Q1 2021 argenx SE Earnings Call

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Good morning, and welcome to the <unk> first quarter 2021 earnings call all participants will be in listen only mode should you need assistance. Please signal conference specialist by pressing the star key followed by zero.

Operator: Welcome to the Argenix first quarter 2021 earnings call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. Please note this event is being recorded. I'd now like to turn the conference over to Best Del Giacchio. Please go ahead.

After today's presentation there'll be an opportunity to ask questions. Please note. This event is being recorded and now.

And I'd like to turn the conference it for too.

That's dealt Jaco. Please go ahead.

Thank you and press release was issued earlier today for their first quarter 2021 financial results and a business update which can be found on our website along with the presentation for today's webcast.

Beth DelGiacchio: A press release was issued earlier today with our first quarter 2021 financial results and a business update.

Before we begin I'd like to remind you on slide two that forward looking statements may be presented during this call. These may include statements about our future expectations clinical developments regulatory timeline and potential success of our product candidates financial projections and upcoming milestones and.

Beth DelGiacchio: business update. This can be found on our website along with the presentation for today's webcast. Before we begin, I'd like to remind you on slide two that forward-looking statements may be presented during this call.

Beth DelGiacchio: These may include statements about our future expectations, clinical developments, regulatory timelines, the potential success of our product candidates, financial projections, and upcoming milestones. However, actual results may differ materially from those indicated by these statements.

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

Beth DelGiacchio: Argenix is not under any obligation to update statements regarding the future or to consider them.

I'm joined on the call today by tender and how our Merritt Chief Executive Officer, Eric Castaldi, Chief Financial Officer, and Keith Woods, Chief Operating Officer, I will now turn the call over to Tim.

Beth DelGiacchio: those statements in relation to actual results unless required by law. I'm joined on the call today by Tim Van Hauer-Mieren, Chief Executive Officer

Beth DelGiacchio: and Chief Executive Officer, Eric Costaldy, Chief Financial Officer, and Keith Woods, Chief Operating Officer. I will now turn the call over to Tim.

Thank you Beth and good morning, everyone. We appreciate you joining us today.

Starting with slide number three.

Tim Van Hauwermeiren: Thank you, Beth, and good morning, everyone. We appreciate you joining us today. Starting with slide number three, during our R&D day in 2019, we shared our plan for how Argenics could become a fully integrated immunology company that reaches patients globally who are suffering from autoimmune diseases. We called it our 2021 vision, and it outlines the key drivers that will continue to build value year over year even beyond 2021. Based on where we are today, we have executed well against our 2021 ambition.

During our R&D day in 2019, we share our plan for Howard Jenny could become a fully integrated immunology company debt reaches patients globally, who are suffering from autoimmune diseases.

Called it our 2020 on vision and it outlines the key drivers that will continue to build value year over year, even beyond 2021 day.

Just on their behalf to day, we have executed well against our 2021 ambitions.

First with reaching patients.

This year, we are on track with our transformation into a commercial organization with a potential U S approval of I've got pick them up in generalized myasthenia gravis.

Tim Van Hauwermeiren: First, with reaching patients. This year, we are on track with our transformation into a commercial organization, with the potential U.S. approval of Afgatigamat in generalized Mystina Gravis, followed shortly by a potential launch in Japan. We are also moving forward in Europe and in China with Xylec.

Shortly by a potential launch in Japan.

We are also moving forward and Europe and in China with xylem.

At the same time, we'd love to be a company known for clinical execution and good business decisions when it comes to pipeline prioritization.

Tim Van Hauwermeiren: At the same time, we want to be a company known for clinical execution and good business decisions when it comes to pipeline prioritization. We are focused on assets with a lot of breadth, like Agatigamat and Nargenix 117, and have demonstrated strong capabilities in advancing these programs. Notably, we have shown proof of concept in all four of our initial Agatigamat Dignat trials. We're hoping for a similar track record with Argenics 117. And finally, we want to be a company that continues to capitalize on early innovation so that we operate at all stages of the value chain.

We are focused on assets with a lot of breath like I've come pick them up and organics for 17 and have demonstrated strong capabilities and advancing these programs.

Notably we have shown proof of concept and all four of our initial epileptic them on indications we're on.

And for a similar track record with allogeneic cell on 17.

And finally, we want to be a company that continues to capitalize on early innovation. So that we operate at all stages of the value chain.

This is the core purpose of our immunology innovation program.

We will continue to grow our pipeline with differentiated candidates that emerged from and immunology breakthrough.

Tim Van Hauwermeiren: This is the core purpose of our immunology innovation program. We will continue to grow our pipeline with differentiated candidates that emerge from an immunology breakthrough. Today, we will update you on our recent achievements related to each of these key drivers, our path to reaching patients, our clinical execution, and our early stage programs. These are all critical elements of our strategy to become a global, sustainable immunology company. First, our path to reaching patients.

Today, we will update you on our recent achievements related to each of these key drivers our path to reaching patients and our clinical execution and our early stage programs.

These are all critical elements of our strategy to become a global sustainable Immunology company.

First our paths to reaching patients.

We announced this morning since we have filed for marketing authorization application to the PMD and Japan.

Tim Van Hauwermeiren: We announced this morning that we have filed the marketing authorization application with the PMDA in Japan, and dispositions as well for an early cadence of expected launches in MG, first in the US around our Padufa date of December 17th, and second in Japan. We are on track to file our marketing application in Europe in the second half of 2021, and Zai anticipates discussions with regulators in China this year about a potential accelerated pathway.

And positions us well for an early cadence of expected launches and energy first and the U S or on our producer date of December 17th and second and Japan.

We are on track to file our marketing application in Europe in the second half of 2021 and.

And sorry, and dissipates discussions with the regulators in China. This year about a potential accelerated pathway.

With close to 200000 and G patients and the market opportunity and China is one of the largest in the world.

Tim Van Hauwermeiren: With close to 200 G patients, the market opportunity in China is one of the largest in the world. We are incredibly excited that we've made important progress towards our global launch in just one year since we presented data from the Phase 3 Adapted trial. There is a core motivator across all of our hardworking employees, and that is the patient. We've been able to spend considerable time with the MG community and have heard firsthand about the challenges they face.

We are incredibly excited that we've made important progress towards our global launch and just one year since we presented data from the phase III adapt trial.

That is core and motivated across all of our hardworking employees and that is the patients.

We've been able to spend considerable time with the <unk> community and have heard firsthand about the challenges they face.

We either people living with MG has had to accept and new reality, either due to disease symptoms or side effects from current treatments.

Tim Van Hauwermeiren: We hear that people living with MG have had to accept a new reality, either due to disease symptoms or side effects from current treatment. This is a truly debilitating disease, characterized by fatigue, depression, and an inability to perform simple daily activities. In some cases, it may result in life-threatening crises.

This is a truly debilitating disease characterized by fatigue depression, and and inability to perform simple daily activities and.

And some cases it may result in a life threatening crisis.

Not only does this and the patients ability to live their own personal and professional lives to the fullest.

Tim Van Hauwermeiren: Not only does this hinder patients' ability to live their own personal and professional lives to the fullest, but it takes a considerable toll on their friends and families as well. It is clear that the battle we are fighting with MG is far from over. Based on the positive phase 3 data we showed from the ADAP trial, shown on slide 4, we believe we can offer a new treatment option to patients with a promising value proposition.

But it takes a considerable tall on their friends and families as well.

It is clear that the battle will be finding with Mg is far from over.

Based on the positive phase II data, we showed from the adapt trial shown on slide four we believe we can offer a new treatment option to patients with a promising value proposition.

We showed on unparalleled response rate of 78% across the first two treatment cycles and a fast onset of action in 84% of responders.

Tim Van Hauwermeiren: We showed an unparalleled response rate of 78% across the first two treatment cycles and a fast onset of action in 84% of responders. With a death of response, where 60% of responders achieved an MGADL of 0 or 1, patients could think about minimal manifestations of their disease.

With a desktop response, where 60% of respondents achieved and Mg ADL of zero or one.

<unk> could think about minimum manifestations of their disease.

Furthermore, the trial demonstrated the potential for individualized dosing based on just your ability of responses, we observed which may provide enhanced optionality to patients.

Tim Van Hauwermeiren: Furthermore, the trial demonstrated the potential for individualized dosing based on the durability of responses we observed, which may provide enhanced optionality to patients, and importantly, the safety profile of ADAPS was comparable to placebo, which is a crucial element to our key stakeholders. As of today, a significant majority of patients who completed ADAPT and rolled over to ADAP Plus still remain in study. In addition to advancing IV at Cartygmot, we have also made progress in advancing our subcoup product forward with the goal of reaching MG patients. Blind 5.

And importantly, the safety profile and adapt.

Comparable to placebo, which is a crucial element to our key stakeholders.

As of today is significant majority of patients who completed adept and rolled over to adapt plus still remained in study.

In addition to advancing IV and crafting them up we have also made progress and advancing our <unk> forward with the goal of reaching Mg patients.

Slide five.

The depths of cute trial is underway with a target enrollment of 50 patients.

And additional and for reality trial will compare <unk> reductions between the IV and subcutaneous and day 29 as the primary endpoint.

Tim Van Hauwermeiren: The ADDAT subcue trial is underway with a target enrollment of 50 patients. In this non-inferiority trial, we will compare IG reductions between the IV and subcue products at day 29 as the primary endpoint. In addition, we have a safety database requirement for filing and will work to achieve this by switching eligible and interested patients from ADAP Plus to adapt subcube. The formulation we are evaluating in this trial, which is being used in all ongoing trials of sub-QR Gartijamot, is equipped with the Hedo-Ziam-enhanced technology. With this product candidate, we hope to offer patients a self-administered single subcutaneous injection that only takes a few minutes to deliver.

