Q3 2024 argenx SE Earnings Call and Business Update
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.
Speaker Change: Thank you. I'd now like to introduce Beth DelGiacco, Vice President, Corporate Communications, and Investor Relations. You may begin your conference.
Beth DelGiacco: Thank you. A privately-created issue earlier today with our third quarter 2024 financial results and business updates. This can be found on our website along with the presentation for today's webcast.
Beth DelGiacco: Before we begin, 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 developments, regulatory timelines, the potential success of our product candidates, financial projections, and upcoming milestones.
Beth DelGiacco: Actual results may differ materially from those indicated by these statements. ArgenX is not under any obligation to update statements regarding the future or to confirm these statements in relation to actual results and less required by law.
Beth DelGiacco: I'm joined on the call today by Timvin Hauwermeiren, Chief Executive Officer, Karl Gubitz, Chief Financial Officer and Karen Massey, Chief Operating Officer. I will now turn the call over to Tim.
Tim: Thank you, Beth, and both of them, everyone.
Tim: I'll begin on slide number three.
Tim: As we approach the end of 2024, it is incredible to reflect on all the feet of a gun blitz, having achieved a goal throughout an hour of 2025 vision ahead of plan.
Tim: We move to Goldforce to get in July, raising our ambition with vision 2030. Building on a momentum from ArgenD Day, we have now executing across the business to advance this vision to getting with our commercial expansion.
Tim: This is our 11th consecutive course of growth and I continue to be impressed with the team's efforts to reach more G&G patients and subscribers and build our wall of data in support of this car as deleting branded biological in NG.
Tim: The CRDP launch has started strong as we leave its powerful data from the teeth and our established relationships with faith and subscribers to support the core that surpassed our expectations.
Tim: Overall, we are thrilled with our initial progress, bringing innovation to CRDP patients.
Tim: Carol will provide metrics that highlight the positive reception of the Garnhart Fellow across Key Stake Holes, but overall, we are very happy with our Storm Start.
Tim: We are navigating the unique market dynamics of CIDP, and we're able to deliver our innovation to more than 300 CIDP patients last quarters, which correlates to revenue that is approaching what we saw in the first quarter of our MG launch.
Tim: Flight 4, we now have the benefit of seeing the ethyde data drive real world outcomes with some patients already experiencing reggae and function early into the treatment journey.
Tim: My personal favorite story comes from the first CRP patient, Dostitica Haxule.
Tim: The patients' wives shandered private treatments for husbands' struggle with mobility.
Tim: The recently checked in and the patient is now more active. He and his wife have enjoyed traveling again and were able to attend the friends wedding.
Tim: He has now been able to take care of himself more independently and is eager to return to activity he loves, like golfing and going to the gym.
Speaker Change: The wife of the patient expects her gratitude for the subunitly use on life.
Speaker Change: This is the type of story that makes this industry so rewarding.
Speaker Change: Slide 5
Speaker Change: Early this month we had a strong presence at A&M where we were able to present new clinical trial and we will data demonstrating have a long-term commitment to the neurologic community and why do transformational outcomes for patients?
Speaker Change: We continue to set a high bar with fifth guard, driving rapid, deep and sustained responses, and now we have multi-year data demonstrating durable efficacy supporting maintenance use.
Speaker Change: Over 50% of GMG patients on this card, the Chief MSC, which positions agreed is an important growth treatment for their patients and the year the speed of onset is a clear advantage.
Speaker Change: We now have more than 8,000 patients use of safety data, which demonstrate consistent, favorable safety, no black box warning, no infection albumin levels, no runs program, no monitoring requirements and no needs to vaccinate.
Speaker Change: Consistent with our goal to bring Zeth Garts into early lung treatment settings, we also presented Louisville data that patients can meaningfully reduce their orce use within six months of treatment.
Speaker Change: This effect was maintained and improved to 12 months with one other four patients taking to 0 milligram of steroids and 42 percent of patients, deepening to 5 milligram or less.
Speaker Change: Even the Enemotional to Believe The First Congress, where we showcase three clinical programs from our pipeline, including and possible bark and ArgenX-19.
Speaker Change: Through these programs, we continue to solidify our leadership in Uramuscular Medicine, the advancing clinical development across multiple indications, including NG, TIDT, Emma Mann, CMS, and ALS.
Speaker Change: and generating early excitement as we address unmet needs with our precision medicines.
Speaker Change: Slide 6.
Speaker Change: We foreturning the call of the caro, I would like to highlight some of the opportunities ahead to advance innovation as we approach the end.
Speaker Change: Remember, we like novel targets with pipeline in a product potential and seek out indications where we believe we can drive the most impact for patients.
Speaker Change: Indications come to you to introduce you to the Cross-Aber Tea Barcline Probe of Amson Declinics, and Carthing Amops and Poshy Probe Art and ArgenX for 19.
Speaker Change: Next up is our Myisitis, go to the physician before you end.
Speaker Change: As your may recall, we thoughtfully designed Al Qisia as our first basket study that would allow us to simultaneously evaluate our contingent of the three success of my Zyles, democratizing anti-centitase and strum of the Miseditis.
Speaker Change: The primary endpoint of the study is the same across all subsets and is based on the total improvements score.
Speaker Change: With the CMF Phase II, please design, we started enrolling in the Phase III as soon as we completed enrollment in the Phase II.
Speaker Change: which means that the decision we will make in the coming weeks is whether we will continue recruitment in one or more subsets based on the signal we see in the first 90 patients from the phase 2.
Speaker Change: Lastly, as you saw into the actual release, we made a decision to discontinue the development of a
Speaker Change: As a part of our strategic alliance with Zynap, we are leveraging Zynap's clinical development in M. and L.N. to kidney indications settled in China.
Speaker Change: We did not see a sufficient advocacy signal from the Indian data to warn further investment in MN. Importantly, no safety signals were detected and now we look forward to the phase 2 data in LN.
