Full Year 2024 argenx SE Earnings Call

February 27, 2025

After the Speakers' remarks, there will be a question and answer session. Thank you I'd now like to introduce Beth <unk>, Vice President Corporate Communications and Investor Relations you May begin your conference.

Thank you our press release was issued earlier today with our fourth quarter and full year 2024 financial results and business update this can be found on our website along with the presentation for today's webcast.

Speaker Change: Before we begin on slide two I'd like to remind you that forward looking statements may be presented during this call may include statements about our future expectations clinical development regulatory timelines the potential success of our product candidates financial protections and upcoming milestone actual results may differ materially from those indicated by these stay.

<unk>.

Speaker Change: Dennis is not under any obligation to update statements regarding the future or to conform. These statements in relation to actual results unless required by law I'm joined on the call today by Tim The HERA Marron, Chief Executive Officer, Carl <unk>, Chief Financial Officer, and Karen Matthews, Chief Operating Officer, I will now turn the call over to Tim.

Before we begin on slide two I'd like to remind you that forward looking statements may be presented during this call is made statements about our future expectation clinical development regulatory timelines the potential success of our product candidates financial projections and upcoming milestones actual results may differ materially from those indicated by these data.

Speaker Change: Thank you Beth and welcome everyone.

Speaker Change: I'll begin on slide number three.

Our guidance is not under any obligation to update statements regarding the future or to conform. These statements in relation to actual results unless required by law.

Speaker Change: 2024 will be some nominal used for our journey.

Speaker Change: We expanded our reach to over 10000 patients globally.

Joined on the call today by Tim that her Marron, Chief Executive Officer, Carl <unk>, Chief Financial Officer, and Karen Matthews, Chief Operating Officer, I will now turn the call over to chip.

Speaker Change: Of course, the approved indications.

Speaker Change: And delivered significant impact to the CIBC community early into launch.

Speaker Change: We also achieved several key clinical milestones.

Chip: Thank you Beth and welcome everyone.

And <unk> have joined the ranks of picking them up.

Speaker Change: I'll begin on slide number three.

Speaker Change: Phase III assets, following and persists and amend data.

Speaker Change: 2024 was a phenomenal year for allogeneic, we expanded our reach to over 10000 patients globally.

Speaker Change: And we successfully advanced our Gulf picking them up into larger registration studies following good decisions insurance disease, and three subsets of my sizes.

Speaker Change: I guess three approved indications and delivered significant impact to the CIBC community early into launch.

Speaker Change: Lastly, we continue to drive innovation identifying additional novel targets and eliminating full pipeline molecules.

Speaker Change: We also achieved several key clinical milestones.

Speaker Change: In pottery barn jumped the ranks with Ive got picking them up.

Speaker Change: 50 assets following impressive and amend data entry.

Speaker Change: These accomplishments have laid a robust foundation for our continued momentum into 2025.

Speaker Change: And we successfully advanced our Gulf picking them up into larger registration studies following go decisions and Shoguns disease, and three subsets of my side.

Speaker Change: As we execute across the priorities highlighted on this slide towards our vision 2030, we remain committed to maximizing the growth opportunities ahead of us in a data driven way always prioritizing transformational impact for patients.

Speaker Change: Lastly, we continue to drive innovation identifying additional novel targets and eliminating all pipeline molecules.

Speaker Change: These accomplishments have laid a robust foundation for our continued momentum into 2025.

Speaker Change: Slide number four.

Speaker Change: Let's begin with the commercial opportunity.

<unk> has meaningfully shifted <unk> treatment landscape by setting the standard for rapid deep and sustained efficacy with favorable safety and without tradeoffs on convenience.

Speaker Change: As we execute across our priorities highlighted on this slide towards our vision 2030.

Speaker Change: We remain committed to maximizing the growth opportunities ahead of us in a data driven way always prioritizing transformational impact for patients.

Speaker Change: We look forward to continuing the growth momentum with multiple regulatory milestones and continued data generation supporting earlier use across the treatment paradigm.

Speaker Change: Slide number four.

Speaker Change: Let's begin with the commercial opportunity.

Speaker Change: Pitcock has meaningfully shifted gmg treatment landscape by setting the standard for rapid deep and sustained efficacy with favorable safety and without tradeoffs on convenience.

Speaker Change: The pieces syringe.

Speaker Change: Which opens the door for self administration in the U S is expected to be a key driver of this growth in 2025 for both LNG and <unk>.

Speaker Change: We look forward to continuing the growth momentum with multiple regulatory milestones and continued data generation supporting earlier use across the treatment paradigm.

Speaker Change: It is incredible to see the strong early adoption of this car type trullo in 30 patients.

Speaker Change: Pending the real unmet need still exists.

Speaker Change: The patient syringe, which opens the door for self administration in the U S is expected to be a key driver of this growth in 2025 for both Mg and see IDP.

Speaker Change: And bringing the first major innovation and treatments to CDP patients in over 30 years.

Speaker Change: We have a significant opportunity before us to set a useful treatment standards, but also an important responsibility.

Speaker Change: It is incredible to see the strong early adoption of this got high to low in Sergipe patients.

With a long term commitment we made to the CIP community.

Speaker Change: We will work to continue delivering transformative impact with this car by executing on our loan strategies.

Speaker Change: Underpinning the real unmet need that still exists.

Speaker Change: And bringing the first major innovation in treatment to see ADP patients in over 30 years.

Speaker Change: While generating new evidence to support physician treatment decisions and advance our understanding of the underlying biology of this complex disease.

Speaker Change: Not only have a significant opportunity before us to set the new treatment standards.

Speaker Change: It's also an important responsibility with a long term commitment we made to the <unk> community.

Speaker Change: This commitment informed our decision to run the IV <unk> switch study soon after launch to help inform treatment decisions, especially with the recognition that over 80% of patients the IV <unk> experience.

Speaker Change: We will work to continue delivering transformative impact with that gap right.

Speaker Change: Executing on our loan strategies, while generating new evidence.

Speaker Change: Imports physician treatment decisions and advance our understanding of the underlying biology of this complex disease.

Speaker Change: It was also the impetus to advance our first in class II inhibitors into a registration study in CIBC.

Speaker Change: This commitment informed our decision to run the IV <unk> switch study soon after launch to help inform treatment decisions, especially with recognition that over 80% of patients the IV <unk> experience.

Speaker Change: We're confident that we.

Speaker Change: Have a unique opportunity to drive meaningful impact across two molecules.

Speaker Change: Slide five.

Speaker Change: Our disciplined approach to scaling will be critical to navigating the full opportunity across our pipeline.

Speaker Change: It was also the impetus to advance our first in class II inhibitors into a registration study in CIBC.

Speaker Change: This year, we look forward to advancing 10 phase three studies and some proof of concept studies.

Speaker Change: We are confident that we have a unique opportunity to drive meaningful impact across two molecules.

Speaker Change: Cros are got pick them up and pass it Reebok and authentic spun one line.

Speaker Change: We are leading in new field of medicine, and Epsilon pushing the boundaries of its potential with the broadest development plan.

Speaker Change: Slide five.

Speaker Change: Our disciplined approach to scaling will be critical to navigating the full opportunity across our pipeline.

Speaker Change: Our Registrational studies in my guidance.

Speaker Change: This year we.

Speaker Change: We look forward to advancing 10 phase three studies and 10 proof of concept studies across a got pick them up and partially for box.

Speaker Change: Sugars and ICP are built on established proof of concept with additional proof of concept studies in systemic sclerosis, EMR and lupus nephritis running in parallel.

Speaker Change: <unk> online.

We are leading in new field of medicine and Epsilon.

Speaker Change: Each of these is grounded in solid biology, with the potential to drive some meaningful impact in high unmet need areas.

Speaker Change: Pushing the boundaries of its potential with the broadest development plan.

Speaker Change: Our Registrational studies in mice Itis E.

Speaker Change: Our first in class <unk> inhibitor and possibly per box is following the same innovation playbook as a captive <unk> model.

Speaker Change: E D sugars and ICP are built on established proof of concept.

Speaker Change: Additional proof of concept studies in systemic sclerosis.

Speaker Change: The phase II auto data and Edelman were impressive with 94% of patients reporting improvement on <unk> compared to <unk>.

Speaker Change: And lupus nephritis running in parallel.

Speaker Change: Each of these is grounded in solid biology.

Speaker Change: With the potential to drive some meaningful impact in high unmet need areas.

Speaker Change: We see an opportunity to disrupt a blockbuster markets, bringing transformative benefits to patients with element and now CIBC as well, which is why we are exploring both indications in registrational head to head studies versus <unk>.

Speaker Change: Our first in class II inhibitors, and possibly per box is.

Speaker Change: Following the same innovation playbook as a captive <unk> model.

The phase II auto data in Edelman were impressive with 94% of patients reporting improvement on embark compared to IV AIG.

Speaker Change: And this is just scratching the surface of the broad potential opportunity ahead for <unk>.

We see an opportunity to disrupt a blockbuster markets, bringing transformative benefits to patients with <unk> and now with CIBC as well, which is why we are exploring both indications in registrational head to head studies versus IV AIG.

Speaker Change: To bring a safe treatment option forward in diseases, where the lectern and classical pathways product play.

Speaker Change: Lastly, we look forward to the first proof of concept data from our third molecule <unk> one line in CMS.

Speaker Change: And this is just scratching the surface of the broad potential opportunity ahead for <unk> and Bob.

Speaker Change: By co, creating with world experts in muscle biology, we have built a molecule that has the potential to alleviate diseases.

Speaker Change: To bring a safe treatment option forward in diseases, where the lectern and classical pathways are at play.

Speaker Change: Mark by impaired neuromuscular synaptic function.

Speaker Change: The CMS data in the second half of the year is the first opportunity to assess.

Speaker Change: Lastly, we look forward to the first proof of concept data from our third molecule <unk> hundred one line in CMS.

Speaker Change: Our clinics one one line is doing what it's supposed to do clinically which will further help us assess the opportunity ahead in SMA and <unk>.

Speaker Change: By co, creating with world experts in muscle biology.

Speaker Change: <unk> built a molecule that has the potential to alleviate diseases hallmark by impaired neuromuscular synaptic function.

Speaker Change: Slide six.

Speaker Change: We had a robust unit activity and have an IP, eliminating four new molecules that we are now advancing into phase one development.

Speaker Change: The CMS data in the second half of the year is the first opportunity to assess whether our Genesis one more line is doing what it's supposed to do clinically which will further help us assess the opportunity ahead in SMA and <unk>.

These molecules, including a second FC <unk> inhibitors are Gen X too lumpy.

Speaker Change: These sweeping antibody and an anti IL six all have significant therapeutic potential across new autoimmune indications.

Speaker Change: Slide six.

Speaker Change: We had a robust unit activity and have an IP, eliminating four new molecules that we are now advancing into phase one development.

