Rekor Systems Q2 2024 Earnings Call Transcript

Quartr
Provided by Quartr
July 25, 2024

There are 14 speakers on the call.

Operator

At this time, I would like to turn the conference over to Investor Relations, Beth Del Jocco. Please go ahead. Thank you. A press release was issued earlier today with our half year twenty twenty four financial results and second quarter business update.

Operator

This can be found on our website along with the presentation for today's webcast. Before we begin, I would 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. 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 those statements in relation to actual results unless required by law.

Operator

I'm joined on the call today by Tim Van Harameuren, Chief Executive Officer Carl Gubitz, Chief Financial Officer and Karen Massey, Chief Operating Officer. I'll now turn the call over to Tim.

Speaker 1

Thank you, Beth, and welcome everyone. I'll begin on Slide 3. Last week, many of you joined us for our R and D Day, where we laid out an ambitious vision 2,030 and shared a comprehensive overview of the growth opportunities ahead in our ability to achieve this vision. We are in a very strong position today to generate substantial value across our business, investing in our internal innovation engine, executing on our differentiated multi asset pipeline and building on the commercial success we have achieved in our first 10 quarters of launch. This is a team that delivers on our innovation mission time and time again all towards our goal to transform autoimmunity and reach 50,000 patients globally.

Speaker 1

Given the recency of this update, we will aim to keep our prepared remarks brief and focus primarily on the 2nd quarter dynamics. But first, I'd like to highlight key themes that emerged from the R and D Day in the context of our 2,030 vision. Slide 4, the first theme is around how we innovate centered on a model of co creation. This model has been core to our growth since our founding and still exists in the most obvious form today with our immunology innovation program. We have a strong track record of success in building out our differentiated pipeline, including 8 out of 12 molecules that demonstrated human proof of concept and 9 that are 1st in class targets.

Speaker 1

We have no shortage of opportunity with identifying novel targets and believe our overall approach sets us up to drive continued pipeline expansion for years to come. A second theme is the new standard we're setting with VIVGARD in MG. We are currently de leading advanced biologic in MG and have delivered 10 consistent quarters of growth since our initial launch. We are making excellent progress across all key indicators and are exactly in line with our internal long term thinking of the MG Marketplace. We think this is a big opportunity and we have a strategic plan to reach more patients as we move into earlier lines of treatment and broaden to new populations through label enabling studies in seva negative and ocular MG patients.

Speaker 1

We've been with the same playbook for CIDP and are happy with the early days of the launch. We got the best possible label, which puts us in a strong position for continued growth as we work to get the excess piece in place. 3rd, we laid out our next wave of indications and expect to initiate all new registration trials this year across Vivgars and empasipibars. We set apart high with a medicine like Vivgars, but we're thrilled to use R and D Day phenomenal patient data in MMN, which we see as the first of many indications where we hope to drive transformational impact. Slide 5, the progress we have made across our business over the quarter moves us another step closer towards achieving our 2,030 vision to bring 5 molecules to Phase 3, advance our late stage pipeline to 10 labeled indications across our molecules and to ultimately have 50,000 patients on an argenx medicine by 2,030.

Speaker 1

While ambitious, we believe we are well positioned to deliver on this goal with a continuum of innovation from discovery all the way to commercial. Underpinning our incredible success to date is the strong financial health of our business, which will enable us to continue delivering on our innovation mission, ultimately driving value for our patients and our shareholders. With that, I would like to turn over the call to Carl. Slide 6. Thank you, Tim.

Speaker 1

The Q2 2024 financial results are detailed in the press release of this morning. Total operating income in the second quarter is $489,000,000 This reflects $478,000,000 in product net sales and $12,000,000 in other operating income. In the Q2, a $478,000,000 in product net sales is attributed solely to MG patients. We received the CIDP approval on June 21, and our teams were immediately in action the next day. It takes time at the start of the launch to get patients through the funnel from script to injection.

Speaker 1

So the first CIDP revenue will be a 3rd quarter event. Product net sales of $478,000,000 represents 20% growth quarter over quarter compared to Q1 'twenty four, which we know with a biologic is typically a more challenging quarter due to insurance reverifications and loss of shipping days with weather and holidays. The product revenue breaks down by region to $407,000,000 in the U. S, dollars 20,000,000 in Japan, dollars 35,000,000 in EMEA and $14,000,000 on product supply to Zai Lab in China. Operating expenses in Q2 are $535,000,000 an increase of $29,000,000 compared with Q1 2024.

Speaker 1

SG and A expenses are $256,000,000 in Q2, which is an increase of $20,000,000 compared to Q1. The increase reflects a full quarter impact of expansion of a customer facing organization in the U. S. As well as incremental expenses to prepare for the CIDP launch. R and D expenses on the continued investment in our pipeline of $225,000,000 in the 2nd quarter, broadly in line with the previous quarter.

Speaker 1

The operating loss of the quarter of $45,000,000 is offset by financial income of $30,000,000 and the tax benefit of $44,000,000 The tax benefit is a result of a deferred tax asset recognized in our U. S. Legal entity due to intra group inventory movements. It is a temporary timing difference and will reverse in future quarters. Overall, we saw a net profit for the quarter of $29,000,000 and earnings per share of $0.49 It is an important distinction that the net profit was primarily driven by the recognition of a deferred tax asset, and we still had an operating loss for the quarter of $45,000,000 We are on a clear path to profitability, but we are not there yet.

Speaker 1

We continue to have a strong balance sheet with $3,100,000,000 in cash. Based on our year to date cash burn of $77,000,000 we are updating our 2024 cash burn guidance from approximately $500,000,000 to less than $500,000,000 Our guidance on expenses remains unchanged. This puts us in a strong position to invest in innovation across our business and we have many opportunities to do so. There's a sizable opportunity in our current markets, in new markets with our Vifgar franchise, with our current pipeline and through our immunology innovation program to expand our pipeline. This is how we will set ourselves up for a sustainable future where we continue to generate significant value for our shareholders.

