Q3 2023 argenx SE Earnings Call
Good morning, My name is Rob and I'll be your conference operator today I'd 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. If you'd like to ask a question. During this time simply press star followed by the number one on your telephone keypad. If you would like to withdraw your question again press Star one thank you.
Like to introduce best El Jocko, Vice President Global head of corporate Communications and Investor Relations you May now begin your conference.
Thank you operator, our press release was issued earlier today with our third quarter 2023 financial results and business update this can be found on our website along with the presentation for today's webcast before we begin I'd like to remind you on slide two that forward looking statements may be presented during this call.
These may include statements about our future expectations clinical development regulatory timelines the potential success of our product candidates financial projections and upcoming milestone actual results may differ materially from those indicated by these statements are genex is not under any.
Again to update statements regarding the future or to conform these statements in relation to actual results unless required by law.
I'm joined on the call today by Kevin Howard Marin, Chief Executive Officer, Carl <unk>, Chief Financial Officer, and Karen Massey, Chief Operating Officer, I will now turn the call over to Tim.
Thank you Beth and welcome everyone slide three.
It is incredible to see what are your Gen X team has accomplished this year.
<unk> is really delivering on the ambitious plan laid out in January.
We are reaching more and more gmg patients around the world and brought a subcutaneous product to the market for the 18 months after the IV launch.
We reported <unk> data.
I'll have a path forward to approval next year.
We advanced our pipeline with an important co decision in women with <unk> and are also keeping our promise to invest in the next generation of exciting preclinical assets, which we will talk about next year.
Stepping back.
We are working on 13 indications for <unk> gut alone with more slated to begin before 2025.
We have accumulated extensive clinical trial and rebuild experience with our first in class <unk> inhibitor.
And continue to publish and present on its differentiated efficacy and safety profile.
All of this is furthering our leadership in this space and broadening our understanding of the potential of <unk> got to change how we view ultra immunity.
I would first like to share key highlights from the quarter.
Rob: Good morning, my name is Rob, and I'll be your conference operator today. I'd like to welcome everyone to the call. At this time, all lines have been placed on mute to prevent any background noise.
And then move onto milestones ahead for the remainder of the year.
The strength of our launch continues with double digit growth quarter over quarter.
Rob: After the speakers remarks, there will be a question and answer session. If you'd like to ask a question during this time, simply press star followed by the number one on your telephone keypad. If you would like to withdraw your question, again press star one. Thank you.
So Adam will share additional details later in the call.
At a high level I'm really pleased with where we are today.
We continue to have countless patients stories and testimonials about fifth card and this is motivating our teams to drive further growth.
Beth DelGiacco: I'd like to introduce Beth DelGiacco, Vice President, Global Head of Corporate Communications, and Investor Relations. You may now begin your conference. Thank you operator.
We focus our fifth got expansion goals across three key areas expanding within the <unk> treatment paradigm, expanding geographically and expanding into new indications.
Beth DelGiacco: Approximately this was issued earlier today with our third quarter, 2023 Financial Results and Business Update. This can be found on our website, along with the presentation for today's webcast.
First on expanding within Gmg, we are already seeing traction with new patients and new prescribers three months into the <unk> launch.
Beth DelGiacco: Before we begin, I'd like to remind you on slide two that forward-looking statements may be presented during this call. These may include statements about our future expectations, clinical development, regulatory timelines, potential success of our product candidates, financial projections, and upcoming milestones. Actual results may differ materially from those indicated by these statements. Our genx is not under any obligation to update statements regarding the future or to conform these statements in relation to actual results unless required by law.
We are the only GMC treatment that is available as an IV and a simple sub Q injection.
Both offering a consistently strong clinical benefit.
This choice in how and where patients want to be treated will help us move into earlier lines.
Looking to our geographic expansion, we received <unk> got approval in Canada.
Our first patients in Italy and China.
Beth DelGiacco: I'm joined on the call today by Kenvin Haramiran, Chief Executive Officer, Carl Gubits, Chief Financial Officer, and Karen Massey, Chief Operating Officer. I will now turn the call over to Tim.
And move to another step closer to bringing <unk> to patients in Europe with a positive <unk> opinion, including self administration on the label.
In addition to our commercial success.
We achieved a key win for the CIBC community over the quarter.
Tim Hauwermeiren: Thank you, Beth, and welcome everyone. Slide three. It is incredible to see what the Argentine team has accomplished this year, meticulously delivering on the ambitious plan delayed out in January. We are reaching more and more GMG patients around the world and brought a subcutaneous product to the markets for the 18 months after the IV launch. We reported stellar CIDP data, and now have it passed forward to approval next year. We advanced our pipeline with an important code decision in an amendment with Ampassia Privat, and are also keeping our promise to invest in the next generation of exciting pre-clinical assets, which we will talk about next year.
We're planning ahead for indication expansion.
We had a positive meeting with the FDA and can confirm we are on track to file our SBA law before the end of the year.
As you will recall the topline results from our <unk> trial.
Nothing short of game changing.
This was the largest global clinical trial for CIBC to date.
And we not only confirms GDP ism <unk> mediated disease.
It also set a new standard for <unk> trials in the future.
Efficacy was a tightened across patient subtypes and we saw is from a mono 99% rollover into the open label extension study.
Tim Hauwermeiren: Starting back, we are working on 13 indications for Vidgard alone, with more slated to begin before 2025. We have accumulated extensive clinical trial and re-world experience with our first-in-class F7 inhibitors and continued to publish and present on its differentiated efficacy and safety profile. All of this is furthering our leadership in the space and broadening our understanding of the potential of Vidgard to change how we view auto-immunity.
Given the high unmet need for a safe and effective treatment alternative.
We feel a strong sense of urgency to bring our therapy to patients as quickly as possible.
Therefore, I'm also pleased to tell you that we have notified the FDA of our intention to use our PRD with the <unk> submission.
Slide four.
Today I am speaking to you from <unk> in Phoenix, Arizona, <unk> team is presenting a significant amount of data on the <unk>.
Tim Hauwermeiren: I would first like to share key highlights from the quarter and then move on to milestones ahead for the remainder of the year. The strength of our launch continues with double-digit growth quarter over quarter. Carrenville's shared additional details lies in the call, but at a high level I'm really pleased with where we are today. We continue to hear countless patient stories and testimonials of our Vyvgart, and this is motivating our teams to drive further growth.
We have now dosed more than 1004.
400 patients.
Generating more than 1000 patients use of data across all clinical trials and in energy. We now have almost two years of real world experience in approximately 6000 patients.
This has provided us confidence in the consistency of the data and a deep understanding of the clinical profile of our FC fragment and why the way in which it binds to a CRM can lead to differentiated results.
Tim Hauwermeiren: We focus our Vyvgart expansion goals across tricky areas, expanding within the GMG team and paradigm, expanding geographically, and expanding into new indications. First, on expanding within GMG, we are already seeing traction with new patients and new prescribers three months into the high-true launch. We are the only GMG treatment that is available as an IV and a simple subcue injection. Both offering a consistently strong clinical benefit. This choice in how and where patients want to be treated will help us move into earlier lines.
At the conference we are presenting aggregated data from adapt the depths of Q and the associated open label extension studies, which extend out beyond three years and 19 treatment cycles.
We see that responses are repeatable cycle over cycle and that the clinical benefit improvements are of a consistent magnitude.
We also see consistent results on minimal symptom expression.
In every datasets where a.
Able to achieve approximately 40% of MSC, which is an important part of our value proposition to patients.
We also show in our data that patients who are able to achieve MSC.
Tim Hauwermeiren: Looking to our geographic expansion, we received Vyvgart approved in Canada, have our first patients in Italy and China, and move another step closer to bringing in high-true low to patients in Europe with a positive CHMP opinion, including self-administration on the label. In addition to our commercial success, we achieved a key win for the CRDP community over the quarter, and I'm planning ahead for indication expansion. We had a positive meeting with the FDA and can confirm we are on track to file our SBLA before the end of the year.
Quality of life measurements compatible to healthy populations.
Which is why we believe this metric should be the goal that physicians seek to attain with LNG patients.
Safety continues to be a key differentiator.
And we showed that across all indications and all dosing schedules treatment emergent adverse events were mild to moderate and do not increase with longer exposure and.
We do not see reduction in albumin or increasing cholesterol.
The unique clinical profile that we confirm that these data can be linked to the unique design of the <unk>, which of course was born out of both the studies towards groundbreaking immunology research on <unk> biology.
Tim Hauwermeiren: As you will recall, the top-line results from our adE trial were nothing short of game-changing. This was the largest global clinical trial for CRDP to date, and we not only confirmed CRDP as an IGG-mediated disease, but also set in new standards for CRDP trials in the future. EthicsC was a time on the cross-patient subtypes, and we saw a phenomenal 99% roll-over into the open label extension study. Given the high-end rate need for a safe and effective treatment alternative, we feel it's a strong sense of urgency to bring our therapy to CRDP patients as quickly as possible. Therefore, I'm also pleased to tell you that we have notified the FDA of our intention to use our PRV with the CRDP submission. Slide 4.
Since that time, we have generated a new understanding of the role of a CRM beyond irregular lasers agg levels in circulation.
We've noticed a cinema is important in the trafficking of antibodies into tissues.
And that's by binding of CRM, our fragments and recent tissues inside of disease very fast.
It is also involved in the ultra antigen presentation process, which may explain the data we saw in <unk>.
In reducing ultra reactive T cells.
Lastly, given.
Given the natural way in which we find the CRM, we can uniquely modulator targets.
Blocking <unk> from binding, but not derailing of certain itself into the lysosomal degradation.
Tim Hauwermeiren: Today, I'm speaking to you from A&E and in Phoenix, Arizona, where the Agenics team is presenting a significant amount of data on Vizgard. We have now those more than 1,400 patients, generating more than 1,000 patient years of data across all clinical trials, and in NG, we now have almost 2 years of real-world experience in approximately 6,000 patients. This has provided us confidence in the consistency of the data, and a deep understanding of the clinical profile of our FC fragments, and why the way in which it binds to FCN can lead to differentiated results.
This has allowed us to select doses and dosing regimens that optimize the clinical benefit of our cartage them up without having to manage for dose related adverse events.
Our leadership in CRM presents itself through our business.
From the efforts of our commercial and medical affairs teams to the ongoing installation work of our scientists who are realizing the textbooks of immunology.
Slide five.
Looking ahead we.
We are excited to advance our pipeline with two upcoming phase III readouts.
First readout will be the top line results from our ICP advance the Pew study followed by our <unk> address study around year end.
Tim Hauwermeiren: At the conference, we are presenting aggregated data from ADAPT, ADAPT sub-Q, and the associated open label extension studies, which extend out beyond 3 years and 19-3 months. Dr, Dr, Dr, Dr, Dr Dr, Dr, Dr Dr, Dr, Dr, Dr, Dr, Dr, Dr, Dr, Dr, Dr, Dr, Dr, Dr, Dr, Dr, Dr, Dr, Dr, Dr, Dr, Dr, Dr, Dr, Dr, Dr, Dr, Dr, Dr, Dr, Dr, Dr,[inaudible] This endpoint is designed to meet the regulatory requirements, but we also will be looking at the fast onset of action, the IWG score and safety.
