible . Many are heavily reliant on steroids in the absence of treatment options .

Speaker #6: These programs reflect our commitment to address underserved populations and redefine care in MG . Setting a higher bar for what patients can expect from treatment .

Speaker #6: Slide 13 . In Cidp , we continue to deliver innovation that translates into patient impact . We're seeing consistent growth in both patient starts and prescriber engagement driven by physician trust in the safety profile of Vyvgart Hytrulo and its ability to deliver meaningful functional improvement .

Speaker #6: We're on track to grow towards our 12,000 addressable market of patients . Not well controlled on current therapy . We continue to hear stories from patients about their positive experience to date , the prefilled syringe is driving additional demand as patients opt for the convenience of self-injection and our activation efforts are empowering patients to ask their neurologists about vyvgart hytrulo .

Karen Massey: We're on track to grow towards our 12,000 addressable market of patients not well controlled on current therapy. We continue to hear stories from patients about their positive experience. To date, the pre-filled syringe is driving additional demand as patients opt for the convenience of self-injection. Our activation efforts are empowering patients to ask their neurologists about VYVGART Hytrulo. Here's the story of one of those patients. Sasha is a mother of four in her 30s. She was hospitalized for over three months earlier this year. Given her symptom progression, she shared the frustration that came with CIDP, completely dependent on her spouse for even the simplest daily activities. After starting VYVGART Hytrulo and later switching to the pre-filled syringe, she said, I can live my life. She's walking her children to the school bus, something she deeply missed.

Speaker #6: Here's the story of one of those patients . Sasha is a mother of four . In her 30s . She was hospitalized for over three months earlier this year .

Speaker #6: Given her symptom progression . She shared the frustration that came with Cidp completely dependent on her spouse for even the simplest daily activities .

Speaker #6: After starting Vyvgart , Hytrulo and later switching to the prefilled syringe , she said , I can live my life . She's walking her children to the school bus , something she deeply missed .

Speaker #6: And thanks to the flexibility of the PFS , she's thrilled to plan a ten day cruise without worrying about having to be home for an injection .

Karen Massey: Thanks to the flexibility of the PFS, she's thrilled to plan a 10-day cruise without worrying about having to be home for an injection. While this is just one patient experience, these stories give us confidence to expand our reach and serve more patients over time. We're now gearing up for five Phase 3 readouts next year, actively engaging with patients and physicians to ensure that if the data are positive and approved, we'll be ready to expand into these markets and deliver broader patient impact. As an example, we're strengthening our rheumatology presence through deeper engagement and increased visibility at major medical conferences with our clinical data. Our focus remains on finishing this year strongly while laying the foundation for multiple future launches. With that, I will now turn the call back to Tim.

Speaker #6: While this is just one patient experience , these stories give us confidence to expand our reach and serve more patients over time . We're now gearing up for five phase three readouts next year .

Speaker #6: Actively engaging with patients and physicians to ensure that if the data are positive and approved , we'll be ready to expand into these markets and deliver broader patient impact .

Speaker #6: As an example , we're strengthening our rheumatology presence through deeper engagement and increased visibility at major medical conferences with our clinical data . Our focus remains on finishing this year strongly while laying the foundation for multiple future launches .

Speaker #6: With that , I will now turn the call back to Tim .

Speaker #4: At the heart of our success is our commitment to transforming patient outcomes with multiple pathways to realize vision 2030 . We're not just positioned for sustained growth .

Tim Van Hauwermeiren: At the heart of our success is our commitment to transforming patient outcomes with multiple pathways to realize Vision 2030. We're not just positioned for sustained growth, we are building a legacy of long-term value for patients and shareholders. We have the strategy, the science, and the momentum behind us. Most importantly, we have the passion and purpose to redefine what's possible in immunology. With that, operator, we'll open the call up to questions.

Speaker #4: We are building a legacy of long term value for patients and shareholders . We have the strategy , the signs , and the momentum behind us .

Speaker #4: But most importantly , we have the passion and purpose to redefine what's possible in immunology . With that operator , we'll open the call up to questions .

Speaker #2: Thank you . We will now begin the question and answer session . If you would like to ask a question , please press star one on your telephone keypad .

Moderator: Thank you. We will now begin the question and answer session. If you would like to ask a question, please press Star one on your telephone keypad. If you would like to withdraw your question, simply press Star one. Again, we ask that you please limit yourself to one question only. Your first question comes from the line of Rajan Sharma from Goldman Sachs. Your line is open. Hi, thanks for taking the question. Just one clarification actually just on the formulation. Except obviously seems that the pre-filled syringe is driving the growth, but could you just confirm that all of the other form or the other two formulations are still growing underlying in both CIDP and MG. Just on the pipeline, I know it's a little bit further out for you at the minute, but be interested to get your perspectives on Sjogren's disease.

Speaker #2: If you would like to withdraw your question , simply press star one again . We ask that you please limit yourself to one question only .

Speaker #2: Your first question comes from the line of Rajan Sharma from Goldman Sachs . Your line is open .

Speaker #7: Hi . Thanks for taking the question . Just one clarification . Actually , just on the on the formulation clip . It's obviously seems that the PFS is driving the growth , but could you just confirm that all of the other or the other two formulations are still growing underlying in both Cidp and NMD .

Speaker #7: And then just on the pipeline , I know it's a little bit further out for you at the minute , but be interested to get your perspectives on Sjogren's disease .

Speaker #7: We saw some phase three data from Novartis in yesterday . And I'll be keen to get your thoughts on that and how you think .

Moderator: We saw some Phase 3 data from Novartis Ianalumab yesterday and I'd be keen to get your thoughts on that and how you think VYVGART could potentially differentiate and what represents could meaningful signal. Thank you.

Speaker #7: Vyvgart could potentially differentiate and what represents clinically meaningful signal . Thank you .

Speaker #6: Yes , thanks for the question . Maybe I can take the first one on the PFS . And Tim , if you want to comment on on Sjogren's .

Beth DelGiacco: Yes, thanks for the question. Maybe I can take the first one on the PFS. Tim, if you want to comment on Sjogren's. You're right, pre-filled syringe is the major driver of growth this quarter and that actually continues the trends that we've seen over time since VYVGART Hytrulo launched or since we launched the subcutaneous version. Having said that, the IV does continue to be an important contributor to the business and to the results that we saw this quarter. There is definitely a segment of patients and physicians that prefer the IV option. The fact that VYVGART has all three presentations and they're all contributing to our performance is important for both, obviously for MG, whereas for CIDP the focus is on Hytrulo as the approved presentation. Tim, do you want to comment on Sjogren's.

Speaker #6: So so you're right . Prefilled syringe is the major driver of growth this quarter . And that actually continues the trend that we've seen over time since Hytrulo launched or since we launched the subcutaneous version .

Speaker #6: Having said that , the IV does continue to be an important contributor to the business and to the results that we saw . This quarter .

Speaker #6: There is definitely a segment of patients and physicians that prefer the IV option . So the fact that Vyvgart has all three presentations and they're all contributing to our performance is important for both for , for obviously for milligram , whereas for Cidp , the focus is on Hytrulo as the approved in presentation .

Speaker #6: Kim , do you want to comment on Sjogren's ?

Speaker #4: Yeah . Thank you , Karen , and thank you for the question . So I think it's important and great news for patients , Sjogren's patients to see the Novartis data , which clearly showed a statistically significant win in Sjogren's .

Tim Van Hauwermeiren: Thank you, Karen, and thank you for the question. I think it's important and great news for patients, Sjogren's patients, to see the Novartis data, which clearly show the statistically significant win in Sigrans. When we look at the efficacy, we believe a two-point improvement is considered clinically meaningful. There's definitely room for improvement. We have strong conviction, of course, in Garthimat based on our own phase two data and peer data in phase two. This is a precision tool, which we believe is going straight after decirculating immune complexes instead of a more broad general B cell suppression. The data need to speak, and the trial is well underway. Thank you for the question.

Speaker #4: When we look at the efficacy , we believe a two point improvement is considered clinically meaningful . So there is definitely room for improvement .

Speaker #4: We have strong conviction, of course, in Efgartigimod based on our own Phase 2 data and peer data in Phase 2.

Speaker #4: This is a precision tool which we believe is going straight after the circulating immune complexes . Instead of a more broad general B-cell suppression .

Speaker #4: So the data need to speak, and the trial is well underway. Thank you for the question.

Speaker #2: Your next question comes from the line of Tazeen Ahmad from Bank of America . Your line is open .

Moderator: Your next question comes from a line of Tazeen Ahmad from Bank of America. Your line is open.