Speaker Change: Our <unk> is an incredible productive innovation engine and we have nearly 20 active programs into discovery stages across many relevant disease areas that will continue to feed our future pipeline.

Speaker Change: These molecules, including a second FC <unk> inhibitors <unk> one fee.

Speaker Change: These sweeping antibody and an anti IL six all have significant therapeutic potential across new autoimmune indications.

Speaker Change: 2025 will be our first year as a profitable company, which is an important achievement and a reflection of our commercial success.

Speaker Change: Our relentless execution and our commitment to scale innovation in a disciplined way.

Speaker Change: We have a long term growth vision that is directly influenced by our ability to continue to innovate.

Speaker Change: To stay ahead of competition and to leverage our financial strength.

Speaker Change: 2025 will be our first year as a profitable company, which is an important achievement and a reflection of our commercial success.

Speaker Change: Investing in mobile pockets and pipeline programs.

Speaker Change: It will be the most impactful to patients.

Speaker Change: This is the future we are building with vision 2030, and well beyond.

Speaker Change: Our relentless execution and our commitment to scale innovation in a disciplined way.

Speaker Change: I will now turn the call over to Carl to discuss our financial position in greater detail.

Speaker Change: We have a long term growth vision that is directly influenced by our ability to continue to innovate to stay ahead of competition and to leverage our financial strength by investing in novel targets and pipeline programs.

Carl: Thank you Tim Slide seven.

Carl: Fourth quarter and full year 2024 financial results are detailed in the press release of this morning.

Speaker Change: It will be the most impactful to patients.

Carl: Product net sales are consistent with our pre announcement in January at 737 million for Q4, and $2 2 billion for the full year.

Speaker Change: This is the future we are building with vision 2030, and well beyond.

Carnival: I will now turn the call over to carnival to discuss our financial position in greater detail.

Carl: This brings total operating income in the fourth quarter to $761 million and $2 3 billion for full year.

Carnival: Thank you Tim Slide seven.

Carnival: Fourth quarter and full year 2024 financial results are detailed in the press release of this morning.

Carl: The product net sales represents 29% quarter over quarter growth and 98% growth compared with the same quarter from the prior year.

Carnival: Product net sales are consistent with our pre announcement in January at 737 million for Q4, and $2 2 billion for the full year.

Carl: The product revenue breaks down by region grew $649 million in the U S $27 million in Japan.

Carnival: This brings total operating income in the fourth quarter to $761 million and $2 3 billion for the full year.

Carl: The $9 million and the rest of the world and $12 million in product supply desired App in China.

Carnival: The product net sales represents 29% quarter over quarter growth of 98% growth compared to the same quarter from prior year.

Carl: Gross to net in the U S continues to be around 12%.

Carl: In 2025, we expect the dynamics will change due to self administration.

Carnival: The product revenue breaks down by region to $649 million in the U S $27 million in Japan.

Carl: <unk> and an increase in gross to net which will be offset by increased patient numbers.

Carnival: $9 million and the rest of the world and $12 million in product supply design lapping China.

Carl: Slide.

Carl: Cost of sales of $73 million in Q4, and $227 million over full year, representing a gross margin of 90%.

Carnival: Gross to net in the U S continues to be around 12%.

Carnival: In 2025, we expect the dynamics will change due to sales administration.

Carl: This is consistent with prior quarters, because supply chain efficiencies.

Carnival: <unk> and an increase in gross to net which will be offset by increased patient numbers.

Carl: Offset by growth from the core side through low which has a higher cost due to hand assignment royalties.

Carnival: Next slide.

Carnival: Cost of sales or $73 million in Q4, and $227 million over full year, representing a gross margin of 90%.

Carl: For combined R&D and SG&A expenses totaled <unk> 2 billion for the full here.

Carl: This is aligned with our financial guidance for 2024.

Carnival: This is consistent with prior quarters, because supply chain efficiencies.

Carl: Total operating expenses in Q4 or $658 million, an increase of $83 million compared with Q3 2024.

Carnival: Offset by growth from <unk> through low, which has a higher cost due to heather's diamond royalties.

Carnival: The combined R&D and SG&A expenses totaled $2 billion over full year.

Carl: The increase is primarily due to a $61 million increase in R&D, reflecting our capital allocation strategy of investing in innovation.

Carnival: <unk> is aligned with our financial guidance for 2024.

Carnival: Total operating expenses in Q4 of $658 million, an increase of $83 million compared with Q3 2024.

Carl: This results in an operating profit for Q4 of underpinned 3 million.

Carl: Operating loss for the full year of $22 million.

Carl: Our quarterly financial income is $39 million and in the quarter, we incurred exchange losses of $55 million, mainly related to unrealized FX formula known.

Carnival: Increase is primarily due to a $61 million increase in R&D, reflecting our capital allocation strategy.

Carnival: <unk> innovation.

Carnival: This results in an operating profit for Q4 of <unk> 3 million.

Carl: Non U S denominated cash balances.

Carl: Income tax is a benefit of $688 million in Q4, and a benefit of $748 million for the full year.

Carnival: Operating loss for the full year of $22 million.

Carnival: Our quarterly financial income is $39 million and in the quarter, we incurred exchange losses of $55 million mainly.

Carl: This is due to recognition of a deferred tax benefit of.

Carnival: Mainly related to unrealized FX one of our non.

$802 million for the full year ended December 31 2024.

Carnival: Non U S denominated cash balances.

Carl: Of which 725 million relates to a one time nonrecurring recognition.

Carnival: Income tax is a benefit of $688 million in Q4, and a benefit of $748 million for the full year.

Carl: Previously unrecognized deferred tax assets existing as of December 31st 2020 feet.

Carnival: This is due to recognition of a deferred tax benefit of $802 million for the full year ended December 31 2024.

Carl: We made the decision to recognize the deferred tax assets because of our assessment, but its probable but future taxable profits will be available.

Carnival: Which 725 million relates to a one time nonrecurring recognition of previously unrecognized deferred tax assets existing as of December 31st 2023.

Carl: This results in profit in Q4 of $774 million in profit for the full year of $833 million.

Carl: Our cash balance represented by cash cash equivalents and current financial assets is.

Carnival: We made the decision to recognize the deferred tax assets because of our assessment, but it's probable that future taxable profits will be available.

Carl: $3 4 billion at year end.

Carl: Our balance increased by $200 million in 2024.

This results in profit in Q4 of $774 million.

Carl: Our opex guidance for 2025 is approximately $2 5 billion.

Carnival: And profits we were for the full year of $833 million.

Carl: Combined R&D and SG&A expenses.

Carnival: Our cash balance.

Carnival: Presented by cash cash equivalents and current financial assets is $3 4 billion at year end.

Carl: This is a 25% increase year over year and reflects our commitment to invest in our R&D engine and pipeline growth.

Carnival: Balance increased by $200 million in 2024.

Carl: Zooming out we are well positioned to prioritize innovation that will support our sustainable future.

Carnival: Our opex guidance for 2025 is approximately $2 $5 billion of.

Carl: Strong balance sheet and transition to profitability in 2025.

Combined R&D and SG&A expenses.

This is a 25% increase year over year and reflects our commitment to invest in our R&D engine and pipeline growth.

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

Karen Matthews: Thank you Carl Slide nine.

Speaker Change: I wanted to start by building on what both Tim and Karl have shed, which is the importance of innovation to <unk>. It's the driving force behind everything we do and we all agree that innovation only matters if it reaches patients and provides meaningful benefits.

Carnival: Zooming out we are well positioned to prioritize innovation that will support our sustainable future.

Strong balance sheet and transition to profitability in 2025.

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

Speaker Change: And looking back at the fourth quarter and of all of last year I'm pleased with the continued momentum we saw from the team and bringing meaningful innovation to patients.

Thank you Carl Slide nine.

Speaker Change: I wanted to start by building on what Tim and Karl have shared which is the importance of innovation to our Gen X.

Speaker Change: Our growth was fueled by both MGE and see ADP and it's encouraging to see how they've got continues to transform outcomes as we broaden and deepen our reach in EMG community.

Speaker Change: The driving force behind everything we do and we all agree that innovation only matters if it reaches patients and provides meaningful benefits.

Speaker Change: And it just two quarters into the sea IDP launch, we're already raising the bar on what patients can demand from net treatment.

Speaker Change: And looking back at the fourth quarter and of all of last year I am pleased with the continued momentum we saw from the team in bringing meaningful innovation to patients.

Speaker Change: On today's call I'll take a deeper dive into our performance highlighting the drivers that will support our continued growth and patient impact.

Speaker Change: Our growth was fueled by both Mg NC IDP and it's encouraging to see how they've got continues to transform outcomes as we broaden and deepen our reach in the Mg community and at just two quarters into the <unk> launch we're already raising the bar on what patients can demand from that treatment.

Speaker Change: Next slide.

Speaker Change: We continue to deliver growth in the Mg in the fourth quarter, driven by consistent patient adds and new prescribers.

Speaker Change: They've got high school has played a key role in reaching patients earlier in the treatment paradigm and predominantly inpatients brand needed they've got rather than switches from IV.

Speaker Change: On today's call I'll take a deeper dive into our performance highlighting the drivers that will support our continued growth and patient impact.

Speaker Change: Some additional growth was supported by a halo effect from the CIP launch, where we saw neurologists, who first write scripts <unk> now also prescribing in Mg.

Speaker Change: Next slide.

Speaker Change: We continue to deliver growth in the Mg in the fourth quarter, driven by consistent patient adds and new prescribers.

Speaker Change: To maintain our leadership as the number one prescribed branded biologic in MG we are prioritizing the anticipated launch of the pre filled syringe and continuing to invest in generating new evidence, including true label extension studies.

Speaker Change: <unk> got high coolant played a key role in reaching patients earlier in the treatment paradigm and predominantly in patient brand, new they've got rather than switches from IV.

Speaker Change: Some additional growth was supported by a halo effect from the CDP launch, where we saw neurologists to first write scripts in CIP now also prescribing in Mg.

Speaker Change: We have a long term strategy to enable continued adoption of they've got in earlier treatment lines and this remains a key focus.

Speaker Change: They've got consistently strong safety and efficacy profile support this goal, particularly as physicians gain more experience with the treatment and we'll further build this confidence by investing in evidence generation.

Speaker Change: Real World data efforts are underway to evaluate reduction in steroid use safety and new patient populations and dosing through our depth next study, which we plan to share at upcoming medical conferences.

Speaker Change: We have a long term strategy to enabled continued adoption of they've got in earlier treatment lines and this remains a key focus.

Speaker Change: Innovation on route of administration will also support our shift earlier in the treatment paradigm.

Speaker Change: And the pre filled syringe is a key step towards expanding our patient reach.

Speaker Change: Real World data efforts are underway to evaluate reduction in steroid use safety and new patient populations and dosing through our debt mix study, which we plan to share at upcoming medical conferences.