Speaker 1

I will now turn the call over to Karen, who will provide details on the commercial front.

Operator

Thank you, Carl. Slide 8. I'm very excited by our Vision 2,030, especially the ambition we have set for ourselves to impact the lives of 50,000 patients globally and their caregivers. To reach this goal, we will need to expand in a multidimensional way, getting more medicines approved across many indications, product presentations and geographies. We have a strong commercial playbook in place, but delivered in MG and we'll be leveraging that same approach for CIDP, focusing on evidence generation that matters most to physicians and patients, empowering patients to demand more from their treatments, and last, the need to execute on our strategies with speed and urgency.

Operator

We know that patients are waiting and we also know that every day counts in building out our 1st in class leadership position. Slide 9. Starting with MG, I'm extremely proud of the team who worked really hard to expand our reach into new patients for our 10th consecutive quarter of revenue growth. We said this in Q1 and can reiterate it today that all key indicators of growth are performing well and the fundamentals to the commercial business are strong. Focusing on the key drivers of growth this quarter.

Operator

We saw the seasonality impact in Q1 normalize in Q2 with the impressive 17% quarter over quarter growth. Within the U. S, Hytrullo continues to attract both new patients and prescribers to the VIBGYPT franchise. This is important for a few reasons. 1st, over 50% of new Hytrullo patients are coming from orals and 60% are brand new to Vivgut, which is consistent with our goal to reach earlier line patients and to expand new patients with Hytrullo.

Operator

2nd, we continue to expand our prescriber base for MG, many of whom have the potential to be CIDP's prescribers. This will serve us well in our early conversations with physicians who have grown accustomed to the favorable safety and efficacy profile of VISGARD HYTRUO. Slide 10. We continue to gain traction outside the U. S.

Operator

As well, where we are focused on securing broad access. We have strong momentum in EMEA and ZivGuard is now available in countries representing 82% of the gMG population in the region. We also continue to see strong growth in Japan, including positive early indicators on the launch of ITP. This launch rolled out rapidly and 74% of HCPs were made aware of VIVGAR in the weeks post approval. It is clear that there is a need for innovation in ITP, which is why we are also launching an efficient label enabling study with VIVGAR IV in the U.

Operator

S. After discussions with the FDA. Lastly, in China, we continue to be very impressed by patient adds each quarter and now subcutaneous is also available following the approval earlier this month. Slide 11. Even with our strong performance to date, we believe that we're still at the front end of the opportunity in MG.

Operator

We are seeing the MG market expand, a dynamic that we have seen play out in other rare disease markets when innovation enters the space. We believe that earlier use of advanced biologics will expand the addressable market significantly and that we can reach broader populations of MG patients with our label expansion studies in seronegative and ocular MG, each of which represents 15% of the total MG population. Based on these evolving dynamics, we have updated our addressable market in MG to 60,000 patients. Slide 12. Following our approval in June, we recognize that all eyes are on CIDP and we share your excitement.

Operator

We are thrilled with the broad label that we got, which will support use across the treatment paradigm. Now, we're leveraging our MG launch playbook to maximize our impact in CIDP, driving rapid adoption with neurologists based on the strength of our data, empowering patients and working diligently with payers to put the necessary policies in place to secure access as quickly as possible. Reception has been incredibly positive with physicians, particularly on the strength of the data and improvement in function. We've already reached 25% of our key targets within 14 days of launch and 20% of the prescriptions we're receiving are from new prescribers to VIVGUARD. Many of the prescribers are starting multiple patients.

Operator

Right now, our priority is to bring as many patients into top of the funnel as possible. Once an enrollment comes in, payer approval at this stage takes a few weeks, after which patients can be scheduled for their first injection. This shows the importance of getting payer policies in place quickly. And as this happens, the time from script to injection gets shorter. Based on where we are today, we're making good progress with payers and we're tracking to plan.

Operator

Slide 13. Looking forward, we have an ambitious plan to successfully execute multiple launches across our pipeline in order to reach 50,000 patients in 2,030. We're on track to start multiple Phase 3 studies before the end of the year, and each of these brings us a step closer to reaching new autoimmune indications where there is high unmet need. The TED registrational study has already started and we see an opportunity here to provide a differentiated and targeted therapy with favorable safety. We look forward to initiating a Phase 3 study in Sjogren's before year end following the positive signal we saw in our Phase 2 proof of concept study.

Operator

There are no approved treatments for Sjogren's patients and we know the disease goes well beyond sicker symptoms and can affect patients' ability to work and complete daily tasks, particularly the fatigue. This is a sizable opportunity and while data will drive the specific target population, we know that there are 100,000 moderate to severe Sjogren's patients in the U. S. And last, we also look forward to decisions in myositis and BP on whether to advance to Phase 3 later this year. Finally, before year end, we will start a Phase 3 trial with our second molecule in pacifruvat in MMN.

Operator

This is an indication that fits perfectly into our neuromuscular focus and is another indication where the unmet need is high and IVIg is the only approved treatment. The data we generated in Phase 2 were tremendous and very meaningful to patients. We demonstrated consistent improvement in grip strength. And in Cohort 1, 94% of patients felt better on IMPLACER PRUVA than they did compared to their peak with IVIg. Similar to MG and CIDP, we believe this is an underdeveloped market likely to grow over time as more innovation enters.

Operator

Overall, this is an exciting time for the company. We've seen phenomenal growth to date and we're eager to continue with this momentum as we enter into the second half of this year, applying innovation to every aspect of our business to reach even more patients. I'll turn it back to you, Tim.

