argenx SE

Thank you. A press release with our first quarter 2020 business update and financial results was issued earlier today and can be found on our website along with the presentation for today's webcast. I'm joined on the call today by Tim Van Hauwermeiren, Chief Executive Officer, Keith Woods, Chief Operating Officer, and Eric Castaldi, Chief Financial Officer. Before we begin, I'd like to remind you on slide two that forward-looking statements may be presented during this call. These may include statements about our future expectations, clinical development, regulatory timelines, the potential success of our product candidates, financial projections, and upcoming milestones. Actual results may differ materially from those indicated by these statements. ArgenX is not under any obligation to update statements regarding the future are to conform those statements in relation to actual results unless required by law. I will now turn the call over to Tim.

Thank you Beth and welcome everyone. I first want to wish you and your families well during a time when COVID-19 has affected all of our lives in a myriad of ways. Slide three, here at Argenix we are committed to protecting and supporting our employees and the communities where we live and work. We have had a work from home mandate in place since March, except for certain essential roles like those in our labs. We continue to have all work-related global and domestic travel suspended. Even with this travel restriction, We have continued to stay close to all of our stakeholders through virtual conferences and meetings, including the investment community, physicians, patients, patient advocacy organizations, and payer groups. We have also continued to work closely together as one team, despite being in different locations. I'm very proud of the important progress we've been able to make across the company since the start of the year. This is in large part due to the investment we've made in IT infrastructure to accommodate our global expansion over three continents, but also due to the hard work, dedication, and flexibility of our teams, allowing for a seamless transition to conducting business virtually. Even during a time when a lot is uncertain, We are confident in the strong fundamentals of our business, including a differentiated antibody pipeline and a solid financial position that allows us to advance our growth and development strategy and ultimately deliver meaningful immunology innovations to patients who need them. Moving on to the topics of our call, slide four, we have a focused agenda today. The primary goal of the call is to provide you with an overview of the impact of COVID-19 across our business and detail what we're doing to mitigate the situation. We will also update you on the development of Argenix 117, our complement inhibitors targeting C2. We have delayed the start of our phase one trial in healthy volunteers, but in the meantime have had the opportunity with one of our immunology innovation program collaborators, to launch a first in human trial of Argenix 117 in COVID-19 patients. There's a growing understanding of the role of complement system in driving severe respiratory symptoms associated with the virus. We feel we are upholding our social contract to help tackle this global health crisis while also gaining critical information about Argenix 117 during a time when it is difficult to enroll trials in healthy volunteers. We also want to use this call to talk about the updated data presented this week on Afgan-Tijamot in our third beachhead indication, Pentagus. Professor Matthias Goebler presented the detailed phase two data at the Society for Investigative Dermatology annual meeting that is being held virtually. The data show the promising tolerability profile and speed at which F-gaptigamot can push patients into disease control and complete remission when combined with suboptimal doses of prednisone. Later in the call, Keith is going to cover our ongoing preparations for our planned 2021 US commercial launch of F-gaptigamot in generalized myasthenia gravis. The last few months have encouraged us to look at our launch preparations with a new lens and we have scenario planning around the unknown and potentially longer-term effects of coronavirus infection. Eric will then walk through our financial results for the quarter. With that, I'd like to update you on our ongoing programs. We have not passed any of our ongoing clinical trials and are diligently monitoring that our patients and physicians are taking appropriate measures to stay safe while participating in the studies. To enable patients in Argenix clinical trials to receive study drug with continuity, we have implemented telehealth and remote monitoring activities and more flexible dosing schedules into protocols where possible. On slide five, ADAPT, our phase three trial of FGAT-Tigamot in GMG, that study remains on track. I must pay tribute here to the hard work from our MG team. We enrolled this trial faster than anticipated, which turned out to be an incredibly important milestone, particularly in view of the current situation. By the time the shelter-in-place restrictions went into effect, all 167 patients in the DATS had already passed the eight-week time point for the analysis of the primary endpoint, and the majority of patients had already rolled over into the open label extension. As an update today, all patients have now completed the 26 week primary trial. We will be reporting top line data mid this year, which sets us up to file a BLA before the end of 2020, assuming success, and to launch in 2021 in the United States. Additionally, we are on track to fire in Japan in 2021. We were very pleased with the high degree of rollover to the open-label extension study, which remains firmly on track. We