Speaker Change: The opportunity to self inject at home is a significant innovation for patients and provides an added level of freedom and that treatment regime.

Speaker Change: We're thrilled to have received our first global approval of they've got pre filled syringe. This month in the EU for Gmg patients and were now looking ahead to the FTA producer date in April so both MGE and <unk>.

Speaker Change: Innovation on route of administration will also support our shift earlier in the treatment paradigm.

Speaker Change: And the pre filled syringe is a key step towards expanding our patient reach.

Speaker Change: Lastly, we see additional opportunity to address the unmet need in the Mg community by expanding our label interferon negative and ocular Mg.

Speaker Change: The opportunity to self inject at home is a significant innovation for patients and provides an added level of freedom and that treatment regime.

Speaker Change: We're thrilled to receive our first global approval of they've got pre filled syringe. This month in the EU for Gmg patients and were now looking ahead to the FDA produced to date in April for both MGE and CIP.

Speaker Change: <unk> is the first of our phase III studies to read out this year, and we have ample real world and clinical dataset supporting our ability to drive responses in this population.

Speaker Change: Ocular Mg presented another exciting opportunity and with 80% of patients progressing to generalized Mg we have the potential to introduce innovation earlier in the treatment paradigm.

Speaker Change: Lastly, we see additional opportunity to address the unmet need in the Mg community by expanding our label into seronegative and ocular Mg.

Speaker Change: <unk> is the first of our phase III studies to read out this year and we have ample real world and clinical data sets supporting our ability to drive responses in this population.

Speaker Change: Next slide.

Speaker Change: We're very encouraged by the continued momentum of the <unk> got high to low launch in CIP.

Speaker Change: Abundantly clear that our data are resonating across patients and physicians with the initial demand highlighting the unmet need for safe and effective treatment alternatives.

Speaker Change: Ocular Mg presents another exciting opportunity and with 80% of patients progressing to generalized Mg we have the potential to introduce innovation earlier in the treatment paradigm.

Speaker Change: One patient shared that she had tried nearly all available CIP treatments and they all failed.

Speaker Change: Next slide.

Speaker Change: We're very encouraged by the continued momentum of the <unk> got high to low launch in CDP.

Speaker Change: She was left with a heavy treatment burden of plasmapheresis every seven to 14 days her physician with dedicated to improving this burden and suggested a switch to they've gone hydrilla.

Speaker Change: Abundantly clear that our data are resonating across patients and physicians with the initial demand highlighting the unmet need for safe and effective treatment alternatives.

Speaker Change: She was initially very hesitant, but at the same improvement she realized she had massively underestimated the disease burden she had still been facing.

Speaker Change: One patient shared that she had tried nearly all available C IDP treatments and they all fail.

Speaker Change: Even as functional as she was it wasn't until they've got high trullo that she felt the enormous balder lifted off her back.

Speaker Change: While these patients improvement was dramatic this is just one of the many inspiring stories from patients and their caregivers, who are empowered to demand more from their treatment.

Speaker Change: She was initially very hesitant, but after seeing the improvements she realized she had massively underestimated the disease burden she had still been facing.

Speaker Change: I'm incredibly proud of the team to building a solid foundation to get us off to a strong start to ultimately reach our target addressable population of 12000 patients.

Speaker Change: Even as functional as she was it wasn't until <unk> got high trullo that she felt the enormous balder lifted off her back.

Speaker Change: Our market access team has done a phenomenal job securing broad access.

Speaker Change: While these patients improvement was dramatic this is just one of the many inspiring stories from patients and caregivers, who are empowered to demand more from their treatment.

Speaker Change: For patients getting on treatment quickly the salesforce expansion further enabled us to successfully reach new prescribers deeper into the community setting and it paid off 25% of prescribers over the last quarter with first time they've got users.

Speaker Change: Incredibly proud of the teams are building a solid foundation to get us off to a strong start to ultimately reach our target addressable population of 12000 patients on <unk>.

Speaker Change: As of yearend, we had approximately 1000 patients on treatment with the majority of these falling within our initial addressable population those who are not sufficiently controlled for all who experienced side effects on IV AIG or steroids.

Speaker Change: Market access team has done a phenomenal job securing broad access to support patients getting on treatment quickly. The sales force expansion further enabled us to successfully reach new prescribers deeper into the community setting and it paid off 25% of prescribers over the last quarter with first time they've got users.

Speaker Change: Most urologists, who treat patients for 12 weeks to assess this response to they've got so we look forward to gaining more insight on response rates and utilization in the coming quarters.

Speaker Change: As of yearend, we had approximately 1000 patients on treatment with the majority of these falling within our initial addressable population those who are not sufficiently controlled to all who experienced side effects on IV AIG or steroids.

Speaker Change: We're just at the beginning.

Speaker Change: Our priority this year will be to reach more patients and more prescribers and repeat the <unk> playbook to consistently generate data to build physician support of hydro low while also empowering patients to ask for more from this the IDP treatment.

Speaker Change: Most of urologists will treat patients for 12 weeks to assess this response to they've got so we look forward to gaining more insight on response rates and utilization in the coming quarters.

Speaker Change: Next slide.

Speaker Change: We also look forward to additional expansion opportunities outside the U S EPA, particularly as we plan to launch the Prefilled syringe and see IDP in multiple regions.

Speaker Change: We're just at the beginning.

Speaker Change: Our priority this year will be to reach more patients and more prescribers and repeat the Mg playbook to consistently generate data to build physician supported by trullo. While also empowering patients to ask for more from this the IDP treatment.

Speaker Change: In Mg we have launched in most of the major markets ex U S and expect consistent steady growth over time as market access dynamics fall into place.

Speaker Change: We're now reimbursed in 13 countries in Europe, including four out of the five major markets.

Speaker Change: Next slide.

Speaker Change: We also look forward to additional expansion opportunities outside the U S. This year, particularly as we plan to launch the Prefilled syringe NCI DP in multiple regions.

Speaker Change: And we're pleased with the recent MTA approval in South Korea, and one that is personally very close to my heart Australia.

Speaker Change: Earlier I highlighted the positive see HMP opinion on PFS, enabling sales in the EU.

Speaker Change: In Mg we have launched in most of the major markets ex U S and expect consistent steady growth over time as market access dynamics fall into place.

Speaker Change: And this is just the first of four regulatory decision on approval this year.

Speaker Change: We're now reimbursed in 13 countries in Europe, including four out of the five major markets.

Speaker Change: We adjusted the beginning of that global Sea IDP launch with additional decisions on approval expected in China, Europe and Canada.

Speaker Change: And we're pleased with the recent MTA approvals in South Korea, and one that is personally very close to my heart Australia.

Speaker Change: Feedback from Japan, the first approval following the U S has been positive across patients and physicians in the sea IDP community.

Speaker Change: Earlier I highlighted the positive see HMP opinion on PFS, enabling sales in the EU and.

Speaker Change: Next slide.

Speaker Change: And this is just a first a full regulatory decisions on approval this year.

Speaker Change: Our expansive pipeline supports our next wave of growth and we're committed to addressing the unique challenges and gaps in treatment for autoimmune patients across multiple indications, where there is often a lack of innovation and high barriers to access.

Speaker Change: We adjusted the beginning of a global see IDP launch with additional decisions on approval expected in China, Europe and Canada.

Speaker Change: Feedback from Japan, the first approval following the U S has been positive across patients and physicians in the <unk> community.

Speaker Change: We built a robust network of relationships in the neurology community with over 3500, they've got prescribers, which will leverage as we advanced each of our next launch wave with zero negative and ocular Mg.

Speaker Change: Next slide.

Speaker Change: The impressive data from the honest studying mmm for impasse approve us have already drawn attention from a prescriber base, where there is a lot of overlap, we see IDP and empty.

Speaker Change: We built a robust network of relationships in the neurology community with over 3500, they've got prescribers, which will leverage as we advance into our next launch wave with zero negative and ocular Mg.

Speaker Change: I sure Timothy excitement about <unk> and about <unk> and our opportunity to transform the treatment paradigm.

Speaker Change: We see <unk> as a nascent market ripe for innovation similar to the initial dynamics, we saw with Mg patients.

Speaker Change: The impressive data from the honest studying mmm for impasse approved but have already drawn attention from a prescriber base, where there is a lot of overlap we see IDP and Mg.

Speaker Change: <unk> to be discouraged with the symptom burden and lack of treatment options for the phase III data in 2026 will be a big moment for us to potentially introduce the first precision treatment to this community.

I sure Timothy excitement about impart to prove up and about <unk> and our opportunity to transform the treatment paradigm.

Speaker Change: Looking ahead, we see an opportunity with <unk> got in my sinus to serve as a bridge from neurology into rheumatology, we subtypes across both therapeutic areas.

Speaker Change: We see <unk> as a nascent market ripe for innovation similar to the initial dynamics, we saw with Mg patients.

Speaker Change: Patients continue to be discouraged with the symptom burden and lack of treatment options. So the phase III data in 2026 will be a big moment for us to potentially introduce the first precision treatment to this community.

Speaker Change: We aim to leverage our neurology playbook as we expand into rheumatology building on the traction we've already gained into community. Following our decision to advance <unk> into a registrational study.

Speaker Change: All in all this is an exciting time for our <unk> across our entire business as we progress towards our vision 2030, Tim.

Speaker Change: Looking ahead, we see an opportunity with <unk> got in my side is to serve as a bridge from neurology into rheumatology with sub types across both therapeutic areas.

Tim Marron: Thank you Karen Slide 14.

Speaker Change: We aim to leverage on urology playbook as we expand into rheumatology building on the traction we've already gained in the community following our decision to advance <unk> into a registrational study.

Tim Marron: I want to extend my sincere appreciation to the organics team, including our board for their outstanding work last year and the unwavering dedication to improving the lives of patients.

Speaker Change: All in all this is an exciting time for our <unk> across our entire business as we progress towards our vision 2030, Tim.

Tim Marron: We have deliberately set a very high bar and as we move forward.

Tim Marron: Critical to our continued innovation in the autoimmune space maintains its best in class standards.

Tim: Thank you Kevin Slide 14.

Tim: Want to extend my sincere appreciation to the organics team, including our board for their outstanding work last year and their unwavering dedication to improving the lives of patients.

Tim Marron: 2025 will be a year of significant growth for us.

Tim Marron: Spanning our commercial reach and introducing new products.

Tim Marron: In your markets.

Tim Marron: And advancing our late stage pipeline.

Tim: We have deliberately set a very high bar and as we move forward. It's critical to our continued innovation in the autoimmune space maintained this best in class standards.

Tim Marron: Importantly, we never lose sight of our mission.

Tim Marron: Promising innovation to develop transformative medicines for the patients we serve.

Tim: 2025 will be a year of significant growth for us expanding our commercial reach and introducing new products and.

Tim Marron: Thank you for your time today.

