Q4 2025 argenx SE Earnings Call

February 26, 2026

Speaker #2: After the speaker's remarks, there will be a question-and-answer session. Thank you. I'd now like to introduce Beth DelGiacco, Vice President of Corporate Affairs. You may now begin your conference.

Speaker #2: Thank you. Two press releases were issued earlier today. One sharing the positive results from our Phase 3 ADAPT Oculus study, and the other which outlines our fourth-quarter and full-year 2025 financial results and business update.

Beth DelGiacco: Thank you. Two press releases were issued earlier today, one sharing the positive results from our Phase 3 ADAPT OCULUS study and the other which outlines our Q4 and full year 2025 financial results and business update. These can be found on our website, along with the presentation for today's webcast. Before we begin, on slide two, I'd like to remind you that forward-looking statements may be presented during this call. These may include statements about our future expectations, clinical developments, regulatory timelines, the potential success of our product candidates, financial projections, and upcoming milestones. 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.

Speaker #2: These can be found on our website along with the presentation for today's webcast. Before we begin, on Slide 2, I'd like to remind you that forward-looking statements may be presented during this call.

Speaker #2: 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 #2: 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.

Speaker #2: I'm joined on the call today by Karen Massey, Chief Operating Officer, Karl Gubitz, Chief Financial Officer, Luke Troyan, Chief Medical Officer, Sandrine Perez-Gerard, Chief Commercialization Officer, and Tim Van Hauwermeiren, Chief Executive Officer.

Beth DelGiacco: I'm joined on the call today by Karen Massey, Chief Operating Officer, Karl Gubitz, Chief Financial Officer, Luc Truyen, Chief Medical Officer, Sandrine Piret-Gerard, Chief Commercialization Officer, and Tim Van Hauwermeiren, Chief Executive Officer. I'll now turn the call over to Karen.

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

Speaker #3: Thank you, Beth, and welcome, everyone. I'll begin on Slide 3. 2025 was an incredible year of execution for ArgenX. We reached 19,000 patients globally driven in part by the successful launch of our pre-filled syringe for self-injection.

Karen Massey: Thank you, Beth, and welcome everyone. I'll begin on slide 3. 2025 was an incredible year of execution for argenx. We reached 19,000 patients globally, driven in part by the successful launch of our prefilled syringe for self-injection. We also continued to advance our deep and differentiated immunology pipeline, including 4 new molecules from our IIP, positioning us for sustained long-term growth. This progress is grounded in our commitment to patients, to innovate in ways that don't just improve care, but meaningfully change what patients can expect from their treatment. I'm speaking to you today from our US national team meeting, where hearing directly from patients is a powerful reminder of why our work matters. One moment in particular stayed with me. We recently received a handwritten note from a patient thanking the team for the impact VYVGART has had on her life.

Speaker #3: We also continue to advance our deep and differentiated immunology pipeline, including four new molecules from our IIP. Positioning us for sustained, long-term growth. This progress is grounded in our commitment to patients, to innovate in ways that don't just improve care, but meaningfully change what patients can expect from their treatment.

Speaker #3: I'm speaking to you today from our US national team meeting, where hearing directly from patients is a powerful reminder of why our work matters.

Speaker #3: One moment in particular stayed with me. We've recently received a handwritten note from a patient, thanking the team for the impact Vyvgart has had on her life.

Speaker #3: We later learned that before starting treatment, she had been living with very severe MG symptoms that significantly limited her day-to-day activities. Today at the meeting, we saw a video of the patient about a year into treatment with Vyvgart Hytrulo, sharing an update from a hike she was on.

Karen Massey: We later learned that before starting treatment, she had been living with very severe MG symptoms that significantly limited her day-to-day activities. Today at the meeting, we saw a video of the patient about a year into treatment with VYVGART Hytrulo, sharing an update from a hike she was on. She is thriving. It's one individual story, but it reinforces the real-world difference VYVGART can make. Slide four. At the start of the year, we outlined our strategic priorities for 2026 that will guide our next chapter of growth towards Vision 2030. We want to impact more patients globally with VYVGART through broader patient adoption and label expansions.

Speaker #3: She is thriving. It's one individual story, but it reinforces the real-world difference Vyvgart can make. Slide 4. At the start of the year, we outlined our strategic priorities for 2026 that will guide our next chapter of growth towards Vision 2030.

Speaker #3: We want to impact more patients globally with Vyvgart through broader patient adoption and label expansions. We're shaping the future of FCRN medicines with next-generation molecules delivery modalities and combination approaches.

Karen Massey: We're shaping the future of FCRN medicines with next-generation molecules, delivery modalities, and combination approaches, and delivering the next wave of immunology innovation, supported by a strong late-stage portfolio and a goal of at least one new pipeline candidate per year. Slide 5. VYVGART is leading the growth of biologics in both MG and CIDP, and we're confident that we have the right strategies and milestones ahead to sustain this momentum. Today marks an exciting moment for ocular MG patients with the positive ADAPT OCULUS results, which Luc will discuss shortly. Together with our progress in seronegative MG, we see a meaningful opportunity to broaden VYVGART's reach to patients who have historically had limited or no targeted treatment options. What's guided us here is a long-standing commitment to the MG community and to advancing our understanding of the underlying biology of the diseases we treat.

Speaker #3: And delivering the next wave of immunology innovation, supported by a strong late-stage portfolio and a goal of at least one new pipeline candidate per year.

Speaker #3: Slide 5. Vyvgart is leading the growth of biologics in both MG and CIDP. And we're confident that we have the right strategies in milestones ahead to sustain this momentum.

Speaker #3: Today marks an exciting moment for ocular MG patients, with the positive ADAPT Oculus results, which Luke will discuss shortly. Together with our progress in seronegative MG, we see a meaningful opportunity to broaden Vyvgart's reach to patients who have historically had limited or no targeted treatment options.

Speaker #3: What's guided us here is a longstanding commitment to the MG community and to advancing our understanding of the underlying biology of the diseases we treat.

Speaker #3: Across MG populations, our data confirm that disease is driven by pathogenic IgGs, regardless of antibody status. In seronegative MG, we demonstrated a clinically meaningful improvement in MG ADL in the overall population with responses becoming more pronounced with subsequent treatment cycles across all subtypes.

Karen Massey: Across MG populations, our data confirm that disease is driven by pathogenic IgGs, regardless of antibody status. In seronegative MG, we demonstrated a clinically meaningful improvement in MGADL in the overall population, with responses becoming more pronounced with subsequent treatment cycles across all subtypes. In ocular MG, we're seeing that same biology extend to another patient population, with VYVGART meeting its primary endpoint and driving clear improvements in ptosis and diplopia. Our seronegative PDUFA date is 10 May, and based on today's results, we see a clear path to expanding our label into ocular MG as well, positioning VYVGART to have the broadest MG label and to reach our target addressable population of approximately 60,000 patients in the US. In CIDP, we're also having a meaningful impact on patients, with clinical data showing functional improvement and these benefits increasingly reflected in real-world experience.

Speaker #3: In ocular MG, we're seeing that same biology extends to another patient population, with Vyvgart meeting its primary endpoint and driving clear improvements in ptosis and diplopia.

Speaker #3: Our seronegative PDUFA date is May 10th, and based on today's results, we see a clear path to expanding our label into ocular MG as well.

Speaker #3: Positioning Vyvgart to have the broadest MG label and to reach our target addressable population of approximately 60,000 patients in the US. In CIDP, we're also having a meaningful impact on patients, with clinical data showing functional improvement, and these benefits increasingly reflected in real-world experience.

Speaker #3: Vyvgart is driving a paradigm shift in CIDP. While there remain significant opportunity within the initial 12,000 addressable patient population, we're also beginning to see expansion beyond that population, a core focus as we build leadership in CIDP.

Karen Massey: VYVGART is driving a paradigm shift in CIDP. While there remains significant opportunity within the initial 12,000 addressable patient population, we're also beginning to see expansion beyond that population, a core focus as we build leadership in CIDP. Sandrine will speak more to this later in the call. Slide 6. Over the next 12 to 18 months, we have multiple avenues for expansion beyond MG and CIDP, including autoimmune myositis and Sjögren's disease, which broadens VYVGART's footprint into rheumatology. In particular, our work in IMNM highlights a significant unmet need, with an estimated 20,000 patients and no approved treatment options today. Meanwhile, our upcoming Q4 readout for empasiprubart in MMN marks an important milestone, positioning us to advance a second medicine to patients and extending our neurology footprint with a first-in-class C2 inhibitor.

Speaker #3: Sandrine will speak more to this later in the call. Slide 6. Over the next 12 to 18 months, we have multiple avenues for expansion beyond MG and CIDP.

Speaker #3: Including autoimmune myositis, and Sjögren's disease, which broaden Vyvgart's footprint into rheumatology. In particular, our work in IMNM highlights a significant unmet need with an estimated 20,000 patients and no approved treatment options today.

Speaker #3: Meanwhile, our upcoming Q4 readout for Impasse de Proubart in MMN marks an important milestone. Positioning us to advance a second medicine to patients and extending our neurology footprint with a first-in-class C2 inhibitor.

Speaker #3: We have an opportunity to address a clear unmet need in MMN with IVIG as the only approved treatment and symptom progression in 60% of patients.

Karen Massey: We have an opportunity to address a clear unmet need in MMN, with IVIG as the only approved treatment and symptom progression in 60% of patients. Slide 7. Lastly, we continue to strengthen the pipeline that will shape our long-term future. VYVGART is just the beginning of FcRn leadership that we aim to establish for decades to come. As part of this, we're advancing 2 next-generation assets, ARGX-213 and ARGX-124. We're investing in efgartigimod-anchored combination approaches and new delivery modalities like the auto-injector and oral peptide capabilities. At the same time, we're seeing real momentum across our broader innovation platform, progressing first-in-class molecules like ARGX-121, targeting IgA, and ARGX-118, targeting Galectin-10. We are deliberately source-agnostic in how we identify new biology, drawing from both leading academic research and opportunities emerging within biopharma.

Speaker #3: Slide 7. Lastly, we continue to strengthen the pipeline that will shape our long-term future. Vyvgart is just the beginning of FCRN leadership that we aim to establish for decades to come.

Speaker #3: As part of this, we're advancing two next-generation assets: ArgenX 213 and ArgenX 124. We're investing in FGARTIGAMOD-anchored combination approaches and new delivery modalities like the autoinjector and oral peptide capabilities.

Speaker #3: At the same time, we're seeing real momentum across our broader innovation platform, progressing first-in-class molecules like ArgenX 121, targeting IgA, and ArgenX 118, targeting galactin-10.

Speaker #3: We are deliberately source agnostic in how we identify new biology during for both leading academic research and opportunities emerging within biopharma. In 2026, we expect to progress three phase one programs, including a program from our Tensegrity collaboration.

Karen Massey: In 2026, we expect to progress three phase I programs, including a program from our Tensegrity collaboration, reinforcing our ability to bring forward high-quality science wherever it originates. We have an exciting year ahead of us, with a strong foundation in place and exciting progress across the pipeline. Let's turn to the data that's shaping our next steps. Luke?

Speaker #3: Reinforcing our ability to bring forward high-quality science wherever it originates. We have an exciting year ahead of us, with a strong foundation in place and exciting progress across the pipeline.

Speaker #3: Let's turn to the data that's shaping our next steps. Luke?

Speaker #2: Thank you, Karen. I'm excited to share the positive outcome of our phase three ADAPT Oculus study. Our second MG expansion milestone to hit just months after we shared positive seronegative 8.

Luc Truyen: Thank you, Karen. I'm excited to share the positive outcome of our Phase 3 ADAPT OCULUS study, our second MG expansion milestone to hit just months after we shared positive seronegative data. Let's turn to slide 8. Together with leading global experts, our team designed the first registration study in ocular MG, filling a long-standing gap for a patient population that has historically been excluded from clinical trials. We leveraged the screening period to ensure patients had a confirmed diagnosis of ocular MG, defined as MGFA Class I, meaning patients have meaningful, measurable eye symptoms without evidence of generalized disease. Patients were also required to be on stable background therapy. 141 patients were randomized 1 to 1 to VYVGART Hytrulo versus placebo. In part A, they received 4 weekly injections. In part B, participants received multiple cycles of VYVGART Hytrulo.