Speaker #8: Hi , guys . Good morning . Thanks for taking my question . I wanted to get some color about how you're thinking about the Cidp launch , specifically , our survey work indicates a high level of excitement from physicians to want to move forward into frontline therapy ahead of IVIg .

Operator: Hi guys. Good morning. Thanks for taking my question. Wanted to get some color about how you were thinking about the CIDP launch. Specifically, our survey work indicates a high level of excitement from physicians to want to move VYVGART into frontline therapy ahead of IVIG. I wanted to hear what your feedback from the sales force is and what efforts would be needed in addition to what you are already detailing in order to make VYVGART the first line option for patients in CIDP. Thanks.

Speaker #8: I wanted to hear what your feedback from the sales force is and what efforts would be needed . In addition to what you are already detailing in order to make safeguard the first line option for patients in Cidp .

Speaker #8: Thanks .

Beth DelGiacco: Right, thanks for the question, Taheen. We're hearing very positive feedback from prescribers about the CIDP launch as well. The feedback that we're hearing is that the real world experience for CIDP patients reflects what we see in the clinical trials, and importantly around efficacy and safety. Obviously, we have the convenience. You'll recall that in our clinical trial and in our label, we have the approved indication for all patients. What we're seeing at the moment is that the early experience is from IVIG switch patients. 85% of our patients are coming from IVIG switch, but we are seeing some of the patients that are starting naive, where they haven't started with IVIG, they're not switching. Just like in the clinical trials, we're seeing good real world experience with that.

Speaker #6: Yeah , thanks for the question . And we're hearing very positive feedback from prescribers about Cidp launch as well , and what the feedback that we're hearing is that the real world experience for Cidp patients reflects what we see in the clinical trials .

Speaker #6: And importantly , around efficacy and safety . And then obviously , we have the convenience . You'll recall that in our clinical trial and in our label , we have the approved indication for for all patients .

Speaker #6: And so what we're seeing at the moment is that the early experience is from IVIg switch patients . So 85% of our patients are coming from IVIg .

Speaker #6: Switch . But we are seeing some some of the patients that are starting naive where they haven't started with IVIg , they're not switching and we're having just like in the clinical trials , we're seeing good real world experience with that .

Speaker #6: So we see that we're at the beginning of the growth curve for Cidp . We see continued momentum . We see continued expansion of the prescriber base .

Beth DelGiacco: We see that we're at the beginning of the growth curve for CIDP, we see continued momentum, we see continued expansion of the prescriber base, and I think that over time we'll start to see more penetration in the market across all patient segments. Thanks for the question.

Speaker #6: And I think that over time , we'll start to see more penetration in the market across all patient segments . Thanks for the question .

Speaker #2: Your next question comes from the line of Derek Akilah from Wells Fargo . Your line is open .

Moderator: Your next question comes from the line of Derek Akila from Wells Fargo. Your line is open.

Speaker #9: Hey good morning and congrats on the progress . Just as the narrative shifts to Vyvgart pivotal readouts in 26 . I mean , can you give us a sense of the revenue potential for those indications and how they may compare to milligram and Cidp ?

Karl Gubitz: Hey, good morning, and congrats on the progress.

Tim Van Hauwermeiren: Just as the narrative shifts to VYVGART's.

Karl Gubitz: Pivotal readouts in 2026, I mean, can.

Tim Van Hauwermeiren: You give us a sense of the revenue potential for those indications and how.

Karl Gubitz: They may compare to MG and CIDP?

Speaker #9: And if I can sneak in a second , I guess what diligence got you about pursuing graves with Vyvgart ? I know there's been some debate about the unmet need there .

Tim Van Hauwermeiren: If I can sneak in a.

Karl Gubitz: Second, I guess what diligence got you.

[Analyst]: Excited about pursuing grades with VYVGART?

Tim Van Hauwermeiren: I know there's been some debate about the unmet need there. Thank you, Derek, and thank you for the question. What we have been saying publicly is that revenue potential wise, each of these phase three indications roughly represent an MG-like opportunity. We will be giving more detailed information when we come closer to the market. You know that Graves has always been on our indication list. I think there's a clear biology rationale, it's established how you do the clinical trials, and we have been digging deeper into the unmet medical needs. Whilst it is true that it is a subset of patients doing well on the cheap available medication, there's a substantial subset of patients which are not doing well.

Speaker #9: Thanks excited .

Speaker #4: Yeah . Thank you Derek , and thank you for the question . What we have been seeing publicly is that , you know , revenue potential wise , each of these phase three indications , roughly represent an MG like opportunity .

Speaker #4: And we will be giving more detailed information when we come closer to the market. You know that Grace has always been on our indication list.

Speaker #4: I think there's a clear biologic rationale . It's established how you do the clinical trials . And we have been digging deeper into the unmet medical needs .

Speaker #4: So while it is true that it is a subset of patients doing well on the cheap available medication , there's a substantial subset of patients which are not doing well .

Speaker #4: And again , from that point of view , it may resemble MG . But , you know , a subset of of of patients is in bad need of an alternative medication because there's not much left .

Tim Van Hauwermeiren: From that point of view, it may resemble MG, but a subset of patients is in bad need of an alternative medication because there's not much left once you fill the cheap available medication today. Thanks for the question.

Speaker #4: Once you fail the cheap available medication today . Thanks for the question .

Speaker #2: Your next question comes from the line of Alex Thompson from Stifel . Your line is open .

Moderator: Your next question comes from the line of Alex Thompson from Stifel. Your line is open.

Speaker #10: Hey , great . Congrats on the quarter . Thanks for taking our question . I guess on the impasse continuation in DM , I wonder if you could speak about the trial issues , the enrollment issues you had there ?

Tim Van Hauwermeiren: Hey, great. Congrats on the quarter.

[Analyst]: Thanks for taking our question. I guess on the empasiprubart discontinuation in dermatomyositis, I wonder if you could speak about sort of the trial issues, the enrollment issues you had there.

Speaker #10: Was that due to the IV presentation and how that compared to the myositis trial with Efgartigimod ? And maybe you could also comment on the Cidp and enrollment as well .

Tim Van Hauwermeiren: Was that due to the IV presentation and how that compared to the myositis trial with efgartigimod?

[Analyst]: Maybe you could also comment on the CIDP and empasiprubart enrollment as well.

Speaker #10: And if that's being affected , thanks , Alex .

Tim Van Hauwermeiren: Thank you for the question. We have the benefit of having Luc with us, our colleague and Chief Medical Officer. Luc, why don't you take the question on the discontinuation of DM and the excitement which we have about Alkivia.

Speaker #4: Thank you for the question . We have the benefit of having looked at us , our colleague and Chief Medical officer . So look , why don't you take the question on on the discontinuation of DM and the excitement which we have about I'll give you .

Speaker #11: Yeah , thanks . Thanks , Tim . And thanks for the question . Yeah . So most of the this was a POC trial phase two trial that we were running .

[Analyst]: Yeah, thanks. Thanks, Tim. Thanks for the question. Most of this was a POC trial, phase two trial that we were running in a highly competitive enrollment environment. It didn't help that C5 read out negatively. We set a bar high for what we want to see. Our inclusion criteria are pretty robust to make sure that we can have a readout that would be predictable for phase three. The enrollment just stumbled on that. We have to make decisions within our portfolio with all the work we have, what we keep trying or what we say, okay. DM is an important indication, hence Alkivia, during which DM enrolled pretty well. Right now for the C2 we felt we had to reprioritize.

Speaker #11: And of course , in a highly competitive enrollment environment . And of course , it didn't help that a C5 readout negatively . And we set a buyer high for what we want to see .

Speaker #11: So our inclusion criteria are pretty robust to to make sure that we can have a readout that would be predictable for phase three .

Speaker #11: And we the enrollment just stumbled on that . And then we have of course have to make decisions within our portfolio with all the work we have , what we keep trying or what we say , okay , DM is an important indication .

Speaker #11: Hence during which DM enrolled pretty well . But right now for the C2 , we felt we had to reprioritize .

Speaker #6: And then on your question on Cidp enrollment , we just .

Beth DelGiacco: On your question on CIDP enrollment, we just started those in empasiprubart trials. It is still too early to say how enrollment is projecting there.

Speaker #3: Started those and postapproval trials . So still too early to say on how is trajectory or projecting . There .

Speaker #4: Thank you . Alex .

Tim Van Hauwermeiren: Thank you.

Moderator: Alex, your next question comes from the line of Yates from Guggenheim. Your line is open.

Speaker #2: Your next question comes from the line of yatin from Guggenheim . Your line is open .

Speaker #12: Guys , thank you for taking my question . Just a quick one for me with regard to the thyroid eye disease studies . Could you just talk about the expectation in this indication , how you're thinking about the potential positioning and then , you know , I think also just talk about , you know , is there a way to capture some of the patient population with grave study that you might be running now ?

