argenex Q2 2025 Earnings Call Transcript

Quartr
Provided by Quartr
July 31, 2025

Key Takeaways

  • Positive Sentiment: Company delivered 97% year-over-year revenue growth with Q2 product sales of $949 million, reflecting strong uptake in MG and CIDP.
  • Positive Sentiment: Treatment base expanded to 15,000 global patients on VYVGART, including 2,500 CIDP patients one year post-launch, supporting long-term growth targets.
  • Positive Sentiment: Pipeline advancement includes three Phase III assets (efgartigimod in rheumatology, empasipravarte head-to-head vs IVIg, ARGX-119 in CMS), with six Phase III readouts expected in the next 18 months.
  • Neutral Sentiment: Gross-to-net adjustments rose to ~20% driven by product mix and Medicare dynamics, while net revenue per patient remains stable and guidance unchanged.
  • Neutral Sentiment: Total operating expenses increased $98 million QoQ due to higher R&D and SG&A investments, with gross margin steady at 11% and cash of $3.9 billion supporting future growth.
AI Generated. May Contain Errors.
Earnings Conference Call
argenex Q2 2025
00:00 / 00:00

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Operator

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.

Operator

Thank you. I'd now like to introduce Bess Del Jocco, Vice President, Corporate Communications and Investor Relations. You may begin your call.

Beth DelGiacco
VP - Corporate Communications & IR at argenx SE

Thank you. A press release was issued earlier today with our half year 2025 financial results and second quarter business update. This can be found on our website along with the presentation for today's webcast. Before we begin, on Slide two, I'd like to remind you that forward looking statements may be presented during this call. These may include statements about our future expectations, clinical developments, regulatory timelines, the potential success of our product candidates, financial projections and upcoming milestones.

Beth DelGiacco
VP - Corporate Communications & IR at argenx SE

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 conform those statements in relation to actual results unless required by law. I'm joined on the call today by Kim Van Harreverein, Chief Executive Officer Karl Gubitz, Chief Financial Officer and Karen Massey, Chief Operating Officer. Luke Troian, Chief Medical Officer, will be available during the Q and A. I'll now turn the call over to Tim.

Tim Van Hauwermeiren
Co-Founder, CEO & Director at argenx SE

Thank you, Beth, and welcome, everyone. I'll begin on slide number three. Vision 2,030 is our roadmap for long term value creation, and I'm proud to say that we are exactly where we set out to be. Over the past twelve months, Plinab has achieved exceptional year over year growth of 97% across all of its approved indications. We've also initiated multiple registrational trials in large market opportunities like Sjogren's, myositis and TED and advanced four new molecules into our pipeline.

Tim Van Hauwermeiren
Co-Founder, CEO & Director at argenx SE

This sets us up to create significant growth with 10 labeled indications and a robust late stage pipeline by 02/1930. While we are building for the long term, we are also delivering today. Fifteen thousand patients globally are now being treated with Vipcart including two thousand five hundred CIDP patients just one year into the launch. We are seeing growth across all indications, formulations and regions and as expected our prefilled syringe is already driving new patient starts and new prescriber demand. This momentum is a direct result of our team's extraordinary execution and I want to thank them for advancing innovation that truly matters to patients.

Tim Van Hauwermeiren
Co-Founder, CEO & Director at argenx SE

Karen will share more later in the call on our commercial performance and the path to reach 50,000 patients by 02/1930. Where I want to focus today is on the opportunity we have to expand Vybqa's broad potential and advance our pipeline of first in class assets. Slide four, we have the opportunity to create significant value in the near term with our three Phase three pipeline assets. We are building momentum with efgartigimod in therapeutic areas beyond neurology. We presented our Phase II proof of concept results in Myasitis and Sjogren's for the first time at EULAR and the reception from the rheumatology community reminds me of the early enthusiasm we saw from neurologists when we first unveiled our MG data.

Tim Van Hauwermeiren
Co-Founder, CEO & Director at argenx SE

Rheumatologists are beginning to see what a targeted approach like efgartigimod could mean for their patients, raising the treatment bar beyond symptom management towards sustained functional improvement. In the myositis study, efgartigimod delivered significant improvement in muscle strength as measured by the TIS, which clinically emitted what we saw preclinically in our mouse passive transfer models. In the Sjogren study, we observed meaningful improvement in systemic disease activity. Empasiprobat is also advancing in two registrational head to head studies versus IVIG in MMN and CIDP. Our decision to run head to head studies illustrates our conviction that empassiprobat has the potential to disrupt these markets.

Tim Van Hauwermeiren
Co-Founder, CEO & Director at argenx SE

The Phase two auto results in MMN support this and recently gained significant attention from treating neurologists at PNS in May. The data point that resonated most comes from the patient global impression of change scale, where over ninety four percent of treated patients felt better on EMPA than their best on IVIg, indicating EMPA could provide a transformative benefit. For CIDP, we are seeing the significant demand from the community from Vivgart Hytrolo indicating that there is still a need for more innovation. We're committed to making the broadest impact by advancing two distinct mechanisms of action with this drug and empasipubart. ARGX-one 119 is our third and most recent molecule to enter a registrational study following positive proof of biology data in CMS.

Tim Van Hauwermeiren
Co-Founder, CEO & Director at argenx SE

The discovery and development of ARGX-one 119 exemplifies our innovation model well. We collaborated with the world's leading experts to design an antibody that activates MuSK in a way that stabilizes and potentially enhances the neuromuscular junction. In our 16 patient Phase one CMS study, we observed consistent functional improvements across multiple endpoints. And this is just the beginning for AGENX-one hundred nineteen. We have identified several opportunities across neurology for this agonistic antibody.

Tim Van Hauwermeiren
Co-Founder, CEO & Director at argenx SE

Slide five, our immunology innovation platform continues to be a powerful engine for long term growth. We are rapidly advancing four new molecules including our IL-six inhibitors, a second FcRn blocker and an IgA targeting antibody, all of which are now in Phase I studies. These programs are part of our broader portfolio of over 20 active IP programs, each targeting areas of high unmet need. Our approach starts with identifying novel, first in class immunology targets and building molecules that address them. As part of our investment in our IIP, we're also expanding our toolbox to optimize our molecules to be best in class.

Tim Van Hauwermeiren
Co-Founder, CEO & Director at argenx SE

We recently announced a collaboration with Unnatural Products to gain access to their AI driven micro cycle discovery platform, enabling the development of potent, selective and orally available peptides against targets that we select. This collaboration both expands our capabilities beyond antibodies and reinforces our commitment to continue to innovate on the patient experience. I will now turn the call over to Karl to discuss our strong financial position, which remains a key lever for us in achieving our long term growth vision to scale efficiently and prioritize our investment in innovation.