Let's begin with a high level overview of high to low in ICP.
Our goal for the <unk> study is to replicate the phase III IV results, which were recently published in the lancet.
The study has the same design and endpoints, although we increased enrollment to give ourselves more room for success with the highly refractory patient population.
The primary endpoint is challenging so in terms of the threshold for success, we will be focused on the delta between treated and placebo.
This endpoint is designed to meet the regulatory requirements, but we also will be looking at the fast onset of action the <unk> score and safety.
The <unk> will be view as the most clinically meaningful endpoint.
It is based on how clinicians make treatment decisions in the real world.
ITD patients are often very fit for.
Suffer from fatigue, and anxiety due to the risk associated with an unexpected bleed.
They typically cycled through multiple treatments in the trial and error approach, including through multiple key deals.
What we have learned in our conversations with the ICP medical community is that that is a real need for a new modality to treat ITT fatigue.
Particularly new modalities that come with a favorable safety profile, which is potentially but if <unk> got a good step in.
Slide six.
Next we can expect to see data from the address to the intensity around yearend.
Meaning the data readout for wide before or after the year end as we navigate the data analysis and communication around the holiday period.
The phase three trials for <unk> builds on the adaptive phase II results, where we saw a fast onset of action with 90% of patients achieved disease control. After just wanted to infusions and a quicker time to CR on a low dose of steroids.
In the phase II study.
We implemented an official steroid tapering protocol and this is integrated in our primary endpoint.
Similar to IPP. The primary endpoint is a challenging one defined as the proportion of patients achieving complete remission on a minimum dose of steroids within 30 weeks.
It combines reaching complete clinical remission shipping to and maintaining a low dose of steroids and sustaining this for eight weeks.
The current standard of care, including steroids Rituximab. This ample of room for a fast new durable treatment with few side effects.
This will be especially important in a post COVID-19 setting another fees has a better understanding of the detriments of long term immune suppression.
Slide seven.
In 2024, we have multiple catalysts from our pipeline to look forward to.
I'm, particularly excited for the amendment topline results to be shipped next year.
This is the first indications for our second pipeline in a product and bar and is a very serious disease, which fits perfectly within the infrastructure. We are building for gmg and <unk>.
We also have two upcoming go no go decisions.
First in <unk> around the end of this year.
And also in <unk>, which is expected in the second half of 2024.
Phase II <unk> results are expected in the first quarter of 2024.
Tim Hauwermeiren: The IWG score is what we view as the most clinically meaningful endpoint as it is based on how clinicians make treatment decisions in the real world. ITP patients are often very fit, but several from fatigue and anxiety due to the risk associated with an unexpected bleed. They typically cycle through multiple treatments in the trial and error approach, including through multiple TPO's.
<unk> has the potential to be a sizable opportunity.
This is a study where we will learn a lot about the role of <unk> in this growing indication.
<unk> results are expected to be shared in the first half of 2024.
This is an exciting opportunity within rheumatology, where we believe strongly in the rollover disease as the disease driver.
Lastly, we are focused on long term sustainable innovation and know to achieve this we need to invest in the growth of our early stage pipeline.
Tim Hauwermeiren: What we have learned in our conversations with the ITP medical community is that there is a real need for a new modality to treat ITP, particularly in new modalities, that can be the favorable safety profile, which is potentially where Vyvgart could step in.
We have several exciting programs through our IP, which we will communicate as we get closer to <unk>.
Tim Hauwermeiren: Flight 6. Next we can expect to see data from the address study in Penceguss around year end, meaning the data data will fall right before or after the year end, as we navigate the data analysis and communication around the holiday period. The Phase T trial for Penceguss was built on the adaptive Phase II results, where we saw a fast onset of action with 90% of patients achieving disease control after just one to two infusions, and a quick time to CR on the load of steroids.
But we are working from a strong track record of success.
That's a program in our pipeline, including dose that we are developing ourselves and dose of that in the hands of others.
All being co created with a top notch academic collaborators and are grounded in our breakthrough immunology innovation.
The new programs will also have this characteristic feature of assets from our IP.
I will now turn the call over to Carl.
Thank you Tim Slide eight our third quarter 2023 financial results are detailed in the press release from this morning, I will highlight the key points here.
Tim Hauwermeiren: In the Phase T study, we implemented an official steroid taping protocol, and this is integrated in our primary endpoint. Similar to IPP, the primary endpoint is a challenging one, defined as the proportion of patients achieving complete remission on a minimum dose of steroids within 30 weeks. It combines reaching complete clinical remission, taping two, and maintaining the load of steroids and sustaining this for eight weeks. The current standard of care, including steroids and addiction mat, is ample of room for a fast, new, durable treatment with few side effects. This will be especially important in a post-COVID setting, now that we have a better understanding of the treatments of long-term immune suppression.
The continued momentum of our launch is reflected in our third quarter revenues reached.
We generated $340 million total revenues, including 329 million in global net product sales and $11 million in collaboration and other avenues. Other revenues include $700000 in royalty revenues from <unk> sales in <unk>.
<unk>.
Our quarter three global product net sales of $329 million represents growth of 22% versus quarter two.
The breakdown is as follows.
The U S sales is $280 million, Japan, $15 million, EMEA $26 million and China salmon.
It is important to note two points on that restaurant net product sales first in EMEA.
Tim Hauwermeiren: Slide 7. In 2024, we have multiple catalysts from our pipeline to look forward to, and particularly excited for the amendment top line results to be shared next year. This is the first indication for our second pipeline in a product, MPA, and it is a very serious disease, which fits perfectly within the infrastructure we are building for GMG and CIDP. We also have two upcoming GONORGO decisions, first in both PENFCOVID, around the end of this year, and also in my side, which is expected in the second half of 2024. These two post results are expected in the first quarter of 2024, and has the potential to be a sizable opportunity.
Net sales includes a one off positive impact of approximately $6 million.
As a result of it through our profit chairman price.
But remember that beginning in March we started to accrue revenue in Germany at the protected negotiated price.
This was finalized in September and the true up reflected in our quarter three results.
Second the product net sales to China of $7 million.
Is the revenue generated on the supply of commercial vials desire that our first party collaborator in China. The sales design lab on a cost plus a nominal management fee.
Tim Hauwermeiren: Lee. This is a study where we will learn a lot about the role of IGGs in this growing indication. And Shervin's results are expected to be shared in the first half of 2024. This is an exciting opportunity within rheumatology where we believe strongly in the role of IGGs as a disease driver.
XI lab self evolved organics as Steve said royalty, which is reflected in the $700000 mentioned earlier.
Our total expenses of $420 million for the third quarter, resulting in an operating loss of $81 million per quarter.
Tim Hauwermeiren: Lastly, we are focused on long-term, sustainable innovation and know to achieve we need to invest in the growth of our early stage pipeline. We have several exciting programs through our IIP, which we will communicate as we get closer to IGGs, that we are working for the strong track record of success. Every program in our pipeline, including those that we are developing ourselves and those that are in the hands of others, have all been co-created with a top-notch academic collaborator and are grounded in the breakthrough immunology innovation. The new programs will also have this characteristic feature of assets from our IIP.
We ended the quarter with $3 $2 billion in cash cash equivalents and current financial assets.
This includes the net proceeds of approximately $1 2 billion from a global offering completed in July.
I will now turn the call over to Karen who will provide detail on the commercial front.
Thank you Carl Slide nine.
Im really happy where we are without they've got launch having rapidly and successfully brought a first in class medicine to patients across multiple markets.
Today I will share the details around the current launch dynamics and then highlight the ambitious plan ahead.
Our goal is to continue to raise the bar for patients globally and what they can expect from a treatment to their autoimmune disease changing well controlled name. So that they don't have to weigh the tradeoffs between efficacy and safety and can experience a low treatment burden that allows them to get back to their lives.
Karl Gubitz: I will now turn the call over to Karl. Thank you, Tim.
Karl Gubitz: Slide 8. Our third quarter, 2023 financial results are detailed in the press release from this morning. I will highlight the key points here. The continued momentum of our launch is reflected in your third quarter revenues. We generated $340 million total revenues, including $329 million in global net product sales and $11 million in collaboration and other revenues. Other revenues include $700,000 in royalty revenues from Webcard sales in China. A quarter-free global product net sales of $329 million represents growth of 22% versus quarter-two.
Before we discuss the performance over the quarter I want to visit the multi dimensional growth strategy, we have in place.
We have a bold vision to they've got bringing an innovative therapy, new patients expanding our geographic reach and maximizing the impact of new indications.
We have already added high to low to our product suite and continue to develop future product presentation to support our plan to move earlier in the treatment paradigm.
We are rapidly, bringing they've got and we've got hikes related to market, a new country and has key pivotal readouts on the horizon, which will further help us realize the broad potential of they've got and have gotten <unk> into new indications.
Karl Gubitz: The breakdown is as follows. The US sales is $280 million Japan $15 million in MIA $26 million and China $7 million. It is important to note two points on the threshold net product sales, first in a MIA. Net sales includes as a one-off positive impact of approximately $6 million as a result of a truer for the German price. Remember that beginning in March, we started to accrue revenue in Germany at the projected negotiated price.
Slide 10.
First on broadening outpatient rates with they've got ended Delhi chiller with our third quarter results. We have now generated an impressive $816 million in net product revenues year to date. The large majority of this revenue is driven by this Scott and there are a number of metrics that we have the debt that gives us confidence in the trajectory of <unk>.
Scott and they've got hydro in the U S.
First we are seeing they've got naive patients comprise the majority of our high true-life prescriptions. So uptake has not been driven by a switch dynamic, but rather by expansion by providing.
Karl Gubitz: The price was finalized in September and the truer reflected in the quarter-free results. Second, the product net sales to China of $7 million is revenue generated on the supply of commercial vials to Zylab, our first-party collaborator in China. The sales to Zylab are at cost plus a nominal management fee. When Zylab sells a vials, organic receives a royalty which is reflected in the $700,000 mentioned earlier. Our total expenses are $420 million of a third quarter resulting in an operating loss of $81 million. $3.00 million of a quarter.
The flexibility in how and where patients receive treatment, we are reaching a broader population, which is why we are hopeful.
The initial feedback from doctors on <unk> got high trailer has been broadly positive and they recognize the benefit of the simple 30% to 92nd single injection enabled by the unique <unk> and Hayes technology.
We also continue to make progress shifting into earlier treatment lines and we've got high <unk> is contributing to this expansion.
With physicians, we're focusing not only on expanding our prescriber base, but are also driving brand loyalty with our current prescribers.
You've got high cumulative is helping with both of these goals and we are still at the front end of the adoption curve with neurologists the opportunity before us is extensive.
Karen Massey: Router, we ended the quarter with 3.2 billion cash, cash equivalence and current financial assets, this includes the net proceeds of approximately 1.2 billion from the global offering completed in July, I will now turn the call over to Karen who will provide detail on the commercial front. Today, I will share the details around the current launch dynamics and then highlight the ambitious plan ahead. Our goal is to continue to raise the bar for patients globally in what they can expect from a treatment for their autoimmune disease, changing what well-controlled means, so that they don't have to weigh the trade-offs between efficacy and safety and can experience a low treatment burden that allows them to move forward.