Tim Marron: 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 would like to ask a question. Please press star one on your telephone keypad to raise your hand to join the queue. If you would like to withdraw your question simply press Star. One again, we ask that you. Please limit yourself to one question and one follow up. Your first question comes from the line of <unk> from Bank of America.

Tim: Entering new markets and advancing our late stage pipeline.

Tim: Importantly, we never lose sight of our mission.

Tim: <unk> innovation to develop transformative medicines for patients we serve.

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

Tim Marron: Your line is open.

Speaker Change: Hi, good morning, Thanks for taking my questions.

Speaker Change: Mine are going to be on the PFS upcoming <unk>.

Speaker Change: So maybe for Karen can you talk about how youre seeing with <unk>.

Speaker Change: Would like to withdraw your question simply press Star one again, we ask that you. Please limit yourself to one question and one follow up. Your first question comes from the line of <unk> Ahmad from Bank of America. Your line is open.

Speaker Change: Pent up demand there could be for PFS or their patients that have.

Speaker Change: <unk> not gone on to therapy, knowing that there potentially could be this convenient option.

Speaker Change: Youre looking for switches to a car with that be.

Ahmad: Hi, good morning, Thanks for taking my questions.

Speaker Change: Mine are going to be on the PFS.

Speaker Change: Gradually or would that be at all or is the fact that we should see upon approval and then I have a follow up.

Ahmad: Coming to do.

Speaker Change: So maybe for Karen can you talk about how youre seeing with <unk>.

Speaker Change: Yeah. Thanks for the question to the entity interests.

Speaker Change: Pent up demand there could be for PFS or their patients that have.

Speaker Change: We are excited for the upcoming PFS producer date in April and potential approval. So here's what I would say I don't think were seeing pent up demand in fact, I'm quite pleased with the momentum we've seen on Mg NC IDP in terms of new patient starts it's pretty consistent.

Speaker Change: <unk> gone on to therapy, knowing that there potentially could be this convenient option.

Speaker Change: Youre looking for switches to occur with that.

Speaker Change: Gradually or would that be a Paul was the fact that we should see upon approval and then I have a follow up.

Speaker Change: But what we do expect is the pre filled syringe for self injection will open up both the prescriber base and the patients.

Speaker Change: Yes, thanks for the question to the enter the interest.

Speaker Change: Excited for the upcoming PFS <unk> date in April and potential approval, so here's what.

Speaker Change: That will can sit up they've got as an option for either Mg <unk>. So we think one of them will enable us to do is maintain that consistent momentum and that consistent growth, which is pretty incredible as we get 13 quarters outcome from launch and I think thats, what the innovation allows us to do it's not specifically a switch strategy that.

Speaker Change: I would say I don't think were seeing pent up demand in fact, I'm quite pleased with the momentum we've seen on Mg NC IDP in terms of new patient starts, it's pretty consistent and but what we do expect is the pre filled syringe for self injection will open up both the prescriber base and the pay.

Speaker Change: Pursuing to the second part of the question that you asked rather we want to focus on expanding outreached to prescribers and to patients. Thanks for the question I think you had a follow up yeah, either for you or Tim how should we be thinking about just generally pricing was for PFS would it be similar to the current options available.

Speaker Change: <unk>.

Speaker Change: That will consider they've got as an option for either Mg <unk>. So we think one of them will enable us to do is maintain that consistent momentum and that consistent growth, which is pretty incredible as we get 13 quarters out from launch and I think thats, what the innovation allows us to do it is not specifically a switch strategy.

Speaker Change: Should we expect any kind of impact.

Speaker Change: We're pursuing to the second part of the question that you asked rather we want to focus on expanding outreached to prescribers and to patients. Thanks for the question I think you had a follow up either for you or Tim how should we be thinking about just generally pricing for PFS would it be similar to the current options available.

Speaker Change: <unk>. Thank you for your questions and.

Speaker Change: Consistent with prior launches, we will provide more color on the price at the time of launch, but let's provide some framework.

Speaker Change: Think about it we will be bringing important innovation to patients.

Speaker Change: Primary goal is to provide broad access and optionality to patients and physicians to choose on what's best for them.

Speaker Change: Or should we expect any kind of difference.

Speaker Change: Hi, <unk>. Thank you for your questions.

Speaker Change: And of course, we will aim to price in a responsible and sustainable way forward again. Thank you for your question.

Speaker Change: Shifting to a prior launches we will provide more color.

Speaker Change: On the price at the time of the launch, but let's provide some framework on how we think about it we will be bringing important innovation to patients and our primary goal is to provide broad access and optionality to patients and physicians to choose on what's best for them.

Speaker Change: Your next question comes from the line of Alex Thomson from Stifel. Your line is open.

Alex Thomson: Hey, great. Thanks for taking my questions and congrats on the quarter I guess as a follow up to that question for Carl you've talked about sort of net price impact with a PFS I guess can you talk a little bit more about <unk>.

Speaker Change: And of course, we will aim to price in a responsible and sustainable way from an organics.

Alex Thomson: Magnitude there and also the rate of some kind of an impact like that you would expect to see.

Speaker Change: For your question.

Alex Thomson: Our next question comes from the line of Alex Thomson from Stifel. Your line is open.

Alex Thomson: Upon launch this year thanks.

Alex Thomson: Okay.

Speaker Change: Hey, great. Thanks for taking my questions and congrats on the quarter I guess as a follow up to that question for Carl you've talked about sort of net price impacts with the PFS I guess can you talk a little bit more about potential magnitude there and also the rate of some kind of an impact like that where you would expect to see.

Alex Thomson: Thank you for your question Alex Yes, the dynamics for self administration and this is based on the FDA approval subject to FDA approval of self administration of course, we will.

Alex Thomson: Be different and gross to net will increase.

Alex Thomson: Currently it's around 12% with a majority of patients currently in Medicaid medical benefit part B, four bravos with growth where self administration.

Upon launch this year thanks.

Alex Thomson: Okay.

Alex Thomson: Thank you for the question Alex Yes, the dynamics for self administration and vessels based on FDA approval subject to FDA approval of self administration of course.

Patients will transition to pharmacy benefit on Medicare part D for Delta.

Alex Thomson: Will be different and gross to net will increase.

Alex Thomson: You will then get the typical rebates for pharmacy benefit, which will be higher than what we see today.

Alex Thomson: Currently it's around 12%.

Alex Thomson: And of course, we will be subject to iras redesign we're from manufacturer S. Good 'twenty.

Alex Thomson: Majority of patients currently in Medicaid and medical benefit part B for Bravo with growth where self administration.

Alex Thomson: 20% of our cost post catastrophic on Medicare part D patients all of that will result in a higher gross to net we would of course expect that increased patient volumes will offset the increase in gross to net and over time you will also.

Alex Thomson: The patients will transition to pharmacy benefit on Medicare part D for Delta.

Alex Thomson: You will then get the typical rebates for pharmacy benefit, which will be higher than what we see today and of course, we will be subject to iras redesign with the manufacturer.

Alex Thomson: It is likely that the dba's will be phasing out. Thank you for your question.

Alex Thomson: 20%.

Alex Thomson: All of our cost post catastrophic on Medicare part D patients all of that will result in a higher gross to net.

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

Alex Thomson: We would of course expect but increased patient volumes will offset the increase in gross to net and over time, you will also see likely but that the bbva's will be phasing out. Thank you for your question.

Speaker Change: Hey, good morning, and thanks for taking the questions just one from US I guess, how should we think about the quarter over quarter growth cadence in Mg in 2025.

Speaker Change: Relative to what we saw in 2004, and then ultimately in <unk> should we expect some seasonal impacts.

Alex Thomson: Our next question comes from the line of Derek <unk> from Wells Fargo. Your line is open.

Speaker Change: Yeah. Thanks for the question Derek.

Speaker Change: I'm happy to take it so.

Derek: Hey, good morning, and thanks for taking the questions just one from us.

Speaker Change: What what I, how I would think about it is what I was mentioning before in MG continued momentum and continued strong uptake in line with the strategy that we have is moving early align in the treatment paradigm and broadening the prescriber base.

Derek: Should we think about the quarter over quarter growth cadence in Mg in 2025.

Derek: Relative to what we saw in 'twenty four and then ultimately in <unk> should we expect some seasonal impacts.

Speaker Change: Well I would expect that those underlying dynamics will continue specifically to your question on Q1.

Derek: Yes, thanks for the question Derrick as Karen I'm happy to take it so.

Speaker Change: Q1 seasonality is an effect that is seen across the industry.

Derek: What what I, how I would think about it is what I was mentioning before in MG continued momentum and continued strong uptake in line with the strategy that we have is moving early align in the treatment paradigm and broadening the prescriber base.

Speaker Change: And don't forget with last year, we had our Q1 growth rate of 6%. So we are doing seeing the benefit verifications that is an industry wide phenomenon.

Derek: I would expect that those underlying dynamics will continue specifically to your question on Q1.

Speaker Change: So take that into consideration, perhaps in Q1, but overall, what we're seeing is continued momentum in our underlying dynamics are good.

Derek: Q1 seasonality is an effect that is seen across the industry.

Speaker Change: Thank you.

Derek: And don't forget we last year, we had our Q1 growth rate of 6%. So we are doing seeing the benefit verifications that is an industry wide phenomenon. So take that into consideration, perhaps the Q1, but overall what we're seeing is continued momentum in our underlying dynamics.

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

Speaker Change: Great.

Speaker Change: A couple of questions.

Speaker Change: 144, Carl the when the Vps expire because of part D. How does that work I assume excess space.

Derek: Good.

Speaker Change: Stays the same or do you need to renegotiate and then for Karen for the first 12 weeks and CDP, our physician is actually doing the <unk>.

Derek: Thank you.

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

Derek: Great.

Speaker Change: Really looking at I've actually assessing formerly whether patients are improving where I imagine, they're just keeping them on therapy and if they are really not benefit they'll take them off thank you.

Speaker Change: Couple of questions.

Speaker Change: 144, Carl when the Vps expire because of part D. How does that work I assume excess stay.

Speaker Change: Thank you for your question on the VBA.

Speaker Change: Stays the same we'll need to renegotiate and then for Karen for the first 12 weeks and CDP, our physician is actually doing and Ken.

Speaker Change: With PFS of course, we will have to go back and the payer agreements will have to be established.

Speaker Change: Really looking at it.

Speaker Change: And we've done that now a couple of times and we need to do it again and acid as a pharmacy benefit our expectation is that the ppas will not be part of those.

Speaker Change: We will be assessing formerly whether patients are improving where I imagine, they're just keeping them on therapy and if they are really not benefit they'll take them off thank you.

Speaker Change: Contacts and so therefore, it will phase out over time.

Speaker Change: Thank you for your question Andre Vba's.

Speaker Change: Thank you for your question.

Speaker Change: With PFS of course, we will have to go back and the payer agreements, we will have to be established.