Tim Van Hauwermeiren: Thank you for taking my question. Just a quick one for me. With regard to the thyroid eye disease studies, could you just talk about the expectation in this indication, how you are thinking about the potential positioning? Also, could you talk about whether there is a way to capture some of the TED patient population with the Graves study that you might be running now? Thank you. Thank you, Yatin. For TED, we decided not to disclose too much about positioning. I think we first need to wait for the data to speak. We think there is a convincing proof of concept out there from a peer molecule and the jury is out on how this mechanism of action is going to differentiate itself from the available mechanisms of action. It is fundamentally different biology, fundamentally different mode of action, but the data need to speak for themselves.

Speaker #12: Thank you .

Speaker #4: Yeah . Thank you for Ted . We we decided not to disclose too much about positioning . I think we first need to wait for the data to speak .

Speaker #4: We think there is a convincing proof of concept out there from a peer molecule . And the jury is out . You know how this mechanism of action is going to differentiate itself from the available mechanisms of action ?

Speaker #4: And it's fundamentally different . Biology , fundamentally different mode of action . But the data need to speak for themselves . I think there is ample of room for improvement , both on the efficacy side and the safety side , and , you know , we're running this trial as well with the prefilled syringe , tenon and graves are basically presentations of the same spectrum , the same disease biology , underlying disease biology .

Tim Van Hauwermeiren: I think there is ample room for improvement both on the efficacy side and the safety side. We are running this trial as well with the pre-filled syringe. TED and Graves are basically presentations of the same spectrum, the same underlying disease biology. With venturing into Graves, which we announced today, we are actually increasing our efforts in the thyroid space. Thank you for the question.

Speaker #4: And so, with venturing into graves, which we announced today, we are actually increasing our efforts in the thyroid space. Thank you for the question.

Speaker #2: Your next question comes from the line of Yaron Werber from TD Cowen . Your line is open .

Moderator: Your next question comes from the line of Yaron Werber from TD Cowen. Your line is open.

Speaker #13: Great . Thanks so much and congrats . Also really nice quarter . I have a couple of questions . Maybe the first one .

Tim Van Hauwermeiren: Great, thanks so much and congrats. All right, really nice quarter. I have a couple of questions. Maybe the first one, can we get any chance to get an update on ARGX-121, the IGA sweeping platform, and then ARGX-213, the long-acting, you know, VHS form of efgartigimod? Then secondly, maybe when we look at sales, sales essentially have now, quarterly sales more or less doubled since about a year ago as you noted when you launched also CIDP, and obviously PFS has now launched. I'm just trying to get a sense, can you say how much of the growth is driven by CIDP versus gMG? Thank you. Karen, why don't you start with a commercial question on the relative growth drivers that impact, and I will take the pipeline question.

Speaker #13: Can we any chance to get an update on 121 . The IGA sweeping platform and then 213 the long acting , you know , VHS volume of of Efgartigimod .

Speaker #13: And then secondly , maybe when we look at sales , sales essentially have now quarterly sales more or less doubled since about a year ago , as you noted , when you launched , also cidp and obviously PFS is now launched .

Speaker #13: I'm just trying to get a sense can you how much of the growth is driven by Cidp versus GMG ? Thank you .

Speaker #4: Okay . Why don't you start with the commercial question on , you know , the relative growth drivers that impact . And I will take the pipeline question .

Speaker #6: Yeah , absolutely . Happy to . Yes . So so you're right . We we saw when you zoom out nearly 100% growth year over year , as you said .

Beth DelGiacco: Yeah, absolutely. Happy to.

Karen Massey: Yes.

Beth DelGiacco: You're right, we saw when you zoom out nearly 100% growth year over year as you said. What we see in the underlying fundamentals of the business is strong growth across both MG and CIDP, both contributing to the growth that we're seeing for the quarter and over the long term. If you look at MG in particular, I think it's important to note we're the number one brand of biologic at this point and we're growing faster than the market, and that market is expanding quickly with biologics being used earlier in the treatment paradigm. In CIDP, just a year out from launch, we're seeing expansion in our market share there as well. I spoke earlier about the increased penetration into that market.

Speaker #6: And what what we see in the underlying fundamentals of the business is strong growth across both milligrams and cidp . Both contributing to the growth that we're seeing for the quarter and over the long term .

Speaker #6: So if you look at milligrams in particular , I think it's important to note where the number one branded biologic at this point and we're growing faster than the market .

Speaker #6: And that market is expanding quickly with biologics being used earlier in the treatment paradigm . And then , of course , in Cidp , just a year out from launch , we're seeing expansion , our market share there as well .

Speaker #6: And I spoke earlier about the increased penetration into that market . So I would see I would say what you can what you can expect moving forward is continued growth in both milligram and Cidp and contribution from from across the different markets .

Beth DelGiacco: I would say what you can expect moving forward is continued growth in both MG and CIDP and contribution from across the different markets and geographies as well.

Speaker #6: And geographies, as well.

Speaker #4: Thank you Karen . And then on your question on the pipeline , which I really appreciate both ArgenX one two , one and 213 are swiftly progressing through the phase one studies .

Tim Van Hauwermeiren: Thank you, Karen. Jeroen, on your question on the pipeline, which I really appreciate, both ARGX-121 and ARGX-213 are swiftly progressing through the phase one studies. Remember, in the dose escalation, single dose, multiple dose, we are of course first and foremost interested in safety and tolerability. These are also molecules which are going to unveil their potential through their PD effect. You know that the ambition level for ARGX-213 is to move to monthly dosing with an equivalent PD effect as VYVGART and no compromise on safety. For ARGX-121, the IgA removal sweeper, the objective is to have a very fast and very deep IgA reduction. These phase one trials will disclose a lot about the potential of these molecules. They're on track. I would say stay tuned for the first data disclosure soon. Thank you.

Speaker #4: Remembering the dose escalation , single dose multiple dose . But of course , first and foremost interested in safety and tolerability . But these are also molecules which are going to unveil their potential through their PD effect .

Speaker #4: So you know that the ambition level for ArgenX 213 is to move to monthly dosing with an equivalent PD effect as Vyvgart and no compromise on safety .

Speaker #4: And for ArgenX one two , one , the IGA removal sweeper , the objective is to have a very fast and very deep IGA reduction .

Speaker #4: So these phase one trials will disclose a lot about the potential of these molecules . They're on track and I would say stay tuned for the first data disclosures soon .

Speaker #4: Thank you .

Speaker #2: As a reminder , we ask that you please limit yourself to one question only . Your first question or your next question . Sorry , comes from the line of Danielle Brill from Truist Securities .

Moderator: As a reminder, we ask you, please limit yourself to one question only. Your first question or your next question comes from the line of Danielle Brill from Truist Securities. Your line is open.

Speaker #2: Your line is open .

Speaker #14: Hi , guys . Good Congrats on the quarter , and thanks for the question . Maybe I'll ask a question about the negative opportunity based on our conversation yesterday .

Operator: Hi guys. Good morning. Congrats on the quarter and thanks for the question. Maybe I'll ask a question about the seronegative opportunity. Based on our conversation yesterday, can you talk about your confidence in the opportunity from a commercial standpoint and the approval based on the subgroup data that you presented? I'm also curious if you could share any MSE data findings given the importance of that endpoint to prescribers. Thank you.

Speaker #14: Can you talk about your confidence in the opportunity from a commercial standpoint and the approval based on the subgroup data that you presented ?

Speaker #14: And I'm also curious if you could share any messy data findings given the importance of that endpoint to prescribers . Thank you .

Speaker #14: And I'm also curious if you could share any messy data findings given the importance of that endpoint to prescribers . Thank you . morning . Yeah .

Speaker #14: And I'm also curious if you could share any messy data findings given the importance of that endpoint to prescribers . Thank you . morning .

Tim Van Hauwermeiren: Thank you, Daniel. We have the benefit of having Luc on the phone. Luc, maybe you share some color on the paths into submission and then from where you sit, the likelihood for an approval. Karen, you comment on the importance from a commercial point of view.

Speaker #4: Danielle . And we have the benefit of having look on the phone . So look , maybe you you show some color , you share some color on , you know , the paths into submission and then how from where you sit , you know , the likelihood for an approval and then maybe can you comment on the importance from a commercial point of view ?

Speaker #11: Yeah . And Daniel , thanks for the question . So we're very excited about the outcome of the serum study because we invested a lot in running the biggest trial in Seronegatives with a rather innovative design , including diagnostic adjudication .