Karl Gubitz
CFO at argenx SE

Thank you, Tim. Slide six. The second quarter twenty twenty five financial results are detailed in this morning's press release. Total operating income in the second quarter was $967,000,000 This reflects $949,000,000 in product net sales and $19,000,000 in other operating income. We are very proud of a 97% growth we have been able to deliver since this time last year, representing the significant unmet need that exists in MG and CIDP and the transformative outcomes Vivkart can offer to patients.

Karl Gubitz
CFO at argenx SE

On a quarter over quarter basis, we delivered 19% or a $158,000,000 in product net sales growth in second quarter compared to first quarter of this year. If you look at the breakdown by region, product net sales were 802,000,000 in The US, $52,000,000 in Japan, 83,000,000 across our rest of world markets, including Europe, Canada, and our partner markets, and $12,000,000 for product supply to Xi Lab in China. We are happy to share, but all global markets grew in the second quarter with the exception of our supply to China, which you'll remember is not reflective of demand and depends on when we ship within the quarter. We continue to expand our patient reach in our non U. S.

Karl Gubitz
CFO at argenx SE

Markets and the overall contribution of these regions now represents more than 15% of our global product net sales. In The U. S. Specifically, we delivered 18% quarter over quarter growth, which reflects strong growth in both gMG and CIDP across all three presentations, the CART IV, subcu vial, and the subcu prefilled syringe. We made the investment to move quickly with PFS because we know it will be a long term growth enabler for all current and future indications.

Karl Gubitz
CFO at argenx SE

We are already seeing this play out in the near term, and PFS has increased patient demand for Percod one quarter into its launch. With the introduction of PFS and the changing dynamics associated with Medicare Part D redesign, there was an increase in gross to net, which we anticipated. Gross to net went from 12% at the 2024 to approximately 20% at the end of the second quarter. Importantly, the net revenue contribution for a gMG patient and a CIDP patient continues to be consistent with our previous guidance. This means that going forward, even with the increased gross to net adjustments, growth will be driven by our ability to broaden our patient reach within the MG and CIDP markets and into new patient populations.

Karl Gubitz
CFO at argenx SE

PFS will help us to achieve this growth. Next slide. Total operating expenses in the second quarter are $766,000,000 an increase of $98,000,000 compared with Q1. This includes a $49,000,000 increase in SG and A and a $19,000,000 increase in R and D, all of which reflects our commitment to deliver on our innovation mission in a disciplined way. Cost of sales for the quarter is $111,000,000 which brings our year to date gross margin to 11%.

Karl Gubitz
CFO at argenx SE

We continue to make important investments into our global supply chain. Our expansion strategy includes our commitment to manufacture in a region for that region and specifically to grow our capacity in The US. R and D and SG and A expenses for q two were $328,000,000 and $325,000,000 respectively, leading to an operating profit $201,000,000 for the period. The quarterly financial income is $38,000,000, and we recorded $49,000,000 of exchange gains mainly relate mainly resulting from your non US dollar denominated cash balances. The year to date effective tax rate is 15%.

Karl Gubitz
CFO at argenx SE

After tax, the profit for the quarter is $245,000,000 and for the year to date is $415,000,000 Our cash balance at the end of the quarter represented by cash, cash equivalents, and current financial assets is $3,900,000,000. This is up from from $3,400,000,000 as of the beginning of the year, mainly driven by net cash flow from operating activities of $400,000,000 for the first half of the year. I will now turn the call over to Karen, who will provide details on the commercial front.

Karen Massey
Chief Operating Officer at argenx SE

Thank you, Carl. Slide eight. At Argenx, everything we do begins with a deep commitment to understanding and meeting patient needs. This got continues to be a transformative medicine, raising the bar for patients of what they can achieve from their treatment. In MG, we have the highest rate of minimum symptom expression across any treatment.

Karen Massey
Chief Operating Officer at argenx SE

And in CIDP, we're seeing real world results that mirror the Adhere data, including around functional improvement. This value proposition for patients supports our position as the leading branded biologic in MG in an increasingly competitive environment, and that's exactly where we hope to go in CIDP as well. Before diving into the success of the quarter, I wanna discuss the real life impact of our treatment. Lynn, a biomedical engineer and marathon runner, was first diagnosed with CIDP when she was training for an Ironman and noticed a strange tingling in her fingers. Her CIDP unfortunately progressed, notwithstanding treatment with IVIG and other therapies.

Karen Massey
Chief Operating Officer at argenx SE

She maintained an active lifestyle and has been vocal about the challenges that come with managing her CIDP. Recently, she switched to Vizgar Hytrolo prefilled syringe, which she cited as an absolute game changer for her treatment experience. She also shared that she's seen an overall improvement in her quality of life. Recently, for the first time in eight years, she didn't plan around a hospital schedule while traveling outside The US for three weeks. And while every patient's experience is different, this is just one of the many inspiring stories we've heard throughout this launch.

Karen Massey
Chief Operating Officer at argenx SE

Next slide. The team delivered another phenomenal quarter, and we saw Vivint growing across all indications, formulations, and regions. In The US, the introduction of the prefilled syringe led to increased demand for Vivgut with more patients initiating treatment across all Vivgut product presentations than we've seen in prior quarters. Fifty percent of PFS patients were brand new to Vibgat with the other switching from HYTULAR vial or Vibgat IV. We also see the PFS expanding our prescriber base, which ultimately opens up our ability to reach new patients.

Karen Massey
Chief Operating Officer at argenx SE

Over a thousand physicians have written a PFS prescription in the first quarter of launch with around fifteen percent being first time prescribers of any Zivgar product presentation. As with our prior launches, early momentum has been enabled by our ability to secure access quickly with favorable policies. As of this week, we have secured policies representing 70% of commercial lives. Let's now look at the growth dynamics for MG and CIDP, both of which meaningfully contributed to the quarter's performance and have near term expansion opportunities. Slide 10.

Karen Massey
Chief Operating Officer at argenx SE

BIVGAR continues to gain momentum in MG. It has now been fourteen quarters since we launched BIVGAR in MG and fourteen quarters of consistent growth. Even so, we believe we are still at the early stages of unlocking the full opportunity, which we estimate be sixty thousand patients in The US. First priority is to shift the treatment paradigm, moving the goalpost for patients and resetting expectations of what a treatment can do. It's no longer that being controlled is being out of the hospital or being reliant on high doses of broad immunosuppressants.

Karen Massey
Chief Operating Officer at argenx SE

It's about being symptom free and getting back to the activities you love. This shift is already underway, and sixty percent of new patients to Vivint come from oral, reflecting the value Vivint delivered through its consistent safety and efficacy. Second, we know that branded biologics still represent only ten percent of the MG market today. We see this expanding as more innovation enters the market, all of which serves to raise treatment expectations for patients. We're focused on maintaining our position as the fastest growing biologic in this evolving landscape.