Colin: Thanks Colin.

Colin: And yes on the question of US. So we are seeing we see IDP, but it's generally doctors are giving us more like a 12 week trial as you as you mentioned, we're not hearing about a lot of use of <unk> and those types of scale, they're more used in clinical trials that in clinical practice.

Speaker Change: We've done that now a couple of times and we need to do it again and acid as a pharmacy benefit.

Speaker Change: Expectation these with Dba's will not be part of those.

Speaker Change: Contracts and so therefore, it will phase out over time.

Excuse me, Sir more generally the doctors will have a conversation with their patient they are using more simple assessments to determine how they how they diseases being controlled by they've got and then making US an assessment on response.

Speaker Change: Thank you for your question.

Speaker Change: Thanks Colin.

Speaker Change: On the question of US. So we are seeing we see IDP that it's generally doctors are giving more like a 12 week trial as you as you mentioned, we're not hearing about a lot of use of <unk> and those types of scale, they're more used in clinical trials that in clinical practice.

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

Speaker Change: Excuse me Sir.

Hi, Thanks, so much for taking my question. So my first question relates to your 235, new slow which is broadly seen gas is lighter than what youre expecting for 236 and <unk>.

Speaker Change: More generally the doctors will have a conversation with their patients they're using more simple assessments to determine how they how they diseases being controlled by they've got and then making US an assessment on response.

Speaker Change: I mean, it's fair to say that 26 was going to be quite stronger in the meantime, what would you say that investors are overlooking the potential for that certainly gets a phase II trial to significantly expand Mg I just want opportunity.

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

Victor: Hi, Thanks, so much for taking my question.

Speaker Change: So my question relates to your 2025, new slow which is broadly seen gangster is lighter than what youre expecting for 236.

Speaker Change: Defensibility to further drive.

Speaker Change: Your line is penetration in both MGE and CVP and might put up on the <unk>.

Speaker Change: Yes.

Speaker Change: I'm just wondering if you could help us understand how important fifth administration as being for Trudeau has penetration ex U S.

Victor: It's fair to say that 2019.

Victor: Great.

Victor: Quite stronger in the meantime would you say that investors are overlooking the potential for the <unk> phase three trial to significantly extend Mg I just wondered what community.

Speaker Change: I know you don't report and he says breakdown and that'd be our structural differences between.

Victor: PFS ability to further drive.

Speaker Change: U S markets and extra widespread.

Speaker Change: I'm just trying to understand how self administration on label in the U S could meaningfully drive Sam Thanks, so much.

Victor: Your line is penetration in both MD and CDP and Mike.

Victor: The Psa fees.

Victor: I am just wondering if you could help us understand how important self administration as being four <unk> penetration ex U S.

Speaker Change: Victor Thanks, Thanks, and great to hear from you in the call you are right to call out that we do have self administration already for <unk> outside of the United States and I will let Karen comment on you know why that is.

Speaker Change: No you don't report any sense breakdown and that'd be arent structural differences between.

Speaker Change: Important for physicians and patients on juice flow. This is an incredibly busy year from an execution point of view I mean, pushing 10 phase III clinical trials and 10 phase two clinical trials.

Victor: U S markets in ex U S.

Victor: Just trying to understand how certain restriction on label in the U S could meaningfully drive Sam Thanks, so much.

Speaker Change: Victor Thanks, Sean Great to hear from you in the call you are right to call out that we do have self administration already fulfill contractual off outside of the United States and I will let Scott comment on you know why.

Speaker Change: At this speed I think is a very serious test, but in the first half of the year I think PFS is important.

Speaker Change: Please self administration of scatter.

Speaker Change: Why that is important for physicians and patients on juice flow. This is an incredibly busy year from an execution point of view I mean, pushing 10 phase three clinical trials in phase II clinical trials.

Speaker Change: In a minute and then youre correct to call option of the significance of hopefully a positive feed outs in seronegative Mg patients. There's a significant volume of patients that are unmet medical needs. We have seen in Japan, how important that patient population actually is and how successful pick up actually is <unk>.

Speaker Change: At this speed I think.

This is a very serious test, but in the first half of the year I think PFS is importance, which hopefully self administration of scatter.

Speaker Change: Treating these patients so that could be very important for our driver and maintaining the momentum youre alluding to.

Speaker Change: And in a minute and then Youre correct to call out you know the significance of hopefully a positive readouts in seronegative Mg patients, there's a significant volume of patients.

Speaker Change: And then I would also like to call out an important proof of concept study in lupus nephritis.

Speaker Change: The second half of this year.

Speaker Change: Medical needs, we have seen in Japan, how important that patient population actually is and how successful. This gap actually is in treating these patients so that could be very important for our driver and maintaining the momentum youre alluding to.

Speaker Change: Gordon you want to continue with the importance of self administration, yeah, absolutely and just to.

Speaker Change: It reinforced we do have self administration on labels in both the EU as well as in Japan, and what we see in those markets is that when patients and physicians have a choice between the IV option and the self administration subcutaneous option that not all patients move to the sales force can.

Speaker Change: And then I would also like to call out an important proof of concept study in lupus nephritis.

Speaker Change: Second half of this year. So currently about to continue with the importance of self administration.

Speaker Change: Absolutely and just to.

Speaker Change: <unk> self administration, there are some patients that choose to stay with IV. That's what makes that's what peak with their lifestyle, perhaps they prefer not to do the self administration because of needle phobia or something like that but a good percentage of patients.

Speaker Change: Reinforce we do have self administration on labels in both the EU as well as in Japan, and what we see in those markets is that when patients and physicians have a choice between the IV option and the self administration subcutaneous option not.

Speaker Change: Do have the preference and it fits into their lifestyle to take the self administration option. So what we see is that there is real benefit to both patients and prescribers to having multiple routes of administration I'll say that the patient and the neurologists can really make a decision together about what makes most sense for that patient based on their.

Speaker Change: Not all patients move to the <unk>.

Speaker Change: <unk> self administration, there are some patients that choose to stay with IV. That's what makes that's what bit with their lifestyle, perhaps they prefer not to do this delta administration because of needle phobia or something like that but a good percentage of patients do have the preference and it fits into their lifestyle to take the self administration.

Speaker Change: Z and then lifestyle.

Speaker Change: And so we think that that same experience.

Speaker Change: <unk> will come through in the U S. If we get approval for self injection on April 10.

Speaker Change: Option. So what we see is that there is real benefit to both patients and prescribers to having multiple routes of administration I'll say that the patient and the neurologist can really make a decision together about what makes most sense for that patient based on their disease and their lifestyle.

Speaker Change: Thanks for the question.

Cashew Ari: Our next question comes from the line of Cashew Ari from Jefferies. Your line is open.

Speaker Change: Hey, this is Amy answer costs. Thanks, so much for taking our question.

Speaker Change: And so we think that that same experience.

Speaker Change: Starting with the Myositis trial are you planning on making any changes to the trial design asking your go no go decision and how are you thinking about the probability for success across each of the subjects now and then finally wanted to get your thoughts on the Bennett.

Speaker Change: <unk> will come through in the U S. If we get approval for self injection on April 10.

Speaker Change: Thanks for the question.

Speaker Change: Our next question comes from the line of a cash story from Jefferies. Your line is open.

Two the mab data and how that meets a crossfield lupus nephritis trial.

Speaker Change: Hey, this is Amy on for <unk>. Thanks, so much for taking our question.

Speaker Change: Sure.

Speaker Change: Starting with the <unk> trial are you planning on making any changes to the trial design asking you go or no go decision and how are you thinking about the probability for success across each of the subsets now and then finally wanted to get your thoughts on that.

Speaker Change: Either.

Speaker Change: As we announced when we made the Golar go decision to go forward in all three of the subtypes with no changes to the political you are correct to call out that we have some degrees of flexibility or freedom to make these changes, but based on the phase II data, we did not see any need to make changes and you can assume that because we.

Speaker Change: <unk> data and how that meets across tier lupus nephritis trial.

Speaker Change: So in myositis.

Speaker Change: Gave the go ahead for all three subsets that doesn't equal belief in all three subsets with success in HD look in lupus nephritis, we see a number of mechanisms are being tested whatever the data, which we see I think there is ample of room for improvement there is a significant unmet medical needs.

Speaker Change: We announced when we made the Golar <unk> decision to go forward in all three of the subtypes with no changes to the protocol you are correct to call out that we had some degrees of flexibility or freedom to make these changes, but based on the phase II data, we did not see any needs to make changes and you can assume that because really.

Speaker Change: The need for toolbox to TD patients and I don't think thats going to be one size fits all so.

Speaker Change: Gave the go ahead for all three subsets that doesn't equal belief in all of these subsets with success in phase III look in lupus nephritis, we see a number of mechanisms are being tested.

Speaker Change: Let's focus on our data we have strong conviction in the biology and with <unk> mechanism of action now in phase III.

Speaker Change: The data speak.

Speaker Change: Whatever the data, which we see I think there is ample of room for improvement there is a significant unmet medical needs.

Speaker Change: But Amy thank you for the questions.

Speaker Change: And due to time constraints, we ask that you. Please limit yourself to one question only your next question comes from the line of Roxanne Sharma from Goldman Sachs. Your line is open.

Speaker Change: The need for a toolbox to treat these patients and I don't think thats going to be one size fits all so.

Speaker Change: Let's focus on our data we have strong conviction in the biology, and we're testing that mechanism of action now in phase two so let the data speak.

Roxanne Sharma: Hi, Thanks for taking my question I'll keep it to just one.

Roxanne Sharma: So just to understand some of the underlying dynamics in myasthenia gravis.

But Amy thank you for the questions.

Speaker Change: Back at launch of Scott, you said that the addressable market was about 17000 patients and you think there is an additional 25000.

Speaker Change: And due to time constraints, we ask that you. Please limit yourself to one question only your next question comes from the line of Roseanne Sharma from Goldman Sachs. Your line is open.

Speaker Change: That will come from growth in the biologics market by 2030, So I'd just be interested back in 2021. When you initially sold out 17000 market.

Roseanne Sharma: Hi, Thanks for taking my question I'll keep it to just one.

Roseanne Sharma: I understand some of the underlying dynamics in myasthenia gravis. So we know that back at launch of <unk> glad you said that the addressable market was about 17000 patients and you think there is an additional 25000.

Speaker Change: Or do you think not biologic share has progressed in Iowa I E. How much through the additional 25000 already thank you.

Speaker Change: Yeah. Thanks.

Thanks for the question around Mg and certainly as we lay out our strategy for MG. We think that we are very much on the beginning of the growth curve and you talk about the market expansion that we're already seeing from the 17000 since.

Roseanne Sharma: That will come from growth in the biologics market by 2030, So I'd just be interested back in 2021. When you. Initially saw about 17000 market. How do you think not biologic share has progressed in Iowa I E. How much through the additional 25000 <unk> we already thank you.