Speaker 1

Thanks, Karen. Slide 14. I'm proud of the argenx team and their tireless commitment to changing the lives of patients through our science. We are perfectly positioned with the right team and the right approach to execute on the broad opportunity ahead of us. We will continue to lead with the strength of our data and deep knowledge to address the sizable MG opportunity ahead and will apply the same rigor with CIDP.

Speaker 1

And this is just the beginning. We are eager to raise the bar for how autoimmune diseases are treated as we continue to expand our horizons, embarking on new paths to create long term value for patients and shareholders. Thank you for your time today. I would now like to open the call to your questions.

Operator

Thank you. We will now begin the question and answer session. We'll take our first question from James Gordon at JPMorgan.

Speaker 2

Hello, James Gordon, JPMorgan. Thanks for taking the questions. Two questions, First question was on Vivcard performance in Q2 and the extent to which we can extrapolate that to Q3. So sales were up $79,000,000 which was a strong performance. But how much, if any, would you say was 1 off phasing that we should sort of take out if we're thinking about what the underlying performance would be?

Speaker 2

And if we're thinking about doing our Q3 modeling, how careful do we need to be about any reversals or seasonality? Or can we make quite a strong extrapolation from how well VIVQUA has done today? That's the first question, please. The second question was Phase 3 initiation for ITP. And I saw a comment or heard a comment about this being an efficient trial.

Speaker 2

So how might this trial differ from the previous 2 Phase 3 in ITP? Can you expedite it if it's an efficient trial? And would it be going for like a smaller patient population in some way or a similar sized population, just a different design?

Speaker 1

Thank you, James. Thank you for asking these two questions. I would like to hand over to Karen to comment on the underlying dynamics of the business and how to see the overall trends in our VIVVQUAD MG business first and then I will take the question on the ITP study in Phase 3. Carla, don't you go ahead with question 1?

Operator

Thanks, Tim. And thanks for the question and for recognizing, I think, like you, I'm really pleased with the results of the quarter, this quarter. The way that I would think about it is that when you look at the first half of the year in totality, what you see is that we maintain that consistent momentum that we've had since launch. So we've had 10 quarters of consistent growth, pretty consistent growth. I would take that longer term view as I was looking to the future if I was you.

Operator

And I'm confident that we will continue that consistent momentum. The underlying dynamics are strong. We continue to get earlier line patients. The majority are coming directly from the orals. We're growing both VIVGAR and HITRULO.

Operator

And we are broadening that prescriber base, which also served us well for the CIDP launch. So I would say, think about consistent momentum and growth as we've seen over the last 10 quarters. I'll hand it back to you, Tim. Thanks.

Speaker 1

Thank you, Karen. And let me briefly comment on the ITP study. First of all, I would like to take a step back and remind the audience about the advanced IV study. But I think we had a very impressive efficacy with an IWG score of more than 50% in a vitally effective patient population and a physician community which is excited also about the very clean safety profile. And we observed the patients in our open label extension study.

Speaker 1

They continue to do actually very well on ITP and also the Japan launch of ITP is actually going according to plan. So the task we gave to the team was sit down with the FDA, go through all the data and propose a smaller confirmatory study in order to push the high TP indication over the finish line. And I think they succeeded in doing that. So by leveraging all the insights and the know how we have on the disease by actually proposing alternative primary endpoints which allows for a small confirmatory study. We think we are on track to start small ITP trial before the end of the year, but I think we will be able to bridge the product over the finish line and in that refractory patient population we have been studying all the way.

Speaker 1

Thanks for the questions.

Operator

We'll go next to Tazeen Ahmad at Bank of America. Hi, good morning guys. Here's my one question. I just was curious about the PFS filing. I know you've talked about already having applied officially, but given that there's no PDUFA, we're just curious about how we should expect to think about communication from your team on what part of the application is in process and what back and forth there might be and do you have an idea of when you would be able to get that salon approval given that doctors in particular seem to be excited about having that as an option for patients?

Operator

Thanks.

Speaker 1

Thanks, Tazeen and thanks for being with us this morning. Important questions and plans for the filing has been submitted and is accepted under review with the FDA. I think we will have a better sense of approval timing when the process unfolds. So stay tuned. We will keep you updated on the progress we make.

Speaker 1

Thank you.

Operator

Next we'll move to Alison Bratzel at Piper Sandler.

Speaker 3

Hey, thank you for taking the question. Maybe just a follow-up from the R and D Day. Could you help us understand just the scope of the data required by FDA that will be needed for filing in seronegative and ocular MG patients. I think you described an ability to leverage existing trial data and real world data at least for seronegative patients. But I've just been getting a bunch of questions on this.

Speaker 3

So any more color there would be helpful. Thank you.

Speaker 1

Yes. Thank you for the question, Allison. So remember that we printed strong results in 0 negative MG patients and as we already have an approval in Japan, but actually in the real world the product is doing very well in seronegative patients and we have impressive case reports out of Europe where people have been successfully using the drug in seronegative patients. So we made a commitment to the patient community. We would not give up and we have been entertaining the dialogue with the FDA on seronegative patients in the background.

Speaker 1

I think where we could land with the FDA is a pretty fast elegant study in seronegative patients with as Luke called it during the R and D Day is somewhat relaxed P value. So I think the FDA is taking the existing evidence into account and is allowing us to run such a trial. So we think there's a high demand. This is an elegant study and we will do everything we can to enroll that study as fast as we can. Thanks for the question.

Operator

We'll move next to Rajan Sharma at Goldman Sachs.

Speaker 4

Hi. Thanks for taking my question. So again, just wanted to discuss kind of competitive landscape in myasthenia gravis and how you see Vivint kind of continuing to differentiate that. There's obviously a busy pipeline. We've got ittacopan in a Phase 3.