In addition, we have a safety database requirement for filing and we will work to achieve this by switching eligible and interest of patients from a debt plus to adapt sub Q.

The formulation, we are reevaluating and this trial, which is being used and all ongoing trials of sub Q and contingent mob is equipped with the Halo Simon has technology.

With this product candidate, we hope to offer patients a self administered single subcutaneous injection debt only takes a few minutes to deliver.

We believe that by advancing both an IV and is self administered subcutaneous <unk>.

Tim Van Hauwermeiren: We believe that by advancing both an IV and sub Q. Afgatigamot, we are capturing patient preferences and can reach a larger population of people suffering from autoimmune diseases. Before moving to the rest of our pipeline, I'd like to close on MG by sharing my pride and gratitude to our team who strongly executed despite the global pandemic. Between our experienced global launch, our strong adapt data, and our dual development of both IV and sub-Q formulations, we hope to support a new treatment option for people living with generalized mycena gravis.

We are capturing patient preferences and can reach a larger population of people suffering from autoimmune diseases.

Before moving to the rest of our pipeline I'd like to close on Mg by sharing my pride and gratitude to our team who strongly executed despite the global pandemic.

Between our experienced global launch day.

And that data and our dual development of both IV and <unk> relations, we hope to support and new treatment option for people living with generalized myasthenia gravis.

This positive readouts from a debt will stop only a significant milestone for the company, but it's further validated the role of I've got to take them up and may have and addressing a range of <unk> mediated autoimmune diseases.

Tim Van Hauwermeiren: This positive readout from adapt was not only a significant milestone for the company, but it further validated that the role of Elgadigamot may have in addressing a range of IGG-mediated autoimmune diseases. This brings me to the second key driver, clinical development, within our differentiated antibody pipeline, slide 6. As I mentioned earlier, we have demonstrated proof of concept with Edgar Digamot in all four of our initial indications and currently have registrational trials ongoing across each. To date, we have dosed over 400 subjects with Afgat Tigamad, some of whom have been treated with Afghts for well over two years.

This brings me to the second key driver clinical development within our differentiated antibody pipeline slide six.

As I mentioned earlier, we have demonstrated proof of concept with epcot dig them up in all four of our initial indications and currently have registrational trials ongoing across each.

To date, we have dosed over 400 subjects with epcot picking them up some of whom have been treated with <unk> for well over two years.

With each trial and through our ongoing translational work, we continue to learn more about our FC fragment and how the unique engineering of F guard they contribute to the unique efficacy and safety profile, we have seen to date.

Tim Van Hauwermeiren: With each trial and through our ongoing translational work, we continue to learn more about our FC fragment and how the unique engineering of FGART may contribute to the unique efficacy and safety profile we have seen to date. Our most recent achievement within the Abgatigama program occurred during the first quarter with the announcement that we surpassed a predefined goal threshold in the Adhier trial in chronic, inflammatory, demilating polyneropathy. We built a planned efficacy assessment into the trial because the role of the auto-antibody in CIDP disease progression is less defined than it is for NG.

Our most recent achievements, we didn't take them off program.

<unk> during the first quarter with the announcements that we had surpassed a predefined go thresholds and the adhere trial in chronic inflammatory demyelinating polyneuropathy.

We had and built the planned efficacy assessment into the trial because the role of the ultra antibody in CDP disease progression is less defined than it is for Mg.

Following this go decision, we can confidently expand enrollment up to approximately 130 <unk> patients into the randomized portion of the trial, which is depicted on slide number seven.

Tim Van Hauwermeiren: Following this Go decision, we can confidently expand enrollment to approximately 130 CRDP patients into the randomized portion of the trial, which is depicted on slide number 7. This decision also validates our indication selection strategy as we move into additional adjacent indications within our therapeutic franchises. We're also actively enrolling patients into the advanced and advanced subcute trials for ITP and the address trial for Penfegas, which are shown on Slice 8 and 9. Given the still unpredictable situation with COVID-19, it is too early to provide guidance on these trials.

This decision also validate a valve and indication selection strategy as we move into additional adjacent indications within our therapeutic franchises.

We are also actively enrolling patients into the advance and advance subdued trials for ITT and the address trial for pemphigus, which are shown on slides eight and nine.

Given the still unpredictable situation with COVID-19, it is too early to provide guidance on these trials.

We will look to provide updates where possible on our upcoming quarterly earnings calls.

We are also well underway with our fifth and sixth indications and we'll be initiating trials this year.

We look forward to sharing more about this during our R&D day in July but have already confirmed that the fit is within our neuro muscular franchise.

Slide 10.

As a first in class and potentially best in class FTR and antagonist, we recognize the vast potential that I've got thinking about could have and auto immunity.

And we want to rollout new indications as quickly as we can.

This is why we were particularly excited to slick design and our profit and China.

Because they are strong development capabilities will be and assets to enhance the long term value of I've got to your models.

Slide 11.

By contributing patients to ongoing global trials, and we hope XI will help accelerate the path to approval for each respective indication.

Tim Van Hauwermeiren: We will look to provide updates where possible on our upcoming quarterly earnings calls. We also began work on our fifth and sixth indications, and we'll be initiating trials this year. We look forward to sharing more about these during our R&D day in July, but have already confirmed that the fifth is within our neuromuscular friendship.

And with XI running phase II proof of concept trials and future aircraft, taking them on indications and we hope to expand the scope of our overall pipeline.

We aspire to take epileptic them up into 10 indications overtime.

Slide 12.

We also recognize that we may have on other pipeline and the product opportunity with Amgen exon 17.

We look forward to showing the first clinical dataset mid years from both on IV formulation and the sub Q formulation equipped with Halo Zions enhanced technology.

Tim Van Hauwermeiren: Slide 10, as a first in class and potentially best in class FCR antagonist, we recognize the vast potential that Aggartygmat could have in autumn unity. We want to roll out new indications as quickly as we can. This is why we were particularly excited to select Zai as our partner in China, because their strong development capabilities will be an asset to enhance the long-term value of FGARTIGMO. Slide 11.

With our phase one data, we will be showing safety and Tolerability PK PD properties, and we look to identify dosing regimens based on complement and biomarkers to take forward into future phase II trials.

Similar to the engineering enhancements, we made to them taking them up we also optimized on Gen X 117 and to have sweeping capabilities we.

We expect these modifications will lead to differentiation in terms of the dosing levels and schedule and we can achieve with our CTO and Peabody.

Slide 13.

We have identified our first indication for <unk> 17 to be multifocal motor neuropathy for amendment, and which will sit within our neuromuscular franchise.

Tim Van Hauwermeiren: By contributing patients to ongoing global trials, we hope Zai will help accelerate the path to approval for each respective indication. And with Zy running phase two proof of concept trials in the future for Gartigabal indications, we hope to expand the scope of our overall pipeline. We aspire to take Epcattecumabat into 10 indications over time. Blind 12.

We used our proven indication selection strategy for EM and men and we'll do the same for additional phase III trials that we will stop.

First we rely on biology and.

And then ease and LNG and mediated disease with <unk> and auto antibodies activate complement via the classical pathway.

Q2 sits at the intersection of the classical and lectin pathway, making it an ideal target for an indication like N and M.

We continue to invest and translational work in the disease pathways of and the men and we'll share more of these data in the future.

Tim Van Hauwermeiren: We also recognize that we may have another pipeline opportunity with Argenix 117. We look forward to showing the first clinical data set mid-year from both an IV formulation and the subcube formulation equipped with halosium enhanced technology. With our phase one data, we will be showing safety and tolerability, PKPD properties, and we look to identify dosing regimens based on complement biomarkers to take forward into future phase two trials.

Beyond the solid biologic rationale that are also known clinical and regulatory endpoints and a man from precedent trials and a strong commercial case.

This is a patient population with a significant unmet need still exists.

As you can see we are very excited to advance our journey for 17 for it is.

We hope to reach even more patients suffering from autoimmune disease.

Before we move to the last key driver our early innovation.

To reiterate that our development program of Q2s and map in collaboration with Janssen remains ongoing as seen on slide 14.

We announced earlier this year that we are prioritizing the triple combination of Qs on asos cited and and for network Lex and the elevate trial.

Tim Van Hauwermeiren: Similar to the engineering enhancements we made to have Gantigamot, we also optimized Argenics 117 to have sweeping capabilities. We expect these modifications will lead to differentiation in terms of the dosing levels and schedule we can achieve with our C2 antibodies. Flight 13.

We will make decisions on next steps for the collaboration once we reviewed data from elevate specifically around response rate and <unk>.

[noise] ability safety and Tolerability and whether there may be trends to identify from AML subsets in the trial.

Slide 15.

Now onto our immunology innovation program for IP, a centerpiece to our long term value creation strategy.

Through our IP, we have been able to add value yield over the years by tuning and immunology breakthrough of our academic collaborators into non Genesis pipeline candidates.

Tim Van Hauwermeiren: We have identified our first indication for Hygienics 117 to be multifocal motor neuropathy, or MMN, which will sit within our neuromuscular franchise. We used our proven indication selection strategy for MMM, and we'll do the same for additional phase two trials that we will start. First, we rely on biology. MMM is an IGM-mediated disease where IGM auto-antibodies activate complement via the classical pathway.