Speaker #2: Together with leading global experts, our team designed the first registration study in ocular myasthenia gravis. Filling a longstanding gap for the patient population that has historically been excluded from clinical trials.

Speaker #2: We leveraged the screening period to ensure patients had a confirmed diagnosis of ocular MG, defined as MGFA class 1, meaning patients had meaningful, measurable eye symptoms, without evidence of generalized disease.

Speaker #2: Patients were also required to be on stable background therapy. 141 patients were randomized one-to-one to Vyvgart-Hytrulo versus placebo. And in part A, they received four weekly injections.

Speaker #2: In part B, participants received multiple cycles of Vyvgart-Hytrulo. The primary endpoint of the study was the change in MGII patient-reported ocular score from baseline to day 29.

Luc Truyen: The primary endpoint of the study was a change in MG-II patient-reported ocular score from baseline to day 29. The measure focused on the key ocular symptoms of myasthenia gravis, diplopia, and ptosis. Slide 9. The study met its primary endpoint. Treatment with VYVGART Hytrulo led to statistically significant improvements in MG-II patient-reported ocular score at week 4 compared to placebo, with a p-value of 0.012. VYVGART-treated patients experienced a mean 4.04 point improvement compared to a 1.99 point improvement on placebo, including clear improvements on diplopia and ptosis. VYVGART was well tolerated, upholding its consistently strong safety profile with no new safety signals. We will present a broader data set at an upcoming medical meeting. This is a big day for patients. ocular MG strips people of independence.

Speaker #2: A measure focused on the key ocular symptoms of myasthenia gravis, diplopia, and ptosis. Slide 9. The study met its primary endpoint. Treatment with Vyvgart-Hytrulo led to statistically significant improvement in MGII patient-reported ocular score at week four compared to placebo with a p-value of 0.012.

Speaker #2: Vyvgart-treated patients experienced a mean 4.04-point improvement compared to a 1.99-point improvement on placebo. Including clear improvements on diplopia and ptosis. Vyvgart was well tolerated, upholding its consistently strong safety profile with no new safety signals.

Speaker #2: We will present a broader data set at an upcoming medical meeting. This is a big day for patients. Ocular MG strips people of independence.

Speaker #2: Many suffer from headaches and the persistent double vision and drooping eyelids don't just affect eyesight. They can take away the ability to drive, work, and confidently engage in daily life.

Luc Truyen: Many suffer from headaches, and the persistent double vision and drooping eyelids don't just affect eyesight. They can take away the ability to drive, work, and confidently engage in daily life, often with a heavy psychological burden and stigma. Today, too many patients are still relying on chronic steroids and symptomatic therapy, which comes with an unacceptable treatment burden over time. For the first time, we are bringing forward a therapy that specifically addresses the underlying pathological mechanism of ocular MG, and that is something we should all be excited about. Based on these results, we plan to file an sBLA with the FDA. Now, before I turn the call over to Karl, I want to sincerely thank the investigator site teams, and most importantly, the patients and families who made this study possible. Karl?

Speaker #2: Often with a heavy psychological burden and stigma. And today, too many patients are still relying on chronic steroids and symptomatic therapy. Which comes with an unacceptable treatment burden over time.

Speaker #2: For the first time, we are bringing forward a therapy that's pathological mechanism of ocular MG. And that is something we should all be excited about.

Speaker #2: Based on these results, we plan to file an SBLA with the FDA. Now, before I turn the call over to Karl, I want to sincerely thank the investigators, site teams, and most importantly, the patients and families who made this study possible.

Speaker #2: Karl?

Speaker #3: Thank you, Luke. Slide 10. The fourth quarter and full year 2025 financial results are detailed in this morning's press release. Product net sales are consistent with our pre-announcements in January, at $1.3 billion for the fourth quarter, and $4.2 billion for the full year.

Karl Gubitz: Thank you, Luc. Slide 10. The Q4 and full year 2025 financial results are detailed in this morning's press release. Product net sales are consistent with our pre-announcement in January, at $1.3 billion for Q4 and $4.2 billion for the full year, which represents a year-over-year growth of 90%. The regional breakdown of product revenue in Q4 2025 reflects $1.1 billion in the US, $63 million in Japan, $110 million in the rest of the world, and $26 million in product supply to Zai Lab in China. The product net sales in the US grew by 68% from Q4 of the prior year, reflecting solid patient demand and prescriber confidence driven by PFS.

Speaker #3: Which represents a year-over-year growth of 90%. The regional breakdown of product revenue in Q4 2025 reflects $1.1 billion in the US, $63 million in Japan, $110 million in the rest of the world, and $26 million in product supply to Zilab in China.

Speaker #3: The product net sales in the US grew by 68% from the fourth quarter of a prior year, reflecting solid patient demand and prescriber confidence driven by PFS.

Speaker #3: The gross-to-net adjustments and the net pricing in the US are in line with the prior quarter. Next slide, slide 11. Total operating expenses in the fourth quarter are $955 million.

Karl Gubitz: The gross to net adjustments and the net pricing in the US are in line with the prior Q. Next slide 11. Total OpEx in Q4 are $955 million, representing an increase of $149 million compared to Q3. Cost of sales for the Q is $150 million, as our year-to-date gross margin remains consistent at 11%. The combined R&D and SG&A expenses total $2.7 billion for the full year, which is in line with the financial guidance for 2025, discussed in our most recent earnings call. Looking ahead into 2026, OpEx will continue to grow at a similar percentage as in prior years. SG&A growth will support the significant revenue growth in our current markets, as well as expansion into new patient populations.

Speaker #3: Representing an increase of $149 million compared to the third quarter. Cost of sales for the quarter is $150 million. As our year-to-date gross margin remains consistent at 11%.

Speaker #3: The combined R&D and SG&A expenses total $2.7 billion for the full year. Which is in line with the financial guidance for 2025 discussed in our most recent earnings call.

Speaker #3: Looking ahead into 2026, operating expenses will continue to grow at a similar percentage as in prior years. SG&A growth will support the significant revenue growth in our current markets as well as expansion into new patient populations.

Speaker #3: R&D expenses will increase due to our continued commitment to execute on our pipeline. Our operating profit for the quarter is $367 million. And $1.1 billion for the year which marks our first year of annual operating profitability.

Karl Gubitz: R&D expenses will increase due to our continued commitment to execute on our pipeline. Our operating profit for the quarter is $367 million, and $1.1 billion for the year, which marks our first year of annual operating profitability. Tax for the quarter and full year reflects a net benefit, which is largely due to non-recurring tax items and favorable foreign exchange movements. Going forward, you should continue to expect an effective tax rate in the low to mid-teens. This brings us to the profit for Q4 of $533 million, and $1.3 billion for the full year, respectively. Our cash balance, represented by cash equivalents, and current financial assets, is $4.4 billion at the end of Q4, which represents a more than $1 billion increase over the year.

Speaker #3: Tax for the quarter and full year reflects a net benefit. This is largely due to non-recurring tax items and favorable foreign exchange movements. Going forward, you should continue to expect an effective tax rate in below to mid-teens.

Speaker #3: This brings us to the profit for the fourth quarter of $533 million. And $1.3 billion for the full year respectively. Our cash balance represents by cash, cash equivalents, and current financial assets is $4.4 billion.

Speaker #3: At the end of the fourth quarter, which represents a more than $1 billion increase over the year. The strength of our balance sheet allows us to invest with confidence in growing our commercial business as well as our pipeline.

Karl Gubitz: The strength of our balance sheet allows us to invest with confidence in growing our commercial business as well as our pipeline. I will now turn the call over to Sandrine, who will provide details on the commercial front.

Speaker #3: I will now turn the call over to Sandrine who will provide details on the commercial front.

Speaker #1: Thank you, Karl. Slide 12. I'm thrilled to be joining ArgenX at such a pivotal moment. What excites me most is the combination of both science and a deeply patient-driven mission.

Sandrine Piret-Gerard: Thank you, Karl. Slide 12. I'm thrilled to be joining argenx at such a pivotal moment. What excites me most is the combination of bold science and a deeply patient-driven mission, what I often describe as science with purpose. I've spent time in the field already, met clinicians, and seen firsthand the real impact our science is having on patients' lives. With Vision 2030 as a roadmap, we have a clear path to meaningfully improve the lives of more than 50,000 patients. Slide 13. Echoing Karen Massey, we enter 2026 from a position of strength, following a year of phenomenal execution. We closed 2025 with approximately 19,000 patients on treatment globally, reflecting consistent growth across all regions and all indications. We successfully launched the prefilled syringe, which has proven to be a key driver in increased overall VYVGART demand.

Speaker #1: What I often describe as science with purpose. I've spent time in the field already, met clinicians, and seen firsthand the real impact our science is having on patients' lives.

Speaker #1: With Vision 2030 as a roadmap, we have a clear path to meaningfully improve the lives of more than 50,000 patients. Slide 13. Echoing Karen, we enter 2026 from a position of strength following a year of phenomenal execution.

Speaker #1: We close 2025 with approximately $19,000 patients on treatment globally. Reflecting consistent growth across all regions, and all indications. We successfully launched the prefill syringe, which has proven to be a key driver in increased overall VivGart demand.

Speaker #1: At the end of the fourth quarter, we had more than 4,700 prescribers including 1,000 new prescribers since the PFS launch. This momentum underscores the execution strength of our field teams, the added convenience the PFS brings to patients, and the growing confidence in VivGart among clinicians.

Sandrine Piret-Gerard: At the end of Q4, we had more than 4,700 prescribers, including 1,000 new prescribers since the PFS launch. This momentum underscores the execution strength of our field teams, the added convenience the PFS brings to patients, and the growing confidence in VYVGART amongst clinicians. As we highlighted at the start of the year, our next chapter is about applying a proven indication expansion playbook to reach even more patients. MG and CIDP remain the cornerstone of our commercial strength, and we are well positioned to build on that foundation as we scale. Slide 14. We entered the MG market with strong biology and a first-in-class therapy. Since then, we have redefined what patients and clinicians can expect with the highest MSC and a favorable safety and tolerability profile.

Speaker #1: As we highlighted at the start of the year, our next chapter is about applying our proven indication expansion playbook to reach even more patients.

Speaker #1: MG and CIDP remain the cornerstone of our commercial strength, and we are well positioned to build on that foundation as we scale. Slide 14.

Speaker #1: We entered the MG market with strong biology and a first-in-class therapy. Since then, we have redefined what patients and clinicians can expect with the highest MSC and a favorable safety and tolerability profile.

Speaker #1: As a result, Vyvgart is the fastest-growing and number one prescribed biologic in MG, with continued momentum driven by earlier line adoption. Six out of ten MG patients starting on a biologic start with Vyvgart.

Sandrine Piret-Gerard: As a result, VYVGART is the fastest-growing and number one prescribed biologics in MG, with continued momentum driven by earlier line adoption. 6 out of 10 MG patients starting on biologic start with VYVGART. 70% of VYVGART patients are already coming from orals, and we believe the PFS will continue to help drive near-term growth. We are now on track to reach 18,000 additional patients through two label expanding opportunities, seronegative and ocular MG. Seronegative MG alone has the potential to move us towards the broadest possible MG label with our May PDUFA just around the corner. Ocular MG gives us a chance to be the first to market in a patient group that has had no precision treatment options.

Speaker #1: 70% of VivGart patients are already coming from orals. And we believe the PFS will continue to help drive near-term growth. We are now on track to reach $18,000 additional patients through two label expanding opportunities.

Speaker #1: Seronegative and ocular MG. Seronegative MG alone has the potential to move us towards the broadest possible MG label with our MEPEDUFA just around the corner.

Speaker #1: And ocular MG gives us a chance to be the first to market in a patient group that has had no precision treatment options. What gives us confidence here is that this expansion built on strong relationships we have already established with neurologists, many of whom are confident in VivGart through the experience treating generalized MG.

