Q1 2024 argenx SE Earnings Call

May 9, 2024

Operator: Good morning. My name is Rob and I will be your conference operator today. I would like to welcome everyone to the call. At this time, all lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star followed by the number 1 on your telephone keypad. If you would like to withdraw your question, again, press the star-1. Thank you. I'd like to introduce Beth DelGiacco, Vice President, Global Head of Corporate Communications and Investor Relations. You may begin your conference.

Okay.

Operator: Good morning. My name is Rob, and I will be your conference operator today. I would like to welcome everyone to the call. At this time, all lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press Star followed by the number one on your telephone keypad. If you would like to withdraw your question, again, press the Star one. Thank you. I'd like to introduce Beth DelJocco, Vice President, Global Head of Corporate Communications and Investor Relations. You may begin your conference.

Rob: Good morning, My name is Rob and I'll be your conference operator today I would like to welcome everyone to the call at this time all lines.

Rob: On mute to prevent any background noise. After the Speakers' remarks, there will be a question and answer session. If you'd like to ask a question. During this time simply press star followed by the number one on your telephone keypad. If you would like to withdraw your question again press. The star one. Thank you I'd like to introduce best Dell Jocko, Vice President Global head of corporate.

Operator: After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press the star followed by the number one on your telephone keypad. If you would like to withdraw your question, again, press the star one. Thank you. I'd like to introduce Beth DelGiacco, Vice President, Global Head of Corporate Communications and Investor Relations. You may begin your conference.

Operator: If you would like to ask a question during this time, simply press Star followed by the number one on your telephone keypad. If you would like to withdraw your question, again, press the Star one. Thank you. I'd like to introduce Beth DelJocco, Vice President, Global Head of Corporate Communications and Investor Relations. You may begin your conference.

I'd like to introduce Beth DelGiacco, Vice President, Global Head of Corporate Communications and Investor Relations. You may begin your conference.

Dell Jocko: <unk> and Investor Relations you May begin your conference.

Beth DelGiacco: Thank you. A press release was issued earlier today with our 1st quarter financial results and a recent business update. This can be found on our website along with the presentation for today's webcast. Before we begin, I'd like to remind you on slide two that forward-looking statements may be presented during this call. These may include statements about our future expectations, clinical development, regulatory timeline, 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.

Beth DelGiacco: Thank you. A press release was issued earlier today with our Q1 financial results and a recent business update. This can be found on our website, along with the presentation for today's webcast. Before we begin, I'd like to remind you on slide two 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. I'm joined on the call today by Tim Van Hauwermeiren, Chief Executive Officer, Karl Gubitz, Chief Financial Officer, and Karen Massey, Chief Operating Officer. I'll now turn the call over to Tim.

Speaker Change: Thank you.

Dell Jocko: The release was issued earlier today with our first quarter financial results and our recent business update.

Dell Jocko: Can be found on our website along with the presentation for today's webcast.

Before we begin, I'd like to remind you on slide two that forward-looking statements may be presented during this call. These may include statements about our future expectations, clinical development, regulatory timeline, 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.

Dell Jocko: Before we begin I'd like to remind you on slide two that forward looking statements may be presented during this call may include statements about our future expectations clinical development regulatory timelines the potential success of our product candidates financial projections and upcoming miles actually.

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

Dell Jocko: <unk> results may differ materially from those indicated by these statements our Jive X is not under any obligation to update statements regarding the future or to conform the statements in relation to actual results unless required by law I'm.

Beth DelGiacco: I'm joined on the call today by Tim Van Hauwermeiren, Chief Executive Officer; Karl Gubitz, Chief Financial Officer and Karen Massey, Chief Operating Officer. I'll now turn the call over to Tim.

Ken: I'm joined on the call today by Tim O'hara, Meredith Chief Executive Officer, Carl Lewis, Chief Financial Officer, and Kerry Massey Chief Operating Officer, I will now turn the call over to Ken. Thank you Beth and welcome everyone.

Tim Van Hauwermeiren: Thank you Beth and welcome, everyone. At the beginning of the year, we shared an ambitious plan to maximize patient impact over time through our three innovation horizons. First, bringing VYVGART to more patients by employing a multidimensional launch strategy. Second, advancing our clinical pipeline, including EMPASIPRUBART and ARGX-119, which have potential across multiple indications with high, unmet need. And third, leveraging our IIP to bring forward the next wave of novel targets to the clinic. Today, I am pleased to share that our execution of the quarter puts us perfectly on track with this plan. Slide four.

Tim Van Hauwermeiren: Thank you Beth and welcome, everyone.

Tim Van Hauwermeiren: Thank you, Beth, and welcome everyone. At the beginning of the year, we shared an ambitious plan to maximize patient impact over time through our three innovation horizons. First, bringing Vyvgart to more patients by employing a multidimensional launch strategy. Second, advancing our clinical pipeline, including empasiprubart and ARGX-119, which have potential across multiple indications with high unmet needs. Third, leveraging our IIP to bring forward the next wave of novel targets to the clinics. Today, I'm pleased to share that our execution over the quarter puts us perfectly on track with this plan. Slide four. Let's dive into some of our recent accomplishments, beginning with the team's success in delivering another quarter of solid revenue growth.

At the beginning of the year, we shared an ambitious plan to maximize patient impact over time through our three innovation horizons. First, bringing VYVGART to more patients by employing a multidimensional launch strategy. Second, advancing our clinical pipeline, including EMPASIPRUBART and ARGX-119, which have potential across multiple indications with high, unmet need. And third, leveraging our IIP to bring forward the next wave of novel targets to the clinic. Today, I am pleased to share that our execution of the quarter puts us perfectly on track with this plan. Slide four.

Dell Jocko: At the beginning of the year.

Ken: As Shannon ambitious plan to maximize patient impact over time through our key innovation horizon.

Dell Jocko: First bringing <unk> to more patients.

Dell Jocko: Our employee and multi dimensional launch strategy.

Dell Jocko: Second advancing.

Dell Jocko: Advancing our clinical pipeline, including and possibly per box and Gen X one line, which have potential across multiple indications with high unmet needs.

Tim Van Hauwermeiren: Third, leveraging our IIP to bring forward the next wave of novel targets to the clinics. Today, I'm pleased to share that our execution over the quarter puts us perfectly on track with this plan. Slide four. Let's dive into some of our recent accomplishments, beginning with the team's success in delivering another quarter of solid revenue growth.

Dell Jocko: And third.

Dell Jocko: <unk>, our IP to bring forward the next wave of novel targets to the clinic.

Dell Jocko: Today, I am pleased to share with our execution over the quarter puts us perfectly on track with this plan.

Dell Jocko: Slide four.

Tim Van Hauwermeiren: Let's dive into some of our recent accomplishments, beginning with the team's success in delivering another quarter of solid revenue growth. We now have 7,500 patients on VYVGART and VYVGART Sub-Q globally, which does not include China, where over 2,700 patients started on therapy in the 1st quarter alone. This means we surpassed the 10,000 patient mark and we continue to reach new patients and prescribers each quarter, gaining market share among all MG treatments. We had two key drivers of revenue growth in the 1st quarter.

Dell Jocko: Let's dive into some of our recent accomplishments beginning with the team's success in delivering another quarter of solid revenue growth.

Tim Van Hauwermeiren: We now have 7,500 patients on Vyvgart and Vyvgart subQ globally, which does not include China, where over 2,700 patients started on therapy in Q1 alone. This means we surpassed the 10,000-patient mark, and we continue to reach new patients and prescribers each quarter, gaining market share among all MG treatments. We had two key drivers of revenue growth in Q1. First, we saw a 34% increase in patients on Vyvgart subQ in the US. The majority of these patients were naive to Vyvgart, so the subcutaneous product is expanding the market in the way we planned. Second, we saw 46% growth in patients on Vyvgart in Europe, driven by strong demand in Germany and new launches in Italy and Spain.

Dell Jocko: We now have 7500 patients on <unk> globally, which does not include China.

Dell Jocko: 2700 patients started on therapy in the first quarter alone.

Dell Jocko: This means we have surpassed the 10000 patient Mark and we continue to reach new patients and prescribers each quarter.

Dell Jocko: Gaining market share among all Mg treatment.

Dell Jocko: We have two key drivers of revenue growth in the first quarter.

Tim Van Hauwermeiren: First, we saw a 34% increase in patients on VYVGART Sub-Q in the U.S. The majority of these patients were naive to VYVGART so, the subcutaneous product is expanding the market in the way we planned. Second, we saw 46% growth in patients on treatment in Europe, driven by strong demand in Germany and new launches in Italy and Spain. And while it's still early days in the ITP launch in Japan, we are pleased to see patients already start therapy in our second indication. Looking ahead to next month and to the expected FDA decision for CIDP, we are making the right choices today with our gMG growth strategy that should serve us well for a CIDP launch in the scenario of an approval. We shared at the beginning of this year that advancing our pre-filled syringe in both gMG and CIDP is the top priority for us and we have a positive update for you today.

First, we saw a 34% increase in patients on VYVGART Sub-Q in the U.S. The majority of these patients were naive to VYVGART so, the subcutaneous product is expanding the market in the way we planned. Second, we saw 46% growth in patients on treatment in Europe, driven by strong demand in Germany and new launches in Italy and Spain. And while it's still early days in the ITP launch in Japan, we are pleased to see patients already start therapy in our second indication. Looking ahead to next month and to the expected FDA decision for CIDP, we are making the right choices today with our gMG growth strategy that should serve us well for a CIDP launch in the scenario of an approval.

Tim Van Hauwermeiren: First, we saw a 34% increase in patients on Vyvgart subQ in the US. The majority of these patients were naive to Vyvgart, so the subcutaneous product is expanding the market in the way we planned. Second, we saw 46% growth in patients on Vyvgart in Europe, driven by strong demand in Germany and new launches in Italy and Spain.

Dell Jocko: We saw a 34% increase in patients on <unk> Q in the U S.

Dell Jocko: The majority of these patients who are naive to this Scott so the subcutaneous product is expanding the market in the way we plan.

Dell Jocko: Secondly, we saw 46% growth in patients on <unk>, and then Europe, driven by strong demand in Germany, and some new launches in Italy and Spain.

Tim Van Hauwermeiren: And while it's still early days for ITP laws in Japan, we are pleased to see patients already starting therapy in our second indication. Looking ahead to next month and to the expected FDA decision for CIDP, we are making the right choices today with our GMG growth strategies that should serve us well for a CIDP launch in the scenario of an approval. We shared at the beginning of this year that advancing our prefilled syringe in both GNG and CIDP is a top priority for us, and we have a positive update for you today.

Tim Van Hauwermeiren: While it's still early days in the ITP launch in Japan, we are pleased to see patients already start therapy in our second indication. Looking ahead to next month and to the expected FDA decision for CIDP, we are making the right choices today with our GMG growth strategy that should serve us well for a CIDP launch in the scenario of an approval. We shared at the beginning of this year that advancing our prefilled syringe in both GMG and CIDP is a top priority for us, and we have a positive update for you today. We have successfully collected all necessary data points from our bioequivalent and human factor studies and are on track to file with the FDA by the end of June. Our goal is to have the broadest product offering available to patients, recognizing that different patients and prescribers have different treatment preferences.

Dell Jocko: And while it's still early days in the ICP loss in Japan.

Dell Jocko: We're pleased to see patients already start therapy in our second indication.

Dell Jocko: Looking ahead to next month and so do you expect it to FDA decision for IDP, we are making the right choices today with our <unk> growth strategy that should serve us well for a <unk> launch in the scenario of an approval.

Tim Van Hauwermeiren: We shared at the beginning of this year that advancing our prefilled syringe in both GMG and CIDP is a top priority for us, and we have a positive update for you today. We have successfully collected all necessary data points from our bioequivalent and human factor studies and are on track to file with the FDA by the end of June. Our goal is to have the broadest product offering available to patients, recognizing that different patients and prescribers have different treatment preferences.

We shared at the beginning of this year that advancing our pre-filled syringe in both gMG and CIDP is the top priority for us and we have a positive update for you today. We have successfully collected all necessary data points from our bioequivalence and human factor studies and are on track to file with the FDA by the end of June. Our goal is to have the broadest product offering available to patients, recognizing that different patients and prescribers have different treatment preferences.

Dell Jocko: We shared at the beginning of this year.

Dell Jocko: Advancing our Prefilled syringe in both PNG and see IDP is a top priority for us and we have a positive update for you today.

Tim Van Hauwermeiren: We have successfully collected all necessary data points from our bioequivalence and human factor studies and are on track to file with the FDA by the end of June. Our goal is to have the broadest product offering available to patients, while recognising that different patients and prescribers have different treatment preferences.

Dell Jocko: We have successfully collected all necessary data points from our bio equivalents and human factor studies and are on track to file with the FDA by the end of June.

Dell Jocko: Our goal is to have the broadest product offering available to patients recognizing that different patients and describe us has a different treatment preferences.

Tim Van Hauwermeiren: With the pre-filled syringe, we continue to innovate on the patient experience and will seek self-administration in the label, which we expect will help us reach patients earlier in the treatment paradigm. On the clinical front, we made important progress in advancing our next set of indications to Phase III and now have studies underway in thyroid eye disease and the anti-acetylcholine receptor antibody negative gMG population. The seronegative study is designed to enable a label expansion into 15% of the broader gMG population, beyond those patients we can serve today.

Tim Van Hauwermeiren: With the prefilled syringe, we continue to innovate on the patient experience and will seek self-administration in the label, which we expect will help us reach patients earlier in the treatment paradigm. On the clinical front, we made important progress in advancing our next set of indications to phase 3 and now have studies underway in thyroid eye disease and the anti-acetylcholine receptor antibody-negative GMG population. The seronegative study is designed to enable a label expansion into 15% of the broader GMG population beyond those patients we can serve today. We are also advancing phase 3 plans for efgartigimod in Sjögren's and empasiprubart in MMN based on phase 2 results in both indications. We still have additional data readouts ahead this year in PC-POTS and three subtypes of myositis, which all could jump-start registrational studies depending on the outcome.

Dell Jocko: With the Prefilled syringe will continue to innovate on the patient experience.

Dell Jocko: <unk> self administration in the label, which we expect will help us reach patients earlier in the treatment paradigm.

Dell Jocko: On the clinical front, we made important progress in advancing our next set of indications to phase III.

Dell Jocko: And now have studies underway empowered IDC and the anti acetylcholine receptor antibody negative gmg population.

Tim Van Hauwermeiren: The seronegative study is designed to enable a label expansion into 15% of the broader GMG population beyond those patients we can serve today. We are also advancing phase 3 plans for efgartigimod in Sjögren's and empasiprubart in MMN based on phase 2 results in both indications. We still have additional data readouts ahead this year in PC-POTS and three subtypes of myositis, which all could jump-start registrational studies depending on the outcome.

Dell Jocko: We've seen a negative study is designed to enable a label expansion into 15% of the broader gmg population beyond those patients we can serve today.

Tim Van Hauwermeiren: We are also advancing Phase III plans for EFGARTIGIMOD in Sjögren's and EMPASIPRUBART in MMN based on Phase III results in both indications. And we still have additional data readouts ahead this year in PC-POTS and three subtypes of myositis, which all could jumpstart registration studies depending on the outcome. The development of our earlier pipeline programs all remain on track, including patient studies of ARGX-119 and our upcoming INDs across four molecules as we rapidly work to advance the next wave of model targets. Slide five.

Dell Jocko: We are also advancing phase III plans for aircraft, taking them off and shortens and impossible bar Mmm based on phase II results in both indications.

Dell Jocko: And we still have additional data Readouts ahead. This year in PC pumps, and three subtypes of myositis, which youll could jumpstart Registrational studies, depending on the outcome.

Tim Van Hauwermeiren: The development of our earlier pipeline programs all remain on track, including patient studies of ARGX-119 and our upcoming INDs across four molecules as we rapidly work to advance the next wave of novel targets. Slide 5. Last month, we presented important data to the neurologist community during AAN, furthering our confidence in the opportunity we have with Vyvgart. In the absence of a cure, the best we can achieve for patients is deep and sustained functional improvement, not just managing symptoms, but getting to the heart of the disease to deliver a better outcome than patients have with current treatments. In GMG, this is Minimal Symptom Expression, or MSE, and we demonstrate that across studies and various dosing regimens, approximately 50% of patients are able to achieve MSE. This comes without compromising safety.

Dell Jocko: The development of our earlier pipeline programs all remain on track, including patient studies of <unk> 119, and our upcoming Imd's across four molecules as we rapidly work to advance the next wave of novel targets.

Dell Jocko: Slide five.

Tim Van Hauwermeiren: Last month, we presented important data to the neurologist community during AAN, furthering our confidence in the opportunity we have with VYVGART. In the absence of a cure, the best we can achieve for patients is deep and sustained functional improvement, not just managing symptoms but getting to the heart of the disease to deliver a better outcome than patients have with current treatments. In gMG, this is Minimum Symptom Expression -- or MSE -- and we demonstrate that across studies and various dosing regimens, approximately 50% of patients are able to achieve MSE. This comes without compromising safety and in fact, we show that patients can meaningfully take steroids post-VYVGART treatment, reducing treatment burden and improving the overall experience. We also presented new ADHERE data at AAN, specifically, on function improvement, showing that some CIDP patients were able to improve more than three or four points of impact, which, to put it into perspective, can mean the difference for a patient between being wheelchair-bound and walking without support. Slide 6.

Last month, we presented important data to the neurologist community during AAN, furthering our confidence in the opportunity we have with VYVGART. In the absence of a cure, the best we can achieve for patients is deep and sustained functional improvement, not just managing symptoms but getting to the heart of the disease to deliver a better outcome than patients have with current treatments. In gMG, this is Minimum Symptom Expression -- or MSE -- and we demonstrate that across studies and various dosing regimens, approximately 50% of patients are able to achieve MSE.

Dell Jocko: Last month, we presented important data to the neurologist community during AAN furthering our confidence in the opportunity we have at setbacks.

Tim Van Hauwermeiren: In the absence of a cure, the best we can achieve for patients is deep and sustained functional improvement, not just managing symptoms, but getting to the heart of the disease to deliver a better outcome than patients have with current treatments. In GMG, this is Minimal Symptom Expression, or MSE, and we demonstrate that across studies and various dosing regimens, approximately 50% of patients are able to achieve MSE. This comes without compromising safety.

Dell Jocko: In the absence of acute.

Dell Jocko: Best we can achieve for patients.

Dell Jocko: And sustained functional improvements.

Dell Jocko: Not just managing symptoms, but getting to the heart of the disease to deliver a better outcome than patients has its current treatments.

Dell Jocko: In Gmg this is minimal symptom expression or NFC and.

Dell Jocko: And we've demonstrated across studies in various dosing regimens.

Dell Jocko: <unk> is 50% of patients are able to achieve MSC.

Dell Jocko: This cost without compromising safety and in fact, we show that patients can meaningfully taper steroids post desktop treatments.

Tim Van Hauwermeiren: In fact, we show that patients can meaningfully taper steroids post-Vyvgart treatment, reducing treatment burden and improving the overall experience. We also presented new ADHERE data at AAN, specifically on functional improvement, showing that some CIDP patients were able to improve more than 3 or 4 points on INCAT, which, to put it into perspective, can mean the difference for a patient between being wheelchair-bound and walking without support. Slide 6. During Q1, we announced our decision to advance efgartigimod to phase 3 in Sjögren's disease following the outcome of the signal-finding RHO study. We are confident in moving forward based on the consistency of data across clinical and biomarker endpoints. This was a relatively small trial, just 34 patients, but one where we could look patient by patient at how these endpoints moved together. We had two objectives with the RHO study.

This comes without compromising safety and in fact, we show that patients can meaningfully take steroids post-VYVGART treatment, reducing treatment burden and improving the overall experience. We also presented new ADHERE data at AAN, specifically, on function improvement, showing that some CIDP patients were able to improve more than three or four points of impact, which, to put it into perspective, can mean the difference for a patient between being wheelchair-bound and walking without support. Slide 6.

Dell Jocko: Reducing treatment burden and improving the overall experience.

Tim Van Hauwermeiren: We also presented new ADHERE data at AAN, specifically, on function improvement, showing that some CIDP patients were able to improve more than three or four points of impact, which, to put it into perspective, can mean the difference for a patient between being wheelchair-bound and walking without support. Slide 6. During the first quarter, we announced our decision to advance abgatikumab to phase 3 in Sjögren's disease, following the outcome We are confident in moving forward based on the consistency of data across clinical and biomarker endpoints.

We also presented new ADHERE data at AAN, specifically, on function improvement, showing that some CIDP patients were able to improve more than three or four points of impact, which, to put it into perspective, can mean the difference for a patient between being wheelchair-bound and walking without support. Slide 6.

Dell Jocko: We also presented new adhere data at AAN, specifically on function improvement showing that some CDP patients were able to improve more than three or four points of impact.

Dell Jocko: To put it into perspective can mean, the difference for patients between being viewed Shane pounds and walking without support.

Tim Van Hauwermeiren: Slide 6. During Q1, we announced our decision to advance efgartigimod to phase 3 in Sjögren's disease following the outcome of the signal-finding RHO study. We are confident in moving forward based on the consistency of data across clinical and biomarker endpoints. This was a relatively small trial, just 34 patients, but one where we could look patient by patient at how these endpoints moved together. We had two objectives with the RHO study.

Dell Jocko: Slide six.

During the 1st quarter, we announced our decision to advance EFGARTIGIMOD to Phase III in Sjögren's disease following the outcome of the [inaudible] RHO study. We are confident in moving forward based on the consistency of data across clinical and biomarker endpoints. This was a relatively small trial, just 34 patients, but one where we could look patient by patient at how these endpoints moved together. We have two objectives with the RHO study. First, to gain confidence to invest in further development and second, to thoughtfully shape the Phase III study. We achieved both and see a clear opportunity ahead for VYVGART in this disease where there is significant unmet need, specifically in those patients with moderate to severe systemic disease who can experience dry eyes and mouth, fatigue, joint pain and even organ damage. Slide seven.

Dell Jocko: During the first quarter, we announced our decision to advance our cap take them up to phase III insured in this disease.

Dell Jocko: Knowing the outcome of the signal finding study.

Dell Jocko: We are confident in moving forward based on the consistency of data across clinical and biomarker endpoints.

Tim Van Hauwermeiren: This was a relatively small trial, just 34 patients, but one where we could look patient by patient at how these endpoints moved together. We have two objectives with the Role Study. First, to gain confidence to invest in further development, and second, to thoughtfully shape the phase 3 study. We achieved both and see a clear opportunity ahead for Vyvgart in this disease where there is significant unmet need, specifically in those patients with moderate to severe systemic disease who can experience dry eyes and mouth, fatigue, joint pain, and even organ damage.

Dell Jocko: This was a relatively small trial, just 34 patients with bundle or we could look patient by patient and how these endpoints moved together.

We have two objectives with the RHO study. First, to gain confidence to invest in further development and second, to thoughtfully shape the Phase III study. We achieved both and see a clear opportunity ahead for VYVGART in this disease where there is significant unmet need, specifically in those patients with moderate to severe systemic disease who can experience dry eyes and mouth, fatigue, joint pain and even organ damage. Slide seven.

Dell Jocko: We had two objectives through the roster.

Tim Van Hauwermeiren: First, to gain confidence to invest in further development. Second, to thoughtfully shape the Phase 3 study. We achieve both and see a clear opportunity ahead for efgartigimod in these diseases where there is significant unmet needs, specifically in those patients with moderate to severe systemic disease who can experience dry eyes and mouth, fatigue, joint pain, and even organ damage. Slide seven. We are leading this new field of medicine with FcRn, and at the end of last year, we made a commitment to apply key learnings from the ADDRESS and ADVANCE IV trials to all ongoing and proposed indications. The first trial in focus was the pilot study of efgartigimod in bullous pemphigoid. We stopped enrollment in the Phase 2 and are currently waiting for data to mature across all patients.

Dell Jocko: First to gain confidence to invest in further development.

Dell Jocko: And second to thoughtfully shape, a phase III study.

Dell Jocko: We achieved both and see a clear opportunity ahead for feedstock in diseases, where there is significant unmet needs.

Dell Jocko: Typically in those patients with moderate to severe systemic disease, who can experience dry eyes, and mouth fatigue joint pain and even organ damage.

Tim Van Hauwermeiren: Slide seven. We are leading this new field of medicine with FcRn, and at the end of last year, we made a commitment to apply key learnings from the ADDRESS and ADVANCE IV trials to all ongoing and proposed indications. The first trial in focus was the pilot study of efgartigimod in bullous pemphigoid. We stopped enrollment in the Phase 2 and are currently waiting for data to mature across all patients.

Tim Van Hauwermeiren: Slide seven. We are leading this new field of medicine with FCRN, and at the end of last year, we made a commitment to apply key learnings from the ADDRESS and ADVANCE subcute trials to all ongoing and proposed indications. The first trial in focus was the ballot study of Edgar Diegemann in Boulos, Pentagon.

