Q2 2024 argenx SE Earnings Call & Business Update

Good morning. My name is Audra and I will be your conference operator today. At this time, I would like to welcome everyone to the ArgenX Second Quarter 2024 Financial Results Conference Call.

Operator: today. At this time, I would like to welcome everyone to the ArgenX second quarter 2024 financial results conference call. Today's conference is being recorded. All lines have been placed on mute to prevent any background noise.

Today's conference is being recorded.

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 the star key followed by the number 1 on your telephone keypad. If you would like to withdraw your question, press star 1 again.

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 key followed by the number 1 on your telephone keypad. If you would like to withdraw your question, press star 1 again. At this time, I'd like to turn the conference over to Investor Relations' Beth DelGiacco. Please go ahead.

At this time, I'd like to turn the conference over to Investor Relations' Beth DelGiacco. Please go ahead.

Beth DelGiacco: A press release was issued earlier today with our half-year 2024 financial results and second quarter business update. This can be found on our website along with the presentation for today's webcast. Before we begin, I would like to remind you that forward-looking statements may be presented during this call. These may include statements about our future expectations, clinical developments, regulatory timelines, the potential success of our product candidates, financial projections, and upcoming milestones. However, actual results may differ materially from those indicated by these statements, and the Company is not under any obligation to update statements regarding the future or to confirm the statements in relation to actual results unless required by law.

Beth DelGiacco: Thank you.

Beth DelGiacco: A press release was issued earlier today with our half year 2024 financial results and second quarter business update. This can be found on our website along with the presentation for today's webcast.

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

Speaker Change: Actual results may differ materially from those indicated by these statements.

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. Thank you, Beth, and welcome, everyone.

Speaker Change: is not under any obligation to update statements regarding the future or to confirm the statements in relation to actual results unless required by law.

Speaker Change: 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.

Tim Van Hauwermeiren: I'll begin on slide three. Last week, many of you joined us for our R&D day, where we laid out an ambitious vision for 2030 and shared a comprehensive overview of the growth opportunities ahead in our efforts to achieve this vision. We are in a very strong position today to generate substantial value across our business by investing in our internal innovation engine, executing on our differentiated multi-asset pipeline, and building on the commercial success we have achieved in our first 10 quarters of launch.

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

Tim Van Hauwermeiren: I'll begin on slide three.

Speaker Change: Last week, many of you joined us for our R&D day, where we laid out an ambitious vision in 2030 and shared a comprehensive overview of the growth opportunities ahead in our quest to achieve this vision.

Speaker Change: We are in a very strong position today to generate substantial value across our business.

Speaker Change: Investing in our internal innovation engine, executing on our differentiated multi-asset pipeline, and building on the commercial success we have achieved in our first ten quarters of launch.

Tim Van Hauwermeiren: This is a team that delivers on our innovation mission time and time again, all towards our goal to transform autoimmunity and reach 50,000 patients globally. Given the recent timeline, we will aim to keep our prepared remarks brief and focus primarily on the second quarter dynamics. But first, I'd like to highlight key themes that emerged from the R&D day in the context of our 2030 vision. Slide four.

Speaker Change: This is a team that delivers on our innovation mission, time and time again, all towards our goal to transform autoimmunity and reach 50,000 patients globally.

Speaker Change: Given the recency of this update, we will aim to keep our prepared remarks brief and focus primarily on the second quarter dynamics.

Tim Van Hauwermeiren: The first theme is around how we innovate, centered on a model of co-creation. This model has been core to our growth since our founding and still exists in the most obvious form today with our Immunology Innovation Program. We have a strong track record of success in building out our differentiated pipeline, including 8 out of 12 molecules that demonstrate human proof of concept and 9 that are first-in-class targets. We have no shortage of opportunity to identify novel targets and believe our overall approach sets us up to drive continued pipeline expansion for years to come. A second theme is the new standard we are studying with Vyvgart in NG.

Speaker Change: But first, I'd like to highlight key themes that emerged from the R&D Day in the context of our 2030 vision.

Speaker Change: Slide 4

Speaker Change: The first theme is around how we innovate, centered on a model of co-creation.

Speaker Change: This model has been core to our growth since our founding and still exists in the most obvious form today with our Immunology Innovation Program.

Speaker Change: We have a strong track record of success in building out our differentiated pipeline, including 8 out of 12 molecules that demonstrated human proof-of-concept, and 9 that are first-in-class targets.

Speaker Change: We have no shortage of opportunity with identifying novel targets and believe our overall approach sets us up to drive continued pipeline expansion for years to come.

Speaker Change: A second theme is the new standards we are studying with Vyvgart in NG.

Tim Van Hauwermeiren: We are currently discontinuing Advanced Biologic NMG and have delivered ten consistent quarters of growth since our initial launch. We are making excellent progress across all key indicators, and this is exactly in line with our internal long-term thinking about the MG marketplace. We think this is a big opportunity, and we have a strategic plan to reach more patients as we move into earlier lines of treatment and broaden to new populations, through label-enabling studies in semen-negative and ocular angiopatient. We will use the same playbook for CIDP and are happy with the early days of the launch.

Speaker Change: We are currently deleting Advanced Biologic NMG and have delivered 10 consistent quarters of growth since our initial launch. We are making excellent progress across all key indicators.

Speaker Change: and are exactly in line with our internal, long-term thinking of the MG marketplace.

Speaker Change: We think this is a big opportunity and we have a strategic plan to reach more patients as we move into earlier lines of treatment and broaden to new populations through label enabling studies in seronegative and ocular energy patients.

Speaker Change: We will use the same playbook for CIDP and are happy with the early days of the launch.

Tim Van Hauwermeiren: We got the best possible label, which puts us in a strong position for continued growth as we work to get the excess piece in place. Third, we laid out our next wave of indications and expect to initiate four new registration trials this year across Vyvgart and Embassy Gubart. We set the bar high with a medicine like Vyvgart, but we improved to use the RNT day to put a possible part more in the spotlight.

Speaker Change: We got the best possible label, which puts us in a strong position for continued growth as we work to get the access piece in place.

Speaker Change: Third, we laid out our next wave of indications and expect to initiate four new registration trials this year across Vyvgart and Basse-Guevart.

Speaker Change: We set the bar high with a medicine like Vyvgart, but we improved to use the RNT day to put a possible bar more in the spotlight.

Tim Van Hauwermeiren: This is his second pipeline in a product opportunity, and we were able to show phenomenal patient data in MMN, which we see as the first of many indications where we hope to drive transformational impact. Slide five.

Speaker Change: This is his second pipeline in a product opportunity, and we were able to show phenomenal patient data in MMN, which we see as the first of many indications.

Speaker Change: where we hope to drive transformational impact.

Tim Van Hauwermeiren: The progress we have made across our business over the quarter moves us another step closer to achieving our 2030 vision to bring five molecules to phase three, advance our late-stage pipeline to 10 labeled indications across our molecules, and to ultimately have 50,000 patients on an argenx medicine by 2030. At OneAmbitious, we believe we are well positioned to deliver on this goal with a continuum of innovation from discovery all the way to commercialization.

Speaker Change: Slide five.

Speaker Change: The progress we have made across our business over the quarter moves us another step closer towards achieving our 2030 vision to bring 5 molecules to phase 3, advance our late stage pipeline to 10 labeled indications across our molecules,

Speaker Change: and to ultimately have 50,000 patients on an ArgenX medicine by 2030.

Speaker Change: While ambitious, we believe we are well-positioned to deliver on this goal with a continuum of innovation from discovery all the way through commercial.

Tim Van Hauwermeiren: Underpinning our incredible success to date is the strong financial health of our business, which will enable us to continue delivering on our innovation mission, ultimately driving value for our patients and our shareholders. With that, I would like to turn over the call to Karl. Slide six.

Speaker Change: Underpinning our incredible success to date is the strong financial health of our business.

Speaker Change: which will enable us to continue delivering on our innovation mission, ultimately driving value for our patients and our shareholders.

Speaker Change: With that, I would like to turn over the call to Karl.

Karl Gubitz: Thank you, Tim. The second quarter 2024 financial results are detailed in the press release this morning. Total operating income for the second quarter is $489 million.

Karl Gubitz: Slide 6. Thank you, Tim. The second quarter 2024 financial results are detailed in the press release of this morning.

Karl Gubitz: Total Operating Income in the second quarter is $489 million.

Karl Gubitz: This reflects 478 million in product net sales and 12 million in operating in. In the second quarter, $478 million in product net sales is attributed solely to MGP. We received the CIDPA approval on June 25, and our teams were immediately in action the next day. It takes time at the start of a launch to get patients through the funnel going to do injections. So the first CIDP revenue will be a third quarter event.

Karl Gubitz: This reflects $478 million in product net sales and $12 million in average operating income.

Speaker Change: In the second quarter, $478 million in product net sales is attributed solely to MG patients.

Karl Gubitz: We received the CIDP approval on June 21st and our teams were immediately in action the next day.

Karl Gubitz: It takes time at the start of a launch to get patients through the funnel from script to injection.

Unknown Executive: So, the first CIDB revenue will be a first quarter event. Product net sales of 478 money and represents 20% growth, quarter of a quarter compared to Q124, which we know with a biologic is typically a more challenging quarter due to insurance, re-verifications, and loss of shipping days with a waiver and holidays. The product revenue breaks down by region to 477 million dollars in the US, 20 million dollars in Japan, 35 million dollars in the MIA, and 14 million product supply to Zayla in China.

Karl Gubitz: So the first CIDP Revenue will be a third quarter event.

Karl Gubitz: Product net sales of 478 million represent 20% growth quarter over quarter compared to Q124, which we know with a biologic is typically a more challenging quarter due to insurance re-verifications and loss of shipping days due to weather and holidays. The product revenue breaks down by region to $407 million in the US, $20 million in Japan, $35 million in EMEA, and $14 million from product supply to Xi Lab in China. Operating expenses in Q2 are $535 million, an increase of $29 million compared with Q1. SG&A expenses are $256 million in Q2, which is an increase of $20 million compared to Q1.

Karl Gubitz: Product net sales of $478 million represents 20% growth quarter-over-quarter compared to Q1 2024.

Karl Gubitz: which we know with a biologic is typically a more challenging quarter due to insurance re-verifications and loss of shipping days with weather and holidays.

Karl Gubitz: The product revenue breaks down by region to $407 million in the U.S., $20 million in Japan, $35 million in EMEA, and $14 million from product supply to Xi Lab in China.

Unknown Executive: Operating expenses in Q2 are 575 million dollars, an increase of 29 million dollars compared to Q1 224. SGNI expenses are 256 million in Q2, which is an increase of 20 million compared to Q1.

Karl Gubitz: Operating expenses in Q2 are $535 million.

Karl Gubitz: an increase of $29 million compared with Q1 2024.

Karl Gubitz: SG&A expenses are $256 million in Q2, which is an increase of $20 million compared to Q1.

Karl Gubitz: The increase reflects a full-quarter impact of the expansion of a customer-facing organization in the U.S., as well as incremental expenses to prepare for the CIDP launch. R&D Expansion, on the continued investment in your pipeline of $225 million in the second quarter, broadly in line with the previous. The operating loss of a quarter of $45 million is offset by financial income of $30 million and the tax benefit of $44 million. A tax benefit is a deferred tax asset recognized in your U.S. legal entity due to intra-group inventory movement.

Unknown Executive: The increase reflects a full quarter impact of the expansion of a customer-facing organization in the US, as well as incremental expenses to prepare for the CIDB launch.

Karl Gubitz: The increase reflects the full-quarter impact of the expansion of a customer-facing organization in the U.S. as well as incremental expenses to prepare for the CIDP launch.

Unknown Executive: R&D expenses on the continued investment in your pipeline are $225 million in the second quarter, broadly in line with a previous quarter. Operating loss of a quarter of $44 million is offset by financial income of $4 million and the tax benefit of $44 million.

Karl Gubitz: R&D expenses on the continued investment in your pipeline are $225 million in the second quarter, broadly in line with the previous quarter.

Karl Gubitz: The operating loss of a quarter of $45 million is offset by financial income of $30 million and the tax benefit of $44 million.

Unknown Executive: The tax benefit is a result of a deferred tax asset recognized in your US legal entity due to intra-group inventory movements. It is a temporary timing difference and will reverse in future quarters.