In the U S injection sites are actively working to set up protocols to enable the injections. This takes time and we're seeing consistent progress.
The first actually payer policies are also being published set between this and the sites becoming available for treatment and the high level of excitement from physicians and patients. We expect to see this pull through to new patient starts as well.
Overall, we are right, where we expect it to be.
On the path towards maintaining the trajectory of our launch consistent quarter over quarter progress towards reaching more gmg patients globally.
Slide 11.
Second in terms of expanding our suite of product presentations.
Hi, truly with a first generation subcutaneous, but our goal is to continue to innovate on the patient experience with future product presentations as well.
Our second generation subcutaneous product is a pre filled syringe, which is already in development are planned for the PFS is to enable self administration in the U S. Given the simplified experience for patients we.
Karen Massey: Before we discuss the performance over the quarter, I want to bid at the multi-dimensional growth strategy we have in place. We have a bold vision for Vyvgart bringing in innovative therapy new patients, expanding our geographic reach and maximizing the impact of new indications. We have already added high true low to our product suite and continue to develop future product presentations to support our plan to move earlier in the treatment paradigm. We are rapidly bringing Vyvgart and Vyvgart high true low to market in new countries and have key pivotal readouts on the horizon, which will further help us realize the broad potential of Vyvgart and FGAT to demand into new indications.
We will also aim to advance our PSS product forward for both MGE and future indications, including <unk> in parallel.
The approval path increased bioequivalence and human factor studies as well as stability data and we expect to be able to share more information with you on timing early next year.
Slide 12.
Thirdly, we're delivering growth by moving into new markets with they've got we are thinking about this both in terms of how we expand geographically and also as we look to repeat the success of Mg in new indications.
Karen Massey: Slide 10. First, on broadening our patient reach with Vyvgart and Vyvgart high true low. With our third quarter results, we have now generated an impressive 816 million in net product revenues year to date. The large majority of this revenue is driven by Vyvgart and there are a number of metrics that we have observed that give us confidence in the trajectory of both Vyvgart and Vyvgart high true low in the US. First, we are seeing Vyvgart and our patients comprise the majority of our high true low prescriptions.
On a geographic expansion.
Starting with China through our partnership with Dilantin.
After June approval. The first patients began they've got treatment during the third quarter.
<unk> also filed for an approval of subcutaneous <unk> got 10 months and we expect to hear back on an approval decision next year.
We continue to make progress on pricing and reimbursement across the EMEA region and have had very good outcome. So far with our negotiations with reinvestment security in Germany, Italy, and now Spain also recognizing the important value that they've got provides gmg patients and to health care systems.
Karen Massey: So uptake is not been driven by a switch dynamic, but rather by expansion. By providing flexibility in how and where patients receive treatment, we are reaching a broader population, which is what we are hopeful. The initial feedback from doctors on Vyvgart high true low has been broadly positive, and they recognize the benefit of the simple 30 to 90 second single injection enabled by the unique Halazine and Hayes technology. We also continue to make progress shifting into earlier treatment lines and Vyvgart high true low is contributing to this expansion.
The subcutaneous they've got Gigamon, we received a positive <unk> opinion in September which was a significant milestone for the region and notably the labeling EMEA will include self administration.
We also received an approval in Canada during the quarter and we're planning for a launch before end of year similar to Europe, the pricing and reimbursement discussions with the HCA in Canada has been going very well and <unk> has been recognized as better value than other entrenched biologics. This is an important win for patients in Canada.
Karen Massey: With physicians, we are focusing not only on expanding our prescriber base, but on also driving brand loyalty with our current prescribers. Vyvgart high true low is helping with both of these goals, and we are still at the front end of the adoption curve with neurologist. The opportunity before us is extensive. In the US, injection sites are actively working to set up protocols to enable the injections. This takes time and we are seeing consistent progress.
Slide 13.
And finally on our indication expansion and here was the largest trial ever run and CIP and the results are impressive. So we are busy preparing for a launch into the ADP next year.
As Tim already mentioned, we'll be filing our application with the priority review voucher, because we recognize that patients are waiting for new innovation and see ADP.
Karen Massey: The first high true low pay-up policies are also being published. So between this and the site becoming available for treatment and the high level of excitement from physicians and patients, we expect to see this pull through into new patients as well. Oval, Overall, we are right where we expected to be. We are on the path towards maintaining the trajectory of our launch, consistent quarter over quarter progress towards reaching more GMG patients globally. Slide 11.
Our priority now is to take those key learnings from the Mg launch and apply them to ask the IDP strategy, while also thinking about where we can expand and improve.
We're also investing for the long term building out our launch capabilities and in a very intentional and disciplined way to enable success across multiple indications down the road. It's certainly an exciting time to be at <unk>.
I'll now turn the call back to Tim.
Karen Massey: Second, in terms of expanding our suite of product presentations. I truly doubt first generation subcutaneous, but our goal is to continue to innovate on the patient experience with future product presentations as well. Our second generation subcutaneous product is a pre-filled syringe, which is already in development. Our plan for the PFS is to enable self-administration in the US, given the simplified experience for patients. We will also aim to advance our PFS product forward for both MG and future indications, including CRDP in parallel. The approval path includes bio-covolence and human factor studies, as well as stability data, and we expect to be able to share more information with you on timing early next year. Slide 12.
Thank you Kevin on Slide 14.
As we conclude let's come back to where we are today and where we're going.
We are leading from a position of strength.
Delivering on our commitments to bring formative treatments to as many patients as possible.
Through intentional launch strategies and relentless execution, we continue to reach new types of stations in new regions and make clear progress expanding into new indications.
As innovators, we're looking forward and we're incredibly excited about the opportunity ahead of us to lead what we believe to be one of the biggest drug classes ever.
Thank you for your continued support of Spotless on this mission.
Karen Massey: Thirdly, we are delivering growth by moving into new markets with Vyvgart. We are thinking about this both in terms of how we expand geographically, and also as we look to repeat the success of MG in new indications. On our geographic expansion, starting with China, through our partnership with ZYLAB. After a June approval, the first patients began Vyvgart treatment during the third quarter. ZY also filed for an approval of subcutaneous FGAT and we expect to hear back on an approval decision next year.
I'll now turn the call back to the operator.
At this time I would like to remind everyone in order to ask a question Press Star then the number one on your telephone keypad.
We ask that you please limit yourself to one question and a follow up and then rejoin the queue for further questions. Your first question comes from the line of <unk> <unk> from Guggenheim Partners. Your line is open.
Hey, guys. Thank you for taking my question a question on the PV study could you maybe talk about what.
Karen Massey: We continue to make progress on pricing your reimbursement across the EMBA region, and have had very good outcomes so far with our negotiations, with reimbursement secured in Germany, Italy, and now Spain, also recognizing the important value that Vyvgart provides to GMG patients and to health care systems. For subcutaneous FGAT, we received a positive CHMP opinion in September, which was a significant milestone for the region, and notably, the label in EMBA will include self-administration.
What do you think you would like to show with regard to the scheme in efficacy.
Endpoint then also have you disclosed the poverty assumption, how should we think about placebo performing thank you so much.
Okay.
Good morning, Thank you for joining us on the call today.
FMC the study, which is on track for Readouts before the end of the year.
It gives topline data in line with how we typically show data so.
It will be sufficiently complete and transparent to understand the clinical utility of the medication.
Karen Massey: We also received an approval in Canada during the quarter, and we're planning for a launch before end of year. Similar to Europe, the pricing reimbursement discussions with the HTA in Canada have been going very well, and Vyvgart has been recognized as better value than other entrenched biologics. This is an important win for patients in Canada.
In this setting.
This will center around the primary endpoint will be.
We'll assess.
The delta between active and placebo on the <unk>.
Primary endpoint of <unk> CRM with.
Where patients need to achieve on a.
A minimum dose of corticosteroids and Thats, what at least eight weeks. We will also disclose the key secondary endpoints, which has to do with steroid tapering and speeds to disease control and of course importantly safety. So it will be a comprehensive topline datasets in line with how we have been showing top line data in other indications.
Karen Massey: Slide 13. And finally, on our indication expansion, and here was the largest trial ever run in CADP and the results were impressive, so we are busy preparing for a launch in CADP next year. As Tim already mentioned, we'll be filing our application with a priority review voucher because we recognize that patients are waiting for new innovation in CADP. Our priority now is to take those key learnings from the MG launch and apply them to our CADP strategy while also thinking about where we can expand and improve.
<unk>.
We have not disclosed powering assumptions, we never do that.
Europe I know, that's a relatively conservative when it comes to powering. The studies remember this is the single biggest benefit study with 222 patients in costs.
Karen Massey: We're also investing for the long term, building out our launch capabilities in a very intentional and disciplined way to enable success across multiple indications down the road. It's certainly an exciting time to be at our genetics.
For the question.
Okay.
Your next question comes from the line of <unk> Ahmad from Bank of America. Your line is open.
Hi, good morning, and thanks for taking my question.
Tim Hauwermeiren: I'll now turn the call back to Tim. Thank you, Karen.
Ken just wanted to get a sense of how youre thinking about what the uptake SBA E P.
Tim Hauwermeiren: Slide 14. Semen, as we conclude, let's come back to where we are today and where we are going. We are leading from a position of strength, delivering on our commitment to bring transformative treatments to as many patients as possible. Through intentional launch strategies and relentless execution, we continue to reach new types of patients in new regions and make clear progress expanding into new indications. As innovators, we are looking forward and are incredibly excited about the opportunity ahead of us to lead what we believe to be one of the biggest drug classes ever.
Look like relative to the very steep uptake.
Uptake you had wind.
Ian Hana, so having with J&J just want to set expectations for that.
Yes.
Thank you for being with US today and thank you for your question on CRE piece of course, we are delighted with the start of the data with discrete generated.
To use trial and it is fair to say that the trial data put us in a position of strength.
I believe that up to pattern here with me in the room today to come in general on some initial thoughts when it comes to take off in the <unk>.
Mark as Claro, yes, Thank you Tim and thanks for the question, we're certainly excited and getting ready for.
Tim Hauwermeiren: Thank you for your continued support and support on this mission.
So the approval of <unk> and we're doing exactly that work up right now to really get a good sense based on the real data that we have and the strong data that we have.
Rob: I will now turn the call back to the operator. At this time, I would like to remind everyone in order to ask a question, press star, then the number one on your telephone keypad. We ask that you please limit yourself to one question and a follow-up and then rejoin the queue for further questions.
To break down the market into the segments of neurologists as well as patients.
To really understand how quickly might be uptake and how can we drive that to be as fast as possible from my perspective based on what we're seeing early on I wouldn't expect it to be as soft as Mg.
Yatin Suneja: Your first question comes from a line of yet in Senea from Guggenheim Partners. Your line is open. Hey, guys, thank you for taking my question. Question on the PV study. Could you maybe talk about what would you think you would like to show with regard to the Semen efficacy? And point and also, have you disclosed the poverty assumption? How should we think about placebo performing? Thank you so much.