[Analyst]: Yeah. Daniel, thanks for the question. We are very excited by the outcome of the serum study because we invested a lot in running the biggest trial in seronegatives with a rather innovative design including diagnostic adjudication. The overall results really enforce VYVGART's potential to really move the dial in this underserved population, as Karen already said. We met the primary endpoint, which by design was on the overall population, with a clinically meaningful and highly robust statistical significance reduction in MGADL score. We also, as we showed at AANM with Chip Howard presenting, showed that over consecutive cycles this impact, this benefit accrued deeper and deeper. This was seen across the three subgroups: the muscle, which coincidentally we have one of the biggest mask data sets here, triple seronegatives, and then LRP4, and across these three, the benefit moves towards the same direction.

Speaker #11: And they really the overall results really enforces Vyvgart potential to to really move the dial in this underserved population . As Karen already said .

Speaker #11: So we met the primary endpoint , which by design was on the overall population with a clinically meaningful and highly robust statistical significance reduction Mg-adl score .

Speaker #11: And we also , as we showed at A&M with Chip Howard presenting , showed that over consecutive cycles , this impact , this benefit accrued deeper and deeper .

Speaker #11: Now , this was seen across the three subgroups . So the mask which coincidentally we have one of the biggest mask data sets here , triple negatives .

Speaker #11: And then LRP for and across these three , the the benefit moved towards the same direction . And that's for us is the basis that we have quite some conviction in the benefit we are providing to these patients .

[Analyst]: That for us is the basis that we have quite some conviction in the benefit we are providing to these patients. Of course, ultimately it's going to be a review decision by the agency. We feel pretty confident that we can have a great discussion on the real benefit that we're bringing to this underserved population.

Speaker #11: But of course , ultimately it's going to be review decision by the agency . But we feel pretty confident that we can have a great discussion on the real benefit that we're bringing to this underserved population .

Speaker #4: Thank you , Luke , and Daniel , on your question . There's a ton of data to unpack . So the long term follow up , the deep dive into these patients , there will be much more data sets disclosed going forward into the future .

Tim Van Hauwermeiren: Thank you. Luke and Danielle, on your MSC question, there's a ton of data to unpack. The long term follow up, the deep dive into these patients, there will be much more data sets disclosed going forward into the future, so please stay tuned. Karen, why don't you comment on the significance from a commercial point of view?

Speaker #4: So please stay tuned and why don't you comment on the significance from a commercial point of view ?

Speaker #6: Yeah , happy to . And I think this is a significant opportunity from a commercial perspective . And we're certainly very pleased to see such strong data from the serum study .

Beth DelGiacco: Happy to. I think this is a significant opportunity from a commercial perspective, and we're certainly very pleased to see such strong data from the Theron study. As you know, we're the leaders in the MG market, and our strategy is to expand that leadership with the broadest label possible. Theron or seronegative opportunity is one angle for that. The other is ocular MG, and we know that we have the data readout coming next year for that. We're well on our path of executing our strategy of expanding our market leadership, and the opportunity that we see in seronegative with the 11,000 patients is very high. One of the indicators that we think is important is how fast this clinical trial enrolled across all three of the subtypes. I think that really demonstrates the unmet need and the enthusiasm about VYVGART in these subtypes.

Speaker #6: So as you know , whether leaders in the market and our strategy is to expand that leadership with the broadest label possible . So siren or Seronegative opportunity is one angle for that .

Speaker #6: The other is ocular MG . And we know that we have the data readout coming next year for that . So so we're well on our path of executing our strategy of expanding our market leadership .

Speaker #6: And the opportunity that we see in Sierra negative with the 11,000 patients is very high . One of the indicators that we think is important is how fast this clinical trial enrolled across all three of the subtypes , and I think that really demonstrates the unmet need and the enthusiasm about Vyvgart in these subtypes .

Speaker #6: So I'm looking forward to to the approval if we if we get the approval , and I know the team is looking forward to being able to bring transformative impact to patients in Sierra negative patients as well .

Beth DelGiacco: I'm looking forward to the approval, if we get the approval, and I know the team is looking forward to being able to bring transformative impact to patients in seronegative patients as well.

Speaker #2: Your next question comes from the line of Akash Tiwari from Jefferies . Your line is open .

Moderator: Your next question comes from a line of Akash Tiwari from Jefferies. Your line is open.

Speaker #14: Hi .

Speaker #15: This is Amy on for thanks so much . And congrats on the quarter . Just a quick question on myositis . Curious to see what your bar for success is across the three subsets and how how you are thinking about integrating the the new steroid tapering protocol .

Operator: Hi, this is Amy on for Akash. Thanks so much and congrats on the quarter. Just a quick question on myositis. Curious to see what your bar for success is across the three subsets and how you are thinking about integrating the new steroid tapering protocol while still mitigating placebo risk.

Speaker #15: While still mitigating placebo risk .

Speaker #4: Thank you , Amy , and thank you for joining us on the call today . So of course , the first thing we want to achieve in this basket trial is to achieve statistically significant separation from placebo .

Tim Van Hauwermeiren: Thank you, Amy, and thank you for joining us on the call today. The first thing we want to achieve in this BASCA trial is to achieve statistically significant separation from placebo. It is generally understood in the community that a total improvement score of 20 represents a clinically meaningful benefit. You may recall the phase two data which we presented where we did the sensitivity analysis looking at TIs of 20, but also TIs of 40 and even 60, where you just see an increasing effect of VYVGART, which is very exciting. That's how you should frame or look at success in the clinical trial. Thank you for your question.

Speaker #4: It is generally understood in the community that the total improvement score of 20 represents a clinically meaningful benefit . You may recall the phase two data , which we presented where we did a sensitivity analysis .

Speaker #4: Looking at this of 20 , but also this of 40 . And even 60 , where you just see an increasing effect of of Vyvgart , which is very exciting .

Speaker #4: So that's how you should frame or look at success in , in the clinical trial . Thank you for your question .

Speaker #2: Your next question comes from the line of Richard Voser from JP Morgan . Your line is open .

Moderator: Your next question comes from the line of Richard Vosser from JP Morgan. Your line is open.

Speaker #16: Hi . Thanks for taking my questions . Maybe you could talk a little bit more around the rationale for the change in endpoint for the Impassion trial , for MPA and and give us an idea of what you're looking for around around the grip strength endpoint .

Tim Van Hauwermeiren: Hi, thanks for taking my questions. Maybe you could talk a little bit more around the rationale for the change in endpoint for the empasiprubart trial for MMN and give us an idea of what you're looking for around the grip strength endpoint. Thanks very much. Thank you, Richard. Thank you for joining us. Great question. Look, this is a great question for you, right?

Speaker #16: Thanks very much .

Speaker #4: Thank you , Richard , thank you for joining us . And great question . Look , this is a great question for you , right ?

Speaker #11: Yeah . Thanks for that question . So we made that change in close consultation with the agencies . We then point had a precedent and felt that this could indeed be an indicator of a meaningful outcome .

[Analyst]: Yeah, thanks for that question. We made that change in close consultation with the agencies who on that endpoint had a precedent and felt that this could indeed be an indicator of a meaningful outcome. That's why we made that switch. We had strong data on this endpoint, by the way, from our phase two trial where there was accruing benefit over time on this measure. We feel pretty confident that with this switch our probability to show the benefit of EMPA is more or less unchanged from the prior endpoint. The MMN rods, on which we also keep doing the work, are going to be a key secondary which will provide further insights in the dimensions of benefit.

Speaker #11: And so that's why we made that switch . We had strong data on this endpoint , by the way , from our phase two trial where there was accruing benefit over time on this measure .

Speaker #11: So we feel pretty confident that with this switch probability to show the benefit of of MPA is is more or less unchanged from the prior endpoint , the rocks on which we also keep doing the work , which is going to be a key secondary , which will provide further insights in the dimensions of benefit .

Speaker #4: Thank you . And I think this is a great advantage for us because the alternative was routes , you know , which was still going through an important validation step .

Tim Van Hauwermeiren: Thank you, Lucy. I think this is a great advantage for us because the alternative was MMN rods, which was still going through an important validation step. Now we see CBER and CDUSH using the same endpoint in a specific indication for IVIG in the past. Now we've got going forward, so we're welcoming that harmonization. Thanks for the question.

Speaker #4: But now we see Sieber and see Dersh using the same endpoint in a specific indication for IVIg in the past and now and now Vyvgart going forward .

Speaker #4: So we're welcoming that harmonization . Thanks for the question .

Speaker #2: Your next question comes from the line of Samantha Semenko from city . Your line is open .

Moderator: Your next question comes from the line of Samantha Simencow from Citi. Your line is open.

Speaker #17: Hey , good morning and thanks very much for taking the question . I wonder , following a lupus nephritis data that you've seen , is there anything that you can take from that data set to help inform additional indication selection for Efgartigimod or even two and three going forward ?