Karl Gubitz: A tax benefit is a result of a deferred tax asset recognized in your U.S. legal entity due to intra-group inventory movements.

Karl Gubitz: It is a temporary timing difference and will reverse in future calls. Overall, we saw a net profit for the quarter of $29 million and earnings per share of $49,000. It is an important distinction that the net profit was primarily driven by the recognition of a deferred tax asset as, and we still have an operating loss for the quarter of $45 million.

Speaker Change: It is a temporary timing difference and will reverse in future quarters.

Unknown Executive: Overall, we saw a net profit for the quarter of $29 million and earnings per share of $49.

Karl Gubitz: Overall, we saw a net profit for the quarter of $29 million and earnings per share of 49 cents.

Unknown Executive: It is an important distinction that the net profit was primarily driven by the recognition of a defer tax asset, and we still had an operating loss for the quarter of $45 million. We are on a clear path to profitability, but we are not there yet.

Speaker Change: It is an important distinction that the net profit was primarily driven by the recognition of a deferred tax asset, and we still had an operating loss of a quarter of $45 million.

Karl Gubitz: We are on a clear path to profitability, but we are not there yet. We continue to have a strong balance sheet with $3.1 billion in cash. Based on our year-to-date cash burn of $77 million, we are updating our 2024 cash burn guidance from approximately $500 million to less than $500 million. Our guidance on expenses remains unchanged.

Karl Gubitz: We are on a clear path to profitability, but we are not there yet.

Unknown Executive: We continue to have a strong balance sheet with 3.1 billion in cash.

Karl Gubitz: We continue to have a strong balance sheet with $3.1 billion in cash.

Unknown Executive: Based on our year-to-date cash-burn of $77 million, we are updating our 20-24 cash-burn guidance from approximately $500 million to less than $500 million. Our guidance on expenses remains unchanged. This puts us in a strong position to invest in innovation across our business, and we have many opportunities to do so. This is a sizable opportunity in our current markets.

Karl Gubitz: Based on our year-to-date cash burn of $77 million, we are updating our 2024 cash burn guidance from approximately $500 million to less than $500 million.

Karl Gubitz: Our guidance on expenses remains unchanged.

Karl Gubitz: This puts us in a strong position to invest in innovation across our business, and we have many opportunities to do so. There is a sizable opportunity in our current markets, in new markets with our Vyvgart franchise, with our current pipeline, and through our Immunology Innovation Program to expand our pipeline. This is how we will set ourselves up for a sustainable future where we continue to generate significant value for our shareholders. I will now turn the call over to Karen, who will provide details on the commercial. Thank you, Carl. Slide eight.

Karl Gubitz: This puts us in a strong position to invest in innovation across our business.

Karl Gubitz: And we have many opportunities to do so.

Unknown Executive: In new markets with our best core franchise, with our current pipeline, and through our immunology innovation program to expand our pipeline.

Karl Gubitz: There's a sizable opportunity in our current markets, in new markets with our Vyvgart franchise.

Karl Gubitz: with our current pipeline and through our Immunology Innovation Program to expand our pipeline.

Karl Gubitz: This is how we will set ourselves up for a sustainable future where we continue to generate significant value for our shareholders.

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

Karen Massey: I'm very excited by our vision 2030, especially the ambition we have set for ourselves to impact the lives of 50,000 patients globally and their caregivers. To reach this goal, we will need to expand in a multidimensional way, getting more medicines approved across many indications, product presentations, and geographies. We have a strong commercial playbook in place that delivered in MG, and we'll be leveraging that same approach for CIDP, focusing on evidence generation that matters most to physicians and patients, empowering patients to demand more from their treatments, and last, the need to execute on our strategies with speed and urgency. We know that patients are waiting. And we also know that every day counts in building out our first-in-class leadership position. Slide nine.

Karen Massey: Thank you, Carl. Slide 8.

Karen Massey: I'm very excited by our Vision 2030, especially the ambition we have set for ourselves to impact the lives of 50,000 patients globally and their caregivers.

Karen Massey: To reach this goal, we will need to expand in a multidimensional way, getting more medicines approved across many indications, product presentations, and geographies.

Speaker Change: We have a strong commercial playbook in place that delivered in MG and will be leveraging that same approach for CIDP Focusing on evidence generation that matters most to physicians and patients

Speaker Change: Empowering patients to demand more from their treatments and last the need to execute on our strategies with speed and urgency. We know that patients are waiting and we also know that every day counts in building out our first-in-class leadership position.

Karen Massey: Starting with MG, I'm extremely proud of the team who worked really hard to expand our reach into new patients for our 10th consecutive quarter of revenue growth. We said this in Q1 and can reiterate it today that all key indicators of growth are performing well, and the fundamentals of the commercial business are strong. Focusing on the key drivers of growth this quarter, we saw the seasonality impact in Q1, normalizing Q2 with an impressive 17% quarter over quarter growth.

Speaker Change: Slide nine.

Speaker Change: Starting with MG, I'm extremely proud of the team who worked really hard to expand our reach into new patients for our 10th consecutive quarter of revenue growth.

Speaker Change: We said this in Q1, and can reiterate it today, that all key indicators of growth are performing well, and the fundamentals to the commercial business are strong.

Speaker Change: Focusing on the key drivers of growth this quarter, we saw the seasonality impact in Q1, normalizing Q2 with the impressive 17% quarter-over-quarter growth.

Karen Massey: Within the U.S., Hytrula continues to attract both new patients and prescribers to the Vyvgart franchise. This is important for a few reasons. First, over 50% of new HITRULO patients are coming from orals, and 60% are brand new to Vyvgart, which is consistent with our goal to reach early-aligned patients and to expand new patients with HITRULO. Second, we continue to expand our prescriber base for MG, many of whom have the potential to be CIDP prescribers. This will serve us well in our early conversations with physicians who have grown accustomed to the favorable safety and efficacy profile of Vyvgart Hytrula. Slide 10.

Speaker Change: Within the U.S., Hytrula continues to attract both new patients and prescribers to the Vyvgart franchise.

Speaker Change: This is important for a few reasons. First, over 50% of new HITRULO patients are coming from orals, and 60% are brand new to Vyvgart, which is consistent with our goal to reach early-aligned patients and to expand new patients with HITRULO.

Speaker Change: Second, we continue to expand our prescriber base for MG, many of whom have the potential to be CIDP prescribers.

Speaker Change: This will serve us well in our early conversations with physicians who have grown accustomed to the favorable safety and efficacy profile of Vyvgart Hytrula.

Karen Massey: We continue to gain traction outside the US as well, where we are focused on securing broad access. We have strong momentum in EMEA, and Vyvgart is now available in countries representing 82% of the GMG population in the region. We also continue to see strong growth in Japan, including positive early indicators on the launch of ITP. This launch rolled out rapidly, and 74% of HCPs were made aware of Vyvgart in the weeks post-approval.

Speaker Change: Slide 10.

Speaker Change: We continue to gain traction outside the U.S. as well, where we are focused on securing broad access.

Speaker Change: We have strong momentum in EMEA and Vyvgart is now available in countries representing 82% of the GMG population in the region.

Speaker Change: We also continue to see strong growth in Japan, including positive early indicators on the launch of ITP.

Speaker Change: This launch rolled out rapidly, and 74% of HCPs were made aware of Vyvgart in the weeks post-approval.

Karen Massey: It is clear that there is a need for innovation in ITP, which is why we are also launching an efficient label-enabling study with Vyvgart IV in the U.S. after discussions with the FDA. Lastly, in China, we continue to be very impressed by patient ads each quarter, and now subcutaneous is also available following the approval earlier this month, slide 11. Even with our strong performance today, we believe that we're still at the front end of the opportunity in MG. We are seeing the MG market expand, a dynamic that we have seen play out in other rare disease markets when innovation enters the space.

Speaker Change: It is clear that there is a need for innovation in ITP, which is why we are also launching an efficient label-enabling study with Vyvgart IV in the U.S. after discussions with the FDA.

Speaker Change: Lastly, in China, we continue to be very impressed by patient ads each quarter, and now subcutaneous is also available, following the approval earlier this month. Slide 11.

Speaker Change: Even with our strong performance today, we believe that we're still at the front end of the opportunity in MG. We are seeing the MG market expand, a dynamic that we have seen play out in other rare disease markets when innovation enters the space.

Karen Massey: We believe that earlier use of advanced biologics will expand the addressable market significantly and that we can reach broader populations of MG patients with our label expansion studies in seronegative and ocular MG, each of which represents 15% of the total MG population. Based on these evolving dynamics, we have updated our addressable market in MG to 60,000 patients. Slide 12.

Speaker Change: We believe that earlier use of advanced biologics will expand the addressable market significantly and that we can reach broader populations of MG patients with our label expansion studies in seronegative and ocular MG, each of which represent 15% of the total MG population.

Speaker Change: Based on these evolving dynamics, we have updated our addressable market in MG to 60,000 patients.

Karen Massey: Following our approval in June, we recognize that all eyes are on CIDP, and we share your excitement. We are thrilled with the broad label that we got, which will support use across the treatment paradigm. Now, we're leveraging our MG launch playbook to maximize our impact in CIDP, driving rapid adoption with neurologists based on the strength of our data, empowering patients, and working diligently with payers to put the necessary policies in place to secure access as quickly as possible. Reception has been incredibly positive with physicians, particularly on the strength of the data on improvement in function.

Speaker Change: Following our approval in June , we recognize that all eyes are on CIDP, and we share your excitement. We are thrilled with the broad label that we got, which will support use across the treatment paradigm.

Speaker Change: Now, we're leveraging our MG Launch Playbook to maximize our impact in CIDP, driving rapid adoption with neurologists based on the strength of our data, empowering patients, and working diligently with payers to put the necessary policies in place to secure access as quickly as possible.

Speaker Change: Reception has been incredibly positive with physicians, particularly on the strength of the data and improvement in function. We've already reached 25% of our key targets within 14 days of launch, and 20% of the prescriptions we're receiving are from new prescribers to Vyvgart.

Karen Massey: We've already reached 25% of our key targets within 14 days of launch, and 20% of the prescriptions we're receiving are from new prescribers to Vyvgart. Many of the prescribers are starting multiple patients. Right now, our priority is to bring as many patients into the top of the funnel as possible. Once an enrollment comes in, payer approval at this stage takes a few weeks, after which patients can be scheduled for their first injection.

Speaker Change: Many of the prescribers are studying multiple patients.

Speaker Change: Right now, our priority is to bring as many patients into the top of the funnel as possible. Once an enrollment comes in, payer approval at this stage takes a few weeks, after which patients can be scheduled for their first injection.

Karen Massey: This shows the importance of getting payer policies in place quickly, and as this happens, the time from script to injection gets shorter. Based on where we are today, we're making good progress with payers, and we're tracking to plan. Slide 13.

Speaker Change: This shows the importance of getting payer policies in place quickly, and as this happens, the time from script to injection gets shorter.

Speaker Change: Based on where we are today, we're making good progress with payers and we're tracking to plan.

Karen Massey: Looking forward, we have an ambitious plan to successfully execute multiple launches across our pipeline in order to reach 50,000 patients in 2030. We're on track to start multiple phase three studies before the end of the year. And each of these brings us a step closer to reaching new autoimmune indications where there is a high unmet need. The TED Registrational Study has already started, and we see an opportunity here to provide a differentiated and targeted therapy with favorable safety.

Speaker Change: Slide 13.

Speaker Change: Looking forward, we have an ambitious plan to successfully execute multiple launches across our pipeline in order to reach 50,000 patients in 2030.

Speaker Change: We're on track to start multiple Phase III studies before the end of the year, and each of these brings us a step closer to reaching new autoimmune indications where there is a high unmet need.

Speaker Change: The TED Registrational Study has already started, and we see an opportunity here to provide a differentiated and targeted therapy with favorable safety.

Karen Massey: We look forward to initiating a Phase 3 study in Sjogren's before year-end, following the positive signal we saw in our Phase 2 proof of concept study. There are no approved treatments for Sjogren's patients, and we know the disease goes well beyond sicker symptoms and can affect patients' ability to work and complete daily tasks, particularly fatigue.

Speaker Change: We look forward to initiating a Phase 3 study in Sjogren before year-end, following the positive signal we saw in our Phase 2 proof-of-concept study.