As we've talked about before.
There is <unk> is approved.
I think we compete well versus IV AIG. However.
Theres some loyalty from the neurologists and from the patients in this progressive disease.
Tim Hauwermeiren: Good morning, Yatin. Thank you for joining us in the call today. The attempt to go study, which is on track for readouts before the end of the year, we'll actually give top-line data in line with how we typically show data. So, they will be sufficiently complete and transparent to understand the clinical utility of the medication. In this setting, it will center around, you know, the primary end point, where we will assess, you know, the delta between active and placebo on the primary end point of, you know, CR-min, where patients need to achieve CR on a minimum dose of corticosteroids, and that for at least eight weeks.
We're shifting to a new medicine.
It is something to be considered deeply so so we're working it up and wait.
Going to do everything that we can we will leverage all of our learnings from MGE will leverage all of the the work that we've done on Mg to maximize the uptake, but I don't think it will be as fast as we've seen in Mg.
Thank you Kevin and thank you for the question.
Your next question comes from the line of Derek <unk> from Wells Fargo. Your line is open.
Hey, good morning, and thanks for taking the question and congrats on the progress maybe question for Karen just in terms of some of the checks that we've done more recently with physicians and really starting to position <unk> earlier line, even as early as first line in Mg.
Tim Hauwermeiren: We will also disclose, you know, the key secondary end points, which have to do with steroid tapering and speed to disease control. And of course, importantly, safety. So, it will be comprehensive top-line data sets in line with how we have been showing top-line data in other indications before. We have not disclosed powering assumptions. We never do that, but you know by now that we relatively conserve different outcomes to powering the studies. Remember, this is the single biggest panthequist study ever with 222 patients involved. Thank you for the question.
That is something Thats consistent with your comments earlier in terms of what Youre seeing and again, how do you kind of navigate the payers if that is the case.
Yeah.
Yeah, absolutely. Thanks for the question and that is consistent with what we're seeing and with what our strategy is of where we think we can provide the most value which is we're seeing consistently moving since launch meeting earlier and earlier in the treatment paradigm.
As a as neurologists get more comfortable with we've got.
We're confident in the safety profile in particular.
Tuzina Mod: Your next question comes from a line of Tuzina Mod from Bank of America. Your line is open. Hi, good morning, and thanks for taking my question. Tim, I just want to get a sense of how you're thinking about what the uptake of CIDP could look like relative to the very steep uptake you had with with GMG and are still having with GMG. Just want to set expectations for that. Thanks. It is in. Thank you for being the rest of the day.
And they're really seeing the benefit to patients certainly from a payer perspective.
It relates to that part of your question, we're not seeing any challenges to date, we have broad access in the U S and obviously, we're securing pricing and reimbursement across Europe very successfully so the value of these got in Mg, including an early aligns us really being recognized.
And most of the policies policy, it's Eric actually stipulate that can be used.
Karen Massey: And thank you for your question on CIDP. Of course, we've delighted with the stellar data, which we generated in the at-year trial. And it is fair to say that the trial data put us in a position of strength. I believe it up to Karen here with me in the room today to comment on some initial thoughts when it comes to take off in the CIDP market Karen. Yeah, thank you, Tim. And thanks for the question.
Right after the MS Chen on for.
<unk> with steroids board, Mr. Amit steroids with one ISP.
That is actually a natural positioning to move upstream in the treatment paradigm. So this is a dynamic we had all hoped for which is happening, but it's happening and its own cadence is going to take time.
Thank you for the question.
Your next question comes from the line of Thomas Smith from Leerink Partners. Your line is open.
Karen Massey: We're certainly excited and getting ready for the approval of CIDP. And we're doing exactly that work up right now to really get a good sense based on the real data that we have and the strong data that we have. To break down the market into the segments of neurologists as well as patients to really understand how quickly might the update be and how can we drive that to be as fast as possible from my perspective, based on what we're seeing early on, I wouldn't expect it to be as fast as MG that you as we've talked about before.
Hey, guys. Good morning, Thanks for taking our questions and congrats on the progress in the quarter just on the timing for the bolus Pemphigoid go no go decision.
Can you comment on what's driving the accelerated timing there is that faster than expected enrollment or is there some triangulating.
This readout with the availability of the phase III pemphigus data or are there. Some other factors we speak considering there. Thanks.
Thanks for the question Thomas.
Spencer going to study is a seamless phase II phase III studies, where we did not have sufficient confidence from the pemphigus data to venture into this.
Karen Massey: There is IDIG is approved. I think we compete well versus IVIG, however. Obviously there's some loyalty from the neurologist and from the patients in this progressive disease where you know shifting to a new medicine is something to be considered deeply. So we're working it up and we're going to do everything that we can will leverage all of our learning from MG will leverage all of the work that we've done MG to maximize the uptake, but I don't think it will be as fast as we've seen in MG. Thank you, Karen.
Karen Massey: Thank you for the question.
The trial design.
40 patients go no go decision points, so 20 patients on active 2000 patients.
Placebo is actually.
On time.
And there'll be the gating event for US to then continue to scale this trial into the phase III.
Part of the of the study so very similar to CRE piece, So I'm very happy with the performance of the team again. This is a significant recruitment efforts and we are on track to show you the data as Glenn.
Thank you for the question.
Alaina Beara K. Killa: Your next question comes from Alaina. Beara K. Killa from Wells Fargo.
Your next question comes from the line of James Gordon from Jpmorgan. Your line is open.
Alaina Beara K. Killa: Your line is open. Hey, good morning and thanks for taking a question and congrats on the progress. We have a question for Karen just you know in terms of some of the checks that we've done more recently with physicians and you know really starting to physicians vivid our earlier line, even as early as first line and MG. Is that something that's consistent with your comments earlier in terms of what you're seeing and again, how do you kind of navigate the payers if that is the case?
Alaina Beara K. Killa: Thanks. Yeah, absolutely. Thanks for the question. And that is consistent with what we're seeing and with what our strategy is of where we think we can provide the most value, which is we're seeing consistently moving since launch, moving earlier and earlier in the treatment paradigm. As neurologists get more comfortable with VivGuard, more confident in the safety profile in particular and they're really seeing the benefit to patients. Certainly from a payer perspective related to that part of your question, we're not seeing any challenges to date.
Hello, James Gordon JP Morgan, Thanks for taking the question.
Two questions on PV and the address trop. Please.
First one is just the timing.
The trial design of clinical trials still covers have been completed the primary all I think it was August 22nd So just in terms of further steps needed before you can reveal the headline results.
What has been the cause of the slight delay announced today because it sounds like that we might not get the data at least the headline data until early 2024, so why the husband that slight delay.
Then the follow up question was just also on the same trial just to understand the specific differences with Rituxan in terms of how quickly the drug.
This efficacy come on.
Also it is a steroid tapering.
Do you think the fixed results from Rituxan, where there was about 30 percentage point placebo benefit is irrelevant comfort or is a small benefit that that still competitive how should we think about that please.
Jamie Thank you for being with US today and thank you for your Panther just questions certainly its an exciting indication and.
Alaina Beara K. Killa: We have broad access in the US and obviously we're securing pricing and reimbursement across Europe very successfully. So the value of VivGuard in MG, including in early aligns is really being recognized. And most of the policies pay policies that actually stipulate that VivGuard can be used either straight after Mestanon or Mestanon with steroids for Mestanon with steroids with one IST. So that is actually a natural positioning to move upstream in the treatment paradigm. So is the dynamic we had all hoped for and which is happening, but it's happening at its own cadence. We're going to take time. Thank you for the question.
A very ambitious trial design.
There is no delay in the <unk> study remember when the study is fully enrolled there is a substantial amount of time involved and follow up of the patients.
<unk> is assessing whether we can push patients into CRM and within a 30 weeks time periods and then actually the rollover into the open label extension study, where we continue to collect data, which will be important for top line data readouts.
In terms of comparing to the <unk> trial I would strongly advise against its I mean, these are molecules with totally different modes of action and therefore, the trial designs are totally different.
The ethics endpoint was taken at a totally different time point. It has its own particular steroid tapering a protocol in the background, we work with our switches specific.
Thomas Smith: Your next question comes from a line of Thomas Smith from Lerring Partners. Your line is open. Hey guys, good morning. Thanks for taking our questions and can graph on the progress in the quarter. Just on the timing for the ball is Pempagoy go-no-go decision. Can you comment on what's driving the accelerated timing there is that they answer the expected enrollment or is there some triangulating of this readout with the availability of a three Pempagot data? Are there some other backers we should be considering there? Thanks. Thanks for the question, Thomas.
I would not really compare the two.
It's a totally different.
Situation.
What we are looking forward for.
Such a stringent endpoint CRM in for at least eight weeks within a 30 weeks timeframe.
Unattainable for Rituximab by the way is a statistically meaningful separation between active and placebo that is basically the definition of the endpoint. The primary endpoint and then in the secondary endpoints, we will unpack the clinical utility of the drug in more detail by looking at the speed to disease control the amount of steroids tapering we can achieve.
Tim Hauwermeiren: The Bullies Pathcoid Study is a seamless phase two phase three study where we derive sufficient confidence from the Pemphagus data to venture into this trial design. The 40 patients going to go decision points for 20 patients on active 20 patients on placebo is actually on time and we'll be degrading event for us to then continue to scale this trial into the phase three part of the study. So very similar to CRDP. So I'm very happy with the performance of the team. Again, this is a significant recruitment efforts and we're on track to show you the data as planned. Thank you for the question.
We will also look at the times I guess, Felicia patients, which is a subset of the study.
And we're also going to look at it over the weekend actually push people into complete remission of therapy.
A portion of the open label extension study, so very exciting very bold endpoints, which could represent the game changing in the <unk> space.
Thanks for the question.
Your next question comes from the line of of cash to worry from Jefferies. Your line is open.
Hi, This is Amy answer cause thanks, so much for taking our question.
James Gordon: Your next question comes from a line of James Gordon from JP Morgan. Your line is open. Hello, James Gordon, JP Morgan. Thanks for taking the question. Two questions on PV in the address trial, please. The first one is just the timing. So the trial design of clinical trials covers haven't completed the primary on I think it was August 22nd. So just in terms of further steps needed before you can reveal the headline results.
One on PD.
That's invoiced severe patients in phase III impacts Yardmen. Additionally, do you need T cell job to have sustained remission or do you consider this as more of a bridge to rituxan. Thanks, so much.
Okay.
Thank you for these two excellent questions. So first of all we do not see any difference between moderato. Most of these patients and their ability to response to <unk> remember we have bolt on trial in phase two it stood at interface.
James Gordon: And what has been the cause of the slight delay announced today, because it sounds like now we might not get the data, at least the headline data to early 2024. So why there has been that slight delay.
Recruiting is somewhat more severe patient population, but we had them in phase two.