Slide seven.

We are leading this new field of medicine with FcRn and at the end of last year, we made a commitment to apply key learnings from the ADDRESS and ADVANCE Sub-Q trials to all ongoing and proposed indications. The first trial in focus was the BALLAD study of EFGARTIGIMOD in bullous pemphigoid. We stopped enrollment in the Phase II and are currently waiting for data to mature across all patients. We will be ready to communicate a path forward this year, whether to change the study design and go on with Phase II, advance to Phase III or stop development in BP altogether. We also completed a thorough risk assessment of all of the programs across EFGARTIGIMOD and EMPA, recognizing the need to be disciplined in where we invest our capital and time. Based on our evaluation, we have decided to discontinue development ANCA-associated vasculitis, or AAV, and to focus instead on a newly-nominated indication, systemic scleroderma. We determined the risk did not outweigh the benefit in AAV, given the potentially unmanageable interference of background medications.

Dell Jocko: Slide seven.

Dell Jocko: We are leading this new field of medicine with SDN and at the end of last year, we made a commitment to applying key learnings from the address and advance of Q trials to all ongoing and proposed indications.

Dell Jocko: The first one and focus was a pilot study of Antarctica Mountain Bolus Panther.

Tim Van Hauwermeiren: We stopped enrollment in phase 2 and are currently waiting for data to mature across all patients. We will be ready to communicate a path forward this year, whether to change the study design and go on with phase 2, advance to phase 3, or stop development in BP altogether. We also completed a thorough risk assessment of all of the programs across Advertisement and EMPA.

Dell Jocko: We stopped enrollment in the phase II and are currently waiting for data to mature across all patients.

Tim Van Hauwermeiren: We will be ready to communicate a path forward this year, whether to change the study design and run a phase 2, advance to phase 3, or stop development in BP altogether. We also completed a total risk assessment of all of the programs across efgartigimod and empa, recognizing the need to be disciplined in where we invest our capital and time. Based on our evaluation, we have decided to discontinue development in ANCA-associated vasculitis, or AAV, and to focus instead on a newly nominated indication, systemic scleroderma. We determined the risk did not outweigh the benefit in AAV, given the potentially unmanageable interference of background medications. All other indications are advancing forward with trials underway in MN, LN, and AMR for efgartigimod, and DGF and DM for empasiprubart. We have plans to nominate additional indications for both assets later this year. Our opportunity to transform autoimmunity remains strong.

Dell Jocko: We will be ready to communicate a path forward this year.

Dell Jocko: That could change the study design and the amount of a phase II study.

Dell Jocko: <unk> for phase III or stop development and BP altogether.

Dell Jocko: We also completed a total risk assessment of all of the programs across our potential and amp up.

We also completed a thorough risk assessment of all of the programs across EFGARTIGIMOD and EMPA, recognizing the need to be disciplined in where we invest our capital and time. Based on our evaluation, we have decided to discontinue development ANCA-associated vasculitis, or AAV, and to focus instead on a newly-nominated indication, systemic scleroderma. We determined the risk did not outweigh the benefit in AAV, given the potentially unmanageable interference of background medications.

Tim Van Hauwermeiren: Recognizing the need to be disciplined in where we invest our capital and time, we have decided to discontinue development for ANCA-associated vasculitis, or AAV, and to focus instead on a newly nominated indication, systemic scleroderma. We determined the risk did not outweigh the benefit of AAV, given the potentially unmanageable interference of background medication.

Dell Jocko: Recognizing the need to be disciplined in where we invest our capital at this time.

Dell Jocko: Based on our evaluation, we have decided to discontinue development <unk> associated vasculitis or AAV.

Dell Jocko: And to focus instead on a newly nominated indication systemic scleroderma.

Tim Van Hauwermeiren: We determined the risk did not outweigh the benefit in AAV, given the potentially unmanageable interference of background medications. All other indications are advancing forward with trials underway in MN, LN, and AMR for efgartigimod, and DGF and DM for empasiprubart. We have plans to nominate additional indications for both assets later this year. Our opportunity to transform autoimmunity remains strong.

Dell Jocko: We determined the risks did not outweigh the benefit in AAV, given the potentially unmanageable interference of background medications.

Tim Van Hauwermeiren: All other indications are advancing forward, with trials underway in MN, LN and AMR for EFGARTIGIMOD and DGF and DM for EMPASIPRUBART. We have plans to nominate additional indications for both assets later this year. Our opportunity to transform our community remains strong. The more data we generate in the clinic and translationally, the more informed we can get in our R&D investments and selecting indications where we can win. This is the best format for long-term value creation and is a perfect transition to Karl, to talk about our financials.

Dell Jocko: All other indications are advancing forward with.

Dell Jocko: With trials underway in MN.

Dell Jocko: <unk> and EMR.

Dell Jocko: <unk> and <unk> for a possible Bob.

Dell Jocko: We have plans to eliminate efficient indications for both assets later this year.

Dell Jocko: Our opportunity to transform auto immunity remained strong.

Tim Van Hauwermeiren: The more data we generate in the clinic and translationally, the more informed we can get in our R&D investments and selecting indications where we can win. This is the best formula for long-term value creation and is a perfect transition to Karl to talk about our financials.

Dell Jocko: More data, we generate in the clinic and translation Lee the morning performance, we can get in our R&D investments and selecting indications where we can win.

Dell Jocko: This is the best Formula for long term value creation and is a perfect transition to Paul to talk about our financials.

Karl Gubitz: Thank you, Tim. Slide 8.

Karl Gubitz: Thank you, Tim. Slide 8. Q1 2024 financial results are detailed in the press release of this morning. I will highlight the key points here. Total operating income in Q1 totaled EUR 413 million. This reflects EUR 398 million in product net sales and EUR 14 million in other income and collaboration revenue, including EUR 2 million in royalty income from Zai Lab for Vyvgart sales in China. Product net sales of EUR 398 million represents 83% growth, +EUR 180 million compared to the same period in 2023. Here is a regional breakdown along with key drivers. EUR 347 million in the US, with notable expansion of patients on VYVGART Hytrulo. $80 million in Japan, indicating strong volume growth offset by a recent 8% price decrease.

Paul: Thank you Tim slide eight.

Karl Gubitz: The 1st quarter 2024 financial results are detailed in the press release of this morning, I will highlight the key points here. Total operating income in the 1st quarter totaled $413 million. This reflects $398 million in product net sales and $14 million in other income and collaboration revenue, including $2 million in royalty income from Zai Lab for VYVGART sales in China. Product net sales of $398 million represent 83% growth plus $180 million compared to the same period in 2023. Here is the regional breakdown along with key drivers.

The 1st quarter 2024 financial results are detailed in the press release of this morning, I will highlight the key points here. Total operating income in the 1st quarter totaled $413 million. This reflects $398 million in product net sales and $14 million in other income and collaboration revenue, including $2 million in royalty income from Zai Lab for VYVGART sales in China. Product net sales of $398 million represent 83% growth plus $180 million compared to the same period in 2023.

Paul: The first quarter 2024 financial results are detailed in the press release of this morning I will.

Paul: Highlight the key points here.

Paul: Total operating income in the first quarter totaled 413 million. This reflects $398 million in product net sales and $14 million in other income and collaboration revenue, including $2 million in royalty income from <unk> for desktop.

Paul: Sales in China.

Karl Gubitz: Product net sales of EUR 398 million represents 83% growth, +EUR 180 million compared to the same period in 2023. Here is a regional breakdown along with key drivers. EUR 347 million in the US, with notable expansion of patients on VYVGART Hytrulo. $80 million in Japan, indicating strong volume growth offset by a recent 8% price decrease.

Paul: Product net sales of $398 million represents 83% growth.

Paul: $118 million compared to the same period in 2023.

Here is the regional breakdown along with key drivers: $347 million in the U.S. with notable expansion of patients on VYVGART HYTRULO; $80 million in Japan, indicating strong volume growth offset by a recent 8% price decrease; EMEA had an excellent quarter with net product revenues of $31 million; the majority of sales still come from Germany, where we had strong volume growth offset by higher accruals due to the planned reassessment of the German price, which will be finalized in 1Q 2025. We saw meaningful revenue contributions this quarter from Italy and Spain and these launches are just ramping up. We also saw our patient reach expand in Eastern European countries like Poland and ex-EU countries like Saudi Arabia and Switzerland through named patient sales. We expect these sales to be an important source of growth going forward as we finalize pricing and reimbursement discussions. We also had $2 million in product net sales to Zai Lab for the launch in China. Slide nine.

Paul: It is a regional breakdown along with key drivers.

Karl Gubitz: $347 million in the U.S. with notable expansion of patients on VYVGART HYTRULO; $80 million in Japan, indicating strong volume growth offset by a recent 8% price decrease; EMEA had an excellent quarter with net product revenues of $31 million. The majority of sales still come from Germany, where we had strong volume growth offset by higher accruals due to the planned reassessment of the German price, which will be finalized in 1Q 2025. We saw meaningful revenue contributions this quarter from Italy and Spain and these launches are just ramping up. We also saw our patient reach expand in Eastern European countries like Poland and ex-EU countries like Saudi Arabia and Switzerland through named patient sales.

Paul: $347 million in the U S with notable expansion of patients on VESCO airfreight rollout.

Paul: $18 million in Japan, indicating strong volume growth offset by a <unk>, 8% price decrease.

Karl Gubitz: EMEA had an excellent quarter with net product revenues of EUR 31 million. The majority of sales still come from Germany, where we had strong volume growth offset by higher accruals due to the planned reassessment of the German price, which will be finalized in Q1 2025. We saw meaningful revenue contributions this quarter from Italy and Spain, and these launches are just ramping up. We also saw our patient reach expand in Eastern European countries like Poland, and ex-EU countries like Saudi Arabia and Switzerland through named patient sales. We expect these sales to be an important source of growth going forward as we finalize pricing and reimbursement discussions. We also had EUR 2 million in product net sales to Zai Lab for the launch in China. Slide nine. Operating expenses in Q1 were EUR 506 million, a decrease of EUR 51 million compared with Q4 2023.

Paul: <unk> had an excellent quarter with net product revenues of 31 million.

Paul: The majority of sales still come from Germany, where we had strong volume growth offset by higher accruals due to the planned re assessment of the German price, which will be finalized in one to 2025.

We saw meaningful revenue contributions this quarter from Italy and Spain and these launches are just ramping up. We also saw our patient reach expand in Eastern European countries like Poland and ex-EU countries like Saudi Arabia and Switzerland through named patient sales. We expect these sales to be an important source of growth going forward as we finalize pricing and reimbursement discussions. We also had $2 million in product net sales to Zai Lab for the launch in China. Slide nine.

Paul: We saw meaningful revenue contributions this quarter from Italy, and Spain, and these launches are just ramping up.

Karl Gubitz: We also saw our patient reach expand in Eastern European countries like Poland, and ex-EU countries like Saudi Arabia and Switzerland through named patient sales. We expect these sales to be an important source of growth going forward as we finalize pricing and reimbursement discussions. We also had EUR 2 million in product net sales to Zai Lab for the launch in China. Slide nine. Operating expenses in Q1 were EUR 506 million, a decrease of EUR 51 million compared with Q4 2023.

Paul: We also saw our patient <unk> expand in eastern European countries, like Poland, and XD EU countries like Saudi Arabia in Switzerland through named patient sales.

Karl Gubitz: We expect these sales to be an important source of growth going forward as we finalize pricing and reimbursement discussions. We also had $2 million in product net sales to Zai Lab for the launch in China. Slide nine. Operating expenses in Q1 were $506 million, a decrease of $51 million compared with Q4 2023, excluding the $102 million impact of a priority review voucher in Q4 2023 for operating expenses increased by $51 million.

We expect these sales to be an important source of growth going forward as we finalize pricing and reimbursement discussions. We also had $2 million in product net sales to Zai Lab for the launch in China. Slide nine.

Paul: We expect these sales to be an important source of growth going forward as we finalized pricing and reimbursement discussions.

Paul: We also had $2 million in product net sales design lab global launch in China.

Paul: Slide nine.

Paul: Operating expenses in Q1 were $506 million a day.

Slide nine. Operating expenses in Q1 were $506 million, a decrease of $51 million compared with Q4 2023, excluding the $102 million impact of a priority review voucher in Q4 2023 for operating expenses increased by $51 million. The increased expenses reflect our continued conviction in the long-term opportunity we have for value creation. SG&A expenses were $236 million in Q1, which is an increase of $27 million compared to Q4-23 due to incremental investment in the commercial infrastructure, most notably expanding our customer-facing organizations in the US to capitalize on the M.G. opportunity and prepare for potential CIDB approval. R&D expenses for the first quarter were $225 million. Excluding the impact of the PRV from the fourth quarter, we had an increase in underlying spend of $21 million. This increase reflects our continued investment in your pipeline. And we currently have 48 clinical trials across 19 indications and three pipeline candidates. The net cash burn for the first quarter was $75 million.

Slide nine.

Operating expenses in Q1 were $506 million, a decrease of $51 million compared with Q4 2023, excluding the $102 million impact of a priority review voucher in Q4 2023 for operating expenses increased by $51 million. The increased expenses reflect our continued conviction in the long-term opportunity we have for value creation. SG&A expenses were $236 million in Q1, which is an increase of $27 million compared to Q4 '23, due to incremental investment in the commercial infrastructure, most notably, expanding our customer-facing organizations in the U.S. to capitalize on the MG opportunity and prepare for potential CIDP approval. R&D expenses for the 1st quarter were $225 million, excluding the impact of the PRV from the 4th quarter, we have an increase in the underlying spend of $21 million. This increase reflects our continued investment in your pipeline and we currently have 48 clinical trials across 19 indications and three pipeline candidates. The net cash burn for the 1st quarter was $75 million. We continue to have a strong balance sheet with $3.1 billion in cash, cash equivalents and current financial assets. Our finance guidance for 2024 remains unchanged. I will now turn the call over to Karen, who will provide details on the commercial front. Thank you, Karl.

Paul: Decrease of $51 million compared with Q4 2023.

Karl Gubitz: Excluding the EUR 102 million impact of a priority review voucher in Q4 2023, the operating expenses increased by EUR 51 million. The increased expenses reflect our continued conviction in the long-term opportunity we have for value creation. SG&A expenses were EUR 236 million in Q1, which is an increase of EUR 27 million compared to Q4 2023 due to incremental investment in the commercial infrastructure, most notably expanding our customer-facing organizations in the US to capitalize on the MG opportunity and prepare for potential CIDP approval. R&D expenses for Q1 were EUR 225 million. Excluding the impact of a PRV from Q4, we had an increase in the underlying spend of $21 million.

Paul: Excluding the $102 million impact of our priority review voucher in Q4, 2020 fleet operating expenses increased by $51 million.

Karl Gubitz: The increased expenses reflect our continued conviction in the long-term opportunity we have for value creation. SG&A expenses were $236 million in Q1, which is an increase of $27 million compared to Q4-23 due to incremental investment in the commercial infrastructure, most notably expanding our customer-facing organizations in the US to capitalize on the M.G. opportunity and prepare for potential CIDB approval. R&D expenses for the first quarter were $225 million. Excluding the impact of the PRV from the fourth quarter, we had an increase in underlying spend of $21 million. This increase reflects our continued investment in your pipeline. And we currently have 48 clinical trials across 19 indications and three pipeline candidates. The net cash burn for the first quarter was $75 million.

Paul: The increased expenses reflect our continued conviction in the long term opportunity we have for value creation.

Karl Gubitz: SG&A expenses were EUR 236 million in Q1, which is an increase of EUR 27 million compared to Q4 2023 due to incremental investment in the commercial infrastructure, most notably expanding our customer-facing organizations in the US to capitalize on the MG opportunity and prepare for potential CIDP approval. R&D expenses for Q1 were EUR 225 million. Excluding the impact of a PRV from Q4, we had an increase in the underlying spend of $21 million.

Paul: SG&A expenses were $236 million in Q1, which is an increase of $27 million compared to Q4, 'twenty three due to incremental investment in the commercial infrastructure.

Paul: Most notably expanding our customer facing organizations in the U S to capitalize on the mgo opportunity and prepare for potential <unk> approval.

R&D expenses for the 1st quarter were $225 million, excluding the impact of the PRV from the 4th quarter, we have an increase in the underlying spend of $21 million. This increase reflects our continued investment in your pipeline and we currently have 48 clinical trials across 19 indications and three pipeline candidates. The net cash burn for the 1st quarter was $75 million. We continue to have a strong balance sheet with $3.1 billion in cash, cash equivalents and current financial assets. Our finance guidance for 2024 remains unchanged.

Paul: R&D expenses for the first quarter were $225 million, excluding the impact of a peer of E. Commerce fourth quarter, we had an increase in the underlying spend of $21 million. This increase reflects our continued investment in neuro pipeline and.

Karl Gubitz: This increase reflects our continued investment in our pipeline, and we currently have 48 clinical trials across 19 indications and 3 pipeline candidates. The net cash burn for Q1 was $75 million. We continue to have a strong balance sheet with 3.1 billion in cash equivalents, and current financial assets. Our finance guidance for 2024 remains unchanged. I will now turn the call over to Karen, who will provide details on the commercial front.

Paul: And we currently have 48 clinical trials.

Paul: 19 indications and three pipeline candidates.

Karl Gubitz: We continue to have a strong balance sheet with $3.1 billion in cash, cash equivalents, and current financial assets. Finance guidance for 2024 remains unchanged. I will now turn the call over to Karen, who will provide details on the commercial front. Thank you, Karl.

Paul: Net cash burn for the first quarter was $75 million.

Paul: We continue to have a strong balance sheet.

Paul: $3 $1 billion in cash cash equivalents and current financial assets.

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

Paul: <unk> guidance for 2024 remains unchanged.

Paul: I will now turn the call over to Karen who will provide details on the commercial front.

Karen Massey: Thank you, Karl. Slide 10.

you, Karl. Thank you, Kyle. Slide 10.

Karen Massey: Thank you, Kyle. Slide 10.

Karen Massey: Thank you, Karl. Slide 10. I'm proud of the continued momentum of the Vyvgart launch, expanding our impact to give more GMG patients the opportunity to return to the activities they love, and preparing to do the same to the CIDP patient community ahead of our June PDUFA date. Before I get into details on the quarter, I want to highlight two things. First, we are changing the GMG treatment paradigm with Vyvgart. Our ambition is to enable patients to live without the constant reminder of their disease, and we can achieve this with Vyvgart in a majority of patients. We now have extensive real-world evidence and clinical trial data extending out beyond 9 treatment cycles that data consistently show approximately 50% of patients are able to achieve MSE or Minimal Symptom Expression.

Karen: Thank you Kal slide 10.

Karen Massey: I'm proud of the continued momentum of the VYVGART launch, expanding our impact to give more gMG patients the opportunity to return to the activities they love and preparing to do the same for the CIDP patient community ahead of our June PDUFA date. Before I get into details on the quarter, I want to highlight two things. First, we are changing the gMG treatment paradigm with VYVGART. Our ambition is to enable patients to live without the constant reminder of their disease and we can achieve this with VYVGART in a majority of patients. We now have extensive real-world evidence and clinical trial data extending out beyond nine treatment cycles. That data consistently shows approximately 50% of patients are able to achieve MSE or Minimum Symptom Expression.

Karen: I am proud of the continued momentum underpinned that launch expanding our impact to give more gmg patients the opportunity to return to the activity They love.

Karen: And preparing to do the same to the <unk> patient community ahead of our June <unk> date.

Karen: Before I get into details on the quarter I want to highlight two things.

Karen Massey: First, we are changing the GMG treatment paradigm with Vyvgart. Our ambition is to enable patients to live without the constant reminder of their disease, and we can achieve this with Vyvgart in a majority of patients. We now have extensive real-world evidence and clinical trial data extending out beyond 9 treatment cycles that data consistently show approximately 50% of patients are able to achieve MSE or Minimal Symptom Expression.

Karen Massey: This translates into a very strong value proposition because patients report quality of life measures that are comparable to a healthy population. This is what paradigm-changing means for patients, for physicians and for the societies in which we operate. Second, we are making decisions today that will benefit us for the CIDP launch and beyond. We are planning for the long-term, sustained growth and we want to ensure that everything we do today can be leveraged to support that growth. We believe we have the right strategy in place and now, with our expanded customer-facing team, we'll be in a better place to reach new patients. Slide 11,

Karen: We are changing the gmg treatment paradigm EBITDA.

Karen: Our ambition is to enable patients to live without the constant reminder of ABB and we can achieve this EBITDA in a majority of patients with.

Karen: We now have extensive real world evidence and clinical trial data extending out beyond nine treatment cycle.

Karen: As data consistently show approximately 50% of patients are able to achieve MSC on mainland tenants.

Karen: <unk>.

Karen Massey: This translates into a very strong value proposition because patients report quality of life measures that are comparable to a healthy population. This is what paradigm changing means for patients, for physicians, and for the societies in which we operate. Second, we are making decisions today that will benefit us for the CIDP launch and beyond. We are planning for the long term, sustained growth, and we want to ensure that everything we do today can be leveraged to support that growth. We believe we have the right strategy in place, and now, with our expanded customer-facing team, we will be in better place to reach new patients. Slide 11. Our launch momentum continues, with 9 consecutive quarters of revenue growth. We have year-over-year revenue growth of 83%, and we see consistent growth across every region, with more than 10,000 patients on treatment globally.

Karen: This translates into a very strong value proposition, we can patients with poor quality of life measures that are comparable to a healthy population.

Karen: This is a paradigm changing means the patient the physician and to the society in which we operate.

Karen: Secondly, we're making decisions today that will benefit us for the <unk> launch and beyond.

Karen: We are planning for the long term sustained growth and we want to ensure that everything we do today can be leveraged to support that growth.

Karen Massey: We believe we have the right strategy in place, and now, with our expanded customer-facing team, we will be in better place to reach new patients. Slide 11. Our launch momentum continues, with 9 consecutive quarters of revenue growth. We have year-over-year revenue growth of 83%, and we see consistent growth across every region, with more than 10,000 patients on treatment globally.

Karen Massey: We believe we have the right strategy in place and now, with our expanded customer-facing team, we'll be in a better place to reach new patients. Slide 11, Our launch momentum continues with nine consecutive quarters of revenue growth. We have year-over-year revenue growth of 83%, and we see consistent growth across every region, with more than 10,000 patients on treatment globally. This is an incredible achievement, and we are very happy with the momentum we continue to generate from our launch strategy.

We believe we have the right strategy in place and now, with our expanded customer-facing team, we'll be in a better place to reach new patients. Slide 11,

Karen: We believe we have the right strategy in place and now with our expanded customer facing team will be even better placed to reach new patients.

Karen: Slide 11.

Our launch momentum continues with nine consecutive quarters of revenue growth. We have year-over-year revenue growth of 83% and we see consistent growth across every region, with more than 10,000 patients on treatment globally. This is an incredible achievement and we are very happy with the momentum we continue to generate from our launch strategy. Even with this sustained growth, we are still at the beginning of what we want to achieve and we are broadening our patient impact through our multi-dimensional expansion strategy. First, we want to reach patients earlier in the treatment paradigm by innovating on the patient experience with formats like the pre-filled syringe. Second, we want to expand our reach by seeking regulatory approval in new geographies.

Karen: Our launch momentum continues with nine consecutive quarters of revenue growth.

Karen: We had a year over year revenue growth of 83% and we see consistent growth across every region with more than 10000 patients on treatment globally.

Karen Massey: This is an incredible achievement, and we are very happy with the momentum we continue to generate from our launch strategy. Even with this sustained growth, we are still at the beginning of what we want to achieve, and we are broadening our patient impact through our multidimensional expansion strategy. First, we want to reach patients earlier in the treatment paradigm by innovating on the patient experience with formats like the prefilled syringe. Second, we wanted to expand our reach by seeking regulatory approval in new geographies. And third, we want to expand our label with new indications. Slide 12. In the US, VYVGART Hytrulo was a key driver of our growth this quarter. Let's start there because it's also an important strategy of how we will leverage momentum for the CIDP launch.

Karen: This is an incredible achievement and we are very happy with the momentum we continue to generate from our launch strategy.

Karen Massey: Even with this sustained growth, we are still at the beginning of what we want to achieve, and we are broadening our patient impact through our multi-dimensional expansion strategy. First, we want to reach patients earlier in the treatment paradigm by innovating on the patient experience with formats like the pre-filtered syringe. Second, we want to expand our reach by seeking regulatory approval in new geographies.

Karen: Even with this sustained growth we are still at the beginning of what we want to achieve and we are broadening our patient impact for a multi dimensional expansion strategy.