Speaker Change: It is part of our mission to prioritize programs that have the potential to drive transformational outcomes in patients. And we do not see this opportunity with a 30-minute amendment.
Speaker Change: 2 Klaus, we are well positioned to continue investing in our innovation, advancing high-value, novel treatments that can improve outposts for patients and maximize value for shareholders.
Speaker Change: I will now turn the call over to Carol.
Carol: Thank you, Tim. Flight 7. The third quarter 2020-4 financial results are detailed in the press release of this morning.
Carol: Total operating income in the third quarter total spy-189 million dollars, Westeriff Lachs 573 million in product-made sales and 16 million dollars in other operating income.
Carol: The product made sales of 573 million dollars, they present 20% quarter of a quarter growth and 74% growth compared with a corresponding prior year quarter.
Carol: A product revenue breaks down by region to 492 million in the US, 24 million in Japan, 46 million in the rest of the world, and 11 million product supply to ZILAP in China.
Carol: The next Siles in the US is Inclusive of both CIDP and MG Revenue.
Speaker Change: will provide additional color in her section on the initial launch performance.
Speaker Change: Flight 8, Turtle Operating Expense in Q3 are $575 million and increase of $40 million compared to a Q2 2020 poll.
Speaker Change: The increase is due to a 22 million increase in SG&I reflecting incremental expenses on the CIDP loans in the US and 11 million increase in R&D and an increase of $7 million in cost of sales.
Speaker Change: Cost of sales is $59 million in Q3, Vyvgart's gross margin of 90% which is in line with previous quarters.
Speaker Change: In Q3, HGNI expenses are 278 million dollars and R&D expenses are 236 million dollars. Vest results in operating profit, 4Q3 of 14 million dollars.
Speaker Change: On a year to date basis, operating loss is $125 million.
Speaker Change: The quarterly net financial income is 41 million dollars and it also benefits from unrealized exchange gains of 34 million only our euro-denominated cash balances.
Speaker Change: After Tax, the profits of a quarter is 91 million dollars and the year to date, profit of the tax is 59 million dollars.
Speaker Change: Karl Cash Balance, represented by Cash Cash Equivalence and Karen Financial Acets, is free point fold by the end at quarter end.
Speaker Change: a balance increased by 272 million in the quarter and our cash guidance for 2024 no longer applies.
Speaker Change: The financial guidance on the combined SGNA and R&D spent of $2 billion in mainstream change. I will now turn the call over to Karen, who will provide details on the commercial front.
Karen: Thank you, Karl. It's an exciting time for ArgenX. I want to first give a huge thank you to the entire team who continue to execute on all fronts to make this possible.
Karen: Patients are at the center of our innovation mission, and I'm pleased that our clear, patient-centric strategy and discipline approach has delivered continuous growth in GMG, while at same time contributing to a strong first quarter of launch in CIT in the U.S. and ITP in Japan.
Karen: All begins with the details about CADP launch before zooming out to the overall performance for the quarter, highlighting the dynamic striving out GMG performance and sharing our outlook for sustained growth. Slide 10.
Karen: The team that successfully advanced each of the coal strategies that we outlined at the CIDF here for Rewel to reach out key stakeholders, patients, physicians and payers.
Karen: Let's begin with Paid, where enabling broad patient access had been its area of course focused.
Karen: Since the ADP approval, it has been out prior to secure access as quickly as possible, leveraging the credibility and strong partnership to establish with payers through our MG experience.
Karen: Today, we are pleased to have broadly favorable policies in place that cover approximately 54% of U.S. commercial lives. Most, but not all policies require some prior IG utilization.
Karen: This is not surprising to us and support their expected growth trajectory because most CRDP patients have prior IVIG experience and it's commonly part of diagnosis.
Karen: Important to note is that four of those policies that require prior IVAG use, it's usually exposure of three months or less at any time with the patient's history, which is favorable for their gut-hectualo.
Karen: It typically takes two quarters to get most policies in place after any launch and where on track with this timeline. With the remaining policies expected to come into place over the next few months, overall pay as recognize the value that had true low-combring to patients.
Karen: Moving on to prescribers, the strength of our data and the clear value proposition of Vyvgart-Hauwermeur to patients is also driving initial uptake in physicians.
Karen: You're all just a excited, gain experience with the first CADP innovation in 30 years, a safe and effective treatment that has the power to drive functional benefit in patients with a 30s to 90 seconds simple injection.
Karen: At the time of launch, we shared that we have an estimated 10,000 total neurologists spanning CIT and MG. With approximately 72% of the lack in physician's retreat boats.
Karen: We expected that physicians with prior vyvgart experience with most likely to be the first CIDP for subscribers. But our goal was also to broaden the vyvgart for scrim of the base.
Karen: I'm pleased to share that 25% of the IDP prescribers today are first-time Vyvgart prescribers. And some who started the IDP have now also prescribed the GNG.
Karen: We're seeing initial bread food out for scrub base as well as steps. Many prescribers have already started multiple patients on treatment.
Karen: Lastly, and most importantly, with thrill to see innovation deliver tangible impact as Vyvgart Hauwermeiren reaches the added patient's in need.
Karen: expanding on Tim Zerlius story, we're inspired by the feedback we received so far. Many patients are able to enjoy more moments with their loved ones and regain the independence to do the activities that UNI often takes for granted.
Karen: We are pleased to share that as a stand of the quarter there are the 300 patients on Zidgahaxrilo delivering a strong quarter of the AT&T revenue which have approached that of our first MG quarter.
Karen: All these patients 85-90% are coming from IVAG, which supports our physicians that this would largely be a switch market.
Karen: Overall, the team has done an incredible job getting patients on treatment smoothly, and we'll continue to monitor how the launch trajectory progresses.
Karen: We will specifically be looking at response rates, patients getting on and staying on treatment and how utilization trends over time. In particular, in light of the OLD data that we will share next year, we buy weekly or every three week dosing.
Karen: Now let's turn our attention to MG by 11.
Karen: M.G. drove the majority of growth over the quarter with continued momentum and steady growth across the gut and Zizde Haukfula.