are working closely with our CRO and trial sites to facilitate patients staying on study. We are also incorporating some of the measures I mentioned above, including remote monitoring and home infusions. Fortunately, the MG-ADL assessment is one that can be accommodated remotely. The primary goal of the OLE is to gather the necessary safety data for our BLA filing and we remain confident this will happen. Supply chain and manufacturing remain a crucial component of our clinical development and commercial launch planning. We have partnered with Lonza and Vetter who have shown their strength through this crisis. Our global supply chain of drug substance and drug products remains unaffected and on track to support the launch in 2021. Our pipeline overview slide is on slide six. Our trials of abgartigamot that have already initiated remain open, including the phase three advanced trial evaluating IV abgartigamot in primary ITP, the Phase II ADHIEV trial evaluating sub-Q FGT in CIDP patients, and the 11 patients still on study in the Phase II trial evaluating IV FGT in pemphigus. We do expect recruitment rates for the ITP and CIDP trials to be slowed due to COVID-19. We will provide an update on any potentially revised timelines as we have greater clarity, but it is currently too early to estimate the real effect. We are fortunate in that we run global trials in North America, Europe and Japan, so we are not confined to one affected area for patient recruitment. We will use this to our advantage as best as we can in opening new sites. We do not currently foresee a delay to the launch of new abgartigamot trials and our guidance remains intact. Two additional ITP Phase C trials are on track to start before the end of the year, which we expect, along with advance, will support registration for abgartigamot in primary ITP, assuming positive data. These trials include the ADVANCE-II confirmatory trial evaluating IV abgartigamot in approximately 50 primary ITP patients that is expected to start in the first half of 2020. And the ADVANCE-SUBQ trial evaluating both IV and SUBQ maintenance abgartigamot that is expected to start in the second half of 2020. The PV registration trial is on track to start by end of year. Our decision to move to Phase C was based on the strength of the data we saw in Phase II, which I will walk through shortly. And finally, for Avghar Digimov, we do still plan to announce our fifth indication this year. Before moving on, I'd like to quickly touch on how our partners have handled ongoing clinical trials. Slide seven. Jensen has passed many trials globally due to COVID-19. At this time, both Culminate and the triple combination trial of Cusatuzumab, Venetoclax and Azacitidine are both passed for enrollment. Additionally, Jensen has passed the launch of new studies of Cusatuzumab. Leofarma has passed this trial of LP0145 for the treatment of atopic dermatitis. This is the compounds that was previously known as Argenix 112. We cannot say today when or under what circumstances DEQs of Thuzanab trials or those in the hands of LEO will be up and running again. We will be sure to update our stakeholders once we know more. Enrollment remains open in at least phase one trial of ABBV151, which was previously Argenix 115, Now onto ArgenX 117. You will note that we did not start the phase one trial in healthy volunteers in the first quarter. We felt it was not prudent to initiate this trial in the current environment given challenges with recruiting healthy volunteers. We did start the phase one dose escalation trial in COVID-19 patients as I mentioned at the start of our call. and I'd like to walk you through the brief rationale for this shown on slide eight. First, it has been a difficult few months to watch tragedies strike the healthcare and broader communities. When Professor Bart Lambrecht, our collaborator from VIB Ghent University Hospital and the Belgian National Commissioner for the Pandemic approached us about sponsoring a trial We felt it was important and our duty to participate. Second, we always base our development decisions on a strong biology rationale and there is one with ArgenX 117 targeting C2. The role of complement system is known in the activation of an inflammatory response that can lead to acute respiratory distress syndrome in coronavirus infections. C2 sits at a junction of the classical and lectin pathways which are both implicated in the downstream inflammatory response. We will first conduct a dose escalation study in patients in recovery from the coronavirus and then shift to dosing patients at risk of developing ARDS. Through this first in human trial, We will also gain important data points about Argenix 117, including PK, PD, safety and tolerability, and possibly an optimal go-forward dose, all of which can be part of our broader development strategy. We still intend to launch a phase one trial of Argenix 117 in healthy volunteers before the end of 2020. We then can move forward with our phase two strategy in severe autoimmune disease including our first planned indication, Multifocal Motor Neuropathy. Moving on to other news. As you saw in the press release from this morning, detailed data were presented this week from the adaptive phase two trial of FGATIGIMOD in Penficus at the SID annual meeting. The meeting changed to be virtual and our pre-recorded oral presentation became available online yesterday. We are grateful to Professor Goebbler from University Hospital of Würzburg for his flexibility in presenting the data in this less traditional format. Slide nine. Recall, in designing this trial, we took a unique and adaptive approach to evaluate the potential of FGAT-Digimod in Penficus while adjusting in a single variable way the dose between 10 and 25 mcg The dosing schedule and the dosing paradigm between monotherapy and combination therapy with corticosteroids. We also assess the ability to taper steroids once patients reach end of consolidation. The updated data shown this week are from a data cutoff of March 25, 2020 and included the below highlights that are also shown on slide 10. 