Speaker Change: Since the since the launches they've got so we do think there has been market expansion and the way that we see that is that since launch we're no longer just being used our advanced biologic can no longer just being used in the most refractory patients rather with the.

Roseanne Sharma: Yes.

Roseanne Sharma: Thanks for the question around Mg and certainly as we lay out our strategy for MG. We think that we are very much on the beginning of the growth curve and you talked about the market expansion that we're already seeing from the 17000 since.

Speaker Change: Advanced biologic to be used early align and this got into let's say, leading the charge on that as the number one prescribed biologic, we shared the statistic that 60% of patients.

Roseanne Sharma: Since the since the launches they've got so we do think there has been market expansion and the way that we see that is that win since launch we're no longer just being used or advanced biologic can no longer just being used in the most refractory patients rather.

Speaker Change: Actually coming directly to they've got from <unk>. So that demonstrates that we are starting to penetrate that 25000, but we believe that there is quite a long way to go and that we can maintain that that's consistent and steady growth certainly pre filled syringe for self injection will help us with that.

Roseanne Sharma: Advanced Biologics is being used early align and this guidance, let's say, leading the charge on that as the number one prescribed biologic we shared the statistic that 60% of patients are actually coming directly that they've got from <unk>. So that demonstrates that we're starting to penetrate that 25000, but we believe that there.

Thanks for the question.

Speaker Change: Your next question comes from the line of from Suzanne Van for Houston from Kempen. Your line is open.

Susan Evan: Hi team. This is Susan Evan Thanks for taking my question.

Roseanne Sharma: It's quite a long way to go and that we can maintain that consistent and steady growth and certainly pre filled syringe for self injection will help us with that.

Susan Evan: I was wondering if you can elaborate a bit on your longer term thinking of the F series franchise.

Susan Evan: I guess youre getting to the point, where you're investing more phase III trials for fifth Clark may not always make sense and you perhaps look towards the next generation of here in 2014.

Roseanne Sharma: Thanks for the question.

Speaker Change: Your next question comes from the line from Suzanne Van for Houston from Kempen. Your line is open.

Susan Evan: Hum.

Susan Evan: 2000, Thirteen's clinical development.

Suzanne Van: Hi team. This is Suzanne gentlemen, thanks for taking my question.

Susan Evan: Do you see possibilities for shorter development timelines.

I was wondering if you can elaborate a bit on your longer term thinking of the SCR and franchise.

Susan Evan: Our element. Thank you can leverage from having developed safeguards. Thank you.

Speaker Change: I guess youre getting to the point, where you're investing more phase III trials for fifth Clark may not always make sense and you perhaps look towards the next generation of yearend 2014.

Susan Evan: Susan I think youre right in calling out that <unk> is going to be a franchise.

Susan Evan: It's an incredible.

Susan Evan: Opportunity I think the size of the opportunity exceeds the ability to serve that with one molecule given the patent lives and the IAA life of.

Suzanne Van: <unk>.

Suzanne Van: 2000, thirteen's clinical development at <unk>.

Suzanne Van: DHT possibilities for a shorter development timelines.

Speaker Change: What are elements that you can leverage from having just Alex <unk>. Thank you.

Susan Evan: A molecule like <unk>.

Susan Evan: So I think developing a molecule like <unk> 13 gives us optionality and we said this is the first of <unk> successful molecules.

Speaker Change: Susan I think youre right in calling out that <unk> is going to be a franchise, it's an incredible.

Susan Evan: It basically unfolds Optionality I mean, either you will go and try to roll up existing indications and then youre spot on I mean, there is so much we know about energy is so much we know about CDP IPP and the other indications to calm that actually you could leverage that knowhow and leapfrog with molecules like <unk>.

Speaker Change: <unk> I think the size of the opportunity exceeds.

Speaker Change: The ability to serve that with one molecule given the patent life on the IAA life of.

Speaker Change: A molecule like <unk>.

So I think developing a molecule like <unk> 13 gives us optionality and we said this is the first of <unk> successful molecules.

Susan Evan: Or you're basically decide they're going to open up new opportunity. What do you have for example, a whole new game plan from a positioning and pricing point of view so.

Speaker Change: It basically unfolds Optionality I mean, either you will go and try to roll up existing indications and then youre spot on I mean, there is so much we know about LNG.

Susan Evan: That optionality is in front of us and we will basically and packet <unk> based on data, we're really focused now on generating the phase one data second half of this year, which will tell us a lot about the potential of this molecule going forward.

Speaker Change: We know about <unk>.

Speaker Change: And the other indications to calm that actually you could leverage that knowhow and leapfrog.

Speaker Change: With molecules like <unk> or you basically decide they're going to open up new opportunity. What do you have for example, a whole new game plan from a positioning and pricing point of view so.

Susan Evan: Thanks for the question.

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

Speaker Change: That optionality is in front of us and we will basically on packet whilst the <unk> based on data. We are really focused now on generating the phase one data second half of this year, which will tell us a lot about the potential of this molecule going forward.

Vikram: Hi, Good morning, Thank you for taking our question.

Speaker Change: We'll keep our question focused on the auto injector.

Speaker Change: Believe your release mentioned that Youll be looking to move this forward in 2027, and so we just wanted to see what the next uptick could be for the auto injector and how youre thinking about.

Speaker Change: Thanks for the question.

Speaker Change: Your next question comes from the line from Vikram <unk>.

Speaker Change: How this form of the guard potentially could expand the opportunity beyond the IV in just a few and the PFS.

Speaker Change: From Morgan Stanley Your line is open.

Speaker Change: Hi, Good morning, Thank you for taking our question.

Speaker Change: Yes. Thank you I think from the significance of the auto injectors or the differentiation of the auto injector from a pre filled syringe is actually having a device where the needle is invisible and doesn't need to be manipulated by the patient. So basically now the only drop left is to hold an advisory against your belly.

Speaker Change: We will keep our question focused on the auto injector.

Speaker Change: I believe your release mentioned that Youll be looking to move this forward in 2027. So we just wanted to see what the next uptick could be for the auto injector and how youre thinking about.

Speaker Change: How this form of the guard potentially could expand the opportunity beyond.

Speaker Change: The <unk> and the PFS.

Speaker Change: The button and then the device is manipulating the needle innovative you don't see it and that is significant for a subset of patients. So in an attempt to continue to innovate in our core markets. This is a logical next step building from the pre filled syringe from the moment for this moment actually we've completely focused in our communication with them.

Vikram: Thank you vikram the significance of the auto injectors or the differentiation of the auto injector from a prefilled syringe is actually having a device where the needle is invisible and does not need to be manipulated by the patients. So basically now the only dropped left is to hold the divisor against your belly you press the button.

Speaker Change: Pizza syringe is a very innovative product.

Vikram: And then the device is manipulating the needle in a way that you don't see it and that is significant for a subset of patients. So in an attempt to continue to innovate in our core markets. This is a logical next step building from the Prefilled syringe from the moment for this moment actually we are completely focused in our communication of the patients already.

Speaker Change: Thanks to you know the technology is really rich in the formulation and the technology to be leveraged for the container. So significant innovation and I think a significant driver for the business stay tuned on the auto injector that we are working very hard on that in the background, but it's too early to commit to a next specific update okay. So 2027 and <unk>.

Vikram: It is a very innovative products. Thanks.

Speaker Change: It all aiming for and then I would say stay tuned.

Vikram: Thanks to you know the technologies for leverage in the formulation and the technologies, we leverage for the container so significant innovation and I think a significant driver for the business stay tuned on the auto injector. We are working very hard on that in the background, but it's too early to commit to specific update okay. So 2027 as the year.

Speaker Change: Kevin.

Speaker Change: Your next question comes from the line of Andy Chen from Wolfe Research. Your line is open.

Speaker Change: Hi, This is on for Andy Thanks for taking our question a.

Speaker Change: A question on CIB P and may be just some metric that you're seeing early on in its launch. It was mentioned majority of patients are <unk> experienced <unk> succeeded in early lines. Other signs of really standard of care transformation, maybe dax performing preferred zipcard over IV AIG, just any insight would be great. Thank you.

Vikram: We're all aiming for and I would say stay tuned.

Vikram: Okay.

Speaker Change: Your next question comes from the line of Andy Chen from Wolfe Research. Your line is open.

Vikram: Hi, This is im on for Andy Thanks for taking a question.

Speaker Change: Yes. Thanks for the question about the IDP launch as I said, I'm really pleased with where we're at with the with the launch with clearly seeing early success.

Vikram: On CIB P and maybe just some metrics you're seeing early on in its launch. It was mentioned majority of patients are IV experience is IV AG succeeded in early lines. Other signs of really standard of care transformation, maybe dax performing preferring zipcard over IV AIG, just any insight would be great. Thank you.

Speaker Change: And there is a clear unmet need that you can see and what we consistently hear the feedback from the community whether it be neurologists patients caregivers is that there is a high treatment burden and a higher disease burden than they had realized so bringing the first innovation in 30 years.

Vikram: Yeah.

Vikram: Yes. Thanks for the question about the IDP launch as I said, I'm really pleased with where we're at with the with the launch with clearly seeing early success.

Speaker Change: Making a big difference and I do think to your question over time, we will we will transform this market and reshape what is standard of care right. Now we're very early in the launch with two quarters in I think we're doing very well, 85% of our patients are switch from IV, AIG and Thats exactly where we thought we would be.

Vikram: And there is a clear unmet need that you can see and what we consistently hear the feedback from the community whether it be neurologists patients caregivers is that there is a high treatment burden and a higher disease burden than they had realized so bringing the first innovation in 30 years.

Speaker Change: So we're pleased with that with the momentum so far.

Vikram: He is making a big difference and I do think to your question over time, we will we will transform this market and reshape what is standard of care right. Now we're very early in the launch with two quarters in I think we're doing very well, 85% of our patients are switch from IV AIG and that's exactly where we thought we would be.

Speaker Change: Okay.

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

Speaker Change: Hi, This is Scott.

Speaker Change: Yeah. Thanks for taking my last question it looks like it just didn't make it to the industrial LNG clients, what's the dosing regimen in the slide you and you're off label use of <unk>. In this population would you anticipate that these patients will need to assume that number one my cycle I see positive gmg, all when they need more.

Vikram: So we're pleased with that with the momentum so far.

Vikram: Okay.

Vikram: Our next question comes from the line of Tim <unk> from Guggenheim. Your line is open.

Speaker Change: Frequent dosing and finally, how should we think about pricing in this indication. Thank you.

Speaker Change: Hi, Yeah. Thanks for taking my question, so far the seronegative industrial LNG claw, yes, what is the dosing regimen in those <unk>.

Speaker Change: So I think the answer to this to discussion. Thank you for the question is very simple we don't.

Vikram: And based on the off label use of <unk> in this population.

Speaker Change: <unk>.