First, we want to reach patients earlier in the treatment paradigm by innovating on the patient experience with formats like the pre-filled syringe. Second, we want to expand our reach by seeking regulatory approval in new geographies. And third, we want to expand our label with new indications. Slide 12. In the U.S., VYVGART HYTRULO was a key driver of our growth this quarter. So, let's start there because it's also an important strategy of how we will leverage momentum for the CIDP launch. As of January 1st, we have payer policies and a dedicated J-code in place and we saw a strong uptake of HYTRULO over the quarter, with 34% growth from Q4 in patients on our subcutaneous product.

Karen Massey: First, we want to reach patients earlier in the treatment paradigm by innovating on the patient experience with formats like the prefilled syringe. Second, we wanted to expand our reach by seeking regulatory approval in new geographies. And third, we want to expand our label with new indications. Slide 12. In the US, VYVGART Hytrulo was a key driver of our growth this quarter. Let's start there because it's also an important strategy of how we will leverage momentum for the CIDP launch.

Karen: But we want to reach patients earlier in the treatment paradigm by innovating on the patient experience with formats like the pre filled syringe.

Karen: We wanted to expand our reach by seeking regulatory approval in new geographies.

Karen Massey: And third, we want to expand our label with new indications. Slide 12, in the U.S. Hartullo was a key driver of our growth this quarter. So let's start there because it's also an important strategy of how we will leverage momentum for the CIDP launch. As of January 1st, we had payer policies and a dedicated J-code in place, and we saw a strong uptake of Hytrulo over the quarter, with 34% growth from Q4 in patients on our subcutaneous products.

Karen: And third we want to expand our label with new indications.

Karen: Slide 12.

Karen: In the U S <unk>.

Karen: <unk> was a key driver of our growth this quarter. So let's start there because it's also an important strategy and how we will leverage momentum for the <unk> launch.

As of January 1st, we have payer policies and a dedicated J-code in place and we saw a strong uptake of HYTRULO over the quarter, with 34% growth from Q4 in patients on our subcutaneous product. The majority of these patients are brand new to the VYVGART franchise, which reflects the opportunity we have to expand within our gMG addressable market with VYVGART HYTRULO. With the backdrop of new innovations coming to market, our total market share across IV and subcutaneous increased over the quarter and we continued to expand the breadth of our prescriber base to now 2,700 neurologists using VYVGART or VYVGART HYTRULO in the U.S. The 1st quarter of the year is notoriously challenging and we were not immune to the impact of recertifications, holidays, and weather.

As of January 1st, we have payer policies and a dedicated J-code in place and we saw a strong uptake of HYTRULO over the quarter, with 34% growth from Q4 in patients on our subcutaneous product.

Karen Massey: As of 1 January, we had payer policies and a dedicated J-code in place, and we saw a strong uptake of Hytrulo over the quarter, with 34% growth from Q4 in patients on our subcutaneous product. The majority of these patients are brand new to the VYVGART franchise, which reflects the opportunity we have to expand within our GMG addressable market with VYVGART Hytrulo. With the backdrop of new innovations coming to market, our total market share across IV and subcutaneous increased over the quarter, and we continued to expand the breadth of our prescriber base to now 2,700 neurologists using VYVGART or VYVGART Hytrulo in the US. The Q1 of the year is notoriously challenging, and we were not immune to the impact of recertifications, holidays, and weather. Taking the seasonality into consideration, I am very pleased with our performance.

Karen: As of January 1st we had payer policies and a dedicated J code in place and we saw a strong uptake of high to low over the quarter with 34% growth from Q4 in patients on a subcutaneous product.

Karen Massey: The majority of these patients are brand new to the Vyvgart franchise, which reflects the opportunity we have to expand within our GMG addressable market with Vyvgart Hytrulo. With the backdrop of new innovations coming to market, our total market share across IV and subcutaneous increased over the quarter, and we continued to expand the breadth of our prescriber base to now 2,700 neurologists using Vyvgart or Vyvgart Hy The first quarter of the year is notoriously challenging, and we were not immune to the impact of recertifications, holidays, and weather.

The majority of these patients are brand new to the VYVGART franchise, which reflects the opportunity we have to expand within our gMG addressable market with VYVGART HYTRULO. With the backdrop of new innovations coming to market, our total market share across IV and subcutaneous increased over the quarter and we continued to expand the breadth of our prescriber base to now 2,700 neurologists using VYVGART or VYVGART HYTRULO in the U.S.

Karen: The majority of these patients are brand new to the <unk> got franchise, which reflects the opportunity we have to expand <unk> addressable market with Zika Hi, Sheila.

Karen Massey: With the backdrop of new innovations coming to market, our total market share across IV and subcutaneous increased over the quarter, and we continued to expand the breadth of our prescriber base to now 2,700 neurologists using VYVGART or VYVGART Hytrulo in the US. The Q1 of the year is notoriously challenging, and we were not immune to the impact of recertifications, holidays, and weather. Taking the seasonality into consideration, I am very pleased with our performance.

Karen: With the backdrop of new innovations coming to market, our total market share across IV and subcutaneous increased over the quarter and we continue to expand the breadth of our prescriber base to now 2700 neurologists using data <unk> in the U S.

The 1st quarter of the year is notoriously challenging and we were not immune to the impact of recertifications, holidays, and weather. Taking the seasonality into consideration, I am very pleased with our performance. The underlying fundamentals of our business are strong and I have confidence that we are well-positioned to maintain our growth momentum in gMG as we look ahead to the additional drivers this year. Slide 13. The contribution from our ex-U.S. markets was another key driver in the quarter and we saw 46% quarter-over-quarter growth in patients on therapy in Europe, specifically. We were encouraged to see this growth materialize, it's consistent with our expectations that Europe will represent an increasingly larger proportion of the opportunity over time.

Karen: The first quarter of the year is notoriously challenging and we were not immune to the impact of recertification holidays and weather, taking the seasonality into consideration I am very pleased with that performance.

Karen Massey: Taking the seasonality into consideration, I am very pleased with our performance. The underlying fundamentals of our business are strong, and I have confidence that we are well positioned to maintain our growth momentum in GMG as we look ahead to the additional drivers this year. Slide 13, The contribution from our ex-US markets was another key driver in the quarter, and we saw 46% quarter-over-quarter growth in patients on therapy in Europe specifically. We are encouraged to see this growth materialize. It's consistent with our expectations that Europe will represent an increasingly larger proportion of the opportunity over time.

Karen Massey: The underlying fundamentals of our business are strong, and I'm confident that we are well-positioned to maintain our growth momentum in GMG as we look ahead to the additional drivers this year. Slide 13. The contribution from our ex-US markets was another key driver in the quarter, and we saw 46% quarter over quarter growth in patients on therapy in Europe, specifically. We were encouraged to see this growth materialize. It's consistent with our expectations that Europe will represent an increasingly larger proportion of the opportunity over time. The volume growth can be attributed to meaningful uptake in Italy and Spain following pricing and reimbursement negotiations in those countries, but also the impact of the approval and launch of Vyvgart Subcutaneous. Whereas in the US, the strategy with subcutaneous is market expansion, in Europe, we see both a patient switch and a market expansion strategy.

Karen: Underlying fundamentals of our business are strong and have confidence that we are well positioned to maintain our growth momentum in gmg as we look ahead to the additional drivers this year.

Karen: Slide 13.

The contribution from our ex-U.S. markets was another key driver in the quarter and we saw 46% quarter-over-quarter growth in patients on therapy in Europe, specifically. We were encouraged to see this growth materialize, it's consistent with our expectations that Europe will represent an increasingly larger proportion of the opportunity over time. The volume growth can be attributed to meaningful uptake in Italy and Spain, following pricing and reimbursement negotiations in those countries but also the impact of the approval and launch of VYVGART Subcutaneous. Whereas in the U.S., the strategy with subcutaneous is market expansion, in Europe, we see both a patient switch and a market expansion strategy -- which is reflected in the growth this quarter. Moving to Japan, it has been a very busy quarter. In addition to delivering continued growth in gMG and securing approval for VYVGART Subcutaneous, we received the first global approval for our second indication, ITP. This is an important milestone for VYVGART and an important moment for ITP patients, where there is a clear unmet need in the market. This was reflected in how quickly after approval, ITP patients in Japan began treatment on VYVGART. And finally, in China, through our partner Zai Lab, we reached an additional 2,700 patients in the 1st quarter alone, driven by VYVGART's inclusion on the NRDL. Demand has been very strong.

Karen: The contribution from our ex U S markets was another key driver in the quarter, and we saw 46% quarter over quarter growth in patients on therapy in Europe specifically.

Karen Massey: We were encouraged to see this growth materialize. It's consistent with our expectations that Europe will represent an increasingly larger proportion of the opportunity over time. The volume growth can be attributed to meaningful uptake in Italy and Spain following pricing and reimbursement negotiations in those countries, but also the impact of the approval and launch of Vyvgart Subcutaneous. Whereas in the US, the strategy with subcutaneous is market expansion, in Europe, we see both a patient switch and a market expansion strategy. This is reflected in the growth this quarter.

Karen: We are encouraged to see that growth materialize, it's consistent with our expectation that Europe will represent an increasingly larger proportion of the opportunity over time.

Karen Massey: The volume growth can be attributed to meaningful uptake in Italy and Spain following pricing and reimbursement negotiations in those countries, but also the impact of the approval and launch of Vyvgart subcutaneous. Whereas in the U.S., the strategy with subcutaneous is market expansion, in Europe, we see both a patient switch and a market expansion strategy, which is reflected in the growth this quarter. Moving to Japan, this has been a very busy quarter In addition to delivering continued growth in GMG and securing approval for Vyvgart subcutaneous, we received the first global approval for our second indication, ITP. This is an important milestone for Vyvgart and an important moment for ITP patients, where there is a clear unmet need in the market. This was reflected in how quickly after approval ITP patients in Japan began treatment with Vyvgart. And finally, in China, through our partner Xilab, we reached an additional 2,700 patients in the first quarter alone, driven by Vyvgart's inclusion on the NRDL. Demand has been very strong.

Karen: The volume growth can be attributed to meaningful uptake in Italy, and Spain, following pricing and reimbursement negotiations in those countries, but also the impact of the approval and the launch of they've got subcutaneous.

Whereas in the U.S., the strategy with subcutaneous is market expansion, in Europe, we see both a patient switch and a market expansion strategy -- which is reflected in the growth this quarter. Moving to Japan, it has been a very busy quarter. In addition to delivering continued growth in gMG and securing approval for VYVGART Subcutaneous, we received the first global approval for our second indication, ITP. This is an important milestone for VYVGART and an important moment for ITP patients, where there is a clear unmet need in the market. This was reflected in how quickly after approval, ITP patients in Japan began treatment on VYVGART. And finally, in China, through our partner Zai Lab, we reached an additional 2,700 patients in the 1st quarter alone, driven by VYVGART's inclusion on the NRDL. Demand has been very strong.

Karen: Whereas in the U S. The strategy with subcutaneous is market expansion in Europe, we see both the patients switch and market expansion strategy. This is reflected in the growth this quarter.

Karen Massey: This is reflected in the growth this quarter. Moving to Japan, it has been a very busy quarter. In addition to delivering continued growth in GMG and securing approval for Vyvgart Subcutaneous, we received the first global approval for our second indication, ITP. This is an important milestone for Vyvgart and an important moment for ITP patients, where there is a clear unmet need in the market. This was reflected in how quickly after approval ITP patients in Japan began treatment on Vyvgart. Finally, in China, through our partner, Zai Lab, we reached an additional 2,700 patients in Q1 alone, driven by Vyvgart's inclusion on the NRDL. Demand has been very strong. You can see that our global launch efforts are steadily progressing.

Karen Massey: Moving to Japan, it has been a very busy quarter. In addition to delivering continued growth in GMG and securing approval for Vyvgart Subcutaneous, we received the first global approval for our second indication, ITP. This is an important milestone for Vyvgart and an important moment for ITP patients, where there is a clear unmet need in the market. This was reflected in how quickly after approval ITP patients in Japan began treatment on Vyvgart.

Karen Massey: Moving to Japan, It has been a very busy quarter.

Karen Massey: In addition to delivering continued growth in GMG and securing approval for Vyvgart subcutaneous, we received the first global approval for our second indication, ITP. This is an important milestone for Vyvgart and an important moment for ITP patients, where there is a clear unmet need in the market. This was reflected in how quickly after approval ITP patients in Japan began treatment with Vyvgart. And finally, in China, through our partner Xilab, we reached an additional 2,700 patients in the first quarter alone, driven by Vyvgart's inclusion on the NRDL. Demand has been very strong.

Karen Massey: In addition to delivering continued growth in gmg and securing approval for <unk> got subcutaneous. We received the first global approval for a second indication ITT. This is an important milestone to they've got and an important moment for ICP patients, where there is a clear unmet need in the market. This is reflected in how quickly out.

This was reflected in how quickly after approval, ITP patients in Japan began treatment on VYVGART. And finally, in China, through our partner Zai Lab, we reached an additional 2,700 patients in the 1st quarter alone, driven by VYVGART's inclusion on the NRDL. Demand has been very strong. You can see that our global launch efforts are steadily progressing. We are expanding our reach into new countries and new indications and expect to further accelerate growth as more opportunities come online. We are on track to receive VYVGART decisions on approval this year in Australia, Switzerland, Saudi Arabia and South Korea and with VYVGART Subcutaneous in China. And we have filed our CIDP regulatory submissions in Japan and China, with the EU to follow. Slide 14.

Karen Massey: <unk> approval ITT patients in Japan began treatment on that Scott.

Karen Massey: Finally, in China, through our partner, Zai Lab, we reached an additional 2,700 patients in Q1 alone, driven by Vyvgart's inclusion on the NRDL. Demand has been very strong. You can see that our global launch efforts are steadily progressing.

Karen Massey: And finally in China through our partners Xylan, we reached an additional 2700 patients in the first quarter alone driven by discuss inclusion on the <unk> demand has been very strong.

Karen Massey: You can see that our global launch efforts are steadily progressing. We are expanding our reach into new countries and new indications, and expect to further accelerate growth as more opportunities come online. We are on track to receive Vyvgart decisions on approval this year in Australia, Switzerland, Saudi Arabia, and South Korea, and with Vyvgart subcutaneous in China, and we have filed our CIDP regulatory submissions in Japan and China, with the EU to follow. Slide 14.

Karen Massey: You can see that our global launch efforts are steadily progressing.

Karen Massey: We are expanding our reach into new countries and new indications and expect to further accelerate growth as more opportunities come online. We are on track to receive Vyvgart decisions on approval this year in Australia, Switzerland, Saudi Arabia, and South Korea, and with Vyvgart Subcutaneous in China. We have filed our CIDP regulatory submissions in Japan and China, with the EU to follow. Slide 14. Moving to indication expansion with CIDP. We expect a decision on approval in the US next month, and preparations are well underway to expand our commercial engine to support this launch. CIDP patients continue to face a significant burden despite the availability of current treatments. The unmet need is high, with patients failing to see meaningful innovation in the last 30 years.

Karen Massey: We are expanding our reach into new countries and new indications.

Karen Massey: And expect to further accelerate growth as more opportunities come online.

Karen Massey: We are on track to receive <unk> got decisions on approval this year in Australia, Switzerland, Saudi Arabia, and South Korea, and we we've got subcutaneous in China.

Karen Massey: And we have filed LC IDP regulatory submissions in Japan, and China with the EU to follow.

Karen Massey: Slide 14. Moving to indication expansion with CIDP. We expect a decision on approval in the US next month, and preparations are well underway to expand our commercial engine to support this launch. CIDP patients continue to face a significant burden despite the availability of current treatments. The unmet need is high, with patients failing to see meaningful innovation in the last 30 years.

Karen Massey: Slide 14.

Karen Massey: Moving to indication expansion with CIDP, we expect a decision on approval in the U.S. next month and preparations are well underway to expand our commercial engine to support this launch. CIDP patients continue to face a significant burden despite the availability of current treatment. The unmet need is high, with patients failing to see meaningful innovation in the last 30 years. Our data suggest that 88% of patients on current therapy still experience residual symptoms and patients are constantly balancing the trade-off between efficacy and the treatment burden.

Karen Massey: Moving to indication expansion, we see ADP, we expect a decision on approval in the U S. Next month and preparations are well underway to expand our commercial engine to support this launch.

Karen Massey: CIBC patients continue to face a significant burden despite the availability of current treatment.

Karen Massey: The unmet need is high with patients failing to see meaningful innovation in the last 30 years.

Karen Massey: Our data suggests that 88% of patients on current therapy still experience residual symptoms, and patients are constantly balancing the trade-off between efficacy and the treatment burden. A couple of weeks ago, the team had the chance to hear first-hand accounts from patients suffering from CIDP. One story really struck me with the patient saying, What hurts the most is not having the treatments we deserve. All I want is to get back to the things that make me feel alive. This patient is on a high dose of IVIG, which typically requires a two-day administration period. She cannot afford to be away from work for this time, so she consolidates her treatment into one day, which is not sufficient to address her needs and has led to disease progression.

Karen Massey: Our data suggests that 88% of patients on <unk> therapy still experience residual symptoms and patients are constantly balancing that tradeoff between efficacy and the treatment burden.

Karen Massey: A couple of weeks ago, the team had the chance to hear first-hand accounts from patients suffering from CIDP. One story really struck me, with a patient saying, "What hurts the most is not having the treatments we deserve. All I want is to get back to the things that make me feel alive". This patient is on a high dose of IVIG, which typically requires a two-day administration period. She cannot afford to be away from work for this time so, she consolidates her treatment into one day, which is not sufficient to address her needs and has led to disease progression. Our goal with VYVGART HYTRULO is to provide the convenience of a 30 to 90-second injection without compromising on safety or efficacy.

A couple of weeks ago, the team had the chance to hear first-hand accounts from patients suffering from CIDP. One story really struck me, with a patient saying, "What hurts the most is not having the treatments we deserve. All I want is to get back to the things that make me feel alive". This patient is on a high dose of IVIg, which typically requires a two-day administration period. She cannot afford to be away from work for this time so, she consolidates her treatment into one day, which is not sufficient to address her needs and has led to disease progression.

Karen Massey: A couple of weeks ago. The team had the chance to hear firsthand accounts from patients suffering from CIBC.

Karen Massey: One story really struck me with the patient, saying what hurts. The most is not having the treatments. We deserve all I want is to get back to the things that make me feel alive.

Karen Massey: This patient is on a high dose of IVIG, which typically requires a two-day administration period. She cannot afford to be away from work for this time, so she consolidates her treatment into one day, which is not sufficient to address her needs and has led to disease progression. Our goal with Vyvgart Hytrula is to provide the convenience of a 30 to 90 second injection without compromising on safety or efficacy.

Karen Massey: This patient is on a high dose of IV, AIG, which typically requires a two day administration period.

Karen Massey: She cannot afford to be away from work for this time in tissue consolidated treatment into one day, which is not sufficient to address any and has led to disease progression.

Karen Massey: Our goal with VYVGART Hytrulo is to provide the convenience of a 30- to 90-second injection without compromising on safety or efficacy. We believe this is possible from the ADHERE data, which we shared with the neurologist community at AAN. This is the largest trial in CIDP ever run, enrolling 322 patients. Data demonstrated a consistently strong response regardless of prior therapy, and we also saw data that showcased the real-world impact for CIDP patients. We successfully demonstrated efgartigimod's ability to drive a sustained improvement in functional strength across prior therapy groups, including almost 30% who improved 3 or more points on the INCAT scale. As Tim mentioned, a 3-point improvement can signify the difference from using a wheelchair to walking. This is what a transformational outcome looks like in CIDP. Slide 15. We are well-positioned to capture the CIDP opportunity in front of us.

Karen Massey: Our goal with <unk> is to provide the convenience of a 30 to 92nd injection without compromising on safety or efficacy.

Our goal with VYVGART HYTRULO is to provide the convenience of a 30 to 90-second injection without compromising on safety or efficacy. And we believe this is possible from the ADHERE data, which we shared with the neurologist community at AAN. This is the largest trial in CIDP ever run, enrolling 322 patients. Data demonstrated a consistently strong response, regardless of prior therapy and we also saw data that showcased the real-world impact for CIDP patients. We successfully demonstrated EFGARTIGIMODs ability to drive a sustained improvement in functional strength across prior therapy groups, including almost 30% who improved three or more points on the INCAT scale. As Tim mentioned, a three-point improvement can signify the difference from using a wheelchair to walking. This is what a transformational outcome looks like in CIDP. Slide 15.

Karen Massey: And we believe this is possible from the ADHEAR data, which was shared with the neurologist community at AAN. This is the largest trial in CIDP ever run, enrolling 322 patients. David demonstrated a consistently strong response, regardless of prior therapy, and we also saw data that showcased the real-world impact for CIDP patients. We successfully demonstrated EFGATIGAMOD's ability to drive a sustained improvement in functional strength across prior therapy groups, including almost 30% who improved three or more points on the NCAT scale. As Tim mentioned, a three-point improvement can signify the difference between using a wheelchair and walking. This is what a transformational outcome looks like in CIDP. Slide 15.

Karen Massey: And we believe this is possible from the 88 data, which we shared with the neurologist community at AAN. This is.

Karen Massey: We successfully demonstrated efgartigimod's ability to drive a sustained improvement in functional strength across prior therapy groups, including almost 30% who improved 3 or more points on the INCAT scale. As Tim mentioned, a 3-point improvement can signify the difference from using a wheelchair to walking. This is what a transformational outcome looks like in CIDP.

We successfully demonstrated EFGARTIGIMODs ability to drive a sustained improvement in functional strength across prior therapy groups, including almost 30% who improved three or more points on the INCAT scale. As Tim mentioned, a three-point improvement can signify the difference from using a wheelchair to walking. This is what a transformational outcome looks like in CIDP. Slide 15.

Karen Massey: Slide 15. We are well-positioned to capture the CIDP opportunity in front of us. As I said earlier, we are making decisions today to support our future success, leveraging our learnings and capabilities from the GMG launch and applying them to CIDP. We will take a consistent approach with each of our stakeholder groups to maximize this potential. Early engagement with payers, disciplined execution to reach the right prescribers, and always putting patients at the center of our innovation mission.

Karen Massey: We are well-positioned to capture the CIDP opportunity in front of us. And as I said earlier, we are making decisions today to support our future success, leveraging our learnings and capabilities from the gMG launch and applying them to CIDP. We will take a consistent approach with each of our stakeholder groups to maximize this potential. Early engagement with payers, disciplined execution to reach the right prescribers and always putting patients at the center of our innovation mission.

Karen Massey: As I said earlier, we are making decisions today to support our future success, leveraging our learnings and capabilities from the GMG launch and applying them to CIDP. We will take a consistent approach with each of our stakeholder groups to maximize this potential. Early engagement with payers, disciplined execution to reach the right prescribers, and always putting patients at the center of our innovation mission. We have already started our work on enabling broad access for patients. In MG, we partnered with payers so that they could see the value VYVGART creates for the healthcare system, and we will take the same approach in CIDP. We have a strong value proposition based on the ADHERE data and the open label extension study. It takes about two quarters after approval for payer policies to kick in, which will have an effect on new patient starts during 2024.

Karen Massey: Payers disciplined execution to reach the right prescribers and always putting patients at the center of our innovation mission.

Karen Massey: We have already started our work on enabling broad access for patients. In MG, we partnered with payers so that they could see the value VYVGART creates for the healthcare system and we will take the same approach in CIDP. We have a strong value proposition based on the ADHERE data and the open-label extension study. But it takes about two quarters after approval for payer policies to kick in, which will have an effect on new patient starts during 2024. With prescribers, we have expanded our customer-facing team to maximize growth in MG while also delivering a successful launch in CIDP. CIDP is an improved indication for IVIg so, this will be a competitive market but we are equipped to meet the challenge. And last, as we saw in MG, patients and their communities will play an incredibly important role. In our market research, we've seen that it is a big step for CIDP patients to consider switching their treatment.

We have already started our work on enabling broad access for patients. In MG, we partnered with payers so that they could see the value VYVGART creates for the healthcare system and we will take the same approach in CIDP. We have a strong value proposition based on the ADHERE data and the open-label extension study. But it takes about two quarters after approval for payer policies to kick in, which will have an effect on new patient starts during 2024. With prescribers, we have expanded our customer-facing team to maximize growth in MG while also delivering a successful launch in CIDP. CIDP is an improved indication for IVIg so, this will be a competitive market but we are equipped to meet the challenge.

Karen Massey: We have already started work on enabling broad access for patients in Mg, we partnered with payers. So that they could see the value they've got creates for the health care system and we will take the same approach in CIP, we have a strong value proposition based on the adhesion data and the open label extension study.

Karen Massey: But it takes about two quarters up for approval to pay policies to kick in which will have an effect on new patient starts during 2024.

Karen Massey: With prescribers, we have expanded our customer-facing team to maximize growth in MG while also delivering a successful launch in C18. CIUP is an improved indication for IVIG, so this will be a competitive market, but we are equipped to meet the challenge. And last, as we saw in MG, patients and their communities will play an incredibly important role. In our market research, we've seen that it is a big step for CIDP patients to consider switching their treatment.