Speaker 4

A plinz is also in a Phase 3. So could you just kind of discuss how you think VIVVIGOART differentiates relative to those mechanisms and then longer term what gives you confidence that VIVVUART and the FcRn class more broadly remains kind of the preferred treatment option in early line patients?

Speaker 1

Thanks for the question. I will first hand over to Karen to comment on how we see the overall dynamics of this market and how we're building it together. Maybe Karen you go first and then I will briefly comment on your differentiation question. Thank you.

Operator

Sounds great. Yes, thanks for the question. And look, I think building on what we shared at R and D Day last week, we believe that innovation coming to the MG market is good, because it grows, the impact that we can have for our patients, expands the market, expands the number of patients who are treated with advanced biologics earlier as well. So we believe innovation is great for patients, and I think we're seeing that. And we believe we're very well positioned to continue to lead in that growing market.

Operator

And I think there's a few things that maybe I'll since you asked about the differentiation that I'll touch on. One is around, we're 1st in class FcRn and it's clear that FcRn and certainly VIVGAT are being used early line. I said earlier, over 50% of our patients are coming directly from the oral. So that's where the growth is and we're positioned well there. I think we compete really well on our we have rapid efficacy, but also deep and sustained efficacy and we have it across cyclical and biweekly dosing regimes.

Operator

So I think that's a really strong position to be competing from. And don't forget about our real world safety, the length of that real world safety, the number of patients as the 1st mover advantage. And of course, we have the treatment low treatment burden. So we have both IV and subcutaneous. We have PFS plan.

Operator

So overall, I think the dynamics in MG are positive. The market is growing and we're well positioned to maintain and even advance our leadership. I'll hand it back to you, Tim.

Speaker 1

Yes. Thank you, Karen. Much appreciated. If you just look at the biology of the disease, it is crystal clear that MG is an IgG mediated disease. Remember the 3 most of action of these pathogenic antibodies complement recruitments just being one of them and that nicely translates into the clinical data, right.

Speaker 1

Let me remind you that 80% of the VIVCAD patients achieve an ADL lower than 5%, which is a threshold for entering a clinical trial and that 50% to 55% of VIBGAR patients achieve minimum symptom expression. So there's always the need of the most infractory line for alternative mechanisms of action because the drug only works in 80% of patients, but it's difficult to go into more detail in absence of data. So let's look at the data to then further understand how that biology really plays. Thanks for the question.

Operator

We'll move next to Derek Archila at Wells Fargo.

Speaker 5

Hey, good morning and congrats on the progress. Thanks for taking the question. So just can you discuss maybe how the time from payer approval to injection that you're currently seeing during the early part of the CIDP launch compares to what you saw in the early part of the MG launch. Is that similar or is it different and maybe a little color on why?

Speaker 1

Karen, would you mind taking this question please?

Operator

Yes, happy to take the question. Thanks for it. First of all, just to start with saying, we're really pleased with the strong and positive response we're having in CIDP. And to answer your specific questions, as enrollments come in, it does take a while for patients to get approved by their payers. And it's that period of time that can take a few weeks before they get injected.

Operator

And that's standard for any launch. It's the reason that we're so focused on getting payer policies in place, because once the payer policy is in place, that process from script to injection can go more quickly. I would say we're exactly on track with where we thought we would be, both in terms of that process as well as most importantly the discussions that we're having with payers around getting those policies in place. We're really pleased with the progress and the team is acting with urgency and I think we're right on track and pleased with where we're at. I'll hand it back to you, Tim.

Speaker 1

Yes, thank you, Karen. We would like to ask a little bit patience, Derek, because remember what we did for MG rights. I mean it took us 2 quarters to install broad and favorable policies. That was our commitment to the patient community and that is fast guys. I mean 2 quarters is really outstanding, an outstanding job done by the team and we will seek to replicate that as for CIDP.

Speaker 1

Thank you.

Operator

Next, we'll take a question from Akash Tewari at Jefferies.

Speaker 6

Hey, thanks so much. So kind of on that point on CIDP, you mentioned in the past you're clearly seeing strong demand from doctors, but you wanted to see how that actually translated to patient impaired demand. Given the label, the overlap and the prescriber base and the amount of IVIg experienced patients here, would it be fair to say the CIDP launch should at least be half as good as gMG out to the 1st year? And maybe to that point, do you think we will see this kind of inflection after 2 quarters with CIDP like we saw with GMG? I just wanted to double click on that point like Beth would say.

Speaker 6

Thanks so much.

Speaker 1

Yes, Akash, and thank you for the question. Thanks for being with us today. It is tempting right to draw analogies between an MG launch and a CIDP launch, but what we're trying to say and explain is that you know that 2 distinctly different markets with their own dynamics, launch dynamics and maybe Karen you want to dig a bit deeper into this question, right?

Operator

Yes, I think that's right. It is it's very hard to draw parallels. They each have their own dynamics. One thing that I would say around the inflection point that you mentioned after 2 quarters, I wouldn't think about an inflection point that the payer policies will come in sort of 1 by 1 over the 2 quarters. And what we like to think about is that sort of by the time you get to the end of 2 quarters, you might have you have sort of that critical mass where neurologists really can start to get confident that favorable payer policies are in place.

Operator

So we do believe that there will be uptake, the same as that we saw in MG, and we think that it will be consistent over the period of time. But the dynamics between the two launches are very different for the reasons that you pointed out. We'll go next to Alex Thompson at Stifel.

Speaker 6

Hey, great. Thanks for taking my question. I guess, I wanted to ask about OpEx trajectory over the next couple of years. How you're thinking about that as it relates to expansion into additional Phase 3 programs as well as thinking about commercial expansion beyond neurology? Thanks.

Speaker 1

Thank you, Alex. It's Carly. I'll take both questions. In terms of SG and A, our infrastructure is now largely in place. As you would remember, we put that expansion into in the U.

