Q1 2025 argenx SE Earnings Call
the Netherlands
Rob: Good morning, my name is Rob and I will be your conference operator today. I would like to welcome everyone to the call. At this time, all lines have been placed on mute to prevent any background noise. After the speakers remarks, there will be a question and answer session. Thank you. I now like to introduce Beth DelGiacco, Vice President, Corporate Communications, and Investor Relations. You may now begin your conference. Thank you.
Beth DelGiacco: Thank you. Approximately this is 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 West past.
Speaker Change: 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.
Speaker Change: Actual results made different materially from those indicated items statement.
Speaker Change: is not under any obligation to update statements regarding the future or just inform these statements in relation to actual results unless required by law.
Speaker Change: I'm joined on the call today by Tim Hauwermeiren, Chief Executive Officer, Karl Gubitz, Chief Financial Officer, and Karen Massey, Chief Operating Officer. Now turn the call over to Tim.
Speaker Change: Thank you, Beth and welcome everyone. I'll begin on slide number three.
Speaker Change: Argenx, we are building our company for the long run. Our strategic decision-making, carried with an HR approach, has positioned us to deliver sustained growth in a dynamic and evolving market landscape.
Speaker Change: It's with this same long-term focus that we introduced an ambitious vision for the 30, to reach 50,000 patients across 10 labeled indications and advanced 5-50 assets.
Speaker Change: Pitch quarter, we continue to execute against a bold innovation agenda, keeping us firmly on track to realize this vision.
Speaker Change: He successfully launched a pretzel syringe in the U.S. and Germany to reach more patients with Vyvgart.
Speaker Change: We are advancing 10 registrational and 10 people's concert studies across our pipeline, and we remain on track to progress 4 INDs in the clinic this year with Argenx 109 and Argenx 213 now in phase one studies
Slide 4.
Our focus on execution continues to yield results.
Speaker Change: Let's begin with our commercial business, where underlying growth is exactly what we expected to be.
Speaker Change: Consistent with last year, first-school results reflected difficult seasonality following an exceptional form quarter.
Speaker Change: Karen will share more details on launch dynamics later in the call, the big picture, deep position and patient metrics across both GMG and CIDP, continue to be strong.
Speaker Change: Looking at the full-year heads, we remain confident in our ability to drive school system growth.
Speaker Change: First, we were thrilled to receive an optimal label in the United States with a recent FDA approval of the Card Hydrolyphal Surrange for self-injection.
Speaker Change: This comes at the perfect time to maintain our growth momentum and broaden our patience which in GMG and CIDP.
Speaker Change: We are excited with the opportunity has for CIDP and have just launched our patient activation campaign.
Speaker Change: This will be critical to empower shared patients in their decision making to choose the best therapy for them.
Speaker Change: Decompti, to see the man's renovation, Indium GMCADP Markets,
Speaker Change: We are building the broadest offering possible to support this unmet need. This includes advancing our auto injectors and progressing our late expansion studies in pseudonegaris and ocular mg.
Speaker Change: Finally, we recognize that the global market is dynamic at the moment.
Speaker Change: 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 our genics to navigate a range of potential outcomes.
Speaker Change: We are prepared to be growing demands for our precision therapies with irreversible global supply chain and its strategy to manufacture in each region for that region.
Speaker Change: This includes continued and long-standing investment in our U.S. manufacturing capabilities to ensure long-term scalability.
Speaker Change: Kaking a step back, in success of our commercial efforts, our rooted in patient and position demand for new and innovative treatment solutions.
Speaker Change: Last month at 8 a.m., we had the opportunity to present data that reinforced the broader potential of Vyvgart and reflect our commitments to generating data that is most meaningful to the neurologist community and the patient they serve.
Speaker Change: This doctor continues to set a high bar with its sustained efficacy and improved quality of life measures for patients living the GMG and CRPD.
Speaker Change: Beginning with GMG, more and more neurologists are recognizing minimum symptom expression, or MSE, as de-metrics most relevant to patients.
Speaker Change: New data from the adept next study showed that 56.5% of patients achieved MSC at any point during treatment.
Speaker Change: We believe that an individualized seat and approach is the best way to treat JNG, given that each patient experiences the disease differently.
Lea Durknexterly, supports this view. [inaudible]
Speaker Change: showing that both fixed and bi-weekly dosing regiments can deliver rapid, meaningful and sustained improvements for up to 126 weeks.
Speaker Change: Recognizing that we are still early in the launch of this kind of high-true loyalty, we were encouraged by our engagement between positions and some of the positive station experiences that are already seen.
Speaker Change: We shed new open little day up, showing that Hightrool can drive sustained functional improvements and highlight that our switch study design, which looks at patients switching to Hightrool within one week of the last IVRG treatment.
Speaker Change: Finally, Vyvgart's strong and predictable safety profile remains a critical part of its value to patients and physicians.
Speaker Change: We have over 8,000 patient years of data across the city and are proud to have a ladle with no vaccinations, no rent, no black box and no monetary.
Speaker Change: Delivering in our Vision 2030, will also depend on the progress of our pipeline and I'm particularly energised by the breadth of indications we're pursuing across multiple person class assets that open the door to new disease areas with high unmet needs.
Speaker Change: We continue to push the boundaries of our understanding of the CRM, as we explore new therapeutic areas with the practicum of, including rheumatology with my side as insurance, and endocrinology with TLD.
Speaker Change: These are high prevalence diseases where we see a clear path to the level meaningful differentiated benefits to patients.
Speaker Change: With M-Bossy Brewer, we have taken a bold approach, advancing our C-2 inhibitors into two registrational heads-to-head studies against IPRG in both MMM and CRDP.
Speaker Change: These trials reflect our commitment to disrupting the treatment paradigm for each of these diseases by challenging the standard of gas and bringing forward innovation for patients in need of new precision treatment options.
Speaker Change: And finally, let's take a look at what's ahead for the rest of the years, with several readouts across the pipeline.
Speaker Change: DeCino-negative GMG study will be the first of our ten registration trial relapse, which has the potential to expand the breadth of GMG patients which we've
Speaker Change: Beyond that, we have proof-of-concept readouts in lupus nephritis with agarthicomot, g-laid graft-functioned and passiprobark, and CMS with argenics 1-1-9, the first clinical readout for our third essay.