Karen Massey: With prescribers, we have expanded our customer-facing team to maximize growth in MG while also delivering a successful launch in CIDP. CIDP is an improved indication for IVIG, so this will be a competitive market, but we are equipped to meet the challenge. Last, as we saw in MG, patients in their communities will play an incredibly important role. In our market research, we have seen that it is a big step for CIDP patients to consider switching their treatment. Our goal is to raise awareness and to empower patients so that they can become advocates for their own care. It will take some time at first, but once the community starts to experience the impact of VYVGART, I'm confident it will happen. I'll now turn the call back to Tim.

Karen Massey: With prescribers, we have expanded our customer facing team to maximize growth in Mg while also delivering a successful launch in <unk>.

Karen Massey: Cie fees and improved indication for IV AIG. So this will be a competitive market, but we are equipped to meet the challenge.

And last, as we saw in MG, patients and their communities will play an incredibly important role. In our market research, we've seen that it is a big step for CIDP patients to consider switching their treatment. Our goal is to raise awareness and empower patients so that they can become advocates for their own care. It will take some time at first, but once the community starts to experience the impact of Vyvgart, I'm confident it will happen. I'll now turn the call back to Tim.

And last, as we saw in MG, patients and their communities will play an incredibly important role. In our market research, we've seen that it is a big step for CIDP patients to consider switching their treatment. Our goal is to raise awareness and to empower patients so that they can become advocates for their own care. It will take some time at first but once the community starts to experience the impact of VYVGART, I'm confident it will happen.

Karen Massey: In la as we saw in Mg patients and their communities will play an incredibly important role in our market research. We've seen that it is a big step to see ADP patients to consider switching that treatment.

Karen Massey: In our market research, we have seen that it is a big step for CIDP patients to consider switching their treatment. Our goal is to raise awareness and to empower patients so that they can become advocates for their own care. It will take some time at first, but once the community starts to experience the impact of VYVGART, I'm confident it will happen. I'll now turn the call back to Tim.

Karen Massey: Our goal is to raise awareness and empower patients so that they can become advocates for their own care. It will take some time at first, but once the community starts to experience the impact of Vyvgart, I'm confident it will happen. I'll now turn the call back to Tim.

Karen Massey: Our goal is to raise awareness and to empower patients. So that they can become advocates for their own care. It will take some time at first but once the community subset experienced the impact of they've got I'm confident that will happen.

I'll now turn the call back to Tim.

Tim: I'll now turn the call back to Jim.

Tim Van Hauwermeiren: Thank you, Karen. Slide 16. I'm truly proud of the Argenx team. Through relentless execution, we achieved an incredible milestone of treating over 10,000 patients globally. Our commitment to innovation on all fronts has supported this phenomenal growth, from generating new data in the clinic that strengthens the use case for Vyvgart to our sales team moving deeper into the community setting to reach early-life patients. We will continue to diligently invest in and execute across our business to maximize the opportunity ahead of us.

Tim Van Hauwermeiren: Thank you, Karen. Slide 16.

Tim Van Hauwermeiren: Thank you, Karen. Slide 16. I'm truly proud of the argenx team. Through their relentless execution, we achieved an incredible milestone of treating over 10,000 patients globally. Our commitment to innovation on all fronts has supported this phenomenal growth from generating new data in the clinics that strengthens the use case for VYVGART, to our sales team moving deeper into the community setting to reach early-line patients. We will continue to diligently invest in and execute across our business to maximize the opportunity ahead of us. It is an exciting time for the company as we actively prepare to bring a game-changing alternative to the CIDP community while staying focused on advancing our pipeline. With Nautilus Biotechnology, we plan to uncover new opportunities to elevate treatment expectations and create value over the long run for autoimmune patients. I would now like to open the floor for questions. Thank you.

Tim: Thank you Kevin on Slide 16.

I'm truly proud of the argenx team. Through relentless execution, we achieved an incredible milestone of treating over 10,000 patients globally. Our commitment to innovation on all fronts has supported this phenomenal growth, from generating new data in the clinic that strengthens the use case for VYVGART, to our sales team moving deeper into the community setting to reach early-line patients. We will continue to diligently invest in and execute across our business to maximize the opportunity ahead of us.

Tim Van Hauwermeiren: I'm truly proud of where Genesis team.

Tim Van Hauwermeiren: Through relentless execution, we achieved an incredible milestone of treating over 10000 patients globally.

Tim Van Hauwermeiren: Our commitment to innovation on all fronts.

Tim Van Hauwermeiren: As reported this phenomenal growth.

Tim Van Hauwermeiren: From generating new data in the clinic that strengthens the use case for this product to.

Tim Van Hauwermeiren: Through our sales team moving deeper into the community setting to reach earlier line patients.

Tim Van Hauwermeiren: We will continue to diligently invest in and execute across our business to maximize the opportunity ahead of us. It is an exciting time for the company as we actively prepare to bring a game-changing alternative to the CIDP community while staying focused on advancing our pipeline. With Nautilus Biotechnology, we plan to uncover new opportunities to elevate treatment expectations and create value over the long run for autoimmune patients. I would now like to open the floor for questions. Thank you.

We will continue to diligently invest in and execute across our business to maximize the opportunity ahead of us. It is an exciting time for the company as we actively prepare to bring a game-changing alternative to the CIDP community while staying focused on advancing our pipeline. With [inaudible], we plan to uncover new opportunities to elevate treatment expectations and create value over the long run for autoimmune patients.

Tim Van Hauwermeiren: We will continue to build.

Tim Van Hauwermeiren: Listen three invest in and execute across our business to maximize the opportunity ahead of us.

Tim Van Hauwermeiren: It is an exciting time for the company as we actively prepare to bring a game-changing alternative to the CIDP community while staying focused on advancing our pipeline. With [inaudible], we plan to uncover new opportunities to elevate treatment expectations and create value over the long run for autoimmune patients.

Tim Van Hauwermeiren: It is an exciting time for the company as we actively prepare to bring game changing alternative to the shared with the community.

Tim Van Hauwermeiren: Staying focused on advancing our pipeline.

Tim Van Hauwermeiren: With local funds, we plan to uncover new opportunities to elevate treatment expectations and create value over the long run for autoimmune patients.

Operator: I would now like to open the floor for questions. Thank you. At this time, I would like to remind everyone that in order to ask a question, press star, then the number one on your telephone keypad. We ask that you please limit yourself to one question and then rejoin the queue for further questions. Your first question comes from the line of Tazeen Ahmad from Bank of America.

I would now like to open the floor for questions. Thank you.

Operator: At this time, I would like to remind everyone, in order to ask a question, press star then the number 1 on your telephone keypad. We ask that you please limit yourself to one question and then rejoin the queue for further questions.

Speaker Change: I would now like to open the floor for questions. Thank you.

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

Operator: At this time, I would like to remind everyone, in order to ask a question, press star, then the number one on your telephone keypad. We ask that you please limit yourself to one question and then rejoin the queue for further questions. Your first question comes from the line of Tazeen Ahmad from Bank of America. Your line is open.

Operator: At this time I would like to remind everyone in order to ask a question Press Star then the number one on your telephone keypad. We ask that you. Please limit yourself to one question and then rejoin the queue for further questions.

Operator: Your first question comes from the line of <unk> from Bank of <unk> Your.

Tazeen Ahmad: Your line is open.

Tazeen Ahmad: Okay, thanks. Hi, guys. Good morning. Thanks for taking my question. Tim, can you just give us a sense about how you're thinking about competitive landscape? Because that seems to be an increasing question that we're getting, maybe just for GMG. You have talked about increased players in this space. In the time that those have been on the market, how can you talk about the market share that you've had? Have you seen any market share loss as a result of increased competition? And where would you think most of the competition is coming from? Thanks.

Tazeen Ahmad: Okay. Thanks, Hi, guys. Good morning, Thanks for taking my question, Tim can you just give us a sense about how you're thinking about competitive landscape because that seems to be increasing question that we're getting.

Tazeen Ahmad: Maybe just for J&J you have talked about increased players in this space.

Tazeen Ahmad: At the time that those have been on the market. How can you talk about the market share that you've had have you seen any market share loss.

Tazeen Ahmad: As a result of increased competition and where would you think most of the competition is coming from banks.

unknown: Okay, thanks. Hi, guys. Good morning, thanks for taking my question. Tim, can you just give us a sense about how you're thinking about competitive landscape because that seems to be an increasing question that we're getting -- maybe just for gMG. You have talked about increased players in this space. In the time that those have been on the market, how can you talk about the market share that you've had? Have you seen any market share lock as a result of increased competition and where would you think most of the competition is coming from? Thanks. Thank you, Tazeen. Thank you for joining us on the call today.

Tazeen Ahmad: Okay, thanks. Hi, guys. Good morning, thanks for taking my question. Tim, can you just give us a sense about how you're thinking about competitive landscape because that seems to be an increasing question that we're getting -- maybe just for gMG. You have talked about increased players in this space. In the time that those have been on the market, how can you talk about the market share that you've had? Have you seen any market share lock as a result of increased competition and where would you think most of the competition is coming from?

Tim Van Hauwermeiren: Thank you, Tazeen. Thank you for joining us on the call today. I think this is an excellent question for Karen to address. I'm going to hand over to Karen straight away on the competition.

Tazeen Ahmad: Thank you Tony and thank you for joining us on our call today.

Thank you, Tazeen. Thank you for joining us on the call today. And I think this is an excellent question for Karen to address so, I'm going to hand over to Karen straightaway on the competition. Yeah. Thank you, Tim. I guess, Tazeen.

Tim Van Hauwermeiren: Thank you, Tazeen. Thank you for joining us on the call today. And I think this is an excellent question for Karen to address so, I'm going to hand over to Karen straightaway on the competition.

Tim Van Hauwermeiren: And I think this is an excellent question for Karen to address, so I'm going to hand over to Karen straightaway in the competition. Yeah. Thank you, Tim. I guess, Tazeen.

unknown: This is an excellent question for Karen to address I'm going to hand over to Kevin straight away on the competition.

Karen Massey: Yeah. Thank you, Tim. I guess, Tazeen, the first question you asked was about the competitive landscape. And what we're seeing and what we expected is increased competition and increased entrance into the market. And what we're seeing in our performance is really strong, underlying fundamentals, despite those competitors coming to the market. You asked specifically about market share, what we've seen quarter-over-quarter, is our market share growing amongst biologics. And the majority of that growth is coming through HYTRULO.

Karen Massey: Yeah, thank you, Tim. I guess, Tazeen, the first question you asked was about the competitive landscape. And what we're seeing and what we expected is increased competition and increased entrance into the market. And what we're seeing in our performance is really strong underlying fundamentals, despite those competitors coming into the market. You asked specifically about market share. What we've seen quarter over quarter is our market share growing amongst biologics. And the majority of that growth is coming through HITRULO.

Karen Massey: Yeah. Thank you, Tim. I guess, Tazeen, the first question you asked was around the competitive landscape. What we're seeing and what we expected is increased competition and increased entrance into the market. What we're seeing in our performance is really strong underlying fundamentals despite those competitors coming to market. You asked specifically about market share. What we've seen quarter over quarter is our market share growing amongst biologics. The majority of that growth is coming through Hytrulo, and it's coming from new patients directly coming from oral to Vyvgart. So at this point in time, we're not seeing significant impact on competition. I think because of the value proposition that we have with Vyvgart and VYVGART Hytrulo.

Karen Massey: Thank you Tim I guess.

Karen Massey: The first question you asked was around the competitive landscape.

Karen Massey: And what we're seeing and what we expected is increased competition and increased entrants into the market.

Karen Massey: And what we're seeing in outperformance is really strong.

Karen Massey: Underlying fundamentals.

Karen Massey: The competitors coming to market, but you are specifically.

Karen Massey: Specifically about market share, what we think what we've seen quarter over quarter as our market share growing amongst biologics and the majority of that growth is coming through high trullo, and it's coming from new patients.

Karen Massey: What we've seen quarter over quarter is our market share growing amongst biologics. The majority of that growth is coming through Hytrulo, and it's coming from new patients directly coming from oral to Vyvgart. So at this point in time, we're not seeing significant impact on competition. I think because of the value proposition that we have with Vyvgart and VYVGART Hytrulo.

Karen Massey: And it's coming from new patients, directly coming from oral to VYVGART. So, at this point in time, we're not seeing significant impact on competition. I think because of the value proposition that we have with VYVGART and VYVGART HYTRULO, we've set the bar really high, in terms of efficacy. We continue to show in the real world that our favorable safety profile plays out and, of course, with both VYVGART and HYTRULO, we have that lower treatment burden. So, the whole package, as well as our team, is competing really well. And, of course, what we see in MG, across the board, is that we're just at the beginning of the opportunity. And I think the more innovation that comes to market, the more the biologic share overall is going to grow and the more that we'll be able to lead within that biologic share.

And it's coming from new patients, directly coming from oral to VYVGART. So, at this point in time, we're not seeing significant impact on competition. I think because of the value proposition that we have with VYVGART and VYVGART HYTRULO, we've set the bar really high, in terms of efficacy. We continue to show in the real world that our favorable safety profile plays out and, of course, with both VYVGART and HYTRULO, we have that lower treatment burden.

Karen Massey: Directly coming from oral <unk>.

Karen Massey: They've got.

Karen Massey: At this point in time, we're not seeing significant impact on competition.

Karen Massey: Because of the value proposition that we have with we've got and we've got high true look we've set the bar really high in terms of efficacy. We continue to show in the real world that a favorable safety profile plays out.

Karen Massey: We've set the bar really high in terms of efficacy. We continue to show in the real world that our favorable safety profile plays out. Of course, with both Vyvgart and Hytrulo, we have that low treatment burden. The whole package, as well as our team is competing really well. Of course, what we see in MG across the board is that we're just at the beginning of the opportunity. I think the more innovation that comes to market, the more the biologic share overall is gonna grow, and the more that we'll be able to lead within that biologic share.

Karen Massey: So the whole package, as well as our team, is competing really well. And, of course, what we see in MG across the board is that we're just at the beginning of the opportunity. And I think the more innovation that comes to market, the more the biologic share overall is going to grow, and the more that we'll be able to lead within that biologic share. Okay, thanks so much, Karen. Your next question comes from a line from Goldman Sachs. Your line is open.

So the whole package, as well as our team, is competing really well. And, of course, what we see in MG across the board is that we're just at the beginning of the opportunity. And I think the more innovation that comes to market, the more the biologic share overall is going to grow, and the more that we'll be able to lead within that biologic share.

So, the whole package, as well as our team, is competing really well. And, of course, what we see in MG, across the board, is that we're just at the beginning of the opportunity. And I think the more innovation that comes to market, the more the biologic share overall is going to grow and the more that we'll be able to lead within that biologic share.

Karen Massey: Course, with both they've got and intellectual look we have got low treatment burden. So the whole package as well as our team is competing really well and of course, what we see in Mg across the board that we're just at the beginning of the opportunity and I think the more innovation that comes to market. The molded biologic share overall is going to grow and the more that we'll be able to.

Karen Massey: To lead within that biologic chef.

Tazeen Ahmad: Okay. Thanks so much, Karen.

Speaker Change: Okay. Thanks, so much Karen.

Okay, thanks so much, Karen. Your next question comes from a line from Goldman Sachs. Your line is open.

Tazeen Ahmad: Okay. Thanks so much, Karen.

Operator: Your next question comes from the line of Irma from Goldman Sachs. Your line is open.

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

Speaker Change: Your next question comes from the line Oh.

Goldman Sachs: From Goldman Sachs. Your line is open.

Rajan Sharma: Hi, thanks for taking the question. Just on the PFS filing and maybe related to that competition question, could you just sort of walk us through the steps to approval from here? Have you had any initial interactions with the agency or shared any data? And is there anything you can say about the potential regulatory review process? Is there a faster market opportunity, for example? Thank you.

Irma Sgarz: Hi, thanks for taking the question. Just on the PFS filing and maybe related to that competition question, could you just sort of walk us through the steps to approval from here? Have you had any initial interactions with the agency or shared any data? Is there anything you can say about the potential regulatory review process? Is it a fast-to-market opportunity, for example? Thank you.

Goldman Sachs: Hi, Thanks for taking the question just on the PFS, finding and maybe it relates to the competition question could you just sort of walk us through.

Speaker Change: That's her approval from here have you had any initial interactions with the agency or shed any data.

Speaker Change: Is there anything you can say about the potential regulatory review processes, a fast to market opportunities for example, thank you.

Tim Van Hauwermeiren: Yeah. Thank you for the question. The PFS, of course, is a centerpiece in our strategy for VYVGART overall. Remember, we're patient-centric and ultimately, we think the pre-filled syringe is going to be an important addition to the toolbox to serve patients in the most complete fashion possible. The meaningful update today -- and I'm delighted to give that update, actually -- is that we did succeed in compiling [inaudible] of data from a bioequivalence point of view and, of course, the human factor study.

Tim Van Hauwermeiren: Yeah. Thank you for the question. The PFS, of course, is a centerpiece in our strategy for VYVGART overall. Remember, we're patient-centric, and ultimately, we think the prefilled syringe is going to be an important addition to the toolbox to serve patients in the most complete fashion possible. The meaningful update today, and I'm delighted to give that update actually, is that we did succeed in compiling solid data from a bioequivalence point of view and of course, the human factor study. Remember, these were the two key datasets we needed to compile in order to submit the dossier. We're on track to submit the dossier with the FDA before the end of June, which is great. Of course, it's going to be in the hands of the FDA.

Speaker Change: Thank you for the question the PFS of course is in the center piece in.

Tim Van Hauwermeiren: Our strategy for <unk> overall remember these patient centric and ultimately we think the pizza syringe is going to be an important addition to the toolbox to serve patients in the most complete fashion possible day.

Tim Van Hauwermeiren: The meaningful update today, and I'm delighted to give that update actually, is that we did succeed in compiling solid data from a bioequivalence point of view and of course, the human factor study. Remember, these were the two key datasets we needed to compile in order to submit the dossier. We're on track to submit the dossier with the FDA before the end of June, which is great.

Tim Van Hauwermeiren: Meaningful update today.

Tim Van Hauwermeiren: It's to give that update actually is that we did succeed in compiling.

Tim Van Hauwermeiren: Data from our bio equivalents point of view and of course, the human factor study remember these are the two key data sets we needed to compile in order to submit the dossier.

Tim Van Hauwermeiren: Remember, these were the two key datasets we needed to compile in order to submit the dossier. So, we're on track to submit the dossier to the FDA before the end of June, which is great. And then, of course, it's going to be in the hands of the FDA. You know, the exact review time remains to be seen but I'm confident in the quality of the data and the strength of the data which we have submitted. So, I would say stay tuned and we will keep you informed on the progress we make with the pre-filled syringe. Thanks for the questions. Your next question comes from Derek Archila from Wells Fargo. Hey,

Remember, these were the two key datasets we needed to compile in order to submit the dossier. So, we're on track to submit the dossier to the FDA before the end of June, which is great. And then, of course, it's going to be in the hands of the FDA. You know, the exact review time remains to be seen but I'm confident in the quality of the data and the strength of the data which we have submitted. So, I would say stay tuned and we will keep you informed on the progress we make with the pre-filled syringe. Thanks for the questions.

Tim Van Hauwermeiren: We are on track to submit a dossier with the FDA before the end of June which is great.

Tim Van Hauwermeiren: Of course, it's going to be in the hands of the FDA. You know, the exact review time remains to be seen, but I'm confident in the quality of the data and the strength of the data which we have submitted. I would say stay tuned, and we will keep you informed on the progress we make with the prefilled syringe. Thanks for the question.

Derek Christian Archila: Of course, it's going to be in the hands of the FDA as you know the exact review.

Tim Van Hauwermeiren: You know, the exact review time remains to be seen, but I'm confident in the quality of the data and the strength of the data which we have submitted. I would say stay tuned, and we will keep you informed on the progress we make with the prefilled syringe. Thanks for the question.

Derek Christian Archila: Review time remains to be seen but I am confident in the quality of the data and the strength of the data, which we which we have submitted so I would say stay tuned and we will keep you informed on the progress we make with the Prefilled syringe. Thanks.

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

Derek Christian Archila: Thanks for the question.

Derek Archila: Hey, good morning and thanks for taking the question. So, this one's for Karen. [inaudible] some market research on CIDP patients potentially switching to VYVGART so, we were wondering -- I guess, from that research, what percent of patients said the would actually switch and what'[s the biggest reason behind the decision to switch? Thanks.

Operator: Your next question comes live, Derek Archila from Wells Fargo. Your line is open.

Derek Christian Archila: Your next question comes from Derek <unk> from Wells Fargo. Your line is open.

Derek Archila: Hey, good morning, and thanks for taking the question. This one's for Karen. You cited some market research on CIDP patients potentially switching to VYVGART. We were wondering, I guess, from that research, what percent of patients said they would actually switch, and what's the biggest, you know, reason behind the decision to switch? Thanks.

Derek Christian Archila: Hey, good morning, and thanks for taking the question. So just one for Karen you cited some market research on CIB patients potentially switching the bid guard. So we were wondering I guess from that research what percent of patients said, they would actually switch and what's the biggest reason behind the decision to switch.

Karen Massey: Yeah, thanks for the question. And we've been learning a lot about the CIDP market as we prepare for launch. You know, according to our market research, what we see is that about 88% of patients still experience residual symptoms despite their ongoing treatment. But as you can imagine -- and as I've shared previously -- the patient willingness to switch off their current therapy is a big step for them. It's a progressive disease, it's a serious disease and so, it takes a lot for a patient to take that step to switch to another therapy.

Karen Massey: Thanks for the question. We've been learning a lot about the CIDP market as we prepare for launch. You know, according to our market research, what we see is that about 88% of patients still experience residual symptoms despite their ongoing treatment. As you can imagine and as I've shared previously, the patient willingness to switch off their current therapy, it's a big step for them. It's a progressive disease. It's a serious disease. It takes a lot for a patient to take that step to switch to another therapy.

Derek Christian Archila: Yes, thanks for the question and we've been learning a lot about the CIP market as we as we prepare to launch.

Karen Massey: According to our market research, what we see is at about 88% of patients still experience residual symptoms. Despite their ongoing treatment, but as you as you can imagine and as I've shared previously.

Karen Massey: The patient willingness to switch off their current therapy, it's a big step for them. It's a progressive disease, it's a serious disease and so it takes a lot for a patient to take that step to switch to another therapy, what we're putting in place I would say is it is a comprehensive launch plan that focuses on educating.

Karen Massey: What we're putting in place, I would say is a comprehensive launch plan that focuses on educating the neurologists so that they understand our data, so that they see the advantage of Vyvgart, as well as empowering patients so that they can advocate for themselves and for their healthcare, and that they can really see the difference. What we see across the board, both with healthcare providers as well as with patients, is that the most meaningful parts of our dataset are, I mean, first of all, the fact that it is the first innovation to come to the market in many years. It's the biggest trial ever run in CIDP.

Karen Massey: What we're putting in place, I would say, is a comprehensive launch plan that focuses on educating neurologists so that they understand our data; so that they see the advantages of VYVGART, as well as empowering patients so that they can advocate for themselves and for their healthcare and that they can really, really see the difference. What we see across the board, both with healthcare providers as well as with patients, is that the most meaningful parts of our dataset are -- I mean, first of all, the fact that it is the first innovation to come to the market in many, many years, it's the biggest trial ever run in CIDP and what they find compelling is the broad response rate, that 70% response rate in stage A as well as the efficacy that's seen in stage B. And Tim shared during the call, in particular, the improvement on function. That is really compelling. And then, of course, the package is rounded out by the safety profile and the low treatment burden. So, overall, what both healthcare providers and patients like about VYVGART is the fact that they don't have to balance that trade-off between efficacy and treatment burden. So, we have strong conviction over the long-term that we'll be able to have a lot of patients on VYVGART.

What we're putting in place, I would say, is a comprehensive launch plan that focuses on educating neurologists so that they understand our data; so that they see the advantages of VYVGART, as well as empowering patients so that they can advocate for themselves and for their healthcare and that they can really, really see the difference. What we see across the board, both with healthcare providers as well as with patients, is that the most meaningful parts of our dataset are -- I mean, first of all, the fact that it is the first innovation to come to the market in many, many years, it's the biggest trial ever run in CIDP and what they find compelling is the broad response rate, that 70% response rate in stage A as well as the efficacy that's seen in stage B.

Karen Massey: <unk>, then neurologists so that they understand our data so that they see the advantage of they've got as well as empowering patients. So that they can advocate for themselves and for their health care and that they can really really see the difference what we see across the board both with health care providers as well as with patients is the most meaningful.

Karen Massey: So parts of our datasets are I mean first of all the fact that it is the first innovation to come to the market in many many years, it's the biggest trial ever run in CIBC.