We have done this with each candidate to date, whether its our wholly owned assets like <unk> or our journey. So on 17 or our partnered programs with abbvie layer or janssen or asset centric companies like anchor map or certain who are working with on Chinese created molecules.

And at our wholly owned candidates, we prioritize those that makes sense within our therapeutic franchises in order to leverage for capabilities across the value chain.

Slide 16.

In order to boost our <unk> toolkit, we are continually looking to enhance our technology capabilities.

We have our proprietary P region, and FC Engineering technologies, simple and hence portela <unk> and epic.

Tim Van Hauwermeiren: T2 sits at the intersection of the classical and lectin pathway, making it an ideal target for an indication like MNM. We continue to invest in translational work in the disease pathways of MMM and we'll share more of these data in the future, Beyond the Solid Biology Rational, there are also known clinical and regulatory endpoints in MN from precedent trials, and the strong commercial case This is a patient population where a significant unmet needs still exists, As you can see, we are very excited to advance Argenics 117 forward, as we hope to reach even more patients suffering from autoimmune disease.

We also have our license agreements with chugai, and Cleveland to amplify our FC engineered and capabilities.

With long term lifecycle management of advantage of modern mind, we are planning for a broad product delivery platform.

We have our collaboration with <unk> for which we still have for socket eliminations available and.

To date, we also announced our recent collaboration with electrify.

And at Boston based company with capabilities to a highly concentrated biologics into smaller volumes.

While still very early in development, we believe the technology could provide us the opportunity to dose I've got to dig them up and also future products with next generation delivery systems.

Similar to our collaboration with <unk>, we have target exclusivity for Epsilon and one additional targets.

These types of technology agreements will continue to be part of our early discovery strategy.

Tim Van Hauwermeiren: Before we move to the last key driver, our early innovation, I'd like to reiterate that our development program of QSatusumab in collaboration with Jansen remains ongoing, as seen on slide 14. We announced earlier this year that we are prioritizing the triple combination of Cusa, Asocytidin, and Venetoclax in the Elevate Trial. We will make decisions on next steps for the collaboration once we review data from Elevates, specifically around response rate, durability, safety, and tolerability, and whether there may be trends to identify from AML subsets in the trial. By 15,

We don't intend to communicate on each one but for you won't be share our commitment to evolving our overall capabilities as we grow and as of next generation technologies emerge.

And we hope that this continued investment will help us build the most differentiated pipeline possible.

Slide 17.

And the acceptance of both on applications for ICF got picking them up.

And give us and Japan, we are solidly positioned for a steady cadence of launches.

We are hopeful that the stellar results from the adapt trial will position us for success in Mg.

This is a space in which there hasn't been literally innovation and patients are still in need of more options.

We are laser focused on execution as we want to grow our team to expand into new indications for aircraft free develop our second pipeline and a product opportunity our journey for 17 and for identifying new high potential assets through our IP.

Tim Van Hauwermeiren: Now onto our immunology innovation program, or IIP, a centerpiece to our long-term value creation strategy. Through our IIP, we have been able to add value year over year by turning an immunology breakthrough by our academic collaborators into an Argenics pipeline candidate. We have done this with each candidate to date, whether it's our wholly owned assets like Avgard or Argenics 117, or our partner programs with AbV, Leia, or Janssen, or asset-centric companies like Agamap or Staten, who are working with Argenics-created molecules. For our wholly owned candidates, we prioritize those that make sense within our therapeutic franchises in order to leverage core capabilities across the value chain. Slide 16.

Finally, as we mentioned and the press release. This morning, we look forward to providing updates on our deep and differentiated pipeline of assets at our upcoming R&D day in July.

With that I will turn the call over to Eric for a financial update.

Thanks, Tim Slide.

Slide 18, Cobos off first quarter of 2021 operating results, which are detailed in today's press release and regulatory filings.

As we stated in this morning for <unk> as of January 2021, we changed our functional and presentation currency from Euro to U S dollars.

You would see our financial I liked reported and U S dollars going forward.

So total operating income increased by 141 $6 million for the first quarter of 2021.

$167 $4 million compared to 25 8 million and build outs for the same period in 2020.

Tim Van Hauwermeiren: In order to boost our IIP toolkit, we are continually looking to enhance our technology capabilities. We have our proprietary V region and FC engineering technologies, simple, enhance, intelligence, and abdx. We also have license agreements with Shugai and Clayton to amplify our FC engineering capabilities. With long-term lifecycle management of Agadjadigamod in mines, we are planning for broad product delivery platforms.

The increase was primarily due to the closing of our strategic collaboration for Siggi mode with Zyla, resulting in the local edition of $151 $9 million and collaboration Hogan.

I think the expenses increased by $17 7 million build outs for the quarter to $122 3 million compared to 100 and for $70 million for the same period last year.

This increase.

And so did the primarily from higher external R&D expenses, mainly related to our evaluation of <unk> in multiple indications and also clinical and preclinical programs.

Tim Van Hauwermeiren: We have our collaboration with Helozine, for which we still have four target nominations available. And today, we also announced our recent collaboration with ElectroFi, a Boston-based company with capabilities to highly concentrate biologics into smaller volumes. Although still very early in development, we believe the technology could provide us the opportunity to dose FGARTA JAMOT and other future products with a next generation delivery system. Similar to our collaboration with Alzheimer, we have target exclusivity for FCRN and one additional target.

Expenses were also due to a planned increase in accounts and the increased cost of the share based payment compensation plans related to the grants of stock options.

SG&A expenses totaled $56 $3 million for the fourth quarter compared to 27 $6 million for the same period in 2020.

The increase resulted primarily from higher facility expenses and <unk>.

And the costs of the share based payment compensation plans relating to the grant of stock options.

And also consulting fees linked to the preparation of a possible future commoditization of Edgar and see demand.

Tim Van Hauwermeiren: These types of technology agreements will continue to be part of our early discovery strategy. We don't intend to communicate on each one, but we want to share our commitment to evolving our overall capabilities as we grow and as next-generation technologies emerge. We hope that this continued investment will help us build the most differentiated pipeline possible. Slide 17. With the acceptance of both our applications for IVF Gatigamov in the US and Japan, we are solidly positioned for a steady cadence of launches. We are hopeful that the stellar results from the ADAP trial will position us for success in MG. This is a space in which there has been little innovation, and patients are still in need of more options.

We saw an increase in fair value on non current financial assets of $11 $2 million for the first quarter.

This is the result of I'd go mom and pop it excluding of series B financing round.

As you are aware, we maintain a profit share and Agua map for granting the license of algae and weeks 114.

Exchange losses totaled $28 $8 million for the three months ended March 31st 2021.

Compared to and exchange gain of $23 million for the same period in the prior year.

Because of the change in on currency exchange losses for the first quarter reflect the unfavorable change in the Euro U S dollar exchange rates.

Finally, we ended the quarter with cash cash equivalents and current financial assets.

Tim Van Hauwermeiren: We are laser focused on execution as we, one, grow our team, and two, expand into new indications for FGARTS. Three, develop our second pipeline in a product opportunity, Argenix 117, and four, identify new high-potential assets through our IIP. Finally, as we mentioned in the press release this morning, we look forward to providing an update on our deep and differentiated pipeline of assets at our upcoming R&D day in July. With that, I will turn the call over to Eric for a financial update. Thanks, Tim.

Moving to $9 billion compared to $2 billion on December 31st 2020.

This increase resulted primarily from the closing of our global offering in February 2021, resulting in $1 1 billion in net for seats.

And the net receipts of all development cost sharing payments received from <unk>.

These were partially offset by payments to buyer for.

For priority review voucher and he owes the net cash flows used in operating activities.

And we'll now turn the call over to Keith for <unk>.

Eric Costaldy: Slide 18 covers our first quarter 2021 operating results, which are detailed in today's press release and regulatory filing. As we stated in this morning press release, as of January 1st, 2021, we changed our functional and presentation currency from the euro to the US dollar, so you will see our financial highlights reported in US dollars going forward. Total operating income increased by $141.6 million for the first quarter of 2021 to $167.4 million, compared to $25.8 million for the same period in 2020.

Based on our commercial activities.

Yeah.

Thank you Eric to Echo <unk> sentiments, it's amazing to consider that the pivotal adapt readout of F guard kick them out at and MG was just one year ago. This was a significant gating event, which let us to meaningfully expand and accelerate the development of our commercial organization.

The driving force, which continues to push US forward as we approach a potential launch is the magnitude of what this treatment could mean for patients.

A significant unmet need for innovative fast acting safe treatments for people living with M. G. We hear that every day from key stakeholders, including the patients themselves their caregivers advocacy partners and the physicians who treat them.

Eric Costaldy: The increase was primarily due to the closing of our strategic collaboration with Edgar Tigimaud with Zeylab, resulting in the recognition of $151.59 million in collaboration revenues. R&D expenses increased by $17.7 million for the quarter to $122.3 million, compared to $104.7 million for the same period last year. This increase resulted primarily from higher external R&D expenses, mainly related to our evaluation of Edgar Sigismod in multiple indications and other clinical and pre-clinical programs.

As part of our ongoing commitment to the MG community. We recently launched our preapproval access program.

We are preparing for and end of year approval and the U S. But in the meantime, we want to ensure that we can offer after taking them out to Mg patients who meet the preapproval access criteria.

<unk> P. A a is currently open and the U S, Canada and seven countries in Europe.

We also continue to provide IV start taking them out to patients who remain on the adapt study.