Speaker Change: There are no approved treatments for Sjogren's patients, and we know the disease goes well beyond sicker symptoms and can affect patients' ability to work and complete daily tasks, particularly the fatigue.

Karen Massey: This is a sizable opportunity, and while data will drive the specific target population, we know that there are 100,000 moderate to severe Sjogren's patients in the U.S. And last, we also look forward to decisions in Myocitis and BP on whether to advance to Phase 3 later this year. Finally, before year-end, we will start a phase 3 trial with our second molecule, Empasaprubat, in MM This is an indication that fits perfectly into our neuromuscular focus.

Speaker Change: This is a sizable opportunity, and while data will drive the specific target population, we know that there are 100,000 moderate to severe Sjogren's patients in the US.

Speaker Change: And last, we also look forward to decisions in Myositis and BP on whether to advance to Phase 3 later this year.

Speaker Change: Finally, before year-end, we will start a Phase 3 trial with our second molecule, Empasaprubat, in MMN. This is an indication that fits perfectly into our neuromuscular focus, and it is another indication where the unmet need is high, and IVIG is the only approved treatment.

Karen Massey: And it is another indication where the unmet need is high, and IVIG is the only approved treatment. The data we generated in phase two were tremendous and very meaningful to patients. We demonstrated consistent improvement in grip strength.

Speaker Change: The data we generated in Phase 2 were tremendous and very meaningful to patients. We demonstrated consistent improvement in grip strength, and in Cohort 1, 94% of patients felt better on impasse-improved ART than they did compared to their peak with IVIG.

Karen Massey: And in cohort one, 94% of patients felt better on impasse-proubat than they did compared to their peak with IVIG. Similar to MG and CIDP, we believe this is an underdeveloped market, likely to grow over time as more innovation enters. Overall, this is an exciting time for the company. We've seen phenomenal growth to date, and we're eager to continue with this momentum as we enter into the second half of this year, applying innovation to every aspect of our business to reach even more patients. I'll turn it back to you, Tim. Thanks, Karen. Slide 14.

Speaker Change: Similar to MG and CIDP, we believe this is an underdeveloped market, likely to grow over time as more innovation enters.

Tim Van Hauwermeiren: Overall, this is an exciting time for the company. We've seen phenomenal growth to date, and we're eager to continue with this momentum as we enter into the second half of this year, applying innovation to every aspect of our business to reach even more patients. I'll turn it back to you, Tim.

Tim Van Hauwermeiren: I'm proud of the ArgenX team and their tireless commitment to changing the lives of patients through our science. We are perfectly positioned with the right team and the right approach to execute on the broad opportunity ahead of us. We will continue to lead with the strength of our data and deep knowledge to address the sizable MG opportunity ahead and will apply the same rigor with CIDP. And this is just the beginning.

Tim Van Hauwermeiren: Thanks Karen, slide 14.

Tim Van Hauwermeiren: I'm proud of the ArgenX team and their tireless commitment to changing the lives of patients through our science.

Tim Van Hauwermeiren: We are perfectly positioned with the right team and the right approach to execute on the broad opportunity ahead of us.

Speaker Change: We will continue to lead with the strength of our data and deep knowledge to address the sizable MG opportunity ahead and will apply the same rigor with CIDP.

Operator: We are eager to raise the bar for how autoimmune diseases are treated as we continue to expand our horizons, embarking on new paths to create long-term value for patients and shareholders. Thank you for your time today. I would now like to open the call to your questions. Thank you. We will now begin the question and answer session. If you have dialed in and would like to ask a question, please press star 1 on your telephone keypad to raise your hand and join the queue. If you would like to withdraw your question, simply press star 1 again.

Speaker Change: And this is just the beginning.

Speaker Change: We are eager to raise the bar for how autoimmune diseases are treated as we continue to expand our horizons, embarking on new paths to create long-term value for patients and shareholders.

Speaker Change: Thank you for your time today. I would now like to open the call to your questions.

Speaker Change: Thank you. We will now begin the question and answer session. If you have dialed in and would like to ask a question, please press star 1 on your telephone keypad to raise your hand and join the queue. If you would like to withdraw your question, simply press star 1 again.

James Daniel Gordon: We'll take our first question from James Gordon at JPMorgan. Hello, James Gordon, JP Morgan. Thanks for taking the questions. Two questions, please. The first question was on Vyvgart's performance in Q2 and the extent to which we can extrapolate that to Q3. So sales were up 79 million, which was a strong performance. But how much, if any, would you say was one-off phasing that we should take out if we're thinking about what the underlying performance would be? And if we're thinking about doing our Q3 modeling, how careful do we need to be about any reversals or seasonality? Or can we make quite a strong extrapolation from how well Vyvgart's done to date?

Speaker Change: We'll take our first question from James Gordon at J.P. Morgan.

Tim Van Hauwermeiren: That's the first question, please. The second question was phase 3 initiation for ITP. And I saw a comment or heard a comment about this being an efficient trial. How might this trial differ from the previous two phase 3s you've done in ITP? Can you expedite it if it's an efficient trial?

Speaker Change: and many more.

Speaker Change: Hello, James Gordon, J.P. Morgan. Thanks for taking the questions. Two questions, please.

Speaker Change: The first question was on Vyvgart performance in Q2 and the extent to which we can extrapolate that to Q3. So sales were up 79 million, which was a strong performance.

Speaker Change: But how much if any would you say was one-off bathing that we should take out if we're thinking about what the underlying performance would be?

Speaker Change: And if we're thinking about doing our Q3 modelling, how careful do we need to be about any reversals or seasonality, or can we make quite a strong extrapolation from how well Vyvgart's done today? That's the first question, please.

Speaker Change: The second question was, uh...

Speaker Change: Feed-to-Initiation for ITP

Speaker Change: and I saw a comment or heard a comment about this being an efficient trial. How might this trial differ from the previous two, phase 3, 2.0 90p?

Speaker Change: can you can you expedite it if it's an efficient trial and would it be going for like a smaller patient population in some way or a similar size population just a different design?

Tim Van Hauwermeiren: And would it be going for a smaller patient population in some way or a similar-sized population, just a different design? Thank you, James. Thank you for asking these two questions. I would like to hand over to Karen to comment on the underlying dynamics of the business and how we see, you know, the overall trends in our VyvgartMG business first, and then I will take the question on the ITP study in phase three. Karen, why don't you go ahead with question one?

Speaker Change: Thank you, James. Thank you for asking these two questions.

Speaker Change: I would like to hand over to Karen to comment on the underlying dynamics of the business and how to see, you know, the overall trends in our VyvgartMG business first and then I will take the question on the ITP study in phase 3. Karen, why don't you go ahead with question 1?

Karen Massey: Thanks, Tim. And thanks for the question. And recognizing I think, like you, I'm really pleased with the results of the quarter, this quarter. The way that I would think about it is that when you look at the first half of the year in totality, what you see is that we maintain that consistent momentum that we've had since launch. So we've had 10 quarters of consistent growth, pretty consistent growth. I would take that longer-term view, as I was looking to the future, if I were, if I were you, and I'm confident that we will continue that consistent momentum. The underlying dynamics are strong. We continue to get early-aligned patients, and the majority are coming directly from the orals. We're growing both Vyvgart and HITRULO.

Speaker Change: and many more.

Karen Massey: Thanks, Tim, and thanks for the question and for recognizing. I think, like you, I'm really pleased with the results of the quarter.

Karen Massey: The way that I would think about it is that when you look at the first half of the year in totality, what you see is that we maintain that consistent momentum that we've had since launch. So we've had ten quarters of pretty consistent growth.

Speaker Change: I would take that longer term view as I was looking to the future if I was you, and I'm confident that we will continue that consistent momentum. The underlying dynamics are strong. We continue to get early aligned patients. The majority are coming directly from the orals.

Karen Massey: And we are broadening that prescriber base, which also serves us well for the CIDP launch. So I would say, think about consistent momentum and growth as we've seen over the last 10. I'll hand it back to you, Tim. Thank you, Karen.

Speaker Change: We're growing both Vyvgart and Hytrulo and we are broadening that prescriber base which also serves as well for the CIDP launch. So I would say think about consistent momentum and growth as we've seen over the last 10 quarters.

Tim Van Hauwermeiren: And let me briefly comment on the ITP study. First of all, I would like to take a step back and remind the audience about the advanced IV study. But I think we had very impressive efficacy with an IWG score of more than 50% in a pretty effective patient population and a physician community which was excited also about the very clean safety profile. And we observed patients in our open-label extension study. They continue to do actually very well on ITP.

Speaker Change: I'll hand it back to you, Tim.

Tim Van Hauwermeiren: Thank you Karen and let me briefly comment on the ITP study. First of all I would like to take a step back and remind the audience about the advanced IV study but I think we had a very impressive efficacy with an IWG score of more than 50%

Tim Van Hauwermeiren: in a pretty defective patient population and a physician community which is excited also about the very clean safety profile.

Speaker Change: and we observed the patients in our open label extension study, they continue to do actually very well on ITP and also the Japan launch of ITP is actually going according to plan.

Tim Van Hauwermeiren: And also, the Japan launch of ITP is actually going according to plan. So the task we gave to the team was, you know, sit down with the FDA, go through all the data, and propose a smaller confirmatory study in order to push the ITP indication over the finish line. And I think I succeeded in doing that.

Speaker Change: So the task we gave to the team was, you know, sit down with the FDA.

Speaker Change: You know go through all the data and propose a smaller confirmatory study and in order to push the ITP indication over the finish line and I think they succeeded in doing that so by leveraging all the insights and the know-how we have on the disease

Tim Van Hauwermeiren: So, by leveraging all the insights and the know-how we have on the disease and by actually proposing an alternative primary endpoint, which allows for a smaller confirmatory study, we think we're on track to start a smaller ITP trial before the end of the year. But I think we will be able to push the product over the finish line.

Speaker Change: by actually proposing an

Speaker Change: alternative primary endpoints which allows for a smaller confirmatory study

Speaker Change: We think we are on track to start a small ITP trial before the end of the year, where I think we will be able to push the product over the finish line in that refractory patient population we have been studying all the way. Thanks for the questions.

Operator: And in that refractory patient population, we have been studying all the way. Thanks for the question. And just a reminder, we ask that you please ask one question to allow everyone an opportunity to ask a question. We'll go next to Tazeen Ahmed at Bank of America.

Speaker Change: And just a reminder, we ask that you please ask one question to allow everyone an opportunity.

Speaker Change: To ask a question, we'll go next to Tazeen Ahmed at Bank of America.

Tazeen Ahmad: Hi, good morning, guys. Here's my one question. I just was curious about the PFS filing.

Tazeen Ahmad: Hi, good morning guys. Here's my one question. I just was curious about the PFS filing. I know you've talked about already having, you know, applied officially, but given that there's no PDUFA, we're just curious about

Tazeen Ahmad: How we should expect to think about communication from your team on what part of the application is in process and what back and forth there might be and do you have an idea of when you would be able to get that full on approval given that doctors in particular seem to be

Tim Van Hauwermeiren: I know you've talked about already having, you know, applied officially, but given that there's no PDUFA, we're just curious about how we should expect to think about communication from your team on what part of the application is in process, and what back and forth there might be. And do you have an idea of when you would be able to get that full approval? I'm excited about having that as an option for patients. Thanks, Nazina.

Speaker Change: Excited about having that as an option for patients. Thanks.

Tim Van Hauwermeiren: Thanks for being with us this morning. Important questions, simple answer: the filing has been submitted, is accepted, and is under review by the FDA. And I think we will have a better sense of approval timing, you know, when the process unfolds. So stay tuned.

Speaker Change: Thanks Tanzina, thanks for being with us this morning.

Speaker Change: Important questions, simple answer, the filing has been submitted, is accepted and under review with the FDA.

Speaker Change: And I think we will have a better sense of approval timing, you know, when the process unfolds. So stay tuned. We will keep you updated on the progress we make. Thank you.

Allison Marie Bratzel: We will keep you updated on the progress we make. Thank you. Next, we'll move to Allison Bratzel at Piper Sandler.

Speaker Change: Next we'll move to Allison Bratzel at Piper Sandler.