Sandrine Piret-Gerard: What gives us confidence here is that these expansions build on strong relationships we have already established with neurologists, many of whom are confident in VYVGART through the experience treating gMG. Slide 15. We are earlier in the CIDP launch trajectory, but are delivering on the same disciplined approach that has led to a successful market expansion in MG. Significant opportunity remains within the 12,000 patients who are not well managed on current treatment, and our focus today is on continued evidence generation, patient activation, and new prescriber adoption. Clinicians continue to respond to the meaningful functional benefit data and well-characterized safety shown in the ADHERE trial. The prefilled syringe is further driving uptake by reducing the administration burden and offering more flexibility to patients. Worth noting, we secured an important access win for PFS in Q4 with UnitedHealthcare, broadening our covered lives to over 90%.

Speaker #1: Slide 15. We are earlier in the CIDP launch trajectory, but our delivering on the same discipline approach that has led to our successful market expansion in MG.

Speaker #1: Significant opportunity remains within the $12,000 patients who are not well managed on current treatment. And our focus today is on continued evidence generation, patient activation, and new prescriber adoption.

Speaker #1: Clinicians continue to respond to the meaningful functional benefit data and well-characterized safety shown in the adhered trial. The prefill syringe is further driving uptake by reducing the administration burden and offering more flexibility to patients.

Speaker #1: Worth noting, we secured an important access win for PFS in Q4 with United Healthcare. Broadening our covered lives to over 90%. CIDP is a highly heterogeneous disease, and we are committed to advancing the science to expand our reach to broader set of patients.

Sandrine Piret-Gerard: CIDP is a highly heterogeneous disease, and we are committed to advancing the science to expand our reach to a broader set of patients. Our biomarker program is designed to better define responders and unlock earlier and broader use, and we are advancing empasiprubart in a head-to-head study against IVIG to further explore the bounds of efficacy. Together, these efforts position us to expand the CIDP population we can serve and continue shaping this market over the long term. Slide 16. Our clinical pipeline continues to broaden and deepen, providing a multiyear runway for commercial growth. I'm excited to join the company at this pivotal moment to help scale the organization thoughtfully and translate this pipeline into even greater patient impact. With that, I'll now turn the call over to Tim.

Speaker #1: Our biomarker program is designed to better define responders and allocate earlier and broader use. And we are advancing empathy for BART in a head-to-head study against IVIG to further explore the bounds of efficacy.

Speaker #1: Together, these efforts position us to expand the CIDP population we can serve and continue shaping this market over the long term. Slide 16. Our clinical pipeline continues to broaden and deepen providing a multi-year runway for commercial growth.

Speaker #1: I'm excited to join the company at this pivotal moment to help scale the organization thoughtfully and translate this pipeline into even greater patient impact.

Speaker #1: With that, I'll now turn the call over to Tim.

Speaker #4: Thank you, Sandrine. Reflecting on where we stand, ArgenX has never been better positioned and our leadership transition comes at the right moment as we enter our next phase of growth.

Tim Van Hauwermeiren: Thank you, Sandrine. Reflecting on where we stand, argenx has never been better positioned, and our leadership transition comes at the right moment as we enter our next phase of growth. Karen is the right leader to take this forward. She understands our innovation playbook, leads with patients at the center of every decision, and brings the operational discipline needed to continue executing against Vision 2030 and beyond. I have complete confidence that she will nurture what has always made argenx special while driving the next chapter of growth for the company. My dedication to argenx and to our mission remains as strong as ever. I look forward to supporting Karen and the entire leadership team as we continue to advance meaningful innovation and deliver for patients and shareholders alike. With that, operators, we'll open the call up to questions.

Speaker #4: Karen is the right leader to take this forward. She understands our innovation playbook, leads with patients at the center of every decision, and brings the operational discipline needed to continue executing against Vision 2030 and beyond.

Speaker #4: I have complete confidence that she will nurture what has always made ArgenX special while driving the next chapter of growth for the company. My dedication to ArgenX and to our mission remains as strong as ever.

Speaker #4: I look forward to supporting Karen and the entire leadership team as we continue to advance meaningful innovation and deliver for patients and shareholders alike.

Speaker #4: With that, operators, we'll open the call up to questions.

Speaker #3: 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.

Ram: 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 today comes from the line of Tazeen Ahmad from Bank of America. Your line is open.

Operator: 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 today comes from the line of Tazeen Ahmad from Bank of America. Your line is open.

Speaker #3: 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 today comes from of America.

Speaker #3: Your line is open.

Speaker #5: Okay. Good morning. Thanks for taking my question. First off, Karen, congratulations on the new role. We're looking forward to continuing to work with you.

Tazeen Ahmad: Okay, good morning. Thanks for taking my question. First off, Karen, congratulations on the new role. We're looking forward to continuing to work with you. Tim, what else can I say, but thank you. You've set the example for everyone to follow, and we wish you the best in your new upcoming role as well. My first question is going to be on the addition of both seronegative as well as based on today's results, assuming ocular MG to the revenue stream for VYVGART. How should we think about, number 1, what the average price would be for each of these sub-indications?

Speaker #5: And Tim, what else can I say but thank you? You've set the example for everyone to follow. And we wish you the best in your new upcoming role as well.

Speaker #5: So my first question is going to be on the addition of both seronegative as well as based on today's results, assuming ocular MG to the revenue stream for VivGart.

Speaker #5: How should we think about, number one, what the average price would be for each of these sub-indications? And can you talk to us about what proportion you've talked to us about how many patients there are?

Tazeen Ahmad: You've talked to us about how many patients there are, but have you done any market data research to indicate what proportion of those patients are more likely to seek this type of treatment? Thanks.

Speaker #5: But have you done any market data research to indicate what proportion of those patients are more likely to seek this type of treatment? Thanks.

Speaker #6: Well, thank you Tazin for your comments. And also for your question. It's a really exciting day for ocular MG patients. And certainly for ArgenX.

Karen Massey: Well, thank you, Tazeen, for your comments, and also for your question. It's a really exciting day for ocular MG patients and certainly for argenx, as you call out. You know, it's important to think about the fact that we are now the first and only, or VYVGART is the first and only to have positive data for patients with ocular MG. A really exciting day for patients. As you called out, that combined with the seronegative data that just read out a few months ago, and we have the producer date in May, really positions us well for continued sustained growth in MG, and I think an expansion even further about our leadership position in MG. We're very excited to share that data today.

Speaker #6: As you call out, it's important to think about the fact that we are now the first and only VivGart is the first and only to have positive data for patients with ocular MG.

Speaker #6: So a really exciting day for patients. And as you called out, that combined with the seronegative data that just read out a few months ago, and we have the PEDUFA date in May, really positions us well for continued sustained growth in MG.

Speaker #6: And I think an expansion even further about our leadership position in MG. So we're very excited to share that data today. I'll let Karl talk to the price in a moment.

Karen Massey: I'll let Karl talk to the price in a moment, just on the second part of your question around the addressable market. We obviously have done quite a bit of market research and we'll continue to do so to prepare for how best to go to market. The best numbers to look at are those that we've provided with the seronegative, expanding the addressable market by 11,000 patients and ocular by 7,000 patients that we've provided before. That 7,000 patients in ocular MG, that's not the total ocular MG patient population. That's actually the portion that when we've done the research before, we thought would be eligible for VYVGART. That's the number that I would stick with.

Speaker #6: But just on the second part of your question around the addressable market, we obviously have done quite a bit of market research and will continue to do so to prepare for how best to go to market.

Speaker #6: But the best numbers to look at are those that we've provided with the seronegative expanding the addressable market by 11,000 patients and ocular by 7,000 patients.

Speaker #6: That we've provided before. That 7,000 patients in ocular MG, that's not the total ocular MG patient population. That's actually the portion that when we've done the research before, we thought would be eligible for VivGart.

Speaker #6: So that's the number that I would stick with. And obviously, as we get closer to as we unpack the data more, as we get closer to submission, and hopefully approval, we'll be able to provide more color on that.

Karen Massey: Obviously, as we unpack the data more, as we get closer to submission and hopefully approval, we'll be able to provide more color on that. Maybe, Karl, you could comment on the price.

Speaker #6: And then maybe Karl, you could comment on the price.

Speaker #7: Thank you, Karen. And Tazin, thank you for the question. Yeah, we still have to have the discussions with the players of course. But I do want to mention that we have a strong capability in market access.

[Company Representative] (argenx): Thank you, Karen, and Tazeen, thank you for the question. Yeah, we still have to have the discussions with the payers, of course, but I do want to mention that we have a strong capability in market access. It is an enabler of our launch, not a hurdle, and the value proposition of VYVGART is well understood and appreciated by all stakeholders. At this stage, I will say that we would expect to have broad access also for seronegative and ocular, and we can assume a similar price as MG, i.e., $225,000, the net benefit or the net price to argenx. Thank you for the question.

Karl Gubitz: Thank you, Karen, and Tazeen, thank you for the question. Yeah, we still have to have the discussions with the payers, of course, but I do want to mention that we have a strong capability in market access. It is an enabler of our launch, not a hurdle, and the value proposition of VYVGART is well understood and appreciated by all stakeholders. At this stage, I will say that we would expect to have broad access also for seronegative and ocular, and we can assume a similar price as MG, i.e., $225,000, the net benefit or the net price to argenx. Thank you for the question.

Speaker #7: It is an enabler of our launch, not a hurdle. And the value proposition of VivGart is well understood and appreciated by all stakeholders. At this stage, I will say that we would expect to have broad access also for seronegative and ocular.

Speaker #7: And we can assume a similar price as MG, i.e., 225,000 net benefit or a net price to ArgenX. Thank you for the question.

Speaker #3: Your next question comes from the line of Danielle Brill from Truist Securities. Your line is open.

Ram: Your next question comes from the line of Danielle Brill from Truist Securities. Your line is open.

Operator: Your next question comes from the line of Danielle Brill from Truist Securities. Your line is open.

Speaker #8: Hi guys. Good morning. Thanks so much for the question. I think I'll ask a question on the CIDP opportunity. Karen, you mentioned in your prepared remarks that you're beginning to see expansion beyond the initial 12,000 patients that you were targeting.

Danielle Brill: Hi, guys. Good morning. Thanks so much for the question. I think I'll ask a question on the CIDP opportunity. Karen, you mentioned in your prepared remarks that you're beginning to see expansion beyond the initial 12,000 patients that you were targeting. Can you elaborate a bit? Are you seeing a step up in frontline use? I think you also mentioned that you secured additional coverage, broadening coverage for PFS to over 90% of covered lives. What impact do you expect this to have on adoption rates in this setting going forward? Thank you.

Speaker #8: Can you elaborate a bit? Are you seeing a step up in frontline use? And then I think you also mentioned that you secured additional coverage broadening coverage for PFS to over 90% of covered lives.

Speaker #8: What impact do you expect this to have on adoption rates in this setting going forward? Thank you.

Speaker #6: Thanks, Danielle, for the question and the interest in CIDP. We're really pleased with the continued growth in CIDP. So yeah, we laid out that the strategy was first to focus on that 12,000 patients that are treated, that are already treated, but continue to have symptoms.

Karen Massey: Thanks, Danielle, for the question and the interest in CIDP. We're really pleased with the continued growth in CIDP. You know, we laid out that the strategy was first to focus on that 12,000 patients that are already treated, but continue to have symptoms. That is continues to be where we see the majority of our patients and the majority of our growth. You'll recall that our label does allow us to be used in a broader patient population, and there are some payer policies actually that also allow that. We are starting to see some use of VYVGART beyond just the switch from IVIG.

Speaker #6: And that is continues to be where we see the majority of our patients and the majority of our growth. But you'll recall that our label does allow us to be used in a broader patient population.

Speaker #6: And there are some payer policies actually that also allow that. So we are starting to see some use of VivGart beyond just the switch from IVIG.

Karen Massey: In general, it's still about at 85% of our patients are being switched from IVIG, but there are some that are coming directly. I think as prescribers and neurologists get more experience with VYVGART and see the impact in the real world, then over time, we'll start to see that expansion even more. As you said, continuing to expand access with the recent UnitedHealthcare decision and having 90% coverage, that also helps to contribute to our growth. I would say what to expect in CIDP is that continued steady momentum. We're still early in the launch, and so I think we still have some quite a bit of growth ahead of us. Thanks for the question.