And sub Q F got take them on to patients enrolling and our adapt sub Q trial, whether it's from rollover from IV or as new participants.

Eric Costaldy: The higher expenses were also due to a planned increase in headcount and the increased cost of the share-based payment compensation plans related to the grants of stock options. SG&A expenses totaled $56.3 million for the first quarter, compared to $27.6 million for the same period in 2020. The increase resulted primarily from higher personal expenses, including the costs of the share-based payment compensation plans related to the grant of stock options, and also consulting fees linked to the preparation of a possible future commercialization of Edgar Sigelma.

As Tim already mentioned, we are still the only company actively evaluating both IV and sub two formulations of and F. C. R and antagonist and this is important for us to reach as many patients as possible.

We believe this optionality will be a significant competitive advantage from both a reimbursement standpoint and from a patient and physician preference perspective.

On slide 19, we remained sharply focused on our engagement efforts with all key stakeholders, including patients health care providers and payers.

Eric Costaldy: We saw an increase in fair value on non-current financial assets of $11.2 million for the first quarter. This is the result of Agomab Therapeutics closing its Series B financing round. As you are aware, we maintain a profit share in Agomab for granting the license for Argenix 14. Exchange losses total $28.8 million for the three months ended March 31, 2021, compared to an exchange gain of $23 million for the same period in the prior year.

For patients, we have awareness and advocacy initiatives well underway as depicted on slide 20.

Our Mg United platform has ongoing engagement from over 25000 unique visitors on.

Our real World evidence study continues to enroll and now has close to 2000 participants day.

Data from this study and addition to our health economics outcomes work will be instrumental and helping us better understand the disease burden associated with Mg.

All of these initiatives are guiding our engagement efforts with a broader mg community as we prepare for our potential launch.

Eric Costaldy: Because of the change in our currency, the exchange losses for the first quarter reflect the unfavorable change in the Euro-US dollar exchange rate. Finally, we ended the quarter with cash, cash equivalence, and current financial assets totaling $2.9 billion, compared to $2 billion on December 31, 2020. This increase resulted primarily from the closing of our global offering in February 2021, resulting in 1.1 billion dollars in net proceeds and the net receipt of our development cost sharing payment received from Zyla.

We have also engaged most of the leading gmg treating neurologists through our disease State awareness campaign, our medical affairs team has been actively engaging with the neurologists as well most recently at the a and meeting a few weeks ago.

Our MRO and T. R. L L. Our hard work and their education efforts as we know how crucial this will be at launch given the new mechanism of action.

From a payer perspective, we continue to engage with national and regional payers on the potential value that FBR check them out could provide to Mg patients. Our team is also engaging with specialty pharmacies specialty distributors and infusion networks to ensure broad access for patients at launch and.

Eric Costaldy: These were partially offset by our payments to the buyer for a priority review voucher and the other net cash flows used in operating activities. I will now turn the call over to Keith for an update on our commercial activities. Thank you, Eric. To echo Chem's sentiments, it's amazing to consider that the pivotal adaptive readout of FGar Tigamo

Other key part of this will be our patient support program, which will be managed closely by our team of nurse case managers, who will work towards building a critical infrastructure to help support access for gmg patients prescribed F guard take them out and following its approval.

Keith Woods: and MG It was just one year ago. This was a significant gating event.

Slide 21.

From a regulatory perspective as you saw on the press release. This morning, we are thrilled to have the J M. A a accepted for review by P. M D E and Japan with a targeted launch in 2020 two.

Keith Woods: gating event which led us to meaningfully expand and accelerate the development of our commercial organization. The driving force which continues to push us forward as we approach a potential launch is the magnitude of what this treatment could mean for patients. There is a significant, unmet need for innovative, fast-acting, safe treatments for people living with MG. We hear this every day from key stakeholders, including the patients themselves, their caregivers, advocacy partners, and the physicians who treat them.

We continue to make strategic hires and expand our global organization and support a series of launches and the coming years.

And we now have over 500 employees globally, including growing commercial organizations within the U S Europe and Japan.

While our key functional heads have been in place for more than a year. We're now on the process of hiring our field sales forces. We recently brought on a regional business directors and are starting the interview process for our territory business managers I've been very impressed with the high caliber of candidates we are engaging with as we expand.

Keith Woods: As part of our ongoing commitment to the MG community, we recently launched our pre-approval access program. We're preparing for an end-of-year approval in the U.S., but in the meantime, we want to ensure that we can offer FGar Tigamad to MG patients who meet the pre-approval access criteria. Our PAA is currently open in the U.S., Canada, and seven countries in Europe. We also continue to provide IV FGARTygmod to patients who remain on the ADAPT Plus study and sub-QFGARTIG to patients enrolling in our ADAPT sub-Q trial, whether it's from rollover from IV or as new participants. As Tim already mentioned, we are still the only company actively evaluating both IV and subcube formulations of an FCRN antagon.

The breadth of experience and core cultural alignment they bring to our organization will help us to get the differentiated medicines to patients in need.

Slide 22. Additionally.

Additionally, we know that the strategic investments, we are making now and top tier candidates will benefit us as we expand our neuromuscular franchise and to see IDP and future indications with FTR take them on and our Gen X 117.

We plan to execute a similar smart growth strategy for our other evolving franchises as we base our future hires around key data events.

Finally, we have strong manufacturing and logistic partnerships in place with World class companies like lines up for drug substance vetter for fill and finish and Cardinal health for third party logistics, we're actively collaborating with global regulators to ensure that in person or virtual inspections can occur as needed.

Keith Woods: This is important for us to reach as many patients as possible. We believe this optionality will be a significant competitive advantage from both a reimbursement standpoint and from a patient and physician preference perspective. On slide 19, we remain sharply focused on our engagement efforts with all key stakeholders, including patients, healthcare providers, and payers. For patients, we have awareness and advocacy initiatives well underway, as depicted on slide 20. Our MG United platform has ongoing engagement from over 25 unique visitors.

To conclude we see signs of hope that the effects of the global pandemic will be somewhat attenuated by our December 17th Paducah date, even so we are preparing for the likelihood that we will launch and are partially virtual environment and.

Growth will be gradual and steady as we are engaging with customers regarding this new mechanism of action on.

I'll now turn the call back to Jim for some concluding remarks Tim.

Thanks Keith.

Before we begin the Q&A I would like to conclude with slide 23.

We are working hard every day to build the next great integrated global Immunology organization that is strongly positioned for long term sustainable growth.

Keith Woods: Our real-world evidence study continues to enroll and now has close to 2,000 participants. Data from this study, in addition to our health economics outcomes work, will be instrumental in helping us better understand the disease burden associated with MG. All of these initiatives are guiding our engagement efforts with the broader MG community as we prepare for our potential loan.

We are well capitalized and our strong balance sheet will provide a foundation to expand our team and reached new indications and geographies.

We have made meaningful progress with our lead asset I've got to get them up and.

And our focus on execution as we advance forward six indications.

We look forward to expanding the breadth of this pipeline with the help of our strategic part of xylem.

Keith Woods: We have also engaged most of the leading GMG treating neurologists through our disease state awareness campaign. Our medical affairs team has been actively engaging with the neurologists as well, most recently at the AAN meeting a few weeks ago. Our MRLs and TRLs are hard at work in their education efforts, as we know how crucial this will be at launch, given the new mechanism of action.

We are also approaching the first clinical data readout from our Chinese for 17, which we hope and launched our next growth pipeline opportunity into meaningful autoimmune indications.

And finally, we remain firmly rooted and groundbreaking immunology research as we grow through our IP and collaborative efforts in order to help improve the lives of patients around the world.

With that I will turn the call back to the operator to open the call for your questions.

Keith Woods: From a payer perspective, we continue to engage with national and regional payers on the potential value that FGgamad could provide to MG patients. Our team is also engaging with specialty pharmacies, specialty distributors, and infusion networks to ensure broad access for patients at launch. Another key part of this will be our patient support program, which will be managed closely by our team of nurse case managers who will work towards building a critical infrastructure to help support access for GMG patients prescribed FGARTIGMOD following its approval. Slide 21.

We will now begin the question and answer session to ask a question you May Press Star then one on your Touchtone phone.

Youre using a speakerphone please pick up your handset before pressing the keys to withdraw your question. Please press Star then two.

And the interest of answering as many questions as possible each person and the Q is limited to one question only at this time, we will pause momentarily to assemble our roster.

Our first question comes from Derek.

Derrick our chiller from Stifel. Please go ahead.

Hey, good morning, and congrats on the progress guys.

One question all right. So maybe this is for Keith you talked about the free approval access program for <unk> or take them on and MG patients. So just wanted to kind of get a sense of what the patient criteria are for getting access and I guess.

Keith Woods: From a regulatory perspective, as you saw in the press release this morning, we are thrilled to have the JMAA accepted for review by PMDA and Japan with a targeted launch in 2022. We continue to make strategic hires and expand our global organization and support a series of launches in the coming year. We now have over 500 employees globally, including growing commercial organizations within the U.S., Europe, and Japan. While our key functional heads have been in place for more than a year, we are now in the process of hiring our field sales staff. We recently brought on our regional business directors and are starting the interview process for our territory business manager.

How are you communicating that that program. If you can at all and is there a cap on the number of patients who can actually enrolling for that program. Thanks.

And good morning, Derrick and thanks for the question. So you know where we.

And we're really pleased to offer the preapproval access program.

This program demonstrates our commitment to the patients who are living with Mg at the time at this time right now.