Karen: In the US, Hauwermeur continues to attract both new patients and new prescribers. This is important for a couple of reasons. First, over 60% of new Vyvgart and Hauwermeur patients are coming from RL, which is consistent with our goal to reach early online patients.
Karen: Second, we continue to expand our prescribed base for MG, Vyvgart, and 12% of prescribers will brand new to zip-cut.
Karen: Our goal is for patients not to have the constant reminder of their disease, and we hope to achieve this with our efficacy results, delivering MSC in over half of our patients, and our demonstrated safety.
Karen: We're generating real well-devinance that shows that more consistent cycles leads to sustained efficacy for patients, and that over half of patients can minimally taper off steroids after they've got initiation.
Karen: We also aim to enhance the patient experience by offering both IV and a simple subcutaneous option.
Speaker Change: Vyvgart Hauwermeiren was an important step forward with this strategy and advancing our pre-filter range is next. A significant amount of innovation went into this regulatory submission, and we're looking forward to the PFS to do today in April 2025.
Speaker Change: Flight 12
Speaker Change: We've also had strong momentum in MG sales globally, and a proud that Vyvgart is now available to over 80% of the GMG population in the EU.
Speaker Change: The ITP launch in Japan is showing early success and the data from advance are playing out in the real world with 50% of patients responding.
Speaker Change: and Loft. We are working to bring our innovation to see IDP patients worldwide. Regulatory reviews are ongoing in China, Japan, and Europe with approval decisions on track for 2025.
Dr. Dean: Dr. Dean.
Dr. Dean: We have a lot to look forward to. There is significant opportunity in the pipeline as we expand into new diseases that all have high unmet need for innovation.
Speaker Change: and the commercial organization is ready to focus on executing our plan to maintain momentum and growth in MG, CODP and ITP. All the fuel are differentiated pipelines and blow the NEL patient impacts globally. I will now turn the call back to Timb.
Timb: Thanks Karen.
Timb: I'd like to attend your ArgenX team for their ongoing commitments to changing the lives of patients through our signs.
Timb: As we approach the end of the year, we are far off all that we have accomplished, gaining insoluble insights along the way to solidify our deep understanding of the immunology.
Timb: We had energized by the opportunity ahead to amplify our impact, recognizing we still early into the CDP launch and have the potential to reach new patients across multiple indications in the clinic.
Timb: With G-rending sites, our Dustin's nationalization shows no sign of slowing down, as we continue to build out long-term failure with Vyvgart and move swiftly to advance our promising clinical candidates.
Timb: Thank you for your time today. I would now like to open the call for your questions.
Speaker Change: Thank you. We will now begin the question and answer session. If you would like to ask a question, please press star 1 in your telephone keypad to raise your hand and join the queue.
Speaker Change: If you'd like to withdraw your questions, simply press star one again. We ask you, please limit yourself to one question and then re-enter the Q-fort further questions. Your first question today comes from the line of Derek Arquilla from Wells Fargo. Your line is open.
Derek Arquilla: Hey, good morning, thanks for taking my questions and congrats on the strong performance here.
Derek Arquilla: Vyvgart's first thought, I was hoping you could talk about the trajectory of the CIDP launch. Since the two patients Karen talked about it the R&D day to now the over 300 at the end of the third quarter. Has that been fairly linear or was there a recent bull-ass?
Speaker Change: And then just to follow up to that, I guess, how do you think about some of the variables in the CIDG launch and how does that figure into your thinking on potentially issuing guidance in 2025?
Speaker Change: Thank you, Eric. Thanks for being with us today and thank you for the confidence on a very strong quote. I think this is a question for you, right, Karen? Yeah, thanks for the question and first of all, thanks for recognize the strong...
Speaker Change: Porter, I think we're really proud of the team and the disciplined execution, the focus stuff that they've delivered us from quarter. In terms of your first question, we have not seen a ballast in the CIDP launch. To use your phrase, I would say, the patient starts of being relatively linear through the quarter.
Speaker Change: As we've any launch, it takes time from when the prescription is written to when the patient gets on therapy as pay a policies have come on board through the quarter. So the majority of our patients start.
Speaker Change: Weren't September, but there has not been a ball of stuff that we've seen.
Speaker Change: On your second question related to what we've seen in terms of the CRDP launch dynamics.
Speaker Change: I would say we're exactly where we thought we would be and we're really proud of the strong stop that we have.
Speaker Change: In terms of how we laid out the strategy, the payer policies we said they would take two quarters to get the payer policies in place. And we're right on track with that. We shared that we have about 54% of commercial lives covered, and we expect that the payer policies will continue to come in over the next quarter.
Speaker Change: We've certainly seen strong uptake amongst physicians. We shared that 75% of the CADP prescribers have had prior Vyvgart youth, but we've also seen a broadening in the prescriber base. So 25% of prescribers with the ADP are new to the Vyvgart franchise. And in fact some of those that wrote for CADP first have also now started a patient on MG. So that's also a really good signal. The reflection from the neurologist is the regained of function data, is resonating very well with them and with their patients. So I would say...
Speaker Change: We're off to a strong start that dynamics are exactly as we expected. Moving forward, what we plan to provide in terms of launch metrics is not guidance on revenue or number of patients, but rather we'll continue to provide those metrics or those KPIs that are most relevant to how the launch is progressing.
Speaker Change: Thanks for the question.
Speaker Change: For next question comes from a line of Tuzina Maud from Bank of America. Your line is open.
Tuzina Maud: Hi guys, good morning, thanks for taking my question. Maybe this is also for Karen. I think at the beginning of the launch you talked about the time it might take to get on to formulary and the time it might take.
Tuzina Maud: for a piece in to receive treatment for CIDP from the time in the grips is written. Can you give us an update on both of those metrics maybe a little bit more focus on the latter because I think people are still wondering, if your initial cautious guidance about time it would take to receive treatment as bill true or is that trending above expectations? Thanks.