Karen Massey: What they find compelling is the broad response rate, that 70% response rate in stage A, as well as the efficacy that's seen in stage B. Tim shared during the call, in particular, the improvement on function. That is really compelling. Then, of course, the package is rounded out by the safety profile and the low treatment burden. Overall, what both healthcare providers and patients like about Vyvgart is the fact that they don't have to balance between that trade-off between efficacy and treatment burden. We have strong conviction over the long term that we'll be able to have a lot of patients on Vyvgart.

Karen Massey: And what we've what they find compelling is the broad response rate that 70% response rate in stage eight as well as the efficacy seen in stage IV and Tim shared during the call. It the in particular the improvement on function that is really compelling and then of course the package is rounded out by the safety profile and the low.

And Tim shared during the call, in particular, the improvement on function. That is really compelling. And then, of course, the package is rounded out by the safety profile and the low treatment burden. So, overall, what both healthcare providers and patients like about VYVGART is the fact that they don't have to balance that trade-off between efficacy and treatment burden. So, we have strong conviction over the long-term that we'll be able to have a lot of patients on VYVGART.

Karen Massey: And then, of course, the package is rounded out by the safety profile and the low treatment burden. So overall, what both healthcare providers and patients like about Vyvgart is the fact that they don't have to balance that trade-off between efficacy and treatment burden. So we have strong conviction over the long term that we'll be able to have a lot of patients on Vyvgart.

Karen Massey: But so overall, what both healthcare providers and patients like about <unk>.

Karen Massey: Is the fact that they don't have to balance between that tradeoff between efficacy and treatment burden. So we have strong conviction over the long term that we'll be able to to have a lot of patients that we've got.

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

Operator: Your next question comes from the line of James Gordon from J.P. Morgan. Your line is open.

Karen Massey: Your next question comes from the line of James Gordon from Jpmorgan. Your line is open.

James Gordon: Hello. James Gordon, JP Morgan. Thanks for taking the question. My question is about VYVGART and CIDP labeling. So, we've seen the ADHERE data presented but I don't think we've seen the open-label extension data yet. So, is your hope or your expectation that we get that data on the label in June? And is the thinking that that would allow for intermittent dosing as well, based on the OLE, and that's how you'd address the potentially quite high price in CIDP? And also, just on pricing in CIDP, am I right that if patients in MG use a lot more than the average patient, that the pricing is capped? Are there mechanisms you would potentially be able to cap the price in CIDP? Because one of the questions I've had is how pricing could work in CIDP and whether that could be a barrier to use.

James Gordon: Hello. James Gordon, J.P. Morgan. Thanks for taking the question. My question is about VYVGART and CIDP labeling. We've seen the ADHERE data presented, but I don't think we've seen the open label extension data yet. Is your hope or your expectation that we get that data on the label in June? And is the thinking that that would allow for intermittent dosing as well based on the OLE, and that's how you would address the potentially quite high price in CIDP? Also just on pricing in CIDP, am I right that if patients in MG use a lot more than the average patient, that the pricing is capped? Are there mechanisms you would potentially be able to cap the price in CIDP?

Operator: Hello, James Gordon Jpmorgan. Thanks for taking the question. My question was about this call uncertainty labeling.

unknown: We've seen the entire thank you presented but I think we've seen the open label extension data yet. So is your hope for your expectation that because I think it's from a labor in June.

Tim Van Hauwermeiren: And is the thinking that that would allow for intermittent dosing as well, based on the OLE? And that's how you'd address the potentially quite high price in CIDP? And also, just on pricing in CIDP, am I right that if patients in MG use a lot more than the average patient, that the pricing is capped? Are there mechanisms you would potentially be able to cap the price in CIDP? Because one of the questions I've had is how pricing could work in CIDP and whether that could be a barrier to use.

James Gordon: And is the thinking that that would allow for intermittent dosing as well based on the OLE, and that's how you would address the potentially quite high price in CIDP? Also just on pricing in CIDP, am I right that if patients in MG use a lot more than the average patient, that the pricing is capped? Are there mechanisms you would potentially be able to cap the price in CIDP? Because one of the questions I've had is how pricing could work in CIDP and whether that could be a barrier to use.

unknown: Is the thinking that that would allow for intermittent dosing as well based on the hourly and that's how you address the potential quite high price sensitivity.

And also, just on pricing in CIDP, am I right that if patients in MG use a lot more than the average patient, that the pricing is capped? Are there mechanisms you would potentially be able to cap the price in CIDP? Because one of the questions I've had is how pricing could work in CIDP and whether that could be a barrier to use.

Speaker Change: Uh huh.

Tim Van Hauwermeiren: Also just some pricing uncertainty I'm all right.

Tim Van Hauwermeiren: <unk> 10, Mg use it up more than the average patient because the pricing is kind of all the mechanisms you would potentially be able to cut the price in <unk> because one of the questions. I've had is how pricing could work in <unk> and whether that could be of priorities.

James Gordon: Because one of the questions I've had is how pricing could work in CIDP and whether that could be a barrier to use.

Tim Van Hauwermeiren: Thank you, James, for the question. Thank you for joining us on the call today. I will hand over, in a second, the pricing question to Karen. From a labeling point of view, James, of course, we need to wait and see how the conversation is going to go with the FDA. I cannot put myself in their shoes but I think it's reasonable to assume that given the randomized control trial was done with weekly Sub-Q dosing, that the label would be reflecting that. And the data you refer to, or you allude to, in the open-label extension where we go to less frequent dosing, that could actually have a meaningful impact in our peer conversation. And that's a nice segue, Karen, into the pricing question.

Tim Van Hauwermeiren: Thank you, James, for the question. Thank you for joining us on the call today. I will hand over in a second the pricing question to Karen. From a labeling point of view, James, of course, we need to wait and see how the conversation is going to go with the FDA. I cannot put myself in their shoes, but I think it's reasonable to assume that given the randomized control trial was done with weekly subq dosing, that the label would be reflecting that. The data you refer to or you allude to in the open-label extension where we go to less frequent dosing, that could actually have a meaningful impact in our payer conversation. That's a nice segue, Karen, into the pricing question.

Speaker Change: Thank you James for the question and thank you for joining us on our call today.

Tim Van Hauwermeiren: I will hand over the pricing question to Karen in a second. From a labeling point of view, James, of course, we need to wait and see how the conversation is going to go with the FDA. I cannot put myself in their shoes, but I think it's reasonable to assume that given the randomized control trial was done with weekly sub-q dosing, that the label would be reflecting that. The data you refer to, or you allude to, in the open label extension where we go to less frequent dosing, that could actually have a meaningful impact in our peer conversation. And that's a nice segue, Karen, into the pricing question. Yeah, happy to address that.

Speaker Change: I will hand over to in a second the pricing question to cure them from a labeling point of view James of course, we need to wait and see how the conversation is going to go with the FDA I cannot put myself into issues, but I think it's reasonable to assume that given the randomized control trial was done with weekly so Q.

Karen Massey: Dosing to the labor would be reflecting that.

Tim Van Hauwermeiren: The data you refer to or you allude to in the open-label extension where we go to less frequent dosing, that could actually have a meaningful impact in our payer conversation. That's a nice segue, Karen, into the pricing question.

Karen Massey: Data you referred to or you alluded to in the open label extension, where we go to a less frequent dosing that could actually have a meaningful impact in our peer conversation and this is.

Karen Massey: A nice segue to turn into the pricing Christian yes happy to address this it's an important one so so as you said the price was set with Mg the price per vial, but at the time with an eye toward the CIP launch and potential CIBC launch Cindy.

Karen Massey: So, as you said, the price was set with MG, the price per vial, but at the time with an eye towards the CIDP launch and potential CIDP launch. So the approach that we'll take setting price aside to ensure access for patients is the same approach that we took with MG. And you mentioned during that part of that approach was value-based arrangements through discussions with payers. And so we'll take a similar approach.

Karen Massey: Yeah, happy to address this. It's an important one. So, as you said, the price was set with MG -- the price per vial. But, at the time, with an eye towards the CIDP launch and potential CIDP launch. So, the approach that we'll take -- setting price aside -- to ensure access for patients, is the same approach that we took with MG. And you mentioned during that -- part of that approach was value-based arrangement through discussions with payers. And so, we'll take a similar approach. Most importantly, when we have discussions with payers and what our commitment is as a company, is that we want to create value for the healthcare system,

Karen Massey: Happy to address this. It's an important one. As you said, the price was set with MG, the price per vial. But at the time, with an eye towards the CIDP launch. The approach that we'll take, setting price aside to ensuring access for patients is the same approach that we took with MG. You mentioned during that part of that approach was value-based arrangements through discussions with payers. We'll take a similar approach. Most importantly, when we have discussions with payers and what our commitment is as a company is that we want to create value for the healthcare system.

Karen Massey: So the approach that we'll take setting price aside to ensuring access for patients is the same approach.

Karen Massey: We took with Mg and.

Karen Massey: And you mentioned during that part of that approach with value based arrangements.

Karen Massey: Discussions with payers and so we'll take a similar approach. Most importantly, when we have discussions with payers and what our commitment is the companies that we want to create value for the health care system. I think we've demonstrated that we can do that with Mg and thats reflected in the favorable payer policies. We have whether you look in the U S are those favorable payer policy.

Karen Massey: We'll take a similar approach. Most importantly, when we have discussions with payers and what our commitment is as a company is that we want to create value for the healthcare system. I think we've demonstrated that we can do that with MG, and that's reflected in the favorable payer policies we have, whether you look in the US,

Karen Massey: Most importantly, when we have discussions with payers and what our commitment is as a company is that we want to create value for the healthcare system, I think we've demonstrated that we can do that with MG, and that's reflected in the favorable payer policies we have, whether you look in the US, those favorable payer policies. When you look in Canada, with the recent CADIS description that Vyvgart is dominant over IVIg, or even the progress in Europe with the reimbursement that we're getting across the board, you can see that Vyvgart is creating value for healthcare systems, and our approach is creating value.

Most importantly, when we have discussions with payers and what our commitment is as a company is that we want to create value for the healthcare system,

system, I think we've demonstrated that we can do that with MG, and that's reflected in the favorable payer policies we have, whether you look in the US, those favorable payer policies. When you look in Canada, with the recent CADIS description that Vyvgart is dominant over IVIg, or even the progress in Europe with the reimbursement that we're getting across the board, you can see that Vyvgart is creating value for healthcare systems, and our approach is creating value.

system,

I think we've demonstrated that we can do that with MG and that's reflected in the favorable payer policies we have, whether you look in the U.S., those favorable payer policies; when you look in Canada, with the recent CADTH description that VYVGART is dominant over IVIg; or even the progress in Europe with the reimbursement that we're getting across the board-- you can see that VYVGART is creating value for healthcare systems and our approach is creating value. And so, we'll take the same approach with CIDP to make sure that we get broad access for patients. And I would say, in terms of preparations for the launch, our discussions are on track and our commitment to broad access for CIDP patients remains the same. Your next question comes from a line of Akash Tewari from Jeffreys. Your line is open. Hey, thanks so much. So looking at the geographic breakdown, it looks like U.S. Vyvgart patient ads are starting to

Karen Massey: I think we've demonstrated that we can do that with MG, and that's reflected in the favorable payer policies we have, whether you look in the US, those favorable payer policies, when you look in Canada, with the recent CADTH description that Vyvgart is dominant over IVIG, or even the progress in Europe with the reimbursement that we're getting across the board. You can see that Vyvgart is creating value for healthcare systems and our approach is creating value. We'll take the same approach with CIDP to make sure that we get broad access for patients. I would say in terms of preparations for the launch, our discussions are on track. Our commitment to broad access to CIDP patients remains the same.

Karen Massey: those favorable payer policies, when you look in Canada, with the recent CADTH description that Vyvgart is dominant over IVIG, or even the progress in Europe with the reimbursement that we're getting across the board. You can see that Vyvgart is creating value for healthcare systems and our approach is creating value. We'll take the same approach with CIDP to make sure that we get broad access for patients. I would say in terms of preparations for the launch, our discussions are on track. Our commitment to broad access to CIDP patients remains the same.

Karen Massey: When you look in Canada with the recent catalyst description that they've got a dominant over IV AIG or even the progress in Europe with the reinvestment that we're getting across the across the board you can see that <unk> got is creating value for health care system and our approach is creating value and so we will take the same approach with CIBC to make sure that we get broad access.

Karen Massey: And so we'll take the same approach with CIDP to make sure that we get broad access for patients. And I would say, in terms of preparations for the launch, our discussions are on track, and our commitment to broad access for CIDP patients remains the same. Your next question comes from a line of Akash Tewari from Jeffreys. Your line is open. Hey, thanks so much. So looking at the geographic breakdown, it looks like U.S. Vyvgart patient ads are starting to

Akash Tewari: Patient and I would say in terms of preparations for the launch out discussions are on track and.

Your next question comes from a line of Akash Tewari from Jeffreys. Your line is open. Hey, thanks so much. So looking at the geographic breakdown, it looks like U.S. Vyvgart patient ads are starting to

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

Akash Tewari: And our commitment to broad access to CIBC patients that remain the same.

Akash Tewari: Hey, thanks so much. So, looking at the geographic breakdown, it looks like U.S. VYVGART patient adds are starting to sequentially flatten out. That said, you mentioned, 50% of your new patients adds are now from patients that are getting out from oral. As we think about 2025 and beyond, do you think that MG will remain a growth market for VYVGART? And have you seen any signs of uptake in the 70k patients upstream to the 17k that are firmly not well-controlled by steroids? Thanks so much.

Operator: Your next question comes from a line of Akash Tewari from Jeffreys. Your line is open.

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

Akash Tewari: Your next question comes from the line of our cash to worry from Jefferies. Your line is open.

Akash Tewari: Hey, thanks so much. Looking at the geographic breakdown, it looks like US Vyvgart patient adds are starting to sequentially flatten out. That said, you mentioned 50% of your new patient adds are now from patients getting off of orals. As we think about 2025 and beyond, do you think that MG will remain a growth market for Vyvgart? And have you seen any signs of uptake in the 70,000 patients upstream to the 17,000 that are currently not well controlled by steroids? Thanks so much.

Akash Tewari: Hey, thanks, so much so looking at the geographic breakdown it looks like U S. V. Gard patient adds are starting to sequentially flattened out that said you mentioned, 50% of your new patient adds are now.

Akash Tewari: Patients getting off with oral <unk> as we think about 2025 and beyond do you think that <unk> will remain a growth market for <unk> and have you seen any signs of uptake in the 70 K patients upstream to the 17 K that are currently not well controlled by steroids. Thanks, so much.

Karen Massey: Hi. Yes, thanks for the question. And I would say, actually, I'm very confident that we're just at the beginning of the growth curve with MG. We actually see quite consistent new patient starts that are coming on board. As you said, they're generally coming from the oral; there were 50% of those are coming from -- directly from the oral. And as part of that, we're advancing our market share amongst biologics. In particular, HYTRULO is really helping us to advance into those earlier lines of treatment and to expand the breadth of our prescriber base.

Karen Massey: Yes. Thanks for the question. Actually, I'm very confident that we're just at the beginning of the growth curve with MG. We actually see quite consistent new patient starts that are coming on board. As you said, they're generally coming from the orals. Over 50% of those are coming from, directly from the oral. As part of that, we're advancing our market share among biologics. In particular, Hytrulo is really helping us to advance into those earlier lines of treatment and to expand the breadth of our prescriber base. So we have about 2,700 prescribers now. The majority of that 34% growth in new patients to Hytrulo are then naive to VYVGART. So those are new patients.

Akash Tewari: Hi, yes, thanks for the question.

Karen Massey: And I would say actually I'm very confident that we're just at the beginning of the growth curve with Mg, we actually see quite consistent new patient starts that are coming aboard as you said, we'll then generally coming from the oral is over 50% of those are coming from directly from the Aro.

Karen Massey: As part of that, we're advancing our market share among biologics. In particular, Hytrulo is really helping us to advance into those earlier lines of treatment and to expand the breadth of our prescriber base. So we have about 2,700 prescribers now. The majority of that 34% growth in new patients to Hytrulo are then naive to VYVGART. So those are new patients. The way I see it, we're at the beginning of the curve. Overall, the biologics in MG are a small percentage of the market. We're leading, that biologic share is growing, and we have a long way to go ahead of us, and a lot of opportunity.

Karen Massey: And as part of that we're advancing our market share amongst biologic.

Karen Massey: A particular high trullo is really helping us to advance into those earlier lines of treatment and to expand the breadth of our prescriber base.

Karen Massey: So, we have about 2,700 prescribers now. The majority is that 34% growth in new patients for HYTRULO -- they're naive to VYVGART. So, those are new patients. So, the way I see it, we're at the beginning of the curve. Overall, the biologics in MG are a small percentage of the market. We're leading, that biologic share is growing and we have a long way to go ahead of us and a lot of opportunity.

Karen Massey: About 2700 prescribers now the majority of that 34% growth in new patients. The hydro low then naive because they've got so those are new patients. So.

Karen Massey: The way I see it, we're at the beginning of the curve. Overall, the biologics in MG are a small percentage of the market. We're leading, that biologic share is growing, and we have a long way to go ahead of us, and a lot of opportunity.

Karen Massey: The way I see it we're at the beginning of the curve overall the biologics.

Karen Massey: <unk> are a small percentage of the market when leading.

Karen Massey: That biologic share is growing and we have a long way to go ahead of us.

Speaker Change: And a lot of opportunity and in addition, our cash to what Kevin Just said, we also announced the start of the Seronegative Mg trial, which is going to be a label expanding our trial right about 15% of Mg patients are estimated to be seronegative. So that will also be a meaningful addition to the label in case. This trial is successful.

Tim Van Hauwermeiren: And in addition, Akash, to what Karen just said, we also announced the start of the seronegative MG trial, which is going to be a label-expanding trial, right? About 15% of MG patients are estimated to be seronegative. So, that will also be a meaningful addition to the label, in case this trial is successful.

Tim Van Hauwermeiren: In addition, Akash, to what Karen just said, we also announced the start of the seronegative MG trial, which is gonna be a label expanding trial, right? About 15% of MG patients are estimated to be seronegative, so that will also be a meaningful addition to the label in case this trial is successful.

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

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

Yaron Werber: Great. Thanks for taking my question. Maybe one that's related to the pipeline. You know, I think in the past you've talked about potentially doing an R&D day kind of at some point this year, maybe in the summer or in the fall. What would you wanna cover, you know, if you were to do such an R&D day? Secondly, the decision to move to systemic scleroderma, it sounds like with ANCA-associated vasculitis, there's too much variability in background meds. What do we know about scleroderma? How homogeneous is it? What percentage of patients are autoantibody positive? If you can give us any sense. Thank you.

Yaron Werber: Great. Thanks for taking my question. So, maybe one that's related to the pipeline. You know, I think in the past, you've talked about potentially doing an R&D day, kind of at some point this year, maybe in the summer or in the fall. What would you want to cover if you were to do such an R&D day? And then, secondly, the decision to move to systemic scleroderma. It sounds like with ANCA-associated vasculitis, there's too much variability in background medication. What do we know about scleroderma? How homogeneous is it? What percentage of patients are autoantibody positive, if you can give us any sense? Thank you.

Yaron Benjamin Werber: Great. Thanks for taking my question so maybe.

Tim Van Hauwermeiren: One that's related to the pipeline.

Tim Van Hauwermeiren: I think in the past you've talked about potentially doing an R&D day kind of at some point this year, maybe somewhere in the fall what would you want to cover if you were to do such an R&D day and then secondly.

Yaron Werber: Secondly, the decision to move to systemic scleroderma, it sounds like with ANCA-associated vasculitis, there's too much variability in background meds. What do we know about scleroderma? How homogeneous is it? What percentage of patients are autoantibody positive? If you can give us any sense. Thank you.

Tim Van Hauwermeiren: The decision to move to systemic scleroderma. It sounds like we've added couple of Zubair <unk> too much variability background meds, what do we know about scleroderma, how homogeneous as it what percentage of patients or auto antibody positive because you can give us some insight. Thank you.

Tim Van Hauwermeiren: And then secondly, the decision to move to systemic scleroderma. It sounds like with ankylosing vasculitis, there's too much variability in background medication. What do we know about scleroderma? How homogeneous is it? What percentage of patients are auto antibody positive, if you can give us any sense? Thank you.

Tim Van Hauwermeiren: Thank you for these questions, Yaron, and thank you for joining us. Look, there's a ton in this company to talk about when you organize an R&D day. So, we will have to make choices and be carefully listening to the customer of such an R&D day. For sure, a central piece will be the full data presentation on MMN, which, you know, is the lead indication for EMPA. But we also received strong feedback about the continuous need to be educated on some of these newer indications, which we started to talk about. So, stay tuned, I think Beth will be communicating in the not-too-distant future about the date and the agenda of the R&D day.

Tim Van Hauwermeiren: Thank you for these questions, Yaron, and thank you for joining us. Look, there's a ton in this company to talk about when you organize an R&D day. We will have to make choices and be carefully listening to the customer of such an R&D day. For sure, a central piece will be the full data presentation on MMN, which is the lead indication for EMPA. But we also received strong feedback about the continuous need to be educated on some of these newer indications which we started to talk about. Stay tuned. I think Beth will be communicating in the not-too-distant future about the dates and the agenda of the R&D day. On systemic scleroderma, this is an indication which was always high on the list.

Speaker Change: Thank you for these questions. So you Don and thank you for joining us so.

Tim Van Hauwermeiren: Theres a tunnel in this company to talk about when you organize on R&D day. So we will have to make choices and we are carefully listening to the customer of such an R&D day for sure a central piece will be the full data presentation on amendment, which you know is the lead indications for <unk>, but he also received strong feedback about the continued.

Tim Van Hauwermeiren: But we also received strong feedback about the continuous need to be educated on some of these newer indications which we started to talk about. Stay tuned. I think Beth will be communicating in the not-too-distant future about the dates and the agenda of the R&D day. On systemic scleroderma, this is an indication which was always high on the list.

Tim Van Hauwermeiren: <unk> needs to be educated on some of these new indications, which we started to talk about so stay tuned I think that we will be communicating in the not too distant future about the date.

Tim Van Hauwermeiren: I think Beth will be communicating in the not too distant future about the date and the agenda of the R&D day. On systemic scleroderma, this is an indication which was always high on the list. You remember that we always start from a very strong biology rationale, so talking about a strong biology rationale in systemic scleroderma, we have a very good understanding of the autoantibodies of the IgG type, and these autoantibodies actually work very well in passive transfer models, where antibodies from patients transferred into animal models actually cause the phenotype of the disease.

I think Beth will be communicating in the not too distant future about the date and the agenda of the R&D day.

Tim Van Hauwermeiren: The agenda of the R&D day.

On systemic scleroderma, this is an indication which was always high on the list. You remember that we always start from a very strong biology rationale but talking about a strong biology rationale in systemic scleroderma, we have a very good understanding of the autoantibodies of the IgG type and these autoantibodies actually work very well in passive transfer models, where antibodies from patients transferred into animal models actually cause the phenotype of the disease. We also know a number of the autoantigens so, if you immunize these animals with the autoantigens, again, they develop the typical symptoms of the disease. And then, of course, plasma exchange works; iVIg works; RITUXIMAB is approved in Japan so, there's a very solid body of evidence -- this is an IgG-driven disease.

Tim Van Hauwermeiren: On a systemic scleroderma.

Tim Van Hauwermeiren: As an indication which was always high on the list you will.

Tim Van Hauwermeiren: You remember that we always start from a very strong biology rationale. Talking about a strong biology rationale in systemic scleroderma, we have a very good understanding of the autoantibodies of the IgG type. These autoantibodies actually work very well in passive transfer models, where antibodies from patients transferred into animal models actually cause the phenotype of the disease. We also know a number of the autoantigens. If you immunize these animals with the autoantigens, again, they develop the typical symptoms of the disease. Of course, plasma exchange works, IVIG works. Rituximab is approved in Japan. There's a very solid body of evidence. This is an IgG-driven disease. There are useful clinical endpoints with no real approved medication outside of Rituximab in Japan.

Tim Van Hauwermeiren: Remember that we always start from a very strong biologic rationale. So we're talking about a strong biologic rationale in systemic scleroderma, we have a very good understanding of the ultra antibodies of the RTG type Mt's ultra antibodies actually and works very well in passive pen for mobiles with antibodies from patients.

Tim Van Hauwermeiren: Transferred into animal models actually caused the phenotype of the disease. We also know a number of the ultra antigens. So if you're immunizing. These animals with the ultra antigens and they developed a typical symptoms of the disease and then of course plasma exchange works <unk> Rituximab was approved in Japan.

Tim Van Hauwermeiren: We also know a number of the autoantigens. If you immunize these animals with the autoantigens, again, they develop the typical symptoms of the disease. Of course, plasma exchange works, IVIG works. Rituximab is approved in Japan. There's a very solid body of evidence. This is an IgG-driven disease. There are useful clinical endpoints with no real approved medication outside of Rituximab in Japan.