Operator: Hi, good morning and thanks very much for taking the question. I wonder, following the lupus nephritis data that you've seen, is there anything that you can take from that data set to help inform additional indication selection for efgartigimod or even ARGX-213 going forward? Just relatedly, how are you thinking about additional indication expansion for empasiprubart and do you have any plans for subcutaneous formulation development there, similar to your playbook that you have for VYVGART?

Speaker #17: And then , just relatedly , how are you thinking about additional indication expansion for MPA ? And do you have any plans for subcutaneous formulation development ?

Speaker #17: There , similar to your playbook that you had for Vyvgart ? Thank you .

Karen Massey: Thank you.

Speaker #4: Yeah , Samantha , thank you for the question . From a playbook point of view , it is indeed the intention to leverage our Subcu platform across all indications .

Tim Van Hauwermeiren: Yeah, Samantha, thank you for the question. From a playbook point of view, it is indeed the intention to leverage our subq platform across all indications. Maybe Luc, you want to comment on the lupus nephritis data?

Speaker #4: But maybe look , you want to comment on the lupus nephritis data .

Speaker #11: Yeah , yeah . And thanks for that question . So we're still fully digesting it . But just from the top line evaluation .

[Analyst]: Thank you for that question. We're still fully digesting it, but just from the top-line evaluation, it was clear that right now there isn't a path forward to a registration study. Given that we want to be transparent about these things, we put it in here. We're still trying to fully understand the data, which, to your point, may inform further decisions on a path forward, potentially with another asset in the portfolio.

Speaker #11: It was clear that right now there isn't a path forward to a registrational study . And given that we want to be transparent about these things , we put it in here , but we're still trying to fully understand the data , which to your point may inform further decisions on a path forward , potentially with another asset in the portfolio .

Speaker #2: Your next question comes from the line of Miles Minter from William Blair . Your line is open .

Moderator: Your next question comes from the line of Miles Minter from William Blair. Your line is open.

Speaker #18: Hey , congrats on the quarter . My question is back on the Mab data that we just saw and placebo responses in Sjogren's disease .

Tim Van Hauwermeiren: Hey, congrats on the quarter. My question's back on the ianalumab data that we just saw and placebo responses in Sjogren's disease and just wondering whether you know that five and a half, five point change from baseline in SDI. Is that within your expectations for your ongoing UNITY study or does seeing that data change your expectations and potentially powering assumptions for that trial? Thanks very much. Thank you, Miles. That's a great question. In Sjogren's, I think we badly need better endpoints. That's why in the phase two proof of concept study we explore the effect of the drug across an entire spectrum of endpoints, also some of the new endpoints which are coming. Unfortunately, today the regulators still force you to use QNSDYE because the Crescent Star endpoints haven't been fully validated yet.

Speaker #18: And just wondering whether , you know that five and a half five point change from baseline in SD is that within your expectations for your ongoing unity study , or does seeing that data change your expectations and potentially powering assumptions for that trial ?

Speaker #18: Thanks very much .

Speaker #4: Thank you . And that's a great question . In Sjogren's , I think we badly need better endpoints . That's why in the phase two proof of concept study , we explored the effect of the drug across an entire spectrum of endpoints .

Speaker #4: Also , some of the endpoints which are coming but unfortunately today the regulators still force you to use SD because the crescent star endpoints haven't been fully validated yet .

Speaker #4: I think the placebo effect , which you see in this study , is actually quite consistent with the placebo effects , which we have seen in historical trials .

Tim Van Hauwermeiren: I think the placebo effect which you see in this study is actually quite consistent with the placebo effects which we have seen in historical trials. It's the ballpark which we expected when we were designing the clinical trial and powering the clinical trial. Thank you for the question.

Speaker #4: So is the ballpark , which we expected when we were designing the clinical trial and powering the clinical trial . So thank you for the question .

Speaker #2: Your next question comes from the line of Sean Lehman from Morgan Stanley . Your line is open .

Moderator: Your next question comes from the line of Shawn Lehman from Morgan Stanley. Your line is open.

Speaker #19: Hi , everyone . Congrats on the quarter . This is Morgan on for Sean . We have two questions . So first just wanted to get your thoughts on J&J announcing the head to head for Amavi versus Vyvgart and Gmmg .

Operator: Hi everyone. Congrats on the quarter. This is Morgan on for Sean. We have two questions. First, just wanted to get your thoughts on J&J announcing the head-to-head for Amavi versus VYVGART in gMG. I know you provided guidance on OpEx for the rest of the year, but given all the pipeline indications and trials you have going on, wanted to know if you could provide any guidance on OpEx and the potential lift over the next 12 months or so. Thank you.

Speaker #19: And then second , I know you provided guidance on OpEx for the rest of the year , but given all the pipeline indications and trials you have going on , wanted to know if you could provide any guidance on OpEx and the potential lift over the next 12 months or so .

Speaker #19: Thank you .

Speaker #4: Hey , look , do you want to first comment on that study from J&J , please ?

Tim Van Hauwermeiren: Hey Lud, do you want to first comment on that study from JJ, please?

Speaker #11: Yeah , yeah . Thanks , Jim . Thanks for the question . So I want to start by saying Atherogenics . Our goal is always to to prioritize evidence generation that will really add significant value to the patient and the community .

[Analyst]: Yeah, thanks Tim. Thanks for the question. I want to start by saying at argenx, our goal is always to prioritize evidence generation that will really add significant value to the patient and the community. If we look at this design of this head-to-head trial, I'm afraid it will not provide that much new information that benefits patients because of the primary endpoints chosen and the timing of the readouts. We already know that when you stop dosing VYVGART or any FcRn for that matter, that IgGs will return to baseline. That is not novel. This study will just prove different PD effect of four doses of VYVGART versus continuous dosing. I don't think that that really adds, and it's also not in line with how VYVGART is actually used in the real world today.

Speaker #11: And if we look at this design of this head to head trial , I'm afraid it will not provide that much new information that benefits patients because of the primary endpoints chosen and the timing of of the readouts .

Speaker #11: We already know that when you stop dosing Vyvgart or any for that matter , that ECGs will return to baseline , that is not novel .

Speaker #11: So this study will just prove different . PD effects of for doses of five card versus continuous dosing . And I don't think that that really adds .

Speaker #11: And it's also . Not in line with how Vyvgart is actually used in the real world today . And that's an for example , we have poster number 12 for those who are interested to show the long term data on Subcut that shows that , you know , with a regimen that really triggers new treatment when the start of deterioration happens , that you can keep people well below the significance difference of minus two points .

[Analyst]: At AAN, for example, we have poster number 12 for those interested to show the long-term data on subcut that shows that with a regimen that really triggers new treatment when the start of deterioration happens, you can keep people well below the significant difference of minus two points. To me, that therefore creates this question how much added value will this study bring in understanding, and overall our perspective on competitive landscape hasn't really changed with this. We welcome competition because it's good for patients and we get to better outcomes ultimately for that patient community. We have not seen really meaningful differentiation being offered here. We continue to be confident about what we have set, the accumulated data shown at AAN with all the data out there across both pediatrics, long-term data, the seronegatives are really in line with our mission to present data that really add value.

Speaker #11: So . I to me that therefore creates this question . How much added value will this study bring . And understanding and overall our our perspective on competitive landscape hasn't really changed with this , we welcome competition because it's good for patients and we get to better outcomes .

Speaker #11: Ultimately for that patient community . But we have not seen really meaningful differentiation being offered here . And so we continue to be confident about we have set the accumulated data shown at A&M with all the data out there across both Pediatrics long term data , the Seronegatives are really in line with our mission to present data that really add value .

Speaker #4: Yeah . Thank you Luke . And I want to remind the audience that for the long term follow up in the Subcu study , we now reach 60% MSK in our patients .

Tim Van Hauwermeiren: Thank you. Luca, I want to remind the audience that for the long-term follow-up in the subQ study, we now reach 60% MSC in our patients. 85% of these patients have sustained MSC of 8 weeks or longer. I think that's what matters to patients most. Thank you for the question.

Speaker #4: 85% of these patients have sustained MSK of eight weeks or longer . I think that's what matters to patients most . Thank you for the question .

Speaker #5: Morgan . Thank you for your question . On operating expenses . Just to repeat what I said earlier this year , we will end between 2.6 and $2.7 billion .

Karl Gubitz: Morgan, thank you for your question on operating expenses. Just to repeat what I said earlier this year, we will end between $2.6 and $2.7 million. Capital allocation priorities is clear. We're investing in growth. We're not going to talk about the operating expenses and guidance for next year now, but what we will say is that the increases you saw in Q3, you can expect that to continue going forward. Thank you for the question.