Karen Massey
Chief Operating Officer at argenx SE

The launch of prefilled syringe will be critical to achieving both of these goals. The PFS is expanding access to new MG patient segments, particularly those we couldn't reach with HCP administration as the only option. It's also emerging as a key differentiator to help us reach that additional 25,000 patients as the total biologic adoption grows. Lastly, we're also advancing registrational trials in seronegative and ocular MG, which together represent 18,000 patients of our total addressable market, and it supports our goal of this got having the broadest MG label. Slide 11.

Karen Massey
Chief Operating Officer at argenx SE

Turning to CIC, we continue to see consistent growth across all key patient and prescriber metrics, the sign of a very successful launch. As of the June, over twenty five hundred patients have been treated globally with Vibgard Hytrula, most of which are coming from The US. The launch in Japan and Germany are also off to a fast start. This momentum is driven by the clear and unmet need, the meaningful outcomes driven by the safety and efficacy we've seen with Vivint High Truro in the real world, and now the added convenience of our prefilled syringe. Importantly, we see significant room to continue to grow within our initial 12,000 patient population, and we believe the strong value proposition of DipGaPitrula will support continued expansion even beyond that over time.

Karen Massey
Chief Operating Officer at argenx SE

We see tremendous opportunity ahead in MG and CIDP. We're just getting started. These indications alone give us a strong foundation for continued growth, and we're applying the same playbook as we expand into new diseases. We're focusing on what matters most, generating meaningful data for patients, moving rapidly, and staying ahead of competition through innovation. And with that, I'll now turn the call back to Tim.

Tim Van Hauwermeiren
Co-Founder, CEO & Director at argenx SE

Thank you, Karen. We are executing across the business to transform the treatment landscape for patients with autoimmune diseases. What we have achieved in MG and CIDP alone reflects the significant value we have already unlocked and the substantial growth still ahead. We are excited to build on our proven ability to translate innovation into commercial success as we enter new markets and the opportunity in front of us is expansive. Over the next eighteen months, we expect data from six Phase three and six Phase two trials across our pipeline, each with the potential to expand our reach into new patient populations and unlock addressable markets well beyond where we are today.

Tim Van Hauwermeiren
Co-Founder, CEO & Director at argenx SE

As we scale for the long term, we remain deeply committed to creating lasting value for our shareholders, our partners and most importantly, the patients we serve. With that operator, we'll open the call up to questions.

Operator

Thank you. We will now begin the question and answer session. Your first question today comes from the line of Alex Thompson from Stifel. Your line is open.

Alex Thompson
Managing Director at Stifel Institutional

Great. Good morning and thanks for taking my questions. I guess really how have your cycles per year in MG evolved as you generated additional chronic dosing data from AdaptDx and and with neurologists getting more comfortable with this idea of chronic FcRn administration? I guess, really, what I'm asking is is is one of the drivers of a higher gross to net here outside of the Part d exposure, a higher gross price per patient in MG followed by greater discounting towards a consistent net price? Thanks.

Tim Van Hauwermeiren
Co-Founder, CEO & Director at argenx SE

Thank you, Alex, joining us on the call today. I would like to kick it off with Karl's answer to the second part of your question. And then I really like where you're going and I would like to give that question, part one of the question to Karim. Karl?

Karl Gubitz
CFO at argenx SE

Thank you, Eric. The net revenue per patients for MG and CIDP remains consistent even with a higher gross to net. There are many variables that go into the net revenue per patient. It includes product mix, list price, gross to net, utilization and adherence. It is fair to assume that the combination of these variables offsets the impact of gross to net.

Karl Gubitz
CFO at argenx SE

And then also for the sake of clarity, we want to confirm that we have not taken any price increase during 2025 in The US. Over to you, Karen.

Karen Massey
Chief Operating Officer at argenx SE

Thanks, Kyle. Yes. And thanks for pointing out. I mean, we had a really strong quarter in MG, and that was actually driven by patient adds is is what I would would suggest. But we continue to guide to five cycles per year on average for an MG patient.

Karen Massey
Chief Operating Officer at argenx SE

But what you want to call out is that there is a potential for high utilization and adherence with Hytrulo and particularly with PFS because of the convenience. You can imagine for patients, convenience of a PFS for self injection. The other big driver here, and what you can imagine, is that once a patient experiences MSE with BIVGART, they wanna stay in that in that minimum symptom expression. That's the advantage of individualized dosing. Right?

Karen Massey
Chief Operating Officer at argenx SE

They can they can pick their dosing that keeps them in MSC. And that's that positive experience that is keeping patients on Vivgut. So those factors combined are really what led us to delivering what is remarkable. I think it's 14 quarter straight of of growth with MG.

Alex Thompson
Managing Director at Stifel Institutional

Great. Thank you.

Operator

Your next question comes from the line of Tazeen Ahmad from bear with me one moment. Your next question comes from the line of Derek Archila from Wells Fargo. Your line is open.

Derek Archila
Derek Archila
MD & Equity Research Analyst - Biotechnology at Wells Fargo

Hey, good morning and congrats on the update here and thanks for taking the questions. So just one on the breakdown of the PFS switches between Hytrula and IV. I know you said that sixty percent of PFS patients were new leaving 40% from switches. But what's that breakdown look like? Thanks.

Tim Van Hauwermeiren
Co-Founder, CEO & Director at argenx SE

Yes, Eric. Thanks for joining us on the call today and thank you for this question which is really focusing to know how are we growing the market with PFS instead of just switching an existing market. Right, Karen?

Karen Massey
Chief Operating Officer at argenx SE

Yeah. Absolutely. So we don't provide the split by product presentation, but we've shared in previous quarters a a few facts that are important. Hytrulo is driving the majority of the growth for Vivgut. And as you rightly called out, fifty percent of prefilled syringe patients are new to Vivgut.

Karen Massey
Chief Operating Officer at argenx SE

So our strategy with bringing these innovations to market in both MG and CIDP is that we're looking to expand the market and improve our differentiation in increasingly competitive markets. And that's exactly what we're seeing the prefilled syringes delivering is that market growth market expansion and product growth. So so the you can expect that to continue, I would say, the end of the year. Thanks for the question. Your

Operator

next question comes from the line of Akash Tewari from Jefferies. Your line is open.

Akash Tewari
Akash Tewari
Global Head - Biopharmaceutical Research at Jefferies

Hey, thanks so much. So, our high level math suggests your gMG patient adds are really meaningfully growing. I think it went from 800 to something over 1,500 in Q2. How much of this was the prefilled syringe allowing you to unlock new patients in an earlier line of setting? And it doesn't seem like you're necessarily cannibalizing from the IV.