Speaker 1

S. In Q1. For the rest of the world, we have infrastructure in most of the markets. There's a few big markets still outstanding in Europe. I would expect SG and A from here on forward to grow, but if we grow, we'll be muted and you won't see that rapid expansion.

Speaker 1

In terms of R and D, again, I think that will grow quarter over quarter as we invest in all the new science, which we talked about last week. I think we have a unique opportunity to invest in ourselves here set us up for a long sustainable future. That's what we're going to do. Thank you for your question, Alex.

Operator

We'll move next to Thomas Smith at Leerink Partners.

Speaker 7

Hey, guys. Good morning. Thanks for taking the questions and congrats on the strong results. For VIVGAR in MG, can you just remind us on the data that's being generated that could support chronic dosing in addition to the current cycle based dosing? And whether you expect to get chronic dosing explicitly added into the label?

Speaker 7

Or how important do you think it is for prescribers to have that chronic dosing flexibility in the label to facilitate access and reimbursement?

Speaker 1

Thanks. Yes, thank you for the question and it's just very simple. We have chronic dosing in the label. The label is basically describing the use of VIVGUARD for the treatment of a statistical intercept antibody positive for gMG patients. So we have cyclical dosing, but that is of course chronic use and we're the only company which has already such a long timeline of chronic dosing of patients.

Speaker 1

But I think it is important to call out that the safety profile of the drug maintains consistent and that we see a consistent minimum symptom expression over multiple years now in 50% to 55% of the patients. What we did do is we run an ADAPT NEXT study which was filling a data gap for those patients which for example are coming from chronic plasma exchange or chronic IVIG patients which we really did not study in the ADAPT trial because these patients cannot stand of course cyclical dosing. If you're on a weekly plasma exchange, you will need to feel intense chronic therapy. And with that next study we have actually shown that every ultrabook dosing with the Duttgart is as powerful as the cyclical dosing, both from an efficacy and a safety point of view. So in summary, I think we're the only company really with chronic dosing data and we're the only company which can offer such a diverse set of dosing schedules.

Speaker 1

Thanks for the question.

Operator

Next we'll move to Jaron Werber at TD Cowen.

Speaker 1

Great. Thanks so much and really nice start showing team. Quick question, just on Europe and Japan, I know Europe is very tough these days and Japan usually got lumpiness as you noted and obviously changes in the pricing. But just any sense kind of what should we expect there in terms of acceleration of sales? Thank you.

Speaker 1

Ayum, that is a great question and thank you for zooming out on the global aspirations of the company. This is a question I would like to hand over to Karen.

Operator

Yes, happy to take this and thanks for the question. So maybe I'll break them out and talk about Europe first and then Japan. I would say in Europe, we're on track. As you know, it takes a little longer, as you already out, in Europe to get pricing and reimbursement in place across all of the different countries. We're pleased with the progress that we've made.

Operator

And certainly, in 3 of the big five markets, Germany, Spain and Italy, we have good reimbursement, we have strong clinical advocacy, and we're really seeing that consistent uptake with what we're seeing in the U. S. And what I mean by that is that we see a broader prescriber base, not just in the academic centers, at broader potential and really pushing towards earlier line use. So I think we're seeing consistent trends there. And as we open up new markets with pricing and reimbursement, then I think you'll start to see that consistent growth as well.

Operator

So we're pleased where we are in Europe. We're on track. We take it step by step. It takes a little bit longer. In Japan, I just want to applaud the team.

Operator

I think they've done a phenomenal job. I mean, if you look back quarter over quarter, it's just so incredibly consistent, the growth in Japan. And we see that again this quarter. I would imagine that you can see you can imagine that outlook being consistent moving forward. So we just recently launched VIVDURA, which is the name for subcutaneous in Japan.

Operator

And that, like in other markets, we're seeing that really expand the patient population that is open to VIVGAT, with those, again, opening up those earlier lines of treatment. So again, I would say consistent growth, as you've seen for the last 10 quarters from Japan that we can expect in the future. Thanks for the question. We'll move next to Matt Phipps at William Blair.

Speaker 8

Hi, thanks for taking my questions. Congrats on all the progress. Quickly, you mentioned a different endpoints in the next ITP trial. Is that just looking at a different timeframe for sustained plate response or can you use something like IWG responders as a primary endpoint? And then maybe just quickly on the launch of ITP in Japan, any sense yet on where VIBGAR is being used in the treatment paradigm for ITP patients?

Speaker 8

Is it after multiple thrombopoietin agonists or can you slot earlier in that treatment paradigm? Thanks.

Speaker 1

Great questions. Thank you, Philip. I will hand over question 2 to Karen. On the ITP trial, I think the reason why we can go with a significantly smaller study in a confirmatory mindset is A, because we can work with an endpoints which is looking for extent of disease control and B, we can really leave this to know how and the expertise size of the global Phase 3 trials which we have done so far and we think it's a responsible investment to make for a significant patient unmet need waiting on the other line. Karen, would you mind discussing the Japan question please?

Operator

Yes, happy to take that. I would start by saying the ITP launch in Japan is going really well. We've applied sort of the same launch playbook that we have in other launches and we're seeing the same strong early performance. And what I would say is that it's clear that there's an unmet need in these ITP patients. So far, what we're seeing to your specific question is that the early experience is in later lines of therapy.

Operator

And that's exactly what you would expect in any of these launches. The doctors want to try to get experience, maybe those refractory patients in those later line patients get experience under their belt and then start to move earlier line. But what we're seeing that I'm really pleased with is that there's a strong belief in the MOA, in the mechanism of action of FcRn. The neurologists sorry, the hematologists are responding that they believe in the MOA, and therefore, that they believe in the reason to try this gut. So I would say strong early results, exactly where we would expect them and really important learnings that we're going to be able to take away from this Japan launch as we think about the U.