Speaker Change: We have two primary objectives with our Group of Concept Studies. First, to gain confidence in the signal of research, to invest in further development, and second, to properly shape a Ph.D. design.
Speaker Change: Before turning the call of the carol, I want to circle back to our innovation mission.
Speaker Change: We have always put innovation at the forefront of our decision making, which means prioritizing what patience needs and ensuring that we remain forward thinking to prepare ourselves for a long term.
Speaker Change: With an enjoyable financial position, we're 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.
Karl: Thank you, Tim. The first quarter, when it 25 financial results are detailed in this morning's press release.
Karl: Total Operating Income, in the first quarter, total 877 million, Vyzreflex, 790 million in product net sales and 17 million in other operating income.
Speaker Change: The product net sales of $790 million represents 99% growth compared to a corresponding prior year code.
Speaker Change: The product net sales breakdown by region to $681 million in the US, $32 million in Japan.
Speaker Change: $57 million in the rest of the world and $20 million for product supply to Zileb in China.
One quarter of a quarter basis.
Speaker Change: Comparing Q1 2025 with Q4 2024 for Groovy 7%, with the U.S. growing at 5%.
Speaker Change: We saw strong underlying demand in both GMG and CIDP with growth in net sales impacted by two factors.
Speaker Change: First, typical Q1 seasonality with re-verification of benefits for patients, and second, Medicare redesign took effect on January 1, which accelerated the evolution of your channel
Speaker Change: Viz had an impact on close to net for the quarter. We expect PFS self-injection to further drive a shift to party.
Speaker Change: Though over time, the impact on revenues from increased growth to net will be offset by patient volume growth.
Speaker Change: Specifically our ability to reach new patient populations with P.F.S. for self-injection.
Speaker Change: In Japan and the rest of the world, the quarter of a quarter growth continues to be in the high teens.
Next slide.
Speaker Change: Cost of sales is 81 million in Q1. This reflects a gross margin of 90% which is in line with previous quarters.
Total operating expenses in Q1 2025 or 668 million
Speaker Change: A quarter-over-quarter growth of 2%, the increase is explained by 12 million dollar increase in R&D, offset by a decrease of 10 million dollars in SGNA.
This results in operating profit 4K1 of $139 million.
Speaker Change: The quarterly net financial income is very $6 million. We benefit in the quarter from unrealized exchange gains of $27 million on our non-US denominated cash balances.
Speaker Change: The effective tax rate for Q1 2025 is 16%. After tax, the profits of a quarter is $169 million.
Speaker Change: Akash Balance, represented by Akash, Akash equivalent and current financial assets, is 3.6 billion at quarter end, an increase of $238 million from Q4 2024, driven primarily by Akash flow from operations.
Speaker Change: How previously issued guidance on total R&D and SGNA for the year remains unchanged, I will now hand it over to Karen.
Thank you, Karl, blind nine. [inaudible]
Karen: Our patient-centric approach to innovation continues to deliver real-world results as we have now successfully bought a first-in-class medicine to patients across multiple markets, executing watches across three indications, three product presentations in over 30 countries in less than four years. [inaudible]
Karen: With this launch cadence, we have maintained steady momentum and delivered 13 quarters of growth. This is a remarkable achievement and I'm incredibly proud of the entire Argenx team for the focus, dedication and the collaboration that has made it possible.
Karen: We continue to drive meaningful impact with this guy, expanding our reach to mutations and prescribes in both CIT and NG as well as ICC in Japan.
Karen: With the recent approval of our pre-self syringe, which further enhances patient access and convenience, we expect that momentum to continue.
Karen: Today I'll walk you through the dynamics behind our performances quarter and how our positions you continue to drive sustained long-term growth and deliver lasting outcomes for patients by 10.
Karen: We're continuing to deliver on our long-term growth strategy with 99% year-over-year revenue growth for the quarter and steady growth delivers across every region and indication.
Karen: After an incredibly strong fourth quarter, we face typical first quarter seasonality in the US, which similar to last year is primarily due to benefit re-verification.
Karen: This quarter also marks the first industry-wide impact of Medicare Part D reform, which is accelerating the evolution of our channel mix towards Part D
Karen: As Karl outlines, Judith Dynamics, we saw an impact on our growth to net over the quarter.
Karen: Looking beyond these technical impacts in the US, we saw a strong quarter and we continue to deliver consistent growth. I am very pleased with our performance in new patient starts, in new prescribers, and in high patient conversion rates.
Karen: We believe there is significant commercial opportunity ahead of us for both GMG and CNP.
Karen: In GMG, Vyvgart achieves the fastest market share growth amongst branded biologics, solidifying the number one position in the MG market. Vyvgart Hydrilo is the key growth driver, contributing to a strong quarter of a quarter increase in new patient initiation.
Karen: In CIT, our strong launch momentum continues, with consistent quarter of a quarter growth in new patient starts. [inaudible]
Karen: Although we recognize the CIDP market dynamics are unique for MNG, early trends re-enforced our confidence in the significant long-term opportunity for Vyvgart actually low in this market.
Karen: In addition to strong patient starts in both MG and CIDC, we continue to see consistent new prescriber growth. Over the quarter, we added about 250 first time Vyvgart prescribers, bringing us to over 3,700 total prescribers. And we saw a reciprocal halo effect between MG and CIDC.
Karen: Reaching new prescribers is a critical priority to increase the breadth and depth of patients that we reach.
Karen: We also saw a solid performance internationally. Japan's CIDP launch is up to an encouraging start, echoing the US experience, with patients and prescribers welcoming the most novel mechanisms of the CIDP treatment in 30 years.
Karen: The contribution from the risk of the world continues to grow, as we secure a practicing reimbursement agreement across Europe and Canada.
Karen: Sokitanius continues to expand our GMG uptake, including initial pre-filter end use in Germany. Lastly, we're close to bringing Vyvgart to its second education in the EU with positive CHMP opinion last month in CIDP.
Slide 11.