Speaker #5: Our capital allocation priorities are clear. We are investing in growth. We're not going to talk about the operating expenses and guidance for next year now.

Speaker #5: But what we will say is that the increases you saw in Q3 , you can you can expect that to continue going forward .

Speaker #5: Thank you for the question .

Speaker #2: Your next question comes from the line of Jacob Mikhail from KBC securities . Your line is open .

Moderator: Our next question comes from the line of Jacob McHale from KBC Securities. Your line is open.

Speaker #20: Hi there and thanks for taking my question . With 4.3 billion on your balance sheet , how are you thinking about external innovation in the future ?

[Analyst]: Hi there and thanks for taking my question. With $4.3 billion on your balance sheet, how are you thinking about external innovation in the future? I believe you did an early stage deal earlier this year, but should we expect more of those going forward, and are there any technologies that you think would be a good fit with your internal efforts?

Speaker #20: I believe you did an early stage deal earlier this year , but should we expect more of those going forward and are there any technologies that you think would be a good fit with your internal efforts ?

Speaker #4: Yeah , Jacob , and thank you for the question and thanks for joining us today . Just as a quick reminder , all innovation at ArgenX starts with a collaboration with the external world .

Tim Van Hauwermeiren: Yeah, Jacob, and thank you for the question and thanks for joining us today. Just as a quick reminder, all innovation at argenx starts with a collaboration with the external world. At the core of each pipeline asset is a very strong fabric of collaborators. It is true that with the increasing cash balance, our aperture for novel biology, which we're hunting for, is opening up. We're no longer just looking in academic labs, but we're also involved in a number of constructive discussions with young biotech companies, typically another place where you find exciting biology. We're looking for the same biology. The hunting ground just increased thanks to the balance sheet. Stay tuned in our innovation mission. More of that biology will be coming in. Thank you.

Speaker #4: So at the core of each pipeline asset is a very strong fabric of of of collaborators . It is true that , you know , with the increasing cash balance , our aperture for novel biology , which we're hunting for , is opening up .

Speaker #4: We no longer just looking in academic labs , but we're also involved in a number of constructive discussions with biotech companies , typically in other places where you find exciting biology .

Speaker #4: So we're looking for the same biology , the hunting ground , just , you know , increased thanks to to the balance sheet .

Speaker #4: So stay tuned in our innovation mission , more of that biology will be coming in . Thank you .

Speaker #2: Your next question comes from the line of Luca Issy from RBC Capital Markets . Your line is open .

Moderator: Your next question comes from the line of Luca Issi from RBC Capital Markets. Your line is open.

Speaker #21: Hi . Thanks . Thanks , team , for taking our question . This is for Luca . Congrats on a robust quarter . And we have a question on Vyvgart for GMG .

Operator: Hi. Thanks team, for taking our question. This is Cassian Felucca. Congrats on the robust quarter. We have a question on VYVGART for gMG. We've been hearing from a few KOLs that patients are receiving the drug using shorter off cycles compared to the label. That is because these physicians are worried that these patients relapse towards the end of the off cycle. They prefer to restart the next cycle sooner rather than later. Is that consistent with your understanding? If so, this is an important tailwind that is partially offsetting your growth to net headwind. Any color there? Much appreciated. If it's okay, we have a quick follow-up on seronegative MG for Luc. Any recognition around why triple seronegative MG patients are not as responsive.

Speaker #21: We've been hearing from a few colleagues that patients are receiving the drug using shorter off cycles compared to the label, and that is because these physicians are worried that these patients relapse towards the end of the off cycle.

Speaker #21: So they prefer to restart the next cycle sooner rather than later . Is that consistent with your understanding , and if so , this is an important tailwind that is partially offsetting your growth to net headwind .

Speaker #21: Any color there much appreciated . And and if it's okay we have a quick follow up on your negative energy for Luc . Any rationalization around why triple negative patients are not as responsive ?

Speaker #21: Thanks so much .

Tim Van Hauwermeiren: Thanks so much, Katie. Thank you for the questions. First of all, in the ADAPT trial, we adapted the cyclical dosing of the drug to the individual need of the patient. That's also what the label says. The label is not prescriptive in how you use the cycles. You read those based on clinical judgment. It is possible that there is a subset of patients which needs the drug more frequently. There's also a tail of patients which needs the dose much less frequently. There's the whole individualization concept behind VYVGART. Your information is correct. Actually, we presented these data in the poster, but you see the total distribution of patients with an average cycle of 5.2 per year, with a number of patients needing it more frequently and a long tail of patients needing it less frequently. The seronegative question is intriguing, right?

Speaker #4: Yeah . Thank you for the questions . So first of all , in the Adapt trial we adapted the cyclical dosing of the drug to the individual need of the patient .

Speaker #4: And that's also what the label says . So the label is not prescriptive in you know how you use the cycles . You read those based on you clinical judgment .

Speaker #4: So it is possible that there is , you a subset of patients which needs the drug more frequently . There's also a tale of patients which needs the dose much less frequently .

Speaker #4: And there's the whole individualization concept behind Vyvgart . So your information is correct . Actually , we presented these data in the poster , but you see the total distribution of patients with an average cycle of 5.2 per year .

Speaker #4: But you know , the number of patients needing it more frequently . And a long tail of patients needing it less frequently . The seronegative question is intriguing , right ?

Speaker #4: Look , why don't you pick up this one ?

Tim Van Hauwermeiren: Luc, why don't you pick up this one?

Speaker #11: Yeah , yeah . And it's important to realize that 000 negatives often have a longer diagnostic course . And therefore present often also with a more severe disease , which is actually what we have observed in the Adapt serum .

[Analyst]: Yeah, yeah. It's important to realize that triple seronegatives often have a longer diagnostic course and therefore present often also with a more severe disease, which is actually what we have observed in ADAPT SERUM. Therefore, and talking through, of course, experts in the field, our hypothesis is that the initial signal may be lower because repair mechanisms may kick in and so forth. What is really encouraging for us is that in these subsequent cycles they really get meaningful benefits. In that sense, that story is not too much different from what we've seen in non-seronegatives, and we find that encouraging. We, of course, will continue to look into the data, as was already said, around can we get to MSE also in these patients given their longer disease journey. Overall, we feel the totality of the data fully supports a robust benefit here.

Speaker #11: And therefore and talking through of course , experts in the field , our hypothesis is , is that the initial signal may be lower because repair mechanisms may to kick in and so forth .

Speaker #11: But what is really encouraging for us is that in these subsequent cycles , they really get to meaningful benefits . And in that sense , that story is not too much different from what we've seen in non seronegatives .

Speaker #11: And so we find that encouraging . We've of course , will continue to to look into the data as was already said around , can we get to MSI also in these patients , given their longer disease journey , but overall we feel the totality of the data fully supports a robust benefit here .

Speaker #4: Thank you. Thank you, Katie.

Tim Van Hauwermeiren: Thank you, Luca, and thank you, Katie.

Speaker #2: Your next question comes from the line of Thomas Smith from Leerink Partners . Your line is open .

Moderator: Your next question comes from the line of Thomas Smith from Leerink Partners. Your line is open.

Speaker #22: Hey guys . Good morning . Thanks for taking the questions . And let me add my congrats on the strong quarter just on graves .

Tim Van Hauwermeiren: Hey guys, good morning.

[Analyst]: Thanks for taking the questions. Let me add my congrats on the strong quarter. Just on Graves, we recently saw some long-term follow-up data from a competitor, SCRM, suggesting potential to drive long-term disease remission in this disease.

Speaker #22: We we recently saw some long term follow up data from a competitor , FCM , suggesting a potential to drive long term disease remission in this disease .

Speaker #22: I was just wondering if you could comment specifically on that data set and how important the potential disease modification was in your decision here to pursue graves with Vyvgart , and then you mentioned some excitement around the market potential .

Tim Van Hauwermeiren: I was just wondering if you could.

[Analyst]: Comment specifically on that data set and how important the potential disease modification was in your decision here to pursue Graves with VYVGART. You mentioned some excitement around the market potential. I was just wondering if you could maybe expand on that and share some of your initial assessment around the potentially addressable market here.

Speaker #22: I was just wondering if you could maybe expand on that and share some of your initial assessment around the potentially addressable market here .

Speaker #22: Thanks so much .

Tim Van Hauwermeiren: Thanks so much. I will start with taking the answer, and maybe Karen, you can shed some qualitative color on our excitement around the size of this opportunity. It is correct that there are data out there from a peer in the FcRn space. We share the passion for FcRn with our peer group. Whilst it is interesting, we have to be very careful because this was a very small sample. I think it warrants further investigation in a large, properly controlled clinical trial. Stay tuned for more data coming out of your own more advanced clinical trial work, and maybe Karen, a few words on excitement around Graves.