James Gordon: And then the follow up question was just also on the same trial, just understand the significant differences with retoxin in terms of how quickly the drug has his efficacy come on. And then maybe also it has a steroid tapering. So do you think the penfix results from retoxin, whether was about 30 percentage point placebo benefit is a relevant comfort or is a smaller benefit than that's still competitive? How should we think about that, please?
They have an equal right to respond equally fast and equally deep and equally beautiful.
Thanks, Scott as the milder patients so that if there is no real differentiation there.
In terms of positioning of the product.
You're correct in calling out that maybe we can go faster to steroid tapering, which is something which patients badly wants and needs. You cannot continue these patients on a high dose of steroids for too long periods of time and then of course, we have this beautiful publication, where we started to unravel the biology behind.
Tim Hauwermeiren: James, thank you for being with us today. And thank you for your panficus questions. Certainly an exciting indication and a very ambitious trial design. There is no delay in the panficus study. Remember, when the study is fully enrolled, there is a substantial amount of time involved and follow up of the patients. So we're assessing whether we can push patients into CR, men within a 30 week time period. And then actually they're all over into the old label extension study where we continue to collect data, which will be important for top line data readouts.
Durable clinical responses, which we have seen in phase II.
As we tried to set in the prepared notes.
Sharon is much more than just a receptor involved in RTG homeostasis. It is also involved in OTA antigen presentation and actually we see not only.
Sustained reduction in auto antibodies, but also a sustained reduction in oil directed T cells in our pemphigus patients, which basically means that Scott is disease modifying.
Tim Hauwermeiren: In terms of comparing to the panficus trial, I would strongly advise against it. I mean, these are molecules with totally different modes of action. And therefore the trial designs are totally different. The panficus endpoint was taken at a totally different time point. It has its own particular steroid tapering protocol in the background. We work with hours, which is specific. So I would not really compare the two. It's a totally different situation.
And has the ability to either postpone or replace completely rituximab.
Thank you for the question.
Your next question comes from the line of Danielle Brill from Raymond James Your line is open.
Hey, guys. Good morning. Thanks for the question I also had a question on PV sort of a follow up.
Tim Hauwermeiren: What we're looking for for such a strange and end point, you know, CR, men for at least eight weeks within a 30 weeks time frame. That's unattainable for it. And I, by the way, is a statistically meaningful separation between active and possible. That is basically the definition of the end point, the primary end point. And then in the secondary end point, we will unpack the clinical utility of the drug in more detail by looking at the speed to disease control, the amount of steroid tapering we can achieve.
To a prior question I'm curious.
And do you think will dictate <unk> rank in the treatment algorithm.
Typically and what do you think it needs to show the leapfrog Rituximab and then how should we think about potential read through to BP. Thank you.
Okay.
Yes. Thank you for the questions of course, we have to be careful here and wait for the phase III data because they will ultimately dictate whether we have a drug in this indication and how to position <unk> got evident the pemphigus treatment paradigm.
Tim Hauwermeiren: We will also look at the panficus fallacious patient, which is a step set of the study, and we're also going to look at where we can actually push people into complete remission of therapy as portion of the Oak Label Extension City. So, very exciting, very bold and points, which could represent the game changer in the pantherical space. Thanks for the question.
We did extensive work with the community both physicians and patients exited the entire global physician community is.
Surrounding this trial and of course, we have been doing extensive work with the patient advocacy group where patients battling it is.
He is a fast response, Dave wants to see.
Stopping the formation of lesions closing of lesions as fast as possible.
I also want to taper steroids as fast as they tend to hate steroids steroids for the fashion, So imagine beacon VP to phase II data in terms of quick onset of action remember 90% of patients in phase II went into disease control within the first two weeks time and then we can keep them.
Tim Hauwermeiren: Thank you for these two excellent questions. So, first of all, we do not see any difference between mother or more severe patients in their ability to respond to Vyvgart. Remember, we had both on trial in phase two. It's true that in phase two recruiting is somewhat more severe patient population, but we had in phase two, and they have an equal right to respond equally fast and equally deep and equally durable to Vyvgart as the milder patients. So, there's no real differentiation there.
In a very low disease activity state of complete remission.
Tapering steroids I think that will position just got very well for.
Our positioning in the perfect this treatment paradigm.
Let's not get ahead of ourselves and wait for these data. Thank.
Thank you.
Your next question comes from the line of Yaron Werber from TD Cowen Your line is open.
Great Thanks for including me and congrats on another great quarter.
A quick also question for me for the address study. So the study is including both nave and experienced patients and if you look again at the Rituxan studies, the placebo vary between 10% and 28% response rate.
Tim Hauwermeiren: In terms of, you know, positioning of the products, you're correct in calling out that maybe we can go faster to steroid tapering, which is something which patients badly want and need. You cannot continue these patients on a high dose of steroids for too long period of time.
A lot of the Kols are kind of talking about a 30% to 40% Delta.
Tim Hauwermeiren: And then, of course, we had this beautiful publication where we started to unravel the biology behind the durable clinical responses, which we have seen in phase two. As we tried to set in the prepared notes, FCRN is much more than just, you know, receptor involved in IGG homeostasis. It is also involved in auto-androgen presentation. And actually, we see not only sustained reduction in auto-antibodies, but also sustained reduction in auto-active p-cells in our pantherical space. So, there's no real difference between these patients, which basically means that God is disease-modifying and has the ability to either postpone or replace completely and reduce the amount.
That was easily achieved sort of if you look at your CR rates from the phase II sort of the seven out of 10 at the optimal dosing can you can you give us a sense sort of in this study the placebo is the 10% to 28% relevant at all or do you think it's going to be even lower just given the tightness of the of the endpoint.
Tim Hauwermeiren: Thank you for the question.
Are you expecting sort of 50 50 in terms of nave and experienced in the study. Thank you.
Thank you your own from them.
<unk> population point of view, we expect to renewables population that means that the majority of the patients of course will have been on therapy.
But maybe some naive patients in there as well I would caution against extrapolating from Rituximab trials in terms of endpoints, which are different duration of treatment which are different.
Danielle Burrell: Your next question comes from a line of Danielle Burrell from Raymond James. Your line is open. Hi guys, good morning. Thanks for the question. I also have a question on PV, sort of a follow-up to a prior question. I'm curious what endpoints you think will dictate Asgard's rank in the treatment algorithm? Specifically, what do you think it needs to show the leapfrog retoxinab? And then, how should we think about potential breakthrough to BP? Thank you. Thank you, Danielle, for the questions.
Background steroid tapering protocols, which are different and therefore placebo behavior in their trial cannot just be extrapolated into our trial. The way we design the primary endpoint as such similar to ITT by the way that we try to really minimize.
Any placebo response in the <unk> trials, so, let's not extrapolate, let's not assume similar placebo responses of delta between active and placebo. This is its own unique trial design and it would be very happy to see statistically significant delta.
Tim Hauwermeiren: Of course, we have to be careful here and wait for the CC data because they will ultimately dictate whether we have a drug in this indication. And how to position Asgard within the pantherical treatment paradigm. We did extensive work with the community, both physicians and patients. Actually, the entire global physician community is surrounding this trial. And of course, we have been doing extensive work with the patient advocacy group. What patients by the endpoints.
Merge between the placebo arm and the extra if it's a very aggressive endpoint.
Thank you for the question.
Your next question comes from the line of Myles Minter from William Blair. Your line is open.
Hi, Thanks for taking the question I think high <unk>.
Okay.
Previously actually announced data showing that they can get a 10000 auto injector in about a 32nd injection time.
Tim Hauwermeiren: Leet, is a fast response. They want to see stopping the formation of lesions, closing of lesions as fast as possible. They also want to tape a steroids as fast as they can. They hate steroids with a passion. So imagine we can repeat the phase two data in terms of, you know, quick onset of action. Remember 90% of patients in phase two went into disease control within the first two weeks time. And then we can keep them, you know, in a very low disease activity state or complete remission, whilst tapering the steroids. I think that will position and they've got very well for positioning in the pantheric steep and paradigm.
Tim Hauwermeiren: But let's not get ahead of ourselves and wait for these data.
Advancing our pre filled syringe version, if it got hot for a while and Thats in development you can update us next year.
Tim Hauwermeiren: Thank you.
That also potentially menu to introduce an auto injector solution based on that data. Thanks.
Okay.
Yes. Thank you for the question wasn't if anything it just shows you the power of the enhanced technology from Halos I'm.
And it underscores again, how important this technology is to win in the <unk> setting.
We are very happy to have the exclusive license to the technology, which positions us in a position of strength, we're the only product out there, which can deliver you know.
A single sub Q injection with this volume of product.
Yurun Werber: Your next question comes from a line of urine, Werber from TD Cowan. Your line is open. Great.
Auto injector of quarters into works as you know <unk> always planning for multiple steps ahead.
So we were really feeling a sense of urgency to launch the first generation <unk> product Asap because patients are waiting.
Yurun Werber: Thanks for including me and congrats on another great quarter. So a quick come also questions for me for the address study. So the study is including both naive and experienced patients. And if you look again at the retoxin studies, the placebo varied between 10% and the 28% response rate. I think a lot of the KOLs are kind of talking about a 30 to 40% Delta. That was easily achieved. So if you look at your CRA from the phase two, sort of the seven out of 10 at the optimal dosing, can you give us a sense sort of in this study, the placebo is the 10 to 28% relevant at all. Or do you think it's going to be even lower just given the tightness of the end point? And are you expecting sort of 50, 50 in terms of naive and experienced in this study?
Yurun Werber: Thank you.
You know that we are already working on the pre filled syringe and we have also been public on the fact that we are working on an auto injector that is a third generation. So the data from <unk>, our boarding very well and they underscore the power of the.
Hello, Sam technology.
In order to delight patients into <unk>, so stay tuned and more more news will come next year. Thank you.
Your next question comes from the line of Joel Beatty from Baird. Your line is open.
Hi, Thanks for taking the question for the post covenant paths in Q1, what would be a good data and good good data there'll be supportive of further development of <unk>.
Tim Hauwermeiren: Thank you, Yurun. From a patient population point of view, we expect to read well population. That means the majority of the patients, of course, will have been on therapy with maybe some naive patients in there as well.
They are studying.
Okay.
Yes. This is an excellent question. So this is one of the few indications where actually we need to go for signal finding first I think there's a strong hypothesis, which was delivered to us by the key opinion leaders and post Covid pulse <unk> mediated we need to establish a firm signal in what is a two phase II trials he didn't post COVID-19.
Tim Hauwermeiren: I would caution against extrapolating from retoxin map trials in terms of end points, which are different duration of treatment, which are different backgrounds, stereotyping protocols, which are different. And therefore placebo behavior in their trial can not just be extrapolated into our trial. So the way we designed the primary endpoint is such similar to ITP, by the way, that we try to really minimize any placebo response in the 30 week trial.
At box before then we can think about entering into the phase III trial. So we will be looking at the totality of data.
We will see conviction that this is truly address remediated. So we have some fundamental analysts attribute gave them before we can go into a phase III.
We believe that post COVID-19 thoughts based on the data we have seen is not different from regular parts.