Operator

S. And potentially other launches with the second study that we're planning. Thanks for the question. We'll go next to Suzanne von Voorheesen at Kempen.

Speaker 9

Hi, team. This is Suzanne with Kempen. Thanks for taking my question. I just have a small follow-up to last week's R and D Day regarding argenx 121, the IgA degrader that was revealed. Can you give some context to the indications where such molecule would fit well?

Speaker 9

How many indications you see? And also how you compare the opportunity in terms of size? Is there a potential for this to be an opportunity of 5th card size? Or do you see more parallels to a drug like AMPA when looking at the commercial opportunity? Any thoughts or direction here will be appreciated.

Speaker 9

Thanks.

Speaker 1

Thanks, Susanne. Thank you for this question. You know that when we take a product forward in the pipeline that it has got the right to play across multiple indications. So it's not a single indication asset. I think what we said on the volume during the R and D Day is that there's a growing understanding of the pathogenic role IgA auto antibodies play in autoimmune disease.

Speaker 1

It's actually remarkable how little we know above and beyond pathogenic IgG. So this is a field which is completely emerging. We are very pleased that we can go in there and find these. That's the work we like to do. And then in terms of indications, we give you a conceptual list of indications where we know that IgA autoantibodies drive disease.

Speaker 1

Of course everyone knows about IgA nephropathy. I think that is a field which is just being built. I think it's a large market opportunity which will support multiple generations of innovation and multiple innovative molecules. So that's an obvious one. We spoke about IGF Escalitis, but again from a biology point of view that is in the bull's eye of the disease.

Speaker 1

There are more indications and at this moment we will stay conceptual because we're still doing some background work on these indications and the opportunity will unfold when we bring this molecule online in all these different clinical trials. So stay tuned. We think it's a significant opportunity where I think we can follow the biology. So we're very excited about the molecule. Thank you.

Operator

We'll go next to Yatin Suneja at Guggenheim Partners.

Speaker 10

Hey, guys. Congrats on the quarter. Two very quick ones for me.

Speaker 1

Could you just talk

Speaker 10

a little bit more about the subcu and IV dynamic, like how is subcu what sort of share subcu has right now versus IVs that's sort of growing the market? And then just as we think about future with the launch of CIDP, any thoughts on establishing guidance for us? Thank you.

Speaker 1

Thank you for both questions, Jatin. Let's start with question 1, the subcu versus IV dynamic. Karen, would you mind commenting on the dynamic? I don't think we quantify, but maybe you can explain the dynamic.

Operator

Yes, happy to. Exactly. So we don't provide the specific breakdown. But what I would say that I think is helpful in terms of the dynamic, both ViViGOT and Hytrullo are growing in terms of new patient starts and in terms of revenue. And what we see and what the real value of Hytrullo is, is that I would say it opens really up new prescribers that might not be for whatever reason, interested or comfortable with an IV option, so new neurologists that are more comfortable with injections.

Operator

And that also opens up new patients, that are seeing those neurologists or potentially there are patients that don't want to go have the IV. Maybe they think that their disease is not severe enough that they need an IV option, but they're open to an injection option. So I would say by having subcutaneous, it aligns directly with our strategy of moving into early aligned treatment, and we see that very clearly. And it also aligns with our strategy of broadening the prescriber base for VIVGUT, which obviously also helps us with CIDP. The other important dynamic that I think I just want to highlight on Hytrullo is that our goal and our strategy is not a switch strategy from ViVgut.

Operator

So around 60% of the Hytrullo patients that are starting on Hytrullo are actually new to the VIVGART franchise. And that just demonstrates how we're really expanding the market, both in terms of prescribers and patients with the subcutaneous option. And I'll hand it back to you, Tim. Actually, we had a cut in our line. If Yatin is still on, if you could just repeat his second question, that would be helpful.

Speaker 6

Yes, I'm online. So the second question was about guidance.

Speaker 10

How should be how are you guys thinking about establishing guidance and when should we expect that?

Speaker 1

Okay, that is clear. Thank you, Jatin, for repeating it. This is a question for Karl, right? Yes. Thank you, Jatin.

Speaker 1

I mean, we didn't provide guidance this year, revenue guidance, due to all the unknowns out there, in particular for CIDP launch and the geographical expansion. So I think as a company matures, clearly, we need to think about guidance. So we will listen to our stakeholders, including our investors and analysts, and this is something which we will consider, maybe this is something we can do in January next year. But for now, we're going to focus on executing and we have provided the expense guidance and the cash guidance and I will leave it at that for now.

Operator

And we'll go next to Vikram Parohit at Morgan Stanley.

Speaker 11

Hi, good morning. Thank you for taking our question. We had one on the commercial opportunity in Ocular MG. So based on the neurologist feedback you received and just the experience you have in the space with this indication overall at this point, how distinctly do you think ocular MG is managed and viewed and treated versus more generalized MG? And based on that, how drastically do you think the cadence of patient adds could change based on a potential label expansion into ocular MG?

Speaker 11

Thanks.

Speaker 1

Thanks for the question on ocular MG. So by having been now in the MG space for some time, we have been hearing more about the unmet medical needs in ocular MG and it could be a wrong assumption that ocular MG is a milder form of MG compared to the generalized form of myasthenia. So ocular MG patients are pretty debilitated and disabled because with double vision there's not too much activities of daily living you can do in terms of working on screens, driving and then I'm not even talking about the headaches these people experience. Today Ocular MG patients are basically only treated with steroids and some of them actually do very well on steroids, but there's a subset of Ocular MG patients which badly needs an other tool in the toolbox. And after close consultation with the community and the experts, we could crystallize I think a pretty elegant OPPO MG study that we had a successful interaction with the FDA, agreeing on trial design and endpoint.