Speaker #4: Yeah , well , I will start with taking the answer . Maybe , you can shed some qualitative color on our excitement around , you know , the size of this opportunity .

Speaker #4: It is correct that , you know , there are data out there from a period in the space . We share the passion for fcrn with with our peer group .

Speaker #4: Whilst it is interesting , we have to be very careful because this was a very small sample . So I think it warrants further investigation in a large , properly controlled clinical trial .

Speaker #4: So stay tuned for more data coming out of , you know , more advanced clinical trial work and maybe Karen , a few words on excitement around graves .

Speaker #6: Yeah . Happy to I mean , whenever we select an indication , we look through three lenses . The biology . Can we develop the indication .

Beth DelGiacco: Yeah, happy to. Whenever we select an indication, we look through three lenses. The biology, can we develop the indication? We always look at the commercial opportunity through the lens of what is the real unmet patient need in this indication and can we bring transformative outcomes to patients. When we looked at the Graves indication, what we saw was that there's a large prevalence of the disease and there is a subset of patients that has a clear unmet need that we think they've got based on the proof of biology study, based on the convenience of our subcutaneous dosing that we think we could fulfill that need. It also creates that franchise, if you will, opportunity, given the connection to TED that Tim talked about earlier. We see that there's a significant commercial opportunity here and look forward to seeing the clinical data readout. Thanks for the question.

Speaker #6: And we always look at the commercial opportunity through the lens of what is the real unmet patient need in this indication . And can we bring transformative outcomes to patients .

Speaker #6: And so when we looked at the graves indication , where what we saw was that there's a large prevalence of the disease and there is a subset of patients that has a clear unmet need that we think Vyvgart , based on the proof of biology study , based on the convenience of our subcutaneous dosing .

Speaker #6: But we think we could fulfill that , that need . It also creates that franchise , if you will , opportunity . Given the connection to Ted that Tim talked about earlier .

Speaker #6: So we see that there's a significant commercial opportunity here and look forward to seeing the clinical data readout . Thanks for the question .

Speaker #2: Your next question comes from the line of Douglas sale from H.C. Wainwright . Your line is open .

Moderator: Your next question comes from the line of Douglas Sale from H.C. Wainwright. Your line is open.

Speaker #23: Hi . Good morning . Thanks for taking the questions . Just maybe sticking to the subject of graves disease . I'm just curious , just , you know , obviously it is a spectrum .

Tim Van Hauwermeiren: Hi, good morning. Thanks for taking the questions. Just maybe sticking to the subject of Graves disease, I'm just curious, obviously it is a spectrum along with TED. Just given the start of this study, are you thinking about targeting a particular time point in that progression, and do you think it's realistic or possible to potentially show that you're able to sort of modify the course of disease in terms of progression to TED? Thank you for the question. We're not going to comment in this call specifically about the trial design. The trial will come live relatively soon, and we will be presenting trial design, inclusion, exclusion criteria, etc. in the appropriate conferences. Stay tuned on the potential disease modification. It's an interesting hypothesis. I think we need more data to come to a firm conclusion there, but thank you for the question.

Speaker #23: You know , along with Ted . And so just given the start of this study , I mean , are you thinking about targeting a particular time point in that progression ?

Speaker #23: And do you think it's realistic or possible to potentially show that you're able to sort of modify the course of disease in terms of progression to Ted?

Speaker #4: Well , thank you for the question . We're not going to comment in this call specifically about the trial design . The trial will come live , you know , relatively soon .

Speaker #4: And we will be presenting , you know , trial design , inclusion , exclusion criteria , etc. in the appropriate conference . So stay tuned on the potential disease modification .

Speaker #4: It's an interesting hypothesis . I think we need more data to come to a firm conclusion . There . But thank you for the question .

Speaker #2: Your next question comes from the line of Victor Falk from BNP Paribas . Your line is open .

Moderator: Your next question comes from the line of Victor Falk from BNP Paribas. Your line is open.

Speaker #24: Hey , thanks so much for taking my question . Actually , a quick follow up on the the peer assets that one of the analysts was before .

Tim Van Hauwermeiren: Hey, thanks so much for taking my question. Actually, a quick follow-up on the peer assets that one of the analysts was mentioning before. That's exactly the one you actually used to leverage their phase two data to go straight to TED a few years ago. I was wondering, that exact asset.

Speaker #24: mentioning

Speaker #24: That's exactly the one you've actually used to leverage their facial data to go straight to Ted a few years ago . So I was wondering , that exact asset is going to report some phase three data in the in the not so distant future .

[Analyst]: Is going to report some phase three.

Tim Van Hauwermeiren: Data in the not so distant future. We're just wondering whether these data sets are a relevant proxy for odds of success in TED or if you have any comments to be made.

Speaker #24: So just just wondering whether these data sets was the relevant proxy for Vyvgart odds of success in TD or if you have any comment on to be made .

Speaker #24: Thanks so much .

[Analyst]: Thanks so much.

Speaker #4: Yeah . Thank you . It's hard for us to comment on the timeline of clinical trials of third parties . I think we're best off asking the question to them .

Tim Van Hauwermeiren: Yeah, thank you. It's hard for us, Victor, to comment on the timeline of clinical trials of third parties. I think we're best off asking the question to them. The way we look at this type of phase two work is it is a proof of biology. I mean, it is an FcRn antagonist. It is firmly establishing the role of FcRn and autoantibodies in the disease. We know these diseases are autoantibody driven. I would be very careful jumping to conclusions because as we know in the FcRn class, not all FcRns are made equal. I think VYVGART is a unique Fc fragment. It's uniquely engineered based on a unique understanding of the biology. I would not just cross compare between molecules in the same class. We have already seen in other indications that actually it's just not appropriate to do so. Strong proof of biology.

Speaker #4: The way we look at this type of phase two work is , you know , it is a proof of biology . I mean , it is an fcrn antagonist .

Speaker #4: It is firmly establishing the role of fcrn and autoantibodies in the disease . And we know these diseases are o20 body driven . I would be very careful jumping to conclusions because

Speaker #4: as we know in the Fcrn class , not all fcrn are made equal . I think Vyvgart is a unique FC fragment . It's uniquely engineered based on a unique understanding of the biology .

Speaker #4: So I would not just cross between the molecules in the same class. We have already seen in other indications that, actually, it is just not appropriate to do so.

Speaker #4: Strong proof of biology . Stay tuned for the ArgenX data . I would say thank you .

Tim Van Hauwermeiren: Stay tuned for the argenx data, I would say. Thank you.

Speaker #2: Your next question comes from the line of Xiandong from UBS . Your line is open .

Moderator: Your next question comes from the line of Xiandang from UBS. Your line is open.

Speaker #25: Hi . Thank you for taking my question . So I have a question on Vyvgart phase two data in myocytes . Please . So just wondering for the phase two data , there were about 23% injection site erythema .

Operator: Hi, thank you for taking my question. I have a question on VYVGART Phase 2 data in myositis, please. For the Phase 2 data, there were about 23% injection site erythema. Could you share any comment on that and any strategies to mitigate that? In general, how serious do you think that is? In terms of physician feedback, given in a small subset of patients, they might have interstitial lung disease. What's your mitigation strategy?

Speaker #25: So just wondering if you could share any comment on that . And any strategies to mitigate that . And so in general , just wondering how serious do you think that is ?

Speaker #25: And in terms of physician feedback given in a small subset of patients , you know , they might have interstitial lung , lung disease .

Speaker #25: So just wondering what's your mitigation strategy there ? And if I may also squeeze in very quickly . And Robin recently announced positive phase three data for their jack tick to inhibitor breakfast in dermatomyositis .

Karen Massey: There's.

Operator: If I may also squeeze in very quickly, Royban recently announced the positive Phase 3 data for their JAK Tyk2 inhibitor riflecitinib in dermatomyositis. Of course, you are running the trial in a much broader general myositis overall. Just wondering, what's your comment on the competitive landscape, please? Thank you.

Speaker #25: I mean , of course you are running the trial in a much broader general myositis overall . So just wondering what's your comment on the competitive landscape , please ?

Speaker #25: Thank you .

Speaker #4: that's two questions in one . Right . But that not a problem . Yeah , Look , yes we have seen we have seen the data in DM .