Akash Tewari
Akash Tewari
Global Head - Biopharmaceutical Research at Jefferies

And really, what's the correct run rate assumption going forward? And maybe just secondly on your seronegative trial, can you talk about your confidence on that study reading out well? And why your primary endpoint for that trial is absolute MG ADL drop versus the MG responder endpoint you've used in the past? Thank you.

Tim Van Hauwermeiren
Co-Founder, CEO & Director at argenx SE

Yeah. Thank you, Rakesh. And we have the benefit of having our Chief Medical Officer here today who is on the call look. So look, we will give question two to you about, you know, the seronegative trial. But let's kick it off with you, Karen.

Karen Massey
Chief Operating Officer at argenx SE

Yes. I think you rightly call out we had a very strong quarter in MG, and that was fueled by prefilled syringe as we expected expanding the market. Prefilled syringe allowed us to grow the prescriber base. We had a thousand prescribers for prefilled syringe in the quarter. A 150 of those are new to Vivgut, and that's exactly what we thought would happen.

Karen Massey
Chief Operating Officer at argenx SE

So so we're really pleased with the launch of prefilled syringe. It's it's delivering on what we thought it would deliver. In parallel to that, we are continuing to see growth in our IV business in MG. And that's because there is a place in the market where certain prescribers and patients prefer the IV option, and that's in line with our strategy that we wanna meet the doctors and the patients where they are. We wanna provide the best efficacy and safety, and we know we have that with this gut.

Karen Massey
Chief Operating Officer at argenx SE

And we have multiple options for product presentations so that we can continue to really expand the market in MG, start to move into those earlier lines of treatment. And as the number one biologic and the fastest growing biologic in the market, we're seeing exactly that play out in in the market. Luke, I'll hand it over to you.

Luc Truyen
Chief Medical Officer at argenx SE

Thanks, Karen, and thanks for the question. We're very excited for these upcoming results. So directly related to the change of primary endpoints. So we changed this to change from baseline in MG ADL because compared to a responder kind of definition and therefore dichotomy, you retain more information and therefore intrinsically it would increase the power. And then secondly, we were also able to negotiate with the agency that based on all the data we already had on seronegatives that we could put to the required T value to be reached at 0.1.

Luc Truyen
Chief Medical Officer at argenx SE

So those are two things that will help. And then what we also added was a better diagnostic accuracy ascertainment at the beginning to make sure we had the right patients in.

Tim Van Hauwermeiren
Co-Founder, CEO & Director at argenx SE

Yes. Thank you, Luke. So to wrap it up, our confidence level is high, but guide this is still a clinical trial which has intrinsic risks. Thanks for the question.

Operator

Your next question comes from the line of Tazeen Ahmad from Bank of America. Your line is open.

Tazeen Ahmad
Tazeen Ahmad
Analyst at Bank of America

Hi, guys. Maybe my phone is just as excited about your beat as I am. I wanted to maybe ask two questions. Can you talk about expectations for increasing competition as the year progresses? You know, specifically, we've been getting a lot of questions about Uplizna.

Tazeen Ahmad
Tazeen Ahmad
Analyst at Bank of America

How are you thinking about the dynamic for that? And then secondly, can you just talk about the drop off rate from treatment for patients? Maybe let's start with gMG since it's been launched longer. Thanks.

Tim Van Hauwermeiren
Co-Founder, CEO & Director at argenx SE

Yes. Thank you, Tazeen, for joining us. And Karen, I think these are two excellent questions for you. Why don't we maybe take it off with our views on the competitive dynamics of our space?

Karen Massey
Chief Operating Officer at argenx SE

Yes, absolutely. As you say, Tazeen, the competitive dynamics or the competition is certainly heating up. And and I would say as the leading biologic and the fastest growing biologic, our task is to continue to raise the bar on what patients and prescribers can expect in MG, and and we're doing exactly that. So, you know, whether you look at our MSC rate, our rapid and sustained efficacy over ten thousand patient years of safety, and we just talked about all of our product presentations, I think we set the bar very high in in MG. Having said that, and and we've said this before, we welcome innovation to MG market, to the CIDP market.

Karen Massey
Chief Operating Officer at argenx SE

Innovation is great for patients, and we believe that we are very well positioned to continue to lead and to be to continue to be the fastest growing biologic within that expanding biologic market in MG. In terms of your second question on the discontinuation rate, I I I wasn't sure if it was for MG or CIDP or both, but I can I can say the the for both MG and CIDP, the discontinuation rate is in line with expectations, what you would expect for a chronic medicine? And in particular, as we talked about earlier, I think in MG, what we're seeing is when once patients get into that MSE, they wanna optimize their dose and they wanna stay on this gut. With CIDP, we're seeing the majority of patients on weekly. They're staying with weekly, but we do expect that some patients will start to switch to biweekly, and our discontinuation rate is in line with what you'd expect for chronic medicine. Thanks for the question.

Operator

Your next question comes from the line of Rajan Sharma from Goldman Sachs. Your line is open.

Analyst

Hi. This is Max for Rajan. So our question is, so based on the patient numbers you disclosed in the release, it looks like the number of patients on VUGAR for CIDP almost doubled from the January to the June. Is that a good proxy for the growth rate during the remainder of the year?

Karen Massey
Chief Operating Officer at argenx SE

Yes. So thanks for the thanks for the question. We're really pleased with that 2,500 patient number. And I think what you can expect is that the growth will continue through the end of the year. I I do wanna remind you that twenty five hundred patients is global.

Karen Massey
Chief Operating Officer at argenx SE

And and in particular, we had a launch in Japan in the beginning of the year. We recently had the EMA approval, so we've also launched in Germany. And I can tell you that both of those markets are off to a very fast start, similar to what we saw in The US. And I think what those fast starts across all markets demonstrate is that patients and providers have been waiting for innovation to come to the CIDP market and they're excited for this guide. Thanks for the question.

Operator

Your next question comes from the line of James Gordon from JPMorgan. Your line is open.

James Gordon
James Gordon
VP - European Pharma Equity Research at JP Morgan

Hello, James Gordon, JPMorgan. Thanks for taking the questions. First question is on the CIDP launch. So I think, President, you pointed us to just being reimbursed in 12,000 U. S. CIDP patients who failed IG. But what are you seeing there and how it might change? Did a survey that said or the respondents said that actually quite a lot the use was already in IG naive CIDP patients, and the growth was going to increase or uptake was going to be growing almost as quickly in the naive patients as the experienced patients. So are you seeing any of that? How might that change? How will you shape it? Are going get some more data in CIDP to try and get used earlier?