Karen: The recent approval of our pre-filter range for self-injection in the US comes at the perfect time to enable our continued growth momentum in MG and CIDP.
Karen: The label we received is an optimal outcome. Patients now have the ability to self-inject in as little as 20 to 30 seconds after being trained with proper instruction, and they can do so at home or in the HTTP office.
Karen: patients will have the flexibility and independence to manage their treatment in a way that fits their lifestyle and continue to benefit from Vyvgart Archila's strong efficacy and favorable safety profile.
Karen: The first patients have already been done with PFS for self-injection in the US and Germany. Reception today has been very positive with encouraging initial patient prescriptions.
Karen: You'll recall, we are not pursuing a conversion strategy with PFS, the self-injection, rather our goal is to reach more patients earlier in the treatment paraben. We're seeing that play out already, with 50% of initial enrollment first time Vyvgart uses.
Karen: Patients have been vocal in their positive feedback, often referencing the PFF as game-changing.
Karen: One patient commented that he was now ready to take back control of his life, and eager to travel with his family. Another patient shared her relief to be able to manage her work schedule instead of taking off significant time for weekly infusion. [inaudible]
Karen: We're just at the beginning of this launch, and we continue to market expansion in the US and future expansion opportunities in Canada, China and Japan.
Slide 12.
and many more. Thank you. Thank you.
Karen: We're transforming the MG and CIDP treatment paradigm of Vyvgart and Vyvgart Hauwermeiren, and we're empowering patients to expect more from their treatment. This is especially true for CIDP patients, who have not seen new novel mechanism of action in the space for close to 30 years.
Karen: Physicians and more conservative in switching their CIDP patients between medications in general, and often prefer an active request from the patient before doing so. In February , we successfully launched our patient activation campaign, which is empowering patients to our senior oligists about Vizgaha Trullo. [inaudible]
Karen: We're seeing a very high grant rate to these requests, demonstrating that urologists believe in the value proposition of Vyvgahitrula for CIDP.
Karen: Our patient engagement efforts across both GMG and CRDP led to a significant increase in patients actively requesting Vyvgart or Vyvgart actual over the quarter.
513.
Karen: What excites me most is the tremendous opportunity ahead to expand the impact of our precision medicine, where exactly where we need to be, if the right strategy in place to reach patients earlier in the treatment journey.
Karen: It successfully launched our pre-filter-enge, and we're generating the data needed to position Vyvgart as the treatment of choice in both MG and CADP.
Karen: And, this is just the beginning. With multiple potential launches ahead, we're ready to expand into new, high unmet need indications, bringing our therapy to thousands more patients, and advancing our vision to redefine the standard of care in autoimmunity.
With that, I'll turn the call back to Tim.
Karen: We have the benefit of this strong financial position to continue investing in our commercial business and early innovation.
Karen: With multiple expansion opportunities ahead, we plan to sustain our growth trajectory in MGM, CIDP.
Karen: Additionally, we have a steady cadence of several milestones across a robust pipeline which will further contribute to patient growth and support our leadership in auto community.
Karen: Execution has always been a key strength of our company and therefore the end of the remainder of the year confident in our ability to deliver value to our patients and shareholders whose long-term support has been critical to our success
They will now open the call for questions.
Speaker Change: Thank you. We will now begin the question and answer session. If you would like to ask a question, please press star one in your telephone keypad to raise your hand and join the queue. If you would like to withdraw your question, simply press star one again. We ask that you please lend yourself to one question only.
Speaker Change: Your first question comes from a line of Tuzina Ma from Bank of America. Your line is open.
Speaker Change: Hi guys, thanks for taking my question. I wanted to ask a more broad one on the profile of the G&G patients at this stage of the launch that are starting with Vyvgart therapy. So
Speaker Change: Can you just tell me, you know, what portion of the curve you're on in terms of onboarding, you know, the patients that are out there, they're not currently receiving therapy and then also are you noticing any changes with this continuation rate and any impact from competing products so far. Thanks.
Speaker Change: Thanks for the question, Tazine, appreciate it, and as you say, I mean...
Speaker Change: where I come from, we're 13 quarters into the launch for MG, and I'm really proud of the fact that we've continued to deliver growth, quarter over quarter, despite off a very high quarter last in Q4, and I think what that indicates is that we're still early in the launch curve for MG.
Speaker Change: And what we're seeing is the market for biologics is growing, and Vyvgart is leading that growth. We can maintain the number one market share amongst biologics in MG.
Speaker Change: So we're expanding our leadership and pre-filled syringe and the launch of pre-filled syringe is only going to accelerate this as we continue in the launch. So I would say we're at the early stage, all early stages of the launch curve at this point. Thanks for the question.
and many more. Thank you. Thank you.
Speaker Change: Your next question comes from a line of James Gordon from JP Morgan. Your line is open.
Hello, can you hear me? [inaudible]
Speaker Change: This is James Hick in here, mate. Yes, we can leave. Yes, we can need you, James.
Alex, can you hear me, okay? Bye.
Yeah James, we can hear you.
Custody, you can hear me.
Speaker Change: We are experiencing some technical difficulties with that line. We're going to move on to the next question from Alex Thompson from Stiefel. Your line is open.
Alex Thompson: Hey, great, congrats on the quarter and thanks for taking our question. I guess, you know, as we think about, you know, the PFS launch now with three Vyvgart forms in the market, can you talk about how we should think about net price over overtime? Thanks.
Alex Thompson: Yeah, thanks. Happy to talk about the PFS launch. Maybe I'll just start by saying that we're really pleased with the label that we received as part of the approval. And I want to share a huge congratulations to the team. We did get the optimal label. And what we're seeing already is positive feedback from the PFS launch from both prescribers and from patients saying that it's a game changer. So we think that this will be an expansion opportunity and that it will drive growth for the PFS launch.
Alex Thompson: and you've grown so they've got through the year. But maybe Karl, you want to comment on their first internet?
Alex Thompson: and the growth of net will have a different dynamic in the formative benefit versus the medical benefit due to a 20% manufacturers have to pay for patients in the catastrophic phase.
Vyfoven net price per patient, four PFS.