Tim Hauwermeiren: So let's not extrapolate. Let's not assume similar placebo responses of Delta between active and placebo. This is its own unique trial design, and we would be very happy to see statistically significant Delta emerge between the placebo arm and the active. So it's a very aggressive endpoint.
But the experiment is ongoing and we will need to show the data now.
Thank you for the question.
Your next question comes from the line of Alex Thomson from Stifel. Your line is open.
Hey, Thanks for taking my question I guess I had a question for Carl how should we think about the net price per patient for Vanguard now in Europe now that we have the final German price how should we think about modeling that moving forward. Thanks.
Tim Hauwermeiren: Thank you for the question.
Myles Minter: Your next question comes from a line of miles, mentor, from William Blair. Your line is open. Hey, thank you for taking the question. I think I was on previously actually announced data showing that they can get a 10 mil auto injector in about a 30 second injection time. I know you're advancing a pre-filled syringe version of if got hot trillo, and that's in development, you can update us next year. But with that also potentially may need introducing auto and get to solution based on that.
Thank you Alex Yeah. As a reminder, we launched in September 22, and we got the final pricing August two ADC, we're very pleased with the outcome as it recognized with clinical benefit.
But of course resulted in the $6 million, which are reflected early on at the moment are bright.
And the business of course is largely Germany, and I do have to mention I've seen but in Germany orphan drugs are subject to a full analog process.
Myles Minter: I hope it was on data. Thanks. Thank you for the question, Martin. If anything, it just shows you the power of the enhanced technology from Helozine. And it underscores again how important this technology is to win in the sub queue setting. And we're very happy to have the exclusive lenses to the technology which positions us in a position of strength with the only product out there which can deliver you know a single sub queue injection with this volume of products.
And the new guys and renegotiations.
That avenue exceeds $30 million and we have now exceeded that threshold.
Basically what I'm, saying is that we will go back and renegotiate again.
So we expect that price to drop.
As you head into 2024.
<unk> said, we are pleased to have a strong commercial performance with the result of builders and we are pleased with our partnership with the German photo of this we look forward to continue discussions with it.
Myles Minter: And auto injector of course is in the works as you know, hygienics is always planning for multiple steps ahead. F, so we were really feeling a sense of urgency to launch this first-generation subcute product ASAP because patients are waiting. You know that we are already working on the pre-filled syringe, and we have also been public on the fact that we are working on an auto-injector as a third-generation. So the data from Hilozyme are boarding very well, and they underscored the power of the Hilozyme technology in order to delight patients in the subcute setting.
For planning purposes of course.
I think you have to assume that the European price will be lower than the U S price.
Thank you.
Your next question comes from the line of Allison <unk> from Piper Sandler Your line is open.
Hey, good morning, Thanks for taking my question and congrats on all the progress.
Just one for you on is on the early France with Dov go ahead, Hey trial.
Myles Minter: So stay tuned, and more news will come next year. Thank you.
It's early days in the launch, but just curious if you have any.
Alina Joel Beatty: Your next question comes from Alina, Joel Beatty from Beard. Your line is open. Hi, thanks for taking the question.
Just on the profile of early adopter to the sub Q format.
The initial uptake concentrated among neurologists, who are already have your prescribers of IV <unk>. I was just wondering are you seeing there and then I know you indicated that actual uptake is primarily and you've got 90 patient so far.
Tim Hauwermeiren: For the post-covered PAPS data in Q1, what would be good data, and could good data be supportive of further development of Vyvgart in other settings? Yeah, this is next on questions.
But just as high to low coverage policies are put into place kind of hoping you could walk us through what you would expect will be the major barriers preventing a patient from switching.
Tim Hauwermeiren: So this is one of the few indications where actually we need to go for signal finding first. I think there's a strong hypothesis, which was delivered to us by the key opinion leaders in post-covered PAPS that this is IGG mediated. We need to establish a firm signal in what is a true face-to-trial hidden post-covered PAPS before then we can think about venturing into the face-to-trial. So we will be looking at the totality of data. And we will see conviction that this is truly IGG mediated.
Just from IV the sub Q and then just second separately just a point of clarification I think you talked about.
$7 million.
Product sales team.
The lab was that that was commercial supply related I think that could you just confirm that.
How we should think about just modeling that.
This quarter and going forward. Thanks.
Thanks, Alison aggregate question to Tucano in the minutes to comment about the transfer of <unk> to sign up in China, but maybe Kevin you want to comment first on the hydro launch dynamics.
Tim Hauwermeiren: So we have some fundamental answers to be given before we can go into phase three. We believe that post-covered PAPS based on the data we have seen is not different from regular PAPS, but the experiment is ongoing and we need to show the data now. Thank you for the question.
<unk> patients phenotype speaking, yes, absolutely thanks for the question.
We're really excited about where we are with the hydro launch I would say we are getting positive feedback from word from urologists from patients and as you mentioned in your question payer policies are now going into place and then broadly reflect IV policies. So it's clear that the market is responding well.
Alex Thompson: Your next question comes from a line of Alex Thompson from Steve Ful. Your line is open. Hey, thanks for taking my question.
Karl Gubitz: I guess a question for Karl. How should we think about the net price per patient for Vyvgart now and in Europe now that we have the final German price? How should we think about modeling that moving forward? Thanks. Thank you, Alex.
To this innovation.
That is being brought forward.
Karl Gubitz: As a reminder, we launched in September 22 and we got the final price in August 23. We very pleased with the outcome as it recognized the clinical benefit. And by the course resulted in the $6 million through which I reflected early on. At the moment, our European business of course is largely Germany. And I do have to mention, I think, but in Germany, often drugs are subject to a full amount of process and renegotiations.
You mentioned and I will just reinforce the majority of patients that we're seeing of they've got naive patients. So this is expanding the pool of patients that are considering they've got and we are adding new prescribers with they've got high to low as well. So if you go back to what we've talked about is is very intentional and very consistent approach.
<unk> got <unk> got high to low.
<unk> focused on expanding quarter over quarter, the prescribers that have experience and confidence with they've got them they've got actual.
Karl Gubitz: If you are annual revenue exceeds very million dollars. And we have now exceeded that threshold. Basically, what I'm saying is that we will go back and renegotiate again. So we expect that price to drop in the year in 2024. That said, we are pleased with a strong commercial performance, which resulted in this. And we are pleased that our partners of the German for this look forward to continue discussions with him for planning purposes. Of course, I think Alex, you have to assume that the European price will be lower than the US price. Thank you.
<unk> the patients to go in early align.
And that's and that's certainly what we're seeing we're getting very positive feedback on <unk> of course, it's taken a little while for some of the logistics, let's call them that to be set up.
Some of the infusion sites.
<unk> infusions in place is standard procedure, they needed to get new protocols in place for doing an injection instead, but we've certainly seen that thats coming online now.
And those <unk> injection sites are seeing the value of they've got as well and then the last thing that I'll say is that not to forget that we do get self administration in the EU.
Sure.
Allison Bratzel: Your next question comes from a line of Alison Bratsel from Piper Sandler. Your line is open. Hey, good morning. Thanks for taking my question and congrats on all the progress. Just one for you on, on the early experience with Vyvgart Hey Trulow. I know it's early days in the launch, but just curious if you have any insight, just on the profile of early adopters of the sub-Q format, you know, is an initial uptake concentrated among neurologists who are already heavy prescribers of IV Vyvgart or just what are you seeing there.
In Japan.
With that with they've got high to low or in that case subcutaneous. We've got answer we're pleased with that as well.
Carl Christian too.
Allison Bratzel: And then I know you indicated that the Trulow uptake is primarily in Vyvgart and I use patients so far, but just as high Trulow coverage policies are put into place, kind of hoping you could walk us through what you would expect would be the major barriers preventing a patient from switching, just from IV to sub-Q.
I would like to thank you for the question so with $7 million, we've sold to China is design labs.
This is essentially stocking of our country.
Inventory analysis and design the warehouses.
By the same amount of the $7 million is both revenues and cost of sales. We only of course get our share of that in the royalties and about 700000 as I mentioned earlier, which is good news.
I think for planning purposes.
You have to exclude it.
And of course.
At zero profit.
Periodically we will of course have to supply the China market, but we will always be transparent on that.
Karen Massey: And then just second separately, just a point of clarification. I think you talked about a seven million in product sales to ZYLAB that was commercial supply-related. I think could you just confirm that and how we should think about just modeling that this quarter and going forward. Thanks. Thanks, Alison.
Excluding for planning purposes.
Thank you.
Your next question comes from the line of Vikram <unk> from Morgan Stanley. Your line is open.
Hi, good morning, Thanks for taking our questions. We had two regarding the potential impact of competition in Mg.
Karen Massey: I would give a question two to Karl in a minute to comment about, you know, the transfer of goods to ZYLAB in China, but maybe Karen, you want to comment first on the high Trulow launch dynamics and, you know, patient phenotypes we get on the road. Yeah, absolutely. Thanks for the question. We're really excited about where we are with the high Trulow launch. I would say we are getting positive feedback from neurologists, from patients and as you mentioned in your question, pay up policies are now going into place and they broadly reflect IV policies.
So first what sort of impact have you seen at this point if any on physician views towards this garden treatment options in <unk> more broadly in the past few months given approval of the competing therapy from UCB and how is the messaging regarding good guard potentially changing in response to competition.
Second given there are additional treatments in development for Mg we'd be curious to understand your perspective on how you think the market settles out over the coming years.
Factors, you think are going to drive patient.
Patient preferences prescriber preferences towards one treatment choice or presentation versus another as the number of moving parts in the marketplace potentially increases and in the next few years. Thanks.
Karen Massey: So it's clear that the market is responding well to this innovation that has been brought forward. You mentioned and I'll just reinforce the majority of patients that we're seeing are Vyvgart naive patients. So this is expanding the pool of patients that are considering Vyvgart and we are adding new prescribers with Vyvgart high[inaudible] them that to be set up. You know, some of the infusion sites, you know, getting infusions in place is standard procedure.
Thanks, Vikram I will hand over these two questions two kind of general yes. Thanks. Thanks for the question.
Look.
The way that I would think about this in a way that we talk about it is that the Mg market is still let's call. It quite immature and as you said, there's a lot of competition a lot of a lot of innovation coming to the market over the coming months and years I actually see that and we see that as a good thing.
Innovation is a great thing for patients.
And suddenly the real competition that we all face is inertia that that there is an assumption that patients are well controlled.
With these with these therapies from from decades ago.
And that's just not the case so from my perspective more innovation.
Addresses that inertia and really expands the market over time, we've talked before about it look maybe something similar to the EMS market. What you really see is an expansion in the treatment.
Karen Massey: They need to get new protocols in place for doing an injection instead. But we've certainly seen that that's coming online now. And those injection sites are seeing the value of Vyvgart as well. And then the last thing that I'll say is that not to forget that we did get self administration in the EU for and Japan. And with Vyvgart high Trulow or in that case subcontainants, we've got, so we're pleased with that as well.
The treatment rates, the diagnosis rates and an improved outcomes for patients.
Along with that.
So that's why we would see the direction of travel for the market and within that I think we are we've got is really well positioned.
We have a first in class.
We have the best molecule with the fragment technology it comes through in <unk>.