James Gordon
James Gordon
VP - European Pharma Equity Research at JP Morgan

Or it just it takes time? And then just a follow-up, which was gross margin assumptions. So I had heard some concerns that gross margin was going to contract as a result of IRA and effectively the discount you have to give and paying to Halozyme. But then I also saw some comments in Zai Lab, which seemed to suggest a very significant reduction in production costs for Vivgar, and that presumably will help your COGS ratio a lot. So what's the gross margin outlook going forward?

Tim Van Hauwermeiren
Co-Founder, CEO & Director at argenx SE

Maybe Karl, started question two on cost of goods and the impact on gross margin. And then, Kare, we can bring it back to you to we are on the adoption curve in CRDP and how we see that evolve, right? Karl?

Karl Gubitz
CFO at argenx SE

Yes. Thank you, James. Thank you for the question. The gross margin on a year to date basis is currently at around 11%. Going forward, we expect that number to remain around 11%, Two offsetting factors going into that.

Karl Gubitz
CFO at argenx SE

We continue to drive down the cost of sales with our CDMOs as we move to larger sites, bespoke sites with higher yields and economies of scale. And that is the reference I think Zai is probably referring to. Also in cost of sales is the royalty we're paying to Halozyme. And with Iturula becoming a bigger share of a business, and remember, we're paying royalties only on iTruler, not on IV, you would expect the royalty number to increase over time. So the decreasing standard cost of sales plus the increasing royalties should largely offset.

Karl Gubitz
CFO at argenx SE

And therefore, we expect the the the cost of sales percentage to be around 11%. Thank you for the question.

Karen Massey
Chief Operating Officer at argenx SE

Yep. Thank you. And in terms of the the CIDP patient dynamics, so we're one year into launch. We're seeing strong growth and patient adds. We are still seeing in our data that eighty five to ninety percent of the patients are coming from IVIG switches.

Karen Massey
Chief Operating Officer at argenx SE

And and you recall, that's what we expected, and that's how we define that 12,000 TAM or addressable market as patients that are uncontrolled on their current medicines, the majority of which is IVIG. So we are still seeing that that's where the majority of our source of business is. That could expand over over time, but I would caution that we are very early on the launch curve. We're just one year into the launch, so we have a lot of growth ahead of us and a long way to go even in those 12,000 uncontrolled patients. To your question about when would we expect to start to get into early align patients or some naive patients, we do see some already.

Karen Massey
Chief Operating Officer at argenx SE

Our label enables it, so we don't need to do an additional study or or change our label. Rather, the key here is making sure that we get the payer access in in place, and and, obviously, HCP and patient experience is gonna be critical as well. But but I think you're pointing out the most important fact, which is we are very early on the growth curve in CIDP despite the strong uptake. Thanks for the question.

Operator

Your next question comes from the line of Yatin Suneja from Guggenheim. Your line is open.

Yatin Suneja
Biotechnology Research Analyst at Guggenheim Partners

Hey guys, thank you for taking my question.

Yatin Suneja
Biotechnology Research Analyst at Guggenheim Partners

Just a quick one on gross to net asset verification. So for this quarter, was 20%. Could you comment on how do you think it is going to evolve for the second half of this year and then as we go into next year? You.

Karl Gubitz
CFO at argenx SE

Yes, and thank you for the question. Yes, the gross to net increased to 20%, and that is a year to date number. It's not referring to the second quarter. So that's an 8% increase from the end of last year to the middle of the year. We talked about the key drivers of gross to net, so I won't repeat that.

Karl Gubitz
CFO at argenx SE

But I think what's really important is that the bulk of the increase is now behind us. Going forward, we will see increases in gross to net, but it will be smaller increases driven by the product mix. If if if PFS become a bigger share of a business, which it will, you're gonna see gross to net creeping up. But the important thing and what we want to emphasize is that the net revenue per patient has not changed. And as I mentioned, at least for the foreseeable future, we're not expecting that to change.

Karl Gubitz
CFO at argenx SE

PFS comes with unique dynamics, but ultimately it's expanding the market resulting in incremental patients which will drive revenues. Thank you for the question.

Operator

Your next question comes from the line of Yaron Werber from TD Cowen. Your line is open.

Yaron Werber
Yaron Werber
MD & Senior Biotechnology Analyst at Cowen and Company

Great. Congrats on a great quarter. Two quick interrelated questions. Maybe just the first one, give us an update on the IV to subcu switch for VivGuard that you're seeing so far. And then secondly, we noticed that new ENERGIZE phase three for EMPA hit the head against placebo, so this is not an IVIG switch.

Yaron Werber
Yaron Werber
MD & Senior Biotechnology Analyst at Cowen and Company

There's almost like a part a and then a part b in the Phase III in adults with CIDP. Can you talk about the trial design and the strategy? Thank you.

Tim Van Hauwermeiren
Co-Founder, CEO & Director at argenx SE

Yes. Thank you, Yvon. Thanks for joining us today in the call. Maybe, Karin, you want to talk a little bit about IV to subcu switch. It's not really switch dynamic we're driving.

Tim Van Hauwermeiren
Co-Founder, CEO & Director at argenx SE

And then Luca, would like to call on you to explain a little bit our ENBA strategy and the high level features of this placebo controlled second trial. Okay? Karen?

Karen Massey
Chief Operating Officer at argenx SE

Yes. Happy to take the question. So as Kim already flagged, our strategy with prefilled syringe or subcutaneous is not a switch strategy. It's a market expansion strategy, and we're seeing that play out in in the market. In fact, we're also seeing and and recall that IV is only indicated for MG.

Karen Massey
Chief Operating Officer at argenx SE

What we're seeing is continued growth in the IV business. So and and we expect that that will continue and that we will continue to see substantial IV business in MG. And and the reason for that is, again, the the prescriber preference as well as patient preference. There is a portion of patients and prescribers who prefer that product presentation, and and we expect that to continue to grow over the coming years. And, Luke, if I can hand it over to you for the energized question.

Luc Truyen
Chief Medical Officer at argenx SE

Yes. It's energizing. So the the the approach we're taking here is that we learned a lot and we've been innovators now in the CIDP field to first bringing efgartigimod forward, which shows you can have up to 70% response, which would indicate an IGC dependency, but a third didn't respond. And that then brings us to the question, okay, we are not satisfied. And then we saw the results of MMN with Empower, which were quite spectacular.

Luc Truyen
Chief Medical Officer at argenx SE

And we started thinking, could we not continue our journey and develop solutions for CIDP patients by also introducing Empathy provides. Once you've made that decision, the first thing is the recognition IVIG is of course widely used and could we be an improvement over IVIG. But that is not the only approach. And that's why we also felt to kind of broaden that ability to get a signaling patient that we should look at patients that are either refractory or naive and look at the power of empacitrivart in that study. Study is pretty simple. It's twenty four week study against placebo.