Speaker Change: Yeah, thanks for the question. Happy to address this. So with any launch, actually, with any patient start, there is a delay between when the prescription is written and the patient actually receives the treatment. And at launch, this is often longer than once you're in steady state, because pay-apolices are coming online during that time. What we've seen for CIDP is in line with what we saw for MG and in line with what our expectations are. So patients are moving relatively smoothly from prescription to getting on therapy when they're pay-apolices in place. And I really do want to recognize the team for their efforts, not just getting...
Speaker Change: Pair Policy in place, but also to the team that does support getting patients through that process and getting them onto treatment.
Speaker Change: The End
Speaker Change: Our next question comes from a line of James Gordon from JP Morgan. Your line is open.
Speaker Change: Hello James Gordon, taking more good and thanks for taking the question. The question was just, if we try and break out how much of cells came from CIDP or MG during the quarter, would it be fair that most of the ads were still MG and it was something like a 20 million ad in terms of CIDP?
Speaker Change: And if that is right, is that pretty much all in the last month, based on when the patient came onto therapy? So is that the number of things that we could analyze or would we need to be a bit careful, so extrapolating what you did in the final month of the quarter and what that would equate to on a yearly basis?
Speaker Change: Thank you James for the question. These are actually two questions in one. I think Karl Waddon, you're coming on question number one and then we can have a question number two right can. Thank you James. I think that actually your numbers are correct in terms of we have 300, more than 300 patients on treatment or CIDP at the end of the quarter.
Speaker Change: Pat Combes to stay under the 80 which we had for MG and during the first quarter.
Speaker Change: For MG, we had 21 million dollars of sales, so your extrapolation to CIDP makes sense because most of our stations came on board or started initiated with treatment I should say at the end of that quarter in September.
Speaker Change: So I think that makes perfect sense.
Speaker Change: and then on your second question James, the quick talk to you from Carol Mites. Yes, in terms of extrapolating moving forward look, I think still early days I wouldn't try to get ahead of ourselves just yet. We still have a few dynamics that we need to see play out in the C.I.D.P. launch. Just a few of those really quick. Don't forget that with the A-Heeer data, there was a 67% response rate. So we need to see what how that plays out in the real world.
Speaker Change: We also have open-level extension data that we'll be sharing next year on bi-weekly and every three week dosing. So we need to see what real-view the li-visation looks like and of course there is competition in this market as well that we'll have to be watching. So I say still early days.
Speaker Change: Your next question comes from a line of Allison Brudso from Piper Sandler. Your line is open.
Allison Brudso: Hey, good morning and congrats on the quarter thanks for taking the question. I think you indicated that around 85% of FIDP patients has switched from IVIG. Could you just talk to those who aren't IVIG switchers?
Allison Brudso: Rene of those newly diagnosed patients, or they coming from a different therapy. Any kind of therapy helpful. Thank you.
Speaker Change: Thanks, Alison for being with us today. So, it is absolutely right that's about 85% of patients are actually on IV Ag. even they come on to Hytrulo.
Speaker Change: We remember that perfectly in line with expectations, right? The line share of the CDP patients are on my VIG. That's also used as a diagnostic tool in the diagnostic journey. So no surprise, the other 15% or so of patients think of them as many coming from steroids or other immunosuppressants.
Speaker Change: Thank you for the question.
Speaker Change: Your next question comes from a line of miles midter from William Blair. Your line is open.
Speaker Change: Thanks for taking the question. Can you just give us a little bit more color on exactly what the prior step through therapy I need me to glob your looks like in that pay a formulary coverage for say IDP like is it?
Speaker Change: You have to respond and then go on to SRIG maintenance and then relapse and that's a patient that would be considered successful in a priori, setting or is it really up to the clinicians to see how their patients are responding to IVIG before they can kind of tick that box and put them on to a bit gut-hutual look. Thanks very much.
Speaker Change: Thanks for the question. So we're really pleased with where we landed without pay-a-pulse, as I'd say they generally say we're full. And as you said, they generally do have some IVIG or IG prior experience in general.
Speaker Change: And what that means is that there has to be some documentation of prior IVIG or Subtutaneous IGU.
Speaker Change: But as you say, there's not a documentation of, for example, a response rate or I-RODs or any of those measures that need to be used. So it is favorable. It's also generally, I-V-Pri-I-V-I-G or sub-Petaneous I-G, you know, lengthy period of time, sometimes through the patient's entire treatment cycle. So the policies are favorable and we're pleased with whether or not.
Speaker Change: The End
Speaker Change: Your next question comes from a line of Alex Thompson from Steephel. Your line is open.
Alex Thompson: Great, thanks for taking my question and could grasp on the quarter as well. I guess it's a follow-up to the pair question.
Alex Thompson: I guess, you know, can you talk a little about your discussions around this IG experience and just given the broader population of it here, do you expect to sort of be able to push past that? And the future is this sort of high-o-expective-to-tea pair of policies moving forward. Thanks.
Alex Thompson: Alex, I guess this is a variation of the same theme, so typically pay a policy's position as behind IG, whether it's IV or sub QIG which is not surprising.
Speaker Change: given the price point, the data which really resonates very well with pace is the vegan of function data. That's where they see value above and beyond the current therapies out there.
Speaker Change: and then we say that the pay policy is typically favorable, it basically means that there needs to be some sort of documentation at some point in the past.
Speaker Change: where the patient had an insufficient response to IG, or and or a tolerability issue. That's how the language reads. Some of these policies are actually visible publicly, but that's what it is. And we think that's not really going to be a practical handicap to the launch of the products.
Speaker Change: Your next question comes from a line of Danielle Brill from Raymond James. Your line is open.
Danielle Brill: Hi guys, good morning, congrats on the strong start of the launch.
Danielle Brill: So on a percent of Tam, basically, it looks like you captured more of the CIDP population right out of the gate than you even did with NG. It has this early strength impact of your thinking on the overall size of the opportunity. I mean, to ask a little more director directly, you said you're committed to treating 50,000 patients by 2030.