Speaker 1

And in the real world, some of these Ocular MG patients are actually seen by ophthalmologists or neuro ophthalmologists and then when these symptoms start to spread they're being referred to a neuromuscular specialist. So I think this is a significant opportunity and a nice addition if we are successful to our presence in the MG space. Thanks for the question.

Operator

We'll take our next question from Charles Pittman King at Barclays.

Speaker 12

Hi, thank you very much for taking my questions. 2 for me. Just coming back to the potential risks from competitor readouts to your kind of dominant position in

Speaker 1

the second half of this year.

Speaker 12

I'm just wondering what metrics will you be looking at from these readouts to determine whether any of these really pose a risk to your increasing market dominance? And then just the second one on the kind of Chinese commercial opportunity. I mean, I understand Zai Lab is not going to be reported on the same August. But just in terms of how you are thinking about this from an Ardentx perspective, how established for other treatments and what is the expected addressable market and pricing structure do you expect to benefit from going forward? Thanks.

Speaker 1

Thank you for both questions. Karen, I will give the second question to you. I think on the first question we can be relatively brief. In absence of data, I think we would find ourselves in an area of speculation which we do not really like to do as a science based company. The only thing I can do is remind you of how high we have set the barge in the MG space.

Speaker 1

I think we have the fastest onset of action. We have the deepest action. We have a very nice durability now over many, many years in our MG patients. And importantly I think with a very clean safety profile. And then from a product presentation point of view, I think we have by far the broadest portfolio of product presentations, which we will continue to aggressively expand.

Speaker 1

So that's fit for the data, but I think we're well equipped to compete. And Karen, do you mind taking on question 2?

Operator

No, happy to take that question, Tim. And look, I won't comment on Q2 results. Of course, we'll let Zai Lab comment on that. But what I will say is a few thoughts on, first of all, starting with the fact that I think Zai are incredible partners, and they've done a great job with the launch of MG. And we see, and with them, a long term partnership and I think a lot of opportunity in the future in China.

Operator

Obviously, it's a big market, and what we've seen to date is a lot of volume coming in early on. Through Q1, you saw a big volume of new patient starts in Q1. And I think that reflects the market opportunity in China. I think we've done a great job of not just getting the approvals, but also the NRDL listing, and that has certainly helped with uptake. We expect that to continue.

Operator

And more recently, we got the subcutaneous version approved in China. So I think overall, between the volume of patients with MGU in China, alongside the great partner we have in Zai Lab. I think we're looking positively at the outlook for China. I'll hand back to you,

Speaker 1

Tim. Thanks, Karen. Thanks for the question.

Operator

We'll go next to Leland Gershell at Oppenheimer.

Speaker 13

Great. Thanks for taking our questions. Just wanted to ask, Karen, you've been consistent in moderating expectations for securing payer agreements for CIBP. Just want to ask if that process has been going in line with your expectations internally? And also want to ask if you've been facing any pushback from payers with respect to requiring a step through from IVIG?

Speaker 13

Thank you.

Speaker 1

I think this is an excellent question.

Operator

Yes. How should you take that?

Speaker 1

Yes. Thank you.

Operator

Yes, sounds great. It's a great question. And we talked earlier about why it's so important to get these payer policies in place. I would say that we're as I said before, we're exactly on track with where we thought we would be. And I mean that in terms of both, the how the conversations with payers are progressing and which are progressing well, and also the conversations that we're having with payers in terms of what those policies should look like.

Operator

In terms of IVIG, I think one thing that's important to remember about the CIDP market is that the majority of patients have been exposed to IVIG at some point. And we know from our clinical trial that we have equal right to respond, whether it's IVIg list background therapy coming off no treatment in the last 6 months or steroids. So we think we're well positioned with our data and we think the payer discussions are going well to get policies in place that will set us up for a successful and a strong launch over the coming quarters. Anything to add, Kim? Thank you for the question.

Operator

We're ready for the next one. We'll go next to Samantha Simicaw at Citi. Hi, good morning and thanks for taking the question. Just one on the PFS for me. Now that you filed and you're preparing for potential launch of the PFS, I'm curious how much more growth in gMG are you really thinking about that formulation will drive?

Operator

What patient segments you expect to open or expand? Do you think this will be more of a switch market than what you've seen with Hytrullo? And just how should we think about the magnitude of impact on revenue assuming you have that approval in the near future? Thank you.

Speaker 1

Yes, thank you. That's a great question on BFS. And Karen, I think why don't you explain why this will just continue that steady, strong trajectory into the MG population, please?

Operator

Yes, I think that's exactly it, Tim, and what I was going to say. I would say this just continues to expand and reinforce the momentum as we continue. We started with IV, then we expanded into subcutaneous and then certainly expanding into PFS. It opens up different prescribers as well as different patients. And I think that's reflected in terms of how we explain the addressable market expansion at R and D Day.

Operator

Certainly, what we see is that there will be a growth in biologics share of market, and that we will be well positioned within that growth. And certainly, PFS helps us to maintain our leadership and certainly with the early aligned patients and the broader prescriber base, given the fact that we will have IV and PFS. So I would think about it as continuing to maintain our momentum and continuing in line with our strategy of earlier line and broader prescriber base. Thanks for the question. We'll go next to Joon Lee at Trus Securities.

Speaker 6

Thanks for the update. Thanks for taking our questions. For the Mogo decision on myositis by year end, are they all coming at once or 1 by 1? And if efgartigimod works in 1, but not in the other myositis subtypes, what would be some of the reasons for that? And what are you looking forward to learning from that to further enhance the choice of your future indications and maybe even reprioritize your existing pipeline indications?

Speaker 6

Thank you.

Speaker 1

Thank you, Jens, for the question and thanks for being with us. So in this Basket trial where we combine 3 subtypes of myositis to go no go decision point will all come at the same time. So we're synchronizing that first 30 patients across the 3 indications to make one decision. Remember that this is an operationally seamless Phase 2, Phase 3 trial. So whilst these data are maturing, we are actually already entering into the Phase III portion of the trial at risk.