Tim Van Hauwermeiren: Yeah, there's two questions in one. Right, but that's not a problem. Yes, we have seen the data in diem. This is, I think, a large market, future medical needs. There will be multiple molecules which will be playing in this marketplace and we are welcoming this molecule. It's going to help us shape and build that market. It will not be the solution for each patient. I think you will need a portfolio of therapies to adequately deal with these patients. They're very complex patients. Back to the erythema. It's much ado about nothing. I would say these are very mild erythemas. It's typically your first administration where it can happen and then it disappears. This is nothing new. We have reported that as well, you know, in our MG and CIDP patients. We know the phenomenon. It's not unusual or atypical.

Speaker #4: This this is I think a large market huge unmet medical needs . There will be multiple molecules which will be playing in this marketplace .

Speaker #4: And we're welcoming this , this , this molecule . It's going to help us shape and build that market . It will not be the solution for each patient .

Speaker #4: I think you will need a portfolio of of therapies to adequately deal with these patients . They're very complex patients . Back to the erythema .

Speaker #4: It's , you know , much ado about nothing . I would say these are very mild erythema . It's typically your first administration where it can happen .

Speaker #4: And then it disappears . This is nothing new . We have reported that as well . You know in our and patients . So we know the phenomenon .

Speaker #4: It's not it's not unusual or atypical . And I think it's mild . It's transient . And it's certainly not stopping us . You know in commercialization of this product .

Tim Van Hauwermeiren: I think it's mild, it's transient and it's certainly not stopping us, you know, in commercialization of this product in other indications to the contrary. Thank you for the questions.

Speaker #4: And other indications to the contrary . Thank questions .

Speaker #2: Your next question comes from the line of Charles Pittman King from

Moderator: Your next question comes from the line of Charles Pittman King from Barclays. Your line is open.

Speaker #2: Barclays . Your line is open .

Speaker #26: Hi , guys . Thanks so much for taking my question . I've got you for the one just on the patient numbers and you've not provided us with an update today on kind of the total number of patients tried on therapy .

[Analyst]: Hi, guys. Thanks so much for taking my question. I've got one just on the patient numbers and you've not provided us with an update today on kind of the total number of patients tried on therapy. I'm just wondering what the next milestones are that you could be announcing. Can we assume from today that you've not hit 20,000 across all indications or say 5,000 for CIDP just given the prior 15,000 total ex China and two and a half thousand guidance that you gave us to Q? Also, just related to that, I wonder if you could give us some commentary on the quarterly patient ad dynamics given you now got MG, CIDP, and PFS launched. When should we expect patient ads to peak ahead of the next indication approval? Thanks very much.

Speaker #26: But I'm just wondering what the next milestones are that you could be announcing . I mean , can we assume from today that you've not kind of hit 20,000 across all indications or say , 5000 for cidp , just given the kind of prior , you know , 15,000 total Ex-china and 2500 in guidance that you gave us to Q and also just related to that , I wonder if you could give us some commentary on just the quarterly patient and dynamics giving you now got Cidp and PFS launched .

Speaker #26: When should we expect kind of patient ads to peak ahead of the next indication approval ? Thanks very much .

Speaker #3: Thanks , Charles . Yeah , we did not provide a patient number this quarter . The last one we provided is still stands , which was from Duke .

Beth DelGiacco: Thanks, Charles. Yeah, we did not provide a patient number this quarter. The last one we provided still stands, which was from Q2. We did a similar communication rhythm with MG in that we provide patient numbers as we cross certain thresholds.

Speaker #3: We did a similar you know , communication rhythm with milligram and that we provide patient numbers as we cross certain thresholds . We're not going to share with those thresholds are .

Karen Massey: We're not going to share what those.

Beth DelGiacco: Thresholds are, but I think it's important to know that we have seen consistent growth and that the revenue in this situation really speaks for itself. Karen, do you want to talk about the patient growth dynamics? Yeah, absolutely. Happy to talk about the patient growth. I'm pleased for the question because I'm really excited about the continued momentum that we see across all indications in terms of patient growth this quarter. I think when you zoom out, certainly for MG it's been 15/4 of consistent momentum in terms of patient growth as we bring more innovation to patients and most recently obviously the PFS has contributed to accelerating that growth. I think what's really important to note is that with pre-filled syringe 50% of the patients are new to VYVGART and that's across both indications.

Speaker #3: But I think it's important to know that we have seen consistent growth and that , you know , the revenue in this situation really speaks for itself .

Speaker #3: And , Karen , do you want to talk about the the patient growth ?

Speaker #6: Yeah , absolutely . Happy to happy to talk about the patient growth . I'm pleased for the question because I'm I'm really excited about the continued momentum that we see across all indications in terms of patient growth this quarter .

Speaker #6: And I think when you zoom out , I mean , certainly for me , it's been 15 quarters . Of consistent momentum in terms of patient growth as we bring more innovation to to patients and most recently , obviously the PFS has has contributed to to accelerating that growth .

Speaker #6: I think what's really important to to note is that with prefilled syringe , 50% of the patients are new to Vyvgart . And that's across both indications .

Speaker #6: And don't forget the 260 prescribers since prefilled syringe launched two quarters ago are new to Vyvgart . They had never these prescribers had never written before .

Beth DelGiacco: Don't forget that 260 prescribers since pre-filled syringe launched 2/4 ago are new to VYVGART. These prescribers had never written before pre-filled syringe launch. What you can see is both patient growth very consistently across the quarter with momentum as well as prescriber growth consistently. That prescriber growth is important because it opens up new pockets of patients in both MG and CIDP and indicates that we're at the beginning of the growth curve for both indications. Thanks for the question.

Speaker #6: Prefilled syringe launched . So what you can see is both patient growth very consistently across the quarter with momentum as well as prescriber growth consistently .

Speaker #6: And that prescriber growth is important because it opens up new pockets of patients in both milligram and Cidp and indicates that we're at the beginning of the growth curve for both indications .

Speaker #6: Thanks for the question .

Speaker #2: And your final question today comes from the line of Colleen QC from Baird . Your line is open .

Moderator: Your final question today comes from the line of Colleen Kucey from Baird. Your line is open. Hey, this is Nick on for Colleen. Congrats on the quarter and thanks for taking our question. If you could comment on the progress you made in the ex U.S. launches, whether you think that could be a meaningful top line growth driver for the next year or whether you think focus will be more so on deepening penetration in the U.S. and what you view as the eventual market opportunity for ex U.S. relative to the opportunity in the U.S. Thank you.

Speaker #27: Hey , this is Nick on for Colleen . Congrats on the quarter and thanks for taking our question . If you could comment on the progress you've made in the Xx's launches , whether you think that could be a meaningful top line growth driver for the next year , or whether you think focus will be more so on deepening penetration in the US and what you view as the eventual market opportunity for us relative to the opportunity in the US .

Speaker #27: Thank you .

Speaker #6: Yes , thanks for the question . What you will have seen is that we have growth across all geographies or all markets . And and what we're pleased to see , certainly , if I , if I go through those markets in Japan , we've launched Cidp .

Beth DelGiacco: Yes, thanks for the question. What you will have seen is that we have growth across all geographies or all markets. What we're pleased to see, certainly if I go through those markets, in Japan we've launched CIDP. We recently got the PFS approval and we're pleased to see continued demand growth for both MG and CIDP. Japan is a very important growth driver for us and we see that continuing in the future with the PFS launch. If we turn our attention to the other major markets in Europe, in Canada, what we see is that in MG, as you'd expect, it takes a little more time for those markets to come online as we negotiate pricing and reimbursement agreements. We have a narrow price band and we have good pricing and reimbursement agreements in place.

Speaker #6: We recently got the PHS approval and we're pleased to see continued demand growth for both Milligram and Cidp . So Japan is a very important growth driver for us .

Speaker #6: And we see that continuing in the future with the PHS launch . If we turn our attention to the other major markets in Europe in Canada , what we see is that in milligram , as you'd expect , it takes a little more time for those markets to come online .

Speaker #6: As we negotiate pricing and reimbursement agreements . We have a narrow price band , and we've we have good pricing and reimbursement agreements in place .

Speaker #6: And what you're starting to see is those revenue contributions for those HTA markets increasing . We recently received the approval for Cidp that's launched in Germany , and we expect that there'll be further launches for Cidp in additional markets in in the upcoming months and years .

Beth DelGiacco: What you're starting to see is those revenue contributions for those HTA markets increasing. We recently received the approval for CIDP that's launched in Germany and we expect that there'll be further launches for CIDP in additional markets in the upcoming months and years. We expect that there will continue to be growth ex U.S., but of course the U.S. will continue to be a strong growth driver for us as well. Thanks for the question.

Speaker #6: So we expect that there will continue to be growth . ex-US . But of course the US will continue to be a strong growth driver for us as well .

Speaker #6: Thanks for the question . .

Moderator: That does conclude today's conference call. Thank you for your participation and you may now disconnect. Thank you.