Danielle Brill: Could you potentially get there? Would just M.G. and CIDP? Thank you.
Speaker Change: Thank you, Daniel. This is an excellent question on me, baby Karen, you would like to say good? Yes, certainly I'll talk to this. So in terms of the CIDP, we are off to a strong start, exactly as you say, and we're really pleased with that early time being strong. The total patient population that we shared for CIDP or the addressable market is 12,000 patients, and we're not changing that. We believe that that's...
Speaker Change: The patient population that's the addressable market and that's those that are uncontrolled on IVIG. We believe that between MG, the IDP as well as the expansion indications that we have coming over the coming years, we're excited to look forward to the 50,000 patients in 2030, but that goes beyond MG and the IDP.
Speaker Change: You are next question comes from a line of a cash to worry from Jeffries. Your line is open.
Speaker Change: Hey, this is Amy on for a cost. Thanks for taking your question and congrats on the quarter. Is there a potential for you to combine your seed to with Vyvgart and CIDP? And when can we start seeing, when can you start these studies and what could they show? And then also, when can we get an update on your remaining Xylab trial in loop-it-neffitis and what's your internal confidence in this? Thanks so much.
Speaker Change: Thank you for the questions.
Speaker Change: That's probably always an opportunity to start combining certain therapies in severe auto-munity, just like people are doing in cancer.
Speaker Change: For the moment we really focused on launching a drug team up, which I think has shown a unparalleled data in CADP, just launching that product into the time which we just have been discussing. We do know that complement is in place, probably as a result of all 20 bodies driving that.
Speaker Change: and so we think Emperor deserves his own individual shot on goal in Saudi peace.
Speaker Change: Combo is a theoretical possibility, let's not take it off the table, but we have plenty of work set out for us for both Vyvgart and Enpa.
Speaker Change: With regards to Zylav, remember that we're doing two proof of concept trials to help us with the big volume of work we need to lift.
Speaker Change: and two kidney indications, Memoronisting Property and Lupus Nephritus. Both studies have been executed very well by Zy or being executed very well by Zy. So stay tuned when these data be complex. We will definitely talk about it.
Speaker Change: The Suified of trial is an warning very well and we are very pleased with the quality which the Zion has shown in its clinical trial execution across both indications.
Speaker Change: Thank you for the question.
Speaker Change: For our next question, come to some line of your own webber from TD Cowan. Your line is open.
Speaker Change: Thanks and congrats on that really it's a rift recorder. Maybe quick question, the Myociders, go and know good decision is coming up in three indications, you know we all know that the IMMN passive transfer date, I was the sort of the best objective.
Speaker Change: Support to moving into phase 3, but there's a lot of biological support for the other two. Maybe just how do you feel about all three indications? Thank you.
Speaker Change: Thank you, you don't know, thank you for the question. You're right to call out my side is because this is the that last
Speaker Change: Data card which we would like to turn before we leave a very productive and successful planet 24.
Speaker Change: An equally strong ball is you can take conviction across the three with a slight preference in detail as you call out for IMNN.
Speaker Change: I think there is convincing biology in place for all three of them.
Speaker Change: I think the field in my side is evolving, more and more, and our people classifying the subsets of my side is not just based on clinical symptoms.
Speaker Change: but also sociology, I.E. the presence of this pathogenic agegy, all 20 bodies that in the serum of the patient.
Speaker Change: I'm positive about all three based on what we know about the biology.
Speaker Change: The Zobeth risk associated with the clinical experiment.
Speaker Change: and that's I think why we make that responsible decision to do that go on or go decision points. Whilst we're enrolling at risk, of course the face-to-face trials. So in practice, you know what you will see as do is just make stop decisions, in case they're warranted. But the face-to-face and rolling in all three subsets.
Speaker Change: Thank you for the question. Your next question comes from a line of Vyvgart, for a hit from Morgan Stanley. Your line is open.
Speaker Change: Hi, good morning. Thank you for taking our question. Sorry if this was discussed already and we missed it, but I was curious to hear your thoughts on what you're seeing in terms of dosing frequency. First, the IDP patients that have started therapy, especially for those that started in July and August. Thanks.
Speaker Change: Thanks for the question, so...
Speaker Change: It's a little too early for us to tell. The majority of patients are just getting started on therapies for CIDP. And what we know is, as I mentioned earlier, that we have the Open Label Extension study coming with the biweekly and the every three weeks dosing. So we really need to see how it plays out with real world utilization as we get more patients on therapy. Thank you, Karen. Vikram, I think it's fair to assume in an early launch.
Speaker Change: that typically patients will be doors to according to the level.
Speaker Change: Your next question comes from the line of Charles Pittman King from Barclays. Your line is open.
Speaker Change: Thanks very much for taking my questions, Charles, for anything from Bartley, and I'd like to thank the congratulations on the very strong quarter. Just following up on the dosing frequency, I was wondering if you could just reiterate to us your expected or your currently booked.
Speaker Change: Price for High True Lo in CIDP originally in the 450,000, I believe was an unexpected balance between weekly and bi-weekly. Obviously given the early launches meant to be in line with the label, this suggests more weekly, so potentially a higher level of cost-booked. So if you just kind of outline what your assumptions behind that are, and how that's progressing, that would be great. Thank you.
Speaker Change: Thank you, Charles, it's called, yeah. Before that in 50 it's a number we came out at launch and just as a reminder how we got to that's going on there in 50
Speaker Change: It depends on the number of eye-true-lo-viles.
Speaker Change: So we utilize the station and it's to be taken into consideration. So at the moment we all know the study was done weekly but in the real world we will have to see how that play out. We have no new information to.
Speaker Change: and then of course you also have to talk about growth in it, which is part of that form that is $50,000. So I think it's too early to talk about to give more information now.
Speaker Change: For our next question comes from a line of Samantha Semankau from See. Your line is open.