The commitment is to only for patients that are with Mg that cannot participate in a clinical trial because remember if a patient can participate in and the clinical trial, we are actively enrolling or sub Q F guard tick them on Mg trial.

If they cannot participate and the clinical trial that can go on to the preapproval access program, but basically it has the same strict inclusion exclusion criterias that we used in our phase III clinical trial and.

Keith Woods: I've been very impressed with the high caliber of candidates we are engaging with as we expand. The breadth of experience and core cultural alignment they bring to our organization will help us to get differentiated medicines to patients in need. Slide 22.

Again. This is just another way to honor our commitment to patients you know that all of our patients that participated and adapt were eligible to roll over into our O L. Eight and more than 75 per cent of the patients that rolled over and still on after they complete a year and that's O L. Eight they will have the option to remain on therapy, we're committed to them or as Tim stated and that.

Keith Woods: Additionally, we know that the strategic investments we are making now in top-tier candidates will benefit us as we expand our neuromuscular franchise into CIDP and future indications with FGARTIGMUD and Argenix 117. We plan to execute a similar smart growth strategy for our other evolving franchises as we base our future hires around key data events. Finally, we have strong manufacturing and logistics partnerships in place with world-class companies like Lonza for drug substance, Vetter for fill and finish, and Cardinal Health for third-party logistics.

Prepared remarks, they can rollover into our sub Q bridging study.

Got it Okay and then there is no cap on the number of patients that you can get into that access program.

So we have we have and internal cap right now just because of the amount of supply that we've shipped to our partner clinics.

But.

We can always change that is needed.

Alright, Thanks, guys and congrats again on the progress.

Yeah.

The next question comes from a cash to worry from Wolfe Research. Please go ahead.

Keith Woods: We're actively collaborating with global regulators to ensure that in-person or virtual inspections can occur as needed. To conclude, we see signs of hope that the effects of the global pandemic will be somewhat attenuated by our December 17th Padupa date. Even so, we're preparing for the likelihood that we will launch in a partially virtual environment, and that growth will be gradual and steady as we engage with customers regarding this new mechanism of action. I will now turn the call back to Tim for some concluding remarks. Tim?

Hi, This is Andy on for a cost and so much for taking a question on.

For electric partnership.

More of a backup option or are you seeing any sort of benefit with their micro petrol threat and suspension technology versus halos and.

And I can cool E. Okay.

And then if I could just sneak on one more on and so I'm, giving you the likes and both are on 24 weekends and trials and you have and earlier eight week kind of en Pointe has the FDA for cyclical spot on looking.

On what they expect for efficacy between the week and 24.

And that's it thank you so much.

Thank you for the question.

Tim Van Hauwermeiren: Thanks, Keith. Before we begin the Q&A, I would like to conclude with slides 23. We are working hard every day to build the next great integrated global immunology organization that is strongly positioned for long-term sustainable growth. We are well capitalized, and our strong balance sheet will provide a foundation to expand our team and reach new indications and geography. We have made meaningful progress with our lead asset of Gatigamat and are focused on execution as we advance forward six indications.

And we take the electrifying question first and then I will hand over to Keith and for the FDA related question. So the way you have to think about our collaboration with Electrifies debt.

We're always thinking five steps ahead and this is a relatively early stage technology.

And it's a promising technology, if you want to break through the body of the typical physical limits of the concentration you would can you kind of achieve for their biological like and antibody or antibody fragments you may remember that for I've got pick them up and we already reached 200 milligram per minute either concentration which is phenomenal.

And if you want to breakthrough that you need you need different type of technology and Thats, what we are seeking to access through the electrify and collaborations.

The backbone of our subcutaneous product presentation approach continues of course would be the Halo zone technology debt sub Q execution is now in place across all our indications and maybe keeps you want to address the FDA question.

Tim Van Hauwermeiren: We look forward to expanding the breadth of this pipeline with the help of our strategic father, Zeylab. We are also approaching the first clinical data readout from Argenics 117, which we hope will launch our next broad pipeline opportunity into meaningful autoimmune indications. And finally, we remain firmly rooted in groundbreaking immunology research as we grow through our IIP and collaborative efforts in order to help improve the lives of patients around the world. With that, I will turn the call back to the operator to open the call to your question. We will now begin the question.

I'm happy to do so Tim So Amy Thanks, Yeah. Our primary endpoint was in fact at week eight but you know we continue to retreat. These patients throughout the entire study and in fact, we've shared that at that primary endpoint at week eight we had a 67, 7% response rate, but after a second <unk>.

Nicole almost 80% of patients that were exposed to ask or take them out had a response. So we're sharing the continued positive clinical efficacy data with the FDA as we go through revenue.

Okay, great. Thank you so much.

Operator: We will now begin the question and answer session. To ask a question, you may press star, then one, on your touchtone phone. If you're using a speaker phone, please pick up your handset before pressing the keys.

The next question comes from <unk> Ahmad from Bank of America. Please go ahead.

Hi, good morning. Thanks, so much for taking my question just wanted to get a little bit of color regarding the specifics of your collaboration with bio lab can you just remind us what are the total milestones and potentially expected and when could the next milestone being the collaboration.

Operator: To withdraw your question, please press star, then two. In the interest of answering as many questions as possible, each person in the queue is limited to one question only. At this time, we'll pause momentarily to assemble our roster. Our first question comes from Derek Archela from Stiefel. Please go ahead.

Thank you Terry and thank you for being with US today and thank you for your question on <unk>.

Partnership is very excited about that.

Remember we spoke about.

$175 million upfront phosphate in cash upon signing and partially in equity and a smaller fraction and associated with the milestone regulator and milestone, which will happen and downstream and then all remaining part of the economics actually situate themselves in a royalty and <unk>.

Derek Christian Archila: Hey, good morning, and congrats on the progress, guys. One question, all right, so maybe this is for Keith. You talked about the pre-approval access program for FFGICOMON and MG patients, so I just want to kind of get a sense of what the patient criteria are for getting access, and I guess how are you communicating that program, if you can at all, and is there a cap on the number of patients you can actually enroll into that program? Thanks.

With day to us on net sales in their tenancy.

Thank you.

Yeah.

Yeah.

The next question comes from Joon Lee from <unk> Securities. Please go ahead.

Hi, Thanks for taking our questions and for the upper.

Can you talk a little bit about your ongoing dialogue with payers ahead of the approval and how youre thinking about price per vial given.

Your individualized dosing regimen and know how.

How much of an inter patient or even intra patient variation.

Keith Woods: Good morning, Derek, and thanks for the question. So, you know, we were really pleased to offer the pre-approval access program because this program demonstrates our commitment to the patients who are living with MG. But at this time, right now, the commitment is only for patients who are with MG who cannot participate in a clinical trial. Because remember, if a patient can participate in a clinical trial, we are actively enrolling our sub Q, F-Gar-Tygamot-MG trial. If they cannot participate in the clinical trial, they can go into the pre-approval access program, but basically, it has the same strict inclusion and exclusion criteria that we used in our phase three clinical trial.

Are there and frequency and how quickly can you also get a J code established post approval. Thank you.

Yeah. So are you on a few things first of all we have a fully staffed U S market access team. So we not only have our teams that cover the national payers, but we also throughout the U S have a teen place that's covering all of the regional payers. So we continue to have regular dialog.

With the payers and I want to remind you that you know they're pleased with it.

On approach such as individualized dosing because they don't want to have to pay for a therapy or medication when it's not needed.

Does lead the question for them, Okay, what can I expect and so you know what we are sharing and Oh.

Keith Woods: Again, this is just another way to honor our commitment to patients. You know that all of our patients that participated in and adapted were eligible to roll over into our OLE, and more than 75% of the patients that rolled over are still on. After they complete a year in that OLA, they will have the option to remain on therapy; we're committed to them, or, as Tim stated in the prepared remarks, they can roll over into our subcube bridging study.

Over time is what occurred and the adapt trial and then the adapt plus trial. So that we can have an idea of what is the average number of cycles that are going to be required and a year.

And youre going to have something we have some patients that get a really long benefit from one cycle of FTR take them on and those patients are going to be the less expensive patients. We have others that are going to require more chronic treatment.

But what we will do is look at the average and see how that how that the distribution curve shapes out and then we were pricing for the annual value to manage a patient and put a patient and a minimum minimal symptom expression and then be able to maintain them there and we will price for the average on that and that Baxter right into our bio price.

Keith Woods: Got it, and there's no cap on the number of patients you can get into that access program. So we have an internal cap right now just because of the amount of supply that we've shipped to our partner Clinogen. But, you know, we can always change that as needed. Cool. All right, thanks guys, and congrats again on the progress.

Great. Thank you.

The next question comes from Danielle Brill from Raymond James. Please go ahead.

Operator: The next question comes from Akash Tawari from Wolf Research. Please go ahead.

Hey, guys. Good morning, Thanks, so much for the question.

I was just wondering if you can maybe comment a little bit more on the TAA program and involvement I'm curious, how it's tracking compared to your internal expectations and I mean, if you could share how many patients you've been around that would be great. Thank.

Amy Li: Hi, this is Amy on behalf of Akosh. Thanks so much for taking your question.

Amy Li: On your electrophy partnership, is this more of a backup option, or are you seeing any sort of benefit with their microparticulate suspension technology versus halos in areas including AE, B.K.? And then, if we could just sneak in one more on NG, given you and Alexeam both ran 26-week NG trials, but you have an earlier eight-week primary endpoint. Has the FDA specifically said anything on what they expect for efficacy between weeks 8 and 26? And that's it. Thank you so much.