Tim Van Hauwermeiren: We also know a number of the autoantigens, so if you immunize these animals with the autoantigens, again, they develop the typical symptoms of the disease, and then, of course, plasma exchange works, IVIg works, rituximab is approved in Japan, so there's a very solid body of evidence this is an IgG-driven disease.

And then, of course, plasma exchange works; iVIg works; RITUXIMAB is approved in Japan so, there's a very solid body of evidence -- this is an IgG-driven disease. There are useful clinical endpoints with no real approved medication outside of RITUXIMAB in Japan so, we will have to interact, of course, with the regulators and calibrate expectations on endpoints. But in terms of biology rationale, unmet medical needs and feasibility of doing the clinical trials, this was an indication which made it high on the list. And, of course, we double-clicked on it, just like we did on all other indications in the portfolio review to really understand the potential impact of background medication on autoantibody levels, taking the learnings into account of the pemphigus trial. Thanks for the questions. Your next question comes from a line from Thomas Smith from Lear Inc. Partners. Your line is open. Hey, great. Thanks. This is Brian Connolly on behalf of Tom Smith.

Tim Van Hauwermeiren: This is a very solid body of evidence. This is an <unk> driven disease. There are useful clinical endpoints with no real approved medication outside of Rituximab in Japan. So we will have to in fact of course with the regulators and calibrate expectations on the endpoints, but in terms of policy rationale unmet medical needs.

Tim Van Hauwermeiren: There are useful clinical endpoints with no real approved medication outside of Fritiximab in Japan. So we will have to interact, of course, with the regulators and calibrate expectations on endpoints. But in terms of the biological rationale and medical needs and feasibility of doing the clinical trials, this was an indication that made it high on the list. And, of course, we double-clicked on it, just like we did on all other indications in the portfolio review to really understand the potential impact of background medication on autoantibody levels, taking the learnings into account from the FemFigure trial. Thanks for the questions. Your next question comes from a line from Thomas Smith from Lear Inc. Partners. Your line is open. Hey, great. Thanks. This is Brian Connolly on behalf of Tom Smith.

Tim Van Hauwermeiren: We will have to interact, of course, with the regulators and calibrate expectations on endpoints. In terms of biology rationale, unmet medical needs, and feasibility of doing the clinical trials, this was an indication which made it high up on the list. Of course, we double-clicked on it, just like we did on all other indications in the portfolio review, to really understand the potential impact of background medication on autoantibody levels, taking the learnings into account of the Fenfigis trial. Thanks for the questions.

Unknown Executive: <unk> and feasibility of doing the clinical trials this wasn't indication, which made it higher on the list and of course, we double click on it just like we did on all of the indications and the portfolio review to really understand the potential impact of background medication.

Your next question comes from the line of Thomas Smith from Leerink Partners. Your line is open. Hey, great. Thanks. This is Brian Connolly on behalf of Tom Smith.

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

Unknown Executive: Two antibody levels, taking the learnings into account of the SUNFISH trial.

Brian Conley: Hey, great. Thanks. This is Brian Conley, on for Thomas Smith. Couple of questions on the TED program. So, with respect to Phase III studies, can you talk about how you see EFGARTIGIMOD fitting into the competitive landscape there? Any specific differentiating aspects you would highlight from the way you've designed your Phase III active TED studies, [inaudible] and competitors? And are you contemplating pursuing broader development in chronic TED? Thanks.

Unknown Executive: For the questions.

Operator: Your next question comes from the line of Thomas Smith from Lyrinc Partners. Your line is open.

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

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

Brian Conley: Hey, great. Thanks. This is Brian Conley on for Tom Smith. A couple questions on the TED program. With respect to your two phase 3 studies, can you talk about how you see efgartigimod fitting into the competitive landscape there? Any specific differentiating aspects you would highlight from the way you've designed your phase 3 active TED studies, compared to some competitors? Are you contemplating pursuing broader development in chronic TED? Thanks.

Speaker Change: Alright, great. Thanks. This is Brian <unk> on for Tom Smith, a couple of questions on the <unk> program. So with respect to two phase III studies can you talk about how you see us taking about fitting into the competitive landscape there.

Speaker Change: Any specific differentiating aspects you would highlight from the way you design your phase III studies.

Speaker Change: Competitors and competitors and are you contemplating pursuing broader development in chronic Ted thanks.

Tim Van Hauwermeiren: Yes. So, as we announced, the Phase III study campaign is open, we are enrolling patients whilst we speak. This will be a global trial, also involving our partner Zai Lab in China. It's a sizable market opportunity and I think in the current treatment paradigm, it is becoming clear what the shortcomings are of the currently available medications. It's a relatively similar patient population which we're enrolling in our studies as compared to the TEPEZZA studies; of course, now, also involving a capped number of patients which can have seen TEPEZZA in their lives. And that's where we're going to stick with the update today on TED and I think we will be ready to talk more about it when we're deeper into these studies. But the big news today is study is live and is also using, by the way, the PFS.

Tim Van Hauwermeiren: Yeah. As we announced, the phase 3 study campaign is open. We are enrolling while we speak. This will be a global trial also involving our partner, Zai Lab in China. It's a sizable market opportunity. I think in the current treatment paradigm, it is becoming clear, you know, what the shortcomings are of the currently available medications. It's a relatively similar patient population which we are enrolling in our studies as compared to the Tepezza studies. Of course, now also involving a capped number of patients which can have seen Tepezza in their lives. That's where we're going to stick with the update today on TED, and I think we will be ready to talk more about it when we're deeper into these studies.

Speaker Change: Yes, so as we announced to be a phase three study campaign is open we are enrolling whilst we speak this will be a global trial also involving our partner <unk> in China.

Tim Van Hauwermeiren: This will be a global trial, also involving our partner XyLab in China. It's a sizable market opportunity, and I think in the current treatment paradigm, it is becoming clear, you know, what the shortcomings are of the currently available medications. It's a relatively similar patient population that we're enrolling in our studies as compared to the TEPEDSA studies, although now also involving a capped number of patients who may have seen TEPEDSA in their lives.

Thomas Jonathan Smith: The sizable market opportunity.

Tim Van Hauwermeiren: And I think in the current treatment paradigm is becoming clear what the shortcomings are of the currently available.

Tim Van Hauwermeiren: Medications.

Tim Van Hauwermeiren: It's relatively similar patient population, which began enrolling in our studies as compared to the petal studies that of course now also involving a number of patients which can have seen at the beds are in their life.

Tim Van Hauwermeiren: Of course, now also involving a capped number of patients which can have seen Tepezza in their lives. That's where we're going to stick with the update today on TED, and I think we will be ready to talk more about it when we're deeper into these studies. The big news today is the study is live and is also using, by the way, the PFS.

Tim Van Hauwermeiren: And that's where we're going to stick with the update today on TED and I think we will be ready to talk more about it when we're deeper into these studies. But the big news today is study is live and is also using, by the way, the PFS.

Tim Van Hauwermeiren: That's where we are going to stick with your update today on a CD and I think we will be ready to talk more about it when we get deeper into these studies, but the big use today is steady as life and is also using by the way the PFS.

Tim Van Hauwermeiren: The big news today is the study is live and is also using, by the way, the PFS.

Operator: Your next question comes from Alex Thompson from Stifel. Your line is open.

Alex Thompson: Hey, great. Thanks for taking my question. I guess I want to ask about self-administration and for CIDP, the expectation for potential for self-administration at launch or whether the PFS is really the route to achieving self-administration on the label for both CIDP and MG. Thanks.

Operator: Your next question comes from a line of Alex Thompson from Stifel. Your line is open.

Tim Van Hauwermeiren: Your next question comes from the line of Alex Thomson from Stifel. Your line is open.

Alex Thompson: Hey, great. Thanks for taking my question. I guess I wanted to ask about self-administration and for CIDP, the expectation for potential self-administration at launch or whether the PFS is really the route to achieving self-administration on the label for both CIDP and MG. Thanks.

Alexander Thompson: Hey, great. Thanks for taking my question I guess I wanted to ask about self administration and first IDP the expectation for potential self administration at launch or whether the PFS is really the route to achieving self administration on the label for both <unk> and Mg.

Karen Massey: Thanks for the question. We see self-administration as a really important step forward overall as we continue with our expansion strategy for Vyvgart and Vyvgart Hytrulo. The label for, if approved in CIDP, will be for the current Hytrulo label. That would be for HCP administration. As we shared earlier in the call, we're excited about the progress we're making with the prefilled syringe. The path there according to the plan that we've laid out is that we will have discussions around self-administration, and we think that there's a good, a positive path forward there for both MG and CIDP. Of course, it's always up to the FDA and a review issue.

Karen Massey: Yeah, thanks for the question. We think self-administration is a really important step forward, overall, as we continue with our expansion strategy for VYVGART and VYVGART HYTRULO. So, the label for -- if approved in CIDP, will be for the current HYTRULO label. So, that would be for HCP administration. But as we shared earlier in the call, we're excited about the progress we're making with the pre-filled syringe. And the path there, according to the plan that we've laid out, is that we will have discussions around self-administration. And we think that there's a good -- positive path forward there for both MG and CIDP. But, of course, it's always up to the FDA and a review issue.

Alexander Thompson: Yes. Thanks, Thanks for the question.

Karen Massey: We think self administration as a really important step forward overall as we continued with our expansion strategy.

Karen Massey: They've got EBITDA baitullah, so the label for <unk>.

Karen Massey: Its that if approved <unk> will be for the current high to low label, so that would be for HCP administration.

Karen Massey: As we shared earlier in the call, we're excited about the progress we're making with the prefilled syringe. The path there according to the plan that we've laid out is that we will have discussions around self-administration, and we think that there's a good, a positive path forward there for both MG and CIDP. Of course, it's always up to the FDA and a review issue.

Karen Massey: But as we said earlier in the call. We're excited about the progress, we're making with the pre filled syringe and the pop there. According to the plan that we've laid out is that we will have discussions around self administration, and we think that that's a good.

Karen Massey: Positive possible with their alpha both Mg NCI D P. But of course, it's always up to the FDA and in a review issue.

Operator: Your next question comes from the line of Xian Deng from UBS. Your line is open.

Operator: Your next question comes from a line of Xian Deng from UBS. Your line is open.

Karen Massey: Our next question comes from the line of Xian Deng from UBS. Your line is open.

Xian Deng: Hi, Xian from UBS. Thank you for taking my question. Just a general question on Sjögren's, please. So, Sjögren's has traditionally been a challenging disease for normal biologics. So, just wondering, what gives you the confidence in VYVGART in Phase III? Do you think it's a mechanism, FcRn is the target or some biomarker data you have collected or it's a primary endpoint? We know you already use a [inaudible] composite endpoint, which is arguably more comprehensive than some others. But on the other hand, Sjögren's, you're probably also going to have quite some patients with a lot of prior medications. So, just wondering, any thoughts on that? That would be great. Thank you.

Xian Deng: Hi, Xian Deng from UBS. Thank you for taking my question. Just a general question on Sjögren's, please. So Sjögren's has traditionally been a challenging disease for normal biologics. Just wondering, you know, what gives you the confidence in Vyvgart in phase 3? Do you think it's a mechanism, you know, FcRn is a target or some biomarker data you have collected, or it's a primary endpoint? We know you already, you know, use a composite endpoint, which is arguably more comprehensive than some others. But on the other hand, in the Sjögren's, you probably also gonna have quite some patients with a lot of prior medications. Just wondering, yeah, any thoughts on that? That would be great. Thank you.

Xian Deng: Hi, Kim from UBS. Thank you for taking my question just a general question a general question on <unk>. Please.

unknown: So she always has traditionally been a challenging disease called novel Biologics. So just wondering what gives you the confidence they've increased three do you think it's a mechanism at Cri target also on biomarker data you have collected all at the primary endpoint, we know the Rd youth compensate on point, which is.

Xian Deng: Do you think it's a mechanism, you know, FcRn is a target or some biomarker data you have collected, or it's a primary endpoint? We know you already, you know, use a composite endpoint, which is arguably more comprehensive than some others. But on the other hand, in the Sjögren's, you probably also gonna have quite some patients with a lot of prior medications. Just wondering, yeah, any thoughts on that? That would be great. Thank you.

unknown: Arguably more comprehensive than some others, but on the other hand show Greens.

unknown: You, probably also going to have quite some patients with lots of prior medications. So just wondering any thoughts on that that would be great. Thank you.

Tim Van Hauwermeiren: Yeah, thanks for the question on Sjögren's. So, the Phase II signal-finding study served two big purposes. Purpose one was to establish confidence in the disease biology and our understanding of the biology. And objective two was to really learn about do's and don'ts for the Phase III clinical trial design. So, let's start with objective number one. I think we see a very convincing biological signal here that by blocking FcRn, you're effectively eliminating the circulating immune complexes, which we think are the trigger of the disease. And by clearing these circulating immune complexes, you basically see a downstream effect in how the immune cell infiltration is going down in the glands and how systemic signs are actually improving. And improving across multiple clinical scales, hand-in-hand, so consistently. Now, that's exactly what we wanted to see in addition to a positive Phase II trial, as announced for NIPOCALIMAB by our colleagues from J&J.

Tim Van Hauwermeiren: Yeah. Thanks for the question on Sjögren's. The phase 2 signal finding study served 2 big purposes. Purpose 1 was to establish confidence in the disease biology and our understanding of the biology. Objective 2 was to really learn about dos and don'ts for the phase 3 clinical trial design. Let's start with objective number 1. I think we see a very convincing biological signal here that by blocking FcRn, you're effectively eliminating the circulating immune complexes, which we think are the trigger of the disease. And by clearing these circulating immune complexes, you basically see a downstream effect in how the immune cell infiltration is going down in the glands and how systemic signs are actually improving across multiple clinical scales hand in hand, so consistently.

unknown: Yeah. Thanks for the question on sugar, so the phase III.

Tim Van Hauwermeiren: Signal finding study surf two big purposes.

Tim Van Hauwermeiren: One was to establish confidence into disease biology, and our understanding of the biology.

Tim Van Hauwermeiren: Objective two of us to really learn about doosan dose for the phase III clinical trial design.

Tim Van Hauwermeiren: I think we see a very convincing biological signal here that by blocking FCRM, you're effectively eliminating the circulating immune complexes, which we think are the trigger of the disease. And by clearing these circulating immune complexes, you basically see a downstream effect on how immune cell infiltration is going down in the glands and how systemic signs are actually improving. And improving across multiple clinical scales, hand in hand, so consistently. Now, that's exactly what we wanted to see in addition to a positive phase two trial as announced by our colleagues from J&J.

Tim Van Hauwermeiren: So let's start with the objective number one.

Tim Van Hauwermeiren: I think we see a very convincing biological signal here that by blocking FcRn, you're effectively eliminating the circulating immune complexes, which we think are the trigger of the disease. And by clearing these circulating immune complexes, you basically see a downstream effect in how the immune cell infiltration is going down in the glands and how systemic signs are actually improving across multiple clinical scales hand in hand, so consistently.

Tim Van Hauwermeiren: We see a very convincing a biological signals you get that by blocking <unk> CRM you are effectively eliminating the circulating immune complexes, which we think are the triggers.

Tim Van Hauwermeiren: Of the disease and by creating these circulating immune complexes to basically see a downstream effect in how the immune cell infiltration is going down and the clients and how systemic.

And by clearing these circulating immune complexes, you basically see a downstream effect in how the immune cell infiltration is going down in the glands and how systemic signs are actually improving. And improving across multiple clinical scales, hand-in-hand, so consistently. Now, that's exactly what we wanted to see in addition to a positive Phase II trial, as announced for NIPOCALIMAB by our colleagues from J&J.

Tim Van Hauwermeiren: Signs are actually improving and improving across multiple clinical skills and enhance who consistently now that's exactly what we wanted to see in addition to our positive phase II trial as announced from the propel them up by our colleagues from J&J.

Tim Van Hauwermeiren: Now, that's exactly what we wanted to see in addition to a positive phase 2 trial, as announced for Nipocalimab by our colleagues from JNJ. Secondly, we learned a great deal about, you know, potential impact of background medication and how to mitigate that, the imperfections of the currently used endpoints. I think all in all, we have conviction in the data set, and we are actually equipped to now go into our end of phase 2 meeting with the FDA to discuss our proposal for phase 3. Thanks for the question.

Tim Van Hauwermeiren: Secondly, we learned a great deal about potential impact of background mitigation and how to mitigate that, the imperfections of the currently used endpoints -- so, I think, all in all, we have conviction in the dataset and we are actually equipped to now go into our end of Phase II meeting with the FDA to discuss our proposal for safety. Thanks for the question. Your next question comes from a line from Vikram Purohit from Morgan Stanley. Your line is open. Hi, good morning. Thanks for taking our questions. We just had two on the pipeline.

Secondly, we learned a great deal about potential impact of background mitigation and how to mitigate that, the imperfections of the currently used endpoints -- so, I think, all in all, we have conviction in the dataset and we are actually equipped to now go into our end of Phase II meeting with the FDA to discuss our proposal for safety. Thanks for the question.

Tim Van Hauwermeiren: <unk> learned a great deal about you know potential impact of background medication and how to mitigate that.

Vikram Purohit: Perfection of the currently used endpoints. So I think all in all we have conviction in the data sets and we are actually equipped to now go into our end of phase II meeting with the FDA to discuss our proposal for 50.

Your next question comes from the line from Vikram Purohit from Morgan Stanley. Your line is open. Hi, good morning. Thanks for taking our questions. We just had two on the pipeline.

Operator: Your next question comes from the line of Vikram Purohit from Morgan Stanley. Your line is open.

Vikram Purohit: Hi, good morning. Thanks for taking our question. We just had two on the pipeline. First, on EMPASIPRUBART for MMN. We're just curious if you could talk a bit about what that Phase III study could look like and just how you're characterizing that commercial opportunity. And then, for pipeline with [inaudible] this year, how are you thinking about the potential outcomes for the ALPHA and ALKIVIA datasets and what would constitute strong outcomes there from your perspective? Thank you.

Vikram Purohit: Thanks for the question.

Operator: Your next question comes from the line of Vikram Purohit from Morgan Stanley. Your line is open.

Operator: Your next question comes from a line of Vikram Purohit from Morgan Stanley. Your line is open.

Vikram Purohit: Your next question comes from the line of Vikram <unk> from Morgan Stanley. Your line is open.

Speaker 15: Hi, good morning. Thanks for taking our questions. We just have 2 on the pipeline. First, on empasiprubart for MMN. We're just curious if you could talk a bit about what that phase 3 study could look like and just kind of how you're characterizing that commercial opportunity. For pipeline readouts for this year, how are you thinking about the potential outcomes for the ALPHA and ALKIVIA data sets, and what would constitute strong outcomes there from your perspective? Thank you.

Vikram Purohit: Hi, good morning, Thanks for taking my questions. So we just have two on the pipeline first on capacity at <unk>, but just curious if you could talk a bit about what that phase III study could look like and just kind of how you're characterizing that commercial opportunity and then four.

Speaker 16: For pipeline readouts for this year, how are you thinking about the potential outcomes for the ALPHA and ALKIVIA data sets, and what would constitute strong outcomes there from your perspective? Thank you.

Vikram Purohit: Pipeline Readouts for this year.

Vikram Purohit: How are you thinking about that.

Vikram Purohit: Potential outcomes for the Alpha and I'll keep your datasets and what would constitute.

Vikram Purohit: Strong outcomes there from your perspective, thank you.

Tim Van Hauwermeiren: Thank you for all these questions. I think MMN is a sizable opportunity. Of course, it's a rare disease. It is a disease, which is, I think, underdiagnosed and under-treated. As we know, the only available therapy out there is iVIG. And similar to markets like, for example, MG, I would not be surprised to see this market grow substantially with real innovation coming in. I think from a trial design point of view, we are very well-equipped to get ready for Phase III because the main objective of the Phase II clinical trial, of course -- next to establishing proof of concept -- was to establish a dose response range where we can basically populate our PK/PD model and predict the Phase III dose and dosing regimen. I think we're very close to that point.

Tim Van Hauwermeiren: Yeah, thank you for all these questions. I think MMN is a sizable opportunity. Of course, it's a rare disease. It is a disease, you know, which is, I think underdiagnosed, and undertreated. As we know, the only available therapy out there is IVIG. Similar to markets like, for example, MG, I would not be surprised to see this market, you know, grow substantially with real innovation coming in. I think from a trial design point of view, we are very well equipped to get ready for phase 3, because the main objective of the phase 2 clinical trial, of course, next to establishing proof of concept, was to establish a dose-response range where we can basically populate our PK/PD model and predict the phase 3 dose and dosing regimen. I think we're very close to that point.

Vikram Purohit: Yeah. Thank you for all discussions.

Tim Van Hauwermeiren: Mmm isn't is a sizeable opportunity but of course, it's a rare disease.

Tim Van Hauwermeiren: It is a disease sooner, which is I think under diagnosed and under treated as we know the only available therapy outlet, it's IV arg and similar to markets. Like for example, Mg I would not be surprised to see this market grow substantially with real innovation coming in.

Tim Van Hauwermeiren: I think from a trial design point of view, we are very well equipped to get ready for phase 3, because the main objective of the phase 2 clinical trial, of course, next to establishing proof of concept, was to establish a dose-response range where we can basically populate our PK/PD model and predict the phase 3 dose and dosing regimen. I think we're very close to that point.

Tim Van Hauwermeiren: I think from a trial design point of view, we are very well equipped.

Tim Van Hauwermeiren: To get ready for phase three because the main objective of the phase II clinical trial of course next to establishing proof of concept was to establish a dose response range, where we can basically populate our PK PD model and predict the phase II dose and dosing regimen.

Tim Van Hauwermeiren: We also had a very rich trial here, in terms of clinical endpoints and we already said that all clinical endpoints really moved in sync with each other. So, we will be able to have a real, educated discussion with the FDA about which endpoint we would suggest and why we would be suggesting that endpoint out of the many ones which we tested. So, I think we will be in a strong position to engage in that end of Phase II discussion with the FDA relatively soon.

Tim Van Hauwermeiren: I think it would be very close to that point. We also had a very rich trial of <unk> in terms of clinical endpoints.

Tim Van Hauwermeiren: We also had a very rich trial here in terms of clinical endpoints. We already said that all clinical endpoints really moved in sync with each other. We will be able to have a real educated discussion with the FDA about which endpoint we would suggest and why we would be suggesting that endpoint out of the many ones which we tested. I think we will be in a strong position to engage in that end of Phase 2 discussion with the FDA relatively soon. In terms of other outcomes, this year, we're of course waiting now after the positive Phase 2 data for Sjögren's. We are waiting for the PC-POTS data, which should come in before the middle of the year.

Tim Van Hauwermeiren: And we already said at all clinical endpoints really moves in sync with each other so we will be able to have a view educated discussion with the FDA about which end points, we would suggest and why we would be suggesting that endpoint out of the many loans, which we test. So I think we will we will be in a strong position to indications at the end of phase.

Tim Van Hauwermeiren: I think we will be in a strong position to engage in that end of Phase 2 discussion with the FDA relatively soon. In terms of other outcomes, this year, we're of course waiting now after the positive Phase 2 data for Sjögren's. We are waiting for the PC-POTS data, which should come in before the middle of the year.

Tim Van Hauwermeiren: A discussion with the FDA relative.

Tim Van Hauwermeiren: Relatively students.

Tim Van Hauwermeiren: In terms of other outcomes this year, we are, of course, waiting now after the positive Phase II data for Sjögren's. We are waiting for the PC-POTS data, which should come in before the middle of the year and then, of course, the three myositis trials -- which will come in during the second half of the year. Similar to Sjögren's, in PC-POTS, we will be really looking for proof of biology; whilst you should be thinking of the go-no-go decision point in the myositis studies, in a similar fashion as we designed them for the CIDP study. So, we will want to see a signal which is reasonably expected to be stronger than what a placebo signal could be in order to advance in one, two or three of these subsets of myositis. And we will be communicating about these go-no-go's at the same time for all three indications. Thanks for the questions. Your next question comes from the line of Danielle Brill from Raymond James. Your line is open. Hey guys, good morning. Thanks so much for the question.

In terms of other outcomes this year, we are, of course, waiting now after the positive Phase II data for Sjögren's. We are waiting for the PC-POTS data, which should come in before the middle of the year and then, of course, the three myositis trials -- which will come in during the second half of the year. Similar to Sjögren's, in PC-POTS, we will be really looking for proof of biology; whilst you should be thinking of the go-no-go decision point in the myositis studies, in a similar fashion as we designed them for the CIDP study. So, we will want to see a signal which is reasonably expected to be stronger than what a placebo signal could be in order to advance in one, two or three of these subsets of myositis. And we will be communicating about these go-no-go's at the same time for all three indications. Thanks for the questions.

Tim Van Hauwermeiren: In terms of other outcomes this year.

Tim Van Hauwermeiren: We are of course waiting now after the positive phase II data for sugar.

Tim Van Hauwermeiren: We're waiting for the PC, Pos data, which should come in before the middle of the year and then of course, the <unk> Zaidis trials, which will come in during the second half of the year.