Speaker Change: Design, and we don't anticipate any difference of dosing in seronegative or ultra deep patients as compared to the general lesson Chi patients, which are acetyl choline receptor antibody positive, which we have currently on label in the states.

Speaker Change: Do you see think that these patients will need.

Vikram: Number one launch cycles.

Speaker Change: Positive gmg.

Vikram: Need more frequent dosing.

Speaker Change: How should we think about pricing in this indication. Thank you.

Speaker Change: So don't anticipate any real pricing difference.

Speaker Change: Yes, I think the answer to this to discussion. Thank you for the question is very simple we don't.

Speaker Change: Is that this is label expanding and is just broadening the offering.

Speaker Change: Two of the MG a community. So you can assume for the models exactly the same parameters.

Speaker Change: And we don't anticipate any difference of dosing in seronegative or ultra mg patients as compared to the general lesson Chi patients, which are acetyl choline receptor antibody positive, which we have currently on label in the states.

Speaker Change: Thank you for the question.

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

Speaker Change: We also don't anticipate any real pricing difference.

Speaker Change: This is label expanding and is just broadening the offering to DMG and community. So you can assume for the models executive same parameters.

I apologize we lost the connection. Your next question comes from the line of Matt Phipps from William Blair. Your line is open.

Matt Phipps: Alright, Thanks for taking my question wanted to follow up on the myositis transitional phase III just wondering if you are.

Speaker Change: Thank you for the question.

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

Matt Phipps: Enrolling select certain number of patients for each of the three subsets.

Matt Phipps: Power each subset individually or will the primary endpoint looked across all patients. Thank you.

Speaker Change: I apologize we lost the connection. Your next question comes from the line of Matt Phipps from William Blair. Your line is open.

Matt Phipps: Yes, Matt I think youre spot on Youre going to want to see your minimum representation of Abbvie subset in the phase III Registrational trial in order to draw data based conclusions. You can then also discussed with the FDA.

Matt Phipps: Alright, Thanks for taking my question wanted to follow up on the myositis transition of Phase III. Just wondering if you are.

Matt Phipps: Enrolling select certain number of patients for each of the three subsets so as to power each subset individually or will the primary end point, if you looked across all patients. Thank you.

Matt Phipps: I think an underlying assumption is correct.

Matt Phipps: Thank you.

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

Matt Phipps: Yes, Matt I think youre spot on you will want to see your minimum representation of every subset in the phase III Registrational trial in order to draw data based conclusions. You can then also discussed with the FDA.

Speaker Change: Hey, guys.

Speaker Change: For the Prefilled syringe and the <unk> with the managed care organizations phasing out I just wanted to clarify in CIB piece, specifically are you planning to not have the same cap on use in those contracts.

Speaker Change: I think your underlying assumption is correct.

Matt Phipps: Thank you.

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

Speaker Change: So I think Gavin it's partly I think.

Speaker Change: Based on price negotiations, which still needs to take place for the PFS.

Speaker Change: Hey, guys for.

Speaker Change: For the Prefilled syringe and the <unk> with the managed care organizations phasing out I just wanted to clarify in CRD piece, specifically are you planning to not have the same cap on use in those contracts.

Speaker Change: But our expectation is that from a pharmacy benefit, but you would to beef incremental discounts good vessels.

Speaker Change: It typically would do but incremental base rebates and that the <unk> would not be asked why the pace. So therefore, it will phase out through May four.

Speaker Change: So I think Gavin it's clear I think.

Speaker Change: Recent price negotiations, which still needs to take place for PFS.

Speaker Change: Yes, it won't be capped.

Speaker Change: Thank you for your question.

Speaker Change: But our expectation is that from a pharmacy benefit.

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

Speaker Change: You would keep incremental discounts because that's what that is.

Speaker Change: Typically do but incremental base rebates and that the vba's would not be asked why the past. So therefore, it will phase out through May four.

Speaker Change: Hi, Good morning are you able to hear me.

Speaker Change: Yes, we can hear you.

Speaker Change: Perfect. Thanks, very much for taking the question I'm wondering can you speak to your confidence and FDA granting the self administration for the PFS and perhaps you can just remind us on fda's concerns surrounding self administration.

Speaker Change: Yes, we won't be capped.

Speaker Change: Thank you for your question.

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

Speaker Change: Fine needle process and how that's factored into your strategy as you looked at the carrier self administration for the PFS. Thank you.

Speaker Change: Hi, Good morning are you able to hear me.

Speaker Change: Yes, we can hear you.

Speaker Change: Yes.

Speaker Change: Perfect. Thanks, very much for taking the question.

Speaker Change: Taking a step back we feel will be submitted a very strong datasets.

Speaker Change: Im wondering can you speak to your confidence and FDA granting the self administration for the PFS and perhaps you can just remind us on fda's concerns surrounding self administration.

To the FDA with regards to the pizza syringe, including I think a very solid human factor study, which is taking to account. The typical questions correctly. It may have on how patients can reliably and robustly manipulate.

Speaker Change: <unk> needle process and how that's factored into your strategy and you looked at the carrier self administration for the PFS. Thank you.

Speaker Change: Yes.

Speaker Change: So we feel will be starting from a very strong dataset I think that issue is on track based on where we sit we think we are on track for the particular date of April 10, and I think the type of questions, which you are getting from the FDA signal that actually we are making good progress with it if you're able to file.

Speaker Change: Taking a step back we feel will be submitted a very strong datasets to the FDA with regards to the pizza range, including I think a very solid human factor study, which is taking to account. The typical questions regulators may have on how patients can reliably and robustly manipulate.

Speaker Change: In <unk>, we should be in light of the total review timelines so.

Speaker Change: The device. So we feel will be starting from a very strong dataset I think that issue is on track based on where we sit we think we're on track for a particular date of April 10, and I think the type of questions, which we are getting from the FDA signal that actually we are making good progress with it if you're able to file.

Speaker Change: Our confidence based on the datasets and the currently ongoing process. Ultimately of course. This is the final call to be made by the FDA and we try to collaborate as much as we can.

Speaker Change: Thank you for the question.

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

Speaker Change: <unk>, we should be in light of the total review timeline. So we are confident based on the datasets and the currently ongoing process. Ultimately of course. This is the final call to be made by the FDA and we tried to collaborate as much as we can.

Speaker Change: Hey, guys. Good morning, Thanks for taking our questions can.

Jim: Jim you called out.

Speaker Change: As an important proof of concept readout in the second half of last year.

Speaker Change: The study is being conducted how your partners are in China and they just recently completed enrollment I was just wondering if you have a sense of sort of the baseline characteristics and disease severity in these patients and how they compare to other contemporary Western Ellen studies.

Speaker Change: Thank you for the question.

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

Speaker Change: Hey, guys. Good morning, Thanks for taking our questions Jimmy.

Speaker Change: Maybe you could just remind us how youre thinking about the bar for success with this readout. Thanks.

Speaker Change: Jim you called out.

Speaker Change: As an important proof of concept readout in the second half of this year.

The study is being conducted by our partners in China.

Speaker Change: Yes.

Speaker Change: Thank you for the question first thing I wanted to applaud Si as a reliable and high quality development partners to not only involved in these phase II proof of concept studies, but they are also involved in a lot of the phase III global registration trials with <unk>.

They just recently completed enrollment I was just wondering if you have a sense of sort of the baseline characteristics and disease severity in these patients and how they compare to other contemporary Western Ellen studies.

Speaker Change: And high quality, so a very strong partnership and specifically to Allen.

Speaker Change: Maybe you could just remind us how youre thinking about the bar for success with this readout. Thanks.

Speaker Change: Patient population, which we are recruiting in China is of course perfectly in line with protocol in the inclusion exclusion criteria, which easily presented it.

Speaker Change: Yes, Thomas Thank you for the question first thing I want to do is applaud Si as a reliable and high quality development partners to not only involved in this phase II proof of concept studies, but they are also involved in a lot of the phase III global registration trials with speed and high quality, So a very strong partnership and specifically.

Speaker Change: I think for <unk> alone.

Speaker Change: Alan patient population with significant unmet medical needs that are some variations in the type of treatments. These patients and the goal for us This phase two and it's a true phase II is approval pumps. So the first question we need to answer in this phase II trial is a responder with this mechanism of action and then B.

Speaker Change: Alan.

Speaker Change: Patient population, which we are recruiting in China is of course perfectly in line with protocol in the inclusion exclusion criteria, which easily presented it.

Speaker Change: Dramatically the juice pathogenic Agg's do you have the right to move the needle in this type of patients. That's a question we can answer and once we have a positive asset to this question, we will flip it into a global phase III registration trial, where do we will take into account you know some of the global of treatment regimens, which are typically being due.

Speaker Change: Thanks for that Alan patient population with significant unmet medical needs that are some variations in the type of treatments. These patients on the go but for US. This phase two and it's a true phase II is approval pumps. So the first question we need to answer in this phase II trial is are we spot on with this mechanism.

Speaker Change: So we take it step by step and for the proof of concept question I think size perfectly equipped to help us with those discussions. So we're very much looking forward to the data. Thank you.

Speaker Change: Action.

Speaker Change: <unk> dramatically reduced pathogenic Agg's do you have the right to move the needle in this type of patients. That's a question we can answer and once we have a positive answer to this question, we will flip it into a global phase III registration trial, where we will take into account you know some of the global a treatment regiments, which are typically being.

Your next question comes from the line of Leland <unk> from Oppenheimer. Your line is open.

Speaker Change: Hey, good morning, Thanks for taking our questions. Just a question on 119 as we look forward to the proof of concept data in CMS. Later this year just wondering if you could touch on what you are looking to see and put those data.

Speaker Change: So we take it step by step and for the proof of concept question I think size perfectly equipped to help us with those discretionary. So we are very much looking forward to the data. Thank you.

Speaker Change: Impacts.

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

Speaker Change: The ongoing development of 119 minutes other indications. Thank you.

Speaker Change: Now I'd like to touch on about 119, thank you for that.

Hey, good morning, Thanks for taking our questions. Just a question on 119 as we look forward to the proof of concept data in CMS. Later this year just wondering if you could touch on what you are looking to see and put those data.

Speaker Change: An indication.

Speaker Change: Genital Myasthenic syndrome, <unk> really in the bullseye of the biology of this target remember, we have been publishing and presenting spectacular data in the top seven animal model, which is perfectly mimicking.

Speaker Change: Impact.

Speaker Change: The ongoing development of 119 and its other indications. Thank you.

Speaker Change: Seven mutation in human beings and its executive orbit testing for CNS.

Speaker Change: Now I'd like to question about 119, thank you for that as an indication.

Speaker Change: Think of.

Speaker Change: Genetic form of Mg richness overlap it autoimmune energy is fatigue bowl, it's typically limb girdle, which is being affected but also the eyes. So we are basically looking for a strong signal that we moved the needle in these patients. So I think it isn't a very important program from approval biology point of view.