Tim Van Hauwermeiren
Co-Founder, CEO & Director at argenx SE

Thank you, Luke. And we believe CDP will become an increasingly competitive space and therefore the clinical development strategy which you see in merchant clinicaltrials.gov is basically there to give MGTO the best possible positioning in that exciting marketplace. Thanks for the questions.

Operator

Your next question comes from the line of Sean Lehman from Morgan Stanley. Your line is open.

Sean Laaman
Sean Laaman
Executive Director at Morgan Stanley

Thank you, operator, and good morning good afternoon, Tim and team. Thanks for taking my question. Thinking strategically, I mean, you guys are now in a new area of profitability. I think cash flow will increase to cash was almost $05,000,000,000 for the six month period. And on the other hand, you've got a number of clinical trials sort of coming up. I'm just wondering how do

Tim Van Hauwermeiren
Co-Founder, CEO & Director at argenx SE

you see the business evolving from here? What do you

Sean Laaman
Sean Laaman
Executive Director at Morgan Stanley

think of margin? And what's the balance sheet strategy going forward?

Tim Van Hauwermeiren
Co-Founder, CEO & Director at argenx SE

Yes. We're not going to comment on margins and it's not a goal for us to strive for certain ratios and margins as an innovator in our spaces. But let us try to answer the question from a capital allocation point of view, right, Karl? Because we are accumulating cash. Maybe you want to comment on this?

Karl Gubitz
CFO at argenx SE

Yes. We have a really strong balance sheet, 3,900,000,000.0. We added $500,000,000 $500,000,000 in the year, but also from an operating cash flow, 400,000,000 in the year, which is really good. I think also as a CFO, I'm really proud to say that the revenue growth is outpacing the OpEx growth, but that resulting in incremental profit quarter over quarter. But that in itself is not the goal here.

Karl Gubitz
CFO at argenx SE

We are focusing on clinical catalyst and the revenue growth. Our capital allocation priorities has always been clear. Priority number one is to deliver on the promise of efgart. There's still a lot of work to do, many indications and studies. Following that is MPA and the rest of the pipeline.

Karl Gubitz
CFO at argenx SE

We've talked about it earlier, lots of exciting assets in science, and we want to invest there. Third, what I want to highlight is the investment in our supply chain. The decisions we've made years ago brings us to the position today that we can say we have enough inventory and supply for all scenarios. And we may need to make those same decisions for tomorrow, and that requires a lot of capital. Fourth is where we're starting to think about business development.

Karl Gubitz
CFO at argenx SE

The company has always looked outside for innovative biology. Epically, we found it in academic centers, but we're now moving to a stage where we can use the strength of our balance sheet to also look at Apple Biotechs. And fifth, of course, we will get to a stage where we're going to return cash to shareholders, but that is not really part of the discussion today. So thank you very much for the question.

Operator

Your next question comes from the line of Thomas Smith from Leerink Partners. Your line is open.

Thomas J. Smith
Thomas J. Smith
Senior MD - Immunology & Metabolism at Leerink Partners

Hey guys, good morning. Thanks for taking the questions and congrats on a really strong quarter. Just on CIDP, I was wondering if you could comment and maybe provide some updated thoughts on the FDA spares update from June. Is there any visibility on where FDA is with their analyses or expectations on the timeline to resolution? And then just curious if there's any feedback you're hearing from prescribers in the field on this, any kind of evolution in thinking about how they're approaching switching from IVIg? Thanks so much.

Tim Van Hauwermeiren
Co-Founder, CEO & Director at argenx SE

Yes. And I'm going to give the floor to Luc to briefly comment on this first question. And then maybe, Karen, time for you to echo the voice of the field, right, the marketplace. Luc, why don't you kick it off?

Luc Truyen
Chief Medical Officer at argenx SE

Yes. And thanks for the question and allowing to give some context to this. But first talk about Spheres itself. So that's an important tool in the safety monitoring established in 02/2004, but it comes with many limitations. So it is actually a building repository or database with inputs from sponsors, providers and patients.

Luc Truyen
Chief Medical Officer at argenx SE

But one thing that is missing in there is denominators. And, it is therefore not really useful to to really assign causality or definitely not, make a benefit risk statement. And, the reason I'm saying that is that a fast increase in exposure could lead to an increase in reporting. And that is maybe one of the reasons here given as you saw the success we're having in CIDP. Now having said that, we of course are monitoring this ourselves and are in conversations with the agency as per normal procedures.

Luc Truyen
Chief Medical Officer at argenx SE

And in that sense, we have to know that this NIS as it's called, was issued as a potential safety signal that requires monitoring. Now, NISS has two levels. One important potential, which has a much shorter window of evaluation or potential, which typically has a twelve month evaluation period. And at the end of that, in many cases nothing happens or the margin period is extended. But of course, we can never exclude that we have to have a dialogue with the agency about a label change.

Luc Truyen
Chief Medical Officer at argenx SE

But at this point, we don't have sight on that. Given the rates we observe ourselves as being a sponsor of less than two percent of these sort of events with over two thousand five hundred patients exposed, We feel that the current benefit risk ratio on CIDP is maintained.

Karen Massey
Chief Operating Officer at argenx SE

Thank you, Carl. And just to add to that in terms of the feedback from prescribers, I would say the early experience that we hear about from prescribers is very positive. And we continually hear that that real world experience mirrors what we saw in Adhere in the clinical trial. The the other positive signal that we see is that, you know, we're investing in patient activations, and many patients are going into us, their neurologist, about this got the CIDP. And what we're seeing is a very high grant rate when the patients ask.

Karen Massey
Chief Operating Officer at argenx SE

And and what that means and what that demonstrates is that neurologists have confidence and belief in Vivgut in both the efficacy and the safety profile of the medicine. And that's obviously translating into the strong patient growth numbers that we're seeing in the quarter as well. So I think really positive early experience. Thanks for the question.

Operator

Your next question comes from the line of Myles Minter from William Blair. Your line is open.

Myles Minter
Myles Minter
Research Analyst - Healthcare at William Blair

Hi. Congrats on the quarter. Thanks for the question. It's following up on this actually. I think at AAN you disclosed that the thirteen sixteen patients as of January 31 on Montreal and CNAP, The worsening rate was three point three percent.

Myles Minter
Myles Minter
Research Analyst - Healthcare at William Blair

It's pretty low now that you've got greater than two thousand five hundred patients on therapy. Can you update us on that right there, or do you plan to update us? And then, the second question is just on the Phase IV IVIG to efgartigimod switch study in CIDP. Are we still expecting data for that this year? Thanks very much.