Thank you.

Yeah, Danielle we have not made that information public yet I can tell you that the P. A a there's been demand coming from the U S from Canada and from Europe already it's a process that we go through to actually enroll the patients and get them started so the demand if it meets our expectations.

And at this point, we just haven't disclosed the total number of patients that are that are in the PAA.

Tim Van Hauwermeiren: Thank you for the question. Let me take the Electrofi question first, and then I will hand over to Keith for the FDA-related question. So the way you have to think about our collaboration with ElectroFi is that, you know, we're always thinking five steps ahead. This is a relatively early stage technology, and it's a promising technology if you want to break through the barrier of the typical physical limit of the concentration you can achieve with a biological like an antibody or an antibody fragment. You may remember that for Aggartenmot, we have already reached the 200 milligram per milliliter concentration, which is phenomenal. But if you want to break through that, you need a different type of technology.

Thanks.

The next question comes from yarn Werber from Cowen. Please go ahead.

Great. Thanks for taking my question and I actually have a question about a 117 for EM and.

And maybe can you I don't know if you can share with US how are you thinking about the the time to evaluate and the primary endpoint and on.

Our old patient is going to have to be anti jam on I, Jim antibody positive to be and the world and I assume they need to be second line onwards. Thank you.

Hello, and thank you for being with us today and.

And what concerns and them and of course, so far we have been talking mainly about our conviction around the biology of this disease, you know clearly driven by pathogenic and.

Jim antibodies, which do recruits the classical pathway, we haven't disclosed details yet on the clinical trial design, but we will do so when we are progressing and two.

Tim Van Hauwermeiren: And that's what we're seeking to access through the electrifying collaboration. The backbone of our subcutaneous product presentation approach continues, of course, to be the halosine technology. That sub-Q execution is now in play across all our indications. Maybe Kichita wants to address the FDA question. Happy to do so, Tim. So, Amy, thanks.

And the R&D day D trial design is something and you kind of get inspiration for when you look at the ICI trials and.

And which we can all our studies are indeed, and the mens space and these are the trials, which has basically established the clinical and regulatory endpoints and.

To answer your second question no and.

We will probably not use and anti GM, one antibodies, a presence as and inclusion criterion and.

Keith Woods: Yeah, our primary endpoint was, in fact, at week eight, but, you know, we continue to treat these patients throughout the entire study. In fact, we've shared that at that primary endpoint at week eight, we had a 67.7% response rate, but after a second cycle, almost 80% of patients that were exposed to FGARTigamad had a response. So we're sharing the continued positive clinical efficacy data with the FDA as we go through a review.

We will disclose of course and more detailed inclusion exclusion criteria, but we believe there is recent evidence.

Amongst all of us from our key collaborations and after Utrecht University, and suggesting that all and the men patients and she has this auto antibodies and actually the title of this ultra antibodies diabetic correlates with disease severity.

Thanks for the question.

Yeah.

The next question comes from Jason Butler from JMP. Please go ahead.

Hi, Thanks, I had another one on one oneself and actually thanks for taking the question and just.

And just if you're thinking about the potential for a longer duration or durability of effect versus IV AG and the fact that this is a slower and slower progressing disease. Just how are you thinking about the control arm and and how to optimize.

Keith Woods: Okay, great. Thank you so much.

Operator: The next question comes from Kazin Ahmad from Bank of America. Please go ahead.

Tazeen Ahmad: Hi, good morning. Thanks so much for taking my question. I just wanted to get a little bit of color regarding the specifics of your collaboration with BILAB. Can you just remind us what the total milestones are potentially expected and when the next milestone in the collaboration could be? Thanks.

And or around that thanks.

Hey, Jason and thank you for being with US today. Thank you for this question and we Havent disclosed Ah trial design, yet and.

We will do so you'll know that we do that.

I would suggest that you take a look at for example, the <unk> trial, which we unveiled the trial designed to give you a feeling of how you could work in this type of diseases and be considered and are meant to be very similar to see IDP. When it comes to thinking through the pitfalls of clinical trial and execution of design and execute.

Tim Van Hauwermeiren: Thank you, Tazin. Thank you for being with us today, and thank you for your question about Xylep.

Tim Van Hauwermeiren: It's a partnership we're very excited about. Remember, we spoke about a total of 175 million up front, partially in cash upon signing, partially in equity, and a smaller fraction associated with a milestone, regulatory milestone, which will happen downstream. And then all remaining parts of the economics actually situate themselves in a royalty, which Xyleap would pay to us on net sales in their territory.

<unk>.

And.

Great. Thanks.

The next question comes from James Gordon from J P. Morgan. Please go ahead.

Hello, James Gordon Jpmorgan, Thanks for taking the question.

And I had a question on a new methods and so I saw the electrical and taking that all factor D inhibitor into phase III for Mg. So the question is how promising do you see that sort of approach for treatment of a disease like Mg and CDR and oral factor D work, even more broadly the and M. G and any of the other indications that you're planning on selling team for the next day by day.

Operator: The next question comes from June Lee from Truist Securities. Please go ahead. Hi.

Joon So Lee: Hi, thanks for taking our questions and for the updates. Can you talk a little bit about your ongoing dialogue with payers, you know, ahead of the approval and how you're thinking about pricing per vial given, you know, your individualized dosing regimen, you know, how much of an interpatient or even intrapatient variation there is in frequency, and how quickly can you also get a J-Code established post-approval? Yeah, June, a few things.

And hip itself or the reason not to be too optimistic there and.

Or is it just a clarification just on and the electro feed formulation weighted.

The earliest that that might potentially be able to come to market place.

Thank you James concerning your question on the involvement of complements in Mg.

And whether you have those and the and the C. Five blocker on effective day blocker.

The board would be.

We know about the disease biology is it actually the ultra antibody is at the heart of the disease biology.

Keith Woods: First of all, we have a fully staffed U.S. market access team. So we not only have teams that cover the national payers, but we also, throughout the U.S., have a team place that covers all of the regional payers. So we continue to have regular dialogue with the payers. I want to remind you that, you know, they're pleased with an approach such as individualized dosing because they don't want to have to pay for therapy or medication when it's needed. It does leave the question for them, okay, what can I expect?

It is exerting multiple pathogenic modes of action at the neuromuscular junction complement recruitment is just one of them is also.

Total Canadian receptor blockade and cross linking and internalization and which are in place and therefore, we think that and IGD moving agents like I've got teach them ups should play upstream of any complement inhibitor, regardless for the debt would be a C. Five broker or effects of deepwater concerning your question on <unk>.

Electrify its too early to give you a timeline for if and when a product could hit the markets.

<unk> is a novel technology, which to a certain extent going to pioneer and close collaboration with our partner electrifying.

Thank you.

Keith Woods: And so, you know, what we are sharing over time is what occurred in the ADAPT trial and in the ADAPT Plus trial so that we can have an idea of what the average number of cycles that are going to be required in a year. And you're going to have some patients that get a really long benefit from one cycle of FGARTIGAMOD. And those patients are going to be, you know, the least expensive of patients.

Yeah.

The next question comes from Douglas <unk> from H C. Wainwright. Please go ahead.

Hi, good morning, and thanks for taking the questions just wanted to revisit the question on on pricing.

As indicated you're going to set a price for the average duration on I'm. Just curious have you engaged with payers and sort of more of a value based model and needing just sort of setting and annual price regardless of how many treatments they need but just sort of controlling somebody's pet somebody's disease beat mg or <unk> or any other disease and development. Thanks.

Keith Woods: We have others that are going to require more chronic treatment. But what we will do is look at the average and see how that distribution curve shapes out. And then we are pricing for the annual value to manage a patient, to put a patient in the minimal symptom expression and then be able to maintain them there. And we will price for the average on that, and that backs us right into our biopartic.

Yeah. So Doug we have engaged with payers on exactly that we've also done a great deal of market research after showing them the data and asking them what they believe the annual value is.

Net stated this before you you have a product that's being used and M. G. Right now that's approved with Soliris debt has a retail it and up to 700000 per year, and it's been pretty well covered by payers for relapsed refractory Mg I.

Operator: The next question comes from Danielle Brill from Raymond James. Please go ahead.

Danielle Brill: Thank you guys, good morning. Thanks so much for the question.

I think that we are going to be able to offer a great value to.

And the payers and said the patients because of the impact the clinical impact that we can have on these patients and again you know we're looking at FBR take them on in the Big picture, it's bigger than just the launch of M. G. You know we're already in for indications will be and six before the end of the year with aspirations to go up to 10 indications. So we need to think about that.

Danielle Brill: I was just wondering if you could maybe comment a little bit more on the PAA program enrollment. I'm curious how it's tracking compared to your internal expectations. And, I mean, if you could share how many patients you've enrolled, that'd be great. Thank you.

Keith Woods: Yeah, Danielle, we have not made that information public yet. I can tell you that the PAA has been demand coming from the U.S., from Canada, and from Europe already. It's a process that we go through to actually enroll patients and get them started. So the demand is meeting our expectations, and at this point, we just haven't disclosed the total number of patients that are in the PAA.

As we go to price as well.

Okay.

Yes.

The next question comes from Craig Susanna Fey from Goldman Sachs. Please go ahead.

Okay. Good morning, and good afternoon, and thank you for taking my question.

And I had a question just on your <unk>.

And it announced and Thats fifth indication and a sixth and vacation for eschar take them on could you just remind us if.