Speaker Change: Genital Myasthenic syndrome.

Speaker Change: So really in the bullseye of the biology of this target remember, we have been publishing and presenting spectacular data in the top seven animal model, which is perfectly mimicking the top seven mutation in human beings and Thats exactly where we are testing for CNS.

Speaker Change: Remember we are running in parallel also a proof of concept study in ALS.

Speaker Change: Think of it.

Speaker Change: Genetic form of Mg richness overlap at autoimmune energy is fatigue Bowl, it's typically limb girdle, which is being affected but also the ice. So we are basically looking for a strong signal that we moved the needle in these patients. So I think it isn't a very important program from approval biology point of view.

Speaker Change: And we are bringing life novel study in SMA I would say that all these three indications or very close to the mechanism of action of the molecule with CMS I think has really close so that is the significance of this first indication for <unk>. We are very much looking forward to the data by the way.

Speaker Change: Remember we're running in parallel also a proof of concept study in ALS.

Speaker Change: Thank you for the question.

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

Speaker Change: And we are bringing life notwithstanding in SMA I would say that all these three indications or very close to the mechanism of action of the molecule with CMS I think has really close so that is the significance of this first indication for <unk>. We are very much looking forward to the data by the way.

Speaker Change: Hi, good morning, Congrats on the quarter. This is magic with RSV arms for June a question related to your early pipeline asset we appreciate them.

Speaker Change: More color on your plans for <unk>.

Thank you for the question.

Speaker Change: 109, anti IL six based on the importance of the targets, but also given it's.

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

Speaker Change: Hi, good morning, Congrats on the quarter. This is Matt <unk> on for June a question related to your early pipeline assets. We appreciate.

Speaker Change: Interesting history of about 15 years and it's.

Speaker Change: 200 patient phase two in <unk> in Brazil, and also it's finally getting back to you and we appreciate the color there.

Speaker Change: More color on your plans for <unk>.

Speaker Change: 109, anti IL six based on the importance of the target, but also given its <unk>.

Speaker Change: I think you are calling out the strength of the molecule I think this is a best in class IL six blockade.

Speaker Change: Picomolar potency at 60 to 80 days half life and already proven safety profile in two phase one was actually one in Brazil, and one in China happy to finally get this molecule backend as a whole new angle, which we could take in the meantime on the biology of IL six and how it is involved in some real interesting orphan disease.

Speaker Change: Interesting history of about 15 years and it's.

Speaker Change: 200 patient phase two in <unk> in Brazil, and also it's finally getting back to you and we appreciate the color there.

Speaker Change: Yes, I think you are calling out the strength of the molecule I think this is the best in class IL six blockade.

Speaker Change: So we decided not to talk too much about these indications, yes, but I think we have a unique and novel angle to the biology, and we are progressing the molecule. This year at high speeds to phase one we are expecting the phase one data second half of this year. So stay tuned more to be told on Bottomline. Soon thank you.

Speaker Change: <unk> Picomolar potency of 60 to 80 days half life and already proven safety profile in two phase one is actually one in Brazil and one in China.

Speaker Change: To finally get this molecule backend as a whole new angle, which we could take in the meantime on the biology of IL six and how it is involved in some real interesting autoimmune diseases. So we decided not to talk too much about these indications yes.

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

Speaker Change: I think we have a unique and novel angle to the biology, and we are progressing the molecule. This year at high speeds through phase one we are expecting the phase one data in second half.

Speaker Change: Good morning, Thanks for taking our question. This is Chris on for Joe just a quick one on PFS.

Speaker Change: They are approved.

Speaker Change: On April one what are your expectations for when they can reach patients. Thank you.

Speaker Change: This year, so stay tuned more to be told on bottom line soon thank you.

Speaker Change: Yeah.

Speaker Change: Yeah. Thanks. Thanks for the question. So we're very excited obviously for the PFS, so that self injection potential approval in April as you said, we'll be ready to launch as soon as I said after the <unk> date in the same way that we had for prior launches. So we expect it to be within days that will be out there with PFS.

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

Speaker Change: Okay.

Speaker Change: Good morning, Thanks for taking our question. This is Chris on for Joe just a quick one on PFS.

Speaker Change: If they are approved in April when you know what are your expectations for when they can reach patients. Thank you.

Speaker Change: The self injection.

Speaker Change: Yes.

Speaker Change: Yeah. Thanks. Thanks for the question. So we're very excited obviously for the PFS self injection potential approval in April as you said, we'll be ready to launch as soon as after the <unk> date in the same way that we have the prior launches. So we expect it to be within days that will be out there with PFS.

Speaker Change: Our next question comes from the line of Douglas Tsao from H C. Wainwright. Your line is open.

Speaker Change: Yeah.

Douglas Tsao: Hi, good morning, Thanks for taking the questions.

Speaker Change: Thank you Karen I think it would be helpful to hear you talk a little bit about how you think a potential approval in ocular M genes.

Speaker Change: The self injection.

Speaker Change: Affect sort of the treatment paradigm for LNG, and whether you sort of might see that pushed earlier, obviously, the some of the patients with ocular symptoms first but sort of really.

Speaker Change: Our next question comes from the line of Douglas Tsao from H C. Wainwright. Your line is open.

Speaker Change: Yes.

Speaker Change: Hi, good morning, Thanks for taking the questions.

Speaker Change: Maybe Karen I think it'd be helpful to hear you talk a little bit about how you think a potential approval in ocular M genes might affect sort of the treatment paradigm for LNG and whether you sort of might see that pushed earlier, obviously, there's some mutations present with ocular.

Speaker Change: Weather conditions, but you had a sort of a disease modifying therapy at that stage. Thank you.

Speaker Change: Yes. Thank you for the question.

And I like how you frame it up as disease modifying.

Speaker Change: We'll have to let the data speak, but but the way that I think about it is very much aligned with how youre thinking about it our strategy is that we believe that treatment with <unk> got in early aligns results in better outcomes for patients and that's why we also wanted to move all the way into the NGL transportation, one with ocular Mg and we would be.

Speaker Change: Symptoms first but sort of really.

Speaker Change: Weather conditions, while you had a sort of a disease modifying therapy at that stage. Thank you.

Speaker Change: Yes. Thank you for the question.

And I like how you frame it up as disease modifying.

The first and only that that would have that indication, we know that 80% of patients with ocular Mg generalize and as you say.

Speaker Change: I'll have to let the data speak, but but the way that I think about it is very much aligned with how youre thinking about it our strategy is that we believe that treatment with <unk> got in early aligns result in better outcomes for patients and that's why we also wanted to move all the way into the <unk> classification, one with ocular Mg and we would be.

Speaker Change: <unk> over time, not with this first data readout that maybe over time, we can imagine.

Speaker Change: You could see data in the real world, where we're able to delay that generalization and I think that's really exciting for Mg patients and certainly that's our vision for how we would transform the market, let's see how the data plays out, but we're relatively confident in that really strong conviction in the strategy.

Speaker Change: First and only that that would have that indication, we know that 80% of patients with ocular Mg generalized.

Speaker Change: And as you say potentially over time not with this first data readout, but maybe over time, we can imagine.

Speaker Change: Thanks for the question.

Speaker Change: Your next question comes from the line of Mono Smith <unk> from Deutsche Bank. Your line is open.

Speaker Change: You could see data in the real world, where we're able to delay that generalization and I think that's really exciting for Mg patients.

Speaker Change: Alright. Thank you for taking my question management strikes from Deutsche Bank.

Speaker Change: And certainly that's our vision for how we would transform the market, let's see how the data plays out, but we're relatively confident in that really strong conviction in the strategy.

Speaker Change: So how do you think about the potential for competitors to further improve upon clinical outcomes and see IDP above.

Speaker Change: Thanks for the question.

Speaker Change: Scott could you months outcomes.

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

Speaker Change: And do you believe complement inhibitors have a role to play in this space. Thank you.

Speaker Change: Yes. Thank you for the question.

Mono Smith: Alright. Thank you for taking my question Manav, Mr. <unk> from Deutsche Bank.

Speaker Change: I think can see IDP, we have written history, because they have shown for the first time that actually this is an <unk> different disease in the majority of patients and I think we have shown a response rate, which is the highest ever reported in this type of clinical trial showed a 70% response rates.

Speaker Change: So how do you think about the potential for competitors to further improve upon clinical outcomes in CDP above.

Mono Smith: Scott tissue months outcomes.

Mono Smith: And do you believe complement inhibitors have a role to play in this space. Thank you.

Speaker Change: Safety profile, which is very much in line with the known safety profile, which we all recognize the splitter units.

Mono Smith: Yes. Thank you for the question.

Speaker Change: I think can see ADP, we have written history, because we have shown for the first time that actually this is an ITT driven disease in the majority of patients and I think we have shown a response rate, which is the highest ever reported in this type of clinical trial showed a 70% response rates.

Speaker Change: In this world and then of course meet advancing fast with the dosing optionality.

Speaker Change: Which we have been in banking in this call. So we've put the poverty hi, we need to see data of course from competing molecules in the class.

Speaker Change: Jacobs, but we have certainly not seen that in myasthenia.

Speaker Change: Safety profile, which is very much in line with the known safety profile, which we all recognize the speed the unique.

Speaker Change: We were also first to market is there a role for compliments I think there is that's also why we are advancing in posture per box in <unk>. Despite the fact that we printed the highest response rate averaged 70% that is a 30% of patients channel, which have medical needs and were not served in the adhere trial.

Speaker Change: In this world and then of course meet advancing fast with the dosing Optionality, which we have been unpacking and discuss so we've put the bar very high we need to see data of course from competing molecules in the class, but they take it but we have certainly not seen that in myasthenia.

Speaker Change: And we do know there are some clues from a battleship point of view for example, some patients having these pathogenic LG ultra antibodies, which do recruit complement and which do not recycle through <unk>. So I think food unraveling the answer to your question.

Speaker Change: It also first to market is there a role for complement I think that is that's also why we are advancing and positive robots in CDP. Despite the fact that we printed the highest response rate averaged 70% that is a 30% of patients channel, which have medical needs and were not served in the acute trial.

Speaker Change: I think <unk> really deserves a shot on goal.

Speaker Change: And we are very keen to start this study and look at complement data.

Speaker Change: And we do know there are some clues from a balance sheet point of view for example, some patients having these pathogenic IGN ultra antibodies, which do recruits a compliment and which do not recycled through <unk>. So I think we had unraveling the answer to your question.

Speaker Change: So there is a lot of the impact and a lot will be developed in CIP. Thank you.

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

Speaker Change: I think <unk> really deserves that shot on goal.

Speaker Change: And we are very keen to start this study and look at complement data.

Speaker Change: There's a lot of the unpacked and a lot to be developed in CIP. Thank you.

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

Speaker Change: Yes.

[music].

Speaker Change: Sure.

Speaker Change: Thanks.

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