Alex Thompson: Patients will be lower than for patients in the medical benefit, which will largely be IV and by the
Alex Thompson: At the moment, we will maintain with 225,000 foreign MG patients and the 454 CIDP patients, but over time that will evolve and we can give you updates later on.
Yep.
Do you want to also just answer the... [inaudible]
Eurasian question from the left. [inaudible]
Alex Thompson: Oh yes, Cousin, sorry, I think you asked about discontinuations as well. And so just to come back to that, we're not seeing any shift in discontinuation. In fact, we see the consistent discontinuation rates. And I would say given that it's a maintenance therapy, an aquatic treatment, it's quite strong. And you can see that the patients are definitely appreciating staying in MSZ and the adverse event profile. So no shift in discontinuation rates for MG.
Speaker Change: You are next question comes from a line of Vikram Purohit from Morgan Stanley . Your line is open.
Vikram Prohit: Hi, great. Good morning. Thanks for taking our questions. Hours is on the IDP. If you could just help us understand in a bit more detail. The cadence of new patient starts, you know, where you ended one cue within terms of patients on therapy and how you might expect that to trend throughout the course of the year. Thank you. Thank you.
Vikram Prohit: Yeah, thanks for the question on the CIDP launch. I would say we're really excited about where we are with the CIDP launch. What we've seen is continued momentum since the beginning of launch and through Q1. The execution continues to be strong. When you look at the underlying fundamentals to your question, what we see is continued new patient ad quarter over quarter. We also continue to see new prescriber growth quarter over quarter, which is a really important measure. The CIDP launch. The CIDP launch. The CIDP launch.
Vikram Prohit: to demonstrate that we're reaching more prescribers and therefore reaching more patients.
Vikram Prohit: And the other really important feedback that we have from this quarter is the consistent patient stories that we're hearing about the transformational impact.
Vikram Prohit: is having on their CIDP. So patients are at the center of our launch and are the key to the CIDP launch. We launch our DTC campaign in Q2. And what we're seeing is that more and more patients are initiating the request to switch. [inaudible]
Vikram Prohit: C, with their prescribers, and in the majority of cases, then urologists are granting that switch request. And what that shows us is that urologists believe in the profile of Vyvgarts for CIDP. So all of the underlying launch metrics for CIDP continue to be very strong.
Speaker Change: Your next question comes from a line over Jean Sharma from Goldman Sachs. Your line is open.
Hi, thanks for taking the question. I'm just...
Speaker Change: To just follow up on the Q1 effects, you mentioned that there were two factors that you kind of talked to as being headwinds, to revenue growth of the quarter, so that was a re-verification, and then the Medicare redesign impact. Could I just push it a little bit on relative magnitude of each of those, and which was the larger impact in Q1? Thank you.
Speaker Change: So, Rajan, thank you for the question. Let me talk about the growth in that impact.
Speaker Change: In prior quarters, we've seen a gradual increase, quarter over quarter of part D. At the close of Q4 2024, it was a minority, a small portion of patience.
At the last earnings call, we discussed that in 2025. . . .
Speaker Change: We have a launch of PFA self-injections, patients under a pharmacy benefit, which is Medicare Part D will grow, and as that mixed evolve between medical and pharmacy will grow to net will increase.
Speaker Change: What we've seen now in Q1 is a Web American redesign. It's an acceleration of patience choosing
Speaker Change: West underscores the need we will be filling with P.S. AFA self-injection as it will expand the market.
Speaker Change: So, in terms of a magnitude of a growth limit, we can't get into more detail now, we will provide probably more detail at the end of Q2, but you did see an increase in growth limit.
Speaker Change: But the majority of impact you're referring to is to do with his analogy or relating to the re-verification of benefits.
Speaker Change: That is an industry impact which you always see, maybe Karen you want to talk about that.
Speaker Change: and continued cadence of growth through the remainder of the year as we continue to launch PFS for both MG and CLDP.
Speaker Change: Your next question comes from a line of James Gordon from JP Morgan. Your line is open.
and others. Thank you. Thank you.
Speaker Change: Hello, thanks James again, thanks for taking the questions and for Barry Woodney for any technical issues here.
Speaker Change: The question was, most favourite nations has come into focus again, and there were some concerns around different list prices for Vyvgart and different places.
Speaker Change: So can you remind me how Vyvgart's list price varies between the US, EU and Japan? And also have you already set the PFS price outside the US? So how the list price varies there?
R, but looking to Q2 in the rest of the year.
Speaker Change: Are you seeing significant further incremental headwinds from this part D-Shift and the falling net price that we need to be wary of when we're thinking about Q2 in the rest of the year? Or is one way of thinking about it looking at the fading we saw last year in 2024?
Speaker Change: Qu1 was a bit softer sequentially, but then Q2 saw quite an acceleration because you didn't have the recertification headwind and then you've got PFS coming in and you've got more CRDP coming in. So should we look at last year's phasing for a bit of a guide for what this year's phasing looks like?
and many more. Thank you. Thank you.
Speaker Change: Okay, thank you, James. I think you asked three questions, so let me take them one by one. First one is on a most favorite nations. We have been very disciplined and aimed to keep the list priced in all our markets within the Narao band. For example, with a launch of Vivgart in Germany, the list price was set very close to the US list price.
Speaker Change: Price is evolved, of course, over time due to foreign exchange, labor expansion and so forth, but that's it. We have done a good job in keeping the list prices in all our priority markets in an narrow band.
Speaker Change: R, on your second question, the BFS pricing have been set in all our priority markets, so I think that's done.
Speaker Change: Inter, your third question, I think on terms of Q2, I think it goes back to what Karen has said, but PFS is an expansion strategy which will give us more prescribers and more patients.
Speaker Change: But yes, close to net will also increase quarter over quarter as the as the product mix between medical and pharmacy changes.
Speaker Change: Yeah, I was going to add, in terms of the rebound effect that you mentioned, I wouldn't think about it like that. I would zoom out and what you can see when you look quarter over quarter since the beginning of the launch of Vyvgart. When you take a line through it, it's relatively consistent growth quarter over quarter. So we don't look at, we don't look at the ups and downs each quarter, but rather I'd encourage you to take that line through it and look at the long term trajectory. And we're confident that that consistent
Washington, Rose, will continue over the long term.