Samantha Semankau: Hi, good morning. Thanks very much for taking this question and let me just add my congratulations on the strong quarter. Just turning back to the pipeline for members of the Net Prophecy. I guess maybe could you give a little bit of background on what drove the initial interest in this indication and a little bit more color on your thoughts on the lack of a sufficient signal to disease. Is there any read through other indications and developments? Thank you.
Speaker Change: Thank you for the question, Samantha. So first of all, that is the misconception and then based on the convincing biology, how that this is indeed a pathogenic antibody, which is mediating the disease biology.
Speaker Change: We know the identity of the antibody we know that the target correlates with disease severity and so on. So typically the facts which we like to see in order to build confidence.
Speaker Change: We were alerted by the DSMB to our study that basically there is no real signal here and they asked us to reconstruct the continuation of the study. This way we decided to take a look at the data and make this decision.
Speaker Change: It comes a bit as a surprise that's why you do face-to-trial, I mean you want to further validate the biology before you make a face-to-einvestment, it's actually perfectly serving the purpose.
Speaker Change: The only thing we can think of at the moment is that, and that is specific for a man, these patients lose a ton of protein to the kidney. So these kidneys are extremely leaky.
Speaker Change: and we're going to double click on the data set where it comes to exposure to the drug, but I would certainly not look at any of you through to other indications where this is actually not the case. So, stay tuned, we will be communicating more about it later. Thank you.
Speaker Change: You are next question, comes from a line of Gavin Clark Gertner from EverCore, ISI. Your line is open.
Speaker Change: Hey guys, congrats on all the progress. I was just wondering from the over 380 P patients that were on treatment at the end of the quarter, are all these reimbursed patients, or any of these patients on bridge or free drug supply, still awaiting reimbursedment approval?
Speaker Change: and I thank you for your question and by all the members.
Speaker Change: and Kei.
Speaker Change: Here are next question comes from the line of the Dan Van Versusen from Campen. Your line is open.
Speaker Change: Hi, Dean, thanks for taking my question. It relates to pipeline news flow. I understand you all guide on timelines when appropriate, but they're still a lot to impact, so to say. So getting framed with this, what we should expect for the coming 12-18 months.
Speaker Change: For example, for Fifth Card, we'll be helping to understand the sequence we should expect the registration of trials to read out data.
Speaker Change: and only on the other hand for MBI and 119, a number of mid-stage trials have been ongoing for a bit. So, can we expect the data rich ahead of year? I had for these by-clines. Thank you.
Speaker Change: Thank you, Susan, thank you for being with us today. Typically it's a start of the new year. We would announce the clinical calendar for the year. So, expect us to show up at JP Morgan with a more granular view on what 2025, helping us as of clinical milestones.
Speaker Change: You're right to call out there's gonna be a lot of activity.
Speaker Change: If I do the math right, I think we will have between 5 and 10, a 50, 12 only.
Speaker Change: and then of course a whole slew of face-to-work and then a number of ID candidates getting into the clinic. So for the moment focused on you know, ending as from years, focusing on executing the last elements of the plan, including hopefully as strong to you for and positive IMMN data.
Speaker Change: and then on the podium in January we will be talking to you about a detailed clinical calendar for 2025. Okay, so stay tuned. Thank you.
Speaker Change: Your next question comes from line of Joel Beady from Beard. Your line is open.
Joel Beady: Hi, congrats on the quarter for the 300 patients who started in CIDP. Were those patients at generally had formal, payer policies in place or were some of those kind of one-offs without formal policies in place yet?
Speaker Change: Thanks for the question. It's a mix of patients that had policies in place and did not generally for policies in place. They're patient-free able to get on therapy more quickly, but we have at this point in launch we have a mix.
Speaker Change: The End
Speaker Change: Your next question comes from the line of Junely from Churus Securities. Your line is open.
Speaker Change: Thanks for taking our questions.
Speaker Change: Really curious to know your latest thoughts on the app to me for ARGS-1-1 in IGNF-2 given several competitor presentations at ASM last week. How do you think ARG-1-21, the sweeping antibody can differentiate versus say those targeting city 28 or Beth and April? Thank you.
Speaker Change: [inaudible]
Speaker Change: by innovation and you basically start to see the first generations of innovation coming into the space. But I think this is going to be a sizable opportunity, it's going to be an opportunity which will require multiple generations of innovation to really get there.
Speaker Change: I think what we have seen for the moment is encouraging data, but clearly room for improvement. And that is, I think, the promise which is held by ArgenX 1.2.1. I haven't seen any program which is so selective and precise.
Speaker Change: in eliminating the bad guys.
Speaker Change: and doing that you know with a speed and a depth of response which is just unparalleled by any of the data we have seen. So I think the design of the molecule is strong.
Speaker Change: Now we need to wait for the clinical experiment and really see whether that strength of design translates into superior clinical efficacy. So I'm very excited about this molecule.
Speaker Change: Remember, it can play in more than one indication. A JNF property is one which speaks to the imagination. But there are, of course, more indications on our table because we typically like to pursue pipelines in a product.
Speaker Change: Thanks for the question.
Speaker Change: Your next question comes from the line of Victor Flock from BNP Paribas. Your line is open.
Speaker Change: Thank you.
Victor Flock: Hi everyone, thanks a lot for taking my question. I do have a question on the pre-telstra range opportunity. I mean, we've seen iTruelo driving your line penetration in MG. So on paper, PFS looks like a game-changer for patients, but in practice, I was wondering if you are expecting it to be also a significant driver.
Victor Flock: to Vyvgart's offline. And if I can squeeze just another one, I was wondering if you can give us a bit of visibility on when you will be able to launch the PFS-XUS. Thanks a lot.
Speaker Change: Thank you very much. Have a great day.
Speaker Change: Thank you, Victor, for the question. I think this is a question for Karen.
Karen: Yeah, absolutely. Look, we're really excited for the April PDUFA date for PFS, and I think what it will do is continue the momentum that we've seen in MG and continue to sustain the launch in CIEP. So it really aligns with the strategy of providing not just the best efficacy and safety, but also convenience.