90% or 28 of 31 patients evaluable for efficacy achieved rapid disease control. The median time to disease control for monotherapy and combination therapy was 15 and 20 days respectively. The majority of patients reached disease control after one or two infusions. Complete clinical remission was observed in 70%. or seven of the 10 patients receiving an optimized dosing regimen determined to be abgartigamot, dosed at least every two weeks in combination with oral prednisone at a dose of 0.25 to 0.5 mcg. 73% or 11 of the 15 patients receiving 25 mcg abgartigamot achieved end of consolidation, including patients who then successfully tapered their steroid dose and 11 patients are currently still on study. We had an independent data monitoring committee that assessed the safety and tolerability profile of abgartigumab and they felt it was favorable. This is very consistent with what we have seen across all our abgartigumab trials. Patients enrolled in the last cohort of the TANFICUS trial will be receiving abgartigamot for up to 34 weeks, which is the longest treatment period to date, excluding open-label extension studies. Taking this data together, we are confident that we have shown important proof of concept in our third beachhead indication and have gathered the necessary information to design a robust registration trial in PV. With that overview, I'll now turn the call over to Keith for a discussion of our commercial readiness.

Thank you, Tim, and good morning, everyone. As Tim noted, we are very excited to be nearing the top line data readout from our phase three ADAPT study in GMG patients. This is a transformational moment for the company and will mark a shift towards our goal of being an integrated immunology company. We built an innovative trial design for our phase three ADAPT trial that we believe closely mirrors how physicians would use efgar-tigamod in practice. As we scale up our commercial team in Boston and throughout the US, these data will provide us with the unique insights into patient management and how efgar-tigamod could integrate into the current MG treatment paradigm. As you look on slide 11, right now, if you look at the current MG treatment landscape, We believe we can play across the spectrum of patients, from earlier in the treatment cycle to the more severe refractory patients. MG first presents with ocular symptoms and patients receive acetylcholine esterase inhibitors, or ACIs, at diagnosis. As symptoms become more generalized, physicians will move to steroids. But in order to taper steroids and reduce the significant side effect burden experienced by the patients, physicians will use broad-spectrum immunosuppressants, which can take time to kick in and come with their own set of side effects and risks. Agents like IVIG, rituximab, and celeris are used later in the progression of the disease when earlier agents are no longer effective. Our goal for F-gartigamide is to allow for earlier steroid tapering and to delay or even eliminate the need for broad immunosuppressants. Moving to slide 12, if we take this positioning and look at the addressable market, we believe we can target about 30% of GMG patients in the U.S. or about 20,000 patients based on a U.S. MG patient population of 65,000 in the U.S. This would be all generalized MG patients who require treatment beyond steroids and ACI's. To reach these patients and the 16,000 neurologists who treat them, we will start to build a sales force of approximately 70 representatives assuming positive data scenario. We've already built a network of medical research liaisons who have been engaging with neurologists across the country for the past 18 months and have more recently built our thought leader liaison network. Moving to Japan. We believe there are about 20,000 patients that suffer from MG being treated by 200 to 300 neurologists in Japan. The concentrated nature of the MG market and the universal healthcare coverage make Japan a very appealing market for our second launch. The COVID-19 pandemic has not slowed our commercial readiness progress, but it has made us stop and consider the environment into which we could be launching our drug into next year. Our team is committed to preparing for all scenarios, including a world that generally returns to normal, where we can activate our sales force to be present in doctors' offices and hospitals, or a world that is in full shutdown after another outbreak, where we have to launch through virtual and digital interactions only. And somewhere in between, where we believe we have to embrace a new normal and rely more heavily on digital and virtual capabilities while still having the option to see customers in person. We will be ready for any of these scenarios and have organized work streams across all key launch functions to consider the implications of this new normal. To wrap up and to reiterate Tim's earlier comments, our global supply chain remains on track for launch. We are grateful to be working with Lonza and Vetter for our global manufacturing and have witnessed the capabilities of both organizations. to activate risk mitigation strategies where necessary. We also continue to prioritize the development of our subcutaneous F-Gardigimod product in MG to provide optionality for patients, physicians, and payers. We are planning to meet with the FDA this year on a potential bridging strategy and will communicate once we have a clear path forward. With that, I'd like to turn the call over to Eric for a review of our financial results.