Operator: The next question comes from Yarn Werber from Callan. Please go ahead. Great. Thanks for taking my question.

Those indications.

Yaron Benjamin Werber: Great, thanks for taking my question. I actually have a question about 117 for MMN. Maybe you can, I don't know if you can, share with us how you think about the time to evaluate the primary endpoint, and are all patients going to have to be anti-GM-1, IGM antibody positive to be enrolled? And I assume they need to be second line onwards. Thank you. Thank you for being with us today.

<unk> evaluate both and IV and a sub Q or if you're <unk>.

Leading with a sub Q formulation and then in terms of the indications and themselves if one or both of them will be.

Overlapping with your existing.

And as these areas of interest or if they will establish a new beachhead.

And then secondly, maybe just a quick one on your upcoming R&D day, how much of that R&D day will you spend talking about perhaps for non eschar taken non 117 and non cause it to some that pipeline and whether they are proprietary or partner. Thank you.

Tim Van Hauwermeiren: What concerns MMM? Of course, so far, we have been talking mainly about our convictions about the biology of this disease, clearly driven by pathogenic IGM antibodies that do recruit the classical pathway. We haven't disclosed details yet on the clinical trial design, but we will do so when we're progressing through the R&D day. The trial design is something you can get inspiration for when you look at the IVIG trials, which we can all study in the MMMN space.

Thank you Greg Thank you for being with US today concerning your first question and it is our efficient to have both IV and subcutaneous available and each and all of our indications you can see from the pipeline updates that we have been prioritizing for the more recent indications.

So Q product execution.

Because it gives us more degrees of freedom during this COVID-19 pandemic.

Tim Van Hauwermeiren: These are the trials that have basically established the clinical and regulatory endpoints. To answer your second question, no. We will probably not use the presence of anti-GM1 antibodies as an inclusion criterion. We will disclose, of course, in more detail, the inclusion criteria. But we believe there is recent evidence, amongst others from our key collaborator at the Utrecht University, suggesting that all MN patients actually have these older antibodies. And actually, the tighter of these auto antibodies correlates with disease severity.

And we already disclosed publicly that the <unk> indication it will fit squarely in our keeps neuromuscular franchise and we will be talking more about you know D sixth indication of course and soon.

<unk> R&D day will mainly focus I think on I've got teach him up and he is a tusa met the day agenda will be made public soon and then maybe we can interact and for further questions on the agenda on that thank you.

The next question comes from Rosie Turner from Barclays. Please go ahead.

Good morning, and good afternoon, and thank you very much for taking my question and just one on manufacturing if I may and I know you don't think and.

Operator: The next question comes from Jason Butler from JMP.

T part and of that.

And they've been having some issues.

Jason Butler: Hi, thanks. I had another one on 111-17, actually. Thanks for taking the question. Just if you're thinking about the potential for a longer duration or durability of effect versus IVIG and the fact that this is a slower, slower progressing disease, just how are you thinking about the control arm and how to optimize, you know, around that? Hey, Jason, thank you for being with us today. Thank you for this question. We haven't disclosed the trial design yet, and we will do so. You know that we do that.

Ashish manufacturing and Montana vaccine and tons of Tonight, and I was just wondering.

Hi on discussions with them are progressing and if there's any indication and could be some delays and then beginning of 2020 team. When you are ready to start and only king. Thank you.

Okay.

Thank you rose and maybe keeps you would like to take this question.

Sure happy to so rosy first of all I want you to rest assure that we already have commercial supply that is manufactured and ready to go for launch. Additionally, we know that the global pandemic has put additional pressure on the supply chain. Fortunately, we had already ramped up production prior to the pandemic.

Tim Van Hauwermeiren: I would suggest that you take a look at, for example, the CIDP trial, which we unveiled the trial design to give you a feeling of, you know, how you could work in this type of disease. We consider MMMN to be very similar to CIDP when it comes to thinking through the pitfalls of clinical trial design and execution, design and execution. Thank you.

Because of the you can see how much are.

You know, we're putting into our pipeline and then going into China, where there's a huge population so.

So we wanted to make sure that we had ramped up our supply well in advance and we did that and finally regarding communication with larger we have a very good relationship with Alonso and I can tell you that we speak to them.

Operator: The next question comes from James Gordon from J.P. Morgan. Please go ahead. Hello,

James Daniel Gordon: Hello, James Gordon, thank you for taking the question. I had a question on a new mechanism, so I saw that Alexion had taken their all-factor D inhibitor into phase two for MG. The question is, how promising do you see that sort of approach for treatment of a disease like MG? And could an all-factor D work even more broadly than MG, like any of the other indications that you're planning on targeting with an FCR inhibitor, or the reason not to be too optimistic there? And also just a clarification, on the electricity formulation, when is the earliest that that might potentially be able to come to market, please? Thank you, James.

Pretty much on a weekly basis going through all of the logistics, So I feel quite confident and where we are now.

And we've taken all the precautions that we can so unless something unforeseen we should be in good shape.

So just one for lot and says that and face and sub keys and IV <unk>.

Yes, I mean right now we're focused on the IV supply from a commercial point of view and the subdued supply we're focused on for a clinical trial drove two separate okay.

Perfect. Thank you very much.

Thank you.

The next question comes from Tien sooner Jay from Guggenheim. Please go ahead.

Hey, guys. This is eddie on for yacht and thanks for taking the questions. So I just wanted to ask how youre thinking about for filing for ITT are the two advanced trials each sufficient on their own or will you need to separate SPL is or do you need to see success and both and filed together and then are there any safety requirements are gating factors that differ between those two formulations.

Tim Van Hauwermeiren: Concerning your question on the involvement of complement in MG, whether you have a C5 blocker or a factor D blocker, what we know about the disease biology is that the autoantibody is at the heart of the disease biology. It's exerting multiple pathogenic effects at the neuromuscular junction, and compliment recruitment is just one of them. It's also satirical unenoreceptor blockades, cross-linking, and internalization, which are in play. And therefore, we think that an IGD-moving agent like FGAMOT should play upstream.

Thanks.

Thank you Andy so the Ids and both the IV and the sub Q or try and and ICP with jointly satisfies the requirements of the FDA for the BLA filings for the the data packages of both trials, which feed into one and the same a BLA and the and indeed would meet.

And their requirements and.

In terms of channel two independent studies, but also the requirement in terms of size of the safety database.

Tim Van Hauwermeiren: of any complement inhibitor, regardless whether that would be a C5 blocker or a factor D blocker. Concerning your question on Electrofi, it's too early to give you a timeline for if and when a product could hit the market. This is a novel technology, which we are, to a certain extent, going to pioneer in close collaboration with our partner electrifying.

Thank you.

The next question comes from Lenny Van <unk> Heiser from KBC. Please go ahead.

And good afternoon, let me here and thanks for taking the question a quick one on 117 and we see that the plan is to involve our XI and labs actively and and of course, taking them on clinical development to expand the breadth of the program I was wondering if this is a strategy that you would consider as well earlier on and 117 development as we entered that phase two development.

Element at the end of the year or would you prefer to take a more stepwise approach from seeing first initial proof of concept before then and expanding to additional geographies for development. Thank you.

Operator: The next question comes from Douglas Tasso from H.P. Wainwright. Please go ahead.

Douglas Dylan Tsao: Hi, good morning; thanks for taking the questions. I just wanted to revisit the question on pricing. You sort of indicated you're going to sort of price for the average duration. I'm just curious, have you engaged with payers in sort of more of a value-based model, meaning just sort of setting an annual price, regardless of how many treatments they need, but just, you know, sort of controlling somebody's disease, be it MG or any other disease.

Thank you Len and thanks for being with US So you're right that the silent for partnerships. The scope for this partnership is limited to F. GAAP did your months it does not reach into any other pipeline asset of the company and look there's a lot of work on the place of Siloed and.

And if they want to help us on up to 10 indications and.

You can see how the partnership evolves. This is to certain extent new territory for us, it's an important strategic component to designs and let's see how that goes before we make any further pipeline decisions.

Alright. Thanks.

Keith Woods: or any other diseases in development.

The next question comes from E on and Xu from Wells Fargo. Please go ahead.

Keith Woods: Yeah, Doug, we have engaged with payers on exactly that. We've also done a great deal of market research after showing them the data and asking them what they believe the annual value is.

Hi, Thanks for taking my question I'm, just wondering about the upcoming data readout for the healthy volunteer study of Oh, Okay next one on one seven.

Keith Woods: Now, as I stated before, you have a product that's being used in MG right now that's approved with Solaris that, you know, has a retail price of up to $700,000 per year, and it's being pretty well covered by payers for relapse refractory MG. I think that we are going to be able to offer great value to the payers and to the patients because of the clinical impact that we can have on these patients.

Could you comment on the.

The what level of P D about PD biomarkers.

And could that could translate into clinical meaningfulness in patients in terms of the C. Two level reduction a free seat to total fee as well as the CH 50, <unk> titers, just what are kind of fun.

Patient do you have for the data from the healthy volunteer study.

Keith Woods: And again, you know, we're looking at FGartigamont from the big picture. It's bigger than just the launch of MG. You know, we're already in four indications. We'll be in six before the end of the year with aspirations to go up to 10 indications. So we need to think about that as we go to price as well. Thanks.

Thank you for the question about the healthy Volunteer study. So you know this is a pretty robust study, we do single ascending dose multiple ascending dose of work for both the IV and the <unk> product. The <unk> product is equipped with the halos arms, and hence technology and <unk>.