Derek Arquillo: David. Your next question comes from a line of Derek Archila from Wells Fargo. Your line is open.
Derek Arquillo: Hey, good morning and thanks for taking the questions. Just wanted to see, given the adapt next publication and the data set there, are you assuming increasing number of treatment cycles in MG patients as part of your growth calculation to offset the part de-exposure. Thanks.
Derek Arquillo: Thanks, Derek, thanks for the question. If you look at the material consumption between that next or cyclical dosing, actually net net you end up using the same amount of materials, so we do not believe
This is going to materially impact.
Derek Arquillo: De dosing of Pitcarts, I think what is really important about that next.
Derek Arquillo: is that now we have taken the individualization to the end. Now each patient can dose the drug the way it should be dose.
Derek Arquillo: from cyclical to continuous dosing, so now we can offer the full spectrum. We're very proud of the data at A.A. and I think we showed impressive efficacy data from that next, you know, with a 56% MSC.
Derek Arquillo: Stikenspan Safety Profile, and a real nice continuation over 126 weeks of use.
Thanks for your question.
Speaker Change: Your next question comes from a line of Yaron Werber from TV Cowan. Your line is open.
Speaker Change: Great, thanks so much, maybe Karen, just a question for you on C-A-D-T. Is there any chance you can give us a little bit of a sense how many patients did you have during the quarter or finish during the quarter and then sort of related to that at A-A-N?
Speaker Change: There was a publication that looked at safety in CIDP and you had just over 1,300, I think it was 1,300 and 1,16 real world patients on Vyvgart at that point. Can you triangulate that maybe to again your commercial patient numbers on CIDP? Thank you.
Yeah, thank you. Thank you for the question.
Speaker Change: We're not updating that number at this moment, what will do in the style of what we've done for other launches is update the number as we hit different milestones. Let's go guys.
Speaker Change: But what I would say, again, just zooming out, is we have had consistent patient abs.
Speaker Change: quarter over quarter, and consistent prescriber growth in CIDP. We've also seen consistency in where the patients are coming from, and what I mean by that is 85 to 90% of the patients continue to be switched. [inaudible]
from IVIG or subcutaneous IG.
Speaker Change: and that's exactly in line with where we thought we would be at this moment in launch and with the 12,000 TAMS. So we think we have a long way to go in terms of our growth, we're just at the start of the growth trajectory with the CIDP launch and certainly PFS will be a strong driver of that continued expansion as we continue to launch PFS through the year.
Thanks for the question.
Speaker Change: Your next question comes from a line of Victor Floch from BNP Parabas. Your line is open.
Victor Flock: Thank you very much for taking my question, Victor Floch, I'm being the party magazine. So, I'll watch this. I mean, obviously, there has been a lot of focus on the pressing duplication of the PFS ramp up at the policy product. But at the same time, I think it would be helpful if you could share with us your expectation in terms of incremental volume attached to the PFS opportunity. I mean, I think you've notably said that
Speaker Change: You were basically not following a conversion strategy, so, I mean, you are looking at two ad patients, so, I mean, I think we tend to look at the pain right now, we tend to look at the
Speaker Change: And at the application on the price, but I mean, what are the, your expectation in terms of, you know, volume growth, time to the PSS, then my fault.
Speaker Change: It's very much close to the first one. It's about the serenegative phase three trial. I mean, a lot of, I mean investors have been pointing pretty light newsflow over the next part of the year. I mean, there is the phase three in serenegative and maybe for some of them is seen as a given, but I mean, I would be, would be nice if you could share also your views on your view on...
Speaker Change: on the opportunity in terms of incremental volume and potentially sales there because obviously it's not nothing to grow the additional opportunity from 80% to 100% of the patient. Even though I agree that I mean, it's fairly said that the risk is pretty low. But yeah, any comment on volume would be, would be, Brian , thanks a much.
Speaker Change: and both Stephen Howell and Karen Mas say again that being prisoners is cozy, that you are alone, that you are free from the border, that, in fact, you enter the country free from fact, that you next transfer your identity as an immigrant coming here and while across Germany and Switzerland. Yes. It's good about being tokens. You don't have to lower yourself down to low levels
Speaker Change: We hear that they're excited. You heard in the script that patients are describing this as a game changer in terms of managing their MG and COUP. So as you said, this is a market expansion opportunity for us.
Speaker Change: What we're seeing in the early data is that 50% of the PFS prescriptions are new to Vivgart patients. So they're not converted rather they're overall new to Vivgart and that's exactly in line with this market expansion strategy. So if you zoom out what we're looking to do in both MG and CIDP is bring new innovation and patient patient centric innovation to the market and we're seeing this exactly in PFS and that's what's going to drive the long term growth. [inaudible]
Tim: Projectory for both of those indications, and then maybe for the fear of negative and the news flow of Tim, do you want to take that?
Tim: Yeah, I think Victor, you're right calling out the news flow for this year, which I think is strong, with one face 3D doubt.
Tim: N.C. Feast 2.0. This company is in a strong position. This company is in a strong position.
Tim: from a useful point of view, so the phase 3 did out and see the negative, my Stenia.
Tim: The Phase 2 in Lutus Nephritis for Apgatigemot, the Phase 2 in Delay Draft function for MPa, and then the Phase 2 proof of concept in CMS for 1-1-9.
Tim: Specifically on Ciro-negative MG, I think we're very excited about the opportunity in front of us. You have to think about 15% of the overall MG patient population, which falls in the Ciro-negative basket.
Tim: We do know from Japan where we have seen the negatives on label that Beth Giacco is offering the same benefit risk profile to see the negative patients as it does to the acetylcholine receptor antibody patients. So very strong performance.
Tim: Now it's all about the design of the experiments. We have been learning and triangulating with the FDA on the endpoint for this clinical trial. We think it's a solid and a clinical trial and we feel very strong about the opportunity in front of us.
Tim: Let me end by falling out our excitement about ocular MG which I think is equally in size and unmet medical needs. So opportunity would be equally in ocular MG, as is Ceunck negative MG. Thank you for the question.