Speaker #6: In general, it's still about an 85% of our patients are being switched from IVIG. But there are some that are coming directly. I think as prescribers and neurologists get more experience with VivGart and see the impact in the real world, then you'll then over time, we'll start to see that expansion even more.

Speaker #6: And as you said, continuing to expand access with the recent United Healthcare decision and having 90% coverage, that also helps to contribute to our growth.

Speaker #6: So I would say what to expect in CIDP is that continued steady momentum we're still early in the launch. And so I think we still have some quite a bit of growth ahead of us.

Speaker #6: Thanks for the question.

Speaker #3: Your next question comes from a line of Derek Arquila from Wells Fargo. Your line is open.

Ram: Your next question comes from a line of Derek Archila from Wells Fargo. Your line is open.

Operator: Your next question comes from a line of Derek Archila from Wells Fargo. Your line is open.

Speaker #9: Hey, good morning and congrats on the progress in the phase three win today. So I had a question on do you think approval in ocular MG will drive more utilization in the less advanced MG patients?

Derek Archila: Hey, good morning, and congrats on the progress in the Phase 3 win today. I had a question on, you know, do you think approval in ocular MG will drive more utilization in the less advanced MG patients? I guess, is there anything in the data set that you'll present in the future that could demonstrate prevention of progression to more generalized disease? Thanks.

Speaker #9: And I guess is there anything in the data set that you'll present in the future that could demonstrate prevention of progression to more generalized disease?

Speaker #9: Thanks.

Speaker #6: Yeah, thanks for the question, Derek. I'll comment on the first and then maybe Luke, I can hand it to you for the data. So certainly, I think that our hypothesis I mean, we know that in MG, the majority of patients first do present with ocular symptoms.

Karen Massey: Yeah. Thanks for the question, Derek. I'll comment on this first, then maybe, Luc, I can hand it to you for the data. Certainly, I think that our hypothesis, I mean, we know that, in MG, the majority of patients first do present with ocular symptoms, and then the majority of those ocular MG patients do transition into gMG. A big part of our strategy is expanding the use of biologics to earlier line uses of MG. We are already seeing that. Biologic use is growing in generalized MG. We get 6 out of 10 of those patients that are first first-use biologics, so we're driving a lot of that earlier use and a lot of that growth.

Speaker #6: And then the majority of those ocular MG patients do transition into GMG. So a big part of our strategy is expanding the use of biologics to early align uses of MG.

Speaker #6: We are already seeing that. Biologic use is growing in generalized MG. We are driving we get 6 out of 10 of those patients that are first-use biologics.

Speaker #6: So we're driving a lot of that earlier use and a lot of that growth. As you say, I think the ocular MG data will help us with that strategy and will provide a halo to that strategy.

Karen Massey: As you say, I think the ocular MG data will help us with that strategy and will provide a halo to that strategy. Maybe, Luc, you could comment on the data and the progression.

Speaker #6: And then maybe Luke, you could comment on the data and progression.

Speaker #7: Yeah. Thanks, Karen. And thanks, Derek, for the question, which is close to my heart. So with the data in hand, we show that we can meaningfully impact the current symptomatology of ocular MG.

[Company Representative] (argenx): Yeah. Thanks, Karen, and thanks, Derek, for the question, which is close to my heart. With the data in hand, we show that we can meaningfully impact the current symptomatology of ocular MG, which is not MG-like. It's a significantly debilitating state to be in. Of course, the excitement of continuing to collect long-term data, as we are planning to do, and compare that to what is known with the natural progression, which, as Karen said, is a high percentage, up to 80%, will allow us to make some statements on: Do we delay progression to generalized MG? I would say stay tuned.

Luc Truyen: Yeah. Thanks, Karen, and thanks, Derek, for the question, which is close to my heart. With the data in hand, we show that we can meaningfully impact the current symptomatology of ocular MG, which is not MG-like. It's a significantly debilitating state to be in. Of course, the excitement of continuing to collect long-term data, as we are planning to do, and compare that to what is known with the natural progression, which, as Karen said, is a high percentage, up to 80%, will allow us to make some statements on: Do we delay progression to generalized MG? I would say stay tuned.

Speaker #7: Which is not MG live. It's a significantly debilitating state to be in. But of course, the excitement of continuing to collect long-term data as we are planning to do and compare that to what is known with the natural progression, which, as Karen said, is a high percentage of the 80%.

Speaker #7: Will allow us to make some statements on do we delay progression to generalized MG. So I would say, stay tuned.

Speaker #6: Great. Thanks, Luke.

Karen Massey: Great. Thanks, Luke.

Speaker #3: Your next question comes from a line of Yetin Saneh from Guggenheim. Your line is open.

Ram: Your next question comes from the line of Yatin Suneja from Guggenheim. Your line is open.

Operator: Your next question comes from the line of Yatin Suneja from Guggenheim. Your line is open.

Speaker #5: Hey guys. Thank you for taking my question. Just with regard to the Q1 dynamics, could you point to us if there are any particular consideration that we should have for Q1 in particular?

Yatin Suneja: Hey, guys. Thank you for taking my question. Just with regard to the Q1 dynamics, could you point to us if there are any particular consideration that we should have for Q1 in particular? Thank you.

Speaker #5: Thank you.

Speaker #6: Yeah. Thanks for the question. And it's important as we're in Q1. So obviously, across the industry, we can see the pattern that there are always Q1 dynamics around re-verifications and windstorms of which we've had quite a few.

Karen Massey: Yeah. Thanks for the question. It's important as we're in Q1. Obviously, across the industry, we can see the patterns that there always are Q1 dynamics around reverifications and winter storms, of which we've had quite a few in the last couple of weeks. argenx and VYVGART are of course privy to the same, those same seasonal dynamics, and we saw that last year as well. If you recall, we did have a slowdown in Q1, and then in the end of the year, we delivered 90% full-year growth. I think you can recognize the pattern and expect that, but maybe, Sandrine, you could comment on the underlying dynamics that we're seeing since you've joined.

Speaker #6: In the last couple of weeks. So ArgenX and VivGart are, of course, privy to the same those same seasonal dynamics. And we saw that last year as well.

Speaker #6: If you recall, we did have a slowdown in Q1. And then, at the end of the year, we delivered 90% full-year growth. So I think you can recognize the pattern and expect that.

Speaker #6: But maybe, Sandrine, you could comment on the seeing since you've joined.

Speaker #4: Yeah. Thank you, Karen. And this is something that I looked at before joining ArgenX. What is the growth we are seeing? And year after year, we have been delivering consistent growth.

Sandrine Piret-Gerard: Yeah, thank you, Karen. This is something that I looked at before joining argenx. What is the growth we are seeing? Year after year, we have been delivering consistent growth, and this is a pattern you can expect this year, full year, because the underlying dynamics are very healthy. I mean, when you look at the new patient starts, the provider and the prescriber expansion. When you look at our access, we just mentioned that, but also how strong we are, and VYVGART is in leading the growth of the overall biologic market. These are all amazing underlying that factors that will help us continue that growth.

Speaker #4: And this is a pattern you can expect this year full year. Because the underlying dynamic has very healthy. I mean, when you look at the new patient starts, the provider and the prescriber expansion, when you look at our access, we just mentioned that, but also our strong we are and VivGart is in leading the growth of the overall biologic market.

Speaker #4: These are all amazing underlying that factors that will help us continue that growth. And then you had the PFS that was launched less than a year ago that drove a lot of momentum last year, plus the expansion of the labels that we are expecting both for seronegative and later for ocular.

Sandrine Piret-Gerard: You had the PFS that was launched less than a year ago, that drove a lot of momentum last year, plus the expansion of the labels that we are expecting, both for seronegative and later for ocular. All are good underlying factor that will help us continue that growth, as Karen mentioned.

Speaker #4: So all are good underlying factors that will help us continue that growth as Karen mentioned.

Speaker #3: Your next question comes from a line of James Gordon from Berkeley's. Your line is open.

[Operator]: Your next question comes from the line of James Gordon from Barclays. Your line is open.

Operator: Your next question comes from the line of James Gordon from Barclays. Your line is open.

Speaker #5: Hello, James Gordon from Berkeley's. Thank you for taking the question. The question was on VivGart from my side. So my question was, what is the efficacy bar you're looking to exceed in the phase three?

James Gordon: Hello, James Gordon from Barclays. Thank you for taking the question. The question was on VYVGART for myositis, and my question was: What is the efficacy bar you're looking to exceed in the phase 3 in myositis in Q3? What's a good result? Is the hope to be more efficacious than Provance/Brepo, so Ajantic, and what they did in the VALOR trial? Is it more, a good result would be if you had a similar efficacy and you were better tolerated as well. What's good and what's really good? Could I also just squeeze in a clarification, not a question, but just normally there's an OpEx guide, but I didn't see a formal guide this year. Should we assume a similar pace of OpEx growth this year as last year, so 25 similar pace to 26?

Speaker #5: In my side, it's in Q3. What's a good result? Is there hope to be more efficacious than Proviance Brepo? So Ajactiq. And what they did in the Valotrial.

Speaker #5: Or is it more a good result would be if you had the similar efficacy and you were better tolerated as well? So what's good and what's really good?

Speaker #5: And could I also just squeeze in a clarification, not a question, but just normally, there's an OPEX guide, but I didn't see a formal guide this year.

Speaker #5: Should we assume a similar pace of OPEX growth this year as last year? So 25 similar pace to 26. And maybe more R&D and less SGNA.

James Gordon: Maybe more R&D and less SG&A. How do we think about spend this year, please?

Speaker #5: How do we think about spend this year, please?

Speaker #6: Yeah. Thanks for the questions. They're James and so I'll open. I'll hand over to Luke to provide some more color on my side and then Carl on OPEX.

Karen Massey: Yeah, thanks for the questions there, James. I'll open. I'll hand over to Luc to provide some more color on myositis and then Karl on OpEx. The first thing that I just wanted to frame is, you know, when you think about myositis, it's right out of the argenx playbook. I mean, there is so little options available to patients here, really limited innovation in the market. What we're looking for is a statistical significant benefit coming out of this study. In the DM, in IM, in IMNM, there are no approved therapies available, and you heard in the script that there are 20,000 patients with IMNM. For them, any benefit, I think, is clinically meaningful.

Speaker #6: But the first thing that I just wanted to frame is when you think about myositis, it's right out of the ArgenX playbook. I mean, there is so little options available to patients here.

Speaker #6: Really limited innovation in the market. And so what we're looking for is a statistical significant benefit coming out of this study in the DM, in IM.

Speaker #6: In IM and M, there are no approved therapies available. And you heard in the script that there are 20,000 patients with IM and M.

Speaker #6: So for them, any benefit, I think, is clinically meaningful. But maybe, Luke, you could talk about how we're thinking about the study.

Karen Massey: Maybe, Luc, you could talk about how we're thinking about the study.

Speaker #7: Yeah. Thanks, and also for laying it up that this is not a singular indication. So this is a constellation of indications that each have somewhat different pathological drivers.

Luc Truyen: Yeah, thanks, and also for laying it out that this is not a singular indication. This is a constellation of indications that each have somewhat different pathological drivers. We continue our phase 3 build program based on the strength of a robust phase 2, which gave us the confidence that we could provide meaningful benefit across the 3 subsets. Ultimately, the data will speak once we complete phase 3. With respect to relative benefit compared to others, of course, studies are hard to compare. The DM results of Brepo certainly is encouraging for the DM patients. We believe that in DM, multiple modes of actions could play a role, and therefore, we will go on the strength of our own data. In any event, positive data in these diseases is always good for the patients.

Speaker #7: We continue our phase three program based on the strength of the robust phase two. Which gave us the confidence that we could provide meaningful benefit across the three subsets.

Speaker #7: Ultimately, the data will speak once we complete phase three. With respect to relative benefit compared to others, of course, studies are hard to compare.

Speaker #7: And the DM results of Brepo certainly is encouraging for the DM patients. But we believe that in DM, multiple modes of actions could play a role.

Speaker #7: And therefore, we will go on the strength of our own data. In any event, positive data in these diseases is always good for the patients.