Karen: for patients, particularly with our goal of self-administration, so that we can really compete very well for patients in both of these markets. And it aligns with our strategy of early-aligned use in MG, as well as broadening the prescriber base. So we're really looking forward to the April PDUFA date.
Speaker Change: And then do you want to just touch on when we expect to launch PFS-XUS, second part of the question. Yes, so we have filings ongoing for the PFS-XUS and they will follow over the coming months and years.
Speaker Change: Thank you, Beth.
Speaker Change: Your next question comes from a line of Xiandeng from UBS. Your line is open.
Hi, thank you so much for taking my question. So I have a question on CIDP, please.
Speaker Change: Understand that, you know, 85-90% of patients are actually coming from IVIG.
But just wondering, what is a typical sort of patient portrait look like? So just wondering, are these patients who really have very poor disease control with IVIG and they're switching, or do you see actually patients with actually very good disease control, but they're switching for convenience? Thank you very much.
Speaker Change: I think the typical phenotype of the patient you would see so early in the launch are actually patients which have a real difficult time tolerating the drug or who are really weakening
Speaker Change: in between IVIG cycles or if she don't have full function. So I think these would be the two main drivers for these early patients coming on drug.
Speaker Change: The convenience of dosing does not go unnoticed. I mean, you need to imagine that a lot of CIDP patients who would be on IVIG would spend one to two days a month in an IV infusion chair, typically spending the bulk of the day in that chair.
Speaker Change: And then, of course, a 30- to 90-second subcu injection is very compelling. But I would say, right, Karen, it's fair to say that it's mainly driven by insufficient response to Ig and or tolerability issues.
Speaker Change: Absolutely, and it's exactly what we would expect at this moment in launch.
Speaker Change: Thanks for the question.
Hauwermeiren, ArgenX, Vyvgart, Karl Gubitz, Beth DelGiacco, Karen Massey
Your next question comes from a line of Leland Gershel from Oppenheimer. Your line is open.
Leland Gershel: Okay, thanks, and my congrats on the quarter as well. Just teeing off the earlier comments on the decision to discontinue in MN, is it fair to say that that was...
based primarily on biomarkers versus having to need to see a lack of clinical response.
And maybe more broadly, as we think about, you know, focusing R&D into the future, is it fair to say that ArgenX can fly a fairly high bar with respect to go-no-go decisions, given the breadth of opportunity and as you look to achieve consistent profitability? Thanks.
Speaker Change #103: No, I like that question. I think your second point is a very important one. I mean, we're looking for indications where we can have a truly transformative effect, not a marginal effect or an incremental effect.
It needs to be a game-changing effect, and that's where we will basically put the mission of the company to work.
Here I think it's very well known and amended, you know, there are a couple of protein biomarkers in the urine which would basically be broadly accepted as proxies for clinical efficacy. So I was not close to the data.
Leland Gershel: There was an EDRT in the company, chaired by our chief medical officer, who was close to the data, but I believe it was based on an EGFR or a protein urea marker. Thanks for the question.
Speaker Change: Your next question comes from the line of Andy Chen from Wolf Research. Your line is open.
Andy Chen: Hey, good morning. Thank you for taking the question. On your pipeline, for both 213 and the IgA drug, can you remind us if the two drugs have been optimized into sub-q formulation? Because the data so far looks like it's IV. And then also, if you can quickly provide an update for the auto-injector status, if you can. Thank you.
Nandi, thank you for the question. Obviously the drugs we designed are carrying the sub-cure possibility in them.
So, yes, we do have the subcutaneous product presentation in the plans for both molecules, and we strongly believe we can get there. From an autoinjector point of view, it's a bit premature for us to be public on timelines. We are fully focused on PFS.
But I think you're right to call out that we're working in the background already very hard on that auto injectors Where we said already a while ago that you know, we've passed the prototyping phase. We're into the industrialization phase So that that project is going forward at full speed
Speaker Change: But we will be communicating about timelines when we get closer to a final product. Thanks for the questions.
Your next question comes from a line of Rajan Sharma from Goldman Sachs. Your line is open.
Hi, thanks for taking the question. Just on the CIDP launch, obviously you kind of talked to a number of patients on therapy after the first quarter relative to myasthenia gravis. Just thinking about kind of trajectory from here and run rate, would you kind of caution against utilising that same run rate that we saw for Vyvgart in myasthenia for CIDP?
and many more. Thank you. Thank you.
Speaker Change #105: Hauwermeiren, ArgenX, Vyvgart, Karl Gubitz, Beth DelGiacco, Karen Massey
Yeah, thanks for the question. And we're asking the same question. I think it's a good one, since we're pleased with where we're at. But as I said earlier, I think it's important that we don't get ahead of ourselves. The market dynamics in CIDP are quite different than MG. So you'll recall it's a switch market, whereas MG was an add-on market. The competitive set is different. The patients are different and also our data is different. So
In particular, what I think is important to take into account is that 67% response rate in adhere. Let's see how that plays out in the real world. And it's still early days in terms of the competition and seeing Vyvgart out only for one quarter. Let's also see what the response is there.
Speaker Change: Your next question comes from a line of Thomas Smith from Lyrinc Partners. Your line is open.
Thomas Smith: Hey, good morning. Thanks for taking our questions and let me have my congrats on the strong quarter. We saw you had a very strong presence at the recent AANEM meeting and there were a ton of
Thomas Smith: also quite a number of competitor data sets there in MG. So I wonder if you could just comment on how you're thinking about some of these emerging targets like CD19 and MG.
And then separately, I wanted to ask about thyroid eye disease, and it sounds like the Phase 3 is progressing as planned, but I was wondering if you could comment on enrollment. Just remind us what your expectations are for the Phase 3 top-line readout. Thanks very much.
Thomas Smith: and many more. Thank you. Thank you.
Speaker Change: Thomas, thank you for the question. I think you're right to call out our leadership at A&EM. I'm very proud of, you know, the continuous stream of data which we continue to produce as a market leader and the first in class.