Speaker Change: And as a reminder, we ask you to please them yourself to one question only. Your next question comes from a line of Tom Smith from Lering Partners. Your line is open.
Speaker Change: Hi, this is Matt Turan Sugan from Thomas Smith. Thank you for taking a question. So following the approval of Prifus Orange, what's your expectation on the split among uses of the three product presentations of Vyvgart, including NV Vyvgart, Sergey Retrollo, and Prifus Orange in MGNZDP? And similarly, how do you expect the pair to mix to evolve following the...
Speaker Change: Yeah. Thanks, Thanks for the question so what we're seeing already with the launch of high <unk> is it the majority of growth in patients and new patients for Mg NCI ADP is coming from high true up that was even with the butterfly execution and we expect that that will continue and even accelerate with pre <unk>.
Speaker Change: Syringe again, we're hearing from the market that people are really excited and the.
Speaker Change: But it really is a game changer, having pre filled syringe self injection available for patients. So we think that will be a growing portion of the market.
Speaker Change: How did you want to take the question around the payer mix I mean, I know we've shared in the past 50, 50 commercial Medicare and I don't think we expect that to change significantly.
Speaker Change: I think that is what it is today not expecting changes, we'll keep you updated if it does thank you.
Speaker Change: King.
Speaker Change: Your next question comes from the line of of cash to worry from Jefferies. Your line is open.
Speaker Change: Hey, this is Amy on for Colin Thanks, So much for taking our question. So.
Speaker Change: So one is.
Speaker Change: We're still finish in better considered substantially transformative and if needed how quickly could you move that into the U S. And then just a theoretical question on MFS.
Speaker Change: What mitigation measures could you potentially employee could you price your PFS differently ex U S is a different it's a different product code and would you consider pulling some of the other formulations. Thanks so much.
Speaker Change: Thanks, Jimmy for these two questions.
Speaker Change: First one in terms of Chanel substantial transformation.
Speaker Change: But to use the drug substance manufacturing as your guide here.
Speaker Change: And drug substance manufacturing of course is taking place on U S territory.
Speaker Change: Secondly, got already explained that I think we're in a strong position from an MFN point of view because we have shown that discipline in the way, we have been maintaining setting and maintaining price in a narrow band globally in our key markets. So let's stay away from speculation, but I think we have strong cards to navigate whatever the future will bring us.
Speaker Change: On these two fronts. Thank you.
Speaker Change: Your next question comes from the line of Charles Pitman Kim from Barclays. Your line is open.
Speaker Change: Hi, guys. Thanks, so much for taking my questions. Just a question on kind of part B part D movements. If you could just give us a little bit more insight on what the actual price differential is between a part b and part D patient over <unk> I think that would be very helpful. And then just kind of following on from that thinking about the kind of future split of patients I mean, I think you kind of highlighted PFS.
Speaker Change: <unk> has become an increasing proportion going forwards, but given you've already been seeing these part D patients move to part D and the $2000 related to the redesign like how would you expect to IV to grow from here or should we expect like what what's the future split of the threet indication of administrations.
Speaker Change: Keith.
Speaker Change: Thank you I mean at a high level the difference between the net price for a part of being a part of the would be the 20% incremental rebate.
Speaker Change: Which we have to pay under part D for Delta to CMS for patients who are on catastrophic but that's at a high level of the difference between the two in terms of our presentations going forward remember, we said that in the U S.
Speaker Change: IV will always continue to be important for the U S market.
Speaker Change: Think of a buy in bulk customers.
Speaker Change: <unk> preference and so forth, but over time from where we are today and today, we already have a minority but we already have.
Speaker Change: Good day for Delta patients overtime, but mix will increase and you're going to see a greater proportion of our patients and for delta. Thank you for the question Charles.
Speaker Change: Your next question comes from the line of Myles Minter from William Blair. Your line is open.
Speaker Change: Hi, Thanks for taking the question just on just got Huntsville, or you can say hey, Thank you mentioned, 85% to 90% of those patients switch switch patients can you just comment on the incidence of <unk> disease.
Speaker Change: Disease worsening when you make that switch.
Thomas: Just wondering if you have any real world data are thanks, Thomas presented at AAN, Thanks very much.
Speaker Change: Yeah. Thanks, Myles for the question so.
Thomas: And I referred to the great conversation, we had with Doctor column in the panel conversation Julien.
Thomas: The first thing you need to know in CDP is that whatever switch you consider to do beach from steroids to immunoglobulins or vice versa of the disc ops, there's always an expectation on the possibility that the patients will relapse. So this this is effects you also see that in the IV <unk> switch studies.
Thomas: I think the <unk>.
Thomas: Symptom bursting, which we have seen in the context of the <unk> trial is perfectly in line with those historical studies and in the real World actually is relatively small phenomenon. We see low single digits are reporting on CDP worsening. So the vast majority of our physicians are doing it the right way.
Thomas: It seems like in those switching to fifth got one week. After the last dose of IV AIG is the recipe for success, but we are trying to document that in our fees for switch study, where we really try to collect evidence on how to switch. So it is a known phenomenon in CDP and it looks like we had in navigating that quite well.
Thomas: Thanks for the question.
Speaker Change: Your next question comes from the line of Suzanne Van for Hudson from Kempen. Your line is open.
Thomas: And again this is Suzanne Kim Thanks for taking my question.
Thomas: Could you please elaborate a bit more on how you look at <unk> relative to <unk> and see ADP.
Thomas: Given the pivotal trials for <unk> is different than what you did for <unk> for <unk>.
Thomas: Can you share how you're thinking about the positioning of each product and commence how to commercial <unk>.
Thomas: For each molecule in this indication perhaps relative to each other thank you.
Thomas: Yeah.
Speaker Change: Thanks, <unk>, thanks for being with us and thanks for the great questions. So therapy.
Speaker Change: <unk> therapy is a heterogeneous disease I think the heat trial, which was the biggest in the highest quality trial ever done in the <unk> space is clearly demonstrating the pathogenic <unk> drive disease at least in about 70% 75% of the patients. The question is then why do the other patients not respond.
Speaker Change: That is a suspicion that complement is in play through pathogenic Archie M antibodies.