Speaker #6: Thank you, Luke. And maybe, Carl, comment on the OPEX.

Karen Massey: Thank you, Luc, and maybe Carl, comment on the OpEx.

[Operator]: Thank you. James, thank you for the question. In 2025, we spent around $2.7 billion on combined R&D and SG&A. That is around 30% increase over 2024. Looking ahead, you can expect the combined R&D and SG&A to grow at a similar rate, with most of the growth in R&D, because that is where we're going to invest to set the company up for the long run, investing in our very exciting pipeline. Thank you for the question, James. Your next question comes from a line of Alex Thompson from Stifel. Your line is open.

Karl Gubitz: Thank you. James, thank you for the question. In 2025, we spent around $2.7 billion on combined R&D and SG&A. That is around 30% increase over 2024. Looking ahead, you can expect the combined R&D and SG&A to grow at a similar rate, with most of the growth in R&D, because that is where we're going to invest to set the company up for the long run, investing in our very exciting pipeline. Thank you for the question, James. Your next question comes from a line of Alex Thompson from Stifel. Your line is open.

Speaker #5: James, thank you for the question. Yeah. In 2025, we spent around 2.7 billion dollars on combined R&D and SGNA. That is around. Very free 0% increase over 2024.

Speaker #5: Looking ahead, you can expect the combined R&D and SGNA to grow at a similar rate with most of the growth in R&D because that is where we're going to invest to set the company up for the long run.

Speaker #5: Investing in our very exciting pipeline. So thank you for the question, James.

Speaker #3: Your next question comes from a line of Alex Thompson from Stifel. Your line is open.

Speaker #8: Hey, great. Good morning. Thanks for taking our question. Maybe on Graves, I was wondering if you could comment on where you're at from a regulatory discussion perspective on starting the pivotal and whether you think that a single pivotal could be sufficient for an SBLA or whether you might need two studies.

Sandrine Piret-Gerard: Hey, great, good morning, thanks for taking our question. Maybe on Graves, I was wondering if you would comment on where you're at from a regulatory discussion perspective on starting the pivotal, and whether you think that a single pivotal could be sufficient for an sBLA or whether you might need two studies. Thanks.

Speaker #8: Thanks.

Speaker #6: Yeah. Thanks for the question. We're excited about our Graves program. And it's well underway. Luke, do you want to comment on our strategy around the single study?

Karen Massey: Yeah, thanks for the question. We're excited about our Graves program, and it's well underway. Luc, do you want to comment on our strategy around the single study?

Speaker #7: Well, I mean, the ability to run a single study as sufficient evidence of efficacy and be able to define a benefit risk is actually not new.

Luc Truyen: Well, I mean, the ability to run a single study as sufficient evidence of efficacy and be able to define a benefit risk is actually not new. That always existed, but it was at the discretion of the individual divisions as to how much they accepted that or not. This particular division has asked us at this moment for two trials, which we are executing on.

Speaker #7: That always existed. But it was at the discretion of the individual divisions as to how much they accepted that or not. This particular division has asked us at this moment for two trials, which we are executing on.

Speaker #6: Thanks for the question.

Karen Massey: Thanks for the question.

Speaker #3: Your next question comes from a line of Matt Phipps from William Blair. Your line is open.

[Operator]: Your next question comes from a line of Matt Phipps from William Blair. Your line is open.

Operator: Your next question comes from a line of Matt Phipps from William Blair. Your line is open.

Speaker #5: Thanks for digging my question here. It's on the quarter and progress here. I was wondering if you might be able to give us any more details on the auto injector, how you can position that versus the PFS, and maybe if that can just continue the continued expansion you're seeing from that PFS launch across indications.

Matt Phipps: Thanks for taking my question here. It's on the quarter and progress here. Just wondering if you might be able to give us any more details on the auto-injector, how you can position that versus the PFS, and maybe if that can just continue the continued expansion you're seeing from that PFS launch across indications. Thank you.

Speaker #5: Thank you.

Speaker #6: Yeah. Thanks for the question. We're excited about the auto injector. And I think it just reinforces our innovation playbook, right? Just continually bringing more and more innovation as we drive leadership in the MG market.

Karen Massey: Yeah, thanks. Thanks for the question. We're excited about the auto-injector, I think it just reinforces our innovation playbook, right? Just continually bringing more and more innovation, as we drive leadership in the MG market. Auto-injector is on track. We have planned for 2027. The way we've talked about it is, it won't be such a step forward in the way that PFS was, because if you recall, the big step forward for prefilled syringe was that we moved from HCP administration to patient administration. That was a meaningful and important step forward for many patients, giving them the freedom to self-inject. Auto-injector doesn't provide that step change, but it does provide an important step for patients that provides a better experience for those patients, and especially those that are needle phobic.

Speaker #6: So auto injector is on track. We have planned for 2027. And the way we've talked about it is it won't be such a step forward in the way that PFS was because if you'll recall, the big step forward for prefilled syringe was that we moved from HCP administration to patient administration.

Speaker #6: And that was a meaningful and important step forward for many patients, giving them the freedom to self-inject. So auto injector doesn't provide that step change.

Speaker #6: But it does provide an important step for patients that provides a better experience for those patients and especially those that are needle phobic. Actually, we mentioned earlier we're here at the US National Field Meeting.

Karen Massey: Actually, we mentioned earlier, we're here at the US national field meeting. We had a patient just yesterday that was talking to our team, and she was sharing that she wanted to wait for auto-injector because the prefilled syringe needle was something that she was a little nervous about. It does provide value to patients, but it's not such a step forward that you should think of it as an accelerator in the way that the prefilled syringe was.

Speaker #6: We had a patient just yesterday that was talking to our team. And she was sharing that she wanted to wait for auto injector because the prefilled syringe needle was something that she was a little nervous about.

Speaker #6: So it does provide value to patients, but it's not such a step forward that you should think of it as an accelerator in the way that the prefilled syringe was.

Speaker #3: Your next question comes from a line of Akash Tawari from Jefferies. Your line is open.

Ram: Your next question comes from the line of Akash Tewari from Jefferies. Your line is open.

Operator: Your next question comes from the line of Akash Tewari from Jefferies. Your line is open.

Speaker #9: Hi. Thanks so much for taking our question. This is Amy on for Akash. Maybe just a quick one on your two next-gen SCRNs, 124 and 213.

Amy: Hi, thanks so much for taking our question. This is Amy on for Akash. Maybe just a quick one on your two next gen FcRns, ARGX-124 and ARGX-213. Are you seeing an accelerated path to registrational study? Can you give us a sense of how you're thinking about the indication and then the size of these trials? Thanks so much.

Amy Li: Hi, thanks so much for taking our question. This is Amy on for Akash. Maybe just a quick one on your two next gen FcRns, ARGX-124 and ARGX-213. Are you seeing an accelerated path to registrational study? Can you give us a sense of how you're thinking about the indication and then the size of these trials? Thanks so much.

Speaker #9: Are you seeing an accelerated path to registrational study? And can you give us a sense of how you're thinking about the indication and then the size of these trials?

Speaker #9: Thanks so much.

Speaker #6: Yeah. Thanks for the question and the interest in our future portfolio. Maybe I can start. The way that we think about our leadership of SCRN over the coming decades is that we know there is a lot of opportunity for SCRN.

Karen Massey: Yeah, thanks for the question and the interest in our future portfolio. Maybe I can start. The way that we think about our leadership of FcRn over the coming decades, is that we know there is a lot of opportunity for FcRn. In fact, probably more than we can explore with VYVGART alone. We see the opportunity of having two next-generation molecules as opening up the opportunity to provide a better patient experience in some of the indications we're already in, but also start to push the biology even further and expand the indications that an FcRn is making a difference to patients. I think that's the strategy that we're planning. We think each of the next-generation molecules will bring that benefit to patients.

Speaker #6: In fact, probably more than we can explore with Vyvgart alone. And so we see the opportunity of having two next-generation molecules as opening up the opportunity to provide a better patient experience in some of the indications we're already in, but also start to push the biology even further and expand the indications that we can that an SCRN is making a difference to patients.

Speaker #6: So I think that's the strategy that we're planning. We think each of the next-generation molecules will bring that benefit to patients. Thanks for the question.

Karen Massey: Thanks for the question.

Speaker #3: Your next question comes from a line of Jeroen Werber from TD Cowen. Your line is open.

Ram: Your next question comes from a line of Yaron Werber from TD Cowen. Your line is open.

Operator: Your next question comes from a line of Yaron Werber from TD Cowen. Your line is open.

Speaker #5: Great. Thanks and congrats on the ocular study. If you don't mind, I'm maybe a couple of questions. For empassion, you switched the primary endpoint to grip strength in the previous study in ARDA.

Yaron Werber: Great, thanks and congrats on the ocular study. If you don't mind, I've maybe a couple of questions. For empasiprubart, you switched the primary endpoint to grip strength. In the previous study in ARDA, you gave us sort of ranges of grip strength. Maybe help us understand how is it powered? Is it superiority sort of head-to-head? What's clinically meaningful? Secondly, Karen, we have a huge confidence in you and congrats on the role. Tim, we're just, you know, we continue to get questions on the timing. I know obviously, Peter is retiring as chair, but maybe give us a little bit of a sense what drove your decision to kind of step up to chair. Thanks so much.

Speaker #5: You gave us all the ranges of grip strength. So maybe help us understand how is it powered? Is it superiority sort of head-to-head? What's clinically meaningful?

Speaker #5: And then secondly, Karen, we have a huge confidence in you and congrats on the role. Tim, we're just we continue to get questions on the timing.

Speaker #5: I know obviously Peter is retiring as chair. But maybe give us a little bit of a sense what drove your decision to kind of step up the chair.

Speaker #5: Thanks so much.

Speaker #6: Thanks for the questions, Jeroen. I'll hand it over to Luke first to talk about empassion and then Tim, maybe you can take the follow-up question.

Karen Massey: Thanks for the questions, Yaron. I'll hand it over to Luc first to talk about empasiprubart, and then Tim, maybe you can take the follow-up question.

Speaker #7: Yeah. So in fact, this is a story of growing insights in data as they matured. As we looked at ARDA and ARDA Plus, so the phase twos, the signal we saw in grip strength gave us increasing confidence that this is really a real and patient-relevant outcome.

Luc Truyen: Yeah. In fact, this is a story of growing insights in data as they matured. As we looked at ARDA and ARDA+, the phase 2s, the signal we saw on grip strength gave us increasing confidence that this is really a real and patient-relevant outcome with an increasing separation over time or improvement over time, which in these patients was not seen before. That's ultimately why, in discussion with the agency, we started utilizing this endpoint as the primary. You asked about superiority. The study is set up as a non-inferiority study, but with a pre-specified option that if non-inferiority is met, that we can formally test superiority. The data will ultimately drive step 3.

Speaker #7: With an increasing separation over time, or improvement over time, which in these patients was not seen before. And that's ultimately why in discussion with agency, we started utilizing this endpoint as the primary.

Speaker #7: You asked about superiority. The study is set up as a non-inferiority study. But with a pre-specified option that if non-inferiority is met, that we can formally test superiority.

Speaker #7: The data will ultimately drive that F3.

Karen Massey: Thank you, Luke. Tim.

Speaker #6: Thank you, Luke. And Tim, comment.

Speaker #5: Hi, Jeroen. Thank you for the question. I think we're doing this transition out of a position of strength. I think now is the time to do the transition because the business and the organization is in a very healthy and a very strong state.

Luc Truyen: Hi, Yaron. Thank you for the question. I think we're doing this transition out of a position of strength. I think now is the time to do the transition because the business and the organization is in a very healthy and a very strong state. You have seen the pipeline. You know the profitability which we achieved, you know, during the course of last year. Very strong foundation of the business. From an internal candidate point of view, we are ready. Karen Massey knows the innovation playbook. She's a very strong carrier of the culture of the company, and she's ready to help us scale into our future because, you know, new therapeutic areas will come back relatively soon. Consider this as a proactive move based on a position of strength. Thanks for the question.

Speaker #5: You have seen the pipeline. You know the profitability which we achieved during the course of last year. Very strong foundation of the business. Also from an internal candidate point of view, we are ready.