On.

Operator: The next question comes next.

Above and beyond your classical phase of on Readouts, which would be safety tolerability and the safety dose for phase two that there would be meaningful information deducted from biomarkers.

unknown: Great, good morning, good afternoon, thank you for taking my question. I had a question just about your expected announcement of the fifth indication and the sixth indication for F-Cartijamod. Could you just remind us if those indications will evaluate both an IV and a sub-Q, or if you're leading with a sub-Q formulation, and then, in terms of the indications in themselves, if one or both of them will be overlapping with your existing disease areas of interest or if they will establish a new beachhead.

<unk> is a very interesting system to study from a biomarker point of view and your rights and we are studying a total city levels free sheet, two levels and complement activity and we will be showing you. Some of these data will be released phase one data around the middle of the year and hard and these data will have informed.

Tim Van Hauwermeiren: And then secondly, maybe it's a quick one on your upcoming R&D day. How much of that R&D day will you spend talking about your non-escartigima, non-117, and non-Kozetuzumab pipeline, whether it be proprietary or partner? Thank you. Thank you, Greg. Thank you for being with us today concerning your first question. It is our vision to have both the IV and SubQ product available in each and every indication. You will see from the pipeline updates that we have been prioritizing the more recent indications, the subcube product execution, simply because it gives us more degrees of freedom during this COVID pandemic.

This about how to dose in phase two for syndication being M M and so stay tuned but you can expect data similar to the Santa Monica Monkey data, which we unveiled during the R&D day in New York and 2019.

Thank you.

Got it thank you.

The next question comes from calling QC from Baird. Please go ahead.

Hi, good morning, Thanks for taking our questions.

For LNG and your market research do you have a sense for how many patients nine press for sub Q versus the IV formulation.

So Kelly and I can only give you. This is not going to be true market research, it's only going to be and speaking with a roughly a cohort of about 50 physicians throughout the U S. I think that you will see that there will be a larger demand to be on sub Q.

Tim Van Hauwermeiren: We have already disclosed publicly that the fifth indication will fit squarely in Keats' neuromuscular franchise, and we will be talking more about, you know, the sixth indication, of course, soon. The R&D day will mainly focus on Agatijamot and Kusat and Kusatusumat, but the agenda will be made public soon, and then maybe we can interact with further questions on the agenda then. Thank you.

But I'm hearing up and there is up to 30% of patients that do not want to stick themselves with a sub Q injection and would want to stay on IV I've actually also seen a very similar figure to that when some of the analysts have done calls with physicians. So havent done any broad based official market research, but that's roughly the numbers that we're thinking.

Operator: The next question comes from Rosie Turner from Barclays. Please go ahead.

And.

Rosie Turner: Good morning, good afternoon; thank you very much for taking my question. Just one on manufacturing, if I may. So I know Lonsa is your key partner there, and they've been having some issues manufacturing the Moderna vaccine in terms of delays. And I was just wondering how your discussions with them are progressing, and if there's any indication, there could be some delays at the beginning of 2022 when you're ready to start launching. Thank you.

Okay.

Yeah.

There are no more questions and the queue. This concludes our question and answer session and I'd like to turn the conference back over to Tim.

Van how how where and Myer mirror and excuse me for any closing remarks.

Thank you operator.

This company is executing strongly on the business plan I think we are moving forward on on all fronts as you could see into Q1 earnings updates and we would like to conclude here and thank you for your participation and to the call and the question is today. Thank you.

Tim Van Hauwermeiren: Thank you, Rosie. Maybe Kittie would like to take this question.

Keith Woods: Sure, so Rosie, first of all, I want you to rest assured that we already have a commercial supply that is manufactured and ready to go for launch. Additionally, we know that the global pandemic has put additional pressure on the supply chain. You know, fortunately, we had already ramped up production prior to the pandemic because of the You can see how much we're putting into our pipeline and then going into China, where there's a huge population.

The conference has now concluded.

Thank you for attending today's presentation you may now disconnect.

Okay.

[music].

Keith Woods: So we wanted to make sure that we were going to make sure that we were going. We had ramped up our supply well in advance, and we did that. And finally, regarding communication with Lonza, we have a very good relationship with Lonza, and I can tell you that we speak to them pretty much on a weekly basis, going through all of the logistics. So I feel quite confident in where we are now, and we've taken all the precautions that we can. So unless something unforeseen happens, we should be in good shape.

Okay.

Yes.

Okay.

Uh huh.

[music].

unknown: So just one follow-up. So is that both a sub-Q and IV supply?

Yeah.

[music].

Keith Woods: Yes, I mean, right now we're focused on the IV supply from a commercial point of view, and the subcube supply we're focused on for clinical trial drugs. Two different things.

Yeah.

Okay.

Okay.

And then.

Yeah.

Okay.

[music].

unknown: Perfect.

Operator: The next question comes from Yaten, Suna Jay from Guggenheim. Please go ahead.

unknown: Hey guys, this is Eddie from Friott, and thanks for taking the question. So I just wanted to ask how you're thinking about the filing for ITP. Are the two advanced trials each sufficient on their own, or will you need two separate SBLAs, or do you need to see success in both and file together? And then are there any safety requirements or gain factors that differ between those two formulations? Thank you.

Okay.

[music].

unknown: So the idea is that both the IV and the Sub Q trial in ITP would jointly satisfy the requirements of the FDA for the BLA filing. So the data packages of both trials would feed into one and the same BLA, and that would then indeed meet their requirements in terms of, you know, two independent studies, but also the requirement in terms of the size of the safety database.

Tim Van Hauwermeiren: The next question comes from Lanny Van Steenheiser from KBC. Please go ahead.

And.

[music] and.

Okay.

[music].

Operator: Good afternoon, Lenny here. Thanks for taking the question. A quick one on 117.

Lenny Van Steenheiser: We see that the plan is to involve Xyle Labs actively in Africa-Tegimod clinical development to expand the breadth of the program. I was wondering if this is a strategy that you would consider as well earlier on in 117 development as we enter that, let's face it, development at the end of the year, or would you prefer to take a more stepwise approach from seeing first initial proof of concept before then expanding to additional geographies for development? Thank you. Thank you, Lenny; thanks for being with us.

Tim Van Hauwermeiren: So you're right that the Xylep partnership, the scope of that partnership is limited to FGARTIGM. It does not reach into any other pipeline asset of the company. And look, there's a lot of work on the plate of Xylab if they want to help us on up to 10 indications. And we will see how the partnership evolves. This is, to a certain extent, new territory for us. It's an important strategic component to the lines. And let's see how that goes before we make any further pipeline decisions.

Yes.

[music].

And.

[music].

Okay.

[music].

Operator: The next question comes from Yoninzu from Wells Fargo. Please go ahead.

unknown: Hi, thanks for taking my question. Just wondering about the upcoming data readout for the healthy volunteer study of Argenics 117; could you comment on what level of PD bowel markers are?

unknown: could translate

unknown: into clinical meaningfulness in patients in terms of the C2 level reduction, free C2, total C2, as well as

unknown: to total C2 as well as the CH50 titers. Just what kind of expectation do you have for the data from the Healthy Volunteer Study? Thanks.

And.

Tim Van Hauwermeiren: Thank you for the question about the healthy volunteer studies. So, you know, this is a pretty robust study. We do single-sending dose and multiple-sending dose work for both the IV and the sub-Q product. The sub-Q product is equipped with halos-zimes enhanced technology, and you're spot-on, above and beyond your classical phase-1 readouts, which would be safety-tolerability and a safe dose for phase two. There would be meaningful information deduced from biomarkers. Complement is a very interesting system to study from a biomarker point of view.

Right.

[music].

Tim Van Hauwermeiren: And you're right. We are studying total C2 levels, three C2 levels, and complement activity. And we will be showing you some of these data when we release phase one data around the middle of the year, and how then these data will have informed us about how to dose in phase two, the first indication being MMM. So stay tuned. But you can expect data similar to that of the synomologist. monkey data, which we unveiled during R&D Day in New York in 2019. Thank you. I got it.

Operator: The next question comes from Colleen Cuse from Baird. Please go ahead.

Colleen Cuse: Hi, good morning. Thanks for taking our questions. So for MG, in your market research, do you have a sense for how many patients might prefer sub Q versus IV formulation? So, Colleen, I can only give you this is not going to be a true market region.

Keith Woods: So, Colleen, I can only give you this: this is not going to be true market research; it's only going to be speaking with roughly a cohort of about 50 physicians throughout the U.S. I think that you will see that there will be a larger demand to be on sub-Q, but I'm hearing up to 30% of patients that do not want to stick themselves with a sub-Q injection and would want to stay on IV.

Keith Woods: I've actually also seen a very similar figure to that when some of the patients and the analysts have done calls with physicians. So we haven't done any broad-based official market research, but those are roughly the numbers that we're thinking.

Okay.

[music].

Operator: There are no more questions in the queue. This concludes our question-and-answer session. I'd like to turn the conference back over to Tim Van Hower-Meyer-Meyer-in for any closing remarks.

Tim Van Hauwermeiren: Thank you, operator. This company is executing strongly on the business plan. I think we're moving forward on all fronts, as you can see in the Q1 earnings update. We would like to conclude here, and thank you for your participation in the call and the questionnaire today. Thank you.

Operator: The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.

unknown: Bhaar and so on. Thank you. I'm Thank you, Thank you, Bres. We're going to be able to be.

unknown: Thank you. Thank you. Thank you. I'm very thankful. Thank you.