Speaker Change: We have pretty strong translational data in hand for Amp in CDP now, we do not want to niche embarked into kind of refractory setting only we really want to give this great molecule. The fullest chance of success in the <unk> setting. So that's why we have designed to clinical trial, you all see and let the data speak.
Speaker Change: I think this is a significant market has significant opportunity, which can harbor multiple innovative molecules to optimally address the patient needs. So let the data speak now.
Speaker Change: Thank you for the question.
Speaker Change: Your next question comes from the line of <unk> <unk> from Guggenheim. Your line is open.
Speaker Change: Hey, guys. Thank you for taking my question question is on the Gmg side could you just talk about the relative penetration indeed targeted patient population you have achieved.
Speaker Change: Also I think in the past you have said that at least in Myasthenia Gravis York consistency consistently seen $40 million to $50 million.
Speaker Change: Quarter over quarter growth is that the same.
Speaker Change: Is that what you are seeing now and how should we think about.
Speaker Change: Oh.
Speaker Change: The code just purely in gmg and any impact from competition, whether it's the CD 19 or anything else that you might be seeing a compliment.
Speaker Change: Yes, thanks for the question.
Speaker Change:
Speaker Change: Always appreciate being able to talk about Mg growth 13 quarters into launch and the fact that we're still delivering that consistent cadence of quarter over quarter growth and to your question I would say it is we are seeing consistent penetration into the earlier line I mentioned that before more than 60% of our patients are coming from.
Speaker Change: Early align and what we're seeing is part of that is.
Speaker Change: The share of the market treated by biologics is growing substantially and this Scott is leading that growth with the number one market share we're growing that number one market share in all of our major market. So we're still I would say at the early stages in terms of penetration we updated the can to 60000.
Speaker Change: Youll recall last year.
Speaker Change: With that I think you can see that we're on the early stages of the growth curve for Mg, even though with 13 quarters into the launch and.
Speaker Change: And what we can what you can expect and what we expect is consistent and continued growth in whether you look at new patient start at prescriber growth or the metric that you mentioned, which is revenue growth. When you take a line through it since launch I think we've been delivering that consistent growth on average since launch and we expect that to continue Jim did you have some.
Jim: I'm not there and you can clearly see that we have broken out of that refractory patient population right. What it takes to be removed first line and lead into first line is the clean safety profile, which we have demonstrated for the drug remember what we said in the prepared remarks, no black box.
Jim: No need for vaccination no lapsed no monitoring that's a very powerful profile to grow frontline as a biological and will be see right. Caroline is that you know about 60% of the new patients coming on drug concentrates from the orders and that is where the growth opportunities in front of us.
Jim: We think PFS will continue to fuel that that's right.
Speaker Change: Our next question comes from the line of Andy Chen from Wolfe Research. Your line is open.
Andy Chen: Hey, Thank you for thank you for taking the question back to the topic of most favorite nation.
Speaker Change: Carl I understand that you had talked about a narrow band.
Andy Chen: Just wondering if that narrow bed.
Andy Chen: Okay, so less than the 20% discount that you will have to pay on part D was more than the 20% just curious if there's a way for you to push your patients to the part D to minimize exposure just because part D price cut is less likely than the part D price cuts.
Andy Chen: Most favorite nation comes.
Andy Chen: It comes to play thank you.
Andy Chen: Andy I think I don't want to talk about percentages, but I think the reference to most favored nations here on list prices and I think unless prices we are in the narrow price band.
Andy Chen: Thank you.
Andy Chen: We shouldnt don't want to speculate on way below will end its clinical interface.
Speaker Change: I think I'll stop there, but maybe Tim you want to add something.
Speaker Change: The business of pushing patients into certain directions, I think what we're trying to offer the broadest product offering possible to satisfy the needs of the different patient segments. So I think what you guys are seeing in Q1 is a very strong appetite of patients to move into self administration at home or product administration at home.
Speaker Change: Despite this acceleration under Medicare part D is coming with <unk>. This is the <unk> in order to spectacularly grow your market. So following the patient demand satisfying the demand is the best way for growth going forward and I think you basically see a signal here that patients and eagerly awaiting the PFS.
Speaker Change: Your next question comes from the line of David Nearing Garden from Wedbush Securities. Your line is open.
Speaker Change: Hey, Thanks for squeezing me in I have one question, which is are the dynamics as you see patients getting treated with ocular Mg currently are those dynamics different from generalized mg and how that might affect your commercialization.
Speaker Change: Commercialization plans.
Speaker Change: Duration of treatment things like that.
Speaker Change: Potential expansion thanks.
Speaker Change: Yes.
Speaker Change: <unk>, you're right I mean your question is valuable to US also of Mg.
Speaker Change: High unmet medical needs, which we overlooked in the beginning when we were approaching.
Speaker Change: <unk> markets.
Speaker Change: It's very debilitating to have ocular Mg theres no ability to work on a screen drive a car that has a big social stigma associated with the symptoms et cetera. So the truth is that today the toolbox to TD patients is even more limited.
Speaker Change: You would typically see that these patients are being treated with <unk> and the high dose of corticosteroids.
Speaker Change: No well the detrimental effects are of high dose corticosteroids used chronically.
Speaker Change: And we are really on a campaign of steroid tapering, we have a strategic alliance with steady for us.
Speaker Change: I think the moment has arrived to actually offer these patients real alternative with the benefit risk profile of our op costs are high unmet needs.
Speaker Change: Very limited treatment toolbox, and an opportunity to disrupt that treatment paradigm. Thank.
Speaker Change: Thank you for the question.
Speaker Change: Your next question comes from the line of Gavin Clark Garden from Evercore ISI. Your line is open.
Speaker Change: Hey, guys I apologize with one more net price question for the pre filled syringe. What are your current assumption for the number of payer contracts that will include Vba's moving forward, specifically wondering on the <unk> side I'm wondering if this could offset the gross to net a little bit. Thank you.
Speaker Change: Yes, so maybe just to start before I hand over to Carl to take a step back and remind everyone that our strategy. We've got is to provide as broad of access as possible to patients and certainly that we don't want them to be choosing between product presentation based on price.