Speaker #5: Karen knows the innovation playbook. She's a very strong carrier of the culture of the company. And she's ready to help us scale into our future because she knows new therapeutic areas will come on deck relatively soon.

Speaker #5: So consider this as a proactive move based on a position of strength. Thanks for the question.

Speaker #3: Your next question comes from a line of Thomas Smith from Larink Partners. Your line is open.

Ram: Your next question comes from a line of Thomas Smith from Leerink Partners. Your line is open.

Operator: Your next question comes from a line of Thomas Smith from Leerink Partners. Your line is open.

Speaker #10: Hey, guys. Good morning. Thanks for taking the questions. I was just wondering if you could provide a bit more color on the phase two A results for adamantobart and ALS.

Thomas J. Smith: Hey, guys. Good morning. Thanks for taking the questions. I was just wondering if you could provide a bit more color on the phase 2A results for adimanebart in ALS. Obviously, really difficult indication, very complex biology, but just wondering if there are any learnings from this study that could be applied to the phase 3 CMS program or potentially other indications. Thanks so much.

Thomas Smith: Hey, guys. Good morning. Thanks for taking the questions. I was just wondering if you could provide a bit more color on the phase 2A results for adimanebart in ALS. Obviously, really difficult indication, very complex biology, but just wondering if there are any learnings from this study that could be applied to the phase 3 CMS program or potentially other indications. Thanks so much.

Speaker #10: Obviously, really difficult indication, very complex biology. But just wondering if there are any learnings from this study that could be applied to the phase three CMS program or potentially other indications.

Speaker #10: Thanks so much.

Speaker #6: Yeah. I'll let Luke comment on the data.

Karen Massey: Yeah, I'll let Luke comment on the data.

Speaker #5: Yeah. Yeah. Thanks for that question. Evidently, not an outcome we were hoping for. We felt we had a moral obligation to explore ALS as an indication given our mode of action.

Luc Truyen: Yeah. Yeah, thanks for that question. Evidently, not an outcome we were hoping for. We felt we had a moral obligation to explore ALS as an indication, given our mode of action, trying to in this disease where there's very, very limited treatment options to see if we could move the dial. From our POC, the data unfortunately don't support progressing, but we learned a lot, not in the least about how novel endpoints could be used, and we hope to share that knowledge with the field. With respect to impact and learnings on CMS, the context of treatment is fundamentally different, and CMS is directly in the biology of this molecule with the Dok-7 and other mutations affecting the MuSK receptor.

Speaker #5: Trying to in this disease with a very, very limited treatment options to see if we could move the dial. From our POC, the data, unfortunately, don't support progressing.

Speaker #5: But we learned a lot. Not in the least about how novel endpoints could be used. And we hope to share that knowledge with the field.

Speaker #5: With respect to impact and learnings on CMS, the context of treatment is fundamentally different. CMS is directly in the biology of this molecule. With the DOC7 and other mutations affecting the mask receptor.

Luc Truyen: That's a much more direct application of this molecule, so we don't think there's a read-through. On our SMA program, likewise, where there is a backdrop of approved treatments, the gene therapies are very well established, and we are gonna evaluate whether we can have an add-on efficacy there, which is a different situation than ALS altogether.

Speaker #5: And so that's a much more direct application of this molecule. So we don't think there's a read-through. And on our SMA program, likewise, there is a backdrop of approved treatments.

Speaker #5: The gene therapies are very well established. And we are going to evaluate whether we can have an add-on efficacy there, which is a different situation than ALS altogether.

Speaker #3: Your next question comes from a line of Rajan Sharma from Goldman Sachs. Your line is open.

Ram: Your next question comes from a line of Rajan Sharma from Goldman Sachs. Your line is open.

Operator: Your next question comes from a line of Rajan Sharma from Goldman Sachs. Your line is open.

Rajan Sharma: Hi, thanks for taking my question. I had just a question on VYVGART growth dynamics through 2026. Just thinking about kind of the underlying growth outside of potential new indications, how should we think about growth across the various formulations of the drug? If you could maybe just comment on competitor dynamics. I realize there's been a recent new approval in myasthenia gravis. Could you just talk to your confidence in the VYVGART profile and to what extent you think you may be impacted by that emerging competition? Thank you.

Speaker #11: Hi. Thanks for taking my question. I had just a question on Vyvgart growth dynamics through 2026. So just thinking about kind of the underlying growth outside of potential new indications, how should we think about growth across the various formulations of the drug?

Speaker #11: And if you could maybe just comment on competitor dynamics. I realize there's been a recent new approval in myciniogravis. Could you just talk to your confidence in the Vyvgart profile and to what extent you think you may be impacted by that emerging competition?

Speaker #11: Thank you.

Speaker #6: Great. Thanks for the question. I'll provide just one comment, which is one of the things that I think is incredible five years out from launch for Vyvgart is that what we're seeing is continued growth across all indications, all geographies, and all product presentations.

Karen Massey: Great! Thanks for the question. What I'll provide just one comment, which is one of the things that I think is incredible 5 years out from launch for VYVGART, is that what we're seeing is continued growth across all indications, all geographies, and all product presentations. I think that's a sign that there's space for all of the different product presentations, and it's important that we're bringing those innovations. Sandrine, maybe I can hand over to you to talk about the growth outlook for MG and CIDP.

Speaker #6: And I think that's a sign that there's space for all of the different product presentations and it's important that we're bringing those innovations. But Sandrine, maybe I can hand over to you to talk about the growth outlook for MG and CIDP.

Speaker #12: Yeah. Thank you, Karen. And I can maybe also help answer the question on the competition. That was the second question. So I think for MG, I mean, we have seen an amazing growth year on year.

Sandrine Piret-Gerard: Yeah. Thank you, Karen. I can maybe also help answer the question on the competition, but that was the second question. I think for MG, I mean, we have seen an amazing growth year-over-year, and we have, as I mentioned, earlier, healthy fundamentals. I mean, our product VYVGART is being used earlier and earlier. I mean, as I mentioned in the opening, 70% actually are coming from all. On VYVGART, when you have 10 patients coming on biologics, 6 of them are actually starting with VYVGART. This shows that this is the molecule that patients start on when they are starting on biologics. PFS is the one that has been driving and helping us drive strong growth last year.

Speaker #12: And we have, as I mentioned, earlier, healthy fundamentals. I mean, our product Vyvgart is being used earlier and earlier. I mean, as I mentioned in the opening, 70% actually are coming from orals.

Speaker #12: And then on Vyvgart, when you have 10 patients coming on biologics, 6 of them are actually starting with Vyvgart. So this shows that this is the molecule that patients start on when they are starting on biologics.

Speaker #12: PFS is the one that has been driving and helping us drive strong growth last year. And as Karen just mentioned, we expect to continue to grow across all road of administration, including PFS.

Sandrine Piret-Gerard: As Karen just mentioned, we can expect to continue to grow across all route of administration, including PFS. The label expansion, of course, is going to help us this year, starting with seronegative. If you look at CIDP, I mean, we are still early launch. We have launched roughly a year and a half ago, and we are still have a lot of room within the 12,000 patients that are not fully well managed. Beyond that, we are working very hard to lift any challenges, either with payers or the inertia of prescribers, to start earlier with VYVGART. Overall, very strong dynamics expected for this year, like we had in the prior years. Now going to your question on the competition. Actually, we welcome competition.

Speaker #12: And then the level expansion, of course, is going to help us this year starting with seronegative. If you look at CIDP, I mean, we are still early in launch.

Speaker #12: So we have launched roughly a year and a half ago. And we are still have a lot of room within the 12,000 patients that are not fully well managed.

Speaker #12: And beyond that, we are working very, very hard to lift any challenges either with payers or the inertia of prescribers. To start earlier with Vyvgart.

Speaker #12: So overall, very strong dynamics expected for this year like we had in the prior years. So not going to your question on the competition.

Speaker #12: Actually, we welcome competition. For me, this is and for us, this is a sign of progress. And this is a sign of innovation. And that's great for patients to have multiple options.

Sandrine Piret-Gerard: For me, this is, and for us, this is a sign of progress, and this is a sign of innovation, and that's great for patients who have multiple options. This expands the overall market, and VYVGART benefits from a market expansion. I just mentioned that 6 out of 10 patients starting on biologics are on VYVGART, so the more the market expands, the better it is for us. As we are a data-driven company, all the data we have generated support or confidence that VYVGART profile will help us continue leading in that category and remain the number 1 prescribed biologics in MG.

Speaker #12: This expands the overall market. And Vyvgart benefits from a market expansion. I just mentioned that 6 out of 10 patients starting on biologics go on Vyvgart.

Speaker #12: So the more the market expands, the better it is for us. And as we are a data-driven company, all the data we have generated support or confidence that Vyvgart profile will help us continue leading that category and remain the number one prescribed biologics in MG.

Speaker #12: From an efficacy viewpoint, and we are the only one that can really show this strong MSC, the robust safety, that fosters earlier use. The ability to meaningfully reduce steroids.

Sandrine Piret-Gerard: From an efficacy viewpoint, we are the only one that can really show this strong MSC, the robust safety that fosters earlier use, the ability to meaningfully reduce steroids, and as we mentioned, multiple flexibility on either IV, subcutaneous, or PFS. When you take that all together, I mean, we believe that we have a very, very strong profile for continuing our leadership there.

Speaker #12: And then, as we mentioned, multiple flexibility on either IV, subcutaneous, or PFS. So when you take that all together, I mean, we believe that we are very, very strong profile for continuing our leadership there.

Speaker #6: Great. Thanks, Sandrine.

Karen Massey: Great. Thanks, Sandrine.

Speaker #3: And as a reminder, ending in the interest of time, we ask that you please limit to one question only. Your next question comes from the line of Sean Lehman from Morgan Stanley.

Ram: As a reminder, and in the interest of time, we ask that you please limit to one question only. Your next question comes from the line of Sean Laaman from Morgan Stanley. Your line is open.

Operator: As a reminder, and in the interest of time, we ask that you please limit to one question only. Your next question comes from the line of Sean Laaman from Morgan Stanley. Your line is open.

Speaker #3: Your line is open.

Speaker #11: Hi. Thanks for taking your question. This is Morgan on for Sean. We have one on the financials. So with Vyvgart delivering 4.2 billion this year in net sales and 90% year-over-year growth resulting in the first year of operating profitability, how should we think about the sustainability of this growth profile as penetration deepens and MG and CIDP throughout this year and next year?

Luc Truyen: Hi, thanks for taking our question. This is Morgan on for Sean. We have one on the financials. With VYVGART delivering $4.2 billion this year in net sales and 90% year-over-year growth, resulting in the first year of operating profitability, how should we think about the sustainability of this growth profile as penetration deepens in MG and CIDP throughout this year and next year? Thank you.

Morgan Gryga: Hi, thanks for taking our question. This is Morgan on for Sean. We have one on the financials. With VYVGART delivering $4.2 billion this year in net sales and 90% year-over-year growth, resulting in the first year of operating profitability, how should we think about the sustainability of this growth profile as penetration deepens in MG and CIDP throughout this year and next year? Thank you.

Speaker #11: Thank you.

Speaker #6: Yeah. Thanks for the question, Carl. Maybe you want to talk about the growth profile?

Karen Massey: Yeah, thanks for the question. Karl, maybe you want to talk about the growth profile?

Speaker #13: Yeah. I think what we're building here is a long-term sustainable business. As Sandrine already mentioned, we see a lot of growth in MG and CIDP going forward.

[Company Representative] (argenx): Yeah, I think what we're building here is a long-term sustainable business. As Sandrine already mentioned, we see a lot of growth in MG and CIDP going forward. The way we look at the financials long term is that revenue growth should exceed OpEx growth, which basically will return operating margins, which will increase over time. That in itself, of course, is not the objective of a company. We have very clear capital allocation priorities, and we're executing on those priorities. What we should see is that we're going to build.

Karl Gubitz: Yeah, I think what we're building here is a long-term sustainable business. As Sandrine already mentioned, we see a lot of growth in MG and CIDP going forward. The way we look at the financials long term is that revenue growth should exceed OpEx growth, which basically will return operating margins, which will increase over time. That in itself, of course, is not the objective of a company. We have very clear capital allocation priorities, and we're executing on those priorities. What we should see is that we're going to build.