Tim Van Hauwermeiren: Hey, thank you for taking the question. Maybe just a follow-up from R&D day. Could you help us understand just the scope of the data required by FDA, you know, that'll be needed for filing in seronegative and ocular MG patients? You know, I think you described an ability to leverage existing trial data and real-world data, at least for seronegative patients, but I've just been getting a bunch of questions on this. So, you know, any more color there would be helpful.

Allison Marie Bratzel: Hey, thank you for taking the question.

Allison Marie Bratzel: Maybe just a follow-up from the R&D day. Could you help us understand just the scope of the data required by FDA, you know, that'll be needed for filing in seronegative and ocular MG patients? You know, I think you described an ability to leverage existing trial data and real-world data.

Speaker Change: at least for seronegative patients. But I've just been getting a bunch of questions on this. So, you know, any more color there would be helpful. Thank you.

Tim Van Hauwermeiren: Thank you. Yeah, and thank you for the question, Allison. So remember that we have shown strong results in seronegative MG patients. And if you already have approval in Japan, but actually in the real world, the product is doing very well in seronegative patients.

Speaker Change: Yeah, and thank you for the question, Allison. So remember that we printed strong results in seronegative MG patients.

Speaker Change: And if you already have an approval in Japan, but actually in the real world the product is doing very well in seronegative patients.

Tim Van Hauwermeiren: And we have impressive case reports out of Europe where people have been successfully using the drug in seronegative patients. So we made an commitment to the patient community that we would not give up. And we have been entertaining the dialogue with the FDA on seronegative patients in the background. I think where we could land with the FDA is, you know, a pretty fast, elegant study in seronegative patients, which, as Luke called it during the R&D day, is somewhat relaxed p value.

Speaker Change: and we have impressive case reports out of Europe where people have been successfully using the drug in seronegative patients. So we made a commitment to the patient community, we would not give up.

Speaker Change: and we have been entertaining the dialogue with the FDA on seronegative patients.

Luke: I think where we could land with the FDA is a pretty fast, elegant study in seronegative patients with, as Luc called it during the R&D day, a somewhat relaxed p-value. So I think the FDA is taking the existing evidence into account.

Tim Van Hauwermeiren: So I think the FDA is taking the existing evidence into account and is allowing us, you know, to run such a trial. So we think there's a high demand. This is an elegant study.

Luke: and is allowing us to know to run such a trial. So we think there's a high demand. This is an elegant study and we will do everything we can to enroll that study as fast as we can.

Tim Van Hauwermeiren: And we will do everything we can to enroll that study as fast as we can. Thanks for the question. We'll move next to Rajan Sharma at Goldman Sachs.

Speaker Change: Thanks for the question.

Speaker Change: We'll move next to Rajan Sharma at Goldman Sachs.

Rajan Sharma: Hi, thanks for taking my question. So again, I just wanted to discuss the competitive landscape in Myasthenia gravis and how you see Vyvgart kind of continuing to differentiate there. There's obviously a busy pipeline; we've got Iptakapan in phase three, and Plinz is also in phase three.

Rajan Sharma: Hi, thanks for taking my question. I just wanted to discuss the competitive landscape in Myasthenia Gravis and how you see Vyvgart continuing to differentiate there. There's obviously a busy pipeline. We've got Iptakapan in a Phase 3. Plinz is also in a Phase 3. Could you just discuss how you think

Rajan Sharma: differentiates relative to those mechanisms and then longer term what gives you confidence that Vyvgart and the SCRN class more broadly remains kind of the preferred treatment option in early line patients.

Karen Massey: So could you just kind of discuss how you think Vyvgart differentiates relative to those mechanisms and, then, longer term, what gives you confidence that Vyvgart and the SCRN class more broadly remains the preferred treatment option in early-line patients? Thank you for the question. And I will first hand over to Karen to comment on how we see, you know, the overall dynamics of this market and how we're building it together. Maybe, Karen, you go first, and then I will briefly comment on your differentiation question.

Speaker Change: Thank you for the question and I will first hand over to Karen to comment on how do you see the overall dynamics of this market and how we are building it together. Maybe Karen you go first and then I will briefly comment on your differentiation question. Thank you.

Karen Massey: Sounds great. Yeah, thanks for the question. And look, I think building on what we shared at R&D Day last week, we believe that innovation coming to the MG market is good because it grows the impact that we can have for patients, expands the market, and expands the number of patients that are treated with advanced biologics earlier, as well. So we believe innovation is great for patients, and I think we're seeing that.

Karen Massey: Thanks for the question, and I think building on what we shared at R&D Day last week,

Karen Massey: We believe that innovation coming to the MG market is good because it grows the impact that we can have for our patients.

Karen Massey: expands the market, expands the number of patients that are treated with advanced biologics.

Speaker Change: earlier as well. So we believe innovation is great for patients. And I think we're seeing that. And we believe we're very well positioned to continue to lead in that growing market. And I think there's a few things that maybe you asked about the differentiation that I'll touch on.

Karen Massey: And we believe we're very well positioned to continue to lead in that growing market. And I think there are a few things that, since you asked about the differentiation, that I'll touch on. One is around, you know, we're first in class FCRN, and it's clear that FCRNs and certainly Vyvgart are being used early on. As I said earlier, over 50% of our patients are coming directly from the oral cavity. So that's where the growth is.

Speaker Change: One is around, you know, we're first-in-class FCRN and it's clear that FCRNs and certainly Vyvgart are being used early line, I said earlier, over 50% of our patients are coming directly from the oral. So that's where the growth is and we're positioned well there. I think we compete really well on our, you know, we have rapid

Speaker Change: We have rapid efficacy but also deep and sustained efficacy, and we have it across cyclical and biweekly dosing regimes.

Karen Massey: And we're positioned well there. I think we compete really well on our, you know, we have rapid efficacy but also deep and sustained efficacy, and we have it across cyclical and biweekly dosing regimes. So I think that's a really strong position to be competing from.

Speaker Change: So I think that's a really strong position to be competing from, and don't forget about our real world safety, the length of that real world safety, the number of patients as the first mover advantage, and of course we have the treatment, low treatment burden, so we have both IV and subcutaneous, we have PFS plans, so overall I think the dynamics in MG are positive, the market is growing, and we're well positioned to maintain and even advance our leadership. I'll hand it back to you Tim.

Karen Massey: And don't forget about our real world safety, the length of that real world safety, the number of patients as the first mover advantage. And, of course, we have treatment, with a low treatment burden. So we have both IV and subcutaneous; we have PFS plants. So overall, I think the dynamics in MG are positive. The market is growing, and we're well positioned to maintain and even advance our leadership. I'll hand it back to you, Tim.

Tim Van Hauwermeiren: Yeah, thank you Karen. I much appreciate it. If you just look at the biology of the disease...

Tim Van Hauwermeiren: Yeah, thank you, Karen. I really appreciate it. If you just look at the biology of the disease, it is crystal clear that M.G. is an IgG-mediated disease.

Tim Van Hauwermeiren: Remember the pre and post infection of these pathogenic antibodies, complement recruitment just being one of them. And that nicely translates into the clinical data, right? So let me remind you that 80% of Vyvgart patients based on... receive an EDL lower than 5, which is the threshold for entering a clinical trial, and that 50 to 55% of Vyvgart patients achieve minimum symptom expression. So there's always the need for alternative mechanisms of action because the drug only works in 80% of patients, but it's difficult to go into more detail in the absence of data. So let's look at the data to then further understand how that biology really works. Thanks for the question. We'll move next to Derek Archila at Wills Fargo.

Speaker Change: You know, it is crystal clear that Mg is an IgG-mediated disease. Remember the three most effective of these pathogenic antibodies, complement recruitment just being one of them. And that nicely translates into the clinical data, right? So let me remind you that 80% of Vyvgart patients

Speaker Change: achieve an EDL lower than 5, which is a threshold for entering a clinical trial, and that 50-55% of Vyvgart patients achieve minimum symptom expression.

Speaker Change: There's always the need in the most effective line for alternative mechanisms of action Because the drug only works in 80% of patients, but it's difficult to go into more detail in absence of data So let's look at the data to then further understand how that biology really plays

Speaker Change: Thanks for the question.

Speaker Change: We'll move next to Derek Archila at Wills Fargo.

Derek Archila: Hey, good morning, and congratulations on the progress. Thanks for taking the question. So, can you discuss maybe how the time from payer approval to injection that you're currently seeing during the early part of the CIDP launch compares to what you saw in the early part of the MG launch? Is that similar? Or is it different? And maybe a little color on why.

Derek Archila: Hey, good morning and congrats on the progress. Thanks for taking the question.

Derek Archila: Can you discuss maybe how the time from payer approval to injection that you're currently seeing during the early part of the CIDP launch compares

Speaker Change: to what you saw in the early part of the MG launch. Is that similar or is it different?

Speaker Change: Maybe a little color on why.

Karen Massey: Dan, would you mind taking this question, please? Yeah, happy to take the question. Thanks for it.

Speaker Change: Dan, would you would you mind taking this question please?

Karen Massey: But first of all, just to start by saying, we're really pleased with the strong and positive response we're having in CIDP. And, and to answer your specific questions, as enrollments come in, it does take a while for patients to get approved by their payers, and that period of time can take a few weeks before they get injected. And that's standard for any launch.

Dan: Yeah, happy to take the question. Thanks for it. But first of all, just to start with saying

Dan: We're really pleased with the strong and positive response we're having in CIDP. And to answer your specific questions,

Speaker Change: As enrollments come in, it does take a while for patients to get approved by their payers and it's that period of time that can take a few weeks before they get injected and that's standard for any launch. It's the reason that we're so focused on getting payer policies in place because once the payer policy is in place...

Karen Massey: It's the reason that we're so focused on getting payer policies in place, because once payer policies are in place, that process from script to injection can go more quickly. I would say we're exactly on track with where we thought we would be, both in terms of that process, as well as, most importantly, the discussions that we're having with payers around getting those policies in place. We're really pleased with the progress and the team's acting with urgency. And I think we're right on track and pleased with where we are. I'll hand it back to you, Tim.

Dan: that process from script.

Dan: to injection can go more quickly. I would say we're exactly on track with where we where we thought we would be, both in terms of that process, as well as most importantly, the discussions that we're having with payers around getting those policies in place. We're really pleased with the progress and the team's acting with urgency. And and I think we're right on track and pleased with where we're at. Transcribed by https://otter.ai

Tim Van Hauwermeiren: Yeah, thank you, Karen. We would like to ask you for a little patience, Derek, because remember what we did for MG Rights. I mean, it took us two quarters to install broad and favorable policies.

Dan: I'll hand it back to you, Tim.

Tim Van Hauwermeiren: Yeah, thank you Karen. We would like to ask a little bit patience Derek because remember what we did for MG Rights I mean it took us two quarters to install broad and favorable policies. That was our commitment to the patient community and that is fast

Speaker Change: Guys I mean two quarters is really outstanding an outstanding job done by the team and we will seek to replicate that for CIDP

Derek Archila: Thank you.

Speaker Change: Next we'll take a question from Akash Tewari at Jeffrey's.

Akash Tewari: Hey, thanks so much. So kind of on that point, on CIDP, you mentioned in the past, you're clearly seeing strong demand from doctors, but you wanted to see how that actually translated to patient impaired demand, given the label, the overlap, and the prescriber base, and the amount of IVIG experienced patients here.

Speaker Change: would it be fair to say, you know, the CIDP launch should at least be half as good as GMG out to the first year? And maybe to that point, do you think we will see this kind of inflection after two quarters with CIDP like we saw with GMG? I just

Derek Archila: Wanted to double click on that point like Beth would would say thanks so much

Tim Van Hauwermeiren: That is our commitment to the patient community. And that is fast. Guys, two quarters is really outstanding, an outstanding job done by the team.

Speaker Change: Yeah, Akash, and thank you for the question. Thanks for being with us today. It is tempting, right, to draw analogies between an MG launch and a CIDP launch,

Speaker Change: but what we're trying to say and explain is that you know that two distinctly different markets with their own dynamics, launch dynamics, and maybe Karen you want to dig a bit deeper into this question, right?

Tim Van Hauwermeiren: And we will seek to replicate that for CIDP. Thank you. Next, we'll take a question from Akash Tewari. Hey, thanks so much.

Karen Massey: Yeah, I think that's right. It is, it's very hard to

Karen Massey: to draw parallel, they each have their own dynamics.