Speaker 1

So technically speaking, the only decision we can make is a stop decision. And of course, the first limitations will be informative. So it will allow us to make stop decisions in 1, 2 or 3 of these indications, but it will also allow us to adjust sample size. Look, all three indications come out of the same argenx mold. I mean, strong conviction in biology.

Speaker 1

I think a responsible thoughtful clinical trial design, but not completely risk free. So, I think we did everything we could to design it and risk mitigate it. So I don't think there is any specific read through of a myositis outcome onto any other indication which we have loaded into the pipeline because they all flow the same blueprint. Thanks for the question.

Operator

We'll go next to Gavin Clark Gartner at Evercore ISI.

Speaker 1

Hey, thanks for taking the question. A quick one on thyroid eye disease. Just wanted to confirm you're doing weekly dosing in the Phase 3s and also just ask how enrollment is going now that you're about 4 months in? Thanks. Thanks for the question on TD.

Speaker 1

You're right that we're in the weekly dosing. We're doing that with the prefilled syringe already. And I think we're in a classical typical trial execution model. So stay tuned on how that study is doing. We will keep you updated over the coming quarters, but we feel very strong about the opportunity and the traction we're getting with this global clinical trial.

Speaker 1

Thank you.

Operator

Next we'll go to Andy Chen at Wolfe Research.

Speaker 10

Good morning. Thank you for taking the question. So this 450,000 pricing, I'm just curious if you can talk about how robustly this pricing can stay at 450,000 because as you have payer contracts, there's a natural pressure for ASP erosion. So just curious if you can comment on the dynamics here. Do you see a room for this number to go up over time in the next few years?

Speaker 10

Or do you think this is going to stay the same at 450 or do you think this is going to go down? Thank you.

Speaker 1

Yes. So Andy, thank you for the question, Rich. I'm happy to take. So let me first briefly comment on the 4.50 numbers. That number of course did not come out of the blue sky.

Speaker 1

I think it is the result of a thorough understanding of I think the value proposition which we have to offer, a careful calibration of course with payers, where we socialize the Phase 3 data with them and the data actually which resonates very well with PACE is the region of function data Karim was already alluding to and especially I think the fact that the majority of the people who entered the trial wheelchair bounds were able to leave the trial outside of the wheelchair. So these are pretty meaningful data which represents significant value. We are now finalizing the paid agreements, so stay tuned and we also discussed that during the call. Look, I cannot predict the future. I think it is fair to assume that with more competition and more indications there may be some pressure on your price.

Speaker 1

But I think as a company we are pricing transparently and responsibly and I think we are very well equipped with our market access strategies to go into our future. Thank you for the question.

Operator

Next, we'll move to Joel Beatty at Baird.

Speaker 10

Thanks and congrats on the strong growth from Q1. Looking back, what led to the weaker Q1 and how much of that was seasonal in nature and would be expected to repeat versus any dynamics that might have been one time in nature?

Speaker 1

Yes. Thank you for asking the question. I think we alluded to that in the prepared remarks, but maybe Karen, do you want to comment when we look through the optics of Q1 and Q2, what the real underlying strength of the businesses?

Operator

Yes, absolutely. When we look at the business, what we look at is those underlying drivers of growth. So are we adding new patients consistently? Are we moving earlier line? Are we broadening our prescriber base?

Operator

And we see those pretty consistently through Q1 and Q2. I would say those Q1 dynamics that you see across the industry, not just with VivGuard around reverifications, weather, I'd say they're always going to be there. Whether they were worse in Q1 because the weather was worse in some parts of the U. S. Or whatever you may have.

Operator

I mean, I think we can all look back at that. But those Q1 dynamics are more, I would say, across the industry. The Vivgart performance and the KPIs, I would say, is pretty consistent throughout actually the 10 quarters of growth that we've had, and we would expect that to continue. Thanks for the question. We'll take our final question from Douglas Tsao at H.

Operator

C. Wainwright.

Speaker 6

Hi, good morning and thanks for taking the questions. Just a quick follow-up on ITP. I understand you think you have from a regulatory standpoint, an efficient way to move forward. I'm just curious what feedback you may have gotten from KOLs as well as how you're thinking about the commercial positioning, just given the finding from the prior Phase 3 study in terms of the effect of low dose steroids? Thank you.

Speaker 1

I'm not sure we understood the question completely because the line was breaking up. Would you mind if we recap any questions?

Speaker 6

Yes, sorry. Can you hear me now, Tim?

Speaker 1

Yes, we can.

Speaker 6

Okay. So I was just asking, so I understand you believe in ITP that you have an efficient path forward from a regulatory standpoint. I'm just curious in terms of how you're thinking about the product's positioning, if it has changed prior to the prior Phase III results and what feedback you may have gotten from KOLs, especially in terms of the efficacy or the apparent efficacy of low dose steroids? Thank you.

Speaker 1

We got it. So there is quite some excitement in the community about the data which we generated in the clinical trial. In this refractory patient population which we are targeting and in which we will be positioning 3rd line after steroids and PPOs. In that patient population, not much is really working and we showed a very high response rate and an unprecedented safety profile and that is really important for the KOLs. They also continue to call us about how well their patients were doing in the study, the ongoing open label extension.

Speaker 1

So there was quite some pull from the marketplace I would say for this product and I think they were also very collaborative in helping us to think through the proposal we would make vis a vis the FDA. So positioning has not changed. KOL feedback is very positive and that stems our determination to go forward. Thanks for the question.

Operator

This concludes today's question and answer session and today's conference call. Thank you for your participation. You may now disconnect.

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Rekor Systems Q2 2024
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