Speaker #13: And the way we look at the financials long-term is that revenue growth should exceed OPEX growth, which basically will return operating margins, which will increase over time.

Speaker #13: That in itself, of course, is not the objective of a company. We are very clear capital allocation priorities. And we're executing on those priorities.

Speaker #13: But what we should see is that we're going to build on our very strong balance sheet. We currently have 4.4 billion of cash in the bank.

Luc Truyen: ... on our very strong balance sheet, we currently have $4.4 billion of cash in the bank. Going forward, that number should increase. I think you can look forward to a long-term, sustainable, and profitable business. Thank you for your question, Morgan.

Karl Gubitz: ... on our very strong balance sheet, we currently have $4.4 billion of cash in the bank. Going forward, that number should increase. I think you can look forward to a long-term, sustainable, and profitable business. Thank you for your question, Morgan.

Speaker #13: And going forward, that number should increase. So I think you can look forward to a long-term sustainable and profitable business. Thank you for your question, Morgan.

Speaker #3: Your next question comes from a line of Sophia Graff, Buell Nielsen from JPMorgan. Your line is open.

Ram: Your next question comes from a line of Sophia Graeff Buhl Nielsen from J.P. Morgan. Your line is open.

Operator: Your next question comes from a line of Sophia Graeff Buhl Nielsen from J.P. Morgan. Your line is open.

Speaker #14: Good afternoon. Thanks for taking my question. So just on the phase three readout for Vyvgart and myositis, could you clarify? Would you have data to support approval by subgroup, or will this largely be dependent on the overall data?

Sophia Graeff Buhl Nielsen: Good afternoon, thanks for taking my question. Just on the phase 3 read out for VYVGART and myositis, could you clarify, would you have data to support approval by subgroup, or will this largely be dependent on the overall data? I think you've been very clear on that, the higher net need within IMNM, and the large patient population that could be addressed there, and also the heterogeneity within DM. Given these dynamics, would you see these as relatively equally sized commercial opportunities, despite the differences in addressable terms you've highlighted?

Sophia Graeff Buhl-Nielsen: Good afternoon, thanks for taking my question. Just on the phase 3 read out for VYVGART and myositis, could you clarify, would you have data to support approval by subgroup, or will this largely be dependent on the overall data? I think you've been very clear on that, the higher net need within IMNM, and the large patient population that could be addressed there, and also the heterogeneity within DM. Given these dynamics, would you see these as relatively equally sized commercial opportunities, despite the differences in addressable terms you've highlighted?

Speaker #14: I think you've been very clear on that, the higher net need within IMNM. And the large patient population that could be addressed there. And also the heterogeneity within DM.

Speaker #14: Given these dynamics, would you see these as relatively equally sized commercial opportunities despite the differences in addressable TAMs you've highlighted?

Speaker #6: Yeah, thanks for the question. Maybe Luke, you can talk to the basket trial and our approach, and then I can comment on the commercial opportunity.

Karen Massey: Yeah, thanks for the question. Maybe, Luc, you can talk to the basket trial and our approach, then I can comment on the commercial opportunity.

Speaker #15: Yeah. So the phase three setup is indeed that we can make statements on all three subsets. And of course, the ultimate reflection of that in label will be connecting the data with the regulatory discussion.

Luc Truyen: Yeah. The, the phase three setup is indeed that we can make statements on all three subsets. Of course, the ultimate reflection of that in label will be the connecting the data with the regulatory discussion. In principle, all three could be in scope.

Speaker #15: But in principle, all three could be in scope.

Speaker #6: Thank you, Luke. And then in terms of the commercial opportunity, the way I think about it, I mean, the total myositis population or that we're studying, we think about in terms of it being in MG-like opportunity.

Karen Massey: Thank you, Luc. In terms of the commercial opportunity, the way I think about it, I mean, the total myositis population that we're studying, we think about in terms of it being an MG-like opportunity. Obviously there are other subtypes. I like to think about the two bookends of the subtypes. You mentioned IMNM. IMNM, there are no other approved treatment options. There's about 20,000 IMNM patients. What you can imagine there is that from a commercial perspective, you could imagine that we'll be able to gain a high portion of those patients because there are no other treatment options, and the biology is so clear. On the other end of the spectrum, you can think of DM.

Speaker #6: But obviously, there are other subtypes. And I like to think about the two bookends of the subtypes. So we talked to you mentioned IMNM.

Speaker #6: So IMNM, there are no other approved treatment options. There's about 20,000 IMNM patients so what you can imagine there, is that from a commercial perspective, you could imagine that we'll be able to gain a high portion of those patients because there are no other treatment options and the biology is so clear.

Speaker #6: On the other end of the spectrum, you can think of DM. There are more patients in DM. But it's also more heterogeneous in dermatomyositis.

Karen Massey: There are more patients in DM, but it's also more heterogeneous in dermatomyositis. There's also more innovation coming to the dermatomyositis side of space. That will grow that patient population. Innovation is good for patients. I think let's see the data, how it reads out, but I think we should have a good value proposition to be able to compete in that population, if the data reads out. Overall, total population MG-like, but the subgroups provide quite different dynamics from a commercial perspective. Thanks for the question.

Speaker #6: There's also more innovation coming to the dermatomyositis space. So that will grow. That population innovation is good for patients. And I think let's see the data, how it reads out.

Speaker #6: But I think we should have a good value proposition to be able to compete in that population if the data reads out. So overall, total population MG-like, but the subgroups provide quite different dynamics from a commercial perspective.

Speaker #6: Thanks for the question.

Speaker #3: Your next question comes from a line of Suzanne Van Verhoezen from Kempen. Your line is open.

Ram: Your next question comes from a line of Suzanne van Voorthuizen from Kempen. Your line is open.

Operator: Your next question comes from a line of Suzanne van Voorthuizen from Kempen. Your line is open.

Speaker #16: Hi, team. Thanks for taking my question. It's one on EMPA in MMN in particular. There was a change in the dosing regimen between the phase two and three.

Suzanne van Voorthuizen: Hi, team. Thanks for taking my question. It's one on empasiprubart and MMN in particular. There was a change in the dosing regimen between phase 2 and 3, and the phase 3 is also head-to-head. Could you elaborate on how you navigate the potential risks that these two changes introduce? What gives you comfort that the study can confirm empasiprubart's non-inferiority? I'm also wondering if you can give some color on how you went about setting the non-inferiority margin in this progressive disease. Thank you.

Speaker #16: And the phase three is also head-to-head. Could you elaborate on how you navigate the potential risks that these two changes introduce? What gives you comfort that the study can confirm EMPA's non-inferiority?

Speaker #16: And I'm also wondering if you can give some color on how you went about setting the non-inferiority margin in this progressive disease. Thank you.

Speaker #6: Thank you. I think that's for you, Luke.

Karen Massey: Thank you. I think that's for you, Luc.

Speaker #15: Yeah. Thanks. Thanks for that question. And I can tell you a lot of thought went into that based on the data, again, from ARDA, where we tested multiple regimens.

Luc Truyen: Yeah, thanks. Thanks for that question. I can tell you a lot of thought went into that based on the data, again, from ADAPT, where we tested multiple regimens and were able to model and look at a exposure-response relationship, which ultimately made us choose the dose regimen we went for. In terms of then choosing to go head-to-head, here, the thinking was if we were taking placebo-controlled study, we could have a lot of events because people on placebo in this progressive disease, as you say, will need rescue. Therefore, we said, Well, why not just do them straight head-to-head? That was that decision. The second one, how do you determine a non-inferiority margin?

Speaker #15: And we're able to model and look at the exposure-response relationship, which ultimately made us choose the dose regimen we went for. In terms of then choosing to go head-to-head, here, the thinking was if we were taking a placebo-controlled study, we could have a lot of events, because paper and placebo, in this progressive disease, as you say, will need rescue.

Speaker #15: And therefore, we said, well, why not just do then straight head-to-head? So that was that decision. The second one, how do you determine a non-inferiority margin?

Speaker #15: And this is actually also where the data on grip strength come in because the only available data on IVIg out on grip strength. So that's why we used that measure to determine the non-inferiority margin.

Luc Truyen: This is actually also where the data on grip strength come in, because the only available data on IVIG are on grip strength. That's why we use that measure to determine the non-inferiority margin. Given the data we see from ARDA, one of the features that is different is that we continuously seem to improve grip strength, something which is not seen in the experience with IVIG, and that gives us confidence that we can at least meet, but hopefully beat IVIG.

Speaker #15: Given the data we see from ARDA, one of the features that is different is that we continuously seem to improve grip strength, something which is not seen in the experience with IVIg.

Speaker #15: And that gives us confidence that we can at least meet but hopefully beat IVIg.

Speaker #6: That's great. Thanks, Luke. And when you zoom out, I think what you can see with your answer is the approach that we take for with our programs: strong biology, rationale, de-risking with a phase two.

Karen Massey: That's great. Thanks, Luc. When you zoom out, I think what you can see with your answer is the approach that we take for with our programs, strong biology rationale, de-risking with a phase two, and I think we're well-positioned for success commercially with this head-to-head data that in the way that you've laid it out. Look forward to that data in Q4. Thanks, Luc.

Speaker #6: And I think we're well positioned for success commercially with this head-to-head data in the way that you've laid it out. So, look forward to that data in Q4.

Speaker #6: Thanks, Luke.

Speaker #3: Your next question comes from a line of Alison Bratzel from Piper Sandler. Your line is open.

Ram: Your next question comes from a line of Allison Bratzel from Piper Sandler. Your line is open.

Operator: Your next question comes from a line of Allison Bratzel from Piper Sandler. Your line is open.

Speaker #16: Hey, good morning, guys. And thanks for taking the question. Just a follow-up on ocular MG and the potential for early treatment with Vyvgart to prevent progression to generalized disease.

Allison Bratzel: Hey, good morning, guys, and thanks for taking the question. Just to follow up on ocular MG and the potential for early treatment with VYVGART to prevent progression to generalized disease, is that something you're able to capture in part B of the OCULUS trial? Or just how long of a follow-up do you need to confidently be able to make that claim? Just any more color there would be appreciated. Thank you.

Speaker #16: Is that something you're able to capture in Part B of the Oculus trial? Or just how long of a follow-up do you need to confidently be able to make that claim?

Speaker #16: Just any more color there would be appreciated. Thank you.

Speaker #15: Yes. Thanks. Thanks for that question to allow me again to go on one of my favorite topics, which is, can we slow MG progression?

Luc Truyen: Yes, thanks. Thanks for the that question, to allow me again to go on one of my favorite topics, which is, can we slow MG progression? The open label extension following stage B, which we call stage B, is gonna give us over two years of data, which, if you look at extent epidemiological data, et cetera, should give us enough window to capture this, if people progressing and whether or not it's to the rate that's there in the outside world. The caveat, of course, is this is non-controlled data, so any expression of this delaying might have to be in a publication or if the real-world evidence is deemed strong enough in a discussion with the agency.

Speaker #15: So the open-label extension following stage B, which we call stage B, is going to give us over two years of data which, if you look at extent epidemiological data, etc., should give us enough window to capture these people progressing and whether or not it's to the rate that their in the outside world.

Speaker #15: The caveat, of course, is this is non-controlled data. So any expression of this delaying might have to be in a publication or if the real-world evidence is being strong enough in a discussion with the agency.

Speaker #6: Yeah. I think that's what's exciting about this data. Along with some of the other evidence generation that we're doing, the phase four study in early disease to be able to see that progression.

Karen Massey: Yeah, I think that's it. What's exciting about this data, along with some of the other evidence generation that we're doing, a phase 4 study in early disease, to be able to see that progression. I think regardless, one thing that's important is with ocular MG, the symptom burden is significant, and the opportunity to transform lives of patients suffering from ocular MG is significant, even without the disease progression. I think we can demonstrate that benefit in the short and the long term. Thanks, Luc.

Speaker #6: But I think regardless, one thing that's important is with ocular MG is the symptom burden is significant. And the opportunity to transform lives of patients suffering from ocular MG is significant, even without the disease progression.