Thomas Smith: agents.
we continue to see in the real world.
labs, no albumin issue, and then of course from a convenience point of view we're the only one showing such a spectrum of dosing possibilities which really allows you to tailor to the individual need of the patient. So we've put the bar high, we see competitors coming into the space, but I haven't seen any particular data set which is actually coming close to the high bar which we have set.
We also continue to evolve and lead the space, you know, by moving upstream in the treatment paradigm. I think we have shown impressive steroid tapering data.
I'm very proud of the fact that after one year, 25% of patients are off steroids, that's a big deal, and more than 40% are at 5 mg or lower a day. That again, you know, is a paradigm shift in the treatment of myasthenia. So, our conclusion of all the new data coming to the space is
We've put the bar very high and we continue to shift that bar.
Thank you for the question.
Your next question comes from the line of Jatin Sinha from Guggenheim. Your line is open.
Hi, this is Thelma Fogliatti. Congrats for the quarter, and thanks for taking our questions. So, for the ShowGrant program, can you please clarify if you have reached alignment with the FDA on the pivotal program, and is there any color you can share on trial design and statistical plan? Thank you.
and many more. Thank you for watching. I hope you enjoyed this video. I'll see you in the next one.
So thank you for the question. I think we're on track to start a study before the end of the year. I think that's the key message for our investment audience.
We did have the appropriate FDA interactions.
So we have calibrated study design and endpoints, so we're actually in operationalization modus, and we're on track to start the study before end of the year. By the way, on TAD, there's a question I forgot to answer a minute ago. You're right, everything is on plan and on track, but too early, of course, to talk about completion dates for both TAD and children.
Thank you for the questions.
and many more. Thank you. Thank you.
And our next question comes from the line of Douglas Hale from HC Wainwright. Your line is open.
Thank you.
Hi, good morning. Thanks for taking the questions. I'm just curious on the commentary regarding the CIDP launch leading to new prescribers in MG. I'm just curious in terms of the profile for some of those prescribers who are now starting. Were they, you know, just not have big practices in MG? Were they just not familiar with the product? Do you have any color in terms of why, you know, just given the such early success you had in MG, why this was the catalyst for them? Thank you very much and congrats on the results.
Yeah, thank you for the question. Look, I would say you will recall that when we were characterizing the CIDP opportunity,
There's a lot more CIDP patients that are out with community neurologists than there are MG patients. However, there are MG patients also with community neurologists.
Speaker Change #106: So we broadened our target list in line with the CIDP launch, and that is reflected by the field force expansion that we also invested in, in preparation for the CIDP launch. So with that field expansion and the target expansion, we're reaching new neurologists. Some of these are new to Vyvgart, and some of them, as you heard, have started with CIDP and then expanded their prescribing to MG.
Our next question comes from a line of David Seneff from Peter Kim. Your line is open.
David Seneff: Hey, good afternoon. Regarding the CIDP trial with AMPA, a bit related to one of the earlier questions asked, can you say a few words on your decision to go immediately into a registrational study, what your conviction is based on, and maybe what exactly you expect from the outcome of the study keeping in mind the data you've generated with FFT-Hemat already? Thank you.
Speaker Change #101: Thank you, David, for the question. Look, there remains work to be done in CIDP.
No one has shown a higher response rate than we did with Vyvgart in the ADHEAR trial. If you're fair, that's actually a 70% response rate in stage A.
The question is, what happened to the 30% patients who did not respond in that first 12 weeks?
We have also seen the data from Sadovi's program underlining the role of complement, clearly complement being recruited by the disease-causing antibodies.
Thomas Smith: based on the in-house XFIVO data.
the data from the fields, we think it is warranted to launch MPAR straight into phase 3, especially given the regain of function data we have seen in MMN. We like to think of MMN as the little sister indication of CIDP. So if you look at the totality of data, we did not want to lose any time in terms of, you know, phase 2 work. We think it's warranted to go forward into phase 3. So we're very excited about the opportunity. And remember, there's a ton of work to be done still in CIDP.
Speaker Change #102: Thank you for the question.
Speaker Change #102: and many more. Thank you. Thank you.
And your next question comes from a line of Emmanuel Papadakis from Deutsche Bank. Your line is open.
Thank you for taking the question. Maybe just following on CIDB launch, given you're starting to get a bit of feel for the market in the US, perhaps you could give us your best current estimate of the absolute number of CIDB patients in the US.
that are either refractory or unsatisfied from a convenience perspective with their current IG treatment. And maybe just in a quick addition, reimbursement timelines in Europe for CRDP, could that start to contribute next year? Is that more of a 2026 event? Thank you.
Hi, yeah, thanks for the two questions. So,
We have sized the addressable market for CIDP as 12,000 patients that we believe that are on therapy but have residual symptoms or are unsatisfied with their current therapy. So that's the addressable market that we see. In terms of ex-US, the CIDP filings are ongoing. Obviously pricing and reimbursement takes a little bit longer, but as soon as we have those approvals in hand, we'll be working diligently and quickly to get access for patients across the globe.
And your final question today comes from the line of Simon Baker from Redburn Atlantic. Your line is open.
Thank you very much for taking my question twice. A question on Vyvgart and I wonder if you could give us any any qualitative commentary on rebating and formula negotiation trends into 2025 and how's the addition of CRDP as an indication affected those negotiations meaningfully at all at this stage. Thanks so much.
Speaker Change #102: Thank you.
Karl: Simon, thank you. It's Karl here. Thank you for the question. What I can say is where we are today, gross to net continues to be around 12 percent. That's public, that's now financials. We don't see a deterioration there, and I think that's what you can expect for the rest of the year. For 2025 and with pre-fall syringe, all of those variables, I think it's a little bit too early to talk about that, and that can be part of a later discussion.
Thank you for the question.
And this concludes our question and answer session and does conclude today's conference call. We thank you for your participation today. You may now disconnect.