Tim Van Hauwermeiren
Co-Founder, CEO & Director at argenx SE

Yeah, Martin. I'm going to give you a very brief answer. So we are monitoring all AEs, of course, in the real world. This specific AE of severe CIDP worsening is actually not going up. It's rather stable and going down.

Tim Van Hauwermeiren
Co-Founder, CEO & Director at argenx SE

It is a very small number. And I want to remind the audience that in the CIDP setting specifically, any therapeutic switch you would consider as a physician carries the risk of CIDP worsening. This is simply a known fact in the space. What I do want to call out is a transformative benefit which we see for Drift Guard in so many patients. The amount of patient anecdotes which are reaching us every week in terms of improvement in functionality, I think is just impressive.

Tim Van Hauwermeiren
Co-Founder, CEO & Director at argenx SE

And to conclude from where we sit we don't see a real benefit risk change. The switch study I think is well on track. It's enrolling and we will keep you updated when the study progresses, finalizes. And as you can expect data will be reported at a clinical conference. Thanks for the question.

Operator

Your next question comes from the line of Samantha Simenko from Citi. Your line is open.

Samantha Semenkow
Samantha Semenkow
VP - SMid Biotech Equity Research Analyst at Citi

Hi, good morning. Thanks very much for taking the question. Just one on the pipeline for me. I'm wondering if you could just share some context on your decision to advance the clinical development of ARGX-one hundred nineteen. Does the data you've seen so far in CMS, does it increase your enthusiasm as well for ALS and SMA?

Samantha Semenkow
Samantha Semenkow
VP - SMid Biotech Equity Research Analyst at Citi

And just more broadly, I'm wondering what the overall market opportunity across indications for 01/2019 is that you're envisioning? Thanks very much.

Tim Van Hauwermeiren
Co-Founder, CEO & Director at argenx SE

Sanathal, thank you for the question on 01/2019, our latest kid on the block. And we have the benefit of having Luke here. So Luke, could you contextualize the go decision for CMS please? And what is your view on potential read through on other indications? And then I will briefly summarize, do you look at the totality of the opportunity. Okay?

Luc Truyen
Chief Medical Officer at argenx SE

Yes, yes, certainly. So, we chose indication CMS, which is an ultra rare indication because that for us will be the best in human proof of the biology at work of an agonistic antibody for MaSK. And therefore, designed a small to also driven by a VALBIA patients, but highly densely monitored with readouts and also building intra patient dose escalation to come to the answer is the approval of biology. And so the basis for our decision is that we did find this. We found that on a clinically relevant endpoint correlated with a digital endpoint and also with a clinician observed strength in the legs.

Luc Truyen
Chief Medical Officer at argenx SE

And so the endpoints are six minutes walk test, a digital measure of cadence and strength on the QMG that we have that signature with an increasing ability to walk longer distances in these patients. And that really made us say we have proof of biology and the we're going to continue the path in CMS as far as we can. With respect to read through to the other indications, there there should be some correlation, but there are two different things here. One is that the diseases that we're testing, ALS and SMA, are of course complex and with different biology. So we should not simply assume that there's a 100% read through.

Luc Truyen
Chief Medical Officer at argenx SE

And that's why we designed ALS in development with a POC testing multiple doses. SMA is currently being designed.

Tim Van Hauwermeiren
Co-Founder, CEO & Director at argenx SE

Yes. Thank you, Luke. So if we zoom out on 109 it's a typical argenx molecule or program. It comes straight from the innovation playbook, So novel targets where we collaborate with the world experts, a hell of an antibody which we made and then a potential pipeline in the product because we're now already in three indications and CMS, ELS, SMA. But just think about a molecule which has the potential to rejuvenate the neuromuscular junction that has exciting potential across a number of nerve regeneration indications, but also muscle diseases.

Tim Van Hauwermeiren
Co-Founder, CEO & Director at argenx SE

So stay tuned. We're still assessing further potential in more indications to come. And thanks for the question on 01/2019.

Operator

Your next question comes from the line of Gavin Clark Gartner from Evercore. Your line is open.

Gavin Clark-Gartner
Gavin Clark-Gartner
Director - Biotechnology Equity Research at Evercore ISI

Hey guys, congrats on the great progress. So this week AstraZeneca noted that they expect forty percent of MG patients to be on self administered therapies by 02/1930. I'm curious if this aligns with your market research and very early PFS experience Ascena date. Thanks.

Tim Van Hauwermeiren
Co-Founder, CEO & Director at argenx SE

Yeah. Thank you, Kevin. And it's not just to comment on market research results from colleagues in the field. I think what we tend to agree that you know, administration is important for patients as we are actually already evidencing today. And remember the R and D Day of last July, where we basically increased our expectations for the total 10 in MG PFS and self administration actually is going wide after that box which we showed of 23,000 extra patients, which we added in addition to the initial 17,000 which we had at the start of the MG launch.

Tim Van Hauwermeiren
Co-Founder, CEO & Director at argenx SE

So very important, but we cannot comment on these numbers specifically. Thanks for the question.

Operator

Your next question comes from the line of Andy Chen from Wolfe Research. Your line is open.

Analyst

Hi, this is Emma on for Andy. Thanks for taking our question and congrats on the strong quarter. In the press release, it's mentioned that you're still in the early stages of MG and CIDP launches. We're just curious how you guys know the launch is still in early stages. Is it because prescriber coverage is still a small percent or are new prescriptions still rising, or are new numbers still just far away from theoretical TAM? Thank you.

Karen Massey
Chief Operating Officer at argenx SE

Yes. Thanks for the question. And I I think it's all of those factors. So let's take it step by step. So first in MG, I mean, we're 14 quarters in, but what we continue to see is that strong quarter over quarter patient growth as as you said.

Karen Massey
Chief Operating Officer at argenx SE

And I think we're fueling that growth with new innovations, for example, bringing prefilled syringe to the market. And as just Tim just talked through, we see that the biologics market share of market will grow in MG. We estimate that it'll grow by about 25,000 patients. We also continue to invest in Vivgart and getting the broadest label for Vivgart. So we have our seronegative and our ocular MG studies, and that means that the the total addressable market in MG ends ends up being around 60,000 patients.

Karen Massey
Chief Operating Officer at argenx SE

So that's where we get to. We're still despite being 14 quarters in and with continuous growth, we're still early in the market opportunity for MG. Likewise, with CIDP, we're only one year into launch with CIDP, and we're seeing continued strong uptake in the market. We said that the TAM there is 12,000 patients, so we still have a way to grow. And I think over time and and certainly over the long term, you can start to imagine that with more innovation coming to market, we just talked about impasse approved art potentially for CIDP, you can start to see that the that that market will start to grow beyond the 12,000 as well over the long term.