Karl Gubitz: Carl, question two. Yeah, I'd like to thank you for the question. So with 7 million we've sold to China is to Xilaps. Which is essentially stocking the country. This is inventory now sitting in the Xilap warehouses. But same amount, the 7 million is both in revenues and in course of sales. We only of course get our share of that in royal business, but the 700,000 I mentioned earlier, which is enough. I think for planning purposes, you have to exclude the revenue and the cost of sale in that zero profit. Periodically, you will of course have to supply the China market, but we will always be transparent on that. But I would exclude it for planning purposes please.
In the efficacy in clinical trials, but also in the real world efficacy that we're seeing.
Vikram Purohit: Thank you. Your next question comes from a line of Vikram Purohit from Morgan Stanley, your line is open. Thanks for taking your question.
Safety profile continues to hold up and continues to be strong and then obviously on the treatment burden.
Started with the with the infusion, but with <unk>, we've been able to able to decouple patients from the infusion chair and Tim just spoke earlier about the continued innovation that we're bringing as we think about PFS and auto inject up so as these markets expand.
I think they've got is incredibly well positioned and will be continue to be intentional and disciplined and we'll be investing for growth.
Thank you Ken.
Your next question comes from the line of Mannose Master acres from Deutsche Bank. Your line is open.
Thank you for taking my question. So just a quick follow up on the CDP and potential.
Launch in terms of sales force planning an expansion. If you can help us understand what are the new sales force will be.
Karen Massey: We have two regarding the potential impact of competition in MG. So first, what sort of impact have you seen at this point, if any, on physician views towards Vivgard and treatment options in MG more broadly in the past few months given approval of the competing therapy from UCB. And how is the messaging regarding Vivgard potentially changing and response to competition and the second given there are additional treatments in development for MG. We'd be curious to understand your perspective on how you think the market settles out over the coming years and which factors you think are going to drive patient preferences, prescribe preferences towards one treatment choice or presentation versus another as the number of moving parts in the marketplace potentially increases in the next few years.
Sorry, whether new Salesforce will be required with different types of expertise and what numbers are you looking to have deployed at least in the U S of course.
In other words, what will be the respective contribution of <unk> to be overall sales force.
And then secondly for indications such as bolus, pemphigoid, where potential competition could be much cheaper.
For example into <unk> on an ongoing basis could be a lot cheaper than what Mccarthy is how do you think about positioning and pricing.
I'm with there.
Yeah, that's it thank you.
Karen Massey: Thanks. Thanks Vikram. I will hand over these two questions to Karen. Thanks for the question. The way that I would think about this and the way that we talk about it is that the MG market is still, let's call it quite immature. And as you said, there's a lot of competition, a lot of innovation coming to the market over the coming months and years. I actually see that and we see that as a good thing.
Thank you for these two questions. So Kevin I suggest you take question one and then I will address DPP question. Please yes suddenly happy to so I'll I'll start where I left off on the last question, which is that we are investing for growth as we think about the opportunity in mg being larger than maybe what we had thought obviously the opportunity we see IDP on the.
<unk> strength of that data and then we'll see where we're ITB, which you included as well as PV come out.
Karen Massey: It's an innovation is a great thing for patients and certainly the real competition that we all face is inertia that there's an assumption that patients are well controlled with these therapies from decades ago. And that's just not the case. So from my perspective, more innovation addresses that inertia and really expands the market over time. We've talked before about it. Maybe something similar to the MS market where what you really see as an expansion in the treatment, the treatment rates, the diagnosis rates and an improved outcomes for patients along with that.
Without getting into details what I would say there is that we're working up we are working up the details at the moment, but the way to think about it is that we're investing.
We will leverage the <unk> field.
Field force and all of the capabilities and the infrastructure that we built for Mg and that we're thinking about investing for growth as we move forward and we'll be able to.
Sure more of the details of what exactly that looks like over the coming months, but the goal for us is to maximize the opportunity and the value creation.
They've got in the in the coming years.
Thank you Karen and then on the BP question look we're not in a different situation than we are in the other indications.
Karen Massey: So that's that's where we would see the direction of travel for the market. And within that, I think we, VivGuard is really well positioned. We have a first in class. I think we have the best molecule with the fragment technology. It comes through in the efficacy in clinical trials, but also in the real world efficacy that we're seeing. The safety profile continues to hold up and continues to be strong. And then obviously on the treatment burden, we started with the with the infusion, but with high trulla, we've been able to decouple patients from the infusion chair and Tim to spoke earlier about the continued innovation that we're bringing as we think about PFS and auto injector. So as these markets expand, I think VivGuard is incredibly well positioned and will we continue to be intentional and disciplined and will be investing for growth. Thank you, Karen.
It is true that as other medications.
Which come with a cheaper price.
<unk> is of course will tell you today offer. So we believe that we will expect with what is a very difficult disease to treat.
There's actually very little competition or competitive activity and development going on for the moment.
And just like them because this is an <unk> driven disease. This is <unk> mediated.
And therefore, we think that by hitting that the season, it's hard to we can have a dramatic impact in these patients.
And let's start with the clinical benefits, which we can demonstrate in these patients to then thereafter value.
Because it will all centered around the value we offer for these patients. So I think let's wait for the data if the data pan out in a similar direction is what we have seen earlier in pemphigus I think we're in a very strong position to really transform the lives of these patients and be able to expect according with all of you from that thank.
Manos Mastorakis: Your next question comes from a line out of Mano's Master Acres from Deutsche Bank. Your line is open. Thank you for taking my question. So, this quick follow up on the CIDP and potential ITP launch in terms of sales force planning and expansion.
Thank you for the question.
Okay.
Next question comes from the line of Douglas Tsao from H C. Wainwright Your line is open.
Karen Massey: If you can help us understand what the new sales force will be, sorry, whether new sales force will be required with different types of expertise and what numbers are you looking to have deployed, at least in the US, of course. In other words, what will be the respective contribution of MGITP, CIDP to the overall sales force?
Oh, good morning, sorry about that thanks for taking my questions.
I'm just curious in terms of the early launch of high to low or.
You've obviously mentioned that it's largely patients who are not switches new patients to therapy I'm. Just curious what was necessarily holding them back or was it just a matter of prescribers getting to these patients or four.
Tim Hauwermeiren: And then secondly, for indications, such as Bulless Pensacord, where potential competition could be much cheaper. For example, in the PICCENT, on an annual basis, could be a lot cheaper than what a CIDP and then we'll see where ITP, which you've included as well as PV, come out. Without getting into details, what I would say is that we're working up, we are working up the details at the moment, but the way to think about it is that we're investing, that we'll leverage the field force and all of the capabilities and the infrastructure that we've built for MG, and that we're thinking about investing for growth as we move forward, and we'll be able to share more of the details.
Some of these patients just not willing to go on to therapy with the IV.
Okay.
Yes. Thanks for the question. It's a good one look I don't think there was anything holding them back necessarily I think this is where we're early in the adoption curve still of they've got even seven quarters in and I think <unk> got high Trullo gave the opportunity.
For new prescribers that might not have considered we've got before suddenly we have a DTC campaign, highlighting hydrilla patients that.
Perhaps they they felt that niv was far more severe disease and they wanted.
To be on that would open up maybe some different patients, but overall I would say the trajectory of the launch is just based on as prescribers and patients get more experience with they've got they see the impact in terms of the quality of life.
I've mentioned, a few times the fact that the safety profile continues to hold up and now we have these two routes of administration I think what we'll see is just that continued momentum and consistency and expanding its been expanding with prescribers and patients.
Yeah.
Thanks for the question.
Tim Hauwermeiren: What exactly that looks like over the coming months, but the goal for us is to maximize the opportunity and the value creation from the gut in the coming years. Thank you, Karen, and then on the BP question, look, we're not in a different situation than we are in the other indications, whether this truth or other medications are there, which are committed at cheaper price. The question is, of course, what the value do they offer?
Your next question comes from the line of Joon Lee from <unk> Securities. Your line is open.
Alright, and congrats on the strong quarter and thanks for taking our questions.
I have missed this but are you still on track to start that trial by year end.
Just didn't seem too.
Might have missed out on the press release. Thank you.
Thank you for the question, yes. Its simple we are on track so.
Tim Hauwermeiren: So we believe that Boulouse-Penfigur is a very difficult disease to treat. There's actually very little competition or competitive activity in development going on for the moment. And just like PENfigur, this is an IGG driven disease. This is IGG mediated, and therefore we think that by hitting the disease in its heart, we can have a dramatic impact in these patients. And let's start with the clinical benefits, which we can demonstrate in these patients to then derive the value, because it will all center around the value we offer for these patients. So I think let's wait for the data.
Actually we are on track with all of the clinical milestones, which we had promised at the beginning at the beginning of the year. So very proud of the execution part of the team.
A ton of work in front of us, but these are all very exciting indications. So yes, we are on track and thank you for the question.
Yeah.
Your next question comes from the line of Suzanne Van versus Gen from VK OK. Your line is open.
Hi team. Thank you for taking my question and it's more of a long term using but I wanted to ask your thoughts on the more recent developments where car T players are moving and LT immunity.
Tim Hauwermeiren: But if the data pen out in a similar direction is what we have seen earlier in PENfigur, I think we're in a very strong position to really transform the lives of these patients and be able to expect a coding value from that.
They see to potentially cure lupus that some players are also moving into indications not too distant from our journey like.
Like my sinus. So could you please elaborate a bit on how you look at this development.
Douglas Hale: Thank you for the question. Your next question comes from a line of Douglas Hale from HC Wainwright. Your line is open.
Or your thoughts on the position of these potential future modality for some stiff card or if you have any other considerations that you think are relevant. Thank you.
Douglas Hale: Oh, I can want to apologize about that. PENfigur takes me questions. We're just curious in terms of the early launch of Haitula, for you've obviously mentioned that it's largely patients who have not switched new patients to therapy. I'm just curious, what was necessarily holding them back, or was it just a matter of prescribers getting to these patients, or for some of these patients that's not willing to go onto therapy with the ice?
Hi, Susan Thank you for being with US today on the call.
Yeah of course, we are watching all sorts of innovation coming into the autoimmune space I think it's an exciting time to be north immunity. These days with multiple modalities coming in we're looking at the car T technology of course to be fair and honest, we need a bit more data. So I think we have all seen that small set of <unk>.
Data in.
SLE patients, let's see how this car T data play out.
Douglas Hale: Yeah, thanks for the question. It's a good one. Look, I don't think there was anything holding them back necessarily. I think this is where early in the adoption curve, still of Vyvgart, even seven quarters in. And I think Vyvgart High Trulow gave the opportunity for new prescribers that might not have considered Vyvgart before. Certainly, we have the DCC campaign highlighting high trulow patients that for perhaps they felt that an IV was for a more severe disease, and they wanted to be on.
In the different indications and I think everyone will be focusing of course on you know what will be the durability of the clinical response, which we can expect with this type of technology. So it's very early days.