Speaker Change: One thing that I would say around the inflection point that you mentioned after two quarters, I wouldn't think about an inflection point that the payer policies will come in sort of one by one over the two quarters. And what we like to think about is that sort of by the time you get to the end of two quarters, you might have you have sort of that critical mass.

Speaker Change: where neurologists really can start to get confident that favorable payer policies are in place.

Akash Tewari: So kind of on that point, on CIDP, you mentioned in the past, you're clearly seeing strong demand from doctors, but you wanted to see how that actually translated to patient impaired demand, given the label, the overlap in the prescriber base, and the amount of IVIG experienced patients here. Would it be fair to say, you know, the CIDP launch should at least be half as good as GMG out to the first year?

Speaker Change: We'll go next to Alex Thompson at Stiefel.

Alex Thompson: Hey, great. Thanks for taking my question. I guess I wanted to ask about, you know, OPEX trajectory over the next couple years, how you're thinking about that as it relates to expansion into the additional phase three programs, as well as thinking about commercial expansion beyond neurology. Thanks.

Akash Tewari: And maybe to that point, do you think we will see this kind of inflection after two quarters with CIDP, like we saw with GMG? I just wanted to double-click on that point, like Beth would say.

Speaker Change: Thank you Alex and Mr. Conley, I'll take that question.

Speaker Change: In terms of SG&A, our infrastructure is now largely in place. As you would remember, we put that expansion in the U.S. in Q1. For the rest of the world, we have infrastructure in most of the markets. There's a few big markets still outstanding in Europe .

Speaker Change: I will expect SG&A from here on forward to grow, but if we grow, we'll be muted and you won't see that rapid expansion.

Speaker Change: In terms of R&D, again, I think that will grow quarter over quarter as we invest

Speaker Change: in all the new science which we talked about last week.

Speaker Change: I think we have a unique opportunity to invest in ourselves and set us up for a long, sustainable future. And that's what we're going to do. Thank you for the question, Alex.

Speaker Change: We'll move next to Thomas Smith at Larynx Partners.

Tim Van Hauwermeiren: Thanks so much. Yeah, Akash, and thank you for the question. Thanks for being with us today. It is tempting, right, to draw analogies between an MG launch and a CIDP launch. But what we're trying to say and explain is that, you know, these are two distinctly different markets with their own dynamics, launch dynamics. And maybe Karen, you want to dig a bit deeper into this question, right? Yeah, I think that's right. It is very hard to draw parallels, they each have their own dynamics.

Thomas Jonathan Smith: Hey guys, good morning. Thanks for taking the questions and congrats on the strong results.

Karen Massey: One thing that I would say about the inflection point that you mentioned after two quarters. I wouldn't think about an inflection point where the payer policies will come in, sort of one by one over the two quarters. And what we like to think about is that, sort of, by the time you get to the end of two quarters, you might have, you have sort of that critical mass where neurologists really can start to get confident that favorable payer policies are in place.

Thomas Jonathan Smith: For Vyvgart in MG, can you just remind us on the data that's being generated that could support chronic dosing in addition to the current cycle-based dosing?

Karen Massey: So we do believe that there will be uptake, the same as that we saw in MG, and we think that there will be, it'll be consistent over, the period of time. But the dynamics between the two launches are very different for the reasons that you pointed out.

Speaker Change: Whether you expect to get chronic dosing explicitly added into the label or how important do you think it is for prescribers to have that chronic dosing flexibility in the label to facilitate access and reimbursement? Thanks.

Karen Massey: We'll go next to Alex Thompson at, Hey, great. Thanks for taking my question. I guess I wanted to ask about, you know, OpEx trajectory over the next couple years, how you're thinking about that as it relates to expansion into, you know, additional phase three programs, as well as thinking about commercial expansion beyond neurology. Thanks. Thank you, Alex and Mr. Conley. I'll take that question.

Alex Thompson: In terms of SG&A, our infrastructure is now largely in place. As you recall, we implemented that expansion in the U.S. in Q1. For the rest of the world, we have infrastructure in most of the markets.

Karl Gubitz: There are a few big markets still outstanding in Europe. I will expect SG&A from here on forward to grow, but if we grow, we'll be muted, and you won't see that rapid expanse. In terms of R&D, again, I think that will grow quarter over quarter as we invest in all the new science which we talked about last week. I think we have a unique opportunity to invest in ourselves here to set us up for a long, sustainable future.

Speaker Change: Thank you for the question and the answer is simple, we have chronic dosing in the label.

Speaker Change: The label is basically describing the use of Vyvgart for the treatment of ascetic cholinergic sub-antibody positive GMG patients. So, we have cyclical dosing, but that is of course chronic use.

Speaker Change: and we're the only company which has already such a long timeline of chronic dosing of patients. But I think it is important to call out that the safety profile of the drug maintains consistence and that we see a consistent minimum symptom expression over multiple years now.

Speaker Change: in 50 to 55 percent of the patients.

Speaker Change: What we did do is we ran an ADAPT-NEXT study.

Speaker Change: which was filling a data gap for those patients which, for example, are coming from chronic plasma exchange.

Karl Gubitz: And that's what we're going to do. Thank you for the question. We'll move next to Thomas Smith at Larynx Partners. Hey, guys, good morning.

Yaron Werber: Next we'll move to Yaron Werber at T.D. Cowan.

Thomas Jonathan Smith: Thanks for taking the questions and congratulations on the strong results. For Vyvgart in MG, can you just remind us of the data that's being generated that could support chronic dosing in addition to the current cycle-based dosing, whether you expect to get chronic dosing explicitly added to the label, or how important do you think it is for prescribers to have that chronic dosing flexibility in the label to facilitate access and reimbursement? Thanks. Now, thank you for the question. And The answer is simple.

Tim Van Hauwermeiren: We have chronic dosing in the label, and the label is basically describing the use of Vyvgart for the treatment of astatid cholinergic sub-antibody positive GMG patients. So we have cyclical dosing, but that is, of course, chronic use.

Tim Van Hauwermeiren: And we're the only company which has already such a long timeline of chronic dosing of patients. But I think it is important to call out that the safety profile of the drug maintains consistency. And that we see a consistent minimum symptom expression over multiple years in 50 to 55% of the patients. What we did was we ran an ADEPT-NEXT study, which was filling a data gap for those patients who, for example, are coming from chronic plasma exchange or chronic IVIG, patients which we really did not study in the ADEPT trial because these patients cannot stand, of course, cyclical dosing. If you're on a weekly plasma exchange, you will need real intense chronic therapy.

Yaron Werber: That is a great question and thank you for zooming out on the global aspirations of the company. This is a question I would like to hand over to Karen.

Karen Massey: Yeah, happy to happy to take this. And thanks for the question. So maybe I'll break them out and talk about Europe first, and then Japan, I would say in Europe , we're on track. As you know, it takes a little longer, as you already called out in Europe , to get pricing and reimbursement in place. Across all of the different countries, we're pleased with the progress that we've made. And certainly in three of the big five markets, Germany,

Karen Massey: Spain and Italy we have good reimbursement we have strong clinical advocacy and we're really seeing that that consistent uptake

Karen Massey: With what we're seeing in the U.S. and what I mean by that is that we see a broader prescriber base, not just in the academic centers.

Karen Massey: at broader potential and really pushing towards early aligned use. So I think we're seeing consistent trends there, and as we open up new markets with pricing and reimbursement, then I think you'll start to see that consistent growth.

Karen Massey: as well. So we're pleased where we are in Europe . We're on track. We take it step by step. It takes a little bit longer.

Karen Massey: In Japan, I just want to applaud the team. I think they've done a phenomenal job. I mean, if you look back quarter over quarter, it's just so incredibly consistent, the growth in Japan.

Karen Massey: And we see that again this quarter. I would imagine that you can see, you can imagine that outlook being consistent moving forward.

Karen Massey: We just recently launched VizDura, which is the name for Subcutaneous in Japan, and that, like in other markets,

Karen Massey: We're seeing that really expand the patient population that is open to Vyvgart with those, again, opening up those earlier lines of treatment. So, again, I would say consistent growth as you've seen for the last 10 quarters from Japan that we can expect in the future. Thanks for the question.

Tim Van Hauwermeiren: And with the ADEPT-NEXT study, we have actually shown that every other week dosing with Vyvgart is as powerful as cyclical dosing, both from an efficacy and a safety point of view. So in summary, I think we're the only company really with chronic dosing data, and we're the only company which can offer, you know, such a diverse set of dosing. Thanks for the question. Next, we'll move on to Yaron Werber at TD Callen.

Karen Massey: We'll move next to Matt Phipps at William Blair.

Yaron Werber: Great, thanks so much and a really nice showing team. Quick question, just in Europe and Japan, you know, Europe is very tough these days, and Japan usually has lumpiness, as you noted, and obviously changes in pricing, but just any sense of what kind of acceleration we should expect there in terms of acceleration of sales? Thank you. That is a great question. And thank you for zooming in on the global aspirations of the company. This is a question I would like to hand over to Karen.

Matt Phipps: Thanks, Jay. My question is congrats on all the progress. Quickly, you mentioned a different endpoint in the next ITP trial. Is that just looking at a different time frame for sustained platelet response, or can you use something like

Karen Massey: Yeah, happy to take this. And thanks for the question. So maybe I'll break them out and talk about Europe first. And then Japan. I would say in Europe, we're on track.

Karen Massey: As you know, it takes a little longer, as you have already pointed out in Europe, to get pricing and reimbursement in place. Across all of the different countries, we're pleased with the progress that we've made. And certainly in three of the big five markets, Germany, Spain, and Italy, we have good reimbursement, we have strong clinical advocacy, and we're really seeing that consistent uptake with what we're seeing in the US. And what I mean by that is that we see a broader prescriber base, not just in the academic centers, broader potential, and really pushing towards early aligned use.

Matt Phipps: IWG responders as a primary endpoint. And then maybe just quickly on the launch of ITP in Japan, any sense yet on where Vyvgart is being used in the treatment paradigm for ITP patients? Is it after multiple thrombocoid anagonists or can you slot earlier in that treatment paradigm? Thanks.

Speaker Change: Two great questions. Thank you for that. I will hand over question two to Karen. On the ATP trial, I think the reason why we can go with a significantly smaller study in a confirmatory mindset

Speaker Change: is A, because we can work with an endpoint,

Speaker Change: which is looking for the extent of disease control.

Karen Massey: And B, we can really leave this to know how and the expertise we have developed in running ITP clinical trials. So I think this is going to be, roughly speaking, a trial less than half the size.

Karen Massey: of the global phase 3 trials which we have done so far, and we think it's a responsible investment to make for a significant patient unmet need waiting on the other line. Karen, would you mind discussing the Japan question, please?

Karen Massey: So I think we're seeing consistent trends there. And as we open up new markets, with pricing and reimbursement, then I think you'll start to see that consistent, consistent growth as well. So we're pleased where we are in Europe; we're on track, we take it step by step, it takes a little bit longer. In Japan, I just want to applaud the team.

Karen Massey: Yeah happy to take that. I would start by saying the ITP launch in Japan is going really well. We've applied sort of the same launch playbook that we have in other in other launches and we're seeing the same strong early performance

Karen Massey: And what I would say is that it's clear that there's an unmet need in these ITP patients. So far, what we're seeing, to your specific question, is that the early experience is in later lines of therapy. And that's exactly what you would expect in any of these launches.

Karen Massey: I think they've done a phenomenal job. I mean, if you look back quarter over quarter, it's just so incredibly consistent with the growth in Japan. And we see that again this quarter; I would imagine that you can imagine that outlook being consistent moving forward. So we just recently launched VizDura, which is the name for Subcutaneous in Japan. And that, like in other markets, we're seeing that really expand the patient population that is open to VizGut, with those, again, opening up those earlier lines of treatment. So again, I would say consistent growth, as you've seen for the last 10 quarters from Japan, that we can expect in the future. Thanks for the question. We'll move next to Matt Phipps at William Blair.

Karen Massey: The doctors want to try to get experience, maybe in those refractory patients, in those late-aligned patients, get experience.

Matt Phipps: Thanks for taking my questions; congrats on all the progress. Quickly, you mentioned a different endpoint in the next ITP trial. Is that just looking at a different time frame for sustained platelet response, or can you use something like IWG responders as a primary endpoint? And then maybe just quickly on the launch of ITP in Japan, any sense yet on where Vyvgart is being used in the treatment paradigm for ITP patients? Is it after multiple thrombopoietin agonists, or can you slot it in earlier in that treatment paradigm? Thanks. Two great questions. Thank you, Fred.