Karen Massey
Chief Operating Officer at argenx SE

So I think if you take a step back, when you look at our continued growth that we've delivered since the Vivint launch and the fact that we have six phase three studies reading out in the next eighteen months, you can see that as a company, we're very much on the early side of the growth trajectory. Thanks for the question.

Operator

Your next question comes from the line of Douglas Sale from H. C. Wainwright. Your line is open.

Douglas Tsao
Douglas Tsao
Managing Director at H.C. Wainwright & Co.

Hi, good morning. Thanks for taking the questions and congrats on all the progress. I'm just curious in terms of the PFS, we've talked to some physicians who have said that they've had some challenge in terms of getting patients access to the product. I'm just curious, you know, is that sort of one offs or, you know, is there still a situation where perhaps demand is is sort of exceeding the available supply?

Karen Massey
Chief Operating Officer at argenx SE

Yeah. Thanks for the question. Look, I think it's we're only one quarter into launch, and and normally with these with into the launch of PFS and, you know, we always say that with any new launch, it takes about two quarters to get access in place. And I think we sometimes forget about that because our access team does such a great job and always beats expectations on that. So, of course, in early stages, there are gonna be some questions like that or some feedback while we get access into place.

Karen Massey
Chief Operating Officer at argenx SE

What we see though is very is that we have 70% of commercial lives covered with prefilled syringe. And in general and we're adding to that all the time. In general, the feedback that we get from the field is that prescribers are very pleased with how quickly we're getting access for patients to prefilled syringe. I think that's reflected in the strong uptake.

Karl Gubitz
CFO at argenx SE

And Douglas, if I can add, we definitely have enough inventory available. It's still driven by inventory.

Tim Van Hauwermeiren
Co-Founder, CEO & Director at argenx SE

Yes. Thanks for the question.

Douglas Tsao
Douglas Tsao
Managing Director at H.C. Wainwright & Co.

Thank you.

Operator

Your next question comes from the line of Victor Flock from BNP Paribas. Your line is open.

Victor Floc'h
Equity Research - Pharmaceuticals at BNP Paribas CIB

Hi, thanks for taking my question. It's Flock from Exane. I have basically just one question on ITP actually. I was wondering if you could update us on the feedback since launch. Because if I remember correctly, your ambition at the time was to position ZipGard as the first TPORA option basically as a first line treatment.

Victor Floc'h
Equity Research - Pharmaceuticals at BNP Paribas CIB

So I was basically wondering if the physician feedback so far in Japan basically support this? And if by any chance you could also share your market share in this market in Japan? Thanks so much.

Tim Van Hauwermeiren
Co-Founder, CEO & Director at argenx SE

Yes. Thank you, Hector, for the question on ITP. So the launch in Japan for ITP is actually going well. And what we find exciting is to see that in the real world, the clinical data are actually perfectly metered. So we see about a fifty percent response rate.

Tim Van Hauwermeiren
Co-Founder, CEO & Director at argenx SE

The drug is landing first in the last line of ITP patients after they fail steroids, IVIG and TPOs. So very refractory patient population and still a very nice fifty percent response rate. And if patients respond just like in the similar in the clinical trial, they respond very quickly and the safety profile of the product is also differentiating. I mean physicians badly need a fast acting safe drug. So I think the drug is landing very well.

Tim Van Hauwermeiren
Co-Founder, CEO & Director at argenx SE

Uptake is nice And I think we will be gradually moving our way up in the treatment paradigm. So all in all according to plan. Thanks for the question.

Operator

Your final question comes from the line of Charles Pittman King from Barclays. Your line is open.

Charles Pitman-King
Charles Pitman-King
VP - European Pharmaceuticals & Equity Research at Barclays

Hi, guys. Thanks very much for taking my questions. Just a final one, please, just on the kind of pricing dynamics. Just thinking about the Medicare process for Argenx, I'm just wondering what potential quarterly fluctuation is there between assuming a Medicare discount and then kind of rightsizing it? What kind of visibility do you have to have confidence in your comments that the net price per patient is going to remain flat going forward as we think about trying to forecast your sales on a quarterly basis going forward and any potential fluctuations that might come up as a result? Thank you.

Tim Van Hauwermeiren
Co-Founder, CEO & Director at argenx SE

Yes, Charles. Let me kick it off and then hand over to Karl. But we will not get into the complexities of The U. S. Healthcare system in today's call.

Tim Van Hauwermeiren
Co-Founder, CEO & Director at argenx SE

But I think what I want you all to remember from the call is the confirmation, right, Karl, that the net contribution for an MGN CIDP patient is actually not changing. And if and when we think it's about to change, we will definitely flag it to this audience. Anything you would like to add?

Karl Gubitz
CFO at argenx SE

No, think that's all. Thank you, Tim. Okay.

Tim Van Hauwermeiren
Co-Founder, CEO & Director at argenx SE

Thanks Charles. Thanks for the question.

Operator

And this concludes today's conference call. We thank you for your participation and you may now disconnect.

Analysts
    • Beth DelGiacco
      VP - Corporate Communications & IR at argenx SE
    • Tim Van Hauwermeiren
      Co-Founder, CEO & Director at argenx SE
    • Karl Gubitz
      CFO at argenx SE
    • Karen Massey
      Chief Operating Officer at argenx SE
    • Alex Thompson
      Managing Director at Stifel Institutional
    • Derek Archila
      MD & Equity Research Analyst - Biotechnology at Wells Fargo
    • Akash Tewari
      Global Head - Biopharmaceutical Research at Jefferies
    • Luc Truyen
      Chief Medical Officer at argenx SE
    • Tazeen Ahmad
      Analyst at Bank of America
    • Analyst
    • James Gordon
      VP - European Pharma Equity Research at JP Morgan
    • Yatin Suneja
      Biotechnology Research Analyst at Guggenheim Partners
    • Yaron Werber
      MD & Senior Biotechnology Analyst at Cowen and Company
    • Sean Laaman
      Executive Director at Morgan Stanley
    • Thomas J. Smith
      Senior MD - Immunology & Metabolism at Leerink Partners
    • Myles Minter
      Research Analyst - Healthcare at William Blair
    • Samantha Semenkow
      VP - SMid Biotech Equity Research Analyst at Citi
    • Gavin Clark-Gartner
      Director - Biotechnology Equity Research at Evercore ISI
    • Douglas Tsao
      Managing Director at H.C. Wainwright & Co.
    • Victor Floc'h
      Equity Research - Pharmaceuticals at BNP Paribas CIB
    • Charles Pitman-King
      VP - European Pharmaceuticals & Equity Research at Barclays
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