Douglas Hale: So it opened up maybe some different patients. But overall, I would say the trajectory of the launch is just based on as prescribers and patients get more experience with Vyvgart. They see the impact in terms of their quality of life. As I've mentioned a few times, the fact that the safety profile continues to hold up. And now we have these two routes of administration. I think what we'll see is just that continued momentum and consistency in expanding, expanding with prescribers and patients. Thanks for the question.
Wait for the data and of course, we are closely monitoring thats now our ambition in autoimmunity.
And explained earlier in the call is not to wait with expensive innovation until your last line patients, but to actually move with general affordable innovation.
Early in the treatment paradigms. So we can hit the disease heart early and hopefully a fortunate as very bad relapsed refractory patients.
Outside of that nothing works anymore. So that is our mission and auto immunity brings it innovation as early as we can in the treatment paradigm to hold further progression of disease and prevent patients from getting into the final station. Thank you for the question.
Your next question comes from the line of Samantha <unk> from Citi. Your line is open.
Hi, good morning, Thanks for taking the questions. Just a couple of follow up questions for me just from a timing perspective should we expect I guess and the boss <unk> data to be read out at the same time or is the guidance that they will be read out.
June Lee: Your next question comes from a line of June Lee from Truist Securities. Your line is open. I address on the strong quarter, and thanks for taking our questions.
June Lee: I have missed this. But, you know, are you still on track to start touch while by your end? Just to see I might have missed it on the press release.
Near each other around year end and then also for Panther guys. Yeah. When we look at the phase two data about 20% of the patients we think that machine.
Within about a 30 week timeframe, just recognizing that the upper Tim on dose and the dose schedule as well alright guessing what's different in phase two and it is in phase II, how should we think about that translating into the readout for the address that is that 20% of all where you expect the bar or would you expect it to be different than that thank you.
Tim Hauwermeiren: Thank you. Hi, June.
Tim Hauwermeiren: Thank you for the question. The answer is simple. We are on track.
Tim Hauwermeiren: So actually, we don't track with all of the clinical milestones, which we had promised at the beginning of the year. So very proud of the execution part of the team. We have a ton of work in front of us, but these are all very exciting indications. So yes, we don't track them.
Tim Hauwermeiren: Thank you for the question.
Thank you for both questions Amanda so from a timing point of view inorganic going to get any more than.
Suzanne Van Boerthusian: Your next question comes from a line of Suzanne Van Boerthusian from VLK. Your line is open. Hi, team. Thank you for taking my question. It's more of a long term using, but I wanted to ask your thoughts on the more recent development where our tea players are moving and out of the community. They seek to potentially cure lupus, but some players are also moving into indications not to distance from our genics, like my insiders.
What we have been disclosing publicly let the teams navigates the Christmas period.
Let them do a thorough data analysis and then we can come out of the gate with the data.
But there will be close together on extrapolating from Panther, just phase II to phase III remember that the objective of phase II was something totally different rights. This is the only indications will be studied monotherapy of safeguards then combination therapy at different doses and dosing regimens with low dose of steroids and therefore.
Suzanne Van Boerthusian: So could you please elaborate a bit on how you look at this development? What are your thoughts on the position of this potential future modality versus fifth card? Or if you have any other considerations that you think are relevant.
You cannot just look at them.
Numbers I think what we did in phase two is fine tune the dose the dosing regimen and the ideal combination with steroids to then take that ideal combination into phase III. So we did test drive the ideal combination with quite spectacular results, but it was relatively small.
Suzanne Van Boerthusian: Thank you.
Tim Hauwermeiren: Hi, Suzanne. Thank you for being with us today and on the call. Yeah, of course, we're watching all sorts of innovation coming into the autoimmune space. I think it's an exciting time to be in the immunity these days with multiple, you know, the modalities coming in. We're looking at the car key technology, of course, to be fair and honest, we need a bit more data. So I think we have all seen that small set of data in SLE patients.
Tim Hauwermeiren: Let's see, you know, how these car key data play out in the different indications. And I think everyone will be focusing, of course, on, you know, what will be the durability of the clinical response, which we can expect with this type of technologies, which very early days, let's wait for the data. And of course, we're closely monitoring that now our ambition in auto immunity. C, as Karen explained earlier in the call, is not too weight with expensive innovation until your last line patients, but to actually move with, you know, affordable innovation early in the treatment paradigms, so we can hit the disease hard early and hopefully avoid, you know, these very bad, we love to see factory patients, which are outfitted and have nothing works anymore.
Patient numbers.
And that's why now we did appropriate for FSP experiment. Thank.
Thank you for the questions.
Your next question comes from the line of John Sherman from Goldman Sachs. Your line is open.
Hi, Thanks for taking my question. So maybe just to follow on from the question on competition.
Could you just share your perspectives on early data from immune <unk> second generation at Cri antibody I realize it's still very early but it'd be helpful to get your thoughts on that and specifically I guess, how important you think an incremental IGT reduction is in driving clinical outcomes and then given the immune event have been.
Quite clear on which indications that targeting initially does that change your thinking on the additional indications you may target with they've got or indeed, how quickly you might see those.
Yes. Thank you for the question. So it's very difficult to comment on someone else's data, especially when that early phase one data I would invite you to study the phase one data of <unk>.
Tim Hauwermeiren: So that is our mission in the community, bring the innovation as early as we can in the community, and paradigm to hold further progression of disease and prevent patients from getting in that final station. Thank you for the question.
And the phase two dose finding data of its got to compare and contrast, our task is the leader in this space actually used to buying is to take what we think is a phenomenal of seven antagonist.
Samantha Semenkow: Your next question comes from a line of Samantha Semankhal from City, your line is open. Hi, good morning, thanks for taking the questions, just a couple of follow-up questions from me, just from a time-make perspective, should we expect both the pedagogists and the near-each other around year-end? And then also for Pumphagus, you know, when we look at the phase two data, about 20% of the patients, they seem to have achieved a CRMN endpoint within about the 30-week timeframe, just recognizing that the effort to do Mando's and the dose schedule as well as Sarah Jostin was different in the phase two than it is in phase three, you know, how should we think about that translating into the readout for the address study, is that 20% around where you expect the bar or would you expect it to be different with that?
Two areas of high unmet medical needs and actually continue to pioneer the understanding of the biology behind safeguard and Epsilon biology. So the only thing I would caution against in this call is to just extrapolate fifth got data to other molecules that Scott.
It is a distinctly different molecular design with distinctive different properties and I think we need to wait for phase III data before we can start to compare and contrast, so we will continue to focus on the pioneering role behalf and we are sharply focused on the patient needs. Thank you.
And we have time for one more question. Your final question comes from the line of Charles Pitman from Barclays. Your line is open.
Hi, guys. Thanks, very much for taking my question just quick.
On <unk> can you just clarify and kind of highlight what it is that you're specifically looking for on the go no go decision.
Samantha Semenkow: Thank you. Thank you for both questions, Samantha, so from a timing point of view, we're not going to get any more lines with them, what we have been disclosing publicly, let the teams navigate the Christmas period, let them do a thorough data analysis, and then we can come out of the gates with the data, but they will be close together on extrapolating from Pumphagus phase two to phase three, remember that the objective of phase two was something totally different on writes, this is the only indication where we studied monotherapy of M5GARC, then combination therapy at different doses and dosing regimens with low dose of steroids, and therefore you cannot just look at numbers, I think what we did in phase two is fine tune the dose, the dosing regimen and the ideal combination with steroids to then take that ideal combination into phase three, so we did test drive the ideal combination with quite spectacular results, but it was relatively small patient numbers, and that's why now we do the proper FISD experiment.
And to what degree at the expected readout of <unk> is expect just kind of help.
Help you in terms of trying to set up the kind of ongoing trial design post the go no go decision.
What degree is that.
So the adaptive to your impending learnings. Thank you.
Thank you for the question you are right in your assumption that the corner go decision point would still allow us to tweak certain aspects of the trial for example sample size to.
We're just filing.
It is a very demanding endpoint.
It's a different endpoint in pemphigus in tons, because the endpoint is CR on a minimum dose of steroids for at least eight weeks.
<unk> expenses or the endpoint is even tougher it is a complete response of.
Steroids. So to go no go decision point allows us to triangulate you know, whether you're ingoing assumptions for the trial design are correct or do we need some tweaking David also gave US an early visibility on the chief ability of course of this primary endpoint. So.
Tim Hauwermeiren: Thank you for the questions.
Alina Regent Sharmer: Sure, next question comes from Alina, Regent Sharmer from Goldman Sachs, your line is open.
Tim Hauwermeiren: Hi, thank you for taking my question, so maybe just to follow on from the question on competition, could you just share your perspectives on early data from immune events second generation FCRN, and to better realise it's still very early, but be helpful to get your thoughts on that, and specifically I guess how important you think an incremental IGG reduction is in driving clinical outcomes, and then given that immune events have been quite clear on which indications they're targeting initially, does that change your thinking on the additional indications you may target with FCRN, or indeed how quickly you may see those. Thank you for the question, so it's very difficult to comment on someone else's data, especially when that early phase one data.
That's the gist of the go no go decision point.
And thank you for your question.
Okay.
And ladies and gentlemen, this does conclude today's conference call. We thank you for your participation and you may now disconnect.
Yeah.
Okay.
Yeah.
Yeah.
Tim Hauwermeiren: I would invite you to study the phase one data of FCRN, and the FISD dose finding data of FCRN to compare and contrast. Our task as the leader in the space actually is to find it, to take, you know, what we think is a phenomenal S&N antagonist into areas of higher medical needs and actually continue to pioneer the understanding of the biology behind Vyvgart and S&N biology.
Tim Hauwermeiren: So the only thing I would caution against in this call is to just extrapolate Vyvgart data to other molecules. Vyvgart is a distinctly different molecular design with distinctly different properties. And I think we need to wait for phase two data before we can start the comparison. So we will continue to focus on the pioneering role we have and we shall be focused on the patient needs.
Charles Pitman: Thank you. And we have time for one more question. Your final question comes from a line of Charles Pittman from Barclays. Your line is open. Hi guys, thanks very much for taking my question. Just quickly on ballad, can you just clarify and kind of highlight what it is that you're specifically looking for on the go-no-go decision. And to what degree as the expected readout of Femke's progress is expected kind of help you in terms of trying to set up the kind of ongoing trial design post the go-no-go decision. To what degree is that design still adaptive to your intending and learnings.
Tim Hauwermeiren: Thank you. Thank you for the question. You're writing your assumption that the go-no-go decision point would still allow us to tweak certain aspects of the trial, for example sample size, to just powering. And this is a very demanding end point. It's a different end point than in Pemke's. In Pemke's the end point is CR on a minimum dose of steroids for at least eight weeks. In ballad, Pemke's or the end point is even tougher.
Tim Hauwermeiren: It is a complete postponement of steroids. So the go-no-go decision point allows us to triangulate, you know, where the in-going assumptions for the trial design correct or do we need some tweaking. They will also give us an early visibility on the achievability, of course, of this primary end point. So that's the gist of the go-no-go decision point.
Tim Hauwermeiren: And thank you for your question.
Rob: And ladies and gentlemen, this does conclude today's conference call. We thank you for your participation.
Rob: And you may now disconnect.