Karen Massey: under their belt and then start to move earlier line.

Karen Massey: But what we're seeing that I'm really pleased with is that there's a strong belief in the MOA, in the mechanism of action of FCRN, the hematologists are responding that they believe in the MOA, and therefore that they believe in the reason to try this gut. So I would say strong early results, exactly where we would expect them, and really important learnings that we're going to be able to take away from this Japan launch as we think about the US and potentially other launches with the second study that we're planning. Thanks for the question.

Tim Van Hauwermeiren: I will hand over question two to Karen. On the ITP trial, I think the reason why we can go with a significantly smaller study in a confirmatory mindset is A, because we can work with an endpoint that is looking for the extent of disease control, and B, we can really leverage the know-how and the expertise we have developed in running ITP clinical trials. So I think this is going to be, roughly speaking, a trial less than half the size of the global phase three trials which we have done so far, and we think it's a responsible investment to make for a significant patient and one that needs waiting on the other line. Karen, would you mind discussing the Japan question, please?

Karen Massey: Yeah, happy to take that. I would start by saying the ITP launch in Japan is going really well. We've applied sort of the same launch playbook that we have in other launches, and we're seeing the same strong early performance. And what I would say is that it's clear that there's an unmet need in these ITP patients. So far, what we're seeing with your specific question is that early experience is in later lines of therapy, and that's exactly what you would expect in any of these launches.

Karen Massey: The doctors want to try to get experience, maybe in those refractory patients, in those later-line patients, get experience under their belts and then start to move earlier. But what we're seeing that I'm really pleased with is that there's a strong belief in the MOA, in the mechanism of action of FCRN. The hematologists are responding that they believe in the MOA and, therefore, in the reason to try this gut.

Karen Massey: So I would say strong early results, exactly where we would expect them, and really important learnings that we're going to be able to take away from this Japan launch as we think about the US and potentially other launches with the second study that we're planning. Thanks for the question. We'll go next to Suzanne von Voorthuizen at Kemper.

Speaker Change: We'll go next to Suzanne von Voorthuizen at Kempen.

Suzanne van Voorthuizen: Hi Team, this is Suzanne van Kempen. Thanks for taking my question. I just have a small follow-up to last week's R&D day regarding ArgenX 1.2.1, the IgA degrader that was revealed. Can you give some context to the indications where such a molecule would fit well, how many indications you see, and also how you compare the opportunity in terms of size?

Speaker Change: Hi team, this is Suzanne van Kempen, thanks for taking my question. I just have a small follow-up to last week's R&D day regarding argenx-121, the IgA degrader that was revealed. Can you give some context to the indications where such a molecule would fit well?

Speaker Change: how many indications you see and also how you compare the opportunity in terms of size

Speaker Change: Is there potential for this to be an opportunity of Vyvgart size or do you see more parallels to a drug like Empa when looking at the commercial opportunity? Any thoughts or direction here would be appreciated. Thanks.

Tim Van Hauwermeiren: Is there potential for this to be an opportunity of Vyvgart size, or do you see more parallels to a drug like EMPA when looking at the commercial opportunity? Any thoughts or direction here would be appreciated, thanks. Thanks, Suzanne. Thank you for this question. And you know that when we take a product forward in the pipeline, it has got the right to be used across multiple indications. So it's not a single indication asset.

Speaker Change: Thanks, Suzanne. Thank you for this question. You know that when we take a product forward in a pipeline

Speaker Change: that it has got the right to play across multiple indications. So it's not a single indication asset.

Tim Van Hauwermeiren: I think what we said on the podium during R&D day is that there's a growing understanding of the pathogenic role IgA autoantibodies play in autoimmune disease. It's actually remarkable how little we know above and beyond pathogenic IgG. So this is a field that is completely emerging. We are very pleased that we can go in there and pioneer it. It's the work we like to do. And then, in terms of indications, we give you a conceptual list of indications where we know that IgA autoantibodies drive disease.

Speaker Change: I think what we said on the podium during the R&D day is that there's a growing understanding

Speaker Change: of the pathogenic role IgA autoantibodies play in autoimmune disease. It's actually remarkable how little we know above and beyond pathogenic IgG. So this is a field which is completely...

Speaker Change: emerging. We're very pleased that we can go in there and find it. That's the work we like to do. And then in terms of indications, we give you a conceptual list of indications.

Tim Van Hauwermeiren: Of course, everyone knows about IgA nephropathy. I think that is a field which is just being built. I think it's a large market opportunity that will support multiple generations of innovation and multiple innovative molecules, so that's an obvious one. We spoke about IGF-ascalitis, but again, from a biology point of view, that is in the bullseye of the disease, but there are more indications.

Speaker Change: where we know that IgA autoantibodies drive disease. Of course, everyone knows about IgA nephropathy.

Speaker Change: I think that is a field which is just being built. I think it's a large market opportunity which will support multiple generations of innovation and multiple innovative molecules, so that's an obvious one.

Speaker Change: We spoke about IGE vasculitis, but again, you know, from a biology point of view, that is in the bullseye of the disease.

Tim Van Hauwermeiren: And at this moment, we will stay conceptual, you know, because we're still doing some background work on these indications, and the opportunity will unfold when we bring this molecule online in all these different clinical trials. So stay tuned. We think it's a significant opportunity where I think we can follow the biology. So we're very excited about the molecule. Thank you. We'll go next to Yaten Senuta at Guggenheim Partners. Hey guys, congrats on the quarter. Two very quick ones for me.

Speaker Change: There are more indications and at this moment we will stay conceptual, you know, because we're still doing some background work on these indications and the opportunity will unfold when we, you know, bring this molecule online in all these different clinical trials.

Speaker Change: We'll go next to Yaten Senuta at Guggenheim Partners.

Yatin Suneja: Could you just talk a little bit more about the sub-Q and IV dynamic, like how sub-Q is, what sort of share sub-Q has right now versus IVs that's sort of growing the market? And then just, you know, as we think about the future, you know, with the launch of CIDP, any thoughts on establishing guidance for us? Thank you. Thank you for both questions answers. And let's start with question one, the sub-Q versus IV dynamic.

Yatin Suneja: Hey guys, congrats on the quarter. Two very quick ones for me. Could you just talk a little bit more about the sub-Q and IV dynamic? Like how is sub-Q, what sort of share sub-Q has right now versus IVs that are growing in the market?

Karen Massey: Karen, would you mind commenting on the dynamic? I don't think we can quantify it right, but maybe you can explain the dynamic. Yeah, happy to, exactly.

Speaker Change: Thank you for both questions. Let's start with question 1, the sub-Q versus IV dynamic. Karen, would you mind commenting on the dynamic? I don't think we quantify, but maybe you can explain the dynamic?

Karen Massey: So we don't provide the specific breakdown. But what I would say that is helpful in terms of the dynamic is that both Vyvgart and Hytrulo are growing in terms of new patient starts and in terms of revenue. And what we see and what the real value of Hytrulo is, I would say it opens up new prescribers that might not be, for whatever reason, interested or comfortable with an IV option.

Karen Massey: Yeah, happy to. Exactly. So we don't provide the specific breakdown, but what I would say that I think is helpful in terms of the dynamic, both Vyvgart and Hytrulo are growing in terms of new patient starts and in terms of revenue. And what we see and what the real value of Hytrulo is, is that I would say it opens really up new prescribers that might not be, for whatever reason, interested or comfortable with an IV option. So new neurologists that are more comfortable with injections. And that also opens up new patients that are seeing those neurologists or potentially there are patients that don't want to have the IV. Maybe they think that their disease is not severe.

Karen Massey: So new neurologists that are more comfortable with injections. And that also opens up new patients that are seeing those neurologists, or potentially, there are patients that don't want to go have the IV. Maybe they think that they're less, their disease is not severe enough, that they need an IV option, but they're open to an injection option.

Karen Massey: are open to an injection option, so I would say by having subcutaneous it aligns directly with our strategy of moving into early aligned treatment and we see that very clearly and it also aligns with our strategy of broadening the prescriber base for Vyvgart which obviously also helps us with CIDP.

Karen Massey: So I would say by having subcutaneous, it aligns directly with our strategy of moving into early aligned treatment, and we see that very clearly. And it also aligns with our strategy of broadening the prescriber base for this Vyvgart, which obviously also helps us with CIDP. The other important dynamic that I think I just want to highlight about Hytrulo is that our goal and our strategy is not a switch strategy from Vyvgart.

Yatin Suneja: The other important dynamic that I think I just want to highlight on HyChulo is that

Yatin Suneja: Our goal and our strategy is not a switch strategy from Vyvgart. So around 60% of the HITRULO patients that are starting on HITRULO are actually new to the Vyvgart franchise. And that just demonstrates how we're really expanding the market both in terms of prescribers and patients with the subcutaneous option.

Karen Massey: So around 60% of the Hytrulo patients that were, that are starting on Hytrulo are actually new to the Vyvgart franchise. And that just demonstrates how we're really expanding the market, both in terms of prescribers and patients with the subcutaneous option. And I'll hand it back to you, Tim. Actually, we had a cut in our line. If Yatin is still on, if you could just repeat his second question, that would be helpful. Yeah, I'm online.

Yatin Suneja: And I'll hand it back to you, Tim.

Tim Van Hauwermeiren: Actually, we had a cut in our line. If Yatin is still on, if you could just repeat his second question, that would be helpful.

Yatin Suneja: So the second question was about guidance. How should we What are you guys thinking about establishing guidance? And when should we expect that?

Yatin Suneja: Yeah, I'm online. So the second question was about guidance. How should we, how are you guys thinking about establishing guidance and when should we expect that?

Karl Gubitz: Okay, that is good. Thank you, Yatin, for repeating it. This is a question for Karl, right?

Karl Gubitz: Okay, that is clear. Thank you, Yatim, for repeating it. This is a question for Karl, right? Yeah, thank you. Thank you, Yatim. I mean, we didn't provide guidance this year, Avenue guidance.

Karl Gubitz: Yeah, thank you. Thank you, Yatin. I mean, we didn't provide guidance this year, revenue guidance, due to all the unknowns out there, in particular for the CIDP launch and the geographical expansion. So I think as a company matures, clearly, we need to think about guidance. So we will listen to our stakeholders, including our investors and analysts, and this is something that we will consider. And maybe this is something we can do in January next year.

Speaker Change: Due to all the unknowns out there, in particular for the CIDP launch.

Speaker Change: and the geographical expansion. So I think as a company mature, clearly, we need to think about guidance. So we will listen to our stakeholders, including our investors and analysts,

Vikram Purohit: But for now, we're going to focus on executing, and we have provided the expense guidance and the cash guidance, and I will leave it at that. And I will go next to Vikram Purohit at Morgan Stanley. Hi, good morning.

Speaker Change: and this is something which we will consider maybe this is something we can do in January next year but for now we're going to focus on executing and we have provided the expense guidance and the cash guidance and I will leave it at that for now.

Speaker Change: And we'll go next to Vikram Purohit at Morgan Stanley .

Andy Chen: Thank you for taking our question. We had one on the commercial opportunity for OcularMG. So based on the neurologist feedback you received and just the experience you have had in the space, with this indication overall, at this point, how distinctly do you think OcularMG is managed, viewed, and treated versus more generalized MG? And based on that, how drastically do you think the cadence of patient ads could change based on a potential label expansion into OcularMG?

Vikram Purohit: Hi, good morning. Thank you for taking our question. We had one on

Vikram Purohit: The Commercial Opportunity and Ocular M.G.

Vikram Purohit: So based on the neurologist feedback you've received and just the experience you have in the space

Vikram Purohit: With this indication overall at this point, how distinctly do you think OcularMG is managed and viewed and treated versus more generalized MG? And based on that, how drastically do you think the cadence of patient ads could change based on a potential label expansion into OcularMG? Thanks.

Andy Chen: Thanks. Thanks for the question on ocular MG. So now having been in the MG space for some time, we have been hearing more about unmet medical needs in ocular MG, and it could be a wrong assumption that ocular MG is a milder form of MG compared to the generalized form of myasthenia. So ocular MG patients are pretty debilitated and disabled because with double vision, there are not too many activities of daily living you can do in terms of, you know, working on screens, driving, and then I'm not even talking about the headaches these people experience.