Tim Van Hauwermeiren: Then, of course, the three myositis trials, which will come in during H2. Similar to Sjögren's in PC-POTS, we will be really looking for proof of biology. While you should be thinking of the go, no-go decision point in the myositis studies in a similar fashion as we designed them for the CIDP study, we will want to see a signal which is reasonably to be expected stronger than what a placebo signal could be in order to advance in one, two, or three of these subsets of myositis. We will be communicating about these go, no-gos at the same time for all three indications. Thanks for the questions.

Tim Van Hauwermeiren: Similar to similar to share growth in PC products, we will be really looking for proof of biology.

Tim Van Hauwermeiren: Whilst we should be thinking of the go no go decision point in the Myositis studies in a similar fashion as we design them for the <unk> study. So we will want to see a signal which is reasonably to be expected stronger than what the placebo signal could be in order to advance in one two or three of these.

So, we will want to see a signal which is reasonably expected to be stronger than what a placebo signal could be in order to advance in one, two or three of these subsets of myositis. And we will be communicating about these go-no-go's at the same time for all three indications. Thanks for the questions.

Tim Van Hauwermeiren: Subsets of my Cyprus, and we will be communicating about these corner goals at the same time for all three indications.

Your next question comes from the line of Danielle Brill from Raymond James. Your line is open. Hey guys, good morning. Thanks so much for the question.

Operator: Your next question comes from the line of Danielle Brill from Raymond James. Your line is open.

Danielle Brill: Hey guys, good morning. Thanks so much for the question. I just want to go back to the CIDP launch. Based on recent doc checks, it seems like many patients may have already been earmarked for therapy with VYVGART, I'm wondering what feedback you're encountering in your market research and is there any reason, at this point, to think that the launch cadence won't be similar to what we saw in MG. Thank you.

Speaker Change: Thanks for the questions.

Operator: Your next question comes from the line of Danielle Brill from Raymond James. Your line is open.

Tim Van Hauwermeiren: And we will be communicating about these GONO goals at the same time for all three indications. Thanks for the question. Your next question comes from the line of Danielle Brill from Raymond James. Your line is open. Hey guys, good morning. Thanks so much for the question.

Operator: Your next question comes from the line of Danielle Brill from Raymond James. Your line is open.

Tim Van Hauwermeiren: Your next question comes from the line of Danielle Brill from Raymond James Your line is open.

Speaker 17: Hey, guys. Good morning. Thanks so much for the question. I want to circle back to the CIDP launch. Based on recent doc checks, it seems like many patients may have already been earmarked for therapy with Vyvgart. I'm wondering what feedback you're encountering in your market research. Is there any reason at this point to think that the launch cadence won't be similar to what we saw in MG? Thank you.

Danielle Brill: Hey, guys. Good morning. Thanks, so much for the question I had I wanted to circle back to the <unk> launch based on recent dot tax. It seems like many patients may have already been earmarks for therapy that they've got I'm wondering what feedback you're encountering in your market research and is there any reason at this point to think that the launch cadence won't be similar to what we.

Speaker Change: Thank you.

Karen Massey: Thanks for the question, Danielle. And we're seeing something similar in market research in one way, in that there is excitement amongst prescribers and patients about VYVGART and the potential. We are not seeing that there's a bolus of patients that are waiting. And in particular, the prescribers have the same question that many of us have, which is, when will payer policies come online? And we know that payer policies generally take a couple of quarters to come online after an approval.

Karen Massey: Thanks for the question, Danielle. We're seeing something similar in market research. In one way is that there is excitement among prescribers and patients about Vyvgart and the potential. We are not seeing that there's a bolus of patients that are waiting. In particular, the prescribers have the same question that many of us have, which is, when will the payer policies come online? We know that payer policies generally take a couple of quarters to come online after an approval. I think the uptake, combined with the payer policies coming online, that patient stickiness to IVIG that I talked about a little bit earlier, as well as the fact that IVIG is approved in this indication, and will be a strong competitor.

Speaker Change: Well thanks for the question Danielle.

Karen Massey: And something similar in market research in one way is it in that there is excitement amongst prescribers and patients about <unk> got and the potential we are not seeing that there's a bolus of patients that are waiting and in particular the.

Karen Massey: Prescribers have the same question that many of us have which is when will the payer policies come online and we know the payer policies generally take a couple of quarters to come online after an approval.

Karen Massey: So, I think that the uptake, combined with the payer policies coming online, that patient stickiness to iVIG that I talked about a little bit earlier, as well as the fact that iVIG is approved in this indication and will be a strong competitor. And if that means that -- so, we can expect to see maybe a little bit of a slower uptake versus MG. However, once we start to het the patient switches happening and once we start to shift the market, then I think that -- I'm confident that, over the long term, this is a big opportunity, even if it won't be easy in the first days. Thanks for the question. Your next question comes from the line of Suzanne Van Verhuizen from Van Lenshock Kempen. Your line is open. Hi, it's Chiara Montironi. I'm on behalf

So, I think that the uptake, combined with the payer policies coming online, that patient stickiness to iVIG that I talked about a little bit earlier, as well as the fact that iVIG is approved in this indication and will be a strong competitor. And if that means that -- so, we can expect to see maybe a little bit of a slower uptake versus MG. However, once we start to het the patient switches happening and once we start to shift the market, then I think that -- I'm confident that, over the long term, this is a big opportunity, even if it won't be easy in the first days. Thanks for the question.

Karen Massey: that payer policies generally take a couple of quarters to come online after an approval. I think the uptake, combined with the payer policies coming online, that patient stickiness to IVIG that I talked about a little bit earlier, as well as the fact that IVIG is approved in this indication, and will be a strong competitor.

Unknown Executive: The uptake combined with the payer policies coming online that patient stickiness to IV I E that I talked about a little bit earlier.

Unknown Executive: As well as the fact that <unk> is approved in this indication.

Unknown Executive: And we will be a strong competitor I think that means that we can expect to see maybe a little bit of a slower uptake versus mg. However, once we start.

Karen Massey: I think that means that we can expect to see maybe a little bit of a slower uptake versus MG. However, once we start to get the patient switches happening, and once we start to shift the market, then I think that I'm confident that over the long term, this is a big opportunity, even if it won't be easy in the first days. Thanks for the question.

Unknown Executive: To get the patients, which is happening and once we start to shift the market then I think that I am confident that over the long term. This is a big opportunity even if it won't be easy in the first days. Thanks for the question.

Your next question comes from the line of Suzanne Van Verhuizen from Van Lenshock Kempen. Your line is open. Hi, it's Chiara Montironi. I'm on behalf

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

Chiara Montironi: Hi, it's Chiara Montironi. I'm on behalf of Suzanne. So, out of curiosity, again on the drop of the ANCA program -- which was replaced by SSc -- I was wondering how those two indications compare in terms of efforts, trial design, timelines -- so, anything that you wish to highlight. Thank you.

Operator: Your next question comes from the line of Suzanne Van Voorthuizen from Van Lanshok Kempen. Your line is open.

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

Unknown Executive: Your next question comes from the line of Suzanne Van Heusen from Van Landshark Kempen. Your line is open.

Speaker 16: Hi, it's Chiara Montironi. I'm on behalf of Susanne. Out of curiosity, again, on the drop of the ANCA program, which was replaced by SSc, I was wondering how those two indications compare in terms of efforts, trial design, timelines, or anything that you wish to highlight. Thank you.

Operator: Hi, It's Ken I wanted to know on the among the household is on him.

Unknown Executive: <unk> I E out of curiosity again on the drop of Bianca program, which was replaced by FCC I was wondering how those two indications compare in terms of exports trial design timeline or anything that you wish to highlight thank you.

Tim Van Hauwermeiren: Roughly speaking, I would pile them in the same ballpark in terms of size of opportunity and size of investment. And the unmet medical need in AAV is substantial. The biology, by the way, is very strong. Actually, the disease is called after these also antibodies and we saw a recent case report published with spectacular data for VYVGART in the hands of physicians in the real world. The real issue for AAV, I think, is the confounding factor of the background medication. The mandated use of high doses of steroids is actually going to blur the effects of VYVGART. And we looked at it, you know, from multiple angles but there is no credible way to go through that steroid barrier despite higher medical needs. That is quite different in systemic scleroderma. So, equally high in medical needs, equal number of patients, equally strong biological rationale but I think in a more straightforward path in clinical development. That's how I would coin it for the time being.

Tim Van Hauwermeiren: Roughly speaking, I would put them in the same ballpark in terms of size of opportunity and size of investment. The unmet medical need in AAV is substantial. The biology, by the way, is very strong. Actually, the disease is called after these autoantibodies, and we saw a recent case report published with spectacular data for Vyvgart in the hands of physicians in the real world. The real issue for AAV, I think, is the confounding factor of the background medication. The mandated use of high dose of steroids is actually going to blur the effects of Vyvgart. We looked at it, you know, from multiple angles, but there is no credible way to go through that steroid barrier despite the higher unmet medical needs.

Unknown Executive: Roughly speaking.

Unknown Executive: Program in the same ballpark in terms of size of opportunity and size of investment.

Speaker Change: The unmet medical need is substantial.

Tim Van Hauwermeiren: <unk> very strong actually the disease is called Afterpiece also antibodies and we saw a recent case report published.

Tim Van Hauwermeiren: And we saw a recent case report published with spectacular data for Vyvgart in the hands of physicians in the real world. The real issue for AAV, I think, is the confounding factor of background medication. The mandated use of high doses of steroids is actually going to blur the effects of Vyvgart. And we looked at it, you know, from multiple angles, but there is no credible way to go through those steroid barriers, despite the higher medical needs.

Tim Van Hauwermeiren: With spectacular data for <unk>.

Tim Van Hauwermeiren:

Tim Van Hauwermeiren: In the hands of physicians in the real world. The real issue for <unk> I think is a confounding factor of the background medication.

Tim Van Hauwermeiren: The real issue for AAV, I think, is the confounding factor of the background medication. The mandated use of high dose of steroids is actually going to blur the effects of Vyvgart. We looked at it, you know, from multiple angles, but there is no credible way to go through that steroid barrier despite the higher unmet medical needs.

The real issue for AAV, I think, is the confounding factor of the background medication. The mandated use of high doses of steroids is actually going to blur the effects of VYVGART. And we looked at it, you know, from multiple angles but there is no credible way to go through that steroid barrier despite higher medical needs. That is quite different in systemic scleroderma. So, equally high in medical needs, equal number of patients, equally strong biological rationale but I think in a more straightforward path in clinical development. That's how I would coin it for the time being.

Tim Van Hauwermeiren: The mandates.

Tim Van Hauwermeiren: Use of high dose steroids is actually going to blur the effects of gift cards.

Tim Van Hauwermeiren: And we looked at it from multiple angles, but there is no credible way to go through that steroid barriers.

Tim Van Hauwermeiren: Despite the high unmet medical need that is quite different.

Tim Van Hauwermeiren: That is quite different in systemic scleroderma. Equally high unmet medical needs, equal number of patients, equally strong biology rationale, but I think a more straightforward path in clinical development. That's how I would call it for the time being.

Tim Van Hauwermeiren: In systemic sclerosis.

Tim Van Hauwermeiren: Burma, so equally high unmet medical needs equal number of patients.

Tim Van Hauwermeiren: Equally strong biologic rationale, but I think in a more straightforward path in <unk>.

Tim Van Hauwermeiren: The nickel development, that's how I would call it.

Tim Van Hauwermeiren: For the time being.

Tim Van Hauwermeiren: That is quite different in systemic scleroderma. So, equally high in medical needs, equal number of patients, equally strong biological rationale but I think in a more straightforward path in clinical development. That's how I would coin it for the time being. Your next question comes from a line from Samantha Semenkow from Citi. Your line is open. Good morning, and thank you for taking the question. My question is just on the uptake of HITRULO. Is there growth?

That is quite different in systemic scleroderma. So, equally high in medical needs, equal number of patients, equally strong biological rationale but I think in a more straightforward path in clinical development. That's how I would coin it for the time being.

Your next question comes from a line from Samantha Semenkow from Citi. Your line is open. Good morning, and thank you for taking the question. My question is just on the uptake of HITRULO. Is there growth?

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

Samantha Semenkow: Good morning and thank you for taking the question. My question is just on the uptake of HYTRULO. Is the growth that you highlighted in the prepared remarks, is that a recent uptake or has it been steadily climbing over the last several quarters. And then, as you think about introducing PFS as an approved option formulation, would you expect a similar trajectory of growth for the PFS or would you expect it to be a sharper uptake? Thank you.

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

Speaker Change: Your next question comes from the line of Samantha Simon Cowell from Citi. Your line is open.

Speaker 18: Good morning, and thank you for taking the question. My question is just on the uptake of Hytrulo. Is the growth that you highlighted in the prepared remarks a recent uptake or has it been steadily climbing over the last several quarters? And then as you think about introducing PFS as an approved option formulation, would you expect a similar trajectory of growth for the PFS or would you expect it to be a sharper uptake? Thank you.

Samantha Lynn Semenkow: Good morning, and thank you for taking the question. My question is just on the uptake of high to low is the growth that you highlighted in the prepared remarks.

Samantha Lynn Semenkow: <unk> uptake or has it been steadily climbing over the last several quarters and then as you think about introducing PFS.

Operator: As an approved <unk>.

Samantha Lynn Semenkow: Option formulation would you expect a similar trajectory of growth for the PFS or would you expect it to be a sharper uptick. Thank you.

Operator: Yes.

Karen Massey: Yes. Thanks for the question, Samantha. I'll take that. We actually did see an acceleration in the uptake of HYTRULO in Q1 and there were specific reasons for that. Mainly that the payer policies were in place and the J-code was established in Q1. So, we did see an acceleration, we expect that to continue. And it's important to note, just in to -- just talking about it with the CIDP launch, it did take about two quarters for those payer policies to come into place with HYTRULO. So, we've seen that now.

Karen Massey: Yes, thanks for the question, Samantha. I'll take that. We actually did see an acceleration in the uptake of Hytrulo in Q1, and there were specific reasons for that. Namely, that the payer policies were in place and the J-code was established during Q1. We did see an acceleration. We expect that to continue. It's important to note, just since we were just talking about it with the CIDP launch, it did take about two quarters for those payer policies to come into place with Hytrulo. We've seen that now. In moving forward, I think we're very excited about the prefilled syringe and being able to offer an even broader product presentation options to patients.

Samantha Lynn Semenkow: Yes. Thanks for the question Samantha I'll take that we actually did see an acceleration in the uptake of <unk> in Q1, and there were specific reasons for that namely that the payer policies.

Samantha Lynn Semenkow: We are in place and the J code was established.

Karen Massey: We did see an acceleration. We expect that to continue. It's important to note, just since we were just talking about it with the CIDP launch, it did take about two quarters for those payer policies to come into place with Hytrulo. We've seen that now. In moving forward, I think we're very excited about the prefilled syringe and being able to offer an even broader product presentation options to patients.

Samantha Lynn Semenkow: In Q1, so we did see an acceleration we expect that to continue.

Samantha Lynn Semenkow: And it's important to note just into a just talking about it with the CIBC launch it did take about two quarters for those payer policies to come into play with high Pulitzer. So we've seen that now.

Karen Massey: We actually did see an acceleration in the uptake of HITRULO in Q1, and there were specific reasons for that, namely that payer policies were in place, and the J code was established in Q1. So we did see an acceleration, and we expect that to continue. And it's important to note, just in terms of just talking about it with the CIDC launch, it did take about two quarters for those payer policies to come into place with HITRULO. So we've seen that now.

Karen Massey: And moving forward I think we're very excited about the pre filled syringe and being able to offer an even broader product presentation options to patients.

Karen Massey: I do think it's a significant advancement on the current gen one of Hytrulo. I do think it'll enable us to further move up to earlier lines of treatment with Vyvgart and further advance or expand our prescriber base as well. We do see that PFS will be another engine for growth, if you will, for Vyvgart. Thanks for the question.

Karen Massey: Do you think it's a significant advancement on the current Gen. One.

Karen Massey: Hi, cooler and I do think it will.

Karen Massey: Enable us to further move up to earlier lines of treatment, we've got and further advanced our expand our prescriber base as well. So we do see that that PFS will be another engine for growth if you will for Scott.

Speaker Change: Thanks for the question.

Karen Massey: In moving forward, I think we're very excited about the pre-filled syringe and being able to offer an even broader product presentation options to patients. I do think it's a significant advancement on the current Gen 1 of YITRULO and I do think it will enable us to further move up to earlier lines of treatment with VYVGART and further advance or expand our prescriber base as well. So, we do see that that PFS will be another engine for growth, if you will, for VYVGART. Thanks for the questions. Your next question comes from the line of Gavin Clark Gartner from Evercore ISI. Your line is open.

In moving forward, I think we're very excited about the pre-filled syringe and being able to offer an even broader product presentation options to patients. I do think it's a significant advancement on the current Gen 1 of YITRULO and I do think it will enable us to further move up to earlier lines of treatment with VYVGART and further advance or expand our prescriber base as well. So, we do see that that PFS will be another engine for growth, if you will, for VYVGART. Thanks for the questions.

Operator: Your next question comes from the line of Gavin Clark-Gartner from Evercore ISI. Your line is open.

Speaker Change: Your next question comes from the line of Gavin Clark Gardner from Evercore ISI. Your line is open.

Speaker 19: Hey, thanks for taking the question. On EMPA in the pipeline, I believe you've noted there's been no cases of lupus in the ongoing MMN study. I also wanted to ask about rates of ANA titer elevations, specifically, any other markers, such as dsDNA. Thank you.

Speaker Change: Hey, Thanks for taking my question on <unk> and the pipeline I believe you've noted there's been no cases of Lucas and the ongoing Mmm study, but I also wanted to ask about rates of AMIA tighter elevations, specifically any other markers such as the SG&A. Thank you.

Operator: Your next question comes from the line of Gavin Clark-Gartner from Evercore ISI. Your line is open.

Tim Van Hauwermeiren: Hey, thanks for taking the question. Yeah, that's a great question and a potential differentiator actually for C2 versus C1. No, we did not see any increase of this type. And at least from a theoretical point of view, we have always believed this could be one of the advantages of an anti-C2 antibody.

Gavin Clark-Gartner: Hey, thanks for taking the question. On EMPA, in the pipeline, I believe you've noted there's been no cases of lupus on the ongoing MMN study but I also wanted to ask about rates of ANA titer elevations, specifically, any other markers such as dsDNA. Thank you.

Tim Van Hauwermeiren: Yeah, that's a great question and a potential differentiator actually for C2 versus the C1s. No, we did not see any increase of such titers. At least from a theoretical point of view, we have always believed this could be one of the advantages of an anti-C2 antibody. None of these signs and a great opportunity for me to remind everyone on the call that the Phase 1 data both for IV and subQ came out, you know, with spick and span safety and tolerability data. So far so good. Thanks for the question.

Speaker Change: No. That's a great question and a potential differentiator actually 42 versus the <unk> no. We did not see any increase of such status.

Yeah, that's a great question. And a potential differentiator, actually, for C2 versus the C1. No, we did not see any increase of such titers. And at least from a theoretical point of view, we have always believed this could be one of the advantages of an anti-C2 antibody. So, none of these signs -- and a great opportunity for me to remind everyone on the call that the Phase I data, both for IV and Sub-Q, came out with spic-and-span safety and tolerability data. So, so far, so good. Thanks for the question. Your next question comes from Yatin Suneja from Guggenheim. Your line is open. Hi. Thank you.

Speaker Change: And at least from a theoretical point of view, we have always believed that this could be one of the advantages of an enticing to them.

Speaker Change: Antibody so none of these signs and a great opportunity for me to remind everyone on the call that the phase one.

Speaker Change: Data both for IV and <unk> came out with the SPIC and span safety and Tolerability data. So far so good thanks for the question.

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

Yatin Suneja: Hi. Quickly for me, on VYVGART, could you comment on what you're seeing in terms of discontinuation there? Is it in that 20% range? And then, anything you are able to say on number of cycles that you are able -- that patients are getting? Thanks.

Tim Van Hauwermeiren: So none of these signs, and a great opportunity for me to remind everyone on the call that the phase one data, both for IV and sub-Q, came out with pick and span safety and tolerability data. So, so far, so good. Thanks for the question. Your next question comes from Yatin Suneja from Guggenheim. Your line is open. Hi. Thank you.

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

Speaker Change: Your next question comes from the line of <unk> <unk> from Guggenheim. Your line is open.

Speaker 20: Hi. A quick one for me. On VYVGART, could you comment on what you're seeing in terms of discontinuation rate? Is it in that 20% range? Anything you are able to say on number of cycles that patients are getting. Thanks.

Tim Van Hauwermeiren: Hi.

Yatin Suneja: One for me.

Yatin Suneja: <unk> got could you comment on what you're seeing in terms of discontinuation rate is at that 20% range and then anything you are able to see a number of cycles that you wanted that patients are getting.

Tim Van Hauwermeiren: Thank you for the question. In this continuation, as you know, 20% of the patients from the ADAPT study did not respond so, you would expect the discontinuation to be 20% plus because there are also other reasons and what we see in the real world is in line with our expectations. And that has been consistent since launch. In terms of the number of cycles, the number of cycles for IV has also been consistent and it's around five, as we previously said. So, there's been no change. Thank you.

Tim Van Hauwermeiren: Thank you for the question. On discontinuation, as you know, 20% of the patients from the ADAPT study did not respond, so you would expect discontinuation to be 20% plus, because there are also other reasons. What we see in the real world is in line with our expectations, and that has been consistent since launch. In terms of a number of cycles, the number of cycles for IV has also been consistent, and it's around 5 as we previously said. There's been no change. Thank you.

Yatin Suneja: Thank you for the question.

Karen Massey: On discontinuation as you know 20% of the patients from the adapt study does not respond. So you would expect the discontinuation to be 20% plus.

Karen Massey: Because now also other reasons than what we've seen but it will be in line with how we expectations.

Karen Massey: But this has been consistent since launch in terms of a number of cycles. The number of cycles for Ibs also being consistent.

Karen Massey: And it's around five <unk> previously said.

Karen Massey: No change.

Speaker Change: Thank you.

Operator: Your next question comes from the line of Victor Floc'h from BNP Paribas. Your line is open.

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

Karen Massey: Your next question comes from the line of Victor <unk> from BNP Paribas. Your line is open.

Victor Floc'h: Hi, thanks a lot for taking my question. Dr. Floc'h, Paribas Exane. So, a couple of questions on my side. First, I was wondering if it's fair to say that the SG&A cost phasing we've seen within this quarter is reflecting a higher need to build up awareness right at launch in CIDP than what was needed for MG back in the day. So, if you could just, you know, remind us the key challenges in CIDP compared to MG, it would be appreciated. And my second question is about ITP. And so, I was just wondering if you could update us on your efforts to potentially expand the ITP opportunity beyond Japan. So, I don't know what is in the balance to take any decision and if you could commit to any timing but any color on that would be very much appreciated. Thanks a lot.

Speaker 21: Hi, thanks a lot for taking my question. Victor Floc'h from BNP Paribas Exane. A couple of questions on my side. First, I was wondering if it's fair to say that the SG&A cost phasing within this quarter is reflecting a higher need to build up awareness, right, of launch in CIDP than what was needed for MG back in the day. If you could just, you know, remind us the key challenges in CIDP compared to MG would be appreciated. My second question is about ITP. I was just wondering if you could update us on your efforts to potentially extend the ITP opportunity beyond Japan.

Victor Flock: Hi, Thanks for taking my question.

Speaker Change: Thanks, Dan.

unknown: A couple of questions on my side first I was wondering if it's fair to say that the X gene a quick thinking.

unknown: We've seen this quarter is reflecting a higher need to build up awareness threat of London to ADP.

unknown: And what was needed for Mg back in the day. So if you could just remind us the key challenges.

Speaker 21: If you could just, you know, remind us the key challenges in CIDP compared to MG would be appreciated. My second question is about ITP. I was just wondering if you could update us on your efforts to potentially extend the ITP opportunity beyond Japan. I don't know what is in the balance to make any decision, and if you could commit to any timing. Yeah, any color on that would be very much appreciated. Thanks a lot.

unknown: CDP compared to Q2.

unknown: And my second question is about ITP. And so I was just wondering if you could update us on your efforts to potentially expand the ITP opportunity beyond Japan. So I don't know what is in the balance to take any decision, and if you could commit to any timing, but any color on that would be very much appreciated. Thanks a lot.

unknown: <unk> would be would be appreciated and my second question is about ICP and so I was just wondering if you could.

unknown: Data from your reports to potentially expand the ACP opportunity beyond Japan. So I don't know what what is in the balance to pick any this isn't an issue.

Speaker 21: I don't know what is in the balance to make any decision, and if you could commit to any timing. Yeah, any color on that would be very much appreciated. Thanks a lot.

unknown: <unk> timing, but any color on that would be very much like a city.

