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argenx SE

Q12025

5/8/2025

speaker
Operator
Conference Call Operator

placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. Thank you. I'd now like to introduce you may now begin your conference.

speaker
Beth
Investor Relations Host

Thank you. A press release was issued earlier today with our first quarter of 2025 financial results and business updates. This can be found on our website along with the presentation for today's webcast. Before we begin on slide two, I'd like to remind you 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 the statement. Argenix is not under any obligation to update statements regarding the future or to conform these statements in relation to actual results unless required by law. I'm joined on the call today by Tim Van Hauermeren, Chief Executive Officer, Carl Gubitz, Chief Financial Officer, and Kerry Mathey, Chief Operating Officer. I'll now turn the call over to Tim.

speaker
Tim Van Hauermeren
Chief Executive Officer

Thank you, Beth, and welcome, everyone. I'll begin on slide number three. At Argenix, we are building our company for the long run. Our strategic decision-making, paired with an agile approach, has positioned us to deliver sustained growth in a dynamic and evolving market landscape. It's with this same long-term focus that we introduced an ambitious Vision 2030 to reach 50,000 patients across 10 labeled indications and advance five case-three assets. This quarter, we continue to execute against a bold innovation agenda keeping us firmly on track to realize this vision. We successfully launched a pre-filled syringe in the U.S. and Germany to reach more patients with VIRGAR. We are advancing 10 registrations and 10 proof-of-concept studies across our pipeline, and we remain on track to progress four INDs in the clinic this year with ARGENIX 109 and ARGENIX 213 now in phase one studies. Slide four. Our focus on execution continues to yield results. Let's begin with our commercial business, where underlying growth is exactly where we expect it to be. Consistent with last year, first quarter results reflected typical seasonality, following an exceptional fourth quarter. Karen will share more details on launch dynamics later in the call, the big picture, key position and patient metrics across both GMG and CIDP, continue to be strong. Looking at the full year ahead, we remain confident in our ability to drive consistent growth. First, we were thrilled to receive an optimal label in the United States with the recent FDA approval of the Carhart-Trullo pre-sealed syringe for self-injection. This comes at the perfect time to maintain our growth momentum and broaden our patient reach in GMJ and CIDP. We are excited with the opportunity it has for CIDP and have just launched our patient activation campaign. This will be critical to empower CIDP patients in their decision making to choose the best therapy for them. We continue to see a demand for innovation in the MGM CIDP market. We are building the broadest offering possible to support this unmet need. This includes advancing our auto injectors and progressing our label expansion studies in seronegative and ocular MG. Finally, we recognize that the global market is dynamic at the moment. While it is still too early to speculate how our industry will be impacted by future policy developments, we are confident that our strategic decisions today have positioned Argenix to navigate a range of potential outcomes. We are prepared to meet growing demand for our precision therapies with a robust global supply chain and a strategy to manufacture in each region for that region. This includes continued and long-standing investment in our U.S. manufacturing capabilities to ensure long-term scalability. Slide five, taking a step back, the success of our commercial efforts are rooted in patient and physician demand for new and innovative treatment solutions. Last month at 8 a.m., we had the opportunity to present data that reinforced the broader potential of DivGuard and reflect our commitment to generating data that is most meaningful to the neurologist community and the patients they serve. DivGuard continues to set a high bar with its sustained efficacy and improved quality of life measures for patients living with GMG and CIDP. Beginning with GMG, more and more neurologists are recognizing Minimum Symptom Expression, or MSC, as D-metrics most relevant to patients. New data from the ADAPTnext study show that 56.5% of patients achieved MSC at any point during treatment. We believe that an individualized treatment approach is the best way to treat GMG, given that each patient experiences the disease differently. The ADAPT-NEXT study supports this view, showing that both fixed and biweekly dosing regimens can deliver rapid, meaningful, and sustained improvements for up to 126 weeks. Recognizing that we're still early in the launch of this type of true-law anxiety, we were encouraged by our engagement with treating physicians and some of the positive patient experiences that are already seen. We shared new open-label data showing that HyTRULO can drive sustained functional improvement and highlighted our switch study design, which looks at patients switching to HyTRULO within one week of their last IVIG treatment. Finally, BlitzGuard's strong and predictable safety profile remains a critical part of its value to patients and physicians. We have over 8,000 patient years of data across studies and are proud to have a label with no vaccinations, no rents, no black box, and no monitoring. Delivering on our Vision 2030 will also depend on the progress of our pipeline, and I'm particularly energized by the breadth of indications we are pursuing across multiple first-in-class assets that open the door to new disease areas with eye unmet need We continue to push the boundaries of our understanding of FCRM as we explore new therapeutic areas with F-graftigamot, including rheumatology with myositis and Sjogren's, and endocrinology with TDD. These are high-prevalence diseases where we see a clear path to deliver meaningful, differentiated benefits to patients. With M-tarsipubar, we have taken a bold approach advancing our C2 inhibitors into two registrational head-to-head studies against IVIG in both MMM and CIDP. These trials reflect our commitment to disrupting the treatment paradigm for each of these diseases by challenging the standard of care and bringing forward innovation for patients in need of new precision treatment options. And finally, Let's take a look at what's ahead for the rest of the year with several readouts across the pipeline. The seronegative GMG study will be the first of our 10 registrational trial readouts, which has the potential to expand the breadth of GMG patients we treat. Beyond that, we have proof-of-concept readouts in lupus nephritis with abgarticumab, delayed graft puncture with empaciprobar, and CMS with Argenix 119, the first clinical readout for our third asset. We have two primary objectives with our group of concept studies. First, to gain confidence in the signal observed to invest in further development. And second, to thoughtfully shape the phase three design. Before turning the call over to Karl, I want to circle back to our innovation mission. We have always put innovation at the forefront of our decision making, which means prioritizing what patients need and ensuring that we remain forward thinking to prepare ourselves for the long term. With an enviable financial position, we are able to continue investing in our innovation engine, capitalizing on both commercial and clinical opportunities to deliver sustained long-term value. And with that, I will turn the call over to Karl.

Disclaimer

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