Speaker Change: It could be a wrong assumption that ocular M.G. is a milder form of M.G. compared to the generalized form of myasthenia. So, ocular M.G. patients

Speaker Change: are pretty debilitated and disabled because with double vision there's not too much activities of daily living you can do in terms of, you know, working on screens, driving, and then I'm not even talking about the headaches these people experience. Today, OQMG patients are basically only treated with steroids.

Tim Van Hauwermeiren: Today, ocular MG patients are basically only treated with steroids, and some of them actually do very well on steroids, but there's a subset of ocular MG patients that badly need another tool in the toolbox, and after close consultation with the community and the experts, we could crystallize, I think, a pretty elegant ocular MG study. We had a successful interaction with the FDA, agreeing on trial design and endpoint. In the real world, some of these ocular MG patients are actually seen by ophthalmologists or neuro-ophthalmologists, and then when the symptoms start to spread, they're being referred to a neuromuscular specialist.

Vikram Purohit: And some of them actually do very well on steroids, but there's a subset of opium G patients which badly need another tool in the toolbox.

Speaker Change: And after close consultation with the community and the experts, we could crystallize, I think, a pretty elegant OCRMG study. We had a successful interaction with the FDA.

Speaker Change: agreeing on trial design and endpoint. And in the real world, some of these Ocular MG patients are actually seen by ophthalmologists or neuro-ophthalmologists.

Speaker Change: And then when these symptoms start to spread, they're being referred to a neuromuscular specialist. So I think this is a significant opportunity and a nice addition if we are successful to our presence in the EMG space.

Tim Van Hauwermeiren: So I think this is a significant opportunity and a nice addition, if we are successful, to our presence in the MG space. Thanks for the question. We'll take our next question from Charles Pitman King at Barclays. Hi, thank you very much for taking my questions. Two from me, just coming back to the potential risks from competitor readouts to your dominant position in the second half of this year. I'm just wondering what metrics you will be looking at from these readouts to determine whether any of these really pose a risk to your increasing market dominance. And then just the second one on the kind of Chinese commercial opportunity.

Speaker Change: Thanks for the question.

Speaker Change: We'll take our next question from Charles Pitman King at Barclays.

Charles Pitman: I mean, I understand Xilab is not going to be a report until the 7th of August, but just in terms of how you are thinking about this from an Argenx perspective, you know, how established are the treatments and what is the expected addressable market and pricing structure that you expect to benefit from going forward. Thanks. Karen, I will give the second question to you.

Speaker Change: Hi, thank you very much for taking my questions. Two from me, just coming back to the potential risks from competitor readouts to your dominant position in the second half of this year, I'm just wondering what metrics will you be looking at from these readouts to determine whether any of these really pose a risk to your increasing market dominance?

Speaker Change: and then just the second one on the kind of Chinese commercial opportunity I mean I understand Xilab is not going to be a report until the 7th of August

Speaker Change: But just in terms of how you are thinking about this from an ArgenX perspective, you know, how established are the treatments, and what is the expected addressable market and pricing structure that you expect to benefit from going forward. Thanks.

Karen Massey: I think on the first question, we can be relatively brief. In the absence of data, I think we would find ourselves in an area of speculation, which we do not really like to do as a science-based company. The only thing I can do is remind you of how high we have set the bar in the MG space. I think we have the fastest onset of action. We have the deepest action.

Speaker Change: Thank you for both questions. Karen, I will give the second question to you. I think on the first question we can be relatively brief. In absence of data, I think we would find ourselves in an area of speculation, which we do not really like to do as a science-based company.

Karen Massey: The only thing I can do is remind you of how high we have set the bar in the MG space. I think we have the fastest onset of action, we have the deepest action, we have a very nice durability now over many, many years in our MG patients.

Speaker Change: and importantly I think with a very clean safety profile.

Speaker Change: And then from a product presentation point of view, I think we have by far the broadest portfolio of product presentations, which we will continue to aggressively expand. So that's it for the data, but I think we're well equipped to compete. And Karen, do you mind taking on question two?

Tim Van Hauwermeiren: We have very good durability now for many, many years in our MG patients. And importantly, I think we have a very clean safety profile. And then, from a product presentation point of view, I think we have by far the broadest portfolio of product presentations, which we will continue to aggressively expand. So, we wait for the data, but I think we are well equipped to compete. And Karen, do you mind taking on question two?

Karen Massey: No, happy to take that question, Tim. And look, I won't comment on the Q2 results, of course; we'll let Xi Lab comment on that. But what I will say is a few thoughts, first of all, starting with the fact that I think Xi are incredible partners, and they've done a great job with the launch of MG. And we see a long-term partnership with them, and I think a lot of opportunity in the future in China, obviously, it's a big market. And what we've seen today is a lot of volume coming in early on, through And I think that reflects the market opportunity in China.

Karen Massey: No, happy to take that question, Tim. And look, I won't comment on Q2 results. Of course, we'll let Xi lab comment on that. But what I will say is a few thoughts on

Karen Massey: First of all, starting with the fact that I think Xi are incredible partners, and they've done a great job with the launch of MG.

Karen Massey: and we see and with them a long-term partnership and I think a lot of opportunity in the in the future in China obviously it's a it's a big market and what we've seen to date is a lot of volume coming in early on through Q1 you saw

Karen Massey: I think we've done a great job of not just getting the approvals but also the NRDL listing. And that has certainly helped with uptake; we expect that to continue. And more recently, we got the subcutaneous version approved in China. So I think overall, between the volume of patients with MG in China, alongside the great partner we have in Xi Lab, I think we're looking positively at the outlook for China. I'll hand it back to you, Tim.

Karen Massey: [inaudible]

Speaker Change: A big volume of new patients starts in Q1.

Speaker Change: and I think that reflects the the market opportunity in China. I think we've done a great job of not just getting the approvals but also the NRDL listing and that has certainly helped with uptake we expect that to continue and more recently we got the subcutaneous version approved in China. So I think overall between the the volume of patients with MG in China alongside the the great partner we have in Xilab I think

Speaker Change: We're looking positively at the outlook for China.

Tim Van Hauwermeiren: Thanks, Karen. Thanks for the question. We'll go next to Leland Gershell at Oppenheimer.

Speaker Change: I'll hand back to you, Jim.

Jim: Thanks Cara, thanks for the question.

Jim: We'll go next to Leland Gershell at Oppenheimer.

Leland Gershell: Great, thanks for taking our questions. I just want to ask Karen, you've been consistent in, you know, moderating expectations for securing payer agreements for CIDP. Just want to ask if that process has been going in line with your expectations internally, and also want to ask if you've been facing any pushback from payers with respect to, you know, requiring less step through from IVIG. Thank you; I think this is next in the question.

Leland Gershell: Great, thanks for taking our questions. I just wanted to ask, Karen, you've been consistent in

Karen Massey: and, you know, moderating expectations for securing payer agreements.

Leland Gershell: For CIDP, just want to ask if that process has been going in line with your expectations internally. And also want to ask if you've been facing any pushback from payers with respect to, you know, requiring a step through from IVIG. Thank you.

Karen Massey: Yeah, happy to take that. Thank you. Yeah, sounds great. It's a great question.

Speaker Change: I think this is the next question. Yeah, happy to take that.

Karen Massey: And we talked earlier about why it's so important to get these payer policies in place. I would say that it's because we're, as I said before, exactly on track with where we thought we would be. And I mean that in terms of both how the conversations with payers are progressing, and which are progressing well, and also the conversations that we're having with payers in terms of what those policies should look like.

Leland Gershell: Thank you.

Leland Gershell: Yeah, sounds great. It's a great question. And we talked earlier about why it's so important to get these payer policies in place.

Leland Gershell: I would say that, as I said before, we're exactly on track with where we thought we would be, and I mean that in terms of both how the conversations with payers are progressing, which are progressing well, and also the conversations that we're having with payers in terms of what those policies should look like.

Leland Gershell: In terms of IVIG, I think one thing that's important to remember about the CIDP market is that the majority of patients have been exposed to IVIG at some point. And we know from our clinical trial that we have equal right to respond, whether it's IVIG as background therapy coming off, no treatment in the last six months, or steroids. So we think we're well positioned with our data, and we think the payer discussions are going well to get policies in place that will set us up for a successful and a strong launch over the coming quarters.

Karen Massey: So, we think we're well positioned with our data, and we think the payer policy, the payer discussions are going well, to get policies in place that will set us up for a successful and strong launch over the coming quarters. Anything to add, Jim?

Jim: Anything to add, Jim?

Jim: and many more.

Tim Van Hauwermeiren: Thank you for the question. We're ready for the next one. We'll go next to Samantha Semenkow at Citi. Hi, good morning, and thanks for taking the question. Just one on the PFS for me, you know, now that you've filed and you're preparing for the potential launch of the PFS, I'm curious, how much more growth in GMG are you really thinking about that that formulation will drive? What patient segments do you expect to open or expand? Do you think this will be more of a switch market than what you've seen with iTRULO?

Jim: Thank you for the question. We're ready for the next one.

Jim: We'll go next to Samantha Semenkow at Citi.

Samantha Semenkow: And just how should we think about the magnitude of the impact on revenue, assuming you have that approval in the near future? Thank you. Yeah, thank you. That's a great question about BFS.

Samantha Semenkow: Hi, good morning, and thanks for taking the question. Just one on the PFS for me, you know, now that you filed and you're preparing for a potential launch of the PFS, I'm curious,

Samantha Semenkow: How much more growth in GMG are you really thinking about that that formulation will drive? What patient segments do you expect to open or expand? Do you think this will be more of a switch market than what you've seen with iTrulo? And just how should we think about the magnitude of impact on revenue, assuming you have that approval in the near future?

Karen Massey: And Karen, I think, why don't you explain why this will just continue that steady, strong trajectory into the MGE population? Yes, I think that's exactly it, Tim. And what I was going to say, I would say this just continues to expand and reinforce the momentum. As we continue, we started with IV, then we expanded into subcutaneous, and then certainly expanding into PFS, it opens up different prescribers, as well as different patients.

Samantha Semenkow: Yeah, thank you. That's a great question on BFS. And Karen, I think, why don't you explain why this will just continue that steady, strong trajectory into the MGE population, please?

Karen Massey: Yes, I think that's exactly it, Tim. And what I was going to say, I would say this just continues to expand and

Karen Massey: and reinforce the momentum as we continue we started with IV then we expanded into subcutaneous and then certainly expanding into PFS it opens up different prescribers as well as different patients and and I think that's reflected in terms of how we explain the the addressable market expansion at R&D Day certainly what we see is that there will be a growth in biologic share of market and that we will be well positioned within that growth

Karen Massey: And I think that's reflected in terms of how we explain the addressable market expansion at R&D Day. Certainly, what we see is that there will be a growth in the biologic share of the market. And that we will be well positioned within that growth. And certainly PFS helps us to maintain our leadership position and certainly with the early aligned patients and the broader prescriber base, given the fact that we will have IV and PFS.

Karen Massey: and certainly PFS helps us.

Samantha Semenkow: to maintain our leadership and certainly with the early aligned patients and the broader prescriber base.

Karen Massey: So I would think about it as continuing to maintain our momentum and, and continuing in line with our strategy of early aligned and broader prescriber base. Thanks for the question. We'll go next to Joon Lee at Truist Security.

Samantha Semenkow: Given that the fact that we will have IV and PFS. So I would think about it as continuing to maintain our momentum And and continuing in line with our strategy of early align and and broader prescriber base. Thanks for the question

Samantha Semenkow: We'll go next to Joon Lee at Truist Securities.

Joon So Lee: Thanks for the update. Thanks for taking our questions. For the no-go decision on myositis by year-end, are they all coming at once or one by one? And if F-carb ketamide works in one but not in the other myositis subtypes, what would be some of the reasons for that?

Joon So Lee: Thanks for the update and for taking our questions.

Joon So Lee: For the no-go decision on myositis by year-end, are they all coming at once or one by one? And if F-carotid mod works in one but not in the other myositis subtypes, what would be some of the reasons for that? And what are you looking forward to learning from that to further enhance the choice of your future indications and maybe even reprioritize your existing pipeline indications?