Tim Van Hauwermeiren: Thank you for the question. I will give the floor in a minute to Karl, who is going to comment on the increase in SG&A expenses in preparation of the CIDP launch. So, Karl, you will be able to give some color there.

Tim Van Hauwermeiren: Thank you for the question. I will give the floor in a minute to Karl, who's going to comment on the increase in SG&A expenses in preparation of the CIDP launch. Karl, you will be able to give some color there. Thank you for your question on ITP. We're of course delighted to see the PMDA approval for ITP. We see the first patients coming on product very quickly, underscoring I think the unmet medical needs which is present in ITP. I think it's fair to say that throughout the interactions with the PMDA, we also gained a number of insights we can use to actually pivot back to the FDA for a follow-up conversation. That's exactly what the team is preparing.

Speaker Change: Thank you for the question I will give thee.

Karl Gubitz: In a minute to Carl was going to comment on the increase in SG&A expenses in preparation of the Sergipe launched Chicago, you will be able to give some color. There. Thank you for your question on ITT.

Tim Van Hauwermeiren: Thank you for your question on ITP. We are, of course, delighted to see the PMDA approval for ITP. We see the first patients coming on the product very quickly, underscoring, I think, the unmet medical needs which is present in ITP. And I think it's fair to say that throughout the interactions with the PMDA, we also gained a number of insights we can use to actually pivot back to the FDA for a follow-up conversation. And that's exactly what the team is preparing. I think we're equipped now to go back to the FDA for a dialogue to see whether we can make progress on the ITP front. So, stay tuned. I certainly don't want to overpromise but I think we're going to make an extra effort there, which I think we owe to ITP patients. Karl, would you mind commenting on the SG&A step-up? Okay, yeah.

Thank you for your question on ITP. We are, of course, delighted to see the PMDA approval for ITP. We see the first patients coming on the product very quickly, underscoring, I think, the unmet medical needs which is present in ITP. And I think it's fair to say that throughout the interactions with the PMDA, we also gained a number of insights we can use to actually pivot back to the FDA for a follow-up conversation. And that's exactly what the team is preparing. I think we're equipped now to go back to the FDA for a dialogue to see whether we can make progress on the ITP front. So, stay tuned. I certainly don't want to overpromise but I think we're going to make an extra effort there, which I think we owe to ITP patients. Karl, would you mind commenting on the SG&A step-up?

Tim Van Hauwermeiren: We're of course delighted to see the PMT approval for IDP.

Tim Van Hauwermeiren: We see the first patients coming on product very quickly, underscoring I think the unmet medical needs which is present in ITP. I think it's fair to say that throughout the interactions with the PMDA, we also gained a number of insights we can use to actually pivot back to the FDA for a follow-up conversation. That's exactly what the team is preparing.

Tim Van Hauwermeiren: The first patients coming on product very quickly underscoring I think the unmet medical needs, which has a presence in.

Tim Van Hauwermeiren: And I think it's fair to say that throughout the interactions with the <unk>. We also gained a number of insights we can use to extra pivot back to the FDA.

Tim Van Hauwermeiren: For a follow up conversation and that's exactly what the team is preparing I think created equipped now to go back to the FDA for a dialogue to see whether we can make progress on the IP front.

Tim Van Hauwermeiren: I think we're equipped now to go back to the FDA for a dialogue to see whether we can make progress on the ITP front. So, stay tuned. I certainly don't want to overpromise, but I think we're going to make an extra effort there, which I think we owe to ITP patients. Karl, would you mind commenting on the SGNA step-up? Okay, yeah.

Tim Van Hauwermeiren: I think we're equipped now to go back to the FDA for a dialogue to see whether we can make progress on the ITP front. Stay tuned. I certainly don't want to overpromise, but I think we're going to make an extra effort there, which I think we owe to ITP patients. Karl, would you mind commenting on the SG&A stuff?

Tim Van Hauwermeiren: So stay tuned I, certainly don't want to over promise, but I think we are going to make an extra effort dish, which I think <unk> ICP patients.

Karl, would you mind commenting on the SG&A step-up?

Karl Gubitz: Carl would you mind, commenting on the SG&A SG&A.

Karl Gubitz: Okay, yeah. SG&A increased by around $27 million in Q1 '24 versus the end of last quarter in '23. That increase is largely driven by the incremental infrastructure we put in place in the U.S. versus customer-facing colleagues, which will be promoting gMG today. And as we said previously, we believe that the gMG opportunity is bigger than we originally thought and now we're expanding that footprint. That same footprint will also be used for the CIDP launch, subject to approval, later this year.

Karl Gubitz: Okay, SG&A increased by around 27 million dollars in Q1 2024 versus the end of the last quarter in 2023. That increase is largely driven by the incremental infrastructure we put in place in the US versus customer-facing colleagues, which will be promoting GMG today. And as we said previously, we believe that the GMG opportunity is bigger than we originally thought, and now we're expanding that footprint. That same footprint will also be used for the CIDP launch, subject to approval later this year.

Karen Massey: Okay, yeah. SG&A increased by around EUR 27 million in Q1 2024 versus the end of Q4 2023. That increase is largely driven by the incremental infrastructure we put in place in the US versus customer-facing colleagues.

Karl Gubitz: SG&A increased by around $27 million in Q1 24 versus <unk>.

Karl Gubitz: Last quarter and 23 that increase is largely driven by the incremental infrastructure, we put in place in the U S. This is customer facing colleagues, which we'll be promoting gmg today and as we said previously we believe that the gmg opportunities be given what we all read.

Tim Van Hauwermeiren: Which will be promoting GMG today. As we said previously, we believe that the GMG opportunity is bigger than what we originally thought, and now we're expanding that footprint. That same footprint will also be used for the CIDP launch subject to approval later this year. Also, part of that increase is the geographical expansion. You've heard us talk about certain markets like Italy, Spain, and other European markets, where we're starting to have sales. We've been very disciplined to guide any expenses in those markets until we have pricing and reimbursement in place. As we start seeing sales in those markets, we are investing in those markets. It is the US and the geographical expansion, which is driving that increase. Thank you for the question.

Operator: Also, part of that increase, is the geographical expansion. You've heard us talk about certain markets like Italy and Spain and other European markets where we're starting to have sales. We've been very disciplined to gate any expenses in those markets until we have pricing and reimbursement in place. And as we start seeing sales in those markets, we are investing in those markets. So, it is the U.S. and the geographical expansion that is driving that increase. Thank you for the question. Your next question comes from the line of Joel Beatty from Baird.

Also, part of that increase, is the geographical expansion. You've heard us talk about certain markets like Italy and Spain and other European markets where we're starting to have sales. We've been very disciplined to gate any expenses in those markets until we have pricing and reimbursement in place. And as we start seeing sales in those markets, we are investing in those markets. So, it is the U.S. and the geographical expansion that is driving that increase. Thank you for the question.

Karl Gubitz: And look toward and now we are expanding that footprint that same footprint will also be used for.

Joel Lawrence Beatty: With <unk> launch is subject to approval later this year also part of that increase is the geographical expansion you've heard us talk about the certain markets like Italy, and Spain, and other European markets, where we starting to have sales we've been very disciplined to any expenses in both.

Tim Van Hauwermeiren: You've heard us talk about certain markets like Italy, Spain, and other European markets, where we're starting to have sales. We've been very disciplined to guide any expenses in those markets until we have pricing and reimbursement in place. As we start seeing sales in those markets, we are investing in those markets. It is the US and the geographical expansion, which is driving that increase. Thank you for the question.

Operator: Markets until we have pricing and reimbursement in place.

Joel Lawrence Beatty: As we start seeing sales in both markets. We are investing in both smokers. So would this be U S and the geographical expansion, which is anything but increase thank you public question.

Operator: Your next question comes from the line of Joel Beatty from Baird. Your line is open.

Joel Beatty: Thanks for taking the question. With Q1 typically being a challenging quarter, how did the trajectory of VYVGART sales change over the course of the quarter into early Q2?

Operator: Your next question comes from the line of Joel Beatty from Baird. Your line is open.

Speaker 22: Thanks for taking the question. With Q1 typically being a challenging quarter, how did the trajectory of Vyvgart sales change over the course of the quarter into early Q2?

Joel Lawrence Beatty: Thanks for taking the question with Q1, typically being a challenging quarter, how did the trajectory of <unk> sales change over the course of the quarter into early Q2.

Karen Massey: Yes, thanks for the question. As you say, Q1 is notoriously challenging -- in particular, in the U.S., with holidays and recertifications and weather, et cetera. We're really pleased with the growth, the quarter-on-quarter growth that we delivered in the U.S., as well as the year-on-year growth. I think it was 76% year-on-year growth for the U.S.. What we're seeing and what we feel is confidence that the underlying fundamentals of what we delivered in Q1 were very strong. And I went over a few of those, whether you look at new patient growth, where the patients are coming from, we're advancing market share -- all of those factors. And we're seeing that continue into Q2 so, we're confident in the remainder of the year. Your next question comes from Manos Mastorakis from Deutsche Bank. Hello, thank you for taking my question, which is basically on the...

Karen Massey: Yeah. Thanks for the question. As you say, Q1 is notoriously challenging, in particular in the US, with holidays, recertifications, and weather, et cetera. We're really pleased with the growth, the quarter-on-quarter growth that we delivered in the US as well as the year-on-year growth. I think it was 76% year-on-year growth for the US. What we're seeing and what we feel is confidence that the underlying fundamentals of what we delivered in Q1 were very strong. I went over a few of those, whether you look at new patient growth, where the patients are coming from, we're advancing market share, all of those factors, and we're seeing that continue into Q2. So we're confident in the remainder of the year.

Joel Lawrence Beatty: Yes, thanks for the question.

Karen Massey: Q1 is notoriously challenging in particular in the U S.

Karen Massey: With holidays, and recertification and weather et cetera, we're really pleased with the growth of the quarter on quarter growth that we delivered in the U S as well as the year on year growth I think it was 76%.

Karen Massey: Year on year growth.

Karen Massey: What we're seeing and what we feel is confidence that the underlying fundamentals of what we delivered in Q1 were very strong. I went over a few of those, whether you look at new patient growth, where the patients are coming from, we're advancing market share, all of those factors, and we're seeing that continue into Q2. So we're confident in the remainder of the year.

Karen Massey: What we're seeing and what we feel is confidence.

Karen Massey: That the underlying fundamentals of what we delivered in Q1 were very strong and I went over a few of those whether you look at new patient growth, where the patients are coming from we're advancing market share all of those factors and we're seeing that continue into Q2.

Karen Massey: I went over a few of those, whether you look at new patient growth, where the patients are coming from, where they're advancing market share, all of those factors. We're seeing that continue into Q2, so we're confident in the remainder of the year. Your next question comes from Manos Mastorakis from Deutsche Bank. Hello, thank you for taking my question, which is basically on the...

Your next question comes from Manos Mastorakis from Deutsche Bank. Your line is open. Hello, thank you for taking my question, which is basically on the...

Operator: Your next question comes from Manos Mastorakis from Deutsche Bank. Your line is open.

Manos Mastorakis: So we're confident in the remainder of the year.

Manos Mastorakis: Hello, thank you for taking my question. Just basically on the key learnings you took away on the exercise you did across indications and -- which led to the discontinuation of ANCA-vasculitis. And how do some of those learnings extend to EMPASIPRUBART? Thank you.

Operator: Your next question comes from the line of Manos Mastorakis from Deutsche Bank.

Operator: Your next question comes from a line of Manos Mastorakos from Deutsche Bank. Your line is open.

Manos Mastorakis: Your next question comes from the line of <unk> from Deutsche Bank. Your line is open.

Operator: Okay.

Speaker 23: Hello. Thank you for taking my question, which is basically on the key learnings you took away from the exercise you did across indications and, which led to the discontinuation of ANCA vasculitis, and how do some of those learnings extend to empasiprubart? Thank you.

Manos Mastorakis: Hello, Thanks for taking my question.

Manos Mastorakis: So basically on the key learnings due to.

Manos Mastorakis: Took away from the exercise you did across indications.

Manos Mastorakis: Which led to the discontinuation of <unk> and how do some of those learnings extend to <unk>.

Manos Mastorakis: Thank you.

Operator: Yeah.

Tim Van Hauwermeiren: Thank you. It's a great question. Actually, when we did the portfolio review, we did not only limit it to efgartigimod, we immediately included also the EMPA indications. We did a full review of all plans and ongoing indications, and we gained confidence for all EMPA indications which are currently on the rails, but also the ones which we're planning in addition, that actually we can master the impact of the background medication. I feel very strong about the big efforts all the teams did in such a short period of time following the PENTAGUS data. We've thoroughly double-clicked on trial designs, understanding the impact of background medication and whether or not we're actually equipped to deal with those.

Tim Van Hauwermeiren: Thank you, it's a great question. Actually, when we did the portfolio review, we did not only limit it to EFGARTIGIMOD; we immediately included also the EMPA indications. So, we did a full review of all planned and ongoing indications and we gained confidence for all EMPA indications, which are currently on the rails but also the ones which we're planning in addition, that we can actually master the impact of the background medication.

Manos Mastorakis: Thank you it's a great question excuse me.

Tim Van Hauwermeiren: Portfolio review.

Tim Van Hauwermeiren: Not only limited to <unk> <unk>.

Tim Van Hauwermeiren: Immediately included also the Empire indications. So we did a full review of all plants and ongoing indications.

Tim Van Hauwermeiren: As we gain confidence for all and by indications, which are currently on the rail but also the ones, which we are planning. In addition that actually became massive impact of the background medications. So I feel very strong about the big efforts. All the teams did in such a short period of time following the <unk> data with totally double click on trial design.

Tim Van Hauwermeiren: So, I feel very strong about the big efforts all the teams did in such a short period of time following the pemphigus data. We've thoroughly double-clicked on trial designs, understanding impact of background medication and whether or not we're actually equipped to deal with those. So, exercise has landed and actually, most indications remain on track, with the exception of AAV, where we no longer feel it's a responsible allocation of capital to take such a risk from a background medication point of view. Thanks for the question.

Tim Van Hauwermeiren: I feel very strong about the big efforts all the teams did in such a short period of time following the PENTAGUS data. We've thoroughly double-clicked on trial designs, understanding the impact of background medication and whether or not we're actually equipped to deal with those.

Tim Van Hauwermeiren: Understanding the impact of background medication, and whether or not we're actually equipped to deal with those so exercise has landed.

Tim Van Hauwermeiren: Exercise has landed, and actually most indications remain on track with the exception of AAV, where we no longer feel it's a responsible allocation of capital to take such a risk from a background medication point of view. Thanks for the question.

Tim Van Hauwermeiren: Most indications remain on track with the exception of AAP will be no longer feel it's responsible allocation of capital to take such a risk from a backdrop medication point of view.

Speaker Change: Thanks for the question.

Operator: Your next question comes from the line of Matt Phillips from William Blair. Your line is open.

Matt Phipps: Thanks for taking my question. Two quick ones. First, on the human factor studies, did you use CID patients in that study? I'm just wondering if somebody with reduced grip strength would be suitable for self-administered PFS. And then, I guess, following the potential CID approval, given what you said about the payer policies -- would you plan you plan to provide some kind of free drug program, given the underlying patient interest and demand?

Your next question comes from the line of Matt Phillips from William Blair. Your line is open. Two quick ones. First, in the human factor studies, did you use CID patients and

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

Operator: Thanks for the question. Your next question comes from the line of Matt Phillips from William Blair. Your line is open. Two quick ones. First, in the human factor studies, did you use CID patients and

Thanks for the question.

Operator: Your next question comes from the line of Myles Minter from William Blair. Your line is open.

Tim Van Hauwermeiren: Your next question comes from the line of Matt Phillips from William Blair. Your line is open.

Speaker 24: Thanks for taking my question. Two quick ones. First, on the human factor studies, did you use CIDP patients in that study? I'm just wondering if somebody with reduced grip strength would be suitable for self-administered PFS. Then, I guess, following the potential CIDP approval, given what you said about the payer policies, would you plan to provide some kind of free drug program given the, you know, underlying patient interest and demand?

Matt Phillips: Thanks for taking my questions two quick ones first on the hemostasis.

Matt Phillips: Studies did you use COPD patients in that study I just wondering if somebody was reduced grip strength would be suitable for self administrated.

Matt Phillips: PFS and then I guess following the potential approval given what you said about the payer policies would you plan to provide some kind of free drug program given the underlying.

Matt Phillips: Patients' interest and demand.

Tim Van Hauwermeiren: Thank you for the two questions. I will hand over the second question, in terms of launch preparation, to Karen. Although I suspect we will not be showing too much of our cards here. From a human factor study point of view, you're absolutely right. I mean, we're targeting the pre-filled syringe for both gMG and CIDP patients. So, you can imagine that in the human factor studies, both patient groups were actively involved. And we feel very strong about the data which we achieved and we feel very strong about the submission, which is now in the works before end of June. Karen, question two please.

Tim Van Hauwermeiren: Yeah. Thank you for the two questions. I will hand over the second question in terms of launch preparation to Karen, although I suspect we will not be showing too much of our cards. From a human factor study point of view, you're absolutely right. I mean, we're targeting the prefilled syringe for both GMG and CIDP patients. You can imagine that in the human factor studies, both patient groups were actively involved. We feel very strong about the data which we achieved, and we feel very strong about the submission, which is now in the works before end of June. Karen, question two, please.

Speaker Change: Thank you for the two questions I will handle the second question in terms of launch preparation to academy, although I suspect, we will not be showing too much of our car seat from a human factor study point of view Youre, absolutely right <unk> is targeting the prefilled syringe for both Gmg and <unk>.

Karen Massey: CDP patients. So you can imagine that in the human factor studies, both patient groups. We're actively involved and we feel very strong about the data, which we achieved and we feel very strong about the submission which has not been to Brooks.

Tim Van Hauwermeiren: So you can imagine that in the human factor studies, both patient groups were actively involved, and we feel very strong about the data which we have achieved. And we feel very strong about the submission, which is now in the works before the end of June. Canem, question two please. Yeah, happy to.

Canem: For the end of June.

Canem: Canada question two please yeah happy to without going into too many details exactly on that on what our plans are maybe it maybe the best way to answer that is we're taking the same approach to the <unk> launch preparation as we did with Mg and the way that I would characterize that is that we're being really thinking very innovative about how we want to go to market.

Karen Massey: Yeah, happy to. Without going into too many details exactly on what our plans are, maybe the best way to answer that is that we're taking the same approach to the CIDP launch preparation as we did with MG. And the way that I would characterize that is that we're being really -- thinking very innovatively about how we want to go to market, how we want to empower patients, how we want to educate prescribers. And we're also thinking in a very disciplined way around our execution and how do we make sure that we're making the right capital investments or the right use of our capital and making the right investment. So, we'll take that same approach for the CIDP launch that we did for MG. And your final question comes from a line from Douglas Dale from HC Wainwright.

Karen Massey: Yeah. Happy to. Without going into too many details exactly on what our plans are. Maybe the best way to answer that is we're taking the same approach to the CIDP launch preparation as we did with MG. The way that I would characterize that is that we're really thinking very innovatively about how we wanna go to market, how we wanna empower patients, how we wanna educate prescribers. We're also thinking in a very disciplined way around our execution, and how do we make sure that we're making the right capital investments or the right use of our capital, and making the right investments. We'll take that same approach for the CIDP launch that we did for MG.

Karen Massey: How do we want to empower patients how are we going to educate.

Karen Massey: We're also thinking in a very disciplined way around our execution, and how do we make sure that we're making the right capital investments or the right use of our capital, and making the right investments. We'll take that same approach for the CIDP launch that we did for MG.

Karen Massey: Scribe it and we're also I think be thinking in a very disciplined way around our execution and how do we make sure that we're making the right capital investments right.

Douglas Dylan Tsao: Alright, you said capital and making the right investments. So we'll take that same approach for the <unk> launch that we did for Mg.

Operator: And your final question comes from a line by Douglas Tsao from HC Wainwright. Your line is open.

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

Karen Massey: And your final question comes from the line of Douglas Tsao from H C. Wainwright. Your line is open.

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

Douglas Tsao: Hi, good morning. Thanks for taking the questions. Just a quick one for me. I'm just curious, ultimately, when we think about the different presentations of EFGARTIGIMOD -- where do you see the pre-filled syringe ultimately falling between the Sub-Q and the IV? Do you think that this could ultimately become the sort of dominant presentation that's utilized? Thank you.

Speaker 25: Hi. Good morning. Thanks for taking the questions. Just a quick one from me. I'm just curious, ultimately, when we think about the different presentations of efgartigimod, where do you see the prefilled syringe ultimately falling between the subcu and the IV? I mean, do you think that this could ultimately become the sort of dominant presentation that's utilized? Thank you.

Douglas Dylan Tsao: Hi, good morning, Thanks for taking the questions just a quick one for me I'm just curious ultimately when we think about the different presentations.

Operator: Hum.

Douglas Dylan Tsao: Cartesian monitor.

Douglas Dylan Tsao: I mean, where do you see the pre filled syringe ultimately falling between the sub Q and the idea I mean do you think that this could ultimately become the sort of dominant presentation. That's utilized thank you.

Tim Van Hauwermeiren: Yes, thank you for the question. So, you know, we are a patient-centric company and it's our ambition to serve the needs of the individual patient segments as completely as we can. We believe that, especially in the U.S. market, the IV product will always be important because a subset of patients but also, actually, physicians do prefer an IV infusion. The interesting thing about VYVGART HYTRULO today is that it's actually a very clean and easy execution, which is still resulting mainly under, I would say, Medicare Part B; whilst the PFS with the self-administration is mainly going to target, I think, or sit in the Medicare Part D channel. So, if you think about a market leader who is patient-centric, I think the PFS will be the closing piece in the totality of the product offering -- maximally serving, I think, different needs and preferences of different market segments. Thanks for the questions.

Tim Van Hauwermeiren: Yeah, thank you for the question. So you know, we are a patient-centric company, and it's our ambition to serve the needs of the individual patient segments as completely as we can. We believe that, especially in the US market, the IV product will always be important because a subset of patients, but also actually physicians, do prefer an IV infusion. The interesting thing about VYVGART Hytrulo today is that it's actually a very clean and easy execution, which is still falling under mainly, I would say Medicare Part B. While the PFS with the self-administration is mainly going to target, I think, or sit in the Medicare Part D channel.

Speaker Change: Yes. Thank you for the question.

Tim Van Hauwermeiren: So we had a patient centric company and it's our ambition to serve the needs of the individual patient segments as completely as we can we believe that especially in the U S market. The IP products will always be important because a subset of patients, but also actually physicians to prefer an IV infusion.

Tim Van Hauwermeiren: The interesting thing about VYVGART Hytrulo today is that it's actually a very clean and easy execution, which is still falling under mainly, I would say Medicare Part B. While the PFS with the self-administration is mainly going to target, I think, or sit in the Medicare Part D channel.

The interesting thing about VYVGART HYTRULO today is that it's actually a very clean and easy execution, which is still resulting mainly under, I would say, Medicare Part B; whilst the PFS with the self-administration is mainly going to target, I think, or sit in the Medicare Part D channel. So, if you think about a market leader who is patient-centric, I think the PFS will be the closing piece in the totality of the product offering -- maximally serving, I think, different needs and preferences of different market segments. Thanks for the questions.

Tim Van Hauwermeiren: The interesting thing about <unk> today is that it's actually a very clean and easy execution, which has two resorting mainly I would say Medicare part D. Whilst the PFS with a self administration is mainly going to target I think or sit in the Medicare part D channel. So if you.

Tim Van Hauwermeiren: So, if you think about a market leader who is patient-centric, I think the PFS will be the closing piece in the totality of the product offering -- maximally serving, I think, different needs and preferences of different market segments. Thanks for the questions. And we have now reached the end of our time.

So, if you think about a market leader who is patient-centric, I think the PFS will be the closing piece in the totality of the product offering -- maximally serving, I think, different needs and preferences of different market segments. Thanks for the questions.

Tim Van Hauwermeiren: If you think about a market leader who is patient-centric, I think the PFS will be the closing piece in the totality of the product offering, maximally serving, I think, different needs and preferences of different market segments. Thanks for the question.

Tim Van Hauwermeiren: Think about the market leaders, who is patient centric I think the PFS will be the closing piece in the totality of the perfect offering maximally, serving I think different needs and preferences of different market segments.

And we have now reached the end of our time.

Tim Van Hauwermeiren: Thanks for the question.

Operator: And we have now reached the end of our question-and-answer period. This concludes today's conference call. Thank you for your participation. You may now disconnect.

Operator: We have now reached the end of our question and answer period. This concludes today's conference call. Thank you for your participation. You may now disconnect. You may now disconnect.

Speaker Change: And we have now reached the end of our question and answer period. This concludes today's conference call. Thank you for your participation you may now disconnect.

Operator: Okay.

Operator:

Speaker Change: You may now disconnect.

Operator: Okay.

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