Speaker #6: So, I think we can demonstrate that benefit in the short and the long term. Thanks, Luke.

Speaker #3: Your next question comes from a line of Luca Issi from RBC Capital. Your line is open.

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

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

Speaker #17: Oh, great. Thanks so much for taking my question. Congrats on the progress. Maybe, Luke, if I could circle back on ocular myasthenia gravis here.

Luca Issi: Oh, great. Thanks so much for taking my question. Congrats on the progress. maybe, Luc, if I circle back on ocular myasthenia gravis here. Again, appreciate this is fresh off the press, but, you know, how should we think about the kind of clinical significance of the data here, again, in the context of the p-value of a 0.012? Then maybe related to it, can you confirm if the use of steroids or other therapy was relatively well-balanced between the two arms, so we can kind of definitively say that the benefit here is coming from VYVGART and is not confounded by any other therapies? thanks so much.

Speaker #17: Again, appreciate this is fresh off the press. But how should we think about the kind of clinical significance of the data here? Again, in the context of the p-value of a 0.012.

Speaker #17: And then maybe related to it, can you confirm the use of steroids or other therapy was relatively well-balanced between the two arms? So we can kind of definitively say that the benefit here is coming from Vyvgart and is not confounded by any other therapies.

Speaker #17: Thanks so much.

Speaker #15: Yeah. Thanks for that question. And of course, we don't share too many detailed data because we want to make sure that the representation in an external conference isn't impacted by doing so.

Luc Truyen: Yeah, thanks for that question. Of course, we don't share too many detailed data because we want to make sure that the representation and external conference isn't impacted by doing so. Yes, we have significant p-value, but that was driven by, in our mind, a very relevant treatment difference between active and placebo. Remember, these endpoints range is between 0 to 18, to show a 4-point difference for that individual patient is certainly a relevant outcome. We feel that in totality, this is a meaningful signal that we have shown. With respect to balancing on steroids were allowed but had to be stable, and we are confident that there's no imbalance in the outcome based on anything there.

Speaker #15: But to come back to the yes, we have significant p-value but that was driven by, in our mind, a very relevant treatment difference. Between active and placebo.

Speaker #15: Remember this endpoints range is between 0 to 18. And to show an active four-point difference, for that individual patient, it's certainly a relevant outcome.

Speaker #15: So we feel that in totality, this is a meaningful signal that we have shown. And with respect to balancing on steroids, steroids were allowed but had to be stable.

Speaker #15: And we are confident that there's no imbalance in the outcome based on anything there.

Speaker #6: And maybe just to add to your question on clinical significance, I mean, Luke mentioned in the script what when you think about what the impact that ocular MG has, what patients will tell you is that it strips some of their independence.

Karen Massey: Maybe just to add to your question on clinical significance, I mean, Luc mentioned in the script. You know, when you think about what the impact that ocular MG has, what patients will tell you is that it strips them of their independence. They lose, because of the double vision, they lose the ability to drive, they lose the ability to work, and it has a real impact on their quality of life. There's no other treatments available other than steroids, so any benefit that we can provide, and certainly a four-point benefit that we've seen, is demonstrable benefit for patients and I think clinically very meaningful.

Speaker #6: They lose because of the double vision. They lose the ability to drive. They lose the ability to work. And so it has a real impact on their quality of life.

Speaker #6: So there's no other treatments available other than steroids. So any benefit that we can provide and certainly this four-point benefit that we've seen is demonstrable benefit for patients.

Speaker #6: And I think clinically very meaningful.

Speaker #3: Your next question comes from a line of Justin Smith from Bernstein. Your line is open.

Ram: Your next question comes from a line of Justin Smith from Bernstein. Your line is open.

Operator: Your next question comes from a line of Justin Smith from Bernstein. Your line is open.

Speaker #18: Thanks very much. It's just a very quick one. If you could talk about the commentary with regards to switching off subcutaneous IG onto Vyvgart and how that's changed over the last three months.

Justin Smith: Thanks very much. It's just a very quick one. If you could talk about the commentary with regards to switching off subcutaneous IG onto VYVGART, and how that's changed over the last three months.

Speaker #6: Yeah. I'm happy to. Well, I think what you're asking about is there was an FDA looking into real-world evidence around switching and CIDP worsening.

Karen Massey: Yeah, I'm happy to. Well, I think what you're asking about is there was an FDA looking into real-world evidence around switching and CIDP worsening. Actually, we had good news that we have completed that review and that, and the label has been updated with some helpful guidance to HCPs around when switching from IVIG to VYVGART. I think we're well positioned moving forward. That label update reinforces what we knew from ADHERE and reinforces the risk-benefit profile of VYVGART. Thanks for the question.

Speaker #6: Actually, we had good news that we have completed that review. And the label has been updated with some helpful guidance to HCPs around when switching from IVIG to Vyvgart.

Speaker #6: So I think we're well positioned moving forward. That label update reinforces what we knew from it here. And reinforces the risk-benefit profile of Vyvgart.

Speaker #6: Thanks for the question.

Speaker #3: Your next question comes from a line of Samantha Semenko from Citi. Your line is open.

Ram: Your next question comes from a line of Samantha Semenkow from Citi. Your line is open.

Operator: Your next question comes from a line of Samantha Semenkow from Citi. Your line is open.

Speaker #16: Hi. Good morning. Thanks very much for taking the question. Just one on the ocular MG opportunity. I'm wondering, can you speak to the mix of treating physicians that you're experiencing for this patient population?

Samantha Semenkow: Hi, good morning. Thanks very much for taking the question. Just one on the ocular MG opportunity. I'm wondering, can you speak to the mix of treating physicians that you're expecting for this patient population? Are they mainly managed by neurologists, ophthalmologists, or even neuro-ophthalmologists? I'm wondering how much education you think you need on the opportunity to drive the great utilization in the segment. Thanks very much.

Speaker #16: Are they mainly managed by neurologists, ophthalmologists, or even neuro-ophthalmologists? And I'm wondering how much education you think you need on the opportunity to drive Vyvgart utilization in the segment.

Speaker #16: Thanks very much.

Speaker #6: Yeah. Thanks for the question. Maybe Sandrine, you can talk about that and also related to seronegative because we have the Padupidate coming up in May.

Karen Massey: Yeah, thanks for the question. Maybe, Sandrine, you can talk about that and also related to seronegative, because we have the PDUFA date coming up in May. Just, you know, are there any changes for our field or the targeting strategy with these potential label expansions?

Speaker #6: And just is there are there any changes for our field or the targeting strategy with this potential label expansion?

Speaker #19: Thank you. That's a great question. Actually, we have a big overlap between the current prescribers and the target group we are visiting. And the people that will be prescribing for MG in both seronegative and ocular.

Sandrine Piret-Gerard: Thank you. That's a great question. Actually, we have a big overlap between the current prescribers and the target group we are visiting and the people that will be prescribing for MG in both seronegative and ocular. It's mostly a neurology-driven disease, so we don't expect to have to change our footprint. Actually, we increased our footprint early 2024. You should remember we doubled our footprint to be able to not only target academic medical centers, but then to also be able to visit the community neurologists, where we feel the majority of the patients are being taken care of. We won't see a change our approach there, and with the big overlap, we're confident we can target the majority of the potential and the prescribers. Thank you.

Speaker #19: So it's mostly a neurology-driven disease. So we don't expect to have to change our footprint. And actually, we increase our footprint early 2024 if you remember.

Speaker #19: We doubled our footprint to be able to not only target academic medical centers but then to also be able to visit the community neurologists where we feel the majority of the patients are being taken care of.

Speaker #19: So you want to see a change of our approach there. And with the big overlap, we're confident we can target the majority of the potential and the prescribers.

Speaker #6: Thank you.

Speaker #3: Your next question comes from a line of Victor Flock from BNP Paribas. Your line is open.

Ram: Your next question comes from a line of Victor Floch from BNP Paribas. Your line is open.

Operator: Your next question comes from a line of Victor Floch from BNP Paribas. Your line is open.

Speaker #20: Hey, thanks so much for taking my question. One question on argenx 213. So I believe the last time you updated us on timelines, you were pointing out phase 1 results sometime in H1 this year.

Victor Floch: Hey, thanks so much for taking my question. One question on ARGX-213. I believe the last time you updated us on timelines, where you were pointing out phase 1 results sometimes in H1 this year. I was just wondering whether we should expect you to discuss

Speaker #20: So I was just wondering whether we should expect you to discuss those data or to better extent, your development program of that product later this year.

[Analyst] (BNP Paribas): those data or to further extend your latest development program, of that product, later this year? Thanks so much.

Speaker #20: Thanks so much.

Speaker #6: Yeah. Thanks for the question. And again, the interest in our next-gen we are excited. So we're moving forward with 213. And we've shared that update.

Karen Massey: Yeah, thanks for the question. Again, the interest in our next gen, we are excited. We're moving forward with ARGX-213, and we've shared that update previously, and it is in the clinic. We're working on the indication strategy at the moment, our path forward, and we'll certainly share that when we have an update to share. Thanks for the question.

Speaker #6: Previously, and it is in the clinic, we're working on the indication strategy at the moment. And our path forward. And we'll certainly share that when we have an update to share.

Speaker #6: Thanks for the question.

Speaker #3: And our final question today comes from a line of Douglas Sale from HC Wainwright. Your line is open.

Ram: Our final question today comes from the line of Douglas Tsao from H.C. Wainwright. Your line is open.

Operator: Our final question today comes from the line of Douglas Tsao from H.C. Wainwright. Your line is open.

Speaker #21: Hi. Good morning. Hi. Good morning. Thanks for taking the question. Sorry. I thought I might have been on mute. Just on OMG as a follow-up, we have heard from clinicians who have tried to use it in patients presenting with ocular symptoms but they've had pushback from payers just given the fact it wasn't sort of on label.

Douglas Tsao: Hi, good morning. Thanks for taking the question. Sorry, I was on mute. Just on oMG as a follow-up, we have heard from clinicians who have tried to use it in patients presenting with ocular symptoms. They've had pushback from payers, just given the fact it wasn't sort of on label. I'm just curious if you could provide some perspective on when you think it might start to become a contributor, or will it be sort of getting it added to the label, or will there be a process where you need to also then talk to payers? Just sort of trying to understand the sequencing when we should think about this, because it does seem to be a fairly meaningful commercial opportunity for you. Thank you.

Speaker #21: I'm just curious if you could provide some perspective on when you think it might start to become a contributor? Will it be sort of getting it added to the label?

Speaker #21: Or will there be a process where you need to also then talk to payers? Just sort of trying to understand the sequencing when we should think about this because it does seem to be a fairly meaningful commercial opportunity for you.

Speaker #21: Thank you.

Speaker #6: Yeah. Thank you. And I agree. It is a meaningful opportunity and a meaningful benefit for patients. So what you can expect, I mean, we'll file as soon as we can based on this data.

Karen Massey: Yes. Thank you, and I agree, it is a meaningful opportunity for, and a meaningful benefit for patients. What you can expect, I mean, we'll file as soon as we can based on this data, and I think we have a well-oiled machine. We'll do that as soon as possible, and then we'll see when the PDUFA date is, assuming the submission is accepted by the FDA. What we normally guide to is because we will need to have conversations with payers, and we will need to change those contracts. What we usually guide to is that it takes about 2 quarters after approval to get those payer policies in place and to really start to see the impact of the opportunity.

Speaker #6: And I think we have a well-oiled machine. So we'll do that as soon as possible. And then we'll see when the Padupidate is assuming the submission is accepted by the FDA.

Speaker #6: What we normally guide to is because we will need to have conversations with payers. And we will need to change those contracts. What we usually guide to is that it takes about two quarters after approval to get those payer policies in place and to really start to see the impact of the opportunity.

Speaker #6: So we'll take it step by step. And step number one will be preparing the filing as quickly as possible. Thank you.

Karen Massey: We'll take it step by step, and step number one will be preparing the filing as quickly as possible. Thank you.

Ram: This concludes today's conference call. We thank you for your participation. You may now disconnect.

Operator: This concludes today's conference call. We thank you for your participation. You may now disconnect.

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