Speaker Change: Them to have access and be able to choose the product presentation that fit into their lives. So that's the strategy that we're pursuing and and what we've seen whether it's with the Mg launch and see IDP launched and what we expect with the PFS launch is that our market access team are experts at getting really good access in place quicker.
Speaker Change: <unk> for patients and we expect that will be the same.
Speaker Change: And the agreements will be signed quickly to get that access in place who pre filled syringe, but Paul did you have anything else to add on the detail.
Speaker Change: Kevin I think the only thing I will say is that generally.
Speaker Change: Our.
Speaker Change: Yeah.
Speaker Change: Important in the pharmacy channel than the medical channel. So I think we'll leave it at that and relate to negotiate the contracts. It during the next few weeks.
Speaker Change: Your next question comes from the line of Samantha <unk> from Citi. Your line is open.
Speaker Change: Hi, good morning, Thanks, very much for taking the question another one on <unk>.
Speaker Change: I'm wondering how has the discontinuation rate and see IDP trended at are you still seeing physicians given the majority of patients.
Speaker Change: <unk> trial or has that trended down as they gain more experience with that guidance population. Thanks very much.
Speaker Change: Yeah. Thanks for the question. So in terms of see IDP, we are still seeing the doctor is it given that 12 week trial and what we've seen is the launches mature is that there has been a little bit of an uptick in discontinuation more towards what you would expect based on the <unk> trial, but there is still a significant gap and I would say where we're <unk>.
Speaker Change: Though that discontinuation rates. So what we're seeing is patients starting on <unk> got having a positive experience and staying on that Scott.
Leland: Your next question comes from the line of Leland <unk> from Oppenheimer. Your line is open.
Leland: Great. Thanks for taking my questions just.
Speaker Change: Two from US if we can just with respect to the upcoming data from the switch study from <unk>.
Speaker Change: I agree with you because its guards in <unk>, just given the dynamics there and the positive launch just wondering out critical do you see those data for physicians to.
Speaker Change: Two two effects of switching their patients and then also wanted to ask with respect to 119 later this year, we'll see the POC did in CMS.
Speaker Change: There are a few clinical endpoints being looked at just wondering if you have any threshold in mind. When you look at those data for taking that program forward in CNS. Thank you.
Speaker Change: Yep. Thank you for the two questions. So the significance of the <unk> switch study is very simple I think the adhere trial was a very ambitious trial, but there's only so much you can answer and one clinical trials. So we address general.
Speaker Change: This is an IAG have driven disease, we are.
Speaker Change: Addressed in order of magnitude of the effects you can show across the board in CDP patients, but we did not really study in detail the switch dynamics.
Speaker Change: Remember patients had to worsen so they could demonstrate active disease before they came on trial that is a bit of an artificial experimental setting. The phase four trials are investigating a practical question. How do you really switching <unk> patients to <unk>. The simple trial design, it's a phase four.
Speaker Change: It's meant to give some practical handle to treating physicians on how to do the switch. So I think it's an important data point.
Speaker Change: With regards to 119 molecule, which is very close to my heart.
Speaker Change: Congenital myasthenic syndrome.
Speaker Change: What we've learned about these patients in the natural history study is did they actually look very much like the auto immune myasthenic patients. There is a very strong fatigue ability aspects to their disease. The limb girdle is really affected so weakness of the shoal. This weakness of the hips and therefore, we really testing.
Speaker Change: Menu of endpoints.
Speaker Change: Testing and know which ones are really truly capturing the nature of the disease. The classical ADL and <unk> measures are in this and we know what the clinical threshold for clinical relevance. So we will be looking to deadlines at our patients and we will inform you of course, when we have the data in hand. Thank you.
Speaker Change: For the question.
Speaker Change: Your next question comes from the line of Joel Beatty from Baird. Your line is open.
Joel Beatty: Good morning, Thanks for taking our question.
Joel Beatty: Just kind of a longer term one I know I know the PFS rollout has just taken place but.
Joel Beatty: Have you started turning your attention a little bit now to firming up timelines and strategy regarding the auto injector. Thank you.
Joel Beatty: Yeah. Thanks for the question I appreciate zooming out and looking over the long term.
Joel Beatty: And yes, our team has consistently working on the.
Joel Beatty: Not just the auto injector, but how we can innovate for patients overall in terms of the auto injector. We continue with that development plan. The latest update we've provided is that we're moving it into being able to understand how to produce it at logic capacity. So everything is on track and we look forward to being able to bring our continued innovation to patients in the future.
Speaker Change: And your last question today comes from the line of Xian Deng from UBS. Your line is open.
Xian Deng: Hey, Thank you so much for taking my question. So really thank you for the comment.
Xian Deng: Europe European and U S have very similar niche surprise, but just wondering could you give us some color on the phone.
Xian Deng: Difference in terms of the net price please.
Speaker Change: Sort of off key in relationship to how should we think about the commercial opportunity for PFS in Europe, because on one hand, Europe does have this kind of lack of IV infrastructure compared to the U S. But then on the other half probably we have probably less net price. So how should we think about that please thank you.
Speaker Change: Yes, thanks for the question and maybe I'll start with I'll reinforce something that.
Speaker Change: <unk> had said in terms of our ex U S expansion, we've taken a very disciplined approach to ensure financial sustainability as we provide access to patients around the world with they've got so I think we're very well positioned in terms of our net price.
Speaker Change: From that perspective, and you're exactly right, we see the PFS opportunity as a big opportunity ex U S. Because of the the hospital dynamics that you mentioned, we've already seen the first patient dosed in Germany.
Speaker Change: What we saw with the high <unk> butterfly execution is a very fast conversion in in Europe in particular of patients from IV to the butterfly execution of high to low and we think that will accelerate with PFS and we will certainly help to accelerate and continue our growth in rest of world or.
Speaker Change: <unk> of the U S.
Speaker Change: In the future. So we're really excited about the opportunity for PFS and not just in U S, but around the around the globe with launches coming thanks for the question.
Speaker Change: And this concludes today's conference call. Thank you for your participation you may now disconnect.
Speaker Change: [music].
Speaker Change: Okay.
Speaker Change: [music].
Speaker Change: Okay.