Tim Van Hauwermeiren: And what are you looking forward to learning from that to further enhance the choice of your future indications and maybe even reprioritize your existing pipeline indications? Thank you. Thank you, Joon, for the question and thanks for being with us. So in this basket trial where we combine three subtypes of myositis, the go-no-go decision point will all come at the same time.

Speaker Change: Thank you.

Speaker Change: Thank you Joon for the question and thanks for being with us. So, in this basket trial where we combined three subtypes of myositis,

Tim Van Hauwermeiren: So we're synchronizing the first 30 patients across the three indications to make one decision. Remember that this is an operationally seamless Phase II, and phase III trial. So while these data are maturing, we are actually already entering the phase III portion of the trial at risk. So technically speaking, the only decision we can make is to stop this.

Speaker Change: To go or no go decision point will all come at the same time. So we're synchronizing the first 30 patients across the three indications.

Speaker Change: to, you know, make one decision. And remember that this is a operationally seamless phase two, phase three trial. So whilst these data are maturing, we are actually already entering into the phase three portion of the trial at risk.

Tim Van Hauwermeiren: And, of course, the first study patients will be informative, so they will allow us to make stop decisions in one, two, or three of these indications. But it will also allow us to adjust the sample size. Look, all three indications come out of the same Argenx mold. I mean, strong conviction in biology. I think a responsible thoughtful clinical trial design is not completely risk free. So I think we did everything we could to design it and mitigate that risk. So I don't think there is any specific read through of a myositis outcome onto any other indication which we have loaded into the pipeline because they all follow the same blueprint.

Speaker Change: So technically speaking, the only decision we can make is a stop decision.

Speaker Change: and of course the first 30 patients will be informative so it will allow us to make stop decisions in one two or three of these indications but it will also allow us to adjust sample size

Speaker Change: Look, all three indications come out of the same ArgenX mold. I mean, strong conviction in biology.

I think a responsible thoughtful clinical trial design but not completely risk-free.

Speaker Change: So, I think we did everything we could to design it and risk mitigate it, so I don't think there is any specific read-through of a myositis outcome onto any other indication which we have loaded into the pipeline, because they all follow the same blueprint.

Tim Van Hauwermeiren: Thanks for the question. We'll go next to Gavin Clark Gartner at Evercore ISI. Hey, thanks for taking the question. A quick one on thyroid eye disease. Just wanted to confirm you're doing weekly dosing in the phase threes and also just ask how enrollment is going now that you're about four months in. Thanks.

Speaker Change: Thanks for the question.

Speaker Change: We'll go next to Gavin Clark Gartner at Evercore ISI.

Speaker Change: Hey, thanks for taking the question. A quick one on thyroid eye disease. Just wanted to confirm you're doing weekly dosing in the phase threes and also just ask how enrollment is going now that you're about four months in. Thanks.

Gavin Clark: Thanks for the question on TD. You're right that we're in weekly dosing. We're doing that with the pre-filled syringe already.

Speaker Change: Thanks for the question on TUD. You're right that we're in weekly dosing. We're doing that with the pre-filled syringe already. And I think we're in a classical, typical trial execution mode.

Tim Van Hauwermeiren: And I think we're in a classical, typical trial execution mode. Stay tuned on how that study is doing. We will keep you updated over the coming quarters, but we feel very strong about the opportunity and the traction we're getting with this global clinical trial. Thank you. Next, we'll go to Andy Chen at Wolf Research. Good morning.

Speaker Change: Stay tuned on how the study is doing. We will keep you updated over the coming quarters But we feel very strong about the opportunity and the traction we're getting with this global clinical trial. Thank you

Andy Chen: Thank you for taking the question for this $450,000 pricing. I'm just curious if you can talk about how robustly this pricing can stay at $450,000 because, as you have payer contracts, there's a natural pressure for ASP erosion. So just curious if you can comment on the dynamics here. Do you see room for this number to go up over time in the next few years? Or do you think this is going to stay the same at $450,000? Or do you think this is going to go down?

Speaker Change: Next we'll go to Andy Chen at Wolf Research.

Speaker Change: There's 450,000 pricing.

Andy Chen: I'm just curious if you can talk about how robustly this pricing can stay at $450 because as you have payer contracts, there's a natural pressure for ASP erosion, so just curious if you can comment on the dynamics here. Do you see room for this number to go up over time in the next few years or do you think this is going to stay the same at $450 or do you think this is going to go down?

Tim Van Hauwermeiren: Yeah, so Andy, thank you for the question, which I'm happy to take. So let me first briefly comment on the 450 numbers. That number, of course, did not come out of the blue sky. I think it is the result of a thorough understanding of, I think, the value proposition which we have to offer, and careful calibration, of course, with payers, where we socialized the phase three data with them.

Speaker Change: Thank you.

Speaker Change: Yeah, so Andy, thank you for the question, which I'm happy to take. So let me first briefly comment on the 450 numbers. That number, of course, did not come out of the blue sky. I think it is the result of a thorough understanding of, I think, the value proposition which we have to offer.

Speaker Change: Be careful, calibration, of course, with the payers.

Tim Van Hauwermeiren: And the data actually, which resonates very well with payers, is the regain of function data Karen was already alluding to. And especially, I think the fact that the majority of the people who entered the trial wheelchair-bound were able to leave the trial outside of the wheelchair.

Karen Massey: where we socialized the phase 3 data with them and the data actually which resonates very well with PACE is the big gain of function data Karen was already alluding to and especially I think the fact that the majority of the people who entered the trial wheelchair bound

Tim Van Hauwermeiren: So these are pretty meaningful data that represents significant value. We are now finalizing the payer agreements, so stay tuned. We also discussed that during the call. Look, I cannot predict the future.

Tim Van Hauwermeiren: were able to leave the trial outside of the wheelchairs. These are pretty meaningful data which represent significant value.

Tim Van Hauwermeiren: We are now finalizing the paid agreements.

Speaker Change: So stay tuned. We also discussed that during the call. Look, I cannot predict the future. I think it is fair to assume that with more competition and more indications, there may be some pressure on your prize.

Tim Van Hauwermeiren: I think it is fair to assume that with more competition and more indications, there may be some pressure on your price. But I think, as a company, we're pricing transparently and responsibly. And I think we're very well equipped with our market access strategies to go into the future. Thank you for the question. Next, we'll move to Joel Beatty at Baird. Thanks and congratulations on the strong growth from Q1. Looking back, what led to the weaker Q1 and how much of that was seasonal in nature and would be expected to repeat versus any dynamics that might have been one-time in nature?

Speaker Change: But I think as a company we're pricing transparently and responsibly and I think we're very well equipped with our market access strategies to go into our future

Speaker Change: Thank you for the question.

Karen Massey: Next we'll move to Joel Beatty at Baird.

Joel Lawrence Beatty: Thanks and congrats on the strong growth from Q1. Looking back, what led to the weaker Q1 and how much of that was seasonal in nature and would be expected to repeat versus any dynamics that might have been one time in nature?

Joel Lawrence Beatty: Yeah, thank you for asking the question. I think we alluded to that in the prepared remarks, but maybe Karen, do you want to comment? When we look through the optics of Q1 and Q2, what is the real underlying strength of the business? Yeah, absolutely. When we look at the business, what we look at are those underlying drivers of growth.

Joel Lawrence Beatty: Yeah, thank you for asking the question. I think we alluded to that in the prepared remarks, but maybe Karen, do you want to comment when we look through the optics of Q1 and Q2, what the real underlying strength of the business is?

Karen Massey: So are we adding new patients consistently? Are we moving earlier in the line? Are we broadening our prescriber base? And we see that pretty consistently through Q1 and Q2. I would say those Q1 dynamics that you see across the industry, not just with Vyvgart, around re-verifications, and weather, I'd say they're always going to be there. You know, whether they were worse in Q1 because the weather was worse in some parts of the US, or whatever you may have. I mean, I think we can all look back on that.

Karen Massey: Yeah, absolutely. When we look at the business, what we look at is those underlying drivers of growth. So are we adding new patients consistently? Are we moving earlier line? Are we broadening our prescriber base? And we see those pretty consistently through Q1 and Q2. I would say those Q1 dynamics that you see across the industry, not just with Vyvgart, around re-verifications, weather, I'd say they're always going to be there.

Karen Massey: So whether they were worse in Q1 because the weather was worse in some parts of the US or whatever you may have I think we can all look back at that. But those Q1 dynamics are more I would say across the industry. The Vyvgart performance and the KPIs I would say is pretty consistent throughout actually the 10 quarters of growth that we've had and we would expect that to continue.

Karen Massey: But those Q1 dynamics are more, I would say, across the industry. The Vyvgart performance and the KPIs, I would say, are pretty consistent throughout actually the 10 quarters of growth that we've had. And we would expect that to continue. Thanks for the question. We'll take our final question from Douglas Tsao at HC Wainwright. Hi, good morning, and thanks for taking the questions.

Karen Massey: Thanks for the question.

Karen Massey: We'll take our final question from Douglas Tsao at HC Wainwright.

Douglas Tsao: Just a quick follow up on ITP. I understand you think you have, from a regulatory standpoint, an efficient way to move forward. I'm just curious what feedback you may have gotten from KOLs as well as how you're thinking about the commercial positioning, just given the findings from the prior phase three study in terms of the effect of low dose steroids. Thank you. I'm not sure we understood the question completely because the line was breaking up. Would you mind briefly recapping the question, please? Yeah, sorry. Can you hear me now, Tim? Yep, you can.

Speaker Change: Hi, good morning and thanks for taking the questions. Just a quick follow-up on ITP. I understand you think you have

Speaker Change: From a regulatory standpoint an efficient way to move forward. I'm just curious

Douglas Tsao: I'm not sure we understood the question completely because the line was breaking up. Would you mind briefly recapping the question, please?

Douglas Tsao: yeah sorry can you can you hear me now Tim

Tim Van Hauwermeiren: Okay, so I was just asking, you know, so I understand you believe in ITP that you have an efficient path forward from a regulatory standpoint. I'm just curious in terms of how you're thinking about the product positioning if it has changed since the prior phase three results, and what feedback you may have gotten from KOLs, especially in terms of the efficacy or the apparent efficacy of low dose steroids. Thank you. We got it.

Speaker Change: Yes, we can.

Tim Van Hauwermeiren: Okay, so I was just asking, you know, so I understand you believe in ITP that you have an efficient path forward from a regulatory standpoint. I'm just curious in terms of how you're thinking about the products positioning if it is changed.

Tim Van Hauwermeiren: prior to the prior phase three results and what feedback you may have gotten from KOLs, especially in terms of the efficacy or the apparent efficacy of low-dose steroids. Thank you.

Tim Van Hauwermeiren: So there is quite some excitement in the community about the data which we generated in the clinical trial. In this refractory patient population, which we are targeting and in which we will be positioning third-line right after steroids and TPOs, in that patient population, not much is really working, and we showed, you know, a very high response rate and an unprecedented safety profile. And that is really important for the KOLs. They also continue to call us about how well their patients are doing in the study, the ongoing open-label extension.

Tim Van Hauwermeiren: We got it. So there is quite some excitement in the community about the data which we generated in the clinical trial.

Tim Van Hauwermeiren: In this refractory patient population which we are targeting and in which we will be positioning third line right after steroids and TPOs

Tim Van Hauwermeiren: In that patient population not much is really working and we showed you know a very high response rate and an unprecedented safety profile and that is really important for the KOLs

Tim Van Hauwermeiren: They also continued to call us about how well their patients were doing in the study, their ongoing open label extension. So there was quite some pull from the marketplace, I would say, for this product.

Tim Van Hauwermeiren: So there was quite some pull from the marketplace, I would say, for this product, and I think they were also very collaborative in helping us to think through the proposal we would make vis-à-vis the FDA. So positioning has not changed. KOL feedback is very positive, and that strengthens our determination to go forward.

Tim Van Hauwermeiren: And I think they were also very collaborative in helping us to think through the proposal we would make vis-a-vis the FDA. So positioning has not changed. The feedback is very positive and that strengthens our determination to go forward. Thanks for the question.

Tim Van Hauwermeiren: Thanks for the question. This concludes today's question and answer session and today's conference call. Thank you for your participation. You may now disconnect.

Tim Van Hauwermeiren: This concludes today's question and answer session and today's conference call. Thank